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Is percutaneous coronary intervention of unprotected left main coronary artery via transradial approach feasible for skilled transfemoral operators? Initial experience in an unselected population
Cardiovascular Revascularization Medicine 14 (2013) 193–196
Contents lists available at SciVerse ScienceDirect
Cardiovascular Revascularization Medicine
Clinical
Is percutaneous coronary intervention of unprotected left main coronary artery via transradial approach feasible for skilled transfemoral operators? Initial experience in an unselected population☆,☆☆ Francesco Tomassini ⁎, Andrea Gagnor, Nicolò Montali, Alfonso Gambino, Mario Bollati, Vincenzo Infantino, Emanuele Tizzani, Ferdinando Varbella Department of Cardiology, Infermi Hospital, Rivoli, Italy
a r t i c l e
i n f o
Article history: Received 8 January 2013 Received in revised form 18 April 2013 Accepted 19 April 2013
a b s t r a c t Background: The feasibility and efficacy of percutaneous coronary intervention (PCI) of unprotected left main coronary artery (ULMCA) via transradial access (TRA) is still a matter of concern, mainly in an unselected population. Methods: We collected data about all PCI performed in patients with ULMCA stenosis by a TRA-dedicated operator and analyzed clinical and procedural characteristics as well as in-hospital and long-term outcomes. Results: From January 2008 to December 2011, 49 PCIs were performed; 27 (55%) via TRA and 22 (45%) via transfemoral access (TFA). Most patients in both groups underwent PCI for acute coronary syndrome (66.7% in the TRA group vs 77.3% in the TFA group, p = 0.73). Patients in the TRA group were more hypertensive (81.5% vs 40.9%, p = 0.008) and had a higher left ventricular ejection fraction (54.6 ± 10.3 vs 46.1 ± 12.8, p = 0.01). There were no significant differences in procedural success (100% in the TRA group vs 90.9% in the TFA group, p = 0.38), as well as in procedural time, in fluoroscopic time and in contrast volume. Bleeding complications occurred in 1 patient in the TFA group (4.5%) vs none in the TRA group (p = 0.91). In-hospital major adverse cardiac events (MACE) occurred in 1 patient (3.7%) in the TRA group vs 3 (13.6%) in the TFA group (p = 0.48). At a follow-up of 32 ± 13 months, MACE occurred in 4 cases (14.8%) in the TRA group vs 7 cases (31.8%) in the TFA group (p = 0.28). Conclusions: The PCI of ULMCA via TRA is feasible with good results, provided that a rigorous learning curve was followed and a TRA volume caseload was maintained. © 2013 Elsevier Inc. All rights reserved.
1. Introduction
2. Methods
Transradial access (TRA) has become an interesting approach for percutaneous coronary intervention (PCI), mainly because of reduced rates of bleeding complications compared to the transfemoral approach (TFA) [1–5]. However, although most coronary lesions can now be successfully treated via the TRA, PCI for unprotected left main coronary artery (ULMCA) disease is usually performed via transfemoral access (TFA) using 7 or 8 French (Fr) guiding catheters because of the high rate of distal bifurcation lesion and the large diameter of the vessel [6,7]. In this retrospective study we evaluated in an unselected population undergoing PCI for ULMCA stenosis the feasibility and the efficacy of TRA compared to TFA, in terms of success of procedure and in-hospital and long-term outcomes.
2.1. Study population and procedural details
☆ ☆☆ ⁎ Italy.
Funding: none. Conflicts of interest: none. Corresponding author. Ospedale degli Infermi, Strada Rivalta, 29, 10098 Rivoli, Tel.: +39 011 9551421; fax: +39 011 9551421. E-mail address: [email protected] (F. Tomassini).
1553-8389/$ – see front matter © 2013 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.carrev.2013.04.007
We reviewed the data of patients undergoing PCI for significant ULMCA stenosis from January 2008 and December 2011 at our hospital. Our catheterization laboratory is a high-volume PCI center (N800 PCI and N150 primary PCI per year) with 3 skilled operators, one of whom is dedicated to TRA procedures. The operator using TRA had similar experience with TFA procedures and no experience with TRA at the onset of the study but, at the end of it, its activity in PCI via TRA rose up to 81% (Fig. 1). In order to avoid confounding factors, only the procedures performed by this operator dedicated to TRA were considered. PCI was chosen as a therapeutic option in case of clinical and/or hemodynamic instability or when cardiac surgery was considered at high risk because of the presence of either old age or severe comorbidities. All patients were categorized into the TRA group (n = 27) or the TFA group (n = 22). Demographic, clinical and procedural data were prospectively collected in a dedicated database (Cardioplanet V.3.0.8, Ebit Aet S.p.A., Genoa, Italy) and, after the coronary angiography, the complexity of the coronary disease was
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F. Tomassini et al. / Cardiovascular Revascularization Medicine 14 (2013) 193–196
2.3. Patient follow-up In-hospital events were derived from clinical records. An angiographic control was scheduled between 6 and 12 months if not contraindicated. Clinical follow-up was performed by ambulatory clinical visits or telephone calls. In case of events, clinical records were checked when available or detailed history was acquired from patients or (in case of death) from patients’ relatives or physicians. 2.4. Statistical analysis
Fig. 1. Number of percutaneous coronary interventions (PCI) via transradial (TRA) and transfemoral approach (TFA) performed by the TRA-dedicated operator across the study period.
