An interventional study of Primary Percutaneous Coronary Intervention (PPCI) in Myocardial Infarction and STEMI, sponsored by Ottawa Heart Institute Research Corporation. Completed at 5 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-29.
Sponsored by Ottawa Heart Institute Research Corporation · Not applicable, Interventional, and Prevention
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.
2,779 studies on the registry are indexed under Myocardial Infarction; 417 are open to participants now.
This study's enrollment of 2,292 is above the median of 148 across 1,613 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Ottawa Heart Institute Research Corporation is the lead sponsor of 181 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
Inability to provide informed consent
Transradial Access
Procedure: Primary Percutaneous Coronary Intervention (PPCI)
Transfemoral Access
Procedure: Primary Percutaneous Coronary Intervention (PPCI)
Participants will be randomly assigned an access site, radial or femoral, for PPCI.
All-cause mortality
The primary outcomes will be all-cause mortality measured at 30 days.
Time frame: 30 days
Death, reinfarction, or stroke
Time frame: 30 days and 6 months
All-cause mortality
Time frame: 6 months
Reinfarction
Time frame: 30 days and 6 months
Stroke
Time frame: 30 days and 6 months
Stent thrombosis
Time frame: 30 days and 6 months
Bleeding
Time frame: 30 days
Number of blood transfusions
Time frame: 30 days
Cardiogenic shock
Time frame: 30 days
Critical time intervals (including door-to-balloon time)
Time frame: Index hospitalization
Fluoroscopy time and radiation exposure
Time frame: Index Catheterization
Length of Hospital Stay
Time frame: Index hospitalization
Resource utilization
Time frame: 30 days
The record gives a start of Jul 2011, a primary completion of Dec 2018 and a completion of Jan 2019. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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