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Download TrialContribution To Literature:
The COMPLETE trial showed that complete revascularization was superior to culprit-only revascularization at reducing death or MI.
Description:
The goal of the trial was to evaluate a complete revascularization strategy compared with a culprit-only revascularization strategy among patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary disease.
Study Design
- Randomized
- Parallel
- Stratified
Patients with STEMI and multivessel coronary disease were randomized to complete revascularization (n = 2,016) versus culprit-only revascularization (n = 2,025). Patients randomized to complete revascularization underwent staged percutaneous coronary intervention (PCI) during the index hospitalization or after hospital discharge (within 45 days).
- Total number of enrollees: 4,041
- Duration of follow-up: 3 years
- Mean patient age: 62 years
- Percentage female: 19%
- Percentage with diabetes: 19%
Inclusion criteria:
- Patient with STEMI undergoing primary PCI
- Nonculprit multivessel coronary disease, defined as a 70% stenosis or 50-69% stenosis with fractional flow reserve (FFR) ≤0.8
Exclusion criteria:
- Intention to revascularize a nonculprit lesion before randomization
- Planned surgical revascularization
- Previous coronary artery bypass grafting
Other salient features/characteristics:
- Thrombus aspiration performed in 24%
Principal Findings:
The primary outcome of cardiovascular death or MI at 3 years occurred in 7.8% of the complete revascularization group compared with 10.5% of the culprit-only revascularization group (p = 0.004).
Secondary outcomes:
- Cardiovascular death, MI, or ischemia-driven revascularization: 8.9% with complete revascularization vs. 16.7% with culprit-only revascularization (p < 0.001)
- Major bleeding: 2.9% with complete revascularization vs. 2.2% with culprit-only revascularization (p = 0.15)
- Contrast-induced nephropathy: 1.5% with complete revascularization vs. 0.9% with culprit-only revascularization (p = 0.11)
Landmark analysis for cardiovascular death or MI:
- Randomization to 45 days, hazard ratio (HR) 0.86, 95% confidence interval (CI) 0.59-1.24
- >45 days to study end, HR 0.69, 95% CI 0.54-0.89
Optical coherence tomography (OCT) substudy (n = 93): OCT was performed on ≥2 nonculprit vessels. Among obstructive lesions, a thin-cap fibroelastoma was present in 39%. Among nonobstructive lesions, a thin-cap fibroelastoma was present in 27%.
Timing of staged nonculprit PCI (HR, 95% CI for complete vs. culprit-only PCI):
- Nonculprit PCI during hospitalization (median 1 day), HR 0.77, 95% CI 0.59-1.0
- Nonculprit PCI after hospitalization (median 23 days), HR 0.69, 95% CI 0.49- 0.97, p for interaction = 0.62
Interpretation:
Among patients with STEMI and multivessel disease undergoing primary PCI, complete revascularization was superior to culprit-only revascularization. Complete revascularization was beneficial if performed either during or after the index hospitalization. Complete revascularization was associated with a reduction in cardiovascular death or MI. This was accomplished without an increase in major bleeding or contrast-induced nephropathy. The OCT substudy revealed a large proportion of thin-cap fibroelastoma in nonculprit obstructive lesions. This may help to explain the benefit that was observed from multivessel revascularization.
Previous trials on the topic have demonstrated benefit for complete revascularization, but benefit was mainly due to a reduction in the risk of revascularization. The COMPLETE trial was able to show that complete revascularization was associated with a reduction in ‘hard outcomes' since the primary outcome was cardiovascular death or MI.
In summary, complete revascularization (before or after the index hospitalization) after primary PCI for STEMI is beneficial.
References:
Wood DA, Cairns JA, Wang J, et al., on behalf of the COMPLETE Investigators. Timing of Staged Nonculprit Artery Revascularization in Patients With ST-Segment Elevation Myocardial Infarction: COMPLETE Trial. J Am Coll Cardiol 2019;74:2713-23.
Editorial Comment: Gershlick AH, Price MJ. Full Revascularization in the Patient With ST-Segment Elevation Myocardial Infarction: The Story So Far. J Am Coll Cardiol 2019;74:2724-7.
Presented by Dr. Natalia Pinilla Echeverri at the American Heart Association Annual Scientific Sessions (AHA 2019), Philadelphia, PA, November 17, 2019.
Mehta SR, Wood DA, Storey RF, et al., on behalf of the COMPLETE Trial Steering Committee and Investigators. Complete Revascularization With Multivessel PCI for Myocardial Infarction. N Engl J Med 2019;381:1411-21.
Editorial: Køber L, Engstrøm T. A More COMPLETE Picture of Revascularization in STEMI. N Engl J Med 2019;381:1472-4.
Presented by Dr. David A. Wood at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2019), San Francisco, CA, September 28, 2019.
Presented by Dr. Shamir R. Mehta at the European Society of Cardiology Congress, Paris, France, September 1, 2019.
Clinical Topics:Acute Coronary Syndromes, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Interventions and ACS, Interventions and Coronary Artery Disease
Keywords:AHA Annual Scientific Sessions, AHA19, ESC Congress, ESC 19, Acute Coronary Syndrome, Cardiac Surgical Procedures, Constriction, Pathologic, Coronary Artery Bypass, Coronary Artery Disease, Fractional Flow Reserve, Myocardial, Hemorrhage, Hospitalization, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention, Thrombosis, Transcatheter Cardiovascular Therapeutics, TCT19
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