article65

AIDA

"Bioresorbable Vascular Scaffolds versus Metallic Stents in Routine PCI"
The New England Journal of Medicine. Date: March 29, 2017.

Clinical Question

Is a bioresorbable vascular scaffold noninferior to a metallic stent regarding target-vessel failure in patients undergoing percutaneous coronary intervention (PCI)?

Bottom Line

In routine PCI, there was no significant difference in the rate of target-vessel failure between patients who received a bioresorbable scaffold and those who received a metallic stent. However, the bioresorbable scaffold was associated with a higher incidence of device thrombosis than the metallic stent through 2 years of follow-up.

Major Points

Guidelines

No guideline recommendations are provided in the article due to the presentation of preliminary results.

Design

- Investigator-initiated, randomized, single-blind, multicenter, noninferiority trial.
- N=1845 patients undergoing PCI.
- Interventions: bioresorbable vascular scaffold (n=924) versus metallic stent (n=921).
- Median follow-up period: 707 days.
- Primary endpoint: target-vessel failure (composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization).

Population

- Inclusion Criteria: Patients with coronary artery disease undergoing PCI.
- Exclusion Criteria: Target lesions >70 mm in length, reference vessel diameter <2.5 mm or >4 mm, planned bifurcation lesions requiring two stents, in-stent restenosis.
- Baseline Characteristics: Well-balanced demographics with a significant portion of patients presenting with acute coronary syndrome (54%).

Interventions

Patients were randomly assigned to receive either an everolimus-eluting BVS or an everolimus-eluting metallic stent

Outcomes

- Primary Outcome: Target-vessel failure occurred in 11.7% of the scaffold group and 10.7% of the stent group (HR 1.12; 95% CI, 0.85 to 1.48; P=0.43).
- Secondary Outcome: Cardiac death, target-vessel myocardial infarction, and target-vessel revascularization rates did not differ significantly between groups.
- Additional Analyses: Definite or probable device thrombosis was recorded in 3.5% of the scaffold group versus 0.9% of the stent group (HR 3.87; 95% CI, 1.78 to 8.42; P<0.001).

Criticisms

The occurrence of higher device thrombosis despite comparable rates of target-vessel failure raises questions regarding the advantages of BVS over DES. Additionally, the study did not perform routine intravascular imaging, limiting the understanding of device thrombosis mechanisms.

Funding

The trial was supported by an unrestricted educational grant from Abbott Vascular.