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Safety and Efficacy of Femoral Access vs Radial Access in ST-Segment Elevation Myocardial Infarction: The SAFARI-STEMI Randomized Clinical Trial.
JAMA Cardiol. 2020 Jan 02 [Online ahead of print]JC

Abstract

Importance

Among patients with ST-segment elevation myocardial infarction (STEMI) referred for primary percutaneous coronary intervention (PCI), a survival benefit associated with radial access compared with femoral access remains controversial.

Objective

To assess whether there is a survival benefit when radial access is used instead of femoral access among patients with STEMI referred for primary PCI.

Design, Setting, and Participants

This multicenter, open-label, randomized clinical trial was conducted at 5 PCI centers in Canada. In total, 2292 patients with STEMI referred for primary PCI were enrolled between July 2011 and December 2018, with a 30-day follow-up. The primary analyses were conducted based on the intention-to-treat population.

Interventions

Patients were randomized to radial access (n = 1136) or to femoral access (n = 1156) for PCI.

Main Outcomes and Measures

Initially, the primary outcome was bleeding, but this outcome was modified to 30-day all-cause mortality following the recommendation of the granting agency. Secondary outcomes included recurrent myocardial infarction, stroke, and Thrombolysis in Myocardial Infarction-defined major or minor bleeding.

Results

Among the 2292 patients enrolled, the mean (SD) age of the patients randomized to radial access was 61.6 (12.3) years and to femoral access was 62.0 (12.1) years, with 883 male patients in the radial access and 901 male patients in the femoral access group. The trial was stopped early following a futility analysis. Primary PCI was performed in 1082 of 1136 patients (95.2%) in the radial access group and 1109 of 1156 patients (95.9%) in the femoral access group. Bivalirudin was administered to 1001 patients (88.1%) in the radial access group and to 1068 patients (92.4%) in the femoral access group, whereas glycoprotein IIb/IIIa inhibitors were administered in only 69 patients (6.1%) in the radial access group and 68 patients (5.9%) in the femoral access group. A vascular closure device was used in 789 patients (68.3%) in the femoral group. The primary outcome, 30-day all-cause mortality, occurred in 17 patients (1.5%) assigned to radial access and in 15 patients (1.3%) assigned to femoral access (relative risk [RR], 1.15; 95% CI, 0.58-2.30; P = .69). There were no significant differences between patients assigned to radial and femoral access in the rates of reinfarction (1.8% vs 1.6%; RR, 1.07; 95% CI, 0.57-2.00; P = .83), stroke (1.0% vs 0.4%; RR, 2.24; 95% CI, 0.78-6.42; P = .12), and bleeding (1.4% vs 2.0%; RR, 0.71; 95% CI, 0.38-1.33; P = .28).

Conclusions and Relevance

No significant differences were found for survival or other clinical end points at 30 days after the use of radial access vs femoral access in patients with STEMI referred for primary PCI. However, small absolute differences in end points cannot be definitively refuted given the premature termination of the trial.

Trial Registration

ClinicalTrials.gov identifier: NCT01398254.

Authors+Show Affiliations

Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.Department of Medicine, Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, Canada.Department of Medicine, St Boniface General Hospital, Winnipeg, Manitoba, Canada.Department of Medicine, Saint John Regional Hospital, Saint John, New Brunswick, Canada.Department of Medicine, Queen Elizabeth II Health Science Centre, Halifax, Nova Scotia, Canada.Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31895439

