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The Transradial Approach to Percutaneous Coronary Intervention
Journal of the American College of Cardiology © 2010 by the American College of Cardiology Foundation Published by Elsevier Inc.
Vol. 55, No. 20, 2010 ISSN 0735-1097/$36.00 doi:10.1016/j.jacc.2010.01.039
STATE-OF-THE-ART PAPER
The Transradial Approach to Percutaneous Coronary Intervention Historical Perspective, Current Concepts, and Future Directions Sunil V. Rao, MD,* Mauricio G. Cohen, MD,† David E. Kandzari, MD,‡ Olivier F. Bertrand, MD, PHD,§ Ian C. Gilchrist, MD储 Durham, North Carolina; Miami, Florida; La Jolla, California; Quebec City, Quebec, Canada; and Hershey, Pennsylvania Periprocedural bleeding complications after percutaneous coronary intervention (PCI) are associated with increased short- and long-term morbidity and mortality. Although clinical trials have primarily assessed pharmacological strategies for reducing bleeding risk, there is a mounting body of evidence suggesting that adoption of a transradial rather than a transfemoral approach to PCI may permit greater reductions in bleeding risk than have been achieved with pharmacological strategies alone. However, despite a long history of use, a lack of widespread uptake by physicians coupled with the technological limitations of available devices has in the past confined transradial PCI to the status of a niche procedure, and many operators lack experience in this technique. In this review, we examine the history of the transradial approach to PCI and discuss some of the circumstances that have hitherto limited its appeal. We then review the current state of the peer-reviewed literature supporting its use and summarize the unresolved issues affecting broader application of this technique, including lack of operator familiarity and an insufficient evidence base for guiding practice. Finally, we describe potential directions for future investigation in the transradial realm. (J Am Coll Cardiol 2010;55:2187–95) © 2010 by the American College of Cardiology Foundation
Percutaneous coronary intervention (PCI) is an integral part of treatment for ischemic heart disease. Coupled with evidence-based pharmacological strategies, the use of PCI in appropriate patients reduces morbidity and mortality across the spectrum of risk (1). Continual evolution of antithrombotic therapy and device technology has resulted in the application of PCI to a wider population of patients (2). Procedural success rates are high and ischemic complications relatively rare (3); thus, attention has turned to periprocedural bleeding complications (4). Considerable
From *The Duke Clinical Research Institute, Durham, North Carolina; †University of Miami, Miami, Florida; ‡Scripps Clinic, La Jolla, California; §Quebec HeartLung Institute, Quebec City, Quebec, Canada; and the 储Penn State-Hershey Medical Center, Hershey, Pennsylvania. Dr. Rao reports receiving funding from Terumo Medical, Portola Pharmaceuticals, Momenta Pharmaceuticals, and Cordis Corporation; is a consultant for Terumo Medical; and consults and is on the Speakers’ Bureaus for The Medicines Company, Bristol-Myers Squibb, and Sanofi-Aventis. Dr. Cohen reports receiving an honorarium for speaking at an event sponsored by Terumo Medical. Dr. Kandzari is a consultant for Abbott Vascular, Medtronic, Cordis, and Terumo Medical; and receives research grant funding from Medtronic, Abbott Vascular, and Cordis. Dr. Bertrand is supported by Cordis, Bristol-Myers Squibb/ Sanofi-Aventis, and GE Healthcare. Dr. Gilchrist receives research contract support from AstraZeneca, Eisi Medical Research, Hoffman-LaRoche, Portola Pharmaceuticals, Boston Scientific, Angel Medical, Bristol-Myers Squibb, and Osiris Therapeutics Inc. Manuscript received October 11, 2009; revised manuscript received January 4, 2010, accepted January 5, 2010.
evidence suggests that post-PCI bleeding is associated with an adverse prognosis (5). Clinical trials evaluating new pharmacological strategies have focused on reducing this risk (6,7); however, absolute reductions in bleeding risk have been modest across most studies. A growing body of evidence suggests that a procedural strategy— using the transradial rather than the transfemoral approach for PCI—is associated with comparatively larger reductions in bleeding complications than those achieved with any anticoagulant strategy. In this review, we provide historical perspective on the transradial approach, examine current literature supporting its use, and summarize unresolved issues and areas for future investigation. Transradial PCI: Historical Perspective Although the transfemoral approach to cardiac catheterization has dominated the explosive growth of invasive cardiology in past decades, transradial access appeared early in the development of cardiac catheterization techniques. In 1948, Radner (8) published one of the first descriptions of transradial central arterial catheterization and attempts at coronary artery imaging using radial artery cut-down and 8- to 10-F catheters. Despite early enthusiasm for the transradial approach, limitations of
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contemporary equipment resulted in a shift to larger vessels such as the brachial, carotid, and femoral ACS ⴝ acute coronary systems for most catheter-based syndrome procedures, and the radial artery CI ⴝ confidence interval was relegated to use as a site for LOS ⴝ length of stay monitoring arterial pressure. OR ⴝ odds ratio In the late 1970s, percutanePCI ⴝ percutaneous ous coronary angioplasty was incoronary intervention troduced using predominantly 9-F guiding catheters (9). Building on reports of successful transradial angiography from Canada in 1989 (10), Kiemeneij and Laarman (11) first reported on the transradial approach for coronary stenting in 1993. Given observed reductions in periprocedural bleeding and reported improvements in patient comfort with this approach, a few enthusiastic early adopters emerged, but the transradial approach generally remained a niche technique. As experience with the transradial approach grew, the lack of severe access-site complications when compared with the transfemoral approach was repeatedly demonstrated in small observational studies. A “learning curve” for developing proficiency in transradial procedures was noted (12), cost-effectiveness was demonstrated (13,14), and small single-center or limited multicenter randomized comparisons to femoral (with or without vascular closure devices) and brachial approaches (15,16) showed the superiority of transradial procedures with respect to vascular access site complications, speed of post-procedural recovery, and patient preference. The safety of transradial PCI in patients therapeutically anticoagulated with warfarin (17) and the potential for same-day coronary revascularization were described (18). In addition, transradial techniques have been expanded to peripheral arterial interventions, including carotid (19), superficial femoral (20), mesenteric (21), and renal (21,22) arteries, as well as for pediatric percutaneous procedures (22). As we summarize below, the future adoption of transradial PCI in the U.S. and other countries with low penetration of transradial techniques will depend on the generation of high levels of evidence that confirm advantages seen in smaller observational and randomized studies, the availability of training programs, commitment from operators and professional societies, and comparative effectiveness data that demonstrate not only better clinical outcomes compared with the transfemoral approach, but also better economic outcomes, such as cost savings or costeffectiveness, and acceptable safety as it pertains to radiation dose and exposure. Abbreviations and Acronyms
Procedural and Clinical Outcomes After Transradial PCI When comparing the transradial with the traditional transfemoral route for PCI, the discussion must include comparisons of procedural success, fluoroscopy times, and bleeding/ vascular complications.
