EBC - ON DEMAND
Results of Bipax study
European Bifurcation Club 2011, EBC 2011 – Lisbon, Portugal
HOT NEWS SESSION
Results of Bipax study
Author: Robert Jan van Geuns, ErasmusMC Rotterdam, The Netherlands
OBJECTIVE
To assess the safety and efficacy of the novel Nile PAX polymer-free drug-eluting coronary stent system for the treatment of single de novo bifurcation lesions in native coronary arteries
CONCLUSION
In patients following the protocol criteria (n=95):
- Angiographic FU at 9 months demonstrated binary restenosis rates in the PV and SB of 13.9% and 12.8%, respectively (primary endpoint), with overall in-bifurcation lesion restenosis of 18.6%
- At 9 months clinical FU, cumulative ischemia-driven TLR rate was 8.4%, and overall TLR rate was 12.6%
- Overall, there were no safety concerns, including absence of cardiac death and stent thrombosis throughout the study, and only 1 case of non-Q wave MI related to a new revascularization procedure