Randomized Comparison of a Biodegradable Polymer Ultrathin Strut Sirolimus-Eluting Stent With a Biodegradable Polymer Biolimus-Eluting Stent in Patients Treated With Percutaneous Coronary Intervention

Abstract

I n percutaneous coronary interventions, drug-eluting stents (DESs) have reduced the risk of restenosis and repeat revascularization compared with bare-metal stents.1-3 The secondgeneration DESs with thinner stent struts 4,5 have improved safety and efficacy compared with the first-generation DESs [6][7][8] and has been associated with a reduced risk of late stent thrombosis. 6,8,9 The persistence of polymer material on first-and second-generation DESs after completion of drug release has been Background-Coronary drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy. Methods and Results-The Scandinavian Organization for Randomized Trials With Clinical Outcome (SORT OUT)VII trial-a large-scale registry-based randomized, multicenter, single-blind, 2-arm, noninferiority trial-compared 2 biodegradable polymer drug-eluting stents: the thin-strut cobalt-chromium sirolimus-eluting Orsiro stent and the stainless steel biolimus-eluting Nobori stent in an all-comer patient population. The primary end point target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 1 year, analyzed by intention to treat (noninferiority margin of 3.0%). Clinically driven event detection based on Danish registries was used. A total of 1261 patients were assigned to receive the sirolimus-eluting stent (1590 lesions) and 1264 patients to the biolimus-eluting stent (1588 lesions). At 1 year, the composite end point target lesion failure occurred in 48 patients (3.8%) in the sirolimus-eluting group and in 58 patients (4.6%) in the biolimus-eluting group (absolute risk difference, −0.78% [upper limit of 1-sided 95% confidence interval, 0.61%]; P<0.0001). Rates of definite stent thrombosis occurred in 5 (0.4%) of the sirolimus-eluting group compared with 15 (1.2%) biolimus-eluting stent-treated patients (rate ratio, 0.33; 95% confidence interval, 0.12-0.92; P=0.034), which largely was attributable to a lower risk of subacute definite stent thrombosis: 0.1% versus 0.6% (rate ratio, 0.12; 95% confidence interval, 0.02-1.00; P=0.05). Conclusions-The thin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent in unselected patients for target lesion failure at 1 year. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01879358.(Circ Cardiovasc Interv. 2016;9:e003610.

Real‐life clinical outcomes with everolimus eluting platinum chromium stent with an abluminal biodegradable polymer in patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

“…The safety of the Synergy stent is supported also by our mortality results up to 1 year showing no significant differences when compared with the other n‐DES. The overall mortality rates are similarly low, considering the clinical profile risk and the higher average age of our study population, when compared with previous randomized studies on newer stent devices . The patients in the Synergy stent group had a higher mean age, a higher proportion with diabetes and prior cardiovascular risk factors as well as more three vessel and left main disease, longer stents with smaller diameter and more bifurcation lesions.…”

From bare metal to barely anything: an update on coronary stenting

“…17–25 However, a direct comparison between different BP-DES suggests that devices with thinner struts are associated with a lower risk of stent thrombosis in the early period after PCI 26. This finding has been confirmed in a network meta-analysis also accounting for available indirect evidence 27.…”

Biodegradable-polymer drug-eluting stents: back to the future?

“…In contrast, a recently developed sirolimus-eluting stent (SES) with a biodegradable polymer (Orsiro; Biotronik, Buülach, Switzerland) has complete degradation of the carrier after 12–24 months and a thinner-strut design. At 1-year follow-up, this latter platform appears more efficacious and safe than the Nobori stent 7. Most importantly, this new biodegradable-polymer SES has 2-year efficacy comparable to that fluoropolymer-based EES, with a superior performance in patients with ST-elevation myocardial infarction 8…”