Twelve-month comparative analysis of clinical outcomes using biodegradable polymer–coated everolimus-eluting stents versus durable polymer–coated everolimus-eluting stents in all-comer patients

Abstract

Aim The purpose of the present study was to examine whether clinical differences exist between the biodegradable polymer (BDP)–coated Tetrilimus everolimus-eluting stent (EES) and the durable polymer (DP)–coated Xience EES by comparing the major adverse cardiac event (MACE) rate at 12 months in all-comer patients. Methods This study was designed as a multicentre, observational, retrospective, investigator-initiated study between January 2016 and October 2016. Two hundred thirteen patients who underwent percutaneous coronary intervention (PCI) with the BDP-EES were compared with 204 patients who underwent PCI with the DP-EES, irrespective of lesion complexity, comorbidities and acute presentation. The primary end point was MACE defined as a composite of cardiac death, myocardial infarction and target lesion revascularization. Results Baseline clinical and lesion characteristics of both the groups were similar, although the BDP-EES group had a significantly higher number of patients with diabetes mellitus (39.9% vs. 30.4%; p = 0.042) and type C lesion (67.4% vs. 48.1%; p < 0.001) than the DP-EES group. The 12-month MACE rate was 4.2% for the BDP-EES group versus 4.9% for the DP-EES group ( p = 0.740). Mortality was lower in the BDP-EES group than in the DP-EES group (0.9% vs. 2.0%; p = 0.441). Conclusion The present comparative analysis shows that the BDP-coated Tetrilimus EES was as safe and effective as the DP-coated Xience EES during the 12-month follow-up period despite complex lesion characteristics.

Ultrathin, biodegradable polymer-coated everolimus-eluting stents for patients undergoing percutaneous coronary intervention: Final three-year results of the PERFORM-EVER registry

“…In addition to ultrathin platform of Tetrilimus EES, its unique biodegradable polymer-coating, novel LDZ-link (making it more flexible and deliverable) and wide range of available size matrix (making it suitable for small vessels [<2.5 mm] as well as long lesions [>40 mm]) demonstrates favorable long-term safety and effectiveness as reported in the current and in the previous studies. 14 , 15 , 16 , 17 , 18 , 28 …”

“…Tetrilimus (Sahajanand Medical Technologies Ltd., Surat, India), an everolimus-eluting stent (EES), is a latest generation DES with biodegradable polymer-coating on an ultrathin (60 μm) cobalt-chromium platform with unique long-dual Z (LDZ) link connectors. The safety and effectiveness of Tetrilimus EES have previously been reported in several studies, 14 , 15 , 16 , 17 , 18 but there are inadequate long-term clinical data (>1 year after implantation) on this latest generation ultrathin DES. 19 Specifically, there is a need to establish whether Tetrilimus EES can overcome the limitations of earlier generation DES, like late in-stent restenosis and very late stent thrombosis.…”

Real-World Clinical Outcomes of Indigenous Biodegradable Polymer Drug-Eluting Stents

“…Recent decades have seen dramatic growth in stent innovation and the manufacturing of indigenous coronary stents with biodegradable polymers. Various studies have shown the feasibility and efficacy of these stents individually [16][17][18][19][20][21][22]26]. However, there is a scarcity of literature regarding the real-life experience related to these stents outside of trial settings, especially outcome analysis with these stents examined together.…”

“…Various Indian manufacturers produce biodegradable or polymer-free stents that are widely used across the world. The safety and efficacy of these Indian stents have been established in well-structured clinical trials [15][16][17][18][19][20][21][22]. However, there is a scarcity of data and evidence related to their safety and efficacy in the real-world or clinical setting.…”

Safety and performance of the EverProTMeverolimus-eluting coronary stent system with biodegradable polymer in a real-world scenario

“…The 12-mo MACE rate following implantation of EES ranged from 0.3% to 6.2% for diverse clinical presentations in randomized trials, and real-world studies[ 19 - 24 ]. The 1-year incidence of MACE following treatment with another indigenous biodegradable polymer DEC ranged from 0.9% to 4.2%[ 25 - 27 ]. No MACE was reported during the 1-year follow-up period in our study.…”