Immediate Complete Revascularization Non-Inferior to Staged Procedure

NEW ORLEANS – Immediate complete revascularization was non-inferior to staged complete revascularization in patients who presented with acute coronary syndrome (ACS) and multivessel disease, according to BIOVASC trial findings.

In the prospective, open-label study, the composite primary outcome occurred in 7.6% of 764 patients in the immediate complete revascularization group and in 9.4% of 761 patients in the staged revascularization group (P=0.0011 for non-inferiority; P=0.166 for superiority), reported Roberto Diletti, MD, PhD, of Erasmus Medical Center in Rotterdam, the Netherlands, at the American College of Cardiology (ACC) annual meeting.

The composite primary outcome was defined as "all-cause mortality, myocardial infarction (MI), any unplanned ischemia-driven revascularization, or cerebrovascular events at 1 year after the index procedure," explained Diletti and colleagues in the Lancet, where the results were simultaneously published.

"We show that, at 1 year of follow-up, immediate complete revascularization is not inferior to staged complete revascularization for the study's primary endpoint...Moreover, immediate complete treatment offered reassurance that patients would not suffer a second heart attack while waiting for their second procedure," Diletti stated at ACC.

Diletti's group also reported that there was no difference in all-cause death between the immediate and staged complete revascularization groups (1.9% vs 1.2%, hazard ratio 1.56, 95% CI 0.68-3.61, P=0.30), and MI occurred in 1.9% versus 4.5%, respectively (HR 0.41, 95% CI 0.22-0.76, P=0.0045). MIs in the latter group "were not procedure-related events but spontaneous," they added.

More unplanned ischemia-driven revascularizations were done in the staged complete revascularization group versus the immediate complete revascularization group (6.7% vs 4.2%, HR 0.61, 95% CI 0.39–0.95, P=0.030), according to Diletti and colleagues.

He explained that controversy exists over whether interventionalists should use angioplasty and stents to attack the culprit lesions causing the acute heart attack or unstable angina, and then have the patient return at a later date to complete stenting of other dangerous, imaging-defined coronary artery lesions, or the immediate complete strategy of stenting all appropriate lesions, including the culprit lesion, in the initial treatment.

David Moliterno, MD, of UK Healthcare in Lexington, Kentucky,told MedPage Today that the title of the Oscar-nominated movie "Everything Everywhere All at Once" applied to the immediate complete revascularization strategy, noting that, with few exceptions, "you can fix it all at once."

Moliterno, who is JACC: Cardiovascular Interventions editor-in-chief, stated that one of the problems with staged revascularization is that it is possible to misidentify the culprit lesions, fix an artery that is not causing the ACS, and then send the patients home without having addressed the acute problem.

'With an immediate complete revascularization, you fix everything, including the culprit lesion," he said.

Study Details

BIOVASC (2018-2021) was done at 29 hospitals in Europe in patients with ST-segment elevation MI or non-ST-segment elevation ACS and multivessel coronary artery disease, described as "two or more coronary arteries with a diameter of 2.5 mm or more and ≥70% stenosis based on visual estimation or positive coronary physiology testing." Participant also had to have a "clearly identifiable culprit lesion," according to the researchers.

Among all participants, the median age was about 65, and the majority were men with a BMI around 27, while almost half were never smokers, and about a third had a family history of cardiovascular disease. About 5% had renal insufficiency.

The trial procedures were:

• Immediate complete revascularization: percutaneous coronary intervention (PCI) of the culprit lesion first, followed by other non-culprit lesions that were flagged as clinically significant by the operator during the index procedure
• Staged complete revascularization: PCI of only the culprit lesion during the index procedure and PCI of all non-culprit lesions labelled clinically significant by the operator within 6 weeks after the index procedure

"Non-inferiority of immediate to staged complete revascularization was considered to be met if the upper boundary of the 95% CI of the hazard ratio...for the primary outcome did not exceed 1.39," the researchers wrote.

They reported that the occurrence of major bleeding (BARC 3 or 5) at 1 year post-index procedure was similar at 1.6% (n=764) in the immediate complete revascularization group versus 0.9% (n=761) in the staged complete revascularization group (HR 1.73, 95% CI 0.68-4.39, P=0.25).

Trial limitations included the higher number of men in the study and the predominantly white patient population. Also, functional and imaging assessment was not used very often, which was "reflective of contemporary European clinical practice. Conceivably, higher adoption of invasive imaging and coronary physiology testing might have provided more comprehensive and accurate culprit lesion identification," according to the researchers.

Other Considerations

Moliterno, who was not involved in the trial, pointed out that among patients in the study with renal disease, there were hints that the immediate complete strategy was less favorable, especially if there were higher doses of contrast agents required during the imaging and stenting procedures. But he also noted that the staged approach used more contrast agents and involved higher radiation exposure.

Moliterno cited another practical consideration when it comes to immediate complete revascularization: "The doctor may have already done four or five of these procedures and he's tired, or the patient comes in at midnight and the lab workers want to go home," he said. In BIOVASC, around 28% of all procedure took place during off-hours. The researcher noted that a subgroup analysis of "office hours...versus off-hours...did not identify significant interactions for the effect of immediate or staged complete revascularization on the primary outcome."

Moliterno said that BIOVASC results "reinforced the [revascularization] timing; that it can be done at the same time. The impressive thing is that most of these people are having a heart attack, and we are still able to perform these procedures, and the mortality is very low."

Gregg Stone, MD, of the Icahn School of Medicine at Mount Sinai in New York City, told MedPage Today that common practice in the U.S. is to perform immediate complete revascularization in unstable angina and non-ST-segment elevated MI patients, but not necessarily in those with ST-segment elevated MIs. BIOVASC findings may lead a patient with a so-called "big heart attack" to immediate complete revascularization, said Stone, who was not involved in the trial.

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