Immediate complete revascularization noninferior to staged in ACS, multivessel CAD
NEW ORLEANS — In patients with ACS and multivessel CAD who underwent PCI, immediate complete revascularization was noninferior to staged complete revascularization, according to results of the BIOVASC trial.
In addition, the immediate group were less likely to have MI within 1 year of the procedure than the staged group, according to the researchers.
For the trial, the researchers randomly assigned patients (median age, 66 years; 78% men) with ACS and multivessel CAD, defined as two or more vessels with a diameter of at least 2.5 mm and at least 70% stenosis, to receive complete revascularization immediately (n = 764) or in stages, with the culprit lesion addressed first and any other lesions addressed later (n = 761). The findings were presented at the American College of Cardiology Scientific Session and simultaneously published in The Lancet.
“A large proportion of patients with acute coronary syndrome are presenting with multivessel coronary artery disease,” Roberto Diletti, MD, PhD, interventional cardiologist at Erasmus University Medical Center, Rotterdam, The Netherlands, said during the presentation. “There are a number of papers demonstrating already that complete coronary revascularization is probably the best way to treat these patients compared with a culprit-only lesion strategy. However, the optimal timing for treatment of nonculprit lesions is still unknown.”
Among the cohort, 40% had STEMI, 52% had non-STEMI and 8% had unstable angina.
The primary outcome of all-cause mortality, MI, any unplanned ischemia-driven revascularization or cerebrovascular events at 1 year after the index procedure occurred in 7.6% of the immediate group and 9.4% of the staged group (HR = 0.78; 95% CI, 0.55-1.11; P for noninferiority = .0011), Diletti said during the presentation.
MI at 1 year occurred more often in the staged group than in the immediate group (1.9% vs. 5.4%; HR = 0.41; 95% CI, 0.22-0.76; P for superiority = .0045), as did unplanned ischemia-driven revascularization (4.2% vs. 6.7%; HR = 0.61; 95% CI, 0.39-0.95; P for superiority = .03), he said.
There were no differences between the groups in mortality at 1 year (immediate, 1.9%; staged, 1.2%; (HR = 1.56; 95% CI, 0.68-3.61; P = .3) or in cerebrovascular events (P = .83), he said.
In the staged group, 44% of MIs occurred after the index procedure but before the staged procedure, Diletti said during the presentation, noting that when periprocedural MIs were excluded, there were still more MIs in the staged group (1.7% vs. 3.3%; HR = 0.52; 95% CI, 0.26-1.01; P = .052).
At 30 days, immediate complete revascularization was superior to staged complete revascularization for the primary outcome (2.2% vs. 5.8%; HR = 0.38; 95% CI, 0.22-0.66; P for superiority = .001), according to the researchers.
“In patients with acute coronary syndrome and multivessel disease, an immediate complete revascularization strategy was noninferior to a staged complete revascularization strategy in terms of the primary endpoint, and was associated with a reduction in MIs and unplanned ischemia-driven revascularization,” Diletti said during the presentation.
In a discussion after the presentation, Cardiology Today Editorial Board Member Dipti Itchhaporia, MD, FACC, FESC, the Eric & Sheila Samson Endowed Chair in Cardiovascular Health and director of disease management for Jeffrey M. Carlton Heart and Vascular Institute at Hoag Memorial Hospital, Newport Beach, California; associate clinical professor of medicine at University of California, Irvine and past president of the ACC, said that “the most surprising thing in this is the infarct rate in the staged [group] seemed remarkably high.”
Diletti said that it was surprising that so many patients were having events between the index and staged procedures.
“I have two hypotheses for this,” he said. “The first is that, although in the protocol, it specifically said a clear culprit [lesion] should be present for enrollment, it might be possible that an investigator misjudged the culprit lesions, and first treated a lesion that was not the actual culprit [of the ACS], and the actual culprit gave a second event in the very early phase. The other possibility is that there are multiple unstable plaques during acute coronary syndrome, and treating only the culprit doesn’t complete the job, so it is not protecting the patient against an event possibly occurring in the other plaques that might also be unstable. In both scenarios, immediate complete revascularization is preventing the event.”
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Perspective
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This is an important study because we have been researching for years whether with patients who come in with unstable chest pain and significant CAD, to take care of the immediate problem, the culprit vessel, or to try to take care of all vessels with obstructive CAD at the initial index procedure. If we do that it, avoids patients coming back and avoids any interim risk if patients were to have other vessels that could cause MI or worse.
Patients were randomly assigned to have immediate complete revascularization or staged complete revascularization, with another procedure up to 6 weeks after the index procedure. Both strategies were equal, and the immediate strategy was noninferior to the staged strategy. This indicates it is safe to go ahead and perform complete revascularization in one setting, which is an efficient way to take care of the problem: Patients will not have to be readmitted to the hospital, have a second procedure or have risk of additional radiation or contrast dye. There was concern about whether immediate complete revascularization would cause increased risk, but that was not the case, and the study showed that in patients who are stable, which is most of them, they do well with complete revascularization in the initial setting. The presumption is that these patients would be having fewer hospitalizations, fewer days in the hospital, less chance of readmission, potentially much less cost and more comfort, because they only had one procedure.
Perspective
Back to TopThere has been a growing body of evidence that among patients presenting with ACS found to have multivessel CAD, a complete revascularization strategy is associated with improved clinical outcomes as compared with culprit intervention alone. The optimal timing for complete revascularization, however, has remained unclear. The BIOVASC study was an open label, randomized clinical trial evaluating an immediate vs. staged approach to complete revascularization.
The study showed that at 1 year, an immediate complete revascularization strategy via a single trip to the cath lab was noninferior to a staged approach, meaning it could be a feasible option for many patients presenting with ACS who are found to have multivessel disease. This immediate approach led to shorter hospitalizations and less total use of radiation and contrast, which are important safety surrogates.
The study found short-term MI and unplanned revascularization were lower in the immediate revascularization arm but the incidence long-term was similar; this early suggestion of benefit may be in part due to the open label nature of the trial. Noteworthy was the underutilization of intracoronary physiology and imaging, which were even more infrequently utilized in the immediate revascularization arm, possibly related to longer procedure times; the long-term effects on clinical outcomes will be important to confirm.
In sum, the trial supports that immediate complete revascularization is a safe and effective strategy for many patients presenting with ACS found to have multivessel disease. Confirming the long-term clinical outcomes will be important before establishing the strategy as the standard of care.
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Diletti R, et al. Joint American College of Cardiology/New England Journal of Medicine Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Session; March 4-6, 2023; New Orleans (hybrid meeting).