Final 5-Year Report of the Randomized BIO-RESORT Trial Comparing 3 Contemporary Drug-Eluting Stents in All-Comers

Abstract

Background In a previous trial, higher 5-year mortality was observed following treatment with biodegradable polymer Orsiro sirolimus-eluting stents (SES). We assessed 5-year safety and efficacy of all-comers as well as patients with diabetes treated with SES or Synergy everolimus-eluting stents (EES) versus durable polymer Resolute Integrity zotarolimus-eluting stents (ZES). Methods and Results The randomized BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) trial enrolled 3514 all-comer patients at 4 Dutch cardiac centers. Patients aged ≥18 years who required percutaneous coronary intervention were eligible. Participants were stratified for diabetes and randomized to treatment with SES, EES, or ZES (1:1:1). The main end point was target vessel failure (cardiac mortality, target vessel myocardial infarction, or target vessel revascularization). Five-year follow-up was available in 3183 of 3514 (90.6%) patients. The main end point target vessel failure occurred in 142 of 1169 (12.7%) patients treated with SES, 130 of 1172 (11.6%) treated with EES, versus 157 of 1173 (14.1%) treated with ZES (hazard ratio [HR], 0.89 [95% CI, 0.71-1.12], Plog-rank=0.31; and HR, 0.82 [95% CI, 0.65-1.04], Plog-rank=0.10, respectively). Individual components of target vessel failure showed no significant between-stent difference. Very late definite stent thrombosis rates were low and similar (SES, 1.1%; EES, 0.6%; ZES, 0.9%). In patients with diabetes, target vessel failure did not differ significantly between stent-groups (SES, 19.8%; EES, 19.2%; versus ZES, 21.1% [Plog-rank=0.69 and Plog-rank=0.63]). Conclusions Orsiro SES, Synergy EES, and Resolute Integrity ZES showed similar 5-year outcomes of safety and efficacy, including mortality. A prespecified stent comparison in patients with diabetes also revealed no significant differences in 5-year clinical outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01674803.

Keywords: biodegradable polymer; drug‐eluting stent; durable polymer; percutaneous coronary intervention; randomized clinical trial.

Figures

Figure 1. Trial profile.

Figure 2. Kaplan–Meier curves for the main end point target vessel failure and its individual components at 5‐year follow‐up.

Cumulative incidence of (A) target vessel failure (main composite end point) and its individual components (B) cardiac death, (C) target vessel–related MI, and (D) TVR. HR indicates hazard ratio; MI, myocardial infarction; TVR, target vessel revascularization; and ZES, zotarolimus‐eluting stent.

Figure 3. Kaplan–Meier curves for target vessel failure and its individual components in patients with diabetes at 5‐year follow‐up.

Cumulative incidence of (A) target vessel failure and its individual components (B) cardiac death, (C) target vessel‐related MI, and (D) TVR. HR indicates hazard ratio; MI, myocardial infarction; TVR, target vessel revascularization; and ZES, zotarolimus‐eluting stent.

Figure 4. Subgroup analyses for target vessel failure at 5 years for SES versus ZES.

Data are expressed as n/N (percentage). SES indicates sirolimus‐eluting stents; and ZES, zotarolimus‐eluting stents.

Figure 5. Subgroup analyses for target vessel failure at 5 years of EES versus ZES.

Data are expressed as n/N (percentage). EES indicates everolimus‐eluting stents; and ZES, zotarolimus‐eluting stents.