Coronary bifurcations treated with thin-strut drug-eluting stents: a prespecified analysis of the randomized BIO-RESORT trial.

ABSTRACT

BACKGROUND: Treatment of a coronary bifurcation lesion is often required in routine clinical practice, but data on the performance of very thin-strut biodegradable polymer drug-eluting stents are scarce. METHODS: Comparison of biodegradable polymer and durable polymer drug-eluting stents in an all comers population (BIO-RESORT) is a prospective, multicenter randomized clinical trial that included 3514 all-comer patients, who were randomized to very thin-strut biodegradable polymer-coated sirolimus- or everolimus-eluting stents, versus thin-strut durable polymer-coated zotarolimus-eluting stents. The approach of bifurcation stenting was left at the operator's discretion, and provisional stenting was generally preferred. This prespecified analysis assessed 3-year clinical outcome of all patients in whom treatment involved at least one bifurcation with a side-branch diameter ≥1.5 mm. RESULTS: Of all BIO-RESORT trial participants, 1236 patients were treated in bifurcation lesions and analyzed. Single- and two-stent techniques were used in 85.8% and 14.2%, respectively. 'True' bifurcation lesions (main vessel and side-branch obstructed) were treated in 31.1%. Three-year follow-up was available in 1200/1236 (97.1%) patients. The main endpoint target vessel failure (composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization) occurred in sirolimus-eluting stents in 42/412 (10.3%) and in zotarolimus-eluting stents in 49/409 (12.1%) patients (P-logrank = 0.40). In everolimus-eluting stents, target vessel failure occurred in 40/415 (9.8%) patients (vs. zotarolimus-eluting stents P-logrank = 0.26). There was no between-stent difference in individual components of target vessel failure. Findings were consistent in patients with single-vessel treatment and patients treated with a single-stent technique. CONCLUSIONS: Three years after stenting all-comers with bifurcation lesions, clinical outcome was similar with the sirolimus-eluting and everolimus-eluting stents versus the zotarolimus-eluting stent.