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Procedural success and procedure time. In a systematic overview of 12 randomized trials (n ⫽ 3,224) comparing radial and femoral approaches for diagnostic (7 studies) and interventional (5 studies) procedures, Agostoni et al. (23) reported significantly higher rates of procedural failure for transradial access (odds ratio [OR]: 3.30; 95% confidence interval [CI]: 1.63 to 6.71) . When compared with earlier studies included in the analysis, more contemporary trials demonstrate no differences in procedural failures between treatment strategies, likely reflecting advances in both technique and technologies, including vasodilator pharmacology and hydrophilic catheters. However, the composite outcome of death, myocardial infarction, emergency repeat revascularization, or stroke did not statistically vary between groups. Mann et al. (15) reported a single-center observational study comparing the transradial with the transfemoral approach in which the Perclose (Abbott Vascular, Santa Clara, California) femoral closure device was used. Procedural success, complications, post-procedural length of stay (LOS), and percentage of patients discharged the same day were similar across groups; however, total procedure time was significantly longer in the femoral group (57 ⫾ 22 min femoral vs. 44 ⫾ 22 min radial, p ⬍ 0.01) because of time needed to deploy the closure device. The largest observational study to compare procedural success rates between radial and femoral approaches used data from the National Cardiovascular Data Registry (593,094 procedures; 606 institutions) (24). Although radial approaches represented a modest proportion (1.32%) of case volume, risk-adjusted procedural success (defined as residual stenosis ⱕ50% and reduction in stenosis ⱖ20% with TIMI flow grade ⱖ2) did not differ between access methods (OR: 1.02; 95% CI: 0.92 to 1.12). In contrast, a more recent systematic overview (23 trials; ⬎7,000 patients) by Jolly et al. (25) found that the radial approach was associated with a trend toward a higher rate of inability to cross the lesion with a wire, balloon, or stent, compared with the femoral approach (Fig. 1). Although overall procedural time may be similar between methods, radial access has been associated with modest but statistically significant increases in fluoroscopic time. Among 420 patients undergoing diagnostic coronary angiography and percutaneous revascularization, procedural duration and fluoroscopic time were significantly longer for radial compared with femoral procedures, corresponding to significantly higher radiation exposure for operators and patients (26), although there was significant variability among operators. In the meta-analysis by Agostoni et al. (23), fluoroscopy time was significantly lower in the femoral cohort (7.8 min vs. 8.9 min, p ⬍ 0.001) . Similarly, in the National Cardiovascular Data Registry, radial PCI had longer fluoroscopy time (13.5 min vs. 11.3 min, p ⬍ 0.01), but there was no significant difference in total volume of contrast used (24). Many of these studies did not correct for potential improvements in procedure and
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Figure 1
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Association Between Vascular Access Site for PCI and Outcomes
Pooled analysis of 23 randomized trials (n ⫽ 7,020) comparing the association between radial versus femoral approaches for percutaneous coronary intervention (PCI) and procedure failure, access site crossover, death, the composite of death, stroke, or myocardial infarction (MI), and major bleeding. Adapted from Jolly et al. (25).
fluoroscopy times that may be realized with greater transradial experience. In general, it seems that increasing experience with the transradial approach is associated with decreased rates of procedure failure. In one observational study, an annual procedural volume ⬎80 transradial cases correlated with significant reductions in access failure, sheath insertion time, and overall procedural time (Fig. 2) (27). Similarly, other trials demonstrate an initial difference in procedural
Figure 2
Radial Volume and Outcomes
Relationship between operator volume of transradial percutaneous coronary intervention over a 15-month period and procedure duration (min, solid diamonds), procedure failure (%, open circles), and sheath insertion time (min, solid circles). Reprinted from Spaulding et al. (27).
time between radial and femoral cases that resolved by trial completion as operator experience improved (12,16,23,28). Jolly et al. (25) demonstrated that among operators who preferred the radial route, there was no significant difference in successful lesion crossing (adjusted OR: 1.18; 95% CI: 0.77 to 1.81; p ⫽ 0.44); among less experienced operators, there was a strong trend toward higher failure rates (adjusted OR: 3.47; 95% CI: 0.91 to 13.21; p ⫽ 0.07) (25). Bleeding and vascular outcomes. Bleeding complications after PCI are most commonly related to vascular access site (Figs. 3 and 4) and are associated with an increased risk of post-PCI morbidity and mortality (4,5,29,30). A consistent body of observational and small randomized studies supports an advantage of the transradial approach in reducing PCI-related hemorrhagic complications compared with the transfemoral approach (24,25). In the National Cardiovascular Data Registry, the radial approach was associated with a significant reduction in bleeding complications that was more pronounced in certain high-risk subgroups, such as women and patients with acute coronary syndromes (ACS) (24). These findings are consistent with those of other studies evaluating the safety of a radial approach regarding significantly reduced bleeding events, especially among ACS patients (31), those receiving more potent antithrombotic agents (32), and elderly patients (33). Jolly et al. (25) found that the transradial approach was associated with a 73% reduction in major bleeding compared with the transfemoral approach (Fig. 1). The radial approach may also afford advantages in patients with peripheral arterial disease and/or obesity, in whom the femoral artery may be difficult to access and compress manually due to body habitus. However, less experienced transradial operators should probably avoid these challenging patients until they gain more experience.
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Figure 3
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Site of Bleeding Complications in an Unselected Cohort of Patients Undergoing PCI
Overall rate of Thrombolysis In Myocardial Infarction (TIMI) major (maj) bleeding ⫽ 5.4%; overall rate of TIMI minor (min) bleeding ⫽ 12.7%. CVA ⫽ cerebrovascular accident (ischemic stroke); GI ⫽ gastrointestinal bleeding; RP ⫽ retroperitoneal hemorrhage. Adapted from Kinnaird et al. (30).
When vascular complications do occur after transradial PCI, they consist mainly of early and late radial artery occlusion (34). Rarely, instances of radial artery eversion or perforation (35), chronic regional pain syndrome (36), and forearm hematoma or compartment syndrome (37) have been described. There are no published reports of hand ischemia occurring after transradial PCI, which may be due to avoidance of the radial approach in patients with a positive Allen test result or reporting bias. Post-PCI radial artery occlusion may be reduced by using smaller diameter catheters and anticoagulation, and by avoiding prolonged high-pressure compression of the radial artery after arterial sheath removal. Two clinical trials have examined the role of “patent hemostasis,” or allowing antegrade flow in the radial artery during hemostatic compression at the occurrence of radial occlusion. In one study, compression was guided by mean arterial pressure (the pressure applied was equal to the mean arterial pressure) versus usual compression (38). The incidence of radial occlusion at 24 to 72 h was 1.1% in the mean arterial pressure– guided group and 12.0% in the usual care group (p ⫽ 0.0001). In the other trial, patients were randomized to either compression that allowed antegrade flow in the radial artery (Table 1) or usual care (39). Again, the incidence of radial occlusion at 24 h and 30 days was significantly reduced (24 h: 5.0% patent hemostasis group vs. 12.0% usual care, p ⬍ 0.05; 30 days: 1.8% vs. 7%, p ⬍ 0.05). Studies have also found an association between the reduction in bleeding events with transradial PCI and an improvement in clinical outcomes such as death and myo-
cardial infarction. In the PRESTO ACS (Comparison of Early Invasive and Conservative Treatment in Patients With Non–ST-Elevation Acute Coronary Syndromes) vascular substudy, for example, the radial approach was associated with a significant decrease in bleeding complications compared with the femoral approach during hospitalization (0.7% vs. 2.4%; p ⫽ 0.05), as well as a significant reduction in 1-year death or recurrent infarction (5.5% vs. 9.9%; p ⫽ 0.05) (31). Among procedural and clinical outcomes data collected for 38,872 PCI patients (radial approach, 20.5%) included in the British Columbia Cardiac Registry, radial access for PCI was associated with a significantly lower rate of post-procedural blood transfusion (1.4% vs. 2.8%, p ⬍ 0.01) and a significant decrease in 30-day (OR: 0.71; 95% CI: 0.61 to 0.82) and 1-year mortality compared with femoral access (40). In contrast, Jolly et al. (25) found no significant association between the radial approach and reduced 1-year mortality (Fig. 1). An important limitation of these data should be noted, however; most of these studies are either observational (and subject to confounding) or are from small randomized trials conducted at centers with operators proficient in the radial approach. The challenges of translating the potential advantages of the radial approach seen in these studies to the interventional community at large are discussed in the following. Transradial Approach and Economic Outcomes As noted previously, the most common complication in patients undergoing PCI via transfemoral access relates to
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Figure 4
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Sites of Bleeding in PCI Trials
Rates of overall and access-site related bleeding in a sample of percutaneous coronary intervention clinical trials (REPLACE-2 [Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events 2] and ESPRIT [European/Australasian Stroke Prevention in Reversible Ischaemia Trial]) (A); non–ST-segment elevation acute coronary syndrome trials (PARAGON [Platelet IIb/IIIa Antagonism for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network] A, PARAGON B, GUSTO [Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries] IIb non–ST-segment elevation cohort, PURSUIT [Platelet Glycoprotein IIb-IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy], and SYNERGY [Superior Yield of the New Strategy of Enoxaparin, Revascularization and GlYcoprotein IIb/IIIa inhibitors]) (B); and ST-segment elevation myocardial infarction clinical trials (GUSTO 1, GUSTO IIb ST-segment elevation cohort, GUSTO 3, HERO-2 [Hirulog Early Reperfusion Occlusion], ASSENT-2 [Assessment of the Safety of a New Thrombolytic]) (C). bld ⫽ bleed.