Data are reported as means (with standard deviations) or proportions. Continuous variables were compared by t test, whereas categorical variables were compared by chi-square test. A p value b 0.05 was always required for statistical significance. Analyses were performed using the statistical software SAS System, Version 9.1 (SAS Institute Inc., Cary, NC). 3. Results
classified using the SYNTAX Score calculation [8]. The study protocol was reviewed and approved by the Ethics Committee of our Institution (ASL 103, Piemonte Region, Italy). The vascular access method and the PCI technique were performed according to the operator’s discretion. Intra-aortic balloon pump (IABP) was used as much as possible, also in stable patients. Intravascular ultrasounds (IVUS) were used, if possible, to achieve optimal stent expansion and lesion coverage. At the end of the procedure the radial hemostasis was accomplished by compressing folded gauze wrapped by an elastic bandage, whereas closure devices (Angioseal, St Jude Medical, St. Paul, Minnesota; Perclose or Star Close, Abbott Vascular, Santa Clara, California) were used for femoral hemostasis if the access site was suitable. All patients were routinely treated with aspirin (325 mg upon arrival, and then 100 mg daily), clopidogrel (loading dose of 300 or 600 mg, and then 75 mg daily) and with an intravenous bolus of unfractionated heparin (100 U/kg body weight, or 60 U/kg body weight if also glycoprotein IIb-IIIa inhibitors were given). Heparin therapy was stopped after the procedure, but, in case of IABP use, it was continued until its removal. Abciximab and eptifibatide were the glycoprotein IIb-IIIa inhibitors used. Bivalirudin was not used in these patients. Beta-adrenergic blockers, ACE inhibitors and statins were used as in-hospital standard therapy, if not contraindicated.
2.2. Study end point The end point of the study was the feasibility of the TRA procedure without need of access crossover, defined as failure to successfully complete the procedure by the TRA, and its efficacy, defined as achievement of final residual stenosis of b30% and of Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 [9]. We assessed also the rate of the in-hospital and long-term major adverse cardiac events (MACE) including death; myocardial infarction (MI), defined as of typical chest pain with new ECG abnormalities and elevation of creatine kinase to twice the basal level; stroke, defined as defined as any focal and nonconvulsive neurological deficit lasting more than 24 hours; target vessel revascularization (TVR), defined as repeated PCI or CABG due to restenosis or progression of the disease in the treated vessels; major bleeding complications, defined according to the Bleeding Academic Research Consortium classification [10]; stent thrombosis (ST), defined as definite and probable according to the Academic Research Consortium classification [11] and contrastinduced nephropathy (CIN) defined as absolute increase in serum creatinine of 0.5 mg/dL (44 μmol/L), or a relative 25% increase from the baseline value, assessed 48–72 hours following intravascular administration of the contrast medium [12].
From January 2008 to December 2011, 172 patients with significant stenosis of ULMCA underwent PCI at our center. Of these, 49 (28.5%) were performed by the TRA-dedicated operator and form the population of the study. 3.1. Clinical and procedural characteristics The clinical characteristics of the two groups are summarized in Table 1, whereas their angiographic and procedural characteristics are shown in Table 2. There was a total of 27 interventions (55%) in the TRA group and 22 interventions (45%) in the TFA group. In the TRA group 25 interventions (92.6%) were performed from right TRA and 2 (7.4%) from the left TRA. In the TRA group there was a crossover to the TFA in 3 patients (11.1%): in 2 of them it occurred after the coronary angiography because the operator was at the beginning of his learning curve and preferred the TFA to perform the PCI, whereas in the other patient the crossover was necessary because of the extreme tortuosity of a calcified brachiocephalic artery that did not let the catheters to get to the coronary vessels. There were no crossovers in the TFA group (p = 0.31). In the TRA group patients were more likely to be hypertensive (81.5% vs 40.9%, p = 0.008) and to present with a higher LVEF (54.6 ± 10.3 vs 46.1 ± 12.8, p = 0.01). In both groups the majority of the patients presented with an acute coronary syndrome (66.7% in the TRA group vs 77.3% in the TFA group, p =
Table 1 Baseline clinical characteristics.
Number of patients Age Males History of CAD Diabetes Current smokers Renal failure⁎ Hypertension LVEF (%) Clinical presentation Acute coronary syndrome Stable ischemia STEMI Cardiogenic shock
All patients
TRA
TFA
49 70 ± 9 36 (73.5) 7 (14.3) 18 (36.7) 16 (32.6) 2 (4.1) 31 (63.3) 51 ± 12
27 (55) 68 ± 9 18 (66.7) 5 (18.5) 11 (40.7) 10 (37) 1 (3.7) 22 (81.5) 54 ± 10
22 (45) 72 ± 9 18 (81.8) 2 (9.1) 7 (31.8) 6 (27.3) 1 (4.5) 9 (40.9) 46 ± 13
35 (71.4) 14 (28.6) 14 (28.6) 8 (16.3)
18 (66.7) 9 (33.3) 7 (25.9) 2 (7.4)
17 (77.3) 5 (22.7) 7 (31.8) 6 (27.2)
Data are n (%) or mean ± SD unless otherwise stated. CAD = coronary artery disease. LVEF = left ventricular ejection fraction. STEMI = ST-segment elevation myocardial infarction. * Renal failure defined as baseline creatinine ≥2.5 mg/deciliter.
p Value 0.11 0.38 0.59 0.72 0.67 0.56 0.008 0.01 0.73
0.14
F. Tomassini et al. / Cardiovascular Revascularization Medicine 14 (2013) 193–196 Table 2 Angiographic findings and procedural details.
