Low Stent Thrombosis Risk with the XIENCE V® Everolimus-Eluting Coronary Stent: Evidence from Randomized and Single-Arm Clinical Trials

Abstract

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).

DES Overview: A Historical and Current Review of Pivotal Clinical Trial Programs

“…Other patient specific characteristics may contribute, such as patient co-morbidities (diabetes, renal failure and acute MI) and lesion characteristics. Compliance to DAPT and platelet responsiveness also plays a role in ST rates observed in DES (Bezenek et al, 2011). Procedural factors related to smaller luminal dimensions, such as stent under-expansion or malapposition are risk factors for ST, in addition to stent length, multi-stenting, persistent slow flow, positive remodeling, dissections, geographic miss, residual stenosis, and late stent malapposition which have all been related to ST (Bezenek et al, 2011).…”

“…Despite these challenges however, few DES have emerged as demonstrating a consistent numerically low rate of ST across clinical trials. The XIENCE V and XIENCE PRIME DES remain two of the DES with the lowest ST event profile across RCT, single-arm, and all-comer trials, despite reduced DAPT compliance observed at 2 years in the COMPARE all-comers trial; the combination of stent design, thin struts, bio-compatible polymer coating technologies, and drug may contribute to numerically low ST rates consistently observed (Bezenek et al, 2011).…”

“…Compliance to DAPT and platelet responsiveness also plays a role in ST rates observed in DES (Bezenek et al, 2011). Procedural factors related to smaller luminal dimensions, such as stent under-expansion or malapposition are risk factors for ST, in addition to stent length, multi-stenting, persistent slow flow, positive remodeling, dissections, geographic miss, residual stenosis, and late stent malapposition which have all been related to ST (Bezenek et al, 2011). Furthermore, well established criteria for the duration and dose with existing antiplatelet m e d i c a t i o n , a s w e l l a s t h e r o l e o f n e w l y emerging antiplatelet medications does not exist currently.…”

“…XIENCE V uses an acrylic polymer primer coating outside of the stent, referred to as PBMA [poly (nbutylmethacrylate)], covered by a fluorinated copolymer coating made of two monomeric compounds (vinylidene fluoride and hexafluoropropylene). XIENCE V was engineered to elute everolimus from a thin (7.8 micron), non adhesive, durable, biocompatible, and fluorinated copolymer (Bezenek et al, 2011). Everolimus is an anti-proliferative drug with anti-inflammatory properties that arrests the cell in the G1 phase.…”

The use of bioresorbable vascular scaffold Absorb BVS® in patients with stable coronary artery disease: one-year results with special focus on the hybrid bioresorbable vascular scaffolds and drug eluting stents treatment

“…At the time of the inclusion stent scaffolds were available in diameters of 2.5, 3.0, and 3.5 mm, and lengths of 18, 23, and 28 mm. If an additional DES was required, it was a Xience Pro ® stent (Abbott Vascular) [5,6].…”