716 Vascular access options in coronary angiogram procedures: Randomized controlled trial of a patient decision aid

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Abstracts

(70%) patients and radial access was used for 605 (30%) patients. The median time from arrival in the cath lab to first balloon inflation was 31 (26, 40) minutes for radial access and 28 (22, 37) minutes for femoral access (P ⬍ 0.0001). For centres that used radial access for ⬎ 50% of primary PCI cases, the median time from arrival in the cath lab to first balloon inflation was 31 minutes for radial, 33 minutes for femoral access (P ⫽ 0.1). For centres that used radial access for ⬍ 50% of cases, the median time from arrival in the cath lab to first balloon inflation was 33 minutes for radial access, 28 minutes for femoral access (P ⬍ 0.001).The proportion of patients undergoing PCI within 90 minutes of the qualifying ECG was similar for radial and femoral procedures. CONCLUSIONS: Radial access for primary PCI is associated with a small but statistically significant delay until first balloon inflation that is unlikely to be clinically relevant. This delay is observed only in centres that use radial access for less than 50% of primary PCI cases.

Canadian Cardiovascular Society (CCS) CCS421 Oral PCI ACCESS SITE ISSUES AND OTHER COMPLICATIONS Tuesday, October 25, 2011

716 VASCULAR ACCESS OPTIONS IN CORONARY ANGIOGRAM PROCEDURES: RANDOMIZED CONTROLLED TRIAL OF A PATIENT DECISION AID JR Schwalm, D Stacey, D Pericak, MK Natarajan Hamilton, Ontario BACKGROUND: Vascular access (radial and femoral) in coronary

715 REPERFUSION TIMES FOR RADIAL VS. FEMORAL ACCESS IN PATIENTS WITH ST-ELEVATION MYOCARDIAL INFARCTION UNDERGOING PRIMARY PCI: OBSERVATIONS FROM THE CCN PROVINCIAL PRIMARY PCI REGISTRY WJ Cantor, DT Ko, M Natarajan, MR Le May, V Džavík, JL Velianou, H Wijeysundera, D Purdham, K Kingsbury Newmarket, Ontario

The use of radial access for patients with STelevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) remains controversial. Trans-radial PCI is associated with a learning curve and may take longer than trans-femoral PCI which may delay reperfusion for primary PCI. The delay may depend on the level of experience with trans-radial PCI. METHODS: The Cardiac Care Network of Ontario Cath/PCI Working Group developed a provincial PPCI registry for all STEMI patients undergoing primary PCI in Ontario. The arterial access site and the times of qualifying electrocardiogram (ECG), arrival at the cath lab and the first balloon inflation were documented. The time interval from arrival at the cath lab to first balloon inflation was compared for radial vs. femoral access for the entire group and among centres with high (⬎50%) and low (⬍50%) use of radial access for primary PCI. RESULTS: From June 1 2010 to March 2011, 2,268 patients underwent primary PCI. Access site and time intervals were available for 1,987 patients. Femoral access was used for 1,382 BACKGROUND:

angiography procedures can be considered a “grey zone” decision, where the benefits and harms may have different levels of significance depending on the patient’s preferences and values. For “grey zone” health care options, Patient Decision Aids (PtDA) significantly improve the quality and the process of decision making by improving knowledge of the patient’s health care options and accurate risk perception, and reducing the patient’s decisional conflict. METHODS: We conducted a single-centre, non-blinded, randomized controlled trial with concealed allocation, to evaluate the impact of an evidence-based PtDA compared to usual care in patients considering vascular access options for coronary angiography procedures. The PtDA was designed to highlight the risks and benefits of both vascular access sites and help guide the patient to make an informed choice that is consistent with their preferences and values. Inclusion criteria: non-emergent indication for coronary angiogram, no prior cardiac catheterization, and candidates for both femoral and radial access as per their treating physician. The primary outcome of decisional conflict was assessed using the validated decisional conflict scale (DCS). Secondary outcomes include: knowledge and accurate risk perception of the patient’s health care option, and vascular access success and procedural complications. (REB approval #09-340, NCT01032551). RESULTS: Between June and December 2010, 150 patients were randomized to a vascular access PtDA (n ⫽ 76) or usual care (n ⫽ 74). Baseline characteristics between the two groups were similar. Patients in the intervention group had a signifi-

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cantly reduced total DCS when compared to the control (14.8 versus 19.5, P ⫽ 0.04). Patients in the PtDA group were also significantly more knowledgeable regarding the risks and benefits associated with each vascular access (mean knowledge score of 3.0/5 (95% confidence intervals (CI) 2.6-3.3) versus 2.0 (95% CI 1.7-2.3, P ⬍ 0.01). Despite 76.3 % of patients actively selecting their vascular access route of choice in the PtDA group as compared to 39.2% in the control group (P ⬍ 0.01), there were no significant differences in safety outcomes. CONCLUSION: A vascular access PtDA for eligible patients undergoing coronary angiography procedures significantly improves the patient’s knowledge of their health care options and reduces decisional conflict, without affecting safety outcomes. This study demonstrates the significant benefits of involving eligible patients in the decision process regarding vascular access for coronary angiography procedures. McMaster University, Dept of Medicine Internal Career Research Award and Division of Cardiology, AFP research competition grant