Bifurcation involved SYNTAX Score Successful procedure⁎ Contrast volume (ml) Time of procedure (min) Fluoroscopic time (min) Guiding catheter N 6 Fr¶ IVUS IABP Glycoprotein IIb-IIIa inhibitors Drug-eluting stent Stent per patient Bifurcation treatment With 2 stents Minicrush Culotte V Stenting TAP
195
Table 3 In-hospital and long-term outcomes.⁎
All patients
TRA
TFA
p Value
45 (91.8) 23.2 ± 9.5 47 (95.9) 256 ± 95 89 ± 40 21 ± 12 16 (32.6) 26 (53.1) 46 (93.9) 15 (30.6) 48 (97.9) 2.1 ± 1.2
25 (92.6) 21.8 ± 10.4 27 (100) 260 ± 96 93 ± 37 22 ± 12 3/24 (12.5) 16 (59.2) 24 (88.9) 9 (33.3) 27 (100) 2.1 ± 1.3
20 (90.1) 24.8 ± 8 20 (90.9) 252 ± 96 84 ± 42 20 ± 11 13 (59.1) 10 (45.4) 22 (100) 6 (27.3) 21 (95.4) 2.1 ± 1.1
0.74 0.27 0.38 0.77 0.42 0.64 0.003 0.49 0.31 0.88 0.91 1 0.97
22/45 (48.8) 9 (20) 2 (4.4) 1 (2.2) 1 (2.2)
10/25 (40) 6 (24) 2 (8) 1 (4) 1 (4)
7/20 (35) 3 (15) 2 (10) 1 (5) 1 (5)
Data are n (%) or mean ± SD unless otherwise stated. IVUS = intravascular ultra sound. IABP = intraaortic balloon pump. TAP = T and protrusion. * Successful procedure was defined as a residual stenosis of treated vessels b30% associated with a Thrombolysis In Myocardial Infarction (TIMI) 3 grade flow. ¶ In the TRA Group 3 procedures were performed via TFA.
0.73) and the rate of the patients with ST-segment elevation myocardial infarction (STEMI) was 25.9% in the TRA group and 31.8% in the TFA group (p = 0.89). Eight patients (16.3%) presented with cardiogenic shock: 2 patients in TRA (7.4%) and 6 patients (27.2%) in the TFA group (p = 0.14). The left main bifurcation was involved in most cases in both groups (92.6% in the TRA group vs 90.1% in the TFA group, p = 0.74) and the SYNTAX Score was not significantly different between the two groups (21.8 ± 10.4 in the TRA group vs 24.8 ± 8 in the TFA group, p = 0.27). Guiding catheters larger than 6 Fr were used in the majority of the patients in the TFA group (13 out of 22, 59.1%), whereas in the TRA group only 3 out of 24 patients (12.5%, p = 0.003) were treated with guiding catheter sheathless 7.5 Fr (Asahi Intecc, Japan). Yet, the rate of the bifurcation managed with 2 stents did not significantly differ between the two groups (40% in the TRA group vs 35% in the TFA group, p = 0.97) and the final kissing balloon was performed in all cases. The use of IVUS and hemodynamic support was similar between the 2 groups as well as the procedural time, the fluoroscopic time and the contrast volume. 3.2. Clinical and angiographic outcomes The success of the procedure was similar between the 2 groups (100% in the TRA group and 90.9% in the TFA group, p = 0.38). During the hospitalization no significant differences were observed in the rates of MACE (Table 3). There was 1 bleeding complication in the TFA group vs none in the TRA group (p = 0.91) and 1 CIN in both groups. Clinical follow-up was complete for all patients over a average of 32 ± 13 months. The angiographic follow-up was performed in 80.4% of patients (85.2% in the TRA group vs 73.7% in the TFA group, p = 0.55) and was driven by symptoms in 5 patients (4 in TFA and 2 in the TRA group, p = 0.36). The rate of TVR and of total MACE was similar in both groups (7.4% in TRA vs 9.1 in the TFA group, p = 0.76 and 14.8% in TRA vs 31.8% in the TFA group, p = 0.28 respectively). ST occurred in 2 patients (4.1%), 1 in each group (p = 0.56). 4. Discussion In this study we assessed the feasibility and efficacy of TRA PCI in patients with ULMCA stenosis and found, in agreement with previous studies, that it appears to be an effective technique compared to the
All patients
TRA
TFA
p Value
In-hospital MACE Death Non-fatal MI Non-fatal stroke Target vessel revascularization Stent thrombosis Emergency CABG Major bleeding CIN
5 (10.2) 3 (6.1) 1 (2) 0 1 (2) 1 (2) 0 1 (2) 2 (4.1)
1 (3.7) 0 1 (3.7) 0 0 0 0 0 1 (3.7)
4 (18.2) 3 (13.6) 0 0 1 (4.5) 1 (4.5) 0 1 (4.5) 1 (4.5)
0.48 0.17 0.91
Long-term follow-up Angiographic follow-up Symptoms MACE Death Non-fatal MI Non-fatal stroke Target vessel revascularization Stent thrombosis Major bleeding
37/46 (80.4) 6/46 (13) 11 (22.4) 4 (8.2) 3 (6.1) 0 4 (8.2) 2 (4.1) 1 (2)
23 (85.2) 2 (7.4) 4 (14.8) 1 (3.7) 1 (3.7) 0 2 (7.4) 1 (3.7) 0
14/19 (73.7) 4/19 (21) 7 (31.8) 3 (13.6) 2 (9.1) 0 2 (9.1) 1 (4.5) 1 (4.5)
0.55 0.36 0.28 0.46 0.85
0.91 0.91 0.91 0.56
0.76 0.56 0.91
Data are n (%) or mean ± SD. MI = myocardial infarction. MACE = major adverse cardiovascular events. CIN = contrast induced nephropathy. CABG = coronary artery bypass graft. * Mean follow-up 32 ± 13 months.
