J Am Heart Assoc. 2026;15(5):e043441.

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.

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제1저자 박상현 · 교신저자 한정규, 김용훈

PMID 41717861 PMC13055759 DOI 10.1161/JAHA.125.043441 IF 6 순환기내과

소속 (13)

Cardiovascular Center Seoul National University Hospital Seoul Republic of Korea.
Department of Internal Medicine, College of Medicine Seoul National University Seoul Republic of Korea.
Cardiovascular Center Kyung Hee University Hospital at Gangdong Seoul Republic of Korea.
Department of Cardiology, Heart Center Saint Carollo Hospital Sun-cheon Republic of Korea.
Division of Cardiology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital Soonchunhyang University College of Medicine Seoul Republic of Korea.
Division of Cardiology, Department of Internal Medicine, Chungnam National University Sejong Hospital Chungnam National University School of Medicine Sejong Republic of Korea.
Division of Cardiology, Department of Internal Medicine Pusan National University Hospital Busan Republic of Korea.
Department of Internal Medicine, Ewha Womans University Medical Center Ewha Womans University School of Medicine Seoul Republic of Korea.
Department of Cardiology, Samsung Changwon Hospital Sungkyunkwan University School of Medicine Changwon Republic of Korea.
Departments of Internal Medicine, Kangdong Sacred Heart Hospital Hallym University College of Medicine Seoul South Korea.
Division of Cardiology, Department of Internal Medicine Hallym University Pyeongchon Sacred Heart Hospital Anyang Republic of Korea.
Division of Cardiology, Nowon Eulji Medical Center Eulji University School of Medicine Seoul Republic of Korea.
Department of Internal Medicine Kangwon National University School of Medicine Chuncheon Republic of Korea.

Abstract

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 12 months), 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 ≥60 mm, left main PCI, or heavy calcification. Target lesion failure (TLF) at 1 year, 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.

CONCLUSIONS Orsiro SES was associated with significantly better TLF outcomes than the Coroflex ISAR SES in complex PCI; however, no significant difference was observed in noncomplex PCI.

Keywords

complex percutaneous coronary interventionthird‐generation drug‐eluting stentsultrathin strut

Figures

**Figure 1** Study flow DES indicates drug‐eluting stents; 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; and PCI, percutaneous coronary intervention.

**Figure 2** Cumulative incidence of TLF by lesion complexity in the PS‐matched population matched for stent type The cumulative incidence of TLF was compared according to the stent type in the complex PCI and noncomplex PCI groups within the PS‐matched population. HR indicates hazard ratio; PCI, percutaneous coronary intervention; PS, propensity score; and TLF, target lesion failure.

**Figure 3** Cumulative incidences of cardiac death, TVMI, and CD‐TLR in the complex PCI group in the PS‐matched population matched for stent type The cumulative incidences of cardiac death, TVMI, and CD‐TLR in the complex PCI group were compared according to the stent type in the complex PCI group within the PS‐matched population. CD‐TLR indicates clinically driven target lesion revascularization; HR, hazard ratio; PCI, percutaneous coronary intervention; PS, propensity score; TLF, target lesion failure; and TVMI, target vessel myocardial infarction.

**Figure 4** Subgroup analyses of the primary end point No significant differences in the target lesion failure depending on the stent type across the various subgroups. DAPT indicates dual antiplatelet therapy; HR, hazard ratio; NSTEMI, non–ST‐segment–elevation myocardial infarction; PS, propensity score; and SIHD, stable ischemic heart disease.

그림 출처: PubMed Central 공개 논문 (PMC13055759)

Conflict of interest statement

Dr Han reports grants from ChongKunDang and HanMi outside the submitted work. Dr Park reports speaker fees from Daiichi Sankyo, AstraZeneca, Sanofi, Bristol‐Myers Squibb, Bayer, and Pfizer outside the submitted work. Dr Kim reports grants or speaker fees from Daiichi Sankyo, Boston Scientific, Terumo, Biotronik, Dio, Medtronic, Abbott Vascular, Edwards Lifesciences, Amgen, and Behringer Ingelheim outside of the submitted work. All other authors declare no competing interests. The sponsors had no role in the design and conduct of this study; the collection, analysis, and interpretation of data; the writing and approval of the article; or the decision to submit the article for publication.

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