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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; STEMI
• Intervention / Treatment: Procedure: Primary Percutaneous Coronary Intervention (PPCI)

• Study Type: Interventional
• Enrollment (Actual): 2292
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface Hospital
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Saint John Regional Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 4G4
      • Queen Elizabeth II Health Sciences Center
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • Thunder Bay Regional Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	Time Frame
All-cause mortality	6 months
Stent thrombosis	30 days and 6 months
Death, reinfarction, or stroke	30 days and 6 months
Reinfarction	30 days and 6 months
Stroke	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

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation

Publications and helpful links

General Publications

• Marbach JA, Wells G, Santo PD, So D, Chong AY, Russo J, Labinaz M, Dick A, Froeschl M, Glover C, Hibbert B, Marquis JF, MacDougall A, Kass M, Paddock V, Quraishi AUR, Chandrasekhar J, Ghosh N, Bernick J, Le May M. Acute kidney injury after radial or femoral artery access in ST-segment elevation myocardial infarction: AKI-SAFARI. Am Heart J. 2021 Apr;234:12-22. doi: 10.1016/j.ahj.2020.12.019. Epub 2021 Jan 7.
• Le May M, Wells G, So D, Chong AY, Dick A, Froeschl M, Glover C, Hibbert B, Marquis JF, Blondeau M, Osborne C, MacDougall A, Kass M, Paddock V, Quraishi A, Labinaz M. Safety and Efficacy of Femoral Access vs Radial Access in ST-Segment Elevation Myocardial Infarction: The SAFARI-STEMI Randomized Clinical Trial. JAMA Cardiol. 2020 Feb 1;5(2):126-134. doi: 10.1001/jamacardio.2019.4852. Erratum In: JAMA Cardiol. 2020 Feb 1;5(2):236. JAMA Cardiol. 2020 Jul 29;: JAMA Cardiol. 2020 Sep 1;5(9):1071.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): January 16, 2019

Study Registration Dates

• First Submitted: July 13, 2011
• First Submitted That Met QC Criteria: July 18, 2011
• First Posted (Estimate): July 20, 2011

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 25, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Mortality; ST-Elevation Myocardial Infarction
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: MRL-SS; 2011311-01H