April 02, 2022
2 minute read
Mehta SR, et al. Featured Clinical Research I. Presented at American College of Cardiology Scientific Session; April 2-4, 2022; Washington, DC (hybrid meeting).
The COMPLETE trial was funded by the Canadian Institutes of Health Research and the Institute of Population Health and received support from AstraZeneca and Boston Scientific. Mehta does not report any relevant financial information.
WASHINGTON — Complete revascularization, as opposed to revascularization of the culprit lesion only, has been associated with improved angina-related quality of life in patients with STEMI and multivascular coronary artery disease, a speaker reported.
During the scientific session of the American College of Cardiology, Shamir R. Mehta, MD, MSc, FRCPC, FACC, FESC, Director of Interventional Cardiology at Hamilton Health Services and Professor in the Division of Cardiology at McMaster University in Hamilton, Ontario, Canada, reported the results of a predefined analysis of the COMPLETE trial.
“In patients with STEMI and multivascular disease, a strategy that was both comprehensive and responsible for lesion alone improved angina-related quality of life compared to baseline, but at a median follow-up of 3 years, more patients had no angina in the full revascularization group than the culprit-only group,” Mehta said during the presentation, “The benefit was seen almost fully in patients with tight nonculpable lesions with stenosis severity greater than or equal to 80% and total angina burden from randomization to follow-up was significantly reduced.
The main COMPLETE study was a multinational randomized trial including more than 4,000 patients with STEMI multivascular coronary artery disease who underwent complete or guilty lesion-only revascularization within 72 hours of successful PCI of the guilty lesion.
As Healio previously reported, complete revascularization was superior to PCI of the culprit lesion only in reducing the risk of CV death or MI in this patient population.
Mehta said the results of the COMPLETE trial led to complete revascularization being labeled as a Class 1A recommendation for concurrent STEMI and multivascular coronary artery disease in the ACC 2021/American Heart Association/American Association for Thoracic Surgery /Society of Thoracic Surgeons/Society for Cardiovascular Angiography and Procedure guidelines for coronary artery revascularization.
For the present COMPLETE data analysis, Mehta and colleagues assessed the effects of complete revascularization versus culprit lesion-only PCI on patients’ angina-related quality of life.
For this purpose, the researchers used responses to the Seattle Angina Questionnaire, a 19-item questionnaire, which was administered at baseline, 6 months, and at the final visit (median, 3 years). The primary outcome was the Seattle Angina Questionnaire score as a continuous variable and the proportion of patients without symptoms of angina. Scoring was assessed on a scale of 0 to 100, with 100 meaning a patient had no angina.
At the end of the COMPLETE trial, 87.5% of people who underwent complete revascularization and 84.3% of those who underwent culprit-only revascularization had no angina at their last visit (difference absolute = 3.2 percentage points; 95% CI, 0.7-5.7).
Mehta reported that this finding translated to a number needed to treat of 31 to prevent a patient from having angina on their last visit (P = 0.013).
Angina-related benefits were primarily seen in patients with non-causative stenosis of 80% or more vision and 60% or more baseline laboratory (P for interaction = 0.017).
Additionally, at the end of the trial, the composite endpoint of new MI, ischemia-induced revascularization, unstable angina, or residual angina was lower in patients who underwent complete revascularization versus lesion-causing revascularization alone (P < .001).
“The implications of this are that complete revascularization improves patient-reported overall health status in addition to its already established benefit in reducing major cardiovascular events,” Mehta said during the presentation. “These data also provide new information for patients and physicians to consider in the context of shared decision-making, which is also a Class I recommendation in the new revascularization guidelines with respect to revascularization of the coronary artery in patients with STEMI.