Complex all-comers and patients with diabetes and prediabetes treated with Xience Sierra everolimus-eluting stents: COASTLINE high-risk.

Aims: PCI is frequently performed in patients with high-risk (HR) of adverse clinical events. Therefore, the COASTLINE HR analysis aimed to assess the safety and efficacy of Xience Sierra everolimus-eluting stents (EES) in patients with diabetes, prediabetes, or other criteria of increased cardiovascular risk. Methods and results: This is the primary analysis of COASTLINE, an investigator-initiated, prospective, multicenter registry in all-comers treated with Xience Sierra EES. After enrolment, HR patients were identified according to prespecified criteria, and per protocol compared with HR patients treated in two randomized all-comer trials with Resolute-type zotarolimus-eluting stents (ZES). Primary endpoint at 1-year follow-up is target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction (TVMI), or target vessel revascularization. Of 1768 all-comers, treated with Xience Sierra EES and enrolled in this registry, 1317 (74.5%) were HR patients. Clinical outcome of these patients was compared with the control group, consisting of 1682 HR patients treated with Resolute-type ZES. At 1-year follow-up, no significant difference was observed in TVF between-stents (EES: 4.9% vs. ZES: 6.0%, adjusted hazard ratio 0.78, 95% confidence interval (CI) 0.57-1.06, Conclusion: In patients with diabetes, prediabetes, or other HR criteria, Xience Sierra EES showed safety and efficacy, comparable to Resolute-type ZES, including Resolute Onyx. The significant difference in TVMI was driven by periprocedural events, as a landmark analysis at 7 days found no between-stent differences. Registration: https://clinicaltrials.gov/study/NCT04475380.