The ARCADIA-ZERO registry: two-year outcomes of complex versus non-complex PCI with resolute onyx zotarolimus-eluting stent.

Drug-eluting stents (DES) have significantly advanced in the twenty-first century, enabling percutaneous coronary intervention (PCI) to treat increasingly complex coronary lesions. However, real-world data regarding outcomes of complex PCI remain limited. We aimed to compare the clinical outcomes between complex and non-complex PCI using a zotarolimus-eluting stent (ZES) registry in Japan. ARCADIA-ZERO is a multi-center registry of ZES from 65 Japanese institutions. Complex PCI was defined as chronic total occlusion (CTO), left main disease, bifurcation lesion requiring a 2-stent technique, lesions requiring a debulking device, use of ≥3 stents, and a total stent length of >60 mm. Device-oriented composite endpoints (DoCE) included cardiac death, spontaneous myocardial infarction, and target lesion revascularization, and were followed for 2 years. Patient characteristics, procedural characteristics, and DoCE were compared between complex and non-complex PCI groups. We analyzed 794 patients, including 257 with complex PCI and 537 with non-complex PCI. The most frequent reason for complex PCI was long stenting (41%), followed by CTO (36%), the need for an atherectomy device (28%), and left main disease (12%). Intravascular imaging was used in > 99% of all patients. The cumulative incidence of DoCE at 2 years was similar between complex and non-complex PCI (crude hazard ratio [HR], 1.14; 95% confidence interval [CI], 0.56-2.30; P=0.72; adjusted HR 1.09; 95% CI, 0.53-2.26; P=0.82). ZES demonstrated favorable clinical outcomes in both complex and non-complex percutaneous coronary intervention (PCI) in this Japanese multi-center registry.