TFA PCI. The largest series was reported by Yang et al. [13] regarding 821 consecutive patients with ULMCA stenosis treated with PCI either via TRA or TFA (43% and 57% of cases respectively). There were no significant differences in both the efficacy of the procedure and the early and long-term clinical outcomes. Another study of Cheng et al. [14] analyzed the results of PCI via TRA in 113 patients with significant ULMCA stenosis with good procedural and clinical results. Furthermore, Bertrand et al. [15] showed that the TRA was feasible and safe for PCI of ULMCA also in very elderly patients (N80 years old), compared to the TFA. However, these studies were carried out in centers with very skilled operators in TRA-PCI (usually N 80% of total PCI) for a long time. We have shown that even for an inexperienced TR operator, this procedure is quite feasible and safe. Although previous studies have shown a crossover rate of less than 5% [16,17], our crossover rate of 11.1% is a consequence of the initial inexperience of the TRA operator. Indeed, 2 crossovers occurred during the first year of the study, in which the operator performed via TRA only 8 PCI and preferred to manage these complex cases via TFA. After this period, only 1 crossover occurred because of an extreme tortuosity of a calcified brachiocephalic artery and shifting to left radial access was impossible, lacking the arterial pulse. The primary concern of interventional cardiologists versed in TFA in this kind of procedure is the usual need of using large guiding catheters, especially in lesions involving the bifurcation, and of catheter back up. However, PCI complications have been shown to increase with the use of guiding catheters N 6 Fr [18]. In our experience, we were able to carry out the majority of the TRA procedures with a 6 Fr guiding catheter, also in complex lesions managed with 2 stents. In 3 cases the operator used a 7.5 Fr sheathless guiding catheter that, in 1 case, allowed him to manage a ULMCA bifurcation with “V stenting” technique, deploying simultaneously two 3.5 sirolimus-eluting stents. Thus, our study, even if in a small but unselected population, shows that the majority of ULMCA-PCI can be carried out with a 6 Fr guiding catheter, even for complex bifurcation treatments. Regarding the use of IABP, the operator preferred to use an hemodynamic support as much as possible, also in stable patients, to avoid hemodynamic changes during the procedure, in agreement with the strategy followed in our center and with a study of Briguori et al., that showed a better
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outcomes in patients with elective use of IABP [19]. Both early and late clinical outcomes were in agreement with other observational studies regarding patients undergoing ULMCA PCI [20]. The main limitation of our study is the small number of the patients that makes the study underpowered to compare the clinical outcomes analyzed, in particular the bleeding complications. Furthermore, the IABP insertion could increase the vascular complications in case of radial approach, but, having put only one femoral sheath, the risk of bleeding should be at least halved in comparison with a double femoral access. Our choice to consider only the procedures performed by the single dedicated TRA operator was to avoid some degree of operator bias, which could affect not only the procedural times and the amount of contrast, but also the outcome of the PCI at least in urgence setting [21]. 5. Conclusions Our study confirms that, compared with TFA PCI, TRA PCI for ULMCA disease is feasible and associated with similar procedural success and with early and long-term clinical outcomes. TRA could be considered a good alternative to TFA, also in these complex and highrisk procedures, provided that a rigorous learning curve was followed and a TRA volume caseload was maintained.
[4] [5]
[6]
[7]
[8]
[9] [10]
[11] [12] [13]
[14]
Acknowledgments We acknowledge the professional contribution of our nursing and technical staff: Antonio Badalì, Giovanni Bovì, Lello Castaldo, Anna Isabello, Giuliana Podio, Cleopatra Sollai, Teresa Strizzi.
[15]
[16]
[17]
References [18] [1] Kiemeneji F, Laarman G. Percutaneous transradial artery approach for coronary stent implantation. Catheter Cardiovasc Diagn 1993;30:173–8. [2] 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. [3] Jolly SS, Amlani S, Hamon M, et al. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic
[19] [20]
[21]
events: a systematic review and meta-analysis of randomized trials. Am Heart J 2009;157:132–40. 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. 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. Park SJ, Hong MK, Lee CW, et al. Elective stenting of unprotected left main coronary artery stenosis: effect of debulking before stenting and intravascular ultrasound guidance. J Am Coll Cardiol 2001;38:1054–60. Chieffo A, Morici N, Maisano F, et al. Percutaneous treatment with drug-eluting stent implantation versus bypass surgery for unprotected left main stenosis: a single-center experience. Circulation 2006;113:2542–7. Sianos G, Morel MA, Kappetein AP, et al. The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease. EuroIntervention 2005;1: 219–27. The TIMI Study Group. The Thrombolysis In Myocardial Infarction (TIMI) trial: phase 1 findings. N Engl J Med 1985;312:932–6. Mehran R, Rao SV, Bhatt DL, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation 2011;123:2736–47. Mauri L, Hsieh W, Massaro JM, et al. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med 2007;356:1020–9. Barrett BJ, Parfrey PS. Preventing nephropathy induced by contrast medium. N Engl J Med 2006;354:379–86. Yang YJ, Kandzari DE, Gao Z, et al. Transradial versus transfemoral method of percutaneous coronary revascularization for unprotected left main coronary artery disease: comparison of procedural and late-term outcomes. JACC Cardiovasc Interv 2010;3:1035–42. Cheng CI, Wu CJ, Fang CY, et al. Feasibility and safety of transradial stenting for unprotected left main coronary stenosis. Circ J 2007;71:855–61. Bertrand O, Bagur R, Cousterousse O, et al. Transradial vs femoral percutaneous coronary intervention for left main disease in octogenarians. Indian Heart J 2010;62:234–7. Kiemeneij F, Laarman GJ, Odekerken D, et al. 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. Burzotta F, Trani C, Mazzari MA, et al. Vascular complications and access crossovers in 10,676 transradial percutaneous coronary procedures. Am Heart J 2012;163:230–8. Grossman PM, Gurm HS, McNamara R, et al. Percutaneous coronary intervention complications and guide catheter size. Bigger is not better. JACC Interv 2009;2:636–44. Briguori C, Airoldi F, Chieffo A, et al. Elective versus provisional intraaortic balloon pumping in unprotected left main stenting. Am Heart J 2006;152:565–72. Palmerini T, Alessi L, Dangas G. Revascularization of unprotected left main coronary artery disease: strategy selection and systematic risk assessment. Catheter Cardiovasc Interv 2012;80:199–205. Vlaar PJ, de Smet BJ, van den Heuvel AF, et al. Operator dependence of outcome after primary percutaneous intervention. EuroIntervention 2011;6:760–7.
