New COMPLETE Data Affirm Benefit of Nonculprit PCI in STEMI Regardless of Timing
It may not matter when the additional lesions are treated, but logistical and reimbursement issues loom.
SAN FRANCISCO, CA—The benefits of opening all blocked arteries—and not just the culprit lesion—in patients with STEMI and multivessel disease are observed whether the additional procedure is done during the index hospitalization or sometime in the several weeks after discharge, an analysis of the COMPLETE trial shows.
Complete revascularization reduced CV death/MI both in patients who underwent a second procedure a median of 1 day after the initial PCI (HR 0.77; 95% CI 0.59-1.00) and in those who had their staged procedure a median of 23 days later (HR 0.69; 95% CI 0.49-0.97). The findings were similar when looking at the endpoint of CV death/MI/ischemia-driven revascularization.
“Whether you do it intended during the index hospitalization or after discharge you accrue the same benefit,” David Wood, MD (Vancouver General Hospital, Canada), said at a press conference here at TCT 2019. “As far as safety and efficacy, there really was no signal for harm whether you did it in hospital or after discharge.”
He noted that the reduction in hard outcomes occurred mostly beyond 45 days. “The benefit occurs late. This is like [in] diabetics and coronary artery bypass graft surgery,” he said. “The fact that what you do now, achieving a residual SYNTAX score of 0 [in] over 90% of patients, resonates 1, 2, 3, 4 years down the road . . . I think is incredibly exciting.”
Deeper Dive Into COMPLETE
The COMPLETE trial randomized 4,041 STEMI patients with multivessel CAD who had undergone successful PCI of the culprit lesion to revascularization of all nonculprit lesions in a staged fashion—stratified by the treating physicians’ intention to do the additional procedure during the index hospitalization or after discharge (but within 45 days)—or to culprit-only PCI.
The main findings, reported earlier this month at the European Society of Cardiology Congress 2019 and published in the New England Journal of Medicine, showed that complete revascularization lowered rates of CV death/MI and CV death/MI/ischemia-driven revascularization through a median follow-up of 3 years. The investigators also reported that the intended timing of the staged procedures didn’t make a significant difference in terms of outcomes.
At TCT, Wood presented a more detailed look into the timing issue; the analysis is in press in the Journal of the American College of Cardiology.
P values for interaction suggested that intended timing of the staged procedure during either the index hospitalization or after discharge did not significantly impact the positive impact of complete revascularization on CV death/MI (P = 0.62) or CV death/MI/ischemia-driven revascularization (P = 0.27).
A landmark analysis showed that there was no difference in the risk of CV death/MI within the first 45 days between the trial arms (HR 0.86; 95% CI 0.59-1.24), with the benefit of complete revascularization emerging beyond that time point (HR 0.69; 95% CI 0.54-0.89). When ischemia-driven revascularization was included in the endpoint, however, intervening on the nonculprit lesions had a benefit both early on (HR 0.61; 95% CI 0.43-0.85) and beyond 45 days (HR 0.48; 95% CI 0.38-0.59).
For safety, there were no differences between trial arms—regardless of the intended timing of the staged procedures—in terms of stroke, NYHA class IV heart failure, stent thrombosis, major bleeding, or contrast-associated acute kidney injury.
Logistics, Reimbursement, and Patient Preference
Wood said during the press conference that the timing of the staged nonculprit interventions has “enormous implications” for patients and institutions.
For patients, showing that the timing doesn’t really matter means that they can either undergo the additional procedure during the initial hospitalization or can be treated weeks later if their physician deems it necessary. “You don’t seem to pay any penalty for that, 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.”
For institutions, there are other issues to consider, Wood said. In British Columbia, there are about 2,300 STEMIs treated each year, he noted, and if 1,000 to 1,200 of those patients need an additional procedure to open the nonculprit arteries, “the logistics of that, at least in our socialized medicine system, are important.”
When patients come back for an additional procedure would have implications in the United States as well, COMPLETE investigator Roxana Mehran, MD (Icahn School of Medicine at Mount Sinai, New York, NY), said at the press conference. The way STEMI care is reimbursed—in addition to appropriate use criteria—may need to be changed to accommodate performing an additional procedure that either extends the initial hospitalization or requires a readmission shortly after discharge, she said.
This will be a tricky issue for US health systems to navigate, Mehran said, but she shifted the focus to the benefit for patients. “For me, [complete revascularization] is a huge advantage for patients and that’s what we should care about most,” she said, adding, “We want to reduce mortality from heart disease and reinfarction and this is what the study shows—that complete revascularization does it.”
Dharam Kumbhani, MD (UT Southwestern Medical Center, Dallas, TX), echoed that sentiment in an interview with TCTMD but acknowledged that reimbursement, as well as how quality metrics are reported, are issues to keep an eye on.
Any readmission within 30 days, even if it’s for a planned, staged procedure, could be seen as a negative, he pointed out. In addition, if a patient comes back for nonculprit PCI at 40 days but does not have any symptoms or objective evidence of ischemia, that procedure might be deemed inappropriate under current guidance. “And then maybe you can get reimbursement denied for that reason,” Kumbhani said. “The whole reimbursement landscape is very challenging in my opinion.”
Ultimately, though, “we should just do what’s right for our patients and then these things would kind of drive themselves,” he said, noting that this new analysis “really tells us that you can do both of them [staged PCI during the index hospitalization or after discharge] and you would be doing right by your patient.”
Kumbhani added that shared decision-making between physicians and patients is important because patients might have a preference in terms of when they get another procedure.
Wood DA, Cairns JA, Wang J, et al. Timing of staged non-culprit revascularization in ST-segment elevation myocardial infarction: insights from the COMPLETE trial. J Am Coll Cardiol. 2019;Epub ahead of print.
- COMPLETE was supported by the Canadian Institutes of Health Research (CIHR), the Canadian Network and Center for Trials Internationally, the Population Health Research Institute, AstraZeneca, and Boston Scientific.
- Wood reports receiving unrestricted grant support from CIHR, AstraZeneca, and Boston Scientific to conduct the COMPLETE study.