Femoral Versus Radial Access for Primary PCI

Study Overview
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Brief Summary
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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.

Official Title
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The Safety and Efficacy of Femoral Access Versus Radial for Primary Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction (SAFARI-STEMI Trial)

Conditions
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Myocardial Infarction, STEMI

Intervention / Treatment
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* Procedure: Primary Percutaneous Coronary Intervention (PPCI)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TRA<br>Transradial Access | Procedure: Primary Percutaneous Coronary Intervention (PPCI)<br>* Participants will be randomly assigned an access site, radial or femoral, for PPCI.<br>|
| Other: TFA<br>Transfemoral Access | Procedure: Primary Percutaneous Coronary Intervention (PPCI)<br>* Participants will be randomly assigned an access site, radial or femoral, for PPCI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | The primary outcomes will be all-cause mortality measured at 30 days. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death, reinfarction, or stroke |  | 30 days and 6 months | 
| All-cause mortality |  | 6 months | 
| Reinfarction |  | 30 days and 6 months | 
| Stroke |  | 30 days and 6 months | 
| Stent thrombosis |  | 30 days and 6 months | 
| Bleeding |  | 30 days | 
| Number of blood transfusions |  | 30 days | 
| Cardiogenic shock |  | 30 days | 
| Critical time intervals (including door-to-balloon time) |  | Index hospitalization | 
| Fluoroscopy time and radiation exposure |  | Index Catheterization | 
| Length of Hospital Stay |  | Index hospitalization | 
| Resource utilization |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST-Elevation Myocardial Infarction, Mortality