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Benefit of nonculprit PCI for STEMI consistent regardless of timing: COMPLETE
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SAN FRANCISCO — In patients with STEMI and multivessel disease, a strategy of nonculprit-lesion PCI with the goal of complete revascularization was superior to culprit-only revascularization for major CV events regardless of whether complete revascularization occurred during the index procedure, days later or weeks later, according to new insights from the COMPLETE trial.
Further, the benefit of complete revascularization on hard clinical outcomes including CV death and MI emerged mainly over the long term, David A. Wood, MD, professor at the University of British Columbia and director of the cardiac catheterization laboratory at Vancouver General Hospital, said during a press conference at TCT 2019.
The findings come on the heels of the main COMPLETE trial presentation at the recent European Society of Cardiology Congress in Paris, which, as Healio previously reported, demonstrated complete revascularization was superior to culprit lesion-only PCI for reducing CV death or MI in this population. Since those data were presented, there have been many questions about the optimal timing of staged non-culprit revascularization.
“Whether you do [the staged nonculprit PCI] during the index hospitalization or after discharge, you accrue the same benefit,” Wood said here.
New data
COMPLETE enrolled 4,041 patients, of whom 2,016 were randomized to undergo complete revascularization and 2,025 to undergo PCI of the culprit lesion only. At the time of randomization, patients were stratified by intended timing of nonculprit PCI, with a maximum of 45 days. Of those assigned complete revascularization, 1,353 had intended nonculprit PCI performed during the index hospitalization (median time, 1 day) and 663 intended after discharge (median time, 23 days), Wood explained at the press conference.
This subanalysis showed that, for nonculprit PCI intended during the index hospitalization, the outcome of CV death or MI was reduced with complete revascularization, compared with culprit-only PCI (HR = 0.77; 95% CI, 0.59-1). For nonculprit PCI intended post-discharge, CV death or MI was also reduced with the complete strategy (HR = 0.69; 95% CI, 0.49-0.97; P for interaction = .62), according to results presented.
Wood also presented data on the time course of CV death or MI in COMPLETE. Landmark analyses of the COMPLETE population performed within 45 days and after 45 days showed that the benefit of complete revascularization, with regard to CV death or MI, accrues mainly in the long term. When the researchers looked at CV death, MI or ischemia-driven revascularization, results showed the benefit occurs early and is driven primarily by ischemia-driven revascularization.
In addition, there were no significant differences in safety outcomes, including stroke, major bleeding, stent thrombosis or contrast-associated acute kidney injury, Wood said.
The researchers noted that this analysis did not directly compare nonculprit PCI at index hospitalization vs. nonculprit PCI after discharge, but rather compared the two randomized groups within the intended times to assess whether the treatment effect was consistent.
‘No price to pay to delay’
During a discussion of the trial at the press conference, Marie-Claude Morice, MD, from the Institut Cardiovasculaire Paris Sud, said there appears to be “no price to pay to delay.”
“The implications are truly staggering, not just for patients, [who we can tell them] you can be fixed during the index hospitalization, you’re going to be kept in from 48 to 72 hours after your first STEMI, so you can be done, especially if, geographically, [they are] from a long way away. Or, if there are characteristics the treating physician sees and they decide to bring this patient back after a few weeks, you don’t seem to pay any penalty for that,” Wood said. “And, we can tell our patients that the benefit isn’t in the short term — it truly is in the long term for CV death and new MI.”
Still, challenges remain, such as questions of reimbursement and how this would affect quality metrics, Dharam J. Kumbhani, MD, SM, associate professor in the department of internal medicine at UTSouthwestern Medical Center and Cardiology Today Next Gen Innovator, said during the press conference.
“In our region in British Columbia, we do 2,300 STEMIs per year. So, if you conservatively think you’re going to help between 1,000 and 1,200 of those patients now coming back for complete revascularization between 1 and 45 days, the logistics of that, at least in our socialized medical system, are important,” Wood said.
Read more about the overall COMPLETE results here. – by Katie Kalvaitis
Reference:
Wood DA. Late-Breaking Science 3. Presented at: TCT Scientific Symposium; Sept. 25-29, 2019; San Francisco.
Disclosure: Wood reports he received grant support from the AstraZeneca, Boston Scientific and the Canadian Institutes of Health Research to conduct the COMPLETE study.