Femoral Versus Radial Access for Primary PCI

NCT ID: NCT01398254

Last Updated: 2019-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2019-01-16

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.

Conditions

Myocardial Infarction; STEMI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

TRA

Transradial Access

Group Type: OTHER

Primary Percutaneous Coronary Intervention (PPCI)

Intervention Type: PROCEDURE

Participants will be randomly assigned an access site, radial or femoral, for PPCI.

TFA

Transfemoral Access

Group Type: OTHER

Primary Percutaneous Coronary Intervention (PPCI)

Intervention Type: PROCEDURE

Participants will be randomly assigned an access site, radial or femoral, for PPCI.

Interventions

Primary Percutaneous Coronary Intervention (PPCI)

Participants will be randomly assigned an access site, radial or femoral, for PPCI.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Michel Le May

Director of Regional ACS Programs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michel R Le May, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Thunder Bay Regional Health Sciences Center

Thunder Bay, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 33422518 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31895439 (View on PubMed)

Other Identifiers

2011311-01H

Identifier Type: -

Identifier Source: secondary_id

MRL-SS

Identifier Type: -

Identifier Source: org_study_id