SAN FRANCISCO — A new analysis shows the benefit of complete revascularization, including non-culprit lesions, in patients with ST-segment elevation myocardial infarction (STEMI) on hard outcomes such as cardiovascular (CV) related death or myocardial infarction (MI) emerges mainly over the long-term.
In addition, a strategy of non-culprit lesion percutaneous coronary intervention (PCI), with the goal of complete revascularization performed either early during index hospitalization or after discharge, confers similar benefit on major CV events.
The new results from the Complete vs Culprit-Only Revascularization Strategies to Treat Multivessel Disease after Early PCI for STEMI (COMPLETE) trial were presented in a late-breaking session here at Transcatheter Cardiovascular Therapeutics (TCT) 2019.
"The main conclusions here are whether you do it during the hospitalization or after discharge, you accrue the same benefit," said study author David Wood, MD, a professor of medicine at the University of British Columbia, Canada, and director of the Centre for Cardiovascular Innovation.
Dr David Wood
"As for safety, there was no signal for harm whether done in hospital or after discharge, which is very compelling, and the benefit occurs late," he said. "This is like for diabetics and coronary bypass graft surgery — what you do now, achieving a residual syntax score of zero, will resonate 1, 2, 3, 4, years down the road, which I think is incredibly exciting."
The main findings of the COMPLETE trial were presented earlier this month at the European Society of Cardiology (ESC) Congress 2019 and reported by the theheart.org | Medscape Cardiology. The results were also published simultaneously online September 1 in the New England Journal of Medicine.
Among patients with STEMI and multivessel coronary artery disease, the study showed that complete revascularization was superior to culprit-lesion-only PCI in reducing the risk of CV death or MI.
Randomized trials have previously shown that non-culprit-lesion PCI will reduce revascularization, but none have been adequately powered to detect even moderate reductions in hard clinical outcomes, such as CV death or MI.
No Penalty for Delay
The COMPLETE trial enrolled 4041 patients with STEMI and multivessel coronary artery disease who had undergone successful PCI of the culprit lesion but who also had non-culprit lesions of at least 70% or a fractional flow reserve measurement of 0.80.
Patients were then randomly assigned to complete revascularization of any additional angiographically significant non-culprit lesions or to no further revascularization. Randomization was further stratified according to the intended timing of non-culprit-lesion PCI — either during or after the index hospitalization (maximum 45 days).
The study had two primary outcomes: the first was the composite of CV death or MI and the second a composite of CV death, MI, or ischemia-driven revascularization.
In the current analysis, Wood and colleagues now looked at the timing of staged non-culprit revascularization.
The objective was to determine if there was a difference in the benefit of a strategy of complete revascularization vs culprit-lesion-only PCI, according to the intended timing of non-culprit PCI. A secondary objective, explained Wood, was to evaluate the time course of the benefits of complete vs culprit-lesion-only PCI.
"According to timing, this could be done anywhere from 1 to 45 days post randomization," said Wood. "So we are looking at this during hospitalization or coming back after discharge, which has enormous implications for our patients and our institutions."
Median follow-up was 3 years and longest follow-up was 5 years (range 2-5 years).
"The randomization was done by the investigators, so it was up to them whether the revascularization was done during hospitalization or after discharge," he explained.
Complete revascularization was performed early during index hospitalization (median 1 day) or after discharge (median 23 days). A total of 2702 patients underwent the procedure during index hospitalization and 1339 returned after discharge.
The first "landmark analysis," which looked at CV death or new MI before and after 45 days, showed a hazard ratio of 0.86 (95% confidence interval [CI], 0.59 - 1.24) for randomization to 45 days. However, after 45 days the hazard ratio goes to 0.69 (95% CI, 0.54 - 0.89), Wood emphasized. "This suggests that the benefit happens after 45 days."
In the second landmark analysis, which evaluated CV death, new MI, and ischemia-driven revascularization before and after 45 days, the hazard ratio was 0.61 (95% CI, 0.43 - 0.85) for randomization to 45 days, and 0.48 (95% CI 0.38 - 0.59) after 45 days.
"The implications for patients are truly staggering," said Wood. "If you live far [away], it can be done right away, but if you come back [and have it done later] there is no penalty. We can tell our patients that the benefit isn't in the short-term but the long-term for CV death and new MI."
Changes to Reimbursement Needed
One of the issues with timing, at least in the US, may be with reimbursement. Roxana Mehran, MD, moderator of a press briefing that highlighted the findings, noted that "the devil is in the details in the US."
"There are huge implications for reimbursement, cost, and quality metrics," said Mehran, professor of medicine and director of interventional cardiovascular research and clinical trials at Icahn School of Medicine at Mount Sinai in New York City. "In other countries outside the US, human healthcare is a right, but unfortunately, in our country, we still have to worry about the uninsured. This study has important implications, so it is important to spread this message of late benefit for these patients."
Panelist Dharam Kumbhani, MD, an assistant professor in UT Southwestern Medical Center's Department of Internal Medicine, Dallas, Texas, agreed and said he was "wondering about that himself, as to what this means for reimbursement and quality metrics."
"When a person comes in with a STEMI, there is a certain period for that diagnosis to continue from the standpoint of reimbursement, so we need to understand the implications based on these findings."
A typical scenario could be a patient brought back in at day 45 after a procedure on the index vessel. "And let's say they have no symptoms, but when looking at the quality metrics, on the face of it, it could seem like an inappropriate PCI even though it's not."
Mehran added that the appropriate use criteria needs to change, as do the ICD-9 codes, "so we can make sure that patients are benefiting without having to deal with the financial issues."
COMPLETE was supported by Canadian Institutes of Health Research (CIHR), Canadian Network and Center for Trials Internationally, Population Health Research Institute (PHRI), and unrestricted grants from AstraZeneca and Boston Scientific. Wood has disclosed no relevant financial relationships.
Transcatheter Cardiovascular Therapeutics (TCT) 2019: COMPLETE Late-Breaker. Presented September 28, 2019.
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Cite this: Complete Revascularization After STEMI Confers Long-term Benefit - Medscape - Oct 01, 2019.
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