Acute and long‐term clinical and angiographic outcome after S‐Stent implantation: S‐Stent multicenter safety and efficacy trial

Chan, C. Y.; Lim, Yu Liang; Santoso, Teguh; Tresukosol, Damras; Sonoda, Shinjo; Fitzgerald, Peter J.

doi:10.1002/ccd.20066

Cited by 3 publications

(1 citation statement)

References 16 publications

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“…Absorbable composite coating is applied onto the abluminal surface of the S‐stent (Biosensors International, Inc.), a stainless steel balloon expandable stent 11 . The coating consists of everolimus (197 μg/mm 2 ), which is combined with a polyhydroxy acid bioabsorbable polymer (polylactic acid, PLA) matrix in a 1:1 ratio (Fig.…”

Section: Everolimus‐eluting Stentsmentioning

confidence: 99%

Clinical Experiences Using Everolimus‐Eluting Stents in Patients with Coronary Artery Disease

Störger

Grube

Hofmann

et al. 2004

J Interven Cardiology

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Despite the growing use of drug-eluting stents, restenosis remains to occur especially in high risk subgroups like patients with diffuse in-stent restenosis. This observation is supporting the search for new and potentially even more effective drug eluting stent systems. Everolimus has been used in conjunction with a new bioabsorbable polymer and gave promising results in initial clinical studies. In FUTURE I, a single-center, single-blinded randomized safety and feasibility study enrolling 15 patients with bare metal stents and 27 patients with everolimus-coated stents, 30-day MACE rate was 0% in both groups. In-stent late loss at six months was 0.83 mm in the control group and 0.10 mm in the everolimus group (p < 0.0001). In FUTURE II, a randomized multi-center study, a total of 64 patients were enrolled confirming safety and feasibility. After 6 months late loss was 0.85 mm in the control group and 0.12 mm in the everolimus group (p < 0.001).

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Section: Everolimus‐eluting Stentsmentioning

confidence: 99%

Clinical Experiences Using Everolimus‐Eluting Stents in Patients with Coronary Artery Disease

Störger

Grube

Hofmann

et al. 2004

J Interven Cardiology

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Rationale and design of the LEADERS FREE trial: A randomized double-blind comparison of the BioFreedom drug-coated stent vs the Gazelle bare metal stent in patients at high bleeding risk using a short (1 month) course of dual antiplatelet therapy

Urban¹,

Abizaid²,

Chevalier³

et al. 2013

American Heart Journal

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Six- and Twelve-Month Results From First Human Experience Using Everolimus-Eluting Stents With Bioabsorbable Polymer

et al. 2004

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Background— Everolimus, an active immunosuppressive and antiproliferative agent of the same family as sirolimus (rapamycin), has demonstrated significant reduction of neointimal proliferation in animal studies. The First Use To Underscore restenosis Reduction with Everolimus (FUTURE) I trial was the first in-human experience to evaluate the safety and efficacy of everolimus-eluting stents (EES), coated with a bioabsorbable polymer, compared with bare metal stents (BMS). Methods and Results— FUTURE I was a prospective, single-blind, randomized trial that enrolled 42 patients with de novo coronary lesions (EES 27, BMS 15). Patient and lesion characteristics were comparable between the groups. Major adverse cardiac event rates were low at 30 days and 6 months, without any early or late stent thrombosis for either group ( P =NS). Between 6 and 12 months, there were no additional reports of major adverse cardiac events. The 6-month angiographic in-stent restenosis rate was 0% versus 9.1% (1 patient) ( P =NS), with an associated late loss of 0.11 mm versus 0.85 mm ( P <0.001), and the in-segment restenosis rate was 4% (1 patient) and 9.1% (1 patient) ( P =NS) for EES and BMS, respectively. Intravascular ultrasound analysis revealed a significant reduction of percent neointimal volume in EES compared with BMS (2.9±1.9 mm 3 /mm versus 22.4±9.4 mm 3 /mm, P <0.001). There was no late stent malapposition in either group. The safety and efficacy of the EES appeared to be sustained at 12 months. Conclusions— In this initial clinical experience, EES with bioabsorbable polymer demonstrated a safe and efficacious method to reduce in-stent neointimal hyperplasia and restenosis.

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Acute and long‐term clinical and angiographic outcome after S‐Stent implantation: S‐Stent multicenter safety and efficacy trial

Cited by 3 publications

References 16 publications

Clinical Experiences Using Everolimus‐Eluting Stents in Patients with Coronary Artery Disease

Clinical Experiences Using Everolimus‐Eluting Stents in Patients with Coronary Artery Disease

Rationale and design of the LEADERS FREE trial: A randomized double-blind comparison of the BioFreedom drug-coated stent vs the Gazelle bare metal stent in patients at high bleeding risk using a short (1 month) course of dual antiplatelet therapy

Six- and Twelve-Month Results From First Human Experience Using Everolimus-Eluting Stents With Bioabsorbable Polymer

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