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for Post-Procedural Patent Hemostasis Hemostasis Technique Patent Technique Table 1 for Post-Procedural Hemostasis 1. Apply hemostasis device (e.g., HemoBand, RAD-Stat, TR-Band) to wrist 2. Place pulse oximeter on ipsilateral index finger or thumb 3. Tighten hemostasis device and remove sheath 4. Occlude ipsilateral ulnar artery 5. Loosen hemostasis device until plethysmographic signal returns or bleeding occurs If bleeding occurs, use manual compression If hemostasis is maintained in the presence of the plethysmographic signal, then leave hemostasis device in place for 2 h 6. Check for maintenance of plethysmographic signal every hour Adapted from Pancholy et al. (39).
the vascular access site. These complications are also associated with increased LOS and costs (24,41,42). Dedicated cost analyses comparing vascular access sites have consistently shown a significant reduction in hospital costs with transradial access. In a randomized study of patients undergoing diagnostic catheterization, Cooper et al. (14) showed that transradial access was associated with a median cost reduction of approximately $290/case driven by lower bed cost, including nursing utilization, and decreased pharmacy costs . A subsequent study comparing diagnostic catheterization via transradial versus transfemoral access with closure devices showed that, despite comparable recovery times, total costs were still significantly lower with transradial access (transradial $369.50 ⫾ $74.60 vs. transfemoral $446.90 ⫾ $60.20 vs. transfemoral with closure devices $553.40 ⫾ $81.00) (43). In a small randomized study of 142 patients undergoing PCI for ACS, post-procedural LOS was reduced by approximately 1.5 days and total hospital charges were decreased from $23,389 to $20,476 with transradial access (44). A study comparing stenting via transradial and transfemoral access with a suture closure device showed a comparable LOS with both strategies at the expense of higher cost and complication rates in the transfemoral group (15). There is also evidence that nursing workload can be significantly reduced when the transradial approach is systematically used. In one single-center study, the time spent to care for patients after PCI can be reduced from 174 min with transfemoral access to 86 min with transradial access. In addition, nursing time outside the catheterization laboratory on the medical ward was also reduced from 720 min with transfemoral access to 386 min with transradial access (45). We note, however, that these studies are small and conducted in limited numbers of centers where practice patterns may have influenced both costs and cost savings. Whether these advantages are widely applicable needs further study in larger multicenter randomized trials. Unresolved Issues and Future Directions The data summarized here illustrate several advantages of the transradial versus the transfemoral approach to PCI.
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Although these data strongly support use of the transradial approach as the default method for coronary intervention, it is also important to review several limitations of this technique and the data supporting it (Table 2). These limitations relate broadly to practical issues (training and experience of operators and catheterization laboratory staff), patient issues (previous coronary artery bypass grafting, challenging forearm and chest arterial anatomy), technical issues (e.g., limitation in the size of the guide catheter that can be used, potentially increased procedure times and radiation exposure), and gaps in evidence (lack of large multicenter randomized data on efficacy and safety). Importantly, changing practice from the transfemoral to the transradial approach will, in most cases, result in increased contrast use and radiation exposure to operator and patient early in the learning curve. Table 3 lists selected transradial procedural challenges and outlines strategies for addressing them. There is scant discussion of the transradial approach in current published training guidelines. Although there is a minimum number of diagnostic and interventional cases recommended for fellows undergoing interventional training, no minimum number of transradial cases is specified (notably, no minimum of femoral or brachial cases is specified either) (46). The obvious result is the continuous production of cardiovascular specialists without training or even exposure to transradial PCI during fellowship. Currently, there are no transradial training programs supported by the major cardiovascular professional societies; there are, however, a limited number of courses supported by industry. This lack of systematic training leads to the transradial PCI being viewed as a niche procedure, a fact underscored by data from large registries showing that the radial approach accounts only for 1.3% of all PCI procedures in the U.S. (24). This ultimately affects both the quality of care provided to the majority of PCI patients as well as the quality of studies examining the relative merits of transradial PCI (see the following text). of Transradial Advantages and Approach Disadvantages to PCI Advantages and Disadvantages Table 2 of Transradial Approach to PCI Advantages Reduced bleeding risk Reduced length of stay and costs Early ambulation Improved patient comfort Obviates discontinuation of oral anticoagulant therapy Same-day discharge possible Disadvantages Learning curve Not routinely taught in fellowship programs Limits guide catheter size Possible greater radiation exposure to operator* Long-term consequences to radial artery (e.g., for re-access or for use as bypass graft) unknown *May be a function of operator experience.
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and Strategies Selected Transradial to Overcome Challenges ThemChallenges Selected Transradial Table 3 and Strategies to Overcome Them Patient setup Prep wrist with patient’s arm at his or her side (radial artery parallel to femoral artery) Prep femoral artery simultaneously in case of crossover Use either a rectangular platform or 2 “banjo” arm boards underneath patient’s arm to create a working space distal to patient’s hand Place towels on working space to elevate working space to level of wrist For left radial cases, elevated left arm using pillows to bring left radial above left groin or have patient bring left arm across body after obtaining left radial artery access Radial artery access Small-caliber artery Inject subcutaneous nitroglycerin Check contralateral radial artery Spasm Intra-arterial nitroglycerin, calcium channel blockers Patient sedation Use smaller French size catheters Repeat access Check patency of artery (ultrasonography or reverse Allen test*); obtain access more proximally Traversing the radiobrachial region Radiobrachial angiogram for any resistance to advancing the wire or catheter Radial loop: use 0.014-inch hydrophilic wires to traverse and straighten loop Consider femoral access bailout if unable to traverse radial loop or if there is significant patient discomfort Traversing the chest arteries Have patient take a deep breath to straighten subclavian/innominate arteries and subclavian/innominate-aortic junction to direct catheter to ascending aorta For extreme z-curves, use hydrophilic 0.035-inch wires to direct catheters into ascending aorta Engaging the coronary arteries Judkins curves: use longer JR curve (e.g., JR5), shorter JL curve (e.g., JL3.5) Specialized curves (e.g., Kimny, Tiger, Jacky, Ikari, Amplatz) Previous CABG: use left wrist with JR4/JL4 catheters, multipurpose catheter, or specialized curves *For reverse Allen test, occlude both radial and ulnar arteries, then release radial artery to determine presence of antegrade flow. CABG ⫽ coronary artery bypass grafting.
