Key result
Everolimus-eluting stents (EES) reduced 2-year target vessel revascularization compared to zotarolimus-eluting stents (2.4% vs 7.7%, P=0.01) in patients with severely calcified coronary lesions.
Why the study?
Severe lesion calcification increases cardiovascular event risk after stenting, but clinical outcome data on all-comers with severely calcified lesions treated with newer drug-eluting stents are lacking.
Do biodegradable polymer everolimus-eluting or sirolimus-eluting stents reduce target vessel failure compared to durable polymer zotarolimus-eluting stents in patients with severely calcified coronary lesions?
RCT (n=783)
randomly assigned
Do biodegradable polymer everolimus-eluting or sirolimus-eluting stents reduce target vessel failure compared to durable polymer zotarolimus-eluting stents in patients with severely calcified coronary lesions?
Absolute Event Rate: 7.6% vs 12.6%
p-value: p=0.07
In patients with severely calcified coronary lesions, biodegradable polymer everolimus-eluting stents were associated with lower 2-year target vessel revascularization rates compared to durable polymer zotarolimus-eluting stents.
EES may reduce revascularization in calcified lesions; extends RCT stent comparisons despite nonsignificant primary endpoint.
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 (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.
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Buiten et al. (2020) conducted an RCT in severely calcified coronary lesions (n=783). Biodegradable polymer Synergy everolimus-eluting stents (EES) vs. Durable polymer Resolute Integrity zotarolimus-eluting stents (ZES) was evaluated on target vessel failure (p=0.07). Everolimus-eluting stents (EES) reduced 2-year target vessel revascularization compared to zotarolimus-eluting stents (2.4% vs 7.7%, P=0.01) in patients with severely calcified coronary lesions.
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