Percutaneous Complete Revascularization Strategies Using Sirolimus-Eluting Biodegradable Polymer-Coated Stents in Patients Presenting With Acute Coronary Syndrome and Multivessel Disease - BIOVASC

Apr 17, 2023
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Erasmus University Medical Center and Biotronik AG.
Date Presented:
03/05/2023
Date Published:
03/05/2023
Date Updated:
04/17/2023
Original Posted Date:
03/05/2023
References

Contribution To Literature:

Highlighted text has been updated as of April 17, 2023.

The BIOVASC trial showed that immediate complete revascularization is noninferior vs. delayed complete revascularization; however, it is associated with reduction in MI and unplanned revascularization.

Description:

The goal of the trial was to evaluate immediate complete revascularization compared with delayed complete revascularization among patients with acute coronary syndrome and multivessel coronary disease.

Study Design

  • Randomized
  • Parallel
  • Open-label
  • Block

Patients with acute coronary syndrome and multivessel disease were randomized to immediate complete revascularization (n = 764) vs. staged complete revascularization (n = 761). Patients in the staged complete revascularization group had percutaneous coronary intervention (PCI) of the culprit vessel during the index hospitalization and delayed PCI of the nonculprit lesions within 6 weeks.

  • Total number of enrollees: 1,525
  • Duration of follow-up: 12 months
  • Mean patient age: 66 years
  • Percentage female: 22%
  • Percentage with diabetes: 21%

Inclusion criteria:

  • Patients 18-85 years of age with acute coronary syndrome and multivessel disease

Exclusion criteria:

  • Previous coronary artery bypass graft surgery
  • Cardiogenic shock
  • Chronic total occlusion

Other salient features/characteristics:

  • ST-segment elevation MI (STEMI): 40%
  • NSTEMI: 53%

Principal Findings:

The primary outcome, all-cause mortality, MI, unplanned revascularization, or cerebrovascular events at 1 year, occurred in 7.6% in the immediate complete revascularization group vs. 9.4% in the delayed complete revascularization group (p for noninferiority = 0.0011, p for superiority = 0.17).

Secondary outcomes:

  • All-cause death: 1.9% in the immediate complete revascularization group vs. 1.2% in the delayed complete revascularization group (p = 0.30)
  • MI: 1.9% in the immediate complete revascularization group vs. 4.5% of the delayed complete revascularization group (p = 0.0045)
  • Unplanned revascularization: 4.2% in the immediate complete revascularization group vs. 6.7% in the delayed complete revascularization group (p = 0.030)

Interpretation:

Among patients with acute coronary syndrome and multivessel coronary disease, immediate complete revascularization was noninferior to delayed complete revascularization. Immediate complete revascularization was associated with a lower incidence of MI and unplanned revascularization compared with delayed complete revascularization. Although immediate complete revascularization for acute coronary syndrome and multivessel coronary artery disease is preferred, delayed complete revascularization might be considered according to patient and lesion characteristics.

References:

Diletti R, den Dekker WK, Bennett J, et al., on behalf of the BIOVASC Investigators. Immediate versus staged complete revascularization in patients presenting with acute coronary syndrome and multivessel coronary disease (BIOVASC): a prospective, open-label, non-inferiority, randomized trial. Lancet 2023;401:1172-82.

Presented by Dr. Roberto Diletti at the American College of Cardiology Annual Scientific Session (ACC.23/WCC), New Orleans, LA, March 5, 2023.

Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and SIHD, Interventions and ACS, Interventions and Coronary Artery Disease, Interventions and Vascular Medicine, Chronic Angina

Keywords: ACC23, ACC Annual Scientific Session, Acute Coronary Syndrome, Arrhythmias, Cardiac, Coronary Artery Disease, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Non-ST Elevated Myocardial Infarction, Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction, Stents


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