A related issue is patient-specific factors that remain challenging in the transradial context. These include difficulties in accessing the radial artery, traversing the radial/ brachial/subclavian arterial anatomy, achieving adequate guiding catheter support, and performing transradial catheterization and PCI using the left radial artery in patients who have undergone previous coronary artery bypass grafting (47). All of these challenges can increase procedure time and radiation exposure to both operator and patient, but can be addressed with adequate operator experience (12). These limitations are offset by the advantages offered to patients (Table 2). Operator experience can be positively influenced through formal training programs and a commitment to transradial PCI in daily practice. Other technical limitations are being addressed through the evolution of radial equipment, such as sheathless 7.5-F guiding catheters that allow greater support and accommodate dual-stent techniques and
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larger devices, but which create arteriotomies that are smaller than 6-F sheaths (48). The compartmentalization of transradial PCI to a few centers or operators has also limited the quality of data supporting its use. Most of the studies reviewed in this article are retrospective and observational and therefore subject to significant selection bias. Even when randomized trials are performed, they are either single-center studies or include only a few centers with high concentrations of experienced radialists. The practice of PCI has evolved to include pharmacotherapy that reduces bleeding risk with the transfemoral approach (7) and very-low-profile coronary devices that substantially improve the odds of procedural success. In this context, unresolved issues related to transradial PCI in the modern era include the true incidence of radial artery occlusion and its clinical sequelae, re-access of the radial artery for repeat procedures, the durability of previously accessed radial arteries as conduits for coronary artery bypass grafting, the utility of the Allen test in preventing complications related to vascular compromise after transradial PCI, the true learning curve for transradial PCI including the rate of crossover to the transfemoral approach, the effect of the transradial approach on bleeding and “hard” clinical outcomes such as death or postprocedural stroke, the influence of transradial PCI on costs, the safety of same-day discharge after transradial PCI, and the advantages and disadvantages of the transradial approach for primary PCI for ST-segment elevation myocardial infarction. Although many of these topics have been addressed in previous studies, none have been the focus of recent studies that take into account modern pharmacotherapy, patent hemostasis for post-procedural radial artery compression, or the current attention on door-to-balloon times for primary PCI. Upcoming investigations capable of illuminating some of these important issues are summarized in Table 4. Another important contribution possible with wider application of transradial PCI is the study and potential application of higher doses of antithrombotics. Antithrombotic doses studied in phase 3 trials are often determined by examining complications that occur across a range of doses explored during phase 2 trials. The upper limit of dosing for anticoagulants and parenteral antiplatelet agents commonly used in PCI is determined by bleeding complications, many of which occur at the vascular access site. Figure 4 displays the overall bleeding rates and proportion of bleeding related to access site across a sampling of PCI, non–ST-segment elevation ACS, and ST-segment elevation myocardial infarction trials. The substantial reduction in access-site bleeding afforded by the transradial approach may allow higher doses to be carried forward into phase 3 trials and ultimately into clinical practice. For example, current guidelines for dosing of unfractionated heparin during PCI are based on data demonstrating an association between higher activated clotting times and increased bleeding events (49). However, some studies have
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Ongoing Evaluating Transradial Table 4Trials Ongoing Trialsthe Evaluating theApproach Transradial Approach ClinicalTrials.gov Identifier
Comparisons
Planned Sample Size, n
Outcomes
NCT01014273
Radial vs. femoral approach to PCI in UA, NSTEMI, STEMI
7,000
30-day death, MI, stroke, or major bleeding
NCT00815997
4- vs. 6-F guide catheter for transradial PCI
160
Radial artery patency 2 days post-procedure
NCT00329979
Radial vs. femoral diagnostic catheterization in severe aortic stenosis
152
Acute brain injury assessed by diffusionweighted brain MRI
NCT00597324
Transradial catheterization in patients with normal and abnormal Allen test results
180
30-day levels of capillary lactate in the thumb of instrumented hand
NCT00821106
Right radial vs. left radial approach for diagnostic and interventional procedures
NCT00638586
Radial vs. femoral access for PCI
1,500 160
Fluoroscopy time and patient radiation dose Post-procedure anxiety, pain, satisfaction
MI ⫽ myocardial infarction; MRI ⫽ magnetic resonance imaging; NSTEMI ⫽ non–ST-segment elevation myocardial infarction; PCI ⫽ percutaneous coronary intervention; STEMI ⫽ ST-segment elevation myocardial infarction; UA ⫽ unstable angina.
also demonstrated an association between higher heparin doses and reduced ischemic events (50). The transradial approach may allow a wider therapeutic index for anticoagulants such as unfractionated heparin—preserving ischemic reduction with higher doses while minimizing the penalty of increased bleeding.
2.
3.
Conclusions 4.
The evolution of PCI practice has led to an emphasis on minimizing post-procedural vascular and bleeding complications while maintaining procedural success. A growing body of literature supports the use of the radial artery over the femoral artery to achieve these goals, and data demonstrate an association between the transradial approach and reduced costs and post-procedural LOS. Despite these advantages, there are some limitations to this approach, such as the potential impact on radial artery patency and greater radiation exposure during the learning curve—a factor that has limited adoption of this technique. Greater penetration of the transradial approach will depend on the availability of educational programs for interventionalists and fellows-in-training, commitment from professional societies to support transradial PCI, and the generation of high-quality evidence to determine its comparative effectiveness against the traditional femoral approach. Systematic use of the transradial approach may also affect drug development by allowing higher (and potentially more efficacious) doses of anticoagulants to be studied in phase 3 trials and implemented in clinical practice. Reprint requests and correspondence: Dr. Sunil V. Rao, The Duke Clinical Research Institute, 508 Fulton Street (111A), Durham, North Carolina 27705. E-mail: [email protected].
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6. 7.
8. 9. 10. 11. 12. 13. 14. 15.
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Heart Association, and the American Society of Nuclear Cardiology. J Am Coll Cardiol 2009;53:530 –53. Batchelor WB, Anstrom KJ, Muhlbaier LH, et al. Contemporary outcome trends in the elderly undergoing percutaneous coronary interventions: results in 7,472 octogenarians. National Cardiovascular Network Collaboration. J Am Coll Cardiol 2000;36:723–30. Singh M, Rihal CS, Gersh BJ, et al. Twenty-five-year trends in in-hospital and long-term outcome after percutaneous coronary intervention: a single-institution experience. Circulation 2007;115: 2835– 41. Doyle BJ, Rihal CS, Gastineau DA, Holmes DR, Jr. Bleeding, blood transfusion, and increased mortality after percutaneous coronary intervention: implications for contemporary practice. J Am Coll Cardiol 2009;53:2019 –27. Rao SV, Eikelboom JA, Granger CB, Harrington RA, Califf RM, Bassand JP. Bleeding and blood transfusion issues in patients with non-ST-segment elevation acute coronary syndromes. Eur Heart J 2007;28:1193–204. Montalescot G, White HD, Gallo R, et al. Enoxaparin versus unfractionated heparin in elective percutaneous coronary intervention. N Engl J Med 2006;355:1006 –17. Lincoff AM, Bittl JA, Harrington RA, et al. Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial. JAMA 2003;289:853– 63. Radner S. Thoracal aortography by catheterization from the radial artery; preliminary report of a new technique. Acta Radiol 1948;29: 178 – 80. Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet 1978;1:263. Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn 1989;16:3–7. Kiemeneij F, Laarman GJ. Percutaneous transradial artery approach for coronary stent implantation. Cathet Cardiovasc Diagn 1993;30: 173– 8. Louvard Y, Lefevre T, Morice MC. Radial approach: what about the learning curve? Cathet Cardiovasc Diagn 1997;42:467– 8. Mann T, Cubeddu G, Bowen J, et al. Stenting in acute coronary syndromes: a comparison of radial versus femoral access sites. J Am Coll Cardiol 1998;32:572– 6. Cooper CJ, El-Shiekh RA, Cohen DJ, et al. Effect of transradial access on quality of life and cost of cardiac catheterization: a randomized comparison. Am Heart J 1999;138:430 – 6. Mann T, Cowper PA, Peterson ED, et al. Transradial coronary stenting: comparison with femoral access closed with an arterial suture device. Catheter Cardiovasc Interv 2000;49:150 – 6. Kiemeneij F, Laarman GJ, Odekerken D, Slagboom T, van der Wieken R. A randomized comparison of percutaneous transluminal coronary angioplasty by the radial, brachial and femoral approaches: the access study. J Am Coll Cardiol 1997;29:1269 –75. Hildick-Smith DJ, Walsh JT, Lowe MD, Petch MC. Coronary angiography in the fully anticoagulated patient: the transradial route is successful and safe. Catheter Cardiovasc Interv 2003;58:8 –10.
