Complete versus culprit-only revascularization strategies to treat multi-vessel disease after primary percutaneous coronary interventions (PCI) for ST-segment elevation myocardial infarction

• Register: ISRCTN
• Last refreshed on: 26 April 2021
• Main ID: ISRCTN21662248
• Date of registration: 16/01/2014
• Prospective Registration: No
• Primary sponsor: Population Health Research Institute (Canada)
• Public title: Complete versus culprit-only revascularization strategies to treat multi-vessel disease after primary percutaneous coronary interventions (PCI) for ST-segment elevation myocardial infarction
• Scientific title: A randomised, comparative effectiveness study of COMPLETE versus culprit-only revascularization strategies to treat multi-vessel disease after primary percutaneous coronary interventions (PCI) for ST-segment elevation myocardial infarction
• Date of first enrolment: 01/01/2013
• Target sample size: 3900
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN21662248
• Study type: Interventional
• Study design: Randomised; Interventional; Design type: Process of Care (Treatment)
• Phase: Not Applicable

Countries of recruitment

Australia, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Israel, Italy, Lithuania, Macedonia, Mexico, Netherlands, Poland, Romania, Russian Federation, Serbia, Spain, Sweden, Ukraine, United Kingdom, United States of America

Contacts

• Name: Emilija Makaji

Key inclusion & exclusion criteria

Inclusion criteria:
1. Men and women within 72 hours after successful PCI (preferably using a drug-eluting stent) to the culprit lesion for STEMI. PCI for STEMI can be either primary PCI or rescue PCI for failed fibrinolysis or a pharmacoinvasive strategy where PCI is performed routinely 3-12 hours after initiation of fibrinolysis
2. Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has
2.1. at least 70% diameter stenosis (visual estimation) or
2.1. at least 50% diameter stenosis (visual estimation) with fractional flow reserve less than or equal to 0.80

Exclusion criteria:
1. Planned revascularisation of non-culprit lesion(s)
2. Planned surgical revascularisation
3. Non-cardiovascular co-morbidity reducing life expectancy to less than 5 years
4. Any factor precluding 5 year follow up.
5. Prior coronary artery bypass graft (CABG) surgery.


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
Circulatory System

Intervention(s)

1. Complete Revascularisation: Staged PCI using second generation drug eluting stents of all suitable non-culprit lesions.
2. Culprit Only Revascularisation, Culprit Lesion-Only Revascularisation: no further revascularisation of non-culprit lesions.

This will be a randomised, comparative effectiveness study of complete versus culprit-only revascularisation strategies to treat multi-vessel disease after primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI).

Screening.
Patients, over the age of 18 years of age, who have undergone index PCI for STEMI and have at least one other non-culprit lesion in a vessel that is greater than or equal to 2.5 mm in diameter with at least 70% diameter stenosis (on visual estimation) or 50-69% stenosis with fractional flow reserve (FFR) less than or equal to 0.80, will be eligible to participate in the COMPLETE study. Index PCI for STEMI can be either primary PCI or rescue PCI for failed fibrinolysis or a pharmacoinvasive strategy where PCI is performed routinely 3-12 hours after initiation of fibrinolysis.

The direct clinical care team performing the primary PCI will be aware of the patient's suitability. The clinical care team, if the clinical situation allows, will ask the patient if they would be interested in helping with the study. The clinical care team will alert the research team, who will approach the patient and provide sufficient information for the patient to decide whether to participate in the study. If it is not appropriate, for clinical reasons, to discuss the study at the procedure, the interventionist or a member of the clinical care team may ask the patient following the

Primary Outcome(s)

Cardiovascular (CV) death or new MI; Timepoint(s): hospital discharge, 30 days, 6 months, 12 months and then annually for up to 5 years

Secondary Outcome(s)

1. To determine whether complete revascularisation reduces the composite of cardiovascular (CV) death, new Myocardial Infarction (MI) or ischaemia-driven revascularisation.
2. To determine whether the initial strategy of complete revascularisation improves angina control, as assessed by the Seattle Angina Questionnaire (SAQ) Frequency Scale, and health-related quality of life scale at 6 months and 5 years/final follow-up compared to baseline.

Other:
To determine whether an initial strategy of complete revascularisation is superior to an initial strategy of culprit lesion only revascularisation in reducing the composite of CV death, new MI, ischaemia-driven revascularisation or rehospitalisation for unstable angina or hospitalisation for heart failure and each component of the key secondary objectives taken separately as well as all-cause mortality, stroke, stent thrombosis, major bleeding, economic evaluation, including health resource utilization, costs and cost-effectiveness.

Secondary ID(s)

15425

NCT01740479

Source(s) of Monetary Support

Astra Zeneca (Canada), Boston Scientific (USA), Population Health Research Institute (Canada)

Ethics review

Status:
Approval date:
Contact:

Medical Research Ethics Committee, 07/10/2013, 13/EM/0343

Results

• Results available: Yes
• Date Completed: 01/01/2018