Contents lists available at SciVerse ScienceDirect
Cardiovascular Revascularization Medicine
Clinical
Is percutaneous coronary intervention of unprotected left main coronary artery via transradial approach feasible for skilled transfemoral operators? Initial experience in an unselected population☆,☆☆ Francesco Tomassini ⁎, Andrea Gagnor, Nicolò Montali, Alfonso Gambino, Mario Bollati, Vincenzo Infantino, Emanuele Tizzani, Ferdinando Varbella Department of Cardiology, Infermi Hospital, Rivoli, Italy
a r t i c l e
i n f o
Article history: Received 8 January 2013 Received in revised form 18 April 2013 Accepted 19 April 2013
a b s t r a c t Background: The feasibility and efficacy of percutaneous coronary intervention (PCI) of unprotected left main coronary artery (ULMCA) via transradial access (TRA) is still a matter of concern, mainly in an unselected population. Methods: We collected data about all PCI performed in patients with ULMCA stenosis by a TRA-dedicated operator and analyzed clinical and procedural characteristics as well as in-hospital and long-term outcomes. Results: From January 2008 to December 2011, 49 PCIs were performed; 27 (55%) via TRA and 22 (45%) via transfemoral access (TFA). Most patients in both groups underwent PCI for acute coronary syndrome (66.7% in the TRA group vs 77.3% in the TFA group, p = 0.73). Patients in the TRA group were more hypertensive (81.5% vs 40.9%, p = 0.008) and had a higher left ventricular ejection fraction (54.6 ± 10.3 vs 46.1 ± 12.8, p = 0.01). There were no significant differences in procedural success (100% in the TRA group vs 90.9% in the TFA group, p = 0.38), as well as in procedural time, in fluoroscopic time and in contrast volume. Bleeding complications occurred in 1 patient in the TFA group (4.5%) vs none in the TRA group (p = 0.91). In-hospital major adverse cardiac events (MACE) occurred in 1 patient (3.7%) in the TRA group vs 3 (13.6%) in the TFA group (p = 0.48). At a follow-up of 32 ± 13 months, MACE occurred in 4 cases (14.8%) in the TRA group vs 7 cases (31.8%) in the TFA group (p = 0.28). Conclusions: The PCI of ULMCA via TRA is feasible with good results, provided that a rigorous learning curve was followed and a TRA volume caseload was maintained. © 2013 Elsevier Inc. All rights reserved.
1. Introduction
2. Methods
Transradial access (TRA) has become an interesting approach for percutaneous coronary intervention (PCI), mainly because of reduced rates of bleeding complications compared to the transfemoral approach (TFA) [1–5]. However, although most coronary lesions can now be successfully treated via the TRA, PCI for unprotected left main coronary artery (ULMCA) disease is usually performed via transfemoral access (TFA) using 7 or 8 French (Fr) guiding catheters because of the high rate of distal bifurcation lesion and the large diameter of the vessel [6,7]. In this retrospective study we evaluated in an unselected population undergoing PCI for ULMCA stenosis the feasibility and the efficacy of TRA compared to TFA, in terms of success of procedure and in-hospital and long-term outcomes.
2.1. Study population and procedural details
☆ ☆☆ ⁎ Italy.
Funding: none. Conflicts of interest: none. Corresponding author. Ospedale degli Infermi, Strada Rivalta, 29, 10098 Rivoli, Tel.: +39 011 9551421; fax: +39 011 9551421. E-mail address: [email protected] (F. Tomassini).
1553-8389/$ – see front matter © 2013 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.carrev.2013.04.007
We reviewed the data of patients undergoing PCI for significant ULMCA stenosis from January 2008 and December 2011 at our hospital. Our catheterization laboratory is a high-volume PCI center (N800 PCI and N150 primary PCI per year) with 3 skilled operators, one of whom is dedicated to TRA procedures. The operator using TRA had similar experience with TFA procedures and no experience with TRA at the onset of the study but, at the end of it, its activity in PCI via TRA rose up to 81% (Fig. 1). In order to avoid confounding factors, only the procedures performed by this operator dedicated to TRA were considered. PCI was chosen as a therapeutic option in case of clinical and/or hemodynamic instability or when cardiac surgery was considered at high risk because of the presence of either old age or severe comorbidities. All patients were categorized into the TRA group (n = 27) or the TFA group (n = 22). Demographic, clinical and procedural data were prospectively collected in a dedicated database (Cardioplanet V.3.0.8, Ebit Aet S.p.A., Genoa, Italy) and, after the coronary angiography, the complexity of the coronary disease was
194
F. Tomassini et al. / Cardiovascular Revascularization Medicine 14 (2013) 193–196
2.3. Patient follow-up In-hospital events were derived from clinical records. An angiographic control was scheduled between 6 and 12 months if not contraindicated. Clinical follow-up was performed by ambulatory clinical visits or telephone calls. In case of events, clinical records were checked when available or detailed history was acquired from patients or (in case of death) from patients’ relatives or physicians. 2.4. Statistical analysis
Fig. 1. Number of percutaneous coronary interventions (PCI) via transradial (TRA) and transfemoral approach (TFA) performed by the TRA-dedicated operator across the study period.
