Complex All-comers and Patients with Diabetes and Prediabetes Treated with Xience Sierra Everolimus-eluting Stents: COASTLINE High-Risk

Background Percutaneous coronary intervention (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 This is the primary analysis of COASTLINE, an investigator-initiated, prospective, multicenter registry in all-comers treated with Xience Sierra EES. After enrollment, high-risk patients were identified according to prespecified criteria, and per protocol compared with high-risk patients treated in 2 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. Results Of 1,768 all-comers, treated with Xience Sierra EES and enrolled in this registry, 1,317(74.5%) were high-risk patients. Clinical outcome of these patients was compared with the control group, consisting of 1,682 high-risk 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%CI 0.57-1.06, p=0.12). Furthermore, a significantly lower rate of secondary endpoint TVMI was observed in Xience Sierra EES patients (1.4% vs.2.5%, adjusted hazard ratio 0.50, 95%CI 0.28-0.87, p=0.014), driven by periprocedural MI. Conclusion In patients with diabetes, prediabetes, or other high-risk 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.