Long-Term Efficacy and Safety of Biodegradable-Polymer Biolimus-Eluting Stents

Abstract

rug-eluting stents (DES) with biodegradable polymers were developed to be as effective as second-generation durable-polymer drug-eluting stents and as safe after 1 year as bare-metal stents (BMS).1 Thus, very late stent thrombosis (VLST: beyond 1 year after implantation), which has been associated with the durable polymer of first-generation DES, Background-Biodegradable-polymer drug-eluting stents (BP-DES) were developed to be as effective as second-generation durable-polymer drug-eluting stents (DP-DES) and as safe >1 year as bare-metal stents (BMS). Thus, very late stent thrombosis (VLST) attributable to durable polymers should no longer appear. Methods and Results-To address these early and late aspects, 2291 patients presenting with acute or stable coronary disease needing stents ≥3.0 mm in diameter between April 2010 and May 2012 were randomly assigned to biolimus-A9-eluting BP-DES, second-generation everolimus-eluting DP-DES, or thin-strut silicon-carbide-coated BMS in 8 European centers. All patients were treated with aspirin and risk-adjusted doses of prasugrel. The primary end point was combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization within 2 years. The combined secondary safety end point was a composite of VLST, myocardial infarction, and cardiac death. The cumulative incidence of the primary end point was 7.6% with BP-DES, 6.8% with DP-DES, and 12.7% with BMS. By intention-to-treat BP-DES were noninferior (predefined margin, 3.80%) compared with DP-DES (absolute risk difference, 0.78%; −1.93% to 3.50%; P for noninferiority 0.042; per protocol P=0.09) and superior to BMS (absolute risk difference, −5.16; −8.32 to −2.01; P=0.0011). The 3 stent groups did not differ in the combined safety end point, with no decrease in events >1 year, particularly VLST with BP-DES. Conclusions-In large vessel stenting, BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS, but without evidence for better safety nor lower VLST rates >1 year. Findings challenge the concept that durable polymers are key in VLST formation. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01166685.

Biodegradable-Polymer Biolimus-Eluting Stents versus Durable-Polymer Everolimus-Eluting Stents at One-Year Follow-Up: A Registry-Based Cohort Study

“…Second, the mean age of our patients was lower than the mean ages of patients in the other studies. The mean age was 58 years in our study, as opposed to 65 years in the studies by Lee and co-authors 11 and Tada and associates, 22 and 62 and 63 years in the studies by Smits and colleagues 21 and Kaiser and associates, 16 respectively.…”

“…[13][14][15][16][17] Trials have revealed the lower rates of MACE in short-and long-term follow-up after the DP-EES implantation in comparison to the earlier generation and have introduced the DP-EES as the standard of DES, versus other design improvements. 18 Investigators have also confirmed the superiority of the BP-BES over the first-generation DES.…”

“…In that trial, survival curves showed increasing divergence at 1, 2, and 3 years, in favor of the BP-BES. After the establishment of BP-BES's noninferiority to DP-EES in randomized trials, 16,21,22 some recent studies have focused on evaluating the advantages of BP-BES over DP-EES. 11,12 Puricel and colleagues 12 compared clinical outcomes in 200 propensity-score-matched pairs of patients (one treated by EES and the other treated by BES) and reported that, at 24 months after PCI, MACE had occurred in 10.5% of the BP-BES group and in 11.5% of the DP-EES group, with no significant difference.…”

Stent Polymers

“…For only 6 of these trials, follow-up data between 2 and 5 years were available. 36,41,43,48,50,52 At longerterm follow-up, a significantly lower risk of stent thrombosis was observed with BP-DES compared with PP-DES (odds ratio, 0.43; 95% CI, 0.25-0.73; Figure 2A-2D). Although promising, this finding should be interpreted with caution.…”

Letter by Jeger and Pfisterer Regarding Article, “Prasugrel Plus Aspirin Beyond 12 Months Is Associated With Improved Outcomes After TAXUS Liberté Paclitaxel-Eluting Coronary Stent Placement”

“…3 In that trial, prasugrel was prescribed at the same doses as in the Garratt et al study and stopped after 12 months in all patients (A small number of patients with stable coronary artery disease and bare-metal stents were treated for 1 month only). The main difference between the 2 trials was the type of stent used: In BASKET-PROVE II, it was either a biodegradable-polymer or a durable-polymer "-limus" drug-eluting stent, whereas in the Garratt et al study, it was a paclitaxel-eluting stent.…”