Data are reported as means (with standard deviations) or proportions. Continuous variables were compared by t test, whereas categorical variables were compared by chi-square test. A p value b 0.05 was always required for statistical significance. Analyses were performed using the statistical software SAS System, Version 9.1 (SAS Institute Inc., Cary, NC). 3. Results
classified using the SYNTAX Score calculation [8]. The study protocol was reviewed and approved by the Ethics Committee of our Institution (ASL 103, Piemonte Region, Italy). The vascular access method and the PCI technique were performed according to the operator’s discretion. Intra-aortic balloon pump (IABP) was used as much as possible, also in stable patients. Intravascular ultrasounds (IVUS) were used, if possible, to achieve optimal stent expansion and lesion coverage. At the end of the procedure the radial hemostasis was accomplished by compressing folded gauze wrapped by an elastic bandage, whereas closure devices (Angioseal, St Jude Medical, St. Paul, Minnesota; Perclose or Star Close, Abbott Vascular, Santa Clara, California) were used for femoral hemostasis if the access site was suitable. All patients were routinely treated with aspirin (325 mg upon arrival, and then 100 mg daily), clopidogrel (loading dose of 300 or 600 mg, and then 75 mg daily) and with an intravenous bolus of unfractionated heparin (100 U/kg body weight, or 60 U/kg body weight if also glycoprotein IIb-IIIa inhibitors were given). Heparin therapy was stopped after the procedure, but, in case of IABP use, it was continued until its removal. Abciximab and eptifibatide were the glycoprotein IIb-IIIa inhibitors used. Bivalirudin was not used in these patients. Beta-adrenergic blockers, ACE inhibitors and statins were used as in-hospital standard therapy, if not contraindicated.
2.2. Study end point The end point of the study was the feasibility of the TRA procedure without need of access crossover, defined as failure to successfully complete the procedure by the TRA, and its efficacy, defined as achievement of final residual stenosis of b30% and of Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 [9]. We assessed also the rate of the in-hospital and long-term major adverse cardiac events (MACE) including death; myocardial infarction (MI), defined as of typical chest pain with new ECG abnormalities and elevation of creatine kinase to twice the basal level; stroke, defined as defined as any focal and nonconvulsive neurological deficit lasting more than 24 hours; target vessel revascularization (TVR), defined as repeated PCI or CABG due to restenosis or progression of the disease in the treated vessels; major bleeding complications, defined according to the Bleeding Academic Research Consortium classification [10]; stent thrombosis (ST), defined as definite and probable according to the Academic Research Consortium classification [11] and contrastinduced nephropathy (CIN) defined as absolute increase in serum creatinine of 0.5 mg/dL (44 μmol/L), or a relative 25% increase from the baseline value, assessed 48–72 hours following intravascular administration of the contrast medium [12].
From January 2008 to December 2011, 172 patients with significant stenosis of ULMCA underwent PCI at our center. Of these, 49 (28.5%) were performed by the TRA-dedicated operator and form the population of the study. 3.1. Clinical and procedural characteristics The clinical characteristics of the two groups are summarized in Table 1, whereas their angiographic and procedural characteristics are shown in Table 2. There was a total of 27 interventions (55%) in the TRA group and 22 interventions (45%) in the TFA group. In the TRA group 25 interventions (92.6%) were performed from right TRA and 2 (7.4%) from the left TRA. In the TRA group there was a crossover to the TFA in 3 patients (11.1%): in 2 of them it occurred after the coronary angiography because the operator was at the beginning of his learning curve and preferred the TFA to perform the PCI, whereas in the other patient the crossover was necessary because of the extreme tortuosity of a calcified brachiocephalic artery that did not let the catheters to get to the coronary vessels. There were no crossovers in the TFA group (p = 0.31). In the TRA group patients were more likely to be hypertensive (81.5% vs 40.9%, p = 0.008) and to present with a higher LVEF (54.6 ± 10.3 vs 46.1 ± 12.8, p = 0.01). In both groups the majority of the patients presented with an acute coronary syndrome (66.7% in the TRA group vs 77.3% in the TFA group, p =
Table 1 Baseline clinical characteristics.
Number of patients Age Males History of CAD Diabetes Current smokers Renal failure⁎ Hypertension LVEF (%) Clinical presentation Acute coronary syndrome Stable ischemia STEMI Cardiogenic shock
All patients
TRA
TFA
49 70 ± 9 36 (73.5) 7 (14.3) 18 (36.7) 16 (32.6) 2 (4.1) 31 (63.3) 51 ± 12
27 (55) 68 ± 9 18 (66.7) 5 (18.5) 11 (40.7) 10 (37) 1 (3.7) 22 (81.5) 54 ± 10
22 (45) 72 ± 9 18 (81.8) 2 (9.1) 7 (31.8) 6 (27.3) 1 (4.5) 9 (40.9) 46 ± 13
35 (71.4) 14 (28.6) 14 (28.6) 8 (16.3)
18 (66.7) 9 (33.3) 7 (25.9) 2 (7.4)
17 (77.3) 5 (22.7) 7 (31.8) 6 (27.2)
Data are n (%) or mean ± SD unless otherwise stated. CAD = coronary artery disease. LVEF = left ventricular ejection fraction. STEMI = ST-segment elevation myocardial infarction. * Renal failure defined as baseline creatinine ≥2.5 mg/deciliter.
p Value 0.11 0.38 0.59 0.72 0.67 0.56 0.008 0.01 0.73
0.14
F. Tomassini et al. / Cardiovascular Revascularization Medicine 14 (2013) 193–196 Table 2 Angiographic findings and procedural details.
