Femoral Versus Radial Access for Primary PCI

Not Applicable

Completed

• Conditions: Myocardial Infarction; STEMI
• Interventions: Procedure: Primary Percutaneous Coronary Intervention (PPCI)

• Registration Number: NCT01398254
• Lead Sponsor: Ottawa Heart Institute Research Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-20
• Primary Completion: 2018-12
• Status Verified: 2019-01
• Study Completion: 2019-01-16
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2292

Inclusion Criteria

1. Ischemic chest discomfort of greater or equal to 30 minutes duration,
2. Onset of chest pain of greater or equal to 12 hrs prior to entry into the study,
3. 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

1. Age < 18 yrs

2. Active bleeding

3. Inadequate vascular access from the femoral arteries (i.e. severe peripheral vascular artery disease precluding right or left femoral approach)

4. Abnormal Allen's test precluding either right or left radial approach

5. PCI within the last 30 days

6. Fibrinolytic agents within the last 7 days

7. Warfarin, dabigatran or other oral anticoagulant within the last 7 days

8. Known coagulation disorder (i.e. INR >2.0, platelets <100,000 / mm3)

9. Allergy to aspirin

10. Participation in a study with another investigational device or drug < four weeks

11. Known severe renal impairment (creatinine >200 umol/L)*

12. Known severe contrast (dye) allergy

13. Prior coronary artery bypass surgery

14. Inability to provide informed consent

    • Bivalirudin is contraindicated in renal failure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TFA	Primary Percutaneous Coronary Intervention (PPCI)	Transfemoral Access
TRA	Primary Percutaneous Coronary Intervention (PPCI)	Transradial Access

Primary Outcome Measures

Name	Time	Method
All-cause mortality	30 days	The primary outcomes will be all-cause mortality measured at 30 days.

Secondary Outcome Measures

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

Trial Locations

Locations (5)

St. Boniface Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Queen Elizabeth II Health Sciences Center; 🇨🇦 Halifax, Nova Scotia, Canada

Thunder Bay Regional Health Sciences Center; 🇨🇦 Thunder Bay, Ontario, Canada

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

Saint John Regional Hospital; 🇨🇦 Saint John, New Brunswick, Canada