Abstract 4150: Real World Outcomes With the BioMatrix™ Stent at 180 Days
Background: The Biolimus-A9 eluting stent platform (BioMatrix; BES) releases Biolimus-A9, a sirolimus analogue, from a biodegradable polymer, polylactic acid (PLA), which is degraded into carbon dioxide and water during a period of 6 –9 months. This effectively eliminates the potential for ongoing inflammation due to persistent polymer, a possible substrate for late stent thrombosis. This stent has been shown in a randomised study (LEADERS) to be a safe and effective alternative to a sirolimus-eluting stent with a durable polymer. The purpose of the present registry is to capture long-term clinical safety and efficacy data on the BioMatrix stent system in a “real world” Asia Pacific population.
Methods: This registry is a prospective, multi-center, observational registry conducted at 12 interventional Asian Pacific cardiac centers. The studied population is a “real-world, all comers” cohort with no limitations on the number of treated lesions (≥2.5 – ≤4.0 mm) and vessels, and lesion length as well as clinical indication (chronic stable angina vs. acute coronary syndromes). The primary endpoint of the registry is a composite of cardiac death, myocardial infarction (Q-wave and non Q-wave), or Ischemia-driven Target Vessel Revascularization at 12 months.
Results: The study enrolled 497 patients with 737 lesions treated. The mean age of patients was 59.6 yr (29 – 88), 80.3% male with acute coronary syndrome in 69.7%. The lesion type included bifurcations 13.9%, long lesions 24.9%, CTOs 9.7% and restenotic lesions in 5.7%. Procedural success was 99.2%. The 30 day analysis showed a MACE rate of 1.6% with cardiac death 0.6%, myocardial infarction 0.8% and TLR 0.6%. The 180 day follow-up data will be presented.
Conclusion: The 30 Day results of the BEACON II Clinical Registry further confirms that the BioMatrix™ stent is safe and effective for use in real world patients. The 180 day follow-up adjudicated data will be presented.