Clinical Outcomes of the First Randomized Clinical Trial Evaluating a Dedicated bifurcation Stent: Lessons Learned
European Bifurcation Club 2014 – EBC 2014 – Bordeaux, France
At last randomized trials with dedicated bifurcation stents!
Clinical Outcomes of the First Randomized Clinical Trial Evaluating a Dedicated bifurcation Stent: Lessons Learned
Author: Philippe Généreux, MD for the Tryton Bifurcation Trial Investigators, Columbia University Medical Center, Cardiovascular Research Foundation, NYC
CONCLUSION
- The Tryton two-stent strategy in true bifurcations (88%) compared with the provisional strategy (8.0% side branch stents) did not meet the non-inferiority clinical endpoint (TVF), due to a relatively higher frequency of small peri-procedural CK-MB elevations.
- However, both strategies were safe (rare clinically significant MIs and stent thrombosis) and both had low 9-month clinically-driven TVR (P:3.6%,T:4.7%).
- DES in the main vessel performed well in both arms.
- Post-hoc subset analyses indicated:
- A striking disparity between binary restenosis and clinically-driven TVR for both arms, indicating that side branch angiographic restenosis is uncommonly expressed clinically.
- Improved clinical outcomes with Tryton in larger side branches (> 2.25 mm side branches = 41% of enrolled patients).