This non-inferiority design study compared the sirolimus-eluting stent with biodegradable polymer versus everolimus-eluting stent with permanent polymer in de novo coronary lesions. The primary endpoint was late lumen loss at nine months. We Included 440 patients with stable coronary lesions randomized 2:1 to receive the new sirolimus eluting stent with biodegradable polymer versus everolimus eluting stent with permanent polymer. Clinical follow-up was performed at 30 days and six months with angiographic using intravascular ultrasound (IVUS) and optical coherence tomography (OCT) at nine months after the procedure.
The rate of failure in the target lesion was not different between the groups and reached the noninferiority criterion, (4.8% versus 5.3%, for non-inferiority <0.0001). The IVUS showed no differences in strut apposition but showed minor neointimal hyperplasia with the new stent, (0.16 versus 0.43 mm, p = 0.043). The OCT did not show differences in apposition, (1% versus 0.6%, p = 0.52), but observed a larger coverage of struts by endothelium in the new stent, (98.3% versus 97.5%, p = 0.042).
Conclusion: The new sirolimus-eluting stent with biodegradable polymer reached the angiographic end point of non-inferiority against the everolimus-eluting stent. Clinical events to nine months were very low using either. More monitoring studies are needed in complex lesions to test the new stent.
Commentary: The lower observed hyperplasia coverage could be an advantage in terms of restenosis, revascularization, thrombosis and dual antiplatelet time but it will take a much larger study to answer these questions.
Stephan Windecker
2013-05-21
Título original: Safety and clinical performance of the drug-eluting Orsiro Stent in the treatment of subjects with single de novo coronary artery lesions-II (BIOFLOW-II).