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JACC Vol. 55, No. 20, 2010 May 18, 2010:2187–95 18. Bertrand OF, De Larochelliere R, Rodes-Cabau J, et al. A randomized study comparing same-day home discharge and abciximab bolus only to overnight hospitalization and abciximab bolus and infusion after transradial coronary stent implantation. Circulation 2006;114: 2636 – 43. 19. Folmar J, Sachar R, Mann T. Transradial approach for carotid artery stenting: a feasibility study. Catheter Cardiovasc Interv 2007;69:355– 61. 20. Casserly IP. Trans-radial treatment of in-stent restenosis of the superficial femoral artery—the importance of case selection. Catheter Cardiovasc Interv 2009;74:499. 21. Raghu C, Louvard Y. Transradial approach for percutaneous transluminal angioplasty and stenting in the treatment of chronic mesenteric ischemia. Catheter Cardiovasc Interv 2004;61:450 – 4. 22. Davenport JJ, Lam L, Whalen-Glass R, et al. The successful use of alternative routes of vascular access for performing pediatric interventional cardiac catheterization. Catheter Cardiovasc Interv 2008;72: 392– 8. 23. Agostoni P, Biondi-Zoccai GG, de Benedictis ML, et al. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; Systematic overview and meta-analysis of randomized trials. J Am Coll Cardiol 2004;44:349 –56. 24. Rao SV, Ou FS, Wang TY, et al. Trends in the prevalence and outcomes of radial and femoral approaches to percutaneous coronary intervention: a report from the National Cardiovascular Data Registry. JACC Cardiovasc Interv 2008;1:379 – 86. 25. Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J 2009;157: 132– 40. 26. Brasselet C, Blanpain T, Tassan-Mangina S, et al. Comparison of operator radiation exposure with optimized radiation protection devices during coronary angiograms and ad hoc percutaneous coronary interventions by radial and femoral routes. Eur Heart J 2008;29:63–70. 27. Spaulding C, Lefevre T, Funck F, et al. Left radial approach for coronary angiography: results of a prospective study. Cathet Cardiovasc Diagn 1996;39:365–70. 28. Goldberg SL, Renslo R, Sinow R, French WJ. Learning curve in the use of the radial artery as vascular access in the performance of percutaneous transluminal coronary angioplasty. Cathet Cardiovasc Diagn 1998;44:147–52. 29. Kugelmass AD, Cohen DJ, Brown PP, Simon AW, Becker ER, Culler SD. Hospital resources consumed in treating complications associated with percutaneous coronary interventions. Am J Cardiol 2006;97:322–7. 30. Kinnaird TD, Stabile E, Mintz GS, et al. Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions. Am J Cardiol 2003;92:930 –5. 31. Sciahbasi A, Pristipino C, Ambrosio G, et al. Arterial access-siterelated outcomes of patients undergoing invasive coronary procedures for acute coronary syndromes (from the ComPaRison of Early Invasive and Conservative Treatment in Patients With Non-ST-ElevatiOn Acute Coronary Syndromes [PRESTO-ACS] Vascular Substudy). Am J Cardiol 2009;103:796 – 800. 32. Choussat R, Black A, Bossi I, Fajadet J, Marco J. Vascular complications and clinical outcome after coronary angioplasty with platelet IIb/IIIa receptor blockade. Comparison of transradial vs transfemoral arterial access. Eur Heart J 2000;21:662–7. 33. Achenbach S, Ropers D, Kallert L, et al. Transradial versus transfemoral approach for coronary angiography and intervention in patients above 75 years of age. Catheter Cardiovasc Interv 2008; 72:629 –35. 34. Stella PR, Kiemeneij F, Laarman GJ, Odekerken D, Slagboom T, van der Wieken R. Incidence and outcome of radial artery occlusion
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Key Words: acute coronary syndromes y percutaneous coronary intervention y review y transradial.
Vol. 55, No. 20, 2010 ISSN 0735-1097/$36.00 doi:10.1016/j.jacc.2010.01.039
STATE-OF-THE-ART PAPER
The Transradial Approach to Percutaneous Coronary Intervention Historical Perspective, Current Concepts, and Future Directions Sunil V. Rao, MD,* Mauricio G. Cohen, MD,† David E. Kandzari, MD,‡ Olivier F. Bertrand, MD, PHD,§ Ian C. Gilchrist, MD储 Durham, North Carolina; Miami, Florida; La Jolla, California; Quebec City, Quebec, Canada; and Hershey, Pennsylvania Periprocedural bleeding complications after percutaneous coronary intervention (PCI) are associated with increased short- and long-term morbidity and mortality. Although clinical trials have primarily assessed pharmacological strategies for reducing bleeding risk, there is a mounting body of evidence suggesting that adoption of a transradial rather than a transfemoral approach to PCI may permit greater reductions in bleeding risk than have been achieved with pharmacological strategies alone. However, despite a long history of use, a lack of widespread uptake by physicians coupled with the technological limitations of available devices has in the past confined transradial PCI to the status of a niche procedure, and many operators lack experience in this technique. In this review, we examine the history of the transradial approach to PCI and discuss some of the circumstances that have hitherto limited its appeal. We then review the current state of the peer-reviewed literature supporting its use and summarize the unresolved issues affecting broader application of this technique, including lack of operator familiarity and an insufficient evidence base for guiding practice. Finally, we describe potential directions for future investigation in the transradial realm. (J Am Coll Cardiol 2010;55:2187–95) © 2010 by the American College of Cardiology Foundation
Percutaneous coronary intervention (PCI) is an integral part of treatment for ischemic heart disease. Coupled with evidence-based pharmacological strategies, the use of PCI in appropriate patients reduces morbidity and mortality across the spectrum of risk (1). Continual evolution of antithrombotic therapy and device technology has resulted in the application of PCI to a wider population of patients (2). Procedural success rates are high and ischemic complications relatively rare (3); thus, attention has turned to periprocedural bleeding complications (4). Considerable
From *The Duke Clinical Research Institute, Durham, North Carolina; †University of Miami, Miami, Florida; ‡Scripps Clinic, La Jolla, California; §Quebec HeartLung Institute, Quebec City, Quebec, Canada; and the 储Penn State-Hershey Medical Center, Hershey, Pennsylvania. Dr. Rao reports receiving funding from Terumo Medical, Portola Pharmaceuticals, Momenta Pharmaceuticals, and Cordis Corporation; is a consultant for Terumo Medical; and consults and is on the Speakers’ Bureaus for The Medicines Company, Bristol-Myers Squibb, and Sanofi-Aventis. Dr. Cohen reports receiving an honorarium for speaking at an event sponsored by Terumo Medical. Dr. Kandzari is a consultant for Abbott Vascular, Medtronic, Cordis, and Terumo Medical; and receives research grant funding from Medtronic, Abbott Vascular, and Cordis. Dr. Bertrand is supported by Cordis, Bristol-Myers Squibb/ Sanofi-Aventis, and GE Healthcare. Dr. Gilchrist receives research contract support from AstraZeneca, Eisi Medical Research, Hoffman-LaRoche, Portola Pharmaceuticals, Boston Scientific, Angel Medical, Bristol-Myers Squibb, and Osiris Therapeutics Inc. Manuscript received October 11, 2009; revised manuscript received January 4, 2010, accepted January 5, 2010.
