Complete v culprit-only revascularisation in PPCI for STEMI -COMPLETE
Research type
Research Study
Full title
A randomised, comparative effectiveness study of complete versus culprit-only revascularization strategies to treat multi-vessel disease after primary percutaneous coronary interventions for ST-segment elevation myocardial infarction.
IRAS ID
134364
Contact name
Robert F Storey
Contact email
Sponsor organisation
Population Health Research Institute
Clinicaltrials.gov Identifier
Research summary
It is common practice to treat patients with a heart attack affecting much of the heart muscle, known as an ST-segment elevation myocardial infarction (STEMI), with primary percutaneous coronary intervention (primary PCI). Doctors trained to carry out this procedure are called interventionists. Interventionists identify the ’culprit’ lesion, which is the blocked coronary artery responsible for the heart attack, clear any blood clot, and usually site a small device known as a stent, in the artery to keep it open and allow the blood to flow freely to the heart muscle (revascularisation). The amount of disease varies from patient to patient. Some patients will have residual narrowings in arteries that have not actually caused the heart attack. These narrowings are referred to as ’non-culprit lesions’. Following PPCI, some interventionists will treat these patients with medical therapy and only if the patients re-presents with worsening symptoms will consider looking at the arteries again. However, other interventionists, following primary PCI, will treat the patient with medication, and in addition, plan to bring the patient back to the catheter laboratory in the near future to treat the non-culprit lesions (’staged PCI’), theorising it will minimise the risk of further ischaemic events.
The COMPLETE study is looking at both of the treatment strategies described above to evaluate whether a strategy of complete revascularisation will be superior to a strategy of culprit-lesion-only revascularisation in reducing major clinical outcomes including the composite of cardiovascular (CV) death or new MI and the composite death, new MI or ischaemia-driven revascularisation.
Patients who have undergone primary PCI and meet the inclusion criteria will be invited to participate in the study within 72 hours of their procedure. Those randomised to complete revascularisation will undergo staged PCI, within 45 days, of all suitable non-culprit lesions.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
13/EM/0343
Date of REC Opinion
7 Oct 2013
REC opinion
Further Information Favourable Opinion