JACC. Cardiovascular interventions · 2009
Clinical and angiographic results with the next-generation resolute stent system: a prospective, multicenter, first-in-human trial.
Клиническое исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Meredith Ian T, Worthley Stephen, Whitbourn Robert, Walters Darren L, McClean Dougal, Horrigan Mark, Popma Jeffrey J, Cutlip Donald E, DePaoli Ann, Negoita Manuela, Fitzgerald Peter J, RESOLUTE Investigators
Аннотация
OBJECTIVES: The RESOLUTE trial examined the safety and efficacy of a next-generation zotarolimus-eluting coronary stent, Resolute (Medtronic CardioVascular Inc., Santa Rosa, California).
BACKGROUND: Revascularization benefits associated with current drug-eluting stents are often diminished in the presence of complex coronary lesions and in certain patient cohorts. Resolute uses a new proprietary polymer coating that extends the duration of drug delivery to match the longer healing duration often experienced in more complex cases.
METHODS: The RESOLUTE trial was a prospective, nonrandomized, multicenter study of the Resolute stent in 139 patients with de novo coronary lesions with reference vessel diameters > or =2.5 and < or =3.5 mm and lesion length > or =14 and < or =27 mm. The primary end point was 9-month in-stent late lumen loss by quantitative coronary angiography. Secondary end points included major adverse cardiac events (MACE) at 30 days, 6, 9, and 12 months; acute device, lesion, and procedure success; and 9-month target vessel failure (TVF), target lesion revascularization (TLR), stent thrombosis, neointimal hyperplastic (NIH) volume, and percent NIH volume obstruction.
RESULTS: The 9-month in-stent late lumen loss was 0.22 +/- 0.27 mm. Cumulative MACE were 4.3%, 4.3%, 7.2%, and 8.7% at 30 days, 6, 9, and 12 months, respectively. Acute lesion, procedure, and device success rates were 100.0%, 95.7%, and 99.3%, respectively. At 9 months, TLR was 0.0%, TVF was 6.5%, stent thrombosis was 0.0%, NIH volume was 6.55 +/- 7.83 mm(3), and percent NIH volume obstruction was 3.73 +/- 4.05%.
CONCLUSIONS: In this feasibility study, the Resolute stent demonstrated low in-stent late lumen loss, minimal neointimal hyperplastic ingrowth, low TLR, no stent thrombosis, and acceptable TVF and MACE. (The RESOLUTE Clinical Trial; NCT00248079).
BACKGROUND: Revascularization benefits associated with current drug-eluting stents are often diminished in the presence of complex coronary lesions and in certain patient cohorts. Resolute uses a new proprietary polymer coating that extends the duration of drug delivery to match the longer healing duration often experienced in more complex cases.
METHODS: The RESOLUTE trial was a prospective, nonrandomized, multicenter study of the Resolute stent in 139 patients with de novo coronary lesions with reference vessel diameters > or =2.5 and < or =3.5 mm and lesion length > or =14 and < or =27 mm. The primary end point was 9-month in-stent late lumen loss by quantitative coronary angiography. Secondary end points included major adverse cardiac events (MACE) at 30 days, 6, 9, and 12 months; acute device, lesion, and procedure success; and 9-month target vessel failure (TVF), target lesion revascularization (TLR), stent thrombosis, neointimal hyperplastic (NIH) volume, and percent NIH volume obstruction.
RESULTS: The 9-month in-stent late lumen loss was 0.22 +/- 0.27 mm. Cumulative MACE were 4.3%, 4.3%, 7.2%, and 8.7% at 30 days, 6, 9, and 12 months, respectively. Acute lesion, procedure, and device success rates were 100.0%, 95.7%, and 99.3%, respectively. At 9 months, TLR was 0.0%, TVF was 6.5%, stent thrombosis was 0.0%, NIH volume was 6.55 +/- 7.83 mm(3), and percent NIH volume obstruction was 3.73 +/- 4.05%.
CONCLUSIONS: In this feasibility study, the Resolute stent demonstrated low in-stent late lumen loss, minimal neointimal hyperplastic ingrowth, low TLR, no stent thrombosis, and acceptable TVF and MACE. (The RESOLUTE Clinical Trial; NCT00248079).
Предметные рубрики MeSH
AgedAngioplasty, Balloon, CoronaryAustraliaCardiovascular AgentsCoronary AngiographyCoronary RestenosisCoronary StenosisDrug-Eluting StentsFeasibility StudiesFemaleHumansHyperplasiaKaplan-Meier EstimateMaleMiddle AgedMyocardial InfarctionNew ZealandProspective StudiesProsthesis DesignSirolimusThrombosisTime FactorsTreatment OutcomeUltrasonography, InterventionalUnited States