Three contemporary thin‐strut drug‐eluting stents implanted in severely calcified coronary lesions of participants in a randomized all‐comers trial

Abstract

Objective The objective was to assess the 2‐year clinical performance of three drug‐eluting stents in all‐comer patients with severely calcified coronary lesions. Background Severe lesion calcification increases cardiovascular event risk after coronary stenting, but there is a lack of data on the clinical outcome of all‐comers with severely calcified lesions who were treated with more recently introduced drug‐eluting stents. Methods The BIO‐RESORT trial (http://clinicaltrials.gov: NCT01674803) randomly assigned 3,514 all‐comer patients to biodegradable polymer Synergy everolimus‐eluting stents (EES) or Orsiro sirolimus‐eluting stents (SES), versus durable polymer Resolute Integrity zotarolimus‐eluting stents (ZES). In a post hoc analysis, we assessed 783 patients (22.3%) with at least one severely calcified target lesion. Results At 2‐year follow‐up (available in 99% of patients), the main composite endpoint target vessel failure occurred in 19/252 (7.6%) of the EES and in 33/265 (12.6%) of the ZES‐treated patients (p = .07). Target vessel failure occurred in 24/266 (9.1%) of the SES‐treated patients (vs. ZES: p = .21). There was a difference in target vessel revascularization, which was required in EES in 6/252 (2.4%) patients and in ZES in 20/265 (7.7%) patients (p = .01); the target vessel revascularization rate in SES was 9/266 (3.4%, vs. ZES: p = .04). Multivariate analysis showed that implantation of EES, but not SES, was independently associated with lower target vessel revascularization rates than in ZES. Conclusions In BIO‐RESORT participants with severely calcified target lesions, treatment with EES was associated with a lower 2‐year target vessel revascularization rate than treatment with ZES.

Biodegradable polymer everolimus-eluting stents versus contemporary drug-eluting stents: a systematic review and meta‑analysis

“…Interestingly, while there was a trend for less TVR associated with BP-EES in several studies 2 , 13 , 28 , 29 , this meta-analysis of all available RCTs showed no significant difference between BP-EES and contemporary DP-DES. The outcomes, while demonstrating no superiority of BP-EES, suggest that the BP-EES is not inferior to newer, widespread used DP-DES.…”

“…1). Fifteen RCTs met our inclusion criteria 2,13,[25][26][27][28][29][30][31][32][33][34][35][36][37] . Some data are from shorter follow-up time of the same study 25,31 or from a single center in a multi-center study 13,[36][37][38] .…”

Clinical Outcomes of Biodegradable versus Durable Polymer Drug Eluting Stents in Rotational Atherectomy: Results from ROCK Registry

“…There is accumulating evidence that newer ultrathin stents and biodegradable polymers are associated with more favorable results in patients undergoing PCI compared to thicker strut SGDES and durable polymers. In post hoc analyses of the BIO-RESORT trial, Synergy EES (strut thickness 74 μm) were associated with lower rates of TLR compared to Resolute Integrity ZES (strut thickness 91 μm) in small coronary arteries [ 13 ] and calcified lesions [ 14 ]. In the BIOFLOW V [ 15 ] and BIOSTEMI [ 16 ] trials, superior outcomes were observed with Orsiro CoCr-SES-BP (strut thickness 60/80 μm) compared to Xience CoCr-EES-DP.…”

“…Second generation DES (SGDES) have been a further improvement on the first-generation stents in terms of safety and efficacy when used after RA [ 10 , 11 , 12 ]. Additionally, there is accumulating evidence that newer ultrathin stents and biodegradable polymers are associated with more favorable results in patients undergoing PCI compared to thicker strut SGDES and durable polymers [ 13 , 14 , 15 , 16 ].…”

3-Year Clinical Outcomes of Ultrathin Biodegradable Polymer-Coated Sirolimus-Eluting Stents

“… 1 However, although 17.3% lesions in this registry were total occlusions, no signal even remotely suggestive of a clinically relevant problem due to insufficient radial force was observed. Neither has such a problem been reported in the BIORESORT (Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion) small coronary vessel subgroup 4 or calcified coronary lesion subgroup, 5 which reported implantation of ultrathin strut stents. Limitations include retrospective, single-arm, and observational study design and the lack of head-to-head comparison with other latest generation stents.…”