Dataset Information

Nitinol Self-Expanding Stents for the Treatment of Obstructive Superficial Femoral Artery Disease: Three-Year Results of the RELIABLE Japanese Multicenter Study.

ABSTRACT: Objective: To assess the use of a nitinol stent to treat symptomatic stenoses or occlusions of the native superficial femoral artery (SFA). Materials and Methods: Seventy-four patients were treated at 12 Japanese sites. The primary endpoint, freedom from target-limb failure (TLF), was a composite of device- or procedure-related death, target-limb amputation, target-vessel revascularization (TVR), or restenosis compared to an objective performance goal (OPG) at 12 months. Secondary endpoints, including primary patency, freedom from TVR/target-lesion revascularization (TLR), improvements in clinical parameters, and major adverse events (MAEs) were evaluated through 36 months. Results: The mean overall lesion length was 80.7±38.9?mm (mean stented length: 98.8±46.1?mm). Freedom from TLF was 81.2% (p<0.001 compared to OPG) with a Kaplan-Meier estimate of 84.2% [95% confidence interval (95%CI) 73.3%, 90.9%] at 12 months. Primary patency was 71.0% at 12 months and 67.8% at 36 months. A total of 94.7% of patients improved by at least one Rutherford category and 70.2% of patients improved ankle-brachial indices ?0.10 from baseline to 36 months. Freedom from TVR/TLR (Kaplan-Meier) was 90% at 12 months and 79.5% at 36 months. Four MAEs were reported; none were found to be device or procedure related. Conclusion: A self-expanding stent was used safely to treat stenotic and occlusive lesions of the SFA in a Japanese patient population. The composite endpoint, freedom from TLF, was superior to an historical control at one year, with low rates of revascularization and good functional and clinical outcomes through three years.

SUBMITTER: Nakamura M

PROVIDER: S-EPMC6200612 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Nitinol Self-Expanding Stents for the Treatment of Obstructive Superficial Femoral Artery Disease: Three-Year Results of the RELIABLE Japanese Multicenter Study.

Nakamura Masato M Jaff Michael R MR Settlage Richard A RA Kichikawa Kimihiko K

Annals of vascular diseases 20180901 3

<b>Objective</b>: To assess the use of a nitinol stent to treat symptomatic stenoses or occlusions of the native superficial femoral artery (SFA). <b>Materials and Methods</b>: Seventy-four patients were treated at 12 Japanese sites. The primary endpoint, freedom from target-limb failure (TLF), was a composite of device- or procedure-related death, target-limb amputation, target-vessel revascularization (TVR), or restenosis compared to an objective performance goal (OPG) at 12 months. Secondary ...[more]

PMID: 30402183

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Project description:BackgroundThere have been few randomized control trials comparing the incidence of stent fracture and primary patency among different self-expanding nitinol stents to date. The SMART™ CONTROL stent (Cordis Corp, Miami Lakes, Florida, United States) has a peak-to-valley bridge and inline interconnection, whereas the COMPLETE™-SE stent (Medtronic Vascular, Santa Rosa, California, United States) crowns have been configured to minimize crown-to-crown interaction, increasing the stent's flexibility without compromising radial strength. Further, the 2011 ESC (European society of cardiology) guidelines recommend that dual antiplatelet therapy with aspirin and a thienopyridine such as clopidogrel should be administered for at least one month after infrainguinal bare metal stent implantation. Cilostazol has been reported to reduce intimal hyperplasia and subsequent repeat revascularization. To date, there has been no randomized study comparing the safety and efficacy of two different antiplatelet regimens, clopidogrel and cilostazol, following successful femoropopliteal stenting.Methods/designThe primary purpose of our study is to examine the incidence of stent fracture and primary patency between two different major representative self-expanding nitinol stents (SMART™ CONTROL versus COMPLETE™-SE) in stenotic or occlusive femoropopliteal arterial lesion. The secondary purpose is to examine whether there is any difference in efficacy and safety between aspirin plus clopidogrel versus aspirin plus cilostazol for one month following stent implantation in femoropopliteal lesions. This is a prospective, randomized, multicenter trial to assess the efficacy of the COMPLETE™-SE versus SMART™ CONTROL stent for provisional stenting after balloon angioplasty in femoropopliteal arterial lesions. The study design is a 2x2 randomization design and a total of 346 patients will be enrolled. The primary endpoint of this study is the rate of binary restenosis in the treated segment at 12 months after intervention as determined by catheter angiography or duplex ultrasound.DiscussionThis trial will provide powerful insight into whether the design of the COMPLETE™-SE stent is more fracture-resistant or effective in preventing restenosis compared with the SMART™ CONTROL stent. Also, it will determine the efficacy and safety of aspirin plus clopidogrel versus aspirin plus cilostazol in patients undergoing stent implantation in femoropopliteal lesions.Trial registrationRegistered on 2 April 2012 with the National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier# NCT01570803).

Dataset Information

Nitinol Self-Expanding Stents for the Treatment of Obstructive Superficial Femoral Artery Disease: Three-Year Results of the RELIABLE Japanese Multicenter Study.

Publications

Nitinol Self-Expanding Stents for the Treatment of Obstructive Superficial Femoral Artery Disease: Three-Year Results of the RELIABLE Japanese Multicenter Study.

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