Clinical performance of biodegradable polymer-coated sirolimus-eluting stents in unselected real-world population with coronary artery disease: results from the multicenter CORE Registry.

BACKGROUND

The main aim of the CORE Registry was to evaluate clinical performance of the Supralimus-Core® biodegradable polymer-coated sirolimus-eluting cobalt-chromium stent (Sahajanand Medical technologies Pvt. Ltd., Surat, India) in unselected real-world patients.

METHODS

This was a multicenter, retrospective, non-randomized, single-arm study. A total of 376 consecutive patients treated with the Supralimus-Core® between April 2010 and June 2014 were enrolled. The primary-end point of the registry was major adverse cardiac events (MACE), which is a composite of cardiac death, target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI) and stent thrombosis (ST). Clinical follow-up were scheduled at 30-day and 6-month.

RESULTS

The mean age of enrolled patients was 54.6±10.3 years. A total of 444 lesions were treated successfully with 457 stents (1.0±0.2 per lesion). The average stent length and diameter was 24.0±8.0 mm and 3.0±0.33 mm, respectively. Out of total patients, 300 (79.8%) were male. Diabetes, hypertension and chronic totally occluded lesions were found in 95 (25.3%), 102 (27.1%) and 125 (28.2%) patients, respectively, reflecting high-risk patients involvement. The incidence of MACE at 30-day and 6-month was found to be in 4 (1.1 %) and 4 (1.1%) patients, respectively. The TLR and ST was found in 1 (0.3 %) and 1 (0.3 %) patient respectively at 6-month follow-up.

CONCLUSIONS

The lower incidence of MACE, TLR and ST clearly delineates safety and efficacy of Supralimus-Core sirolimus-eluting stent in "real-world" patients with complex coronary lesions.