Randomized prospective study comparing the everolimus-eluting polymer-coated stent versus a biodegradable polymer with biolimus coated stent.
While the use of first generation DES effectively reduces restenosis and reintervention rates, several meta-analyzes have shown a higher rate of late events of thrombotic origin associated with inflammatory phenomena and delayed reendothelialization at the site of implantation compared with conventional stents. In order to reduce thrombotic events observed in the follow-up with first generation drug-eluting stents (DES), new generations of SF have modified polymer to improve its biocompatibility or creating a biodegradable polymer or directly without using a polymer.
Nobori stent has a biodegradable polymer that releases biolimus, the family of sirolimus but more lipophilic at its abluminal side.
The COMPARE study II (n = 2707) possesses an All Comers design, which means an extremely wide inclusion. It aims to demonstrate non-inferiority compared with the XIENCE stent, which has permanent polymer everolimus release. At one year follow-up there were no significant differences in the primary endpoint (cardiac death, myocardial revascularization and ischemia-driven target lesion), with final thrombosis rate very low with both stents (0.7% degradable polymer and permanent polymer 0.4%, p = NS).
According to Dr. Pieter Smits, principal researcher, results of this study indicate that this stent has a similar performance with XIENCE, at least until the first year and could be an option of additional SF. On the other hand, Dr. David Holmes says to place another stent over nurtured inventory of cath lab is required to have an advantage over XIENCE. According to Dr. Pieter Smits, this SF degradable polymer has a “potential” advantage, to reduce the rate of thrombotic events in the long term (2-5 years), although we will have to wait. According to Dr. David Holmes this study does not change medical practice immediately.
COMPARE-II-Trail
Pieter Smits
2012-05-15