Safety and clinical performance of a drug eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries: Pooled 12-month outcomes of BIOSOLVE-II and BIOSOLVE-III

Michael Haude* (Corresponding Author), Hüseyin Ince, Stephan Kische, Alexandre Abizaid, Ralph Tölg, Pedro Alves Lemos, Nicolas M. Van Mieghem, Stefan Verheye, Clemens von Birgelen, Evald Høj Christiansen, Emanuele Barbato, Hector M. Garcia-Garcia, Ron Waksman

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

30 Citations (Scopus)
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Abstract

Objectives: Based on outcomes of the BIOSOLVE-II study, a novel second generation drug-eluting absorbable metal scaffold gained CE-mark in 2016. The BIOSOLVE-III study aimed to confirm these outcomes and to obtain additional 12-month angiographic data.

Background: Bioresorbable scaffolds are intended to overcome possible long-term effects of permanent stents such as chronic vessel wall inflammation, stent crushing, and fractures. Methods: The prospective, multicenter BIOSOLVE-II and BIOSOLVE-III studies enrolled 184 patients with 189 lesions (123 patients in BIOSOLVE-II and 61 patients in BIOSOLVE-III). Primary endpoints were in-segment late lumen loss at 6 months (BIOSOLVE-II) and procedural success (BIOSOLVE-III).

Results: Mean patient age was 65.5 ± 10.8 years and mean lesion reference diameter was 2.70 ± 0.43 mm. In BIOSOLVE-III, there were significantly more type B2/C lesions than in BIOSOLVE-II (80.3% versus 43.4%, P < 0.0001) and significantly more moderate-to-severe calcifications (24.2% versus 10.7%, P = 0.014). At 12 months, there was no difference in late lumen loss between the two studies; in the overall population, it was 0.25 ± 0.31 mm in-segment and 0.39 ± 0.34 mm in-scaffold. Target lesion failure occurred in six patients (3.3%) and included two cardiac deaths, one target-vessel myocardial infarction, and three clinically driven target lesion revascularizations. No definite or probable scaffold thrombosis was observed.

Conclusion: The pooled outcomes of BIOSOLVE-II and BIOSOLVE-III provide further evidence on the safety and performance of a novel drug-eluting absorbable metal scaffold with constant clinical and angiographic performance parameters at 12 months and no definite or probable scaffold thrombosis.

Original languageEnglish
Pages (from-to)E502-E511
JournalCatheterization and cardiovascular interventions
Volume92
Issue number7
DOIs
Publication statusE-pub ahead of print/First online - 5 Aug 2018

Keywords

  • UT-Hybrid-D
  • Coronary artery disease
  • Percutaneous coronary intervention (PCI)
  • Stent bioabsorbable
  • Stent restenosis
  • Thrombosis
  • Clinical trials

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