First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent: Angiographic, IVUS, OCT, and Clinical Outcomes From the RevElution Study

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• 作者：Stephen G. Worthley ; MD^a ; ^{stephen.worthley@genesiscare.com.au} ; Alexandre Abizaid ; MD^b ; Ajay J. Kirtane ; MD ; SM^c ; Daniel I. Simon ; MD^d ; Stephan Windecker ; MD^e ; Sandeep Brar ; MD^f ; Ian T. Meredith ; MD^g ; Sharad Shetty ; MD^h ; Ajay Sinhalⁱ ; Alexandra Popma Almonacid ; MD^j ; Daniel Chamié ; MD^b ; Akiko Maehara ; MD^c ; Gregg W. Stone ; MD^c ; on behalf of the RevElution InvestigatorsStephen Worthley ; Sharad Shetty ; Ajay Sinhal ; Ian Meredith ; Alexandre Abizaid ; Nigel Jepson ; Ravinay Bhindi ; Soo Teik Lim ; Peter Stewart ; Peter Barlis ; Darren Walters ; David Muller ; Stephen Cox ; Rohan Bhagwandeen
• 关键词：drug-eluting stent(s) ; drug-filled stent(s) ; percutaneous coronary intervention ; polymer-free stent
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2017
• 出版时间：23 January 2017
• 年：2017
• 卷：10
• 期：2
• 页码：147-156
• 全文大小：918 K
• 卷排序：10

文摘

This study sought to assess the safety and effectiveness of the drug-filled stent (DFS) (Medtronic, Santa Rosa, California) in the treatment of patients with coronary artery disease.BackgroundPolymer-free drug-eluting stents have the potential to improve clinical outcomes and facilitate shorter durations of dual antiplatelet therapy. The polymer-free DFS is made from a trilayered continuous wire with an outer cobalt chromium layer, a middle tantalum layer, and an inner lumen coated with sirolimus. Small laser-drilled holes on the abluminal stent surface control drug elution.MethodsThe RevElution trial enrolled 100 patients with de novo coronary lesions 2.25 to 3.50 mm in diameter and length ≤27 mm in 2 cohorts of 50 patients for angiographic, intravascular ultrasound, and clinical assessment at 9 or 24 months, with optical coherence tomography performed in a subset of 30 patients at each time period. The primary endpoint was angiographic in-stent late lumen loss at 9 months compared with Resolute zotarolimus-eluting stent (Medtronic) historical control data.ResultsFifty patients with 56 lesions were treated with DFS in the 9-month cohort. In-stent late lumen loss was 0.26 ± 0.28 mm for DFS and 0.36 ± 0.52 mm for Resolute (pnoninferiority <0.001). The binary angiographic restenosis rate was 0%. Median stent strut coverage by optical coherence tomography was 91.4%, 95.6%, and 99.1% at 1, 3, and 9 months, respectively. One non–Q-wave myocardial infarction occurred, with a 9-month target lesion failure rate of 2.1%. No stent thrombosis occurred.ConclusionsAt 9 months, the polymer-free DFS was safe and effective with high rates of early strut coverage and noninferior late lumen loss compared to Resolute. (Medtronic RevElution Trial [RevElution]; NCT02480348)