717 RADIAL VS. FEMORAL ACCESS IN PATIENTS REFERRED FOR PRIMARY PERCUTANEOUS CORONARY INTERVENTION: CHARACTERISTICS AND CLINICAL OUTCOMES S Mansour, MJ Bertrand, LM Stevens, N Noiseux, A Kokis, JB Masson, F Gobeil Montréal, Québec BACKGROUND: Although a recent randomised clinical trial compar-

ing radial vs. femoral approach did not show any difference in clinical outcome in patients with acute coronary syndrome, a subgroup analysis of patients with ST-elevation myocardial infarction (STEMI) showed a superiority of the radial access to reduce serious adverse events. Therefore, we aim to determine in a real-life cohort the characteristics and outcomes of STEMI patients referred for primary percutaneous coronary intervention (PCI) according to arterial access. METHODS AND RESULTS: Five-hundred-and-fifty-three consecutive patients with STEMI treated with primary PCI from January 2008 to December 2009 were prospectively followed. The mean age was 61 ⫾ 13 years with a predominance of male (75%), 16% diabetics, 42% anterior MI and 88% Killip class 1. The median door-to-balloon (DtB) was 97 [interquartile range:80,125] minutes. The arterial access was femoral in 24% (n ⫽ 132) and radial in 76% (n ⫽ 420). The femoral group had more females (34% vs. 23% P ⫽ 0.017), previous CABG (7% vs. 0%; P ⬍ .001), chronic renal failure (11% vs. 2%; P ⬍ .001), anterior MI (50% vs. 39%; P ⫽ 0.033) and high (⬎1) killip class (30% vs. 6%; P ⬍ .001) compared to radial group. Of note, 38% (n ⫽ 50) of patients in the femoral group had a radial access attempt. Usage of GIIb/ IIIa glycoprotein inhibitors was lower in the femoral group (49% vs. 60%; P ⫽ 0.034). No difference was found in the median DtB time 100 [85,120] vs. 95 [78, 126]; P ⫽ 0.260) or the final TIMI 3 flow between the two groups (93% vs. 95%; P ⫽ 0.158). During the inhospital follow-up, the femoral group had a higher incidence of

Canadian Journal of Cardiology Volume 27 2011

death (14% vs. 1%; P ⬍ .001) and major bleeding (12% vs. 2%, P ⬍ .001). CONCLUSION: In centers where the radial approach is usually privileged, patients treated with trans-femoral primary PCI had a high rate of co-morbidities and therefore had a higher rate of in-hospital adverse events. In STEMI patients, using the radial approach significantly decrease the risk of bleeding and serious events. Further randomized studies are warranted to compare between both approaches in this high risk population.

718 RADIAL VERSUS FEMORAL ACCESS FOR PERCUTANEOUS CORONARY INTERVENTION IN ST-ELEVATION MYOCARDIAL INFARCTION PATIENTS TREATED WITH FIBRINOLYSIS: A PATIENT-LEVEL META-ANALYSIS OF THE RANDOMIZED EARLY ROUTINE INVASIVE CLINICAL TRIALS JJ Graham, WJ Cantor, M Tan, AT Yan, MR Le May, S Jolly, F Piscione, C Di Mario, B Scheller, PW Armstrong, M Madan, S Halvorsen, F Fernandez-Aviles, S Goodman Toronto, Ontario BACKGROUND: Bleeding following percutaneous coronary intervention (PCI) is associated with adverse short and long-term outcomes. Radial access as compared to femoral access has been associated with reduced vascular access site complications and bleeding. The choice of vascular access site and associated outcomes in fibrinolytic-treated ST-elevation myocardial infarction (STEMI) patients who are undergoing routine early angiography and PCI vs. standard care (including rescue PCI) is unknown. METHODS: Patient-level data from trials (6 of 7 where arterial access site was recorded) of STEMI patients receiving fibrinolysis and randomized to an early invasive approach vs. standard care were included as part of a collaborative meta-analysis (SIAM III, GRACIA-1, CAPITAL AMI, WEST, CARESS-inAMI, TRANSFER-AMI, and NORDISTEMI). The primary endpoint was 30-day major bleeding; secondary endpoints included 30-day death and re-infarction. The association between major bleeding and access site was evaluated in multivariable models with propensity score adjustment since vascular access site choice was not randomized. RESULTS: Of 2789 patients (median age 59 years, 20% female, BMI 27 kg/m2), 1900 underwent PCI (radial 342, femoral 1558). Patients undergoing radial PCI were less likely to be randomized to the routine early invasive strategy (54% vs. 65%), be older than 75 years (2% vs. 8%), diabetic (8% vs. 17%), heavier (median weight 82 [72,91] vs. 80 [70,90] kg), and more likely in Killip class I at presentation (87% vs. 82%); initial estimated creatinine clearance was higher in radial PCI patients (99 [78,122] vs. 87 [68,109])(all P ⱕ 0.02). Unfractionated heparin (vs. enoxaparin) with fibrinolysis (19% vs. 81%) and glycoprotein IIb/IIIa inhibitor use (39% vs. 66%) were less frequent in the radial PCI patients (P ⬍ 0.0001). Unadjusted and adjusted* 30-day outcomes are listed in the