Dataset Information

Safety and Efficacy of Femoral Access vs Radial Access in ST-Segment Elevation Myocardial Infarction: The SAFARI-STEMI Randomized Clinical Trial.

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.

SUBMITTER: Le May M

PROVIDER: S-EPMC6990931 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Safety and Efficacy of Femoral Access vs Radial Access in ST-Segment Elevation Myocardial Infarction: The SAFARI-STEMI Randomized Clinical Trial.

Le May Michel M Wells George G So Derek D Chong Aun Yeong AY Dick Alexander A Froeschl Michael M Glover Christopher C Hibbert Benjamin B Marquis Jean-Francois JF Blondeau Melissa M Osborne Christina C MacDougall Andrea A Kass Malek M Paddock Vernon V Quraishi Ata A Labinaz Marino M

JAMA cardiology 20200201 2

<h4>Importance</h4>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.<h4>Objective</h4>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.<h4>Design, setting, and participants</h4>This multicenter, open-label, randomi ...[more]

PMID: 31895439

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Project description:AimsThere are limited contemporary data on the use of initial fibrinolysis in ST-segment elevation myocardial infarction cardiogenic shock (STEMI-CS). This study sought to compare the outcomes of STEMI-CS receiving initial fibrinolysis vs. primary percutaneous coronary intervention (PPCI).MethodsUsing the National (Nationwide) Inpatient Sample from 2009 to 2017, a comparative effectiveness study of adult (>18 years) STEMI-CS admissions receiving pre-hospital/in-hospital fibrinolysis were compared with those receiving PPCI. Admissions with alternate indications for fibrinolysis and STEMI-CS managed medically or with surgical revascularization (without fibrinolysis) were excluded. Outcomes of interest included in-hospital mortality, development of non-cardiac organ failure, complications, hospital length of stay, hospitalization costs, use of palliative care, and do-not-resuscitate status.ResultsDuring 2009-2017, 5297 and 110 452 admissions received initial fibrinolysis and PPCI, respectively. Compared with those receiving PPCI, the fibrinolysis group was more often non-White, with lower co-morbidity, and admitted on weekends and to small rural hospitals (all P < 0.001). In the fibrinolysis group, 95.3%, 77.4%, and 15.7% received angiography, PCI, and coronary artery bypass grafting, respectively. The fibrinolysis group had higher rates of haemorrhagic complications (13.5% vs. 9.9%; P < 0.001). The fibrinolysis group had comparable all-cause in-hospital mortality [logistic regression analysis: 28.8% vs. 28.5%; propensity-matched analysis: 30.8% vs. 30.3%; adjusted odds ratio 0.97 (95% confidence interval 0.90-1.05); P = 0.50]. The fibrinolysis group had comparable rates of acute organ failure, hospital length of stay, rates of palliative care referrals, do-not-resuscitate status use, and lesser hospitalization costs.ConclusionsThe use of initial fibrinolysis had comparable in-hospital mortality than those receiving PPCI in STEMI-CS in the contemporary era in this large national observational study.

Project description:BackgroundST-segment elevation myocardial infarction (STEMI) is a clinically distinguishable yet lethal sequela of ischaemic heart disease (IHD). In sub-Saharan Africa (SSA), death due to acute STEMI is increasing. In South Africa, there is a paucity of data available on the clinical outcomes of acute STEMI within one year for individuals treated in the public healthcare sector. This study primarily seeks to determine the one-year all-cause mortality rate of acute STEMI. The study also assesses the value of serum cardiac biomarkers of myocardial damage and serum uric acid in predicting all-cause mortality in STEMI.MethodsThis is a single-centre observational prospective cohort of all consecutive individuals presenting with an acute STEMI to the Charlotte Maxeke Johannesburg Academic Hospital (CMJAH) in Johannesburg, South Africa. Research data will be sourced on admission through electronic medical records, blood laboratory results and coronary angiography reports, and at follow-up through periodic telephonic interviews and standardised echocardiograms. At least 355 eligible participants will be continuously followed over one year, and clinical outcomes will be measured 30 days, three months, six months and one year after the index hospitalisation.DiscussionThis study provides insights into the demographic, risk factors and clinical profiles of individuals with STEMI in South Africa. Its findings may improve the risk stratification, prognostication, and therapeutic management of STEMI patients in our setting. By comparing the clinical outcomes between the different coronary reperfusion strategies, our results may guide clinicians in providing better patient treatment, particularly in sub-Saharan Africa, where access to percutaneous coronary intervention may be limited. Furthermore, the study offers insights into the routine use of baseline serum uric acid as a potential low-cost prognostic biomarker of all-cause mortality in STEMI. Finally, this study's findings may be of public health significance to local policymakers to aid in reinforcing primary prevention strategies and developing structured referral networks for timely coronary reperfusion of acute STEMI.

Dataset Information

Safety and Efficacy of Femoral Access vs Radial Access in ST-Segment Elevation Myocardial Infarction: The SAFARI-STEMI Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Safety and Efficacy of Femoral Access vs Radial Access in ST-Segment Elevation Myocardial Infarction: The SAFARI-STEMI Randomized Clinical Trial.

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