One-year Outcomes of XIENCE Skypoint 48-mm Drug-Eluting Stents in Long Coronary Lesions: The SPIRIT 48 Trial

Park, Ki E.; Wu, Chiung-Jen; Chehab, Bassem; Maksoud, Aziz; Bertolet, Barry; Ying, Shih-Wa; Simoes, Tiessa; Pingle, Sandeep C.; Chang, Chi-Jen

doi:10.1016/j.jscai.2023.101001

Cited by 1 publication

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“…Among other studies on long stents, the SPIRIT 48 trial evaluated the safety and efficacy of the XIENCE Skypoint 48 mm DES in 107 subjects with coronary artery disease having long de novo native coronary le- sions. Though the device success rate was 97.2%, the rate of cardiac death/all MI at 1 year was 5.8% and the TLF rate was 5.7%, which were much higher than the rates with Bio-Mime™ Morph SES [33].…”

Section: Discussionmentioning

confidence: 72%

Long-Term Safety and Performance of BioMime™ Morph Sirolimus-Eluting Coronary Stent System for Very Long Coronary Lesions

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2024

Cardiol Res

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Background The use of multiple overlapping stents for long lesions in tapered coronary arteries has been associated with poor outcomes. This study was conducted to evaluate the 3-year safety and performance of the BioMime™ Morph sirolimus-eluting stent (SES) in very long (length 30 to ≤ 56 mm) coronary lesions in native coronary arteries with a reference vessel diameter of 2.25 to 3.50 mm. Methods This was a prospective, single-center, observational, real-world, post-marketing surveillance study. Eligible patients were implanted with BioMime™ Morph SES. Patients were followed up at 6, 12, 24, and 36 months. Results A total of 88 patients were enrolled in the study. The mean age was 58.72 ± 10.10 years and 82.95% were male. Most patients had angina (81.82%) and ischemic heart disease (78.41%), and there was a high prevalence of comorbidities like diabetes mellitus (59.09%), and hypertension (54.55%). A total of 92 long coronary de novo lesions were treated with BioMime™ Morph SES with an average stent length of 45.54 ± 10.20 mm. Device and procedural success rates were 100%. One patient died at 30 days and one case of myocardial infarction was recorded. The cumulative rates of major adverse cardiovascular events (MACEs) at 6, 12, 24, and 36 months were 3.41%, 6.82%, 7.95%, and 7.95%, respectively. There were no cases of stent thrombosis (ST), ischemia-driven target vessel revascularization, or ischemia-driven target lesion revascularization until 36 months of follow-up. Conclusion BioMime™ Morph SES showed favorable outcomes up to 3 years in treating very long coronary lesions in native coronary arteries, as demonstrated by an acceptable rate of MACEs and absence of ST, based on clinical outcomes up to 3 years.

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Section: Discussionmentioning

confidence: 72%

Long-Term Safety and Performance of BioMime™ Morph Sirolimus-Eluting Coronary Stent System for Very Long Coronary Lesions

Patted

2024

Cardiol Res

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One-year Outcomes of XIENCE Skypoint 48-mm Drug-Eluting Stents in Long Coronary Lesions: The SPIRIT 48 Trial

Cited by 1 publication

References 10 publications

Long-Term Safety and Performance of BioMime™ Morph Sirolimus-Eluting Coronary Stent System for Very Long Coronary Lesions

Long-Term Safety and Performance of BioMime™ Morph Sirolimus-Eluting Coronary Stent System for Very Long Coronary Lesions

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