Primary Reperfusion Secondary Stenting Trial (PRIMACY)

Immediate vs. Delayed Stenting After Primary Percutaneous Reperfusion in ST Elevation Myocardial Infarction

The purpose of this research project is to improve how we treat heart attacks. The study will assess whether it might not be better to wait a few hours before implanting the coronary stent into the coronary artery rather than implanting it immediately, in order to allow the drugs to completely dissolve the clot. This might help to reduce the risks of the clot migrating and damaging the heart. By delaying coronary stent implantation, we hope to be able to reduce the size of the infarction and reduce the risk of suffering from heart failure following a heart attack.

Study Overview

• Status: Completed
• Conditions: ST-elevation Myocardial Infarction
• Intervention / Treatment: Procedure: Stent

Detailed Description

The PRIMACY trial seeks to assess whether a strategy of delayed stent implantation combined with adjunctive anticoagulation is superior to immediate stent implantation at improving cardiovascular outcomes in patients with mechanically reperfused ST-elevation Myocardial Infarction (STEMI). The investigators hypothesize that delayed stent implantation combined with systemic anticoagulation and maximal antiplatelet therapy will reduce the combined occurrence of cardiac death, non-fatal myocardial infarction, congestive heart failure, or unplanned target vessel revascularization over a 9-month period.

• Study Type: Interventional
• Enrollment (Actual): 307
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
    • Montreal, Quebec, Canada, H4J 1C5
      • Hopital Du Sacre Coeur de Montreal
    • Montreal, Quebec, Canada, H2W 1T8
      • CHUM-Hotel-Dieu de Montreal
    • St-Charles-Borromée, Quebec, Canada, J6E 6J2
      • Centre hospitalier régional de Lanaudière
    • Trois Rivières, Quebec, Canada, G8Z 3R9
      • CHR CSSS de Trois Rivières
• France
  • Bastia, France, 20200
    • CH de Bastia
  • Cannes, France, 06401
    • CH de Cannes
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont-Ferrand
  • Le Coudray, France, 28360
    • Hôpital Louis-Pasteur
  • Lyon, France, 69317
    • HCL Hôpital Croix Rousse
  • Metz-Tessy, France, 74370
    • CH Annecy Genevois
  • Montpellier, France, 34295
    • Ch de Montpellier-Hôpital A. de Villneuve
  • Nimes, France, 30029
    • CH de Nimes
  • Pau, France, 64000
    • CH de Pau
  • Toulouse, France, 31059
    • CHU de Toulouse-Hôpital Rangueil
  • Vichy, France, 03200
    • CH de Vichy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age between 18 and 80 years;
2. STEMI, presenting within 12 hours of symptoms onset, and persisting for more than 20 minutes;
3. ECG that fulfills any of the following criteria: ≥ 2 mm ST elevation in two anterior or lateral leads; or ≥ 1 mm ST elevation in two inferior leads; or new left bundle branch block (LBBB) with at least 1 mm concordant ST elevation;
4. Infarct-related artery with TIMI flow 0 or 1 at baseline angiogram;
5. Successful reperfusion (TIMI 2-3 flow), either spontaneously or after wire passage, thrombectomy, small size (≤ 2.0mm) angioplasty catheter, and persisting for more than 10 minutes;
6. Infarct related artery with a diameter above 2.5 mm.

Exclusion Criteria:

1. Prior STEMI in the qualifying coronary artery;
2. Coronary dissection following reperfusion;
3. STEMI caused by acute stent thrombosis or a venous or arterial bypass graft occlusion;
4. Significant left main disease, as determined by angiography (≥ 50%) or other imaging technologies;
5. Cardiac condition requiring emergent or urgent surgical repair;
6. Failed thrombolysis and rescue PCI;
7. High risk of bleeding;
8. Contraindication to either ticagrelor or GpIIb/IIIa inhibitors;
9. STEMI with Killip III-IV or cardiogenic shock or presenting as sudden death, ventricular fibrillation, or sustained ventricular tachycardia;
10. Women who are pregnant or breastfeeding;
11. Creatinine clearance < 20 ml/min;
12. Other contraindication to PCI;
13. Participation with another investigational drug or investigational device study within 30 days prior to randomization (participation to registries is allowed);
14. Any condition that in the opinion of the investigator would preclude compliance with the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Immediate stenting; the stent selection (bare metal vs drug eluting) and implantation will be performed as recommended by current practice guidelines.	Procedure: Stent; Percutaneous coronary intervention: reperfusion with a thrombectomy catheter or a small balloon angioplasty catheter, followed by coronary stenting; Other Names: Coronary stent; Thrombectomy catheter; Balloon angioplasty catheter
Experimental: Delayed stenting; participants randomised to delayed stenting will be treated with GPIIb-IIIa inhibitors for 12-18 hours after reperfusion followed by anticoagulation for until the control angiogram, expected no sooner than 18-24 hours after the index reperfusion.	Procedure: Stent; Percutaneous coronary intervention: reperfusion with a thrombectomy catheter or a small balloon angioplasty catheter, followed by coronary stenting; Other Names: Coronary stent; Thrombectomy catheter; Balloon angioplasty catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The combined occurence of cardiac death, non-fatal myocardial infarction, congestive heart failure, and urgent target vessel revascularization	As defined by standardized definitions	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major bleeding	As defined by the Bleeding Academic Research Consortium (BARC).	9 months

Collaborators and Investigators

• Sponsor: Montreal Heart Institute
• Investigators: Study Chair: Marc E Jolicoeur, MD MSc MHS, Montreal Heart Institute, Université de Montréal; Study Director: Nandini Dendukuri, PhD, Centre for Outcomes Research, McGill University Health Centre - Research Institute; Study Director: Loic Belle, MD, Hospital of Annecy, Centre Hospitalier Annecy Genevois, Annecy, France

Publications and helpful links

Helpful Links

• Canadian Journal of Cardiology Editorial
• Methods paper

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: February 16, 2012
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: PCI; STEMI; Thrombectomy; Percutaneous coronary intervention; Angioplasty; acute myocardial infarction; Deferred stenting; Delayed stenting; Late stenting; postponed stenting
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: PRIMACY