Commentary: The Pitfalls of Femoropopliteal Stenting Trials

Mwipatayi, Bibombe P.; Leong, B D K; Hockley, Joseph A.; Vijayan, Vikram

doi:10.1583/jevt-12-3898c.1

Cited by 3 publications

(2 citation statements)

References 19 publications

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“…Self‐expanding nitinol stents are a safe and effective treatment for symptomatic lower extremity peripheral artery disease (PAD), yet controversy surrounds the clinical durability and efficacy of these devices . Recently, the 1‐year safety and efficacy results were reported from the STROLL (S.M.A.R.T.® Nitinol Self‐Expanding Stent in the Treatment of Obstructive Superficial Femoral Artery Disease) study, which used the S.