SAfety and Efficacy of Femoral Access vs RadIal Access in STEMI - SAFARI-STEMI

Contribution To Literature:

The SAFARI-STEMI trial failed to show that radial access was superior to femoral access in primary PCI.

Description:

The goal of the trial was to evaluate radial access compared with femoral access among patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI).


Study Design

  • Randomized
  • Parallel

Patients with STEMI undergoing primary PCI were randomized to radial access (n = 1,136) versus femoral access (n = 1,156). Prior to randomization, all patients received aspirin 160 mg, P2Y12 inhibitor load, and unfractionated heparin 60 U/kg (maximum 4000 U).

  • Total number of enrollees: 2,292
  • Duration of follow-up: 30 days
  • Mean patient age: 62 years
  • Percentage female: 22%
  • Percentage with diabetes: 17%

Inclusion criteria:

  • STEMI with onset of symptoms ≤12 hours

Exclusion criteria:

  • Fibrinolytic therapy
  • Oral anticoagulants
  • Prior coronary artery bypass grafting (CABG)

Other salient features/characteristics:

  • During the procedure, bivalirudin was used 88% in the radial group and 92% in the femoral group; glycoprotein IIb/IIIa inhibitor was used 6.1% in the radial group and 5.9% in the femoral group; peak activated clotting time (ACT) was 395 seconds in the radial group and 389 seconds in the femoral group.
  • Vascular closure devices were used in 68% of the femoral group.

Principal Findings:

The trial was terminated early due to futility in detecting a difference in the primary outcome according to treatment strategy.

The primary outcome, all-cause mortality at 30 days, occurred in 1.5% of the radial group compared with 1.3% of the femoral group (p = 0.69). The primary outcome was the same in all prespecified subgroups.

Secondary outcomes:

  • Reinfarction: 1.8% for radial vs. 1.6% for femoral (p = 0.83)
  • Stroke: 1.0% for radial vs. 0.4% for femoral (p = 0.12)
  • Death, reinfarction, or stroke: 4.0% for radial vs. 3.4% for femoral (p = 0.45)
  • Definite/probable stent thrombosis: 1.5% for radial vs. 1.1% for femoral (p = 0.83)
  • Non-CABG TIMI major bleeding: 1.1% for radial vs. 1.3% for femoral (p = 0.74)

Interpretation:

Among patients with STEMI undergoing primary PCI, radial access was not superior to femoral access. SAFARI-STEMI was terminated early due to futility; however, based on the available data, radial access versus femoral access was not associated with a reduction in 30-day mortality, or any of the individual ischemic outcomes. Although unfractionated heparin was given to all patients prior to randomization and high ACTs were recorded during the procedure, major bleeding events were also similar between treatment groups.

Similar to the MATRIX trial, we can conclude that radial access is safe but not superior to femoral access. Operators and catheterization laboratories need to remain facile with femoral access, so that either access site can be utilized safely, where appropriate.

References:

Presented by Dr. Michel R. Le May at the American College of Cardiology Annual Scientific Session (ACC 2019), New Orleans, LA, March 18, 2019.

Keywords: ACC19, ACC Annual Scientific Session, Acute Coronary Syndrome, Aspirin, Heparin, Medical Futility, Myocardial Infarction, Peptide Fragments, Percutaneous Coronary Intervention, Platelet Glycoprotein GPIIb-IIIa Complex, Stents, Stroke, Thrombosis, Vascular Closure Devices, Vascular Diseases


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