Clinical trial NCT01398254: Femoral Versus Radial Access for Primary PCI
Official title: The Safety and Efficacy of Femoral Access Versus Radial for Primary Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction (SAFARI-STEMI Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
STEMI
Keywords: ST-Elevation Myocardial Infarction
Mortality
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2011-07-20
Enrollment: 2292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: All-cause mortality
timeFrame: 30 days
Secondary outcomes:
measure: Death, reinfarction, or stroke
timeFrame: 30 days and 6 months
measure: All-cause mortality
timeFrame: 6 months
measure: Reinfarction
timeFrame: 30 days and 6 months
measure: Stroke
timeFrame: 30 days and 6 months
measure: Stent thrombosis
timeFrame: 30 days and 6 months
measure: Bleeding
timeFrame: 30 days
measure: Number of blood transfusions
timeFrame: 30 days
measure: Cardiogenic shock
timeFrame: 30 days
measure: Critical time intervals (including door-to-balloon time)
timeFrame: Index hospitalization
measure: Fluoroscopy time and radiation exposure
timeFrame: Index Catheterization
measure: Length of Hospital Stay
timeFrame: Index hospitalization
measure: Resource utilization
timeFrame: 30 days
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
state: Nova Scotia
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Center
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Michel R Le May, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.