Experience with biodegradable polymer coated sirolimus-eluting coronary stent system in "real-life" percutaneous coronary intervention: 24-month data from the manipal-s registry

Abstract

Introduction: Despite the undeniable clinical efficacy of drug-eluting stents with durable polymers, concerns regarding their long-term safety have been raised, especially in more complex subsets. The Manipal-S Registry was designed to evaluate the safety and effectiveness of the biodegradable polymer coated Supralimus(®) Sirolimus-Eluting Coronary Stent for the treatment of coronary artery disease, across a wide range of patients who are treated in real-life clinical practice.

Methods: All the consecutive 116 patients who underwent single-vessel or multiple vessel percutaneous coronary interventions with the use of Supralimus(®) sirolimus-eluting stents between September 2009 and December 2010, were included in this study. Patients were clinically followed-up at 1, 9, 12 and 24 months post-procedure. All clinical, procedural, and follow-up information were collected and analysed.

Results: In total 116 patients, 126 lesions were implanted with 144 stents which had an average stent length of 25.8±8.0 mm. The incidences of any major adverse cardiac and cerebral events at 1, 9, 12 and 24 months were 0, 5 (4.3%), 8 (6.9%), and 10 (8.6%) respectively.

Conclusion: These 24-month results clearly provide evidence for safety and effectiveness of the Supralimus(®) Sirolimus-eluting coronary stent system with the biodegradable polymer in real-life patients, even in those with acute myocardial infarctions.

Keywords: Biodegradable polymer; Coronary artery disease; Sirolimus-eluting stent.

[Table/Fig-1]:

Design of Matrix stent platform

[Table/Fig-5]:

Two year MACCE free survival curve (90.5%, n =116)