Nine-Month Primary Endpoint Results of the Evolve Ii Qca Study: A Prospective, Multicenter Trial Assessing Clinical, Angiographic, and Intravascular Ultrasound Outcomes With the Novel Platinum-Chromium Abluminally-Coated Bioabsorbable Polymer Synergy Everolimus-Eluting Stent in De Novo Coronary Stenoses

Meredith, Ian T.; Jaffe, Warwick M.; El‐Jack, Seif; Webster, Mark; Scott, Douglas; Saïto, Shigeru; Wong, Aaron; Ormiston, John; McClean, Dougal; Tan, Huay Cheem; Whelan, Alan; Walters, D.; Allocco, Dominic J.; Dawkins, Keith D.

doi:10.1016/s0735-1097(15)61789-2

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“…SYNERGY has also been tested in an angiographic cohort of patients in EVOLVE II QCA, a prospective, single-arm, multicenter study (N=100; Table 2 ) [ 45 ]. The primary endpoint, in-stent late loss at 9 months, was 0.23±0.34 mm which was significantly less than the performance goal of 0.40 mm ( P <0.0001).…”

Section: Clinical Trials Of Bioabsorbable Polymer-coated Desmentioning

confidence: 99%

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Current State of Bioabsorbable Polymer-Coated Drug-Eluting Stents

Akinapelli¹,

Chen

Roy

et al. 2017

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Drug-eluting stents (DES) have been shown to significantly reduce clinical and angiograph-ic restenosis compared to bare metal stents (BMS). The polymer coatings on DES elute antiproliferative drugs to inhibit intimal proliferation and prevent restenosis after stent implantation. Permanent poly-mers which do not degrade in vivo may increase the likelihood of stent-related delayed arterial healing or polymer hypersensitivity. In turn, these limitations may contribute to an increased risk of late clinical events. Intuitively, a polymer which degrades after completion of drug release, leaving an inert metal scaffold in place, may improve arterial healing by removing a chronic source of inflammation, neoath-erosclerosis, and/or late thrombosis. In this way, a biodegradable polymer may reduce late ischemic events. Additionally, improved healing after stent implantation could reduce the requirement for long-term dual antiplatelet therapy and the associated risk of bleeding and cost. This review will focus on bioabsorbable polymer-coated DES currently being evaluated in clinical trials.

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Section: Clinical Trials Of Bioabsorbable Polymer-coated Desmentioning

confidence: 99%

“…There were no deaths; 5 subjects had periprocedural non-Q-wave MI based on the conservative protocol definition (based on CK-MB >3x URL). No patient experienced a definite or probable ST through 12 months [ 45 ].…”

Section: Clinical Trials Of Bioabsorbable Polymer-coated Desmentioning

confidence: 99%