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Original Investigation
September 27, 2019

Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study

Author Affiliations
  • 1The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
  • 2The Cardiovascular Research Foundation, New York, New York
  • 3Kyoto University Hospital, Kyoto, Japan
  • 4Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
  • 5The Christ Hospital, Heart and Vascular Center, Lindner Research Center, Cincinnati, Ohio
  • 6Cleveland Clinic, Cleveland, Ohio
  • 7Erasmus Medical Center, Rotterdam, the Netherlands
  • 8Institut Cardiovasculaire Paris Sud, Massy, France
  • 9Abbott Vascular, Santa Clara, California
  • 10Columbia University Medical Center, New York, New York
  • 11the Cardiovascular Research Foundation, New York, New York
  • 12International Centre for Cardiovascular Health, Imperial College, London, England
JAMA Cardiol. Published online September 27, 2019. doi:10.1001/jamacardio.2019.4101
Key Points

Question  Do the outcomes of bioresorbable scaffolds in patients with coronary artery disease vary during the course of their bioresorption?

Findings  In this individual patient data pooled analysis and summary-level meta-analysis of 4 randomized clinical trials of a polymeric bioresorbable scaffold and a contemporary metallic drug-eluting stent in 3884 patients, scaffold-related adverse events increased within 3 years of implantation but not thereafter.

Meaning  If new scaffolds are shown to have improved early results, bioresorbable scaffolds may be an acceptable alternative for many patients with coronary artery disease.

Abstract

Importance  Bioresorbable scaffolds were designed to provide clinical benefits after their complete bioresorption. Prior studies demonstrated early risks with the Absorb polymeric bioresorbable vascular scaffold (BVS). Whether this risk profile changes over time during the course of its bioresorption is unknown.

Objective  To examine outcomes of the first-generation BVS before and after 3 years, the point of its complete bioresorption in animals.

Data Sources  We searched MEDLINE and the Cochrane database, conference proceedings, and public websites for relevant studies.

Study Selection  Eligible studies were randomized clinical trials of BVS vs metallic drug-eluting stents in patients with coronary artery disease with at least 5-year follow-up. Four trials of BVS vs everolimus-eluting stents (EES) with 3384 patients met criteria.

Data Extraction and Synthesis  Individual patient data from the 4 trials were pooled, and summary-level meta-analysis was performed.

Main Outcomes and Measures  The major effectiveness and safety measures were target lesion failure (TLF; cardiac death, target vessel–related myocardial infarction, or ischemia-driven target lesion revascularization) and device thrombosis. Outcomes were examined through 5-year follow-up and between 0 to 3 and 3 to 5 years.

Results  Mean age for the 3384 patients was 62.8 years; 2452 patients were men (72.5%), and diabetes was present in 1020 patients (30.2%). Through 5-year follow-up, treatment with BVS compared with EES was associated with higher rates of TLF (14.9% vs 11.6%; HR, 1.26; 95% CI, 1.03-1.54; P = .03) and device thrombosis (2.5% vs 0.8%; HR, 2.87; 95% CI, 1.46-5.65; P = .002). Target lesion failure occurred in 11.6% of BVS-treated patients vs 7.9% of EES-treated patients between 0 to 3 years (HR, 1.42; 95% CI, 1.12-1.80), and 4.3% of BVS-treated patients vs 4.5% of EES-treated patients between 3 to 5 years (HR, 0.92; 95% CI, 0.64-1.31) (P for interaction = .046). Device thrombosis occurred in 2.4% of BVS-treated patients vs 0.6% of EES-treated patients between 0 to 3 years (HR, 3.86; 95% CI, 1.75-8.50) and 0.1% of BVS-treated patients vs 0.3% of EES-treated patients between 3 to 5 years (HR, 0.44; 95% CI, 0.07-2.70) (P for interaction = .03). These results were consistent by spline analysis and after multiple imputation and multivariable analysis.

Conclusions and Relevance  The period of excess risk for the first-generation Absorb BVS ends at 3 years. These data provide mechanistic insights into the timing of adverse events after BVS and identify the hurdles to be overcome for bioresorbable technology to be accepted as a valid alternative for patients with coronary artery disease.

Trial Registration  ClinicalTrials.gov identifiers: NCT01751906, NCT01844284, NCT01923740, and NCT01425281

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