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Biodegradable Polymer Versus Polymer-Free Ultrathin Sirolimus-Eluting Stents: Analysis of the Stent Arm Registry From the HOST-IDEA Randomized Trial.
- Source :
-
Circulation. Cardiovascular interventions [Circ Cardiovasc Interv] 2024 Jul; Vol. 17 (7), pp. e013585. Date of Electronic Publication: 2024 May 24. - Publication Year :
- 2024
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Abstract
- Background: The efficacy and safety of each third-generation drug-eluting stent with ultrathin struts and advanced polymer technology remain unclear. We investigated the clinical outcomes of percutaneous coronary intervention using the Coroflex ISAR polymer-free sirolimus-eluting stent (SES) or Orsiro biodegradable polymer SES.<br />Methods: The HOST-IDEA trial (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Coronary Intervention With Next-Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy), initially designed with a 2×2 factorial approach, sought to randomize patients undergoing percutaneous coronary intervention based on dual antiplatelet therapy duration (3 versus 12 months) and stent type (Coroflex ISAR versus Orsiro). Despite randomizing 2013 patients for dual antiplatelet therapy duration, the stent arm transitioned to a registry format during the trial. Among these, 328 individuals (16.3%) were randomized for Coroflex ISAR or Orsiro SES, while 1685 (83.7%) underwent percutaneous coronary intervention without stent-type randomization. In this study, the Coroflex ISAR (n=559) and Orsiro groups (n=1449) were matched using a propensity score. The prespecified primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 12 months.<br />Results: The baseline patient and procedural characteristics were well balanced between the Coroflex ISAR and Orsiro groups after propensity score matching (n=559, each group). The Coroflex ISAR group was significantly associated with a higher rate of target lesion failure, mainly driven by clinically driven target lesion revascularization, compared with the Orsiro group (3.4% versus 1.1%; hazard ratio, 3.21 [95% CI, 1.28-8.05]; P =0.01). A higher risk of target lesion failure in the Coroflex ISAR group was consistently observed across various subgroups. The rates of any bleeding (hazard ratio, 0.85 [95% CI, 0.51-1.40]; P =0.52) and major bleeding (hazard ratio, 1.58 [95% CI, 0.61-4.08]; P =0.34) were comparable between the 2 groups.<br />Conclusions: In this propensity score-matched analysis of the stent arm registry from the HOST-IDEA trial, the Orsiro SES was associated with significantly better outcomes in terms of 1-year target lesion failure, mainly driven by clinically driven target lesion revascularization, than the Coroflex ISAR SES.<br />Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02601157.<br />Competing Interests: Dr Han reports grants from ChongKunDang and HanMi outside the submitted work. Dr K.W. Park reports speaker fees from Daiichi Sankyo, AstraZeneca, Sanofi, Bristol-Myers Squibb, Bayer, and Pfizer outside the submitted work. Dr H.-S. Kim reports grants or speaker fees from Daiichi Sankyo, Boston Scientific, Terumo, Biotronik, Dio, Medtronic, Abbott Vascular, Edwards Life Science, Amgen, and Behringer Ingelheim outside of the submitted work. The other authors report no conflicts.
- Subjects :
- Humans
Male
Female
Aged
Middle Aged
Treatment Outcome
Time Factors
Risk Factors
Dual Anti-Platelet Therapy
Hemorrhage chemically induced
Risk Assessment
Coronary Stenosis therapy
Coronary Stenosis diagnostic imaging
Coronary Stenosis mortality
Prospective Studies
Myocardial Infarction etiology
Drug-Eluting Stents
Percutaneous Coronary Intervention instrumentation
Percutaneous Coronary Intervention adverse effects
Percutaneous Coronary Intervention mortality
Registries
Prosthesis Design
Absorbable Implants
Polymers chemistry
Coronary Artery Disease therapy
Coronary Artery Disease diagnostic imaging
Coronary Artery Disease mortality
Platelet Aggregation Inhibitors administration & dosage
Platelet Aggregation Inhibitors adverse effects
Sirolimus administration & dosage
Sirolimus adverse effects
Cardiovascular Agents administration & dosage
Cardiovascular Agents adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1941-7632
- Volume :
- 17
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Circulation. Cardiovascular interventions
- Publication Type :
- Academic Journal
- Accession number :
- 38786579
- Full Text :
- https://doi.org/10.1161/CIRCINTERVENTIONS.123.013585