Summary: Randomized, open, pragmatic essay PROTECT (patient related outcomes of Endeavor versus Cypher stenting trial) compared two drug-eluting stents with different behaviors, (Cypher ® and Endeavor ®), in the reendothelialization degree and antiproliferative potency.
Cypher has a permanent sirolimus-eluting polymer which generates a potent antiproliferative effect and a suboptimal healing (or reendothelialization). Furthermore, Endeavor has a neutral polymer releasing zotarolimus which heals as well as being a non-pharmacological stent, (with excellent reendothelialization), and generates a moderate antiproliferative effect.
The study included 8,709 patients who were followed for three years. The primary endpoint was definite and probable stent thrombosis (ARC definition) to three years. The authors estimated a 40% difference between stents (1.5% with Endeavor and 2.5% with Cypher), requiring for this purpose 8,700 patients. The primary objective was not significant, (1.4% for Endeavor and 1.8% for Cypher, p = NS), which showed a difference of only 20%. While the final thrombosis rate was lower with Endeavor, (0.7% versus 1.25%, p = 0.03), the reoperation rate of treated lesion was higher (3.5% versus 5.6%, p <0.0001).
Commentary: Large pragmatic studies like PROTECT allow impact assessment of one stent choice over another in our interventional routine. Obviously, the clinical difference between these devices is reduced.
W. Wijns
2012-08-26
Original title: PROTECT Trial: Primary Results from PROTECT: the Patient Related Outcomes with Endeavor versus Cypher Stenting Trial. Stents
