Late thrombotic events after bioresorbable scaffold implantation: a systematic review and meta-analysis of randomized clinical trials

Eur Heart J. 2017 Sep 1;38(33):2559-2566. doi: 10.1093/eurheartj/ehx155.

Abstract

Aims: To compare the long-term safety and efficacy of bioresorbable vascular scaffold (BVS) with everolimus-eluting stent (EES) after percutaneous coronary interventions.

Methods and results: A systematic review and meta-analysis of randomized clinical trials comparing clinical outcomes of patients treated with BVS and EES with at least 24 months follow-up was performed. Adjusted random-effect model by the Knapp-Hartung method was used to compute odds ratios (OR) and 95% confidence intervals (CI). The primary safety outcome of interest was the risk of definite/probable device thrombosis (DT). The primary efficacy outcome of interest was the risk of target lesion failure (TLF). Five randomized clinical trials (n = 1730) were included. Patients treated with Absorb BVS had a higher risk of definite/probable DT compared with patients treated with EES (OR 2.93, 95%CI 1.37-6.26, P = 0.01). Very late DT (VLDT) occurred in 13 patients [12/996 (1.4%, 95%CI: 0.08-2.5) Absorb BVS vs. 1/701 (0.5%, 95%CI: 0.2-1.6) EES; OR 3.04; 95%CI 1.2-7.68, P = 0.03], 92% of the VLDT in the BVS group occurred in the absence of dual antiplatelet therapy (DAPT). Patients treated with Absorb BVS had a trend towards higher risk of TLF (OR 1.48, 95%CI 0.90-2.42, P = 0.09), driven by a higher risk of target vessel myocardial infarction and ischaemia-driven target lesion revascularization. No difference was found in the risk of cardiac death.

Conclusion: Compared with EES, the use of Absorb BVS was associated with a higher rate of DT and a trend towards higher risk of TLF. VLDT occurred in 1.4% of the patients, the majority of these events occurred in the absence of DAPT.

Keywords: Meta-analysis; Randomized trial; Scaffold; Thrombosis.

Publication types

  • Comparative Study
  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Absorbable Implants*
  • Coronary Artery Disease / therapy
  • Coronary Thrombosis / etiology*
  • Drug-Eluting Stents
  • Everolimus / administration & dosage
  • Graft Occlusion, Vascular
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Percutaneous Coronary Intervention / adverse effects
  • Postoperative Complications / etiology
  • Prosthesis Failure*
  • Randomized Controlled Trials as Topic
  • ST Elevation Myocardial Infarction / therapy
  • Tissue Scaffolds*

Substances

  • Immunosuppressive Agents
  • Everolimus