A multicenter post-marketing evaluation of the Elixir DESolve® Novolimus-eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study

Holger Nef, Jens Wiebe, Niklas Boeder, Oliver Dörr, Timm Bauer, Karl Eugen Hauptmann, Azeem Latib, Antonio Colombo, Dieter Fischer, Tanja Rudolph, Nicolas Foin, Gert Richardt, Christian Hamm

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

Abstract

Objectives: To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease. Background: The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor. Methods: One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post-procedural angiographic assessment was performed, and a device-oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined. Results: The device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with a DESolve BRS. Post-procedural angiographic assessment indicated an in-scaffold acute gain of 1.54 ± 0.44 mm, with a reduction in % diameter stenosis from 61.00 ± 11.29 to 12.69 ± 0.44. At 12 months, the device-oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths. Conclusions: Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long-term prospective studies are needed.

Original languageEnglish (US)
Pages (from-to)1021-1027
Number of pages7
JournalCatheterization and Cardiovascular Interventions
Volume92
Issue number6
DOIs
StatePublished - Nov 15 2018
Externally publishedYes

Keywords

  • bioabsorbable stent
  • bioresorbable devices/polymers
  • coronary artery disease

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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