Sustained safety and clinical performance of a drug-eluting absorbable metal scaffold up to 24 months: Pooled outcomes of BIOSOLVE-II and BIOSOLVE-III

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

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

64 Citations (Scopus)
54 Downloads (Pure)

Abstract

Aims: We aimed to assess the safety and performance of the DREAMS 2G scaffold up to 24 months post implant.

Methods and results: The present study population comprises a total of 184 patients with 189 lesions who were enrolled in the prospective, multicentre BIOSOLVE-II and BIOSOLVE-III trials. Clinical followup was scheduled at one, six, 12, 24 and 36 months. The present report includes pooled follow-up data at six months and BIOSOLVE-II data at 24 months. Patients were 65.5±10.8 years old, and lesions were 12.5±5.1 mm long with reference diameters of 2.7±0.4 mm. Procedural success was obtained in 97.8%. At six months, the composite clinical endpoint target lesion failure was 3.3% (95% CI: 1.2-7.1), based on two cardiac deaths (1.1%, one unknown and one not device-related), one target vessel myocardial infarction (0.6%), and three clinically driven target lesion revascularisations (1.7%). For BIOSOLVE-II at 24 months, the target lesion failure rate was 5.9% (95% CI: 2.4-11.8), based on two cardiac deaths (1.7%), one target vessel myocardial infarction (0.9%) and four target lesion revascularisations (3.4%). There was no definite or probable scaffold thrombosis.

Conclusions: The present analysis provides additional evidence on the safety of a drug-eluting absorbable metal scaffold with promising clinical outcomes up to 24 months and absence of definite or probable scaffold thrombosis.

Original languageEnglish
Pages (from-to)432-439
Number of pages8
JournalEuroIntervention
Volume13
Issue number4
DOIs
Publication statusPublished - 20 Jul 2017

Keywords

  • Bioresorbable scaffolds
  • Myocardial infarction
  • Stable angina
  • Stent thrombosis

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