The COMPLETE-2 study team has recruited the first patient to their multinational trial of physiology-guided versus angiography-guided non-culprit lesion complete revascularization strategies in patients with acute heart attack and multi-vessel coronary artery disease.
“After the success of the COMPLETE randomized controlled trial (RCT) showing that complete revascularization improves outcome in patients with acute heart attack, we are delighted to start COMPLETE-2,” says PHRI Senior Scientist Shamir Mehta, principal investigator on both trials.
“We hope to reduce the number of unnecessary percutaneous coronary interventions (PCI) by as much as 50% – thereby improving safety while maintaining efficacy,” says Mehta.
The COMPLETE-2 RCT team plans to recruit 5100 patients at 140 sites in 24 countries.
“This trial will build on the successful results of the COMPLETE trial by defining exactly which lesions benefit from revascularization based on their physiological significance, rather than just relying on the stenosis severity,” says Mehta.
“We are using state-of-the-art techniques to determine the hemodynamic significance of the non-culprit lesion. In those lesions that are hemodynamically significant, we plan to open them. Those lesions that are not hemodynamically significant will be treated with guideline-directed medical therapy alone,” he adds.
OCT imaging sub-study
“In addition, we will also be using state-of-the-art intracoronary imaging using optical coherence tomography (OCT) – a novel advance that uses light to look inside the coronary artery and characterize the plaque phenotype and whether it predicts major cardiovascular events,” says Mehta.
COMPLETE-2’s prospective, observational, multi-centre OCT imaging sub-study will involved an expected 1500 patients with ST elevation myocardial infarction (STEMI) or NSTEMI and multi-vessel coronary artery disease.
Mehta and Brian McGrath noted in an European Heart Journal editorial earlier this year that that “it is possible, perhaps even likely, that intravascular imaging assessing plaque morphology is complementary to a physiology-guided strategy.”
Landmark trial, COMPLETE
The COMPLETE trial (NEJM, 2019) changed how the global medical field treats a heart attack involving a completely blocked coronary artery. Its results received full marks in evidence and recommendation in the 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization.
COMPLETE was named a NEJM Notable Article of 2019, and one of the Top Cardiology Trials of 2019 by Robert Harrington and C. Michael Gibson in Medscape.