Citation

Le May, Michel, et al. "Safety and Efficacy of Femoral Access Vs Radial Access in ST-Segment Elevation Myocardial Infarction: the SAFARI-STEMI Randomized Clinical Trial." JAMA Cardiology, 2020.
Le May M, Wells G, So D, et al. Safety and Efficacy of Femoral Access vs Radial Access in ST-Segment Elevation Myocardial Infarction: The SAFARI-STEMI Randomized Clinical Trial. JAMA Cardiol. 2020.
Le May, M., Wells, G., So, D., Chong, A. Y., Dick, A., Froeschl, M., Glover, C., Hibbert, B., Marquis, J. F., Blondeau, M., Osborne, C., MacDougall, A., Kass, M., Paddock, V., Quraishi, A., & Labinaz, M. (2020). Safety and Efficacy of Femoral Access vs Radial Access in ST-Segment Elevation Myocardial Infarction: The SAFARI-STEMI Randomized Clinical Trial. JAMA Cardiology. https://doi.org/10.1001/jamacardio.2019.4852
Le May M, et al. Safety and Efficacy of Femoral Access Vs Radial Access in ST-Segment Elevation Myocardial Infarction: the SAFARI-STEMI Randomized Clinical Trial. JAMA Cardiol. 2020 Jan 2; PubMed PMID: 31895439.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and Efficacy of Femoral Access vs Radial Access in ST-Segment Elevation Myocardial Infarction: The SAFARI-STEMI Randomized Clinical Trial. AU - Le May,Michel, AU - Wells,George, AU - So,Derek, AU - Chong,Aun Yeong, AU - Dick,Alexander, AU - Froeschl,Michael, AU - Glover,Christopher, AU - Hibbert,Benjamin, AU - Marquis,Jean-Francois, AU - Blondeau,Melissa, AU - Osborne,Christina, AU - MacDougall,Andrea, AU - Kass,Malek, AU - Paddock,Vernon, AU - Quraishi,Ata, AU - Labinaz,Marino, Y1 - 2020/01/02/ PY - 2020/1/3/entrez JF - JAMA cardiology JO - JAMA Cardiol N2 - Importance: Among patients with ST-segment elevation myocardial infarction (STEMI) referred for primary percutaneous coronary intervention (PCI), a survival benefit associated with radial access compared with femoral access remains controversial. Objective: To assess whether there is a survival benefit when radial access is used instead of femoral access among patients with STEMI referred for primary PCI. Design, Setting, and Participants: This multicenter, open-label, randomized clinical trial was conducted at 5 PCI centers in Canada. In total, 2292 patients with STEMI referred for primary PCI were enrolled between July 2011 and December 2018, with a 30-day follow-up. The primary analyses were conducted based on the intention-to-treat population. Interventions: Patients were randomized to radial access (n = 1136) or to femoral access (n = 1156) for PCI. Main Outcomes and Measures: Initially, the primary outcome was bleeding, but this outcome was modified to 30-day all-cause mortality following the recommendation of the granting agency. Secondary outcomes included recurrent myocardial infarction, stroke, and Thrombolysis in Myocardial Infarction-defined major or minor bleeding. Results: Among the 2292 patients enrolled, the mean (SD) age of the patients randomized to radial access was 61.6 (12.3) years and to femoral access was 62.0 (12.1) years, with 883 male patients in the radial access and 901 male patients in the femoral access group. The trial was stopped early following a futility analysis. Primary PCI was performed in 1082 of 1136 patients (95.2%) in the radial access group and 1109 of 1156 patients (95.9%) in the femoral access group. Bivalirudin was administered to 1001 patients (88.1%) in the radial access group and to 1068 patients (92.4%) in the femoral access group, whereas glycoprotein IIb/IIIa inhibitors were administered in only 69 patients (6.1%) in the radial access group and 68 patients (5.9%) in the femoral access group. A vascular closure device was used in 789 patients (68.3%) in the femoral group. The primary outcome, 30-day all-cause mortality, occurred in 17 patients (1.5%) assigned to radial access and in 15 patients (1.3%) assigned to femoral access (relative risk [RR], 1.15; 95% CI, 0.58-2.30; P = .69). There were no significant differences between patients assigned to radial and femoral access in the rates of reinfarction (1.8% vs 1.6%; RR, 1.07; 95% CI, 0.57-2.00; P = .83), stroke (1.0% vs 0.4%; RR, 2.24; 95% CI, 0.78-6.42; P = .12), and bleeding (1.4% vs 2.0%; RR, 0.71; 95% CI, 0.38-1.33; P = .28). Conclusions and Relevance: No significant differences were found for survival or other clinical end points at 30 days after the use of radial access vs femoral access in patients with STEMI referred for primary PCI. However, small absolute differences in end points cannot be definitively refuted given the premature termination of the trial. Trial Registration: ClinicalTrials.gov identifier: NCT01398254. SN - 2380-6591 UR - https://www.unboundmedicine.com/medline/citation/31895439/Safety_and_Efficacy_of_Femoral_Access_vs_Radial_Access_in_ST-Segment_Elevation_Myocardial_Infarction:_The_SAFARI-STEMI_Randomized_Clinical_Trial L2 - https://jamanetwork.com/journals/jamacardiology/fullarticle/10.1001/jamacardio.2019.4852 DB - PRIME DP - Unbound Medicine ER -
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