The results of a substudy of the COMPLETE Trial were presented at TCT 2019 by Dr. David Wood, an interventional cardiologist, and Professor of Medicine at the University of British Columbia, Canada. The analyses revealed that compared with culprit-lesion only PCI, the timing of complete revascularization, whether performed early during the index hospitalization or after discharge have similar benefits on major cardiovascular events.
The COMPLETE Trial was recently published in the New England Journal of Medicine and simultaneously presented at ESC congress 2019. Patients with STEMI and multi-vessel coronary artery disease who had undergone successful culprit-lesion PCI were randomly assigned to a strategy of either complete revascularization with PCI of the angiographically significant non-culprit lesion (NCL) or no further intervention. Randomization was stratified according to the intended timing of non-culprit lesion PCI (either during the index hospitalization or after the discharge). The first co-primary outcome was the composite of cardiovascular death or new myocardial infarction; the second co-primary outcome was the composite of cardiovascular death, new myocardial infarction, or ischemia-driven revascularization (IDR). At a median follow-up of 3 years, complete revascularization was superior to culprit-lesion-only PCI in reducing the risk of cardiovascular death or myocardial infarction, as well as the risk of cardiovascular death, myocardial infarction, or ischemia-driven revascularization.
The current substudy of the COMPLETE Trial focused on the importance of revascularization timing. Compared with culprit-lesion only PCI, a strategy of non-culprit lesion PCI with the goal of complete revascularization performed early during index hospitalization (median 1 day) or after discharge (median 23 days) confers similar benefit on major CV events (Hazard ratio [HR] of first co-primary outcome, 0.77, 95% confidence interval [CI], 0.59 to 1.00, P = 0.047 for complete revascularization done at index hospitalization vs. HR of 0.69, 95% CI, 0.49 to 0.97, P = 0.032 for complete revascularization done after discharge. For secondary co-primary outcomes similar results were observed; HR,0.47, 95% CI, 0.38 to 0.59, P < 0.001 for complete revascularization performed at index hospitalization vs. HR, 0.59, 95% CI, 0.43 to 0.79, P < 0.001 for complete revascularization done after discharge. Moreover, there were no statistically significant differences in safety outcomes, including stroke, stent thrombosis, major bleeding, and contrast-associated acute kidney injury between allocated therapy (complete vs. culprit-only PCI group) in either the index hospitalization or after discharge non-culprit PCI strata. The benefit of complete revascularization on hard outcomes (CV death or MI) emerges mainly over the long term (> 45 days to study end).
In an interview with Dr. C. Michael Gibson, an interventional cardiologist at Beth Israel Deaconess Medical Center and Professor of Medicine at Harvard Medical School, Dr. David Wood highlighted that mean baseline Syntax score of the patients was 16 which after fixing the culprit lesion, dropped to 7. In complete revascularization group, more than 90% of the patients had Syntax score of 0 at the end. So, it is kind of resetting the natural history of these patients and therefore the implication for the healthcare system, patients, and care-givers is massive.
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