BIOFLOW-IV, a randomised, intercontinental, multicentre study to assess the safety and effectiveness of the Orsiro sirolimus-eluting stent in the treatment of subjects with de novo coronary artery lesions: primary outcome target vessel failure at 12 months
Shigeru Saito, Ralph Toelg, Bernhard Witzenbichler, Michael Haude, Monica Masotti, Ruiz Salmeron, Adam Witkowski, Masaaki Uematsu, Akihiko Takahashi, Ron Waksman, Ton Slagboom, Shigeru Saito, Ralph Toelg, Bernhard Witzenbichler, Michael Haude, Monica Masotti, Ruiz Salmeron, Adam Witkowski, Masaaki Uematsu, Akihiko Takahashi, Ron Waksman, Ton Slagboom
Abstract
Aims: The BIOFLOW-IV clinical trial was designed for regulatory submission in Japan. It assessed the safety and efficacy of a new third-generation sirolimus-eluting stent system with bioresorbable polymer (Orsiro, BP-SES) compared with an everolimus-eluting stent system with permanent polymer (XIENCE Prime/Xpedition, PP-EES).
Methods and results: This prospective, international, multicentre, 2:1 randomised, non-inferiority trial enrolled 575 patients (385 BP-SES and 190 PP-EES) with 659 stenotic de novo lesions. Of these, 137 patients (23.8%) were Japanese. Follow-up until five years is ongoing. We herein report outcomes at 12 months. Baseline parameters were well balanced. Device success was 98.9% for BP-SES versus 99.6% for PP-EES, p=0.670. Non-inferiority related to 12-month target vessel failure was met (pnon-inferiority <0.001). Further, there was no significant difference in clinical outcomes between the groups. The target vessel failure rate was 5.5% for BP-SES and 7.5% for PP-EES, the target lesion failure rate was 4.2% versus 5.4%, and the definite or probable stent thrombosis rate was 0.8% versus 0%.
Conclusions: The randomised BIOFLOW-IV trial provides further evidence on the safety and efficacy of the Orsiro BP-SES and its non-inferiority to the current benchmark, an everolimus-eluting permanent polymer stent. ClinicalTrials.gov: NCT01939249.
Source: PubMed