This new stent is a sirolimus-eluting low-profile cobalt chrome platform (80 µm) with a rapid resorption polymer (3 months). Theoretically, it presents less risk of inflammation of the vessel due to the kinetics of drug elution and polymer degradation. The objective of this study was to test the safety and efficacy of the new device. The study compared the new device with a historical control of patients who received conventional stents, also evaluating angiographic parameters by IVUS and OCT after 6 months. The primary endpoint was late lumen loss at 6 months and the secondary endpoints were death, stroke and stent thrombosis.
The study included 105 patients who received the new device and were compared to 282 historical controls who received BMS. Angiographic restenosis was 0.9% vs 17% (p <0.0001) with a late lumen loss of 0.0 ± 0.37 mm vs. 0.5 ± 0.43 mm (p<0.0001). There were no differences in major clinical events or stent thrombosis.
Conclusion: This new device showed superior efficacy relative to historical control with conventional stents, with a relative reduction of the risk of stenosis of 95%.
Editorial comment: such a low late lumen loss may correspond eventually to malappositioned structures, with the subsequent risk of thrombosis.
emanuele_barbato_europcr
Emanuele Barbato, MD.
2013-05-22
Original title: Clinical evaluation of new drug-eluting coronary stent system in the treatment of patients with coronary artery disease.The CENTURY Study.