Bifurcation involved SYNTAX Score Successful procedure⁎ Contrast volume (ml) Time of procedure (min) Fluoroscopic time (min) Guiding catheter N 6 Fr¶ IVUS IABP Glycoprotein IIb-IIIa inhibitors Drug-eluting stent Stent per patient Bifurcation treatment With 2 stents Minicrush Culotte V Stenting TAP
195
Table 3 In-hospital and long-term outcomes.⁎
All patients
TRA
TFA
p Value
45 (91.8) 23.2 ± 9.5 47 (95.9) 256 ± 95 89 ± 40 21 ± 12 16 (32.6) 26 (53.1) 46 (93.9) 15 (30.6) 48 (97.9) 2.1 ± 1.2
25 (92.6) 21.8 ± 10.4 27 (100) 260 ± 96 93 ± 37 22 ± 12 3/24 (12.5) 16 (59.2) 24 (88.9) 9 (33.3) 27 (100) 2.1 ± 1.3
20 (90.1) 24.8 ± 8 20 (90.9) 252 ± 96 84 ± 42 20 ± 11 13 (59.1) 10 (45.4) 22 (100) 6 (27.3) 21 (95.4) 2.1 ± 1.1
0.74 0.27 0.38 0.77 0.42 0.64 0.003 0.49 0.31 0.88 0.91 1 0.97
22/45 (48.8) 9 (20) 2 (4.4) 1 (2.2) 1 (2.2)
10/25 (40) 6 (24) 2 (8) 1 (4) 1 (4)
7/20 (35) 3 (15) 2 (10) 1 (5) 1 (5)
Data are n (%) or mean ± SD unless otherwise stated. IVUS = intravascular ultra sound. IABP = intraaortic balloon pump. TAP = T and protrusion. * Successful procedure was defined as a residual stenosis of treated vessels b30% associated with a Thrombolysis In Myocardial Infarction (TIMI) 3 grade flow. ¶ In the TRA Group 3 procedures were performed via TFA.
0.73) and the rate of the patients with ST-segment elevation myocardial infarction (STEMI) was 25.9% in the TRA group and 31.8% in the TFA group (p = 0.89). Eight patients (16.3%) presented with cardiogenic shock: 2 patients in TRA (7.4%) and 6 patients (27.2%) in the TFA group (p = 0.14). The left main bifurcation was involved in most cases in both groups (92.6% in the TRA group vs 90.1% in the TFA group, p = 0.74) and the SYNTAX Score was not significantly different between the two groups (21.8 ± 10.4 in the TRA group vs 24.8 ± 8 in the TFA group, p = 0.27). Guiding catheters larger than 6 Fr were used in the majority of the patients in the TFA group (13 out of 22, 59.1%), whereas in the TRA group only 3 out of 24 patients (12.5%, p = 0.003) were treated with guiding catheter sheathless 7.5 Fr (Asahi Intecc, Japan). Yet, the rate of the bifurcation managed with 2 stents did not significantly differ between the two groups (40% in the TRA group vs 35% in the TFA group, p = 0.97) and the final kissing balloon was performed in all cases. The use of IVUS and hemodynamic support was similar between the 2 groups as well as the procedural time, the fluoroscopic time and the contrast volume. 3.2. Clinical and angiographic outcomes The success of the procedure was similar between the 2 groups (100% in the TRA group and 90.9% in the TFA group, p = 0.38). During the hospitalization no significant differences were observed in the rates of MACE (Table 3). There was 1 bleeding complication in the TFA group vs none in the TRA group (p = 0.91) and 1 CIN in both groups. Clinical follow-up was complete for all patients over a average of 32 ± 13 months. The angiographic follow-up was performed in 80.4% of patients (85.2% in the TRA group vs 73.7% in the TFA group, p = 0.55) and was driven by symptoms in 5 patients (4 in TFA and 2 in the TRA group, p = 0.36). The rate of TVR and of total MACE was similar in both groups (7.4% in TRA vs 9.1 in the TFA group, p = 0.76 and 14.8% in TRA vs 31.8% in the TFA group, p = 0.28 respectively). ST occurred in 2 patients (4.1%), 1 in each group (p = 0.56). 4. Discussion In this study we assessed the feasibility and efficacy of TRA PCI in patients with ULMCA stenosis and found, in agreement with previous studies, that it appears to be an effective technique compared to the
All patients
TRA
TFA
p Value
In-hospital MACE Death Non-fatal MI Non-fatal stroke Target vessel revascularization Stent thrombosis Emergency CABG Major bleeding CIN
5 (10.2) 3 (6.1) 1 (2) 0 1 (2) 1 (2) 0 1 (2) 2 (4.1)
1 (3.7) 0 1 (3.7) 0 0 0 0 0 1 (3.7)
4 (18.2) 3 (13.6) 0 0 1 (4.5) 1 (4.5) 0 1 (4.5) 1 (4.5)
0.48 0.17 0.91
Long-term follow-up Angiographic follow-up Symptoms MACE Death Non-fatal MI Non-fatal stroke Target vessel revascularization Stent thrombosis Major bleeding
37/46 (80.4) 6/46 (13) 11 (22.4) 4 (8.2) 3 (6.1) 0 4 (8.2) 2 (4.1) 1 (2)
23 (85.2) 2 (7.4) 4 (14.8) 1 (3.7) 1 (3.7) 0 2 (7.4) 1 (3.7) 0
14/19 (73.7) 4/19 (21) 7 (31.8) 3 (13.6) 2 (9.1) 0 2 (9.1) 1 (4.5) 1 (4.5)
0.55 0.36 0.28 0.46 0.85
0.91 0.91 0.91 0.56
0.76 0.56 0.91
Data are n (%) or mean ± SD. MI = myocardial infarction. MACE = major adverse cardiovascular events. CIN = contrast induced nephropathy. CABG = coronary artery bypass graft. * Mean follow-up 32 ± 13 months.
