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

Overview

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.

Interventions

• Procedure Physiology-guided NCL PCI
  For RFR, PCI will be performed as per local practice for all lesions with RFR ≤0.89. For FFR, PCI will be performed as per local practice for all NCLs with FFR ≤0.80.
• Procedure Angiography-guided NCL PCI
  PCI will be performed as per local practice

Primary outcome measures

• Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR [Time frame: at study completion, a minimum of 2 years]
• Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury. [Time frame: at study completion, a minimum of 2 years]

Secondary outcome measures (2)

• Time to first occurrence of the composite of CV death or new MI. [Time frame: at study completion, a minimum of 2 years]
• 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. [Time frame: at study completion, a minimum of 2 years]

Eligibility criteria

Inclusion criteria

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

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

Exclusion criteria

• Planned or prior coronary artery bypass graft (CABG) surgery
• 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
• Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
• Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
• Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or >90% visual diameter stenosis
• 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)
• The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
• 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
• Non-cardiovascular co-morbidity with expected life expectancy <2 years
• Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Canada · 24 centers

• McGill University Health Centre (MUHC) — Montreal
• William Osler Health System — Brampton
• University of Alberta Hospital, Mazankowski Heart — Edmonton
• Hamilton Health Sciences — Hamilton
• Kingston Health Sciences Centre — Kingston
• St. Mary's General Hospital — Kitchener
• London Health Sciences Centre — London
• Centre Hospitalier de l'Universite de Montreal — Montreal
• … and 16 more centers

United Kingdom · 19 centers

Center list to be confirmed — check the primary protocol.

United States · 13 centers

• UCLA — Los Angeles
• University of California, San Francisco — San Francisco
• Cardiovascular Research Institute of Kansas — Wichita
• The Johns Hopkins University School of Medicine — Baltimore
• University of Michigan — Ann Arbor
• Metropolitan Cardiology Consultants / Metropolitan Heart and Vascular Institute (MCC/MHVI) — Coon Rapids
• RWJ Barnabas Health — Jersey City
• Bassett Medical Center — Cooperstown
• … and 5 more centers

India · 10 centers

• Lisie Hospital — Ernākulam
• Meditrina Hospital — Kollam
• Caritas Hospital Trust — Kottayam
• Apollo Rajshree Hospitals — Indore
• Rukmani Birla Hospital — Jaipur
• Apollo Hospital — Chennai
• The Madras Medical Mission — Chennai
• Meenakshi Mission Hospital and Research Center — Madurai
• … and 2 more centers

Germany · 7 centers

• St. Vinzenz-Hospital — Cologne
• Helios Amper-Klinikum — Dachau
• Universitatsklinikum Frankfurt — Frankfurt
• Marienkrankenhaus — Hamburg
• Schoen Klink Hamburg — Hamburg
• University Heart & Vascular Center Hamburg — Hamburg
• WKK Heide — Heide

Spain · 7 centers

Center list to be confirmed — check the primary protocol.

Sweden · 7 centers

Center list to be confirmed — check the primary protocol.

Italy · 6 centers

• Azienda USL Toscana Sud Est — Arezzo
• UOC Cardiologia - Ospedale Maggiore — Bologna
• Azienda Ospedaliero - Universitaria di Ferrara — Ferrara
• Misericordia Hospital — Grosseto
• Azienda USL-IRCCS di Reggio Emilia, Reggio — Reggio Emilia
• Sant Andrea Hospital - Sapienza University — Rome

Norway · 4 centers

• Sorlandet Hospital Arendal — Kristiansand
• Oslo University Hospital Ulleval — Oslo
• Stavanger University Hospital — Stavanger
• University Hospital Tromso — Tromsø

Denmark · 3 centers

• Aalborg University Hospital — Aalborg
• Aarhus University Hospital — Aarhus
• Rigshospitalet - Copenhagen University Hospital — Copenhagen

Finland · 3 centers

• Helsinki University Hospital — Helsinki
• TAYS Sydankeskus Oy — Tampere
• Turku University Hospital — Turku

Poland · 3 centers

• Provincial Specialized Hospital — Legnica
• Miedziowym Centrum Zdrowia S.A. w Lubinie — Lubin
• Medical University of Warsaw — Warsaw

Hungary · 2 centers

• Gottsegen National Cardiovascular Center — Budapest
• University of Szeged — Szeged

Serbia · 2 centers

• Institute for Cardiovascular Diseases Dedinje — Belgrade
• University Clinical Center of Serbia — Belgrade

Australia · 1 center

• Westmead Hospital — Westmead

Austria · 1 center

• Klinik Floridsdorf — Vienna

Czechia · 1 center

• St. Anne's University Hospital — Brno

Identifiers

NCT: NCT05701358 · COMPLETE-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