COMPLETE

The findings of the COMPLETE trial received 1A Recommendation & Evidence in the 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization.

COMPLETE determined that, on a background of optimal medical therapy with low dose ASA and ticagrelor, a strategy of multi-vessel revascularization, involving staged PCI using drug eluting stents of all suitable non-infarct related artery lesions, was superior to a strategy of culprit lesion-only revascularization in reducing the composite outcome of cardiovascular (CV) death or new MI in patients with multi-vessel disease who have undergone successful culprit lesion primary PCI for STEMI.

Key secondary objectives were:

• To determine whether complete revascularization reduces the composite of CV death, new MI or ischemia-driven revascularization, and;
• To determine whether the initial strategy of complete revascularization improves angina control, as assessed by the Seattle Angina Questionnaire (SAQ) Frequency Scale, and health-related quality of life, as assessed by the EQ-5D Quality of Life scale at six months and five year/final follow up compared to baseline.

COMPLETE Long-Term Follow Up

In an observational registry, up to 1500 consenting COMPLETE study participants (at a planned 55 sites in 3 countries) will be followed passively for five to 10 years. During this period, there will be no protocol-mandated therapies, and the primary care physicians will determine treatment of all study participants based on their interpretation of the available evidence.

The COMPLETE Follow-up study is focused on identifying the occurrence of deaths and major CV events and, if possible, linkages to administrative national or regional databases that record mortality and major morbidity (e.g. hospitalizations for myocardial infraction or stroke) will be conducted.

COMPLETE-2

A large international randomized trial is now underway investigating physiology-guided versus angiography-guided non-culprit lesion complete revascularization strategies in patients with acute myocardial infarction and multi-vessel coronary artery disease (COMPLETE-2).