evidence suggests that post-PCI bleeding is associated with an adverse prognosis (5). Clinical trials evaluating new pharmacological strategies have focused on reducing this risk (6,7); however, absolute reductions in bleeding risk have been modest across most studies. A growing body of evidence suggests that a procedural strategy— using the transradial rather than the transfemoral approach for PCI—is associated with comparatively larger reductions in bleeding complications than those achieved with any anticoagulant strategy. In this review, we provide historical perspective on the transradial approach, examine current literature supporting its use, and summarize unresolved issues and areas for future investigation. Transradial PCI: Historical Perspective Although the transfemoral approach to cardiac catheterization has dominated the explosive growth of invasive cardiology in past decades, transradial access appeared early in the development of cardiac catheterization techniques. In 1948, Radner (8) published one of the first descriptions of transradial central arterial catheterization and attempts at coronary artery imaging using radial artery cut-down and 8- to 10-F catheters. Despite early enthusiasm for the transradial approach, limitations of
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contemporary equipment resulted in a shift to larger vessels such as the brachial, carotid, and femoral ACS ⴝ acute coronary systems for most catheter-based syndrome procedures, and the radial artery CI ⴝ confidence interval was relegated to use as a site for LOS ⴝ length of stay monitoring arterial pressure. OR ⴝ odds ratio In the late 1970s, percutanePCI ⴝ percutaneous ous coronary angioplasty was incoronary intervention troduced using predominantly 9-F guiding catheters (9). Building on reports of successful transradial angiography from Canada in 1989 (10), Kiemeneij and Laarman (11) first reported on the transradial approach for coronary stenting in 1993. Given observed reductions in periprocedural bleeding and reported improvements in patient comfort with this approach, a few enthusiastic early adopters emerged, but the transradial approach generally remained a niche technique. As experience with the transradial approach grew, the lack of severe access-site complications when compared with the transfemoral approach was repeatedly demonstrated in small observational studies. A “learning curve” for developing proficiency in transradial procedures was noted (12), cost-effectiveness was demonstrated (13,14), and small single-center or limited multicenter randomized comparisons to femoral (with or without vascular closure devices) and brachial approaches (15,16) showed the superiority of transradial procedures with respect to vascular access site complications, speed of post-procedural recovery, and patient preference. The safety of transradial PCI in patients therapeutically anticoagulated with warfarin (17) and the potential for same-day coronary revascularization were described (18). In addition, transradial techniques have been expanded to peripheral arterial interventions, including carotid (19), superficial femoral (20), mesenteric (21), and renal (21,22) arteries, as well as for pediatric percutaneous procedures (22). As we summarize below, the future adoption of transradial PCI in the U.S. and other countries with low penetration of transradial techniques will depend on the generation of high levels of evidence that confirm advantages seen in smaller observational and randomized studies, the availability of training programs, commitment from operators and professional societies, and comparative effectiveness data that demonstrate not only better clinical outcomes compared with the transfemoral approach, but also better economic outcomes, such as cost savings or costeffectiveness, and acceptable safety as it pertains to radiation dose and exposure. Abbreviations and Acronyms
Procedural and Clinical Outcomes After Transradial PCI When comparing the transradial with the traditional transfemoral route for PCI, the discussion must include comparisons of procedural success, fluoroscopy times, and bleeding/ vascular complications.
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Procedural success and procedure time. In a systematic overview of 12 randomized trials (n ⫽ 3,224) comparing radial and femoral approaches for diagnostic (7 studies) and interventional (5 studies) procedures, Agostoni et al. (23) reported significantly higher rates of procedural failure for transradial access (odds ratio [OR]: 3.30; 95% confidence interval [CI]: 1.63 to 6.71) . When compared with earlier studies included in the analysis, more contemporary trials demonstrate no differences in procedural failures between treatment strategies, likely reflecting advances in both technique and technologies, including vasodilator pharmacology and hydrophilic catheters. However, the composite outcome of death, myocardial infarction, emergency repeat revascularization, or stroke did not statistically vary between groups. Mann et al. (15) reported a single-center observational study comparing the transradial with the transfemoral approach in which the Perclose (Abbott Vascular, Santa Clara, California) femoral closure device was used. Procedural success, complications, post-procedural length of stay (LOS), and percentage of patients discharged the same day were similar across groups; however, total procedure time was significantly longer in the femoral group (57 ⫾ 22 min femoral vs. 44 ⫾ 22 min radial, p ⬍ 0.01) because of time needed to deploy the closure device. The largest observational study to compare procedural success rates between radial and femoral approaches used data from the National Cardiovascular Data Registry (593,094 procedures; 606 institutions) (24). Although radial approaches represented a modest proportion (1.32%) of case volume, risk-adjusted procedural success (defined as residual stenosis ⱕ50% and reduction in stenosis ⱖ20% with TIMI flow grade ⱖ2) did not differ between access methods (OR: 1.02; 95% CI: 0.92 to 1.12). In contrast, a more recent systematic overview (23 trials; ⬎7,000 patients) by Jolly et al. (25) found that the radial approach was associated with a trend toward a higher rate of inability to cross the lesion with a wire, balloon, or stent, compared with the femoral approach (Fig. 1). Although overall procedural time may be similar between methods, radial access has been associated with modest but statistically significant increases in fluoroscopic time. Among 420 patients undergoing diagnostic coronary angiography and percutaneous revascularization, procedural duration and fluoroscopic time were significantly longer for radial compared with femoral procedures, corresponding to significantly higher radiation exposure for operators and patients (26), although there was significant variability among operators. In the meta-analysis by Agostoni et al. (23), fluoroscopy time was significantly lower in the femoral cohort (7.8 min vs. 8.9 min, p ⬍ 0.001) . Similarly, in the National Cardiovascular Data Registry, radial PCI had longer fluoroscopy time (13.5 min vs. 11.3 min, p ⬍ 0.01), but there was no significant difference in total volume of contrast used (24). Many of these studies did not correct for potential improvements in procedure and
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Figure 1
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Association Between Vascular Access Site for PCI and Outcomes
Pooled analysis of 23 randomized trials (n ⫽ 7,020) comparing the association between radial versus femoral approaches for percutaneous coronary intervention (PCI) and procedure failure, access site crossover, death, the composite of death, stroke, or myocardial infarction (MI), and major bleeding. Adapted from Jolly et al. (25).
fluoroscopy times that may be realized with greater transradial experience. In general, it seems that increasing experience with the transradial approach is associated with decreased rates of procedure failure. In one observational study, an annual procedural volume ⬎80 transradial cases correlated with significant reductions in access failure, sheath insertion time, and overall procedural time (Fig. 2) (27). Similarly, other trials demonstrate an initial difference in procedural
Figure 2
Radial Volume and Outcomes
Relationship between operator volume of transradial percutaneous coronary intervention over a 15-month period and procedure duration (min, solid diamonds), procedure failure (%, open circles), and sheath insertion time (min, solid circles). Reprinted from Spaulding et al. (27).
time between radial and femoral cases that resolved by trial completion as operator experience improved (12,16,23,28). Jolly et al. (25) demonstrated that among operators who preferred the radial route, there was no significant difference in successful lesion crossing (adjusted OR: 1.18; 95% CI: 0.77 to 1.81; p ⫽ 0.44); among less experienced operators, there was a strong trend toward higher failure rates (adjusted OR: 3.47; 95% CI: 0.91 to 13.21; p ⫽ 0.07) (25). Bleeding and vascular outcomes. Bleeding complications after PCI are most commonly related to vascular access site (Figs. 3 and 4) and are associated with an increased risk of post-PCI morbidity and mortality (4,5,29,30). A consistent body of observational and small randomized studies supports an advantage of the transradial approach in reducing PCI-related hemorrhagic complications compared with the transfemoral approach (24,25). In the National Cardiovascular Data Registry, the radial approach was associated with a significant reduction in bleeding complications that was more pronounced in certain high-risk subgroups, such as women and patients with acute coronary syndromes (ACS) (24). These findings are consistent with those of other studies evaluating the safety of a radial approach regarding significantly reduced bleeding events, especially among ACS patients (31), those receiving more potent antithrombotic agents (32), and elderly patients (33). Jolly et al. (25) found that the transradial approach was associated with a 73% reduction in major bleeding compared with the transfemoral approach (Fig. 1). The radial approach may also afford advantages in patients with peripheral arterial disease and/or obesity, in whom the femoral artery may be difficult to access and compress manually due to body habitus. However, less experienced transradial operators should probably avoid these challenging patients until they gain more experience.
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Figure 3
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Site of Bleeding Complications in an Unselected Cohort of Patients Undergoing PCI
Overall rate of Thrombolysis In Myocardial Infarction (TIMI) major (maj) bleeding ⫽ 5.4%; overall rate of TIMI minor (min) bleeding ⫽ 12.7%. CVA ⫽ cerebrovascular accident (ischemic stroke); GI ⫽ gastrointestinal bleeding; RP ⫽ retroperitoneal hemorrhage. Adapted from Kinnaird et al. (30).
