Myocardial InfarctionSAFARI-STEMINCT01398254
Femoral Versus Radial Access for Primary PCI
A study testing Primary Percutaneous Coronary Intervention (PPCI) in people with Myocardial Infarction and STEMI, run by Ottawa Heart Institute Research Corporation at 5 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, STEMI
- What is being tested?
- Primary Percutaneous Coronary Intervention (PPCI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,292 participants
- Where
- 5 sitesCanada
- Study dates
- Jul 2011to 16 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic chest discomfort of greater or equal to 30 minutes duration,
- Onset of chest pain of greater or equal to 12 hrs prior to entry into the study,
- 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
Who cannot join
- Age < 18 yrs
- Active bleeding
- Inadequate vascular access from the femoral arteries (i.e. severe peripheral vascular artery disease precluding right or left femoral approach)
- Abnormal Allen's test precluding either right or left radial approach
- PCI within the last 30 days
- Fibrinolytic agents within the last 7 days
Show all 15Show fewer
- Warfarin, dabigatran or other oral anticoagulant within the last 7 days
- Known coagulation disorder (i.e. INR >2.0, platelets <100,000 / mm3)
- Allergy to aspirin
- Participation in a study with another investigational device or drug < four weeks
- Known severe renal impairment (creatinine >200 umol/L)*
- Known severe contrast (dye) allergy
- Prior coronary artery bypass surgery
- Inability to provide informed consent
- Bivalirudin is contraindicated in renal failure.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 4G4
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Thunder Bay Regional Health Sciences Center
Thunder Bay, Ontario, P7B 6V4
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: 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.
- Conditions
- Myocardial Infarction, STEMI
- Being tested
- Primary Percutaneous Coronary Intervention (PPCI)
- Keywords
- ST-Elevation Myocardial Infarction, Mortality
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Percutaneous Coronary Intervention (PPCI)Procedure or surgery
Participants will be randomly assigned an access site, radial or femoral, for PPCI.
| Study group | Role | What they receive |
|---|---|---|
| TRA | Other | Transradial Access Receives: Procedure: Primary Percutaneous Coronary Intervention (PPCI) |
| TFA | Other | Transfemoral Access Receives: Procedure: Primary Percutaneous Coronary Intervention (PPCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
The primary outcomes will be all-cause mortality measured at 30 days.
Measured: 30 days
Secondary outcomes (12)
Death, reinfarction, or stroke
Measured: 30 days and 6 months
All-cause mortality
Measured: 6 months
Reinfarction
Measured: 30 days and 6 months
Stroke
Measured: 30 days and 6 months
Stent thrombosis
Measured: 30 days and 6 months
Bleeding
Measured: 30 days
Number of blood transfusions
Measured: 30 days
Cardiogenic shock
Measured: 30 days
Critical time intervals (including door-to-balloon time)
Measured: Index hospitalization
Fluoroscopy time and radiation exposure
Measured: Index Catheterization
Length of Hospital Stay
Measured: Index hospitalization
Resource utilization
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2018
- Study completion16 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Le May, Ottawa Heart Institute Research Corporation
- Investigators
- Michel R Le May, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398254
- Sponsor's protocol ID
- MRL-SS
- Other IDs
- 2011311-01H
- Acronym
- SAFARI-STEMI
- Status last verified
- Jan 2019
- First submitted
- 13 Jul 2011
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 33422518Le 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.
PubMed 31895439
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Femoral Access Versus Radial for Primary Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction (SAFARI-STEMI Trial)
- ClinicalTrials.gov ID
- NCT01398254
- Acronym / sponsor ID
- SAFARI-STEMI / MRL-SS
- Conditions
- Myocardial Infarction, STEMI
- Keywords
- ST-Elevation Myocardial Infarction, Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,292 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2018 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRA | Other | Procedure: Primary Percutaneous Coronary Intervention (PPCI)Transradial Access |
| TFA | Other | Procedure: Primary Percutaneous Coronary Intervention (PPCI)Transfemoral Access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ischemic chest discomfort of greater or equal to 30 minutes duration,
- Onset of chest pain of greater or equal to 12 hrs prior to entry into the study,
- 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
Key exclusion criteria (15 listed)
- Age < 18 yrs
- Active bleeding
- Inadequate vascular access from the femoral arteries (i.e. severe peripheral vascular artery disease precluding right or left femoral approach)
- Abnormal Allen's test precluding either right or left radial approach
- PCI within the last 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Percutaneous Coronary Intervention (PPCI)Participants will be randomly assigned an access site, radial or femoral, for PPCI. | Procedure or surgery | TFA, TRA |
Primary outcome
All-cause mortality
Time frame: 30 days
The primary outcomes will be all-cause mortality measured at 30 days.
12 secondary outcomes
Death, reinfarction, or stroke
Time frame: 30 days and 6 months
All-cause mortality
Time frame: 6 months
Reinfarction
Time frame: 30 days and 6 months
Stroke
Time frame: 30 days and 6 months
Stent thrombosis
Time frame: 30 days and 6 months
Bleeding
Time frame: 30 days
Number of blood transfusions
Time frame: 30 days
Cardiogenic shock
Time frame: 30 days
Critical time intervals (including door-to-balloon time)
Time frame: Index hospitalization
Fluoroscopy time and radiation exposure
Time frame: Index Catheterization
Length of Hospital Stay
Time frame: Index hospitalization
Resource utilization
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Derived from this study: PubMed 33422518Marbach 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.
- Derived from this study: PubMed 31895439Le 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel R Le May, MD principal investigator
Ottawa Heart Institute Research Corporation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Percutaneous Coronary Intervention (PPCI) in people with Myocardial Infarction and STEMI, run by Ottawa Heart Institute Research Corporation at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01398254, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.