BIOVASC: Immediate Complete Revascularization Beneficial in ACS

March 05, 2023

Immediate complete revascularization during the index procedure might become the new treatment paradigm in patients with an acute coronary syndrome (ACS) and multivessel disease, based on results of the BIOVASC trial.

In the trial, patients presenting with ACS and multivessel disease, immediate complete revascularization was noninferior to staged complete revascularization for the primary composite outcome and was associated with a reduction in myocardial infarction (MI) and unplanned ischemia-driven revascularization.

The BIOVASC trial was presented on March 5 by Roberto Diletti, MD, Erasmus University Medical Center, Rotterdam, the Netherlands, at the American College of Cardiology (ACC) Scientific Session/World Congress of Cardiology (WCC) 2023. The study was simultaneously published online in The Lancet.

"We did not detect an early safety signal against an immediate complete revascularization strategy," the authors state in the Lancet paper, adding: "Treating physicians should not be concerned about potential risks associated with immediate treatment of nonculprit lesions."

They note, "This strategy might be particularly effective in patients with only two-vessel disease and reasonably simple lesions, with a high likelihood of procedural success without excessive use of radiation, contrast dye, or other resources."

The trial also showed a shorter hospital stay with an immediate complete revascularization strategy.

"Immediate complete revascularization might have potential health economic benefits because of the lower rate of myocardial infarction, including spontaneous myocardial infarction, and unplanned revascularizations, and the shorter overall hospital stay," the researchers conclude.

Introducing his presentation, Diletti explained that multiple studies have established the clinical benefit of complete coronary revascularization as compared with exclusive reperfusion of the culprit lesion, but the optimal timing for nonculprit lesion revascularization remains unclear.

The BIOVASC trial, conducted in Belgium, Italy, the Netherlands, and Spain, involved 1525 patients with ST-segment elevation MI (STEMI) or non-STEMI ACS and multivessel coronary artery disease with a clearly identifiable culprit lesion.

They were randomly assigned to undergo immediate complete revascularization (percutaneous coronary intervention [PCI] of the culprit lesion first, followed by other nonculprit lesions deemed to be clinically significant by the operator during the index procedure) or staged complete revascularization (PCI of only the culprit lesion during the index procedure and PCI of all nonculprit lesions deemed to be clinically significant within 6 weeks after the index procedure).

The primary outcome was the composite of all-cause mortality, MI, any unplanned ischemia-driven revascularization, or cerebrovascular events at 1 year after the index procedure.

The trial had a noninferiority design, with noninferiority of immediate to staged complete revascularization considered to be met if the upper boundary of the 95% CI of the hazard ratio (HR) for the primary outcome did not exceed 1.39.

Among the trial population, 40% of patients had STEMI, 52% had non-STEMI, and 8% had unstable angina.

In the immediate complete revascularization group, 16 patients did not receive complete revascularization during the index procedure primarily because of prolonged procedure time, procedural complexity, or excessive contrast dye use. 

In the staged group, 30% of patients underwent all subsequent procedures during the index hospitalization.

Results showed that the primary composite outcome at 1 year occurred in 7.6% of the immediate revascularization group and in 9.4% of the staged group, meeting the noninferiority criteria (HR, 0.78; 95% CI, 0.55 - 1.11; P for noninferiority = .0011).

Superiority of the immediate over the staged complete revascularization strategy was not met at 1-year follow-up (P for superiority = .17).

However, in the prespecified analysis of clinical events at 30 days after the index procedure, immediate complete revascularization was superior to staged revascularization in terms of the composite primary outcome (2.2% vs 5.8%; HR, 0.38; P for superiority = .0007).

One-year results showed no difference in all-cause death between the two groups, but the immediate complete revascularization group appeared to have a reduction in MI (1.9% vs 4.5%)  and fewer unplanned ischemia-driven revascularizations (4.2% vs 6.7%).

The difference in MI was mainly driven by spontaneous MIs (not procedure related) that predominantly occurred in the time window between the index procedure and the planned date for the staged intervention, and an originally nonculprit lesion was identified as the cause for these events in almost all cases.

Subgroup analysis showed similar results across the patient population, including age, sex, and STEMI vs non-STEMI presentation.

High Rate of MI in Staged Group

Discussant of the study at the ACC session, Dipti Itchhaporia, MD, University of California, Irvine, School of Medicine, said this was a "very important trial."  

She expressed surprise over the "remarkably high rate" of MI in the staged procedure group and asked Diletti why that might have occurred.

He responded that the operator may have misjudged the culprit lesion or that patients with ACS may have multiple unstable plaques and "treating the culprit lesion alone does not do the job."

He added: "We need to look at the data more thoroughly to better understand this, but in both scenarios, immediate complete revascularization would prevent these events." 

Itchhaporia also pointed out a low rate of functional imaging used in the study.  

Diletti replied that this reflected current European practice, but he acknowledged that "In my opinion this reduces our ability to detect the culprit lesion."

Commenting at an ACC press conference, David Moliterno, MD, Gill Heart and Vascular Institute, Lexington, Kentucky, said the trial poses the question  "Can we fix it all at once?" and the results suggest "Yes, we can."

He said this approach had the advantage of removing any uncertainly as to which was the culprit lesion. "We just fix everything — leave no blockage behind."

But he pointed out that for  some patients this may not be appropriate, such as those with compromised renal function, in whom excessive amounts of contrast material should be avoided.

CABG Still Needs to Be Considered

In a Comment accompanying the Lancet publication, Tobias Pustjens, MD, Pieter Vriesendorp, MD, and Arnoud W.J. van't Hof, MD, Cardiovascular Research Institute Maastricht, the Netherlands, note that more than half of the patients presenting with an ACS have multivessel coronary disease. 

They say the trial results suggest that "Pursuing an immediate complete revascularisation strategy, especially in times of reduced hospital capacity and staff scarcity, not only benefits the individual patient in clinical outcomes but can also safely reduce the pressure on health-care systems."

But they also point out that the possibility of coronary artery bypass grafting (CABG) should not be omitted, and that CABG is still the treatment of choice in patients with diabetes or complex coronary artery disease.

They conclude: "The results of the BIOVASC study move clinical practice forward from culprit-only to an immediate, complete revascularisation strategy.… However, further fine tuning of this treatment strategy to substantiate a role for intracoronary physiology assessment, intracoronary imaging, and guidance of the heart team decision is needed."

The BIOVASC trial was supported by an unrestricted research grant from Biotronik AG. Diletti has received institutional research grants from Biotronik, Medtronic, ACIST Medical Systems, and Boston Scientific. van't Hof has received institutional research grants from Biotronik.

American College of Cardiology (ACC) Scientific Session/World Congress of Cardiology (WCC) 2023. Late-Breaking Clinical Trials. Presented March 5, 2023.

Lancet. Published online March 5, 2023. Full text, Comment

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