The Osiro sirolimus-eluting stent failed to show non-inferiority to the Xience everolimus-eluting stent (EES) in terms of in-segment late lumen loss, according to the results of the PRISON-IV Trial presented Nov. 2 at TCT 2016 and simultaneously published in JACC: Cardiovascular Interventions.

Koen Teeuwen, MD, et al., evaluated the non-inferiority of the sirolimus-eluting stent as compared to the EES in a randomized, multicenter trial of 330 consecutive patients with successfully recanalized native total or chronic total coronary occlusions. Follow-up angiography was performed at nine months after the procedure. In addition, clinical follow-up was obtained during the hospital stay and at one, six, nine and 12 months. The primary non-inferiority end point was in-segment late lumen loss assessed at nine-months by angiography.

The results of the trial showed that the primary endpoint of in-segment late lumen loss was not met for the sirolimus-eluting stent compared with EES (0.12±0.59 versus 0.07±0.46 mm, respectively). Further, the incidence of in-stent/in-segment binary restenosis was higher with the sirolimus-eluting stent compared to the EES (8.0 vs. 2.1 percent) with comparable rates of reocclusions (2.2 vs. 1.4 percent). At 12-month follow-up, clinically indicated target lesion and vessel revascularization, target vessel failure and major adverse cardiac events were comparable between both groups.

According to the authors, “future developments in stent technology should focus on the challenging characteristics of chronic total occlusions to improve device efficacy and clinical outcomes.”

Keywords: Transcatheter Cardiovascular Therapeutics, Absorbable Implants, Angina, Stable, Coronary Vessels, Drug-Eluting Stents, Myocardial Ischemia, Polymers, Sirolimus, Stents, Angiography, Coronary Occlusion, Coronary Restenosis, Follow-Up Studies, Length of Stay

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