When vascular complications do occur after transradial PCI, they consist mainly of early and late radial artery occlusion (34). Rarely, instances of radial artery eversion or perforation (35), chronic regional pain syndrome (36), and forearm hematoma or compartment syndrome (37) have been described. There are no published reports of hand ischemia occurring after transradial PCI, which may be due to avoidance of the radial approach in patients with a positive Allen test result or reporting bias. Post-PCI radial artery occlusion may be reduced by using smaller diameter catheters and anticoagulation, and by avoiding prolonged high-pressure compression of the radial artery after arterial sheath removal. Two clinical trials have examined the role of “patent hemostasis,” or allowing antegrade flow in the radial artery during hemostatic compression at the occurrence of radial occlusion. In one study, compression was guided by mean arterial pressure (the pressure applied was equal to the mean arterial pressure) versus usual compression (38). The incidence of radial occlusion at 24 to 72 h was 1.1% in the mean arterial pressure– guided group and 12.0% in the usual care group (p ⫽ 0.0001). In the other trial, patients were randomized to either compression that allowed antegrade flow in the radial artery (Table 1) or usual care (39). Again, the incidence of radial occlusion at 24 h and 30 days was significantly reduced (24 h: 5.0% patent hemostasis group vs. 12.0% usual care, p ⬍ 0.05; 30 days: 1.8% vs. 7%, p ⬍ 0.05). Studies have also found an association between the reduction in bleeding events with transradial PCI and an improvement in clinical outcomes such as death and myo-
cardial infarction. In the PRESTO ACS (Comparison of Early Invasive and Conservative Treatment in Patients With Non–ST-Elevation Acute Coronary Syndromes) vascular substudy, for example, the radial approach was associated with a significant decrease in bleeding complications compared with the femoral approach during hospitalization (0.7% vs. 2.4%; p ⫽ 0.05), as well as a significant reduction in 1-year death or recurrent infarction (5.5% vs. 9.9%; p ⫽ 0.05) (31). Among procedural and clinical outcomes data collected for 38,872 PCI patients (radial approach, 20.5%) included in the British Columbia Cardiac Registry, radial access for PCI was associated with a significantly lower rate of post-procedural blood transfusion (1.4% vs. 2.8%, p ⬍ 0.01) and a significant decrease in 30-day (OR: 0.71; 95% CI: 0.61 to 0.82) and 1-year mortality compared with femoral access (40). In contrast, Jolly et al. (25) found no significant association between the radial approach and reduced 1-year mortality (Fig. 1). An important limitation of these data should be noted, however; most of these studies are either observational (and subject to confounding) or are from small randomized trials conducted at centers with operators proficient in the radial approach. The challenges of translating the potential advantages of the radial approach seen in these studies to the interventional community at large are discussed in the following. Transradial Approach and Economic Outcomes As noted previously, the most common complication in patients undergoing PCI via transfemoral access relates to
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Figure 4
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Sites of Bleeding in PCI Trials
Rates of overall and access-site related bleeding in a sample of percutaneous coronary intervention clinical trials (REPLACE-2 [Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events 2] and ESPRIT [European/Australasian Stroke Prevention in Reversible Ischaemia Trial]) (A); non–ST-segment elevation acute coronary syndrome trials (PARAGON [Platelet IIb/IIIa Antagonism for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network] A, PARAGON B, GUSTO [Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries] IIb non–ST-segment elevation cohort, PURSUIT [Platelet Glycoprotein IIb-IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy], and SYNERGY [Superior Yield of the New Strategy of Enoxaparin, Revascularization and GlYcoprotein IIb/IIIa inhibitors]) (B); and ST-segment elevation myocardial infarction clinical trials (GUSTO 1, GUSTO IIb ST-segment elevation cohort, GUSTO 3, HERO-2 [Hirulog Early Reperfusion Occlusion], ASSENT-2 [Assessment of the Safety of a New Thrombolytic]) (C). bld ⫽ bleed.
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for Post-Procedural Patent Hemostasis Hemostasis Technique Patent Technique Table 1 for Post-Procedural Hemostasis 1. Apply hemostasis device (e.g., HemoBand, RAD-Stat, TR-Band) to wrist 2. Place pulse oximeter on ipsilateral index finger or thumb 3. Tighten hemostasis device and remove sheath 4. Occlude ipsilateral ulnar artery 5. Loosen hemostasis device until plethysmographic signal returns or bleeding occurs If bleeding occurs, use manual compression If hemostasis is maintained in the presence of the plethysmographic signal, then leave hemostasis device in place for 2 h 6. Check for maintenance of plethysmographic signal every hour Adapted from Pancholy et al. (39).
the vascular access site. These complications are also associated with increased LOS and costs (24,41,42). Dedicated cost analyses comparing vascular access sites have consistently shown a significant reduction in hospital costs with transradial access. In a randomized study of patients undergoing diagnostic catheterization, Cooper et al. (14) showed that transradial access was associated with a median cost reduction of approximately $290/case driven by lower bed cost, including nursing utilization, and decreased pharmacy costs . A subsequent study comparing diagnostic catheterization via transradial versus transfemoral access with closure devices showed that, despite comparable recovery times, total costs were still significantly lower with transradial access (transradial $369.50 ⫾ $74.60 vs. transfemoral $446.90 ⫾ $60.20 vs. transfemoral with closure devices $553.40 ⫾ $81.00) (43). In a small randomized study of 142 patients undergoing PCI for ACS, post-procedural LOS was reduced by approximately 1.5 days and total hospital charges were decreased from $23,389 to $20,476 with transradial access (44). A study comparing stenting via transradial and transfemoral access with a suture closure device showed a comparable LOS with both strategies at the expense of higher cost and complication rates in the transfemoral group (15). There is also evidence that nursing workload can be significantly reduced when the transradial approach is systematically used. In one single-center study, the time spent to care for patients after PCI can be reduced from 174 min with transfemoral access to 86 min with transradial access. In addition, nursing time outside the catheterization laboratory on the medical ward was also reduced from 720 min with transfemoral access to 386 min with transradial access (45). We note, however, that these studies are small and conducted in limited numbers of centers where practice patterns may have influenced both costs and cost savings. Whether these advantages are widely applicable needs further study in larger multicenter randomized trials. Unresolved Issues and Future Directions The data summarized here illustrate several advantages of the transradial versus the transfemoral approach to PCI.
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Although these data strongly support use of the transradial approach as the default method for coronary intervention, it is also important to review several limitations of this technique and the data supporting it (Table 2). These limitations relate broadly to practical issues (training and experience of operators and catheterization laboratory staff), patient issues (previous coronary artery bypass grafting, challenging forearm and chest arterial anatomy), technical issues (e.g., limitation in the size of the guide catheter that can be used, potentially increased procedure times and radiation exposure), and gaps in evidence (lack of large multicenter randomized data on efficacy and safety). Importantly, changing practice from the transfemoral to the transradial approach will, in most cases, result in increased contrast use and radiation exposure to operator and patient early in the learning curve. Table 3 lists selected transradial procedural challenges and outlines strategies for addressing them. There is scant discussion of the transradial approach in current published training guidelines. Although there is a minimum number of diagnostic and interventional cases recommended for fellows undergoing interventional training, no minimum number of transradial cases is specified (notably, no minimum of femoral or brachial cases is specified either) (46). The obvious result is the continuous production of cardiovascular specialists without training or even exposure to transradial PCI during fellowship. Currently, there are no transradial training programs supported by the major cardiovascular professional societies; there are, however, a limited number of courses supported by industry. This lack of systematic training leads to the transradial PCI being viewed as a niche procedure, a fact underscored by data from large registries showing that the radial approach accounts only for 1.3% of all PCI procedures in the U.S. (24). This ultimately affects both the quality of care provided to the majority of PCI patients as well as the quality of studies examining the relative merits of transradial PCI (see the following text). of Transradial Advantages and Approach Disadvantages to PCI Advantages and Disadvantages Table 2 of Transradial Approach to PCI Advantages Reduced bleeding risk Reduced length of stay and costs Early ambulation Improved patient comfort Obviates discontinuation of oral anticoagulant therapy Same-day discharge possible Disadvantages Learning curve Not routinely taught in fellowship programs Limits guide catheter size Possible greater radiation exposure to operator* Long-term consequences to radial artery (e.g., for re-access or for use as bypass graft) unknown *May be a function of operator experience.
