OBJECTIVES: The SPIRIT Small Vessel (SV) was designed to evaluate the safety and effectiveness of the 2.25-mm XIENCE V everolimus eluting coronary stent system (EECSS), known as the XIENCE nano EECSS, in subjects with SVs and ischemic heart disease. BACKGROUND: The core sizes of XIENCE V EECSS are associated with low rates of restenosis and thrombosis in the general population, but the XIENCE nano EECSS has not been tested in the United States. METHODS: This prospective, single-arm, open-label study was conducted at 33 centers and in 150 patients in the United States. The primary endpoint was the target lesion failure (TLF) rate at 1 year, required to meet the prespecified performance goal (PG) of 20.4%, derived from historical data. RESULTS: The mean patient age was 63 years, 38% were women, 39.2% were diabetic, 49.3% had multivessel disease, and the reference vessel diameter was 2.13 ± 0.23 mm. The 1-year TLF rate was 8.1% in with an upper limit of the one-sided 95% confidence interval of 13.0%, which met the PG of 20.4% (P < 0.0001). At 1 year, the rate of cardiac death was 1.5%, the target vessel myocardial infarction rate was 1.5%, and clinically indicated target lesion revascularization rate was 5.1%. The 8-month angiographic in-stent late loss was 0.2 ± 0.4 mm, respectively. The 1-year academic research consortium defined definite/probable stent thrombosis rate was 1.5%. CONCLUSIONS: Based on the 1-year clinical and 8-month angiographic SPIRIT SV data, the XIENCE nano EECSS is considered safe and effective in the treatment of SVs.
OBJECTIVES: The SPIRIT Small Vessel (SV) was designed to evaluate the safety and effectiveness of the 2.25-mm XIENCE V everolimus eluting coronary stent system (EECSS), known as the XIENCE nano EECSS, in subjects with SVs and ischemic heart disease. BACKGROUND: The core sizes of XIENCE V EECSS are associated with low rates of restenosis and thrombosis in the general population, but the XIENCE nano EECSS has not been tested in the United States. METHODS: This prospective, single-arm, open-label study was conducted at 33 centers and in 150 patients in the United States. The primary endpoint was the target lesion failure (TLF) rate at 1 year, required to meet the prespecified performance goal (PG) of 20.4%, derived from historical data. RESULTS: The mean patient age was 63 years, 38% were women, 39.2% were diabetic, 49.3% had multivessel disease, and the reference vessel diameter was 2.13 ± 0.23 mm. The 1-year TLF rate was 8.1% in with an upper limit of the one-sided 95% confidence interval of 13.0%, which met the PG of 20.4% (P < 0.0001). At 1 year, the rate of cardiac death was 1.5%, the target vessel myocardial infarction rate was 1.5%, and clinically indicated target lesion revascularization rate was 5.1%. The 8-month angiographic in-stent late loss was 0.2 ± 0.4 mm, respectively. The 1-year academic research consortium defined definite/probable stent thrombosis rate was 1.5%. CONCLUSIONS: Based on the 1-year clinical and 8-month angiographic SPIRIT SV data, the XIENCE nano EECSS is considered safe and effective in the treatment of SVs.
Authors: Christopher R Kelly; Paul S Teirstein; Ian T Meredith; Bruno Farah; Christophe L Dubois; Robert L Feldman; Joseph Dens; Nobuhisa Hagiwara; Abram Rabinowitz; Didier Carrié; Vincent Pompili; Alain Bouchard; Shigeru Saito; Dominic J Allocco; Keith D Dawkins; Gregg W Stone Journal: JACC Cardiovasc Interv Date: 2017-12-11 Impact factor: 11.195
Authors: Nicole Gilgen; Ahmed Farah; Bruno Scheller; Marc-Alexander Ohlow; Norman Mangner; Daniel Weilenmann; Jochen Wöhrle; Peiman Jamshidi; Gregor Leibundgut; Sven Möbius-Winkler; Robert Zweiker; Florian Krackhardt; Christian Butter; Leonhard Bruch; Christoph Kaiser; Andreas Hoffmann; Peter Rickenbacher; Christian Mueller; Frank-Peter Stephan; Michael Coslovsky; Raban Jeger Journal: Clin Cardiol Date: 2018-05-10 Impact factor: 2.882
Authors: Mingduo Zhang; Jingwen Yong; Yuan Zhou; Min Zhang; Xiantao Song; Shubin Qiao; Lefeng Wang; Qian Tong; Li Zhang; Bei Shi Journal: Ann Transl Med Date: 2022-04
Authors: Bartłomiej Orlik; Krzysztof Milewski; Kamil Derbisz; Michał Jelonek; Patrycja Chrząszcz; Sonia Beil; Adam Młodziankowski; Wojciech Picheta; Piotr P Buszman; Paweł E Buszman Journal: Postepy Kardiol Interwencyjnej Date: 2018-06-19 Impact factor: 1.426