Femoral Versus Radial Access for Primary PCI (SAFARI-STEMI)

University of Ottawa Heart Institute

Status

Completed

Conditions

Myocardial Infarction

STEMI

Treatments

Procedure: Primary Percutaneous Coronary Intervention (PPCI)

Study type

Interventional

Funder types

Other

Identifiers

NCT01398254

MRL-SS

2011311-01H

Details and patient eligibility

About

Primary percutaneous coronary intervention (PPCI) has become the dominant strategy for the treatment of ST-elevation myocardial infarction (STEMI), as studies have shown that PPCI is superior to fibrinolytic therapy. Recent evidence suggests that transradial access (TRA) is superior to transfemoral (TFA) for patients undergoing PPCI. Two large trials report a mortality benefit favouring TRA. The results of these two trials could significantly impact practice guidelines and lead to a recommendation that the approach of choice for primary PCI be radial rather than femoral. This would have significant implications for both PCI centers and interventionalists associated with a large impact on practice and education. Yet, many centers and interventionalists in Canada and in the USA prefer TFA and currently feel pressured in making the change to TRA. With that said, these trials did not include new pharmacotherapy and new technology that would likely have closed or eliminated the gap between TFA and TRA by improving the safety and efficacy of these two approaches. Furthermore, these trials were not powered to conclusively show a mortality benefit. The authors of the two large trials emphasized the need for further trials to confirm the benefits of TRA.

The SAFARI-STEMI trial aims to compare TFA with TRA in patients undergoing primary percutaneous intervention (PPCI). The primary outcome will be defined as all cause mortality measured at 30 days. The trial will also evaluate: 1) bleeding events and 2) the composite of death, reinfarction, or stroke defined as major adverse clinical events (MACE). The trial will include the use of antithrombotic therapy with monotherapy, with either bivalirudin or unfractionated heparin; the use of glycoprotein inhibitors IIb/IIIa inhibitors will be avoided. The study will encourage liberal use of vascular closing devices. The trial will also compare delays to reperfusion between the two strategies. Finally, a cost analysis is proposed.

In view of recent publications, there is now a need for a large randomized trial using contemporary adjunct therapies to assess the safety and efficacy of the TRA vs. the TFA in PPCI. The proposed trial aims to conclusively show whether there is a survival benefit associated with the TRA approach.

Enrollment

2,292 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ischemic chest discomfort of greater or equal to 30 minutes duration,
Onset of chest pain of greater or equal to 12 hrs prior to entry into the study,
ST segment elevation of > 1 mm (0.1 mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead ECG) or left bundle branch block not known to be old

Exclusion criteria

Age < 18 yrs
Active bleeding
Inadequate vascular access from the femoral arteries (i.e. severe peripheral vascular artery disease precluding right or left femoral approach)
Abnormal Allen's test precluding either right or left radial approach
PCI within the last 30 days
Fibrinolytic agents within the last 7 days
Warfarin, dabigatran or other oral anticoagulant within the last 7 days
Known coagulation disorder (i.e. INR >2.0, platelets <100,000 / mm3)
Allergy to aspirin
Participation in a study with another investigational device or drug < four weeks
Known severe renal impairment (creatinine >200 umol/L)*
Known severe contrast (dye) allergy
Prior coronary artery bypass surgery
Inability to provide informed consent
- Bivalirudin is contraindicated in renal failure.