Clinical trial NCT05701358: Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
Official title: A Randomized Trial of Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization Strategies & an Observational Study of Optical Coherence Tomography in Patients With Acute MI & Multivessel Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Myocardial Infarction
Coronary Artery Disease
Keywords: NSTEMI
STEMI
multi-vessel disease
optical coherence tomography
FFR
RFR
percutaneous coronary intervention
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 5100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI).

COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.

Detailed description: COMPLETE-2 STUDY OBJECTIVES

1. To determine whether a strategy of physiology-guided complete revascularization is non-inferior to a strategy of angiography-guided complete revascularization on the efficacy composite outcome of cardiovascular (CV) death, new myocardial infarction (MI) or ischemia-driven revascularization (IDR).
2. To determine whether a physiology-guided complete revascularization strategy is superior to an angiography-guided complete revascularization strategy in reducing the safety composite outcome of clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.

Eligibility criteria: Inclusion Criteria:

1. Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
2. Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria:

   1. Amenable to successful treatment with PCI
   2. At least 50% diameter stenosis by visual estimation
   3. At least 2.5 mm in diameter
3. Planned complete revascularization strategy for qualifying MI

Exclusion Criteria:

1. Planned or prior coronary artery bypass graft (CABG) surgery
2. Inability to clearly identify a culprit lesion for STEMI or NSTEMI based on angiographic appearance and/or ECG changes and/or regional wall motion abnormalities
3. Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
4. Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
5. Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or \>90% visual diameter stenosis
6. Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culprit lesion (patients with a CTO plus additional qualifying non-culprit lesions are eligible)
7. The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
8. Baseline STEMI or NSTEMI was due to a suspected non-atherothrombotic mechanism such as type 2 MI (supply-demand mismatch), including spontaneous coronary artery dissection or coronary artery embolism
9. Non-cardiovascular co-morbidity with expected life expectancy \<2 years
10. Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up

Primary outcomes:
measure: Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR
timeFrame: at study completion, a minimum of 2 years
measure: Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury.
timeFrame: at study completion, a minimum of 2 years
Secondary outcomes:
measure: Time to first occurrence of the composite of CV death or new MI.
timeFrame: at study completion, a minimum of 2 years
measure: Net clinical outcome: Time to first occurrence of the composite of CV death, new MI, clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.
timeFrame: at study completion, a minimum of 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Wichita
country: United States
facility: Cardiovascular Research Institute of Kansas
state: Kansas
city: Baltimore
country: United States
facility: The Johns Hopkins University School of Medicine
state: Maryland
city: Cooperstown
country: United States
facility: Bassett Medical Center
state: New York
city: Calgary
country: Canada
facility: University of Calgary - Foothills Medical Centre
city: Edmonton
country: Canada
facility: University of Alberta Hospital, Mazankowski Heart
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
city: Kitchener
country: Canada
facility: St. Mary's General Hospital
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
city: Montréal
country: Canada
facility: Hopital du Sacre-Coeur de Montreal
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
city: Saskatoon
country: Canada
facility: Royal University Hospital
city: St. John's
country: Canada
facility: Newfoundland and Labrador Health Services
city: Toronto
country: Canada
facility: St. Michael's Hospital (Unity Health Toronto)
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet - Copenhagen University Hospital
city: Hamburg
country: Germany
facility: University Heart & Vascular Center Hamburg
city: Ferrara
country: Italy
facility: Azienda Ospedaliero - Universitaria di Ferrara
city: Reggio Emilia
country: Italy
facility: Azienda USL-IRCCS di Reggio Emilia, Reggio
city: Rome
country: Italy
facility: Sant Andrea Hospital - Sapienza University
city: Huddinge
country: Sweden
facility: Karolinska University Hospital
city: Lund
country: Sweden
facility: Skane University Hospital
city: Stockholm
country: Sweden
facility: Danderyd Hospital
city: Umeå
country: Sweden
facility: Umeå University Hospital
city: Kettering
country: United Kingdom
facility: Kettering General Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals
Study officials:
affiliation: Population Health Research Institute
name: Shamir Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References: