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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Ottawa Heart Institute Research Corporation
Sponsor:
Information provided by (Responsible Party):
Michel Le May, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:
NCT01398254
First received: July 13, 2011
Last updated: April 12, 2016
Last verified: April 2016
  Purpose

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.


Condition Intervention
Myocardial Infarction
STEMI
Procedure: Primary Percutaneous Coronary Intervention (PPCI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Safety and Efficacy of Femoral Access Versus Radial for Primary Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction (SAFARI-STEMI Trial)

Resource links provided by NLM:


Further study details as provided by Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    The primary outcomes will be all-cause mortality measured at 30 days.


Secondary Outcome Measures:
  • Death, reinfarction, or stroke [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: Yes ]
  • All-cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Reinfarction [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: Yes ]
  • Bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Number of blood transfusions [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Cardiogenic shock [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Critical time intervals (including door-to-balloon time) [ Time Frame: Index hospitalization ] [ Designated as safety issue: Yes ]
  • Fluoroscopy time and radiation exposure [ Time Frame: Index Catheterization ] [ Designated as safety issue: Yes ]
  • Length of Hospital Stay [ Time Frame: Index hospitalization ] [ Designated as safety issue: No ]
  • Resource utilization [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 4884
Study Start Date: July 2011
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TRA
Transradial Access
Procedure: Primary Percutaneous Coronary Intervention (PPCI)
Participants will be randomly assigned an access site, radial or femoral, for PPCI.
TFA
Transfemoral Access
Procedure: Primary Percutaneous Coronary Intervention (PPCI)
Participants will be randomly assigned an access site, radial or femoral, for PPCI.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398254

Contacts
Contact: Michel R Le May, MD 613-761-4223 mlemay@ottawaheart.ca
Contact: Melissa Blondeau 613-798-5555 ext 18948 mblondeau@ottawaheart.ca

Locations
Canada, Manitoba
St. Boniface Hospital Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Dolores Friesen         
Contact: James Ducas         
Principal Investigator: Malek Kass, MD         
Canada, New Brunswick
Saint John Regional Hospital Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Contact: Gail O'Blenis         
Principal Investigator: Vernon Paddock, MD         
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center Recruiting
Halifax, Nova Scotia, Canada, B3H 4G4
Contact: Margaret Pitts-Lesnick         
Contact: Mirjam Moeller         
Principal Investigator: Ata-Ur-Rehman Quraishi, MD         
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Michel R Le May, MD    613-761-4223    mlemay@ottawaheart.ca   
Contact: Melissa Blondeau    613-798-5555 ext 18948    mblondeau@ottawaheart.ca   
Principal Investigator: Michel Le May, MD         
Thunder Bay Regional Health Sciences Center Recruiting
Thunder Bay, Ontario, Canada, P7B 6V4
Contact: Jessica Dickson         
Contact: Crystal Forsyth         
Principal Investigator: Andrea MacDougall, MD         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Principal Investigator: Michel R Le May, MD Ottawa Heart Institute Research Corporation
  More Information

Responsible Party: Michel Le May, Director of Regional ACS Programs, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT01398254     History of Changes
Other Study ID Numbers: MRL-SS  2011311-01H 
Study First Received: July 13, 2011
Last Updated: April 12, 2016
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Heart Institute Research Corporation:
ST-Elevation Myocardial Infarction
Mortality

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2016