Biodegradable polymer drug-eluting stents versus first-generation durable polymer drug-eluting stents

Abstract

Background:Even if drug-eluting stents (DES) showed beneficial effects in patients with coronary artery diseases (CADs), limitations have been observed with the first-generation durable polymer DES (DP-DES). Recently, biodegradable polymer DES (BP-DES) have been approved to be used as an alternative to DP-DES, with potential benefits. We aimed to systematically compare BP-DES with the first-generation DP-DES using a large number of randomized patients.Methods:Electronic databases were searched for randomized controlled trials (RCTs) comparing BP-DES with first-generation DP-DES. The main endpoints were the long-term (≥2 years) adverse clinical outcomes that were reported with these 2 types of DES. We calculated odds ratios (ORs) with 95% confidence intervals (CIs) and the analysis was carried out by RevMan 5.3 software.Results:Twelve trials with a total number of 13,480 patients (7730 and 5750 patients were treated by BP-DES and first-generation DP-DES, respectively) were included. During a long-term follow-up period of ≥2 years, mortality, myocardial infarction (MI), target lesion revascularization (TLR), and major adverse cardiac events (MACEs) were not significantly different between these 2 groups with OR: 0.84, 95% CI: 0.66–1.07; P = .16, I2 = 0%, OR: 1.01, 95% CI: 0.45–2.27; P = .98, I2 = 0%, OR: 0.91, 95% CI: 0.75–1.11; P = .37, I2 = 0% and OR: 0.86, 95% CI: 0.44–1.67; P = .65, I2 = 0%, respectively. Long-term total stent thrombosis (ST), definite ST, and probable ST were also not significantly different between BP-DES and the first-generation DP-DES with OR: 0.77, 95% CI: 0.50–1.18; P = .22, I2 = 0%, OR: 0.71, 95% CI: 0.43–1.18; P = .19, I2 = 0% and OR: 1.31, 95% CI: 0.56–3.08; P = .53, I2 = 6%, respectively.Conclusion:Long-term mortality, MI, TLR, MACEs, and ST were not significantly different between BP-DES and the first-generation DP-DES. However, the follow-up period was restricted to only 3 years in this analysis.

Biodegradable polymer versus second‐generation durable polymer drug‐eluting stents in patients with coronary artery disease: A meta‐analysis

“…However, this benefit was not realized in the present meta‐analysis, which found no significant difference between BP‐DES and second‐generation DP‐DES for the risk of definite or probable ST at 5 years of follow‐up and on landmark analysis beyond 1 year of follow‐up. Similarly, a meta‐analysis of 13,480 patients showed no significant difference between BP‐DES and first‐generation DP‐DES for the risk of definite or probable ST. Some animal studies demonstrated higher rates of inflammation associated with biodegradable polymers than durable polymers.…”

Nanotechnology in development of next generation of stent and related medical devices: Current and future aspects

“…Different polymers like poly(lactic acid) (PLA), poly( dl ‐lactide) (PDLLA), poly(glycol acid) (PGA), and their copolymers, polylactic‐ co ‐glycolic acid (PLGA), and so on have been used in preparing bioresorbable polymeric stents (Makadia & Siegel, 2011). By the end of the first year of implantation, BP‐DES and the standard‐bearer DP‐DES were proven to be clinically equivalent (Bundhun et al, 2017). Rather, early generation biodegradable polymer DES platforms showed lower rates of stent thrombosis at long‐term follow‐up (Rizas & Mehilli, 2016).…”

Drug-Eluting Stents and Balloons—Materials, Structure Designs, and Coating Techniques: A Review

“…Recently, third-generation stents covered with fully biodegradable polymers such as PLGA and PLA have appeared on the market. [ 71 , 72 ]. One example is the everolimus-eluting stent, which consists of a platinum-chromium (Pt-Cr) platform coated with a biodegradable PLGA copolymer.…”