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and Strategies Selected Transradial to Overcome Challenges ThemChallenges Selected Transradial Table 3 and Strategies to Overcome Them Patient setup Prep wrist with patient’s arm at his or her side (radial artery parallel to femoral artery) Prep femoral artery simultaneously in case of crossover Use either a rectangular platform or 2 “banjo” arm boards underneath patient’s arm to create a working space distal to patient’s hand Place towels on working space to elevate working space to level of wrist For left radial cases, elevated left arm using pillows to bring left radial above left groin or have patient bring left arm across body after obtaining left radial artery access Radial artery access Small-caliber artery Inject subcutaneous nitroglycerin Check contralateral radial artery Spasm Intra-arterial nitroglycerin, calcium channel blockers Patient sedation Use smaller French size catheters Repeat access Check patency of artery (ultrasonography or reverse Allen test*); obtain access more proximally Traversing the radiobrachial region Radiobrachial angiogram for any resistance to advancing the wire or catheter Radial loop: use 0.014-inch hydrophilic wires to traverse and straighten loop Consider femoral access bailout if unable to traverse radial loop or if there is significant patient discomfort Traversing the chest arteries Have patient take a deep breath to straighten subclavian/innominate arteries and subclavian/innominate-aortic junction to direct catheter to ascending aorta For extreme z-curves, use hydrophilic 0.035-inch wires to direct catheters into ascending aorta Engaging the coronary arteries Judkins curves: use longer JR curve (e.g., JR5), shorter JL curve (e.g., JL3.5) Specialized curves (e.g., Kimny, Tiger, Jacky, Ikari, Amplatz) Previous CABG: use left wrist with JR4/JL4 catheters, multipurpose catheter, or specialized curves *For reverse Allen test, occlude both radial and ulnar arteries, then release radial artery to determine presence of antegrade flow. CABG ⫽ coronary artery bypass grafting.
A related issue is patient-specific factors that remain challenging in the transradial context. These include difficulties in accessing the radial artery, traversing the radial/ brachial/subclavian arterial anatomy, achieving adequate guiding catheter support, and performing transradial catheterization and PCI using the left radial artery in patients who have undergone previous coronary artery bypass grafting (47). All of these challenges can increase procedure time and radiation exposure to both operator and patient, but can be addressed with adequate operator experience (12). These limitations are offset by the advantages offered to patients (Table 2). Operator experience can be positively influenced through formal training programs and a commitment to transradial PCI in daily practice. Other technical limitations are being addressed through the evolution of radial equipment, such as sheathless 7.5-F guiding catheters that allow greater support and accommodate dual-stent techniques and
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larger devices, but which create arteriotomies that are smaller than 6-F sheaths (48). The compartmentalization of transradial PCI to a few centers or operators has also limited the quality of data supporting its use. Most of the studies reviewed in this article are retrospective and observational and therefore subject to significant selection bias. Even when randomized trials are performed, they are either single-center studies or include only a few centers with high concentrations of experienced radialists. The practice of PCI has evolved to include pharmacotherapy that reduces bleeding risk with the transfemoral approach (7) and very-low-profile coronary devices that substantially improve the odds of procedural success. In this context, unresolved issues related to transradial PCI in the modern era include the true incidence of radial artery occlusion and its clinical sequelae, re-access of the radial artery for repeat procedures, the durability of previously accessed radial arteries as conduits for coronary artery bypass grafting, the utility of the Allen test in preventing complications related to vascular compromise after transradial PCI, the true learning curve for transradial PCI including the rate of crossover to the transfemoral approach, the effect of the transradial approach on bleeding and “hard” clinical outcomes such as death or postprocedural stroke, the influence of transradial PCI on costs, the safety of same-day discharge after transradial PCI, and the advantages and disadvantages of the transradial approach for primary PCI for ST-segment elevation myocardial infarction. Although many of these topics have been addressed in previous studies, none have been the focus of recent studies that take into account modern pharmacotherapy, patent hemostasis for post-procedural radial artery compression, or the current attention on door-to-balloon times for primary PCI. Upcoming investigations capable of illuminating some of these important issues are summarized in Table 4. Another important contribution possible with wider application of transradial PCI is the study and potential application of higher doses of antithrombotics. Antithrombotic doses studied in phase 3 trials are often determined by examining complications that occur across a range of doses explored during phase 2 trials. The upper limit of dosing for anticoagulants and parenteral antiplatelet agents commonly used in PCI is determined by bleeding complications, many of which occur at the vascular access site. Figure 4 displays the overall bleeding rates and proportion of bleeding related to access site across a sampling of PCI, non–ST-segment elevation ACS, and ST-segment elevation myocardial infarction trials. The substantial reduction in access-site bleeding afforded by the transradial approach may allow higher doses to be carried forward into phase 3 trials and ultimately into clinical practice. For example, current guidelines for dosing of unfractionated heparin during PCI are based on data demonstrating an association between higher activated clotting times and increased bleeding events (49). However, some studies have
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Ongoing Evaluating Transradial Table 4Trials Ongoing Trialsthe Evaluating theApproach Transradial Approach ClinicalTrials.gov Identifier
Comparisons
Planned Sample Size, n
Outcomes
NCT01014273
Radial vs. femoral approach to PCI in UA, NSTEMI, STEMI
7,000
30-day death, MI, stroke, or major bleeding
NCT00815997
4- vs. 6-F guide catheter for transradial PCI
160
Radial artery patency 2 days post-procedure
NCT00329979
Radial vs. femoral diagnostic catheterization in severe aortic stenosis
152
Acute brain injury assessed by diffusionweighted brain MRI
NCT00597324
Transradial catheterization in patients with normal and abnormal Allen test results
180
30-day levels of capillary lactate in the thumb of instrumented hand
NCT00821106
Right radial vs. left radial approach for diagnostic and interventional procedures
NCT00638586
Radial vs. femoral access for PCI
1,500 160
Fluoroscopy time and patient radiation dose Post-procedure anxiety, pain, satisfaction
MI ⫽ myocardial infarction; MRI ⫽ magnetic resonance imaging; NSTEMI ⫽ non–ST-segment elevation myocardial infarction; PCI ⫽ percutaneous coronary intervention; STEMI ⫽ ST-segment elevation myocardial infarction; UA ⫽ unstable angina.
also demonstrated an association between higher heparin doses and reduced ischemic events (50). The transradial approach may allow a wider therapeutic index for anticoagulants such as unfractionated heparin—preserving ischemic reduction with higher doses while minimizing the penalty of increased bleeding.
2.
3.
Conclusions 4.
The evolution of PCI practice has led to an emphasis on minimizing post-procedural vascular and bleeding complications while maintaining procedural success. A growing body of literature supports the use of the radial artery over the femoral artery to achieve these goals, and data demonstrate an association between the transradial approach and reduced costs and post-procedural LOS. Despite these advantages, there are some limitations to this approach, such as the potential impact on radial artery patency and greater radiation exposure during the learning curve—a factor that has limited adoption of this technique. Greater penetration of the transradial approach will depend on the availability of educational programs for interventionalists and fellows-in-training, commitment from professional societies to support transradial PCI, and the generation of high-quality evidence to determine its comparative effectiveness against the traditional femoral approach. Systematic use of the transradial approach may also affect drug development by allowing higher (and potentially more efficacious) doses of anticoagulants to be studied in phase 3 trials and implemented in clinical practice. Reprint requests and correspondence: Dr. Sunil V. Rao, The Duke Clinical Research Institute, 508 Fulton Street (111A), Durham, North Carolina 27705. E-mail: [email protected].
5.
6. 7.
8. 9. 10. 11. 12. 13. 14. 15.
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Key Words: acute coronary syndromes y percutaneous coronary intervention y review y transradial.