COMPLETE-2: Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease

Sponsor

Population Health Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05701358

Collaborator

(none)

5,100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction Coronary Artery Disease	Procedure: Physiology-guided NCL PCI Procedure: Angiography-guided NCL PCI	N/A

Detailed Description

COMPLETE-2 STUDY OBJECTIVES

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).
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2028

Anticipated Study Completion Date :

Mar 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Physiology-guided Non-Culprit-Lesion (NCL) PCI Patients randomized to this group will have their physiology assessment using RFR and/or FFR of all qualifying NCLs that were identified prior to randomization. Other validated non-hyperemic physiology ratios (eg. iFR) may only be used when RFR is not available.	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.
Other: Angiography-guided NCL PCI Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization.	Procedure: Angiography-guided NCL PCI PCI will be performed as per local practice

Arm

Intervention/Treatment

Active Comparator: Physiology-guided Non-Culprit-Lesion (NCL) PCI

Patients randomized to this group will have their physiology assessment using RFR and/or FFR of all qualifying NCLs that were identified prior to randomization. Other validated non-hyperemic physiology ratios (eg. iFR) may only be used when RFR is not available.

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.

Other: Angiography-guided NCL PCI

Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization.

Procedure: Angiography-guided NCL PCI

PCI will be performed as per local practice

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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