Efficacy and Safety of a Novel Bioabsorbable Polymer-Coated, Everolimus-Eluting Coronary Stent

Abstract

Background-Drug eluting stents with durable polymers may be associated with hypersensitivity, delayed healing, and incomplete endothelialization, which may contribute to late/very late stent thrombosis and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety. The SYNERGY stent is a thin-strut, platinum chromium metal alloy platform with an ultrathin bioabsorbable Poly(D,L-lactide-co-glycolide) abluminal everolimus-eluting polymer. We performed a multicenter, randomized controlled trial for regulatory approval to determine noninferiority of the SYNERGY stent to the durable polymer PROMUS Element Plus everolimus-eluting stent. Methods and Results-Patients (n=1684) scheduled to undergo percutaneous coronary intervention for non-ST-segmentelevation acute coronary syndrome or stable coronary artery disease were randomized to receive either the SYNERGY stent or the PROMUS Element Plus stent. The primary end point of 12-month target lesion failure was observed in 6.7% of SYNERGY and 6.5% PROMUS Element Plus treated subjects by intention-to-treat (P=0.83 for difference; P=0.0005 for noninferiority), and 6.4% in both the groups by per-protocol analysis (P=0.0003 for noninferiority). Clinically indicated revascularization of the target lesion or definite/probable stent thrombosis were observed in 2.6% versus 1.7% (P=0.21) and 0.4% versus 0.6% (P=0.50) of SYNERGY versus PROMUS Element Plus-treated subjects, respectively. Conclusions-In this randomized trial, the SYNERGY bioabsorbable polymer everolimus-eluting stent was noninferior to the PROMUS Element Plus everolimus-eluting stent with respect to 1-year target lesion failure. These data support the relative safety and efficacy of SYNERGY in a broad range of patients undergoing percutaneous coronary intervention. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01665053.(Circ Cardiovasc Interv. 2015;8:e002372.

Diagnosis and Management of Cardiovascular Disease in Advanced and End‐Stage Renal Disease

“…Important factors to consider in perioperative DAPT management are the type, number, and size of stents versus the risk of delaying renal transplantation in favor of prolonging DAPT to prevent stent thrombosis. A newer generation of DESs with enhanced biocompatibility and reduced thrombogenicity may require only 1 to 6 months of DAPT depending on the type of stent, but more evidence is needed 61, 66, 67. These considerations highlight the fact that DAPT should be tailored to the individual patient.…”

Stent Polymers

“…target lesion revascularization rates were 4.0% with BP-SES and 3.1% with PP-EES (rate ratio, 1.30; 95% CI, 0.82-2.06; P=0.27), whereas the incidence of definite/probable stent thrombosis was numerically lower with BP-SES (2.8%) compared with P-EES (3.4%; rate ratio, 0.83; 95% CI, 0.50-1.35; P=0. 45). 38 To highlight is the very low in-stent LLL observed with the ultrathin Orsiro stent (0.1 mm), which is also identical to the in-stent LLL observed with the BP-EES (Synergy stent; Boston Scientific Corp).…”

“…In the Assess the Synergy Stent System for the Treatment of Atherosclerotic Lesion(s) (EVOLVE II) trial, target lesion failure at 1 year was virtually identical with both BP-EES and PP-EES (Promus Element stents; Boston Scientific Corp)-6.7% versus 6.4% respectively (P noninferiority =0.0003). 45 In the Randomized MicroPort's Firehawk DES Versus Xience V (TARGET I) trial, the Firehawk stent (86-μm cobalt-chromium with abluminal grooves filled with polylactide acid and sirolimus; Microport Medical, Shangai, China) was noninferior to PP-ESS on the primary end point 9-month instent LLL (0.13±0.24 versus 0.13±0.18 mm, respectively; P noninferiority <0.001). 56 Another concept is tested in the design of BP-SES (MiStent platform; Micell Technologies, Durham, NS).…”

Interventional Cardiology

“…The drug and polymer coating is absorbed by 3 months. 17 Recently, the polymer-free biolimus A9 stent was tested against bare metal stents in patients with a high risk of bleeding, and it was found to be superior with lower rates of target vessel revascularization and similar safety despite only 1 month of dual-antiplatelet therapy. 18 Further refinements in coating and stent design are likely to continue to reduce late complications.…”