Low stent thrombosis risk with the XIENCE V® Everolimus-Eluting Coronary Stent: evidence from randomized and single-arm clinical trials

The XIENCE V® Everolimus-Eluting Coronary Stent System (EECSS) has been evaluated in multiple randomized controlled trials (RCTs) with several different comparators (SPIRIT FIRST, SPIRIT II, SPIRIT III, SPIRIT IV, COMPARE, ISAR-TEST 4, SORT-OUT IV, and RESOLUTE All-Comers RCT). The available results consistently demonstrated numerically low stent thrombosis (ST) rates in the XIENCE V arm treated patients. The use of XIENCE V in complex patients with diabetes, overlapping stents, multistenting, and other known risk factors has not significantly increased the occurrence of ST, as evident in the 2-year rates of both per protocol and Academic Research Consortium (ARC)-defined ST rates in the SPIRIT IV RCT, as well as the COMPARE real-world RCT. Furthermore, available long-term follow-up in the SPIRIT FIRST, SPIRIT II, and SPIRIT III RCTs showed continued numerically low very late ST rates as well. High compliance rates of dual antiplatelet therapy (DAPT) were observed in the SPIRIT trials, which may have contributed to consistently numerically low ST rates in the XIENCE V arm treated patients. Several potential risk factors for developing ST may well have been minimized through the selective XIENCE V thin strut design, biocompatible polymers, and antiproliferative drug usage. (J Interven Cardiol 2011;24:326-341).