TFA PCI. The largest series was reported by Yang et al. [13] regarding 821 consecutive patients with ULMCA stenosis treated with PCI either via TRA or TFA (43% and 57% of cases respectively). There were no significant differences in both the efficacy of the procedure and the early and long-term clinical outcomes. Another study of Cheng et al. [14] analyzed the results of PCI via TRA in 113 patients with significant ULMCA stenosis with good procedural and clinical results. Furthermore, Bertrand et al. [15] showed that the TRA was feasible and safe for PCI of ULMCA also in very elderly patients (N80 years old), compared to the TFA. However, these studies were carried out in centers with very skilled operators in TRA-PCI (usually N 80% of total PCI) for a long time. We have shown that even for an inexperienced TR operator, this procedure is quite feasible and safe. Although previous studies have shown a crossover rate of less than 5% [16,17], our crossover rate of 11.1% is a consequence of the initial inexperience of the TRA operator. Indeed, 2 crossovers occurred during the first year of the study, in which the operator performed via TRA only 8 PCI and preferred to manage these complex cases via TFA. After this period, only 1 crossover occurred because of an extreme tortuosity of a calcified brachiocephalic artery and shifting to left radial access was impossible, lacking the arterial pulse. The primary concern of interventional cardiologists versed in TFA in this kind of procedure is the usual need of using large guiding catheters, especially in lesions involving the bifurcation, and of catheter back up. However, PCI complications have been shown to increase with the use of guiding catheters N 6 Fr [18]. In our experience, we were able to carry out the majority of the TRA procedures with a 6 Fr guiding catheter, also in complex lesions managed with 2 stents. In 3 cases the operator used a 7.5 Fr sheathless guiding catheter that, in 1 case, allowed him to manage a ULMCA bifurcation with “V stenting” technique, deploying simultaneously two 3.5 sirolimus-eluting stents. Thus, our study, even if in a small but unselected population, shows that the majority of ULMCA-PCI can be carried out with a 6 Fr guiding catheter, even for complex bifurcation treatments. Regarding the use of IABP, the operator preferred to use an hemodynamic support as much as possible, also in stable patients, to avoid hemodynamic changes during the procedure, in agreement with the strategy followed in our center and with a study of Briguori et al., that showed a better
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outcomes in patients with elective use of IABP [19]. Both early and late clinical outcomes were in agreement with other observational studies regarding patients undergoing ULMCA PCI [20]. The main limitation of our study is the small number of the patients that makes the study underpowered to compare the clinical outcomes analyzed, in particular the bleeding complications. Furthermore, the IABP insertion could increase the vascular complications in case of radial approach, but, having put only one femoral sheath, the risk of bleeding should be at least halved in comparison with a double femoral access. Our choice to consider only the procedures performed by the single dedicated TRA operator was to avoid some degree of operator bias, which could affect not only the procedural times and the amount of contrast, but also the outcome of the PCI at least in urgence setting [21]. 5. Conclusions Our study confirms that, compared with TFA PCI, TRA PCI for ULMCA disease is feasible and associated with similar procedural success and with early and long-term clinical outcomes. TRA could be considered a good alternative to TFA, also in these complex and highrisk procedures, provided that a rigorous learning curve was followed and a TRA volume caseload was maintained.
[4] [5]
[6]
[7]
[8]
[9] [10]
[11] [12] [13]
[14]
Acknowledgments We acknowledge the professional contribution of our nursing and technical staff: Antonio Badalì, Giovanni Bovì, Lello Castaldo, Anna Isabello, Giuliana Podio, Cleopatra Sollai, Teresa Strizzi.
[15]
[16]
[17]
References [18] [1] Kiemeneji F, Laarman G. Percutaneous transradial artery approach for coronary stent implantation. Catheter Cardiovasc Diagn 1993;30:173–8. [2] 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. [3] Jolly SS, Amlani S, Hamon M, et al. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic
[19] [20]
[21]
events: a systematic review and meta-analysis of randomized trials. Am Heart J 2009;157:132–40. 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. 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. Park SJ, Hong MK, Lee CW, et al. Elective stenting of unprotected left main coronary artery stenosis: effect of debulking before stenting and intravascular ultrasound guidance. J Am Coll Cardiol 2001;38:1054–60. Chieffo A, Morici N, Maisano F, et al. Percutaneous treatment with drug-eluting stent implantation versus bypass surgery for unprotected left main stenosis: a single-center experience. Circulation 2006;113:2542–7. Sianos G, Morel MA, Kappetein AP, et al. The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease. EuroIntervention 2005;1: 219–27. The TIMI Study Group. The Thrombolysis In Myocardial Infarction (TIMI) trial: phase 1 findings. N Engl J Med 1985;312:932–6. Mehran R, Rao SV, Bhatt DL, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation 2011;123:2736–47. Mauri L, Hsieh W, Massaro JM, et al. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med 2007;356:1020–9. Barrett BJ, Parfrey PS. Preventing nephropathy induced by contrast medium. N Engl J Med 2006;354:379–86. Yang YJ, Kandzari DE, Gao Z, et al. Transradial versus transfemoral method of percutaneous coronary revascularization for unprotected left main coronary artery disease: comparison of procedural and late-term outcomes. JACC Cardiovasc Interv 2010;3:1035–42. Cheng CI, Wu CJ, Fang CY, et al. Feasibility and safety of transradial stenting for unprotected left main coronary stenosis. Circ J 2007;71:855–61. Bertrand O, Bagur R, Cousterousse O, et al. Transradial vs femoral percutaneous coronary intervention for left main disease in octogenarians. Indian Heart J 2010;62:234–7. Kiemeneij F, Laarman GJ, Odekerken D, et al. 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. Burzotta F, Trani C, Mazzari MA, et al. Vascular complications and access crossovers in 10,676 transradial percutaneous coronary procedures. Am Heart J 2012;163:230–8. Grossman PM, Gurm HS, McNamara R, et al. Percutaneous coronary intervention complications and guide catheter size. Bigger is not better. JACC Interv 2009;2:636–44. Briguori C, Airoldi F, Chieffo A, et al. Elective versus provisional intraaortic balloon pumping in unprotected left main stenting. Am Heart J 2006;152:565–72. Palmerini T, Alessi L, Dangas G. Revascularization of unprotected left main coronary artery disease: strategy selection and systematic risk assessment. Catheter Cardiovasc Interv 2012;80:199–205. Vlaar PJ, de Smet BJ, van den Heuvel AF, et al. Operator dependence of outcome after primary percutaneous intervention. EuroIntervention 2011;6:760–7.