Biodegradable Polymer Versus Polymer-Free Ultrathin Sirolimus-Eluting Stents in Complex Percutaneous Coronary Intervention: Post Hoc Analysis of the Stent Arm Registry From the HOST-IDEA Randomized Trial

BACKGROUND: The performance of third-generation drug-eluting stents with ultrathin struts and advanced polymer technology in complex percutaneous coronary intervention (PCI) remains unclear. This study compared the clinical outcomes of Coroflex ISAR polymer-free sirolimus-eluting stent (SES) and Orsiro biodegradable polymer SES, 2 third-generation drug-eluting stents, based on PCI complexity. METHODS: A post hoc analysis of the HOST-IDEA (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis–Coronary Intervention With Next-Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy) trial, which randomized 2013 patients undergoing PCI with Coroflex ISAR or Orsiro SES based on the duration of dual antiplatelet therapy (3 versus 12months), was conducted herein. The baseline characteristics were balanced through propensity score matching. Complex PCI satisfied ≥1 of the following criteria: ≥3 stents implanted, ≥3 lesions or vessels treated, bifurcation PCI, total stent length of ≥60mm, left main PCI, or heavy calcification. Target lesion failure (TLF) at 1year, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization, was the primary end point. RESULTS: Each stent group comprised 546 patients after propensity score matching. In total, 336 and 756 patients underwent complex PCI and noncomplex PCI, respectively. Complex PCI exhibited a significant association with a higher risk of TLF compared with noncomplex PCI (5.7% versus 1.3%, P<0.01). In the complex PCI group, the TLF rate in the Coroflex ISAR SES group was significantly higher than that in the Orsiro SES group (8.9% versus 2.4%; hazard ratio [HR], 3.74 [95% CI, 1.24–11.26]; P=0.02). However, the TLF rates in the 2 stent groups in the noncomplex PCI group were comparable (1.1% versus 1.6%; HR, 0.66 [95% CI, 0.19–2.35]; P=0.53; P for interaction=0.04). Multivariable analysis identified Coroflex ISAR SES and chronic kidney disease as independent predictors of TLF.