Femoral Versus Radial Access for Primary PCI

Myocardial Infarction Clinical Trial

— SAFARI-STEMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398254
• Other study ID #: MRL-SS
• Secondary ID: 2011311-01H
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: January 16, 2019

Study information

• Verified date: January 2019
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2292
• Est. completion date: January 16, 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI

Intervention

Procedure:
• Primary Percutaneous Coronary Intervention (PPCI)
Participants will be randomly assigned an access site, radial or femoral, for PPCI.

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences Center	Halifax	Nova Scotia
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Thunder Bay Regional Health Sciences Center	Thunder Bay	Ontario
Canada	St. Boniface Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	The primary outcomes will be all-cause mortality measured at 30 days.	30 days
Secondary	Death, reinfarction, or stroke		30 days and 6 months
Secondary	All-cause mortality		6 months
Secondary	Reinfarction		30 days and 6 months
Secondary	Stroke		30 days and 6 months
Secondary	Stent thrombosis		30 days and 6 months
Secondary	Bleeding		30 days
Secondary	Number of blood transfusions		30 days
Secondary	Cardiogenic shock		30 days
Secondary	Critical time intervals (including door-to-balloon time)		Index hospitalization
Secondary	Fluoroscopy time and radiation exposure		Index Catheterization
Secondary	Length of Hospital Stay		Index hospitalization
Secondary	Resource utilization		30 days