Five-Year Clinical Outcome of the Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent Compared to the Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention: From the SORT OUT VII Trial

Abstract

Background: Biodegradable polymer drug-eluting stents were developed to improve safety and efficacy outcomes for patients undergoing percutaneous coronary intervention. However, few long-term follow-up efficacy studies are available. The study sought to investigate 5-year results from the SORT OUT VII trial (Scandinavian Organization for Randomized Trials With Clinical Outcome) comparing the biodegradable polymer ultrathin-strut sirolimus-eluting Orsiro stent (O-SES) versus the biodegradable polymer biolimus-eluting Nobori stent (N-BES). Methods: This registry-based, randomized, multicenter, single-blinded, noninferiority trial compared O-SES and N-BES in an all-comer population. The composite primary end point, target lesion failure, consisted of cardiac death, myocardial infarction related to the target lesion, or target lesion revascularization within 1 year. Follow-up was extended to 5 years. Results: Five-year follow-up was completed for 2521 patients (99.8%). Five-year target lesion failure did not differ between O-SES (12.4%) and N-BES (13.1%; rate ratio [RR], 0.94 [95% CI, 0.75–1.18]). Cardiac death (RR, 0.95 [95% CI, 0.67–1.34]), target myocardial infarction (RR, 1.14 [95% CI, 0.76–1.71]), target lesion revascularization (RR, 0.90 [95% CI, 0.67–1.21]), and definite stent thrombosis rates (RR, 0.73 [95% CI, 0.41–1.33]) did not differ significantly between the 2 stents. Within the first year, definite ST was significantly lower for O-SES (0.4%) compared to N-BES (1.2%; RR, 0.33 [95% CI, 0.12–0.92]), but no difference was from 1 through 5 years: O-SES 1.2% and N-BES 0.9% (RR, 1.28 [95% CI, 0.58–2.82]). Conclusions: Five years after treatment with biodegradable polymer stents, target lesion failure did not differ among O-SES and N-BES. Definite stent thrombosis was less often seen within the first year in the O-SES but the difference was not maintained after 5 years. Registration: URL: https://clinicaltrials.gov ; Unique identifier: NCT01879358.

Final 5‐year report of BIONYX comparing the thin‐composite wire‐strut zotarolimus‐eluting stent versus ultrathin‐strut sirolimus‐eluting stent

“…Although the Orsiro SES has been thoroughly investigated, only few studies have assessed the long‐term clinical outcome after PCI with this stent in all‐comers: The most recently published randomized clinical trial that reported 5‐year follow‐up data (SORT OUT VII) compared the Orsiro SES with the Nobori biodegradable polymer biolimus‐eluting stent (Terumo Corporation) 13 . In that trial, the composite primary endpoint TLF did not differ between the Orsiro SES and Nobori biolimus‐eluting stent groups (12.4% vs. 13.1%), and it was similar to our findings in the Orsiro SES group (12.0%).…”

“…So far, no 5-year results have been published for the Onyx ZES, while a few all-comer trials have reported 5-year outcomes for the Orsiro SES. [13][14][15] Therefore, in this final report of the BIONYX trial, we analyzed for the first time the 5-year follow-up data, comparing all-comers treated with Onyx ZES versus Orsiro SES. In addition, we performed a prespecified subgroup analysis in patients with known diabetes.…”

“…Only few other randomized all‐comer trials have reported 5‐year outcomes after PCI with one of the study stents. So far, no 5‐year results have been published for the Onyx ZES, while a few all‐comer trials have reported 5‐year outcomes for the Orsiro SES 13–15 …”

Atlas drug-eluting coronary stents inhibits neointimal hyperplasia in sheep modeling

“…Additionally, the multilayer absorbable PLGA coating completely degrades in vitro in approximately 8 weeks, immediately after complete elution of the drug (4,23). In addition to these, there are many studies demonstrating that biodegradable polymer coated sirolimus-eluting stents are both safe and feasible in preventing restenosis in human or experimental animal models (24)(25)(26)(27). The metal structure of Atlas drug-eluting stents enables the stent to be prepared with a very thin support structure and allows radioopacity (8,28).…”

Long‐term outcomes after coronary intervention with biodegradable polymer stents in patients with acute coronary syndromes

“…In the SORT OUT (Scandinavian Organisation for Randomized Trials with clinical Outcome) VII trial the biodegradable ultrathin strut sirolimus-eluting stent (Orsiro; Biotronik) (O-SES) was compared to the biodegradable polymer biolimus-eluting stent (Nobori; Terumo) (N-BES) regarding target lesion failure (TLF). [11][12][13] This study aimed to assess the long-term outcomes for O-SES and N-BES in an all-comer patient population with particular attention to the ACS subgroup.…”