Abstract 14948: Polymer-Free Biolimus A9-Coated Stents in the Treatment of De-Novo Coronary Lesions With Short DAPT: 9 Month Angiographic and Clinical Follow-Up of the Prospective, Multicenter BioFreedom USA Clinical Trial
Background: Biofreedom is a polymer-free and carrier-free drug-coated stent (DCS) that transfers biolimus A9, a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month. The purpose of this study was to evaluate the efficacy and safety of this DCS in patients who received short duration (3 months) of dual antiplatelet therapy.
Methods: The BioFreedom USA trial was an open-label single-arm study of patients requiring stenting of de-novo lesions. Patients received 3 months of dual antiplatelet therapy (DAPT), and were followed by repeat angiogram and clinically at 9 months. The primary efficacy endpoint, late lumen loss at 9 months, was compared to a historical control of the first generation paclitaxel drug eluting stents. The primary safety endpoint was the composite of cardiac death, myocardial infarction, target lesion revascularization or stent thrombosis (MACE)
Results: A total of 72 patients from 10 sites had the BioFreedom DCS implanted in 83 lesions. Baseline characteristics included: mean age, 63.5+9.0 years, female gender, 20.8%, diabetes, 31.9%, patients with unstable angina 38.3%. At 1 month the proportion of patients taking DAPT was 96.8% and was 18.2% by 4 months. At 9 months 6.5% of patients were on DAPT. The 9-months (lesion n=66) late lumen loss in-stent was 0.32±0.53 mm (p=0.19), and in-segment was 0.34±0.51 mm. Twenty-five lesions were available for paired IVUS analyses between post-procedure and 9 months with low in-stent neointimal volume obstruction, 5.39% ± 5.28%, and a neointimal hyperplasia of 7.43 ± 8.04 (mm3). At 9 months, the composite safety endpoint was 9.9%, and the target lesion revascularization was 2.9%. There was no definite/probable stent thrombosis.
Conclusions: The Biofreedom DCS’s angiographic and IVUS follow-up demonstrated similar effectiveness to drug eluting stents and was superior to bare metallic-stents. Short DAPT of 3 months was safe without occurrence of stent thrombosis. The Biofreedom DCS may offer reasonable effectiveness and safety for stable patients who necessitate a shorter duration of DAPT. ClinicalTrials.gov number, NCT02131142
Author Disclosures: R. Waksman: None. G.N. Piegari: None. A. Kabour: None. L. Cannon: None. J. Wang: None. G. Adams: None. N. Solankhi: None. A. Smeglin: None. D.J. Kereiakes: None. R. Leiboff: None. H. Garcia-Garcia: None. M. Spad: None. R. Torguson: None.
- © 2016 by American Heart Association, Inc.