1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis

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1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis

Stone et al., 2016 | Lancet | Meta Analysis

Citation

Stone Gregg W, Gao Runlin, ... Serruys Patrick W. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016-Mar-26;387(10025):1277-89. doi:10.1016/S0140-6736(15)01039-9

Abstract

BACKGROUND: Compared with metallic drug-eluting stents, bioresorbable vascular scaffolds (BVS) offer the potential to improve long-term outcomes of percutaneous coronary intervention. Whether or not these devices are as safe and effective as drug-eluting stents within the first year after implantation is unknown. METHODS: We did a patient-level, pooled meta-analysis of four randomised trials in which 3389 patients with stable coronary artery disease or a stabilised acute coronary syndrome were enrolled at 301 academic and medical centres in North America, Europe, and the Asia-Pacific region. These patients were randomly assigned to the everolimus-eluting Absorb BVS (n=2164) or the Xience cobalt-chromium everolimus-eluting stent (CoCr-EES; n=1225). The primary endpoints were the 1-year relative rates of the patient-oriented composite endpoint (all-cause mortality, all myocardial infarction, or all revascularisation) and the device-oriented composite endpoint of target lesion failure (cardiac mortality, target vessel-related myocardial infarction, or ischaemia-driven target lesion revascularisation). All analyses were by intention to treat. The four randomised trials included in our meta-analysis are all registered with ClinicalTrials.gov, numbers NCT01751906, NCT01844284, NCT01923740, and NCT01425281. FINDINGS: The summary treatment effect for the 1-year relative rates of the patient-oriented composite endpoint did not differ significantly different between BVS and CoCr-EES (relative risk [RR] 1·09 [0·89-1·34], p=0·38). Similarly, the 1-year relative rates of the device-oriented composite endpoint did not differ between the groups (RR 1·22 [95% CI 0·91-1·64], p=0·17). Target vessel-related myocardial infarction was increased with BVS compared with CoCr-EES (RR 1·45 [95% CI 1·02-2·07], p=0·04), due in part to non-significant increases in peri-procedural myocardial infarction and device thrombosis with BVS (RR 2·09 [0·92-4·75], p=0·08). The relative rates of all-cause and cardiac mortality, all myocardial infarction, ischaemia-driven target lesion revascularisation, and all revascularisation did not differ between BVS and CoCr-EES. Results were similar after multivariable adjustment for baseline imbalances, and were consistent across most subgroups and in sensitivity analysis when two additional randomised trials with less than 1 year of follow-up were included. INTERPRETATION: In this meta-analysis, BVS did not lead to different rates of composite patient-oriented and device-oriented adverse events at 1-year follow-up compared with CoCr-EES. FUNDING: Abbott Vascular.

Key Findings

The summary treatment effect for the 1-year relative rates of the patient-oriented composite endpoint did not differ significantly different between BVS and CoCr-EES (relative risk [RR] 1·09 [0·89-1·34], p=0·38). Similarly, the 1-year relative rates of the device-oriented composite endpoint did not differ between the groups (RR 1·22 [95% CI 0·91-1·64], p=0·17). Target vessel-related myocardial infarction was increased with BVS compared with CoCr-EES (RR 1·45 [95% CI 1·02-2·07], p=0·04), due in p

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population stable coronary artery disease
Sample Size 2164
Age Range See abstract
Condition See abstract

MeSH Terms

  • Absorbable Implants
  • Coronary Artery Disease
  • Humans
  • Randomized Controlled Trials as Topic
  • Time Factors
  • Tissue Scaffolds
  • Treatment Outcome

Evidence Classification

  • Level: Meta Analysis
  • Publication Types: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't
  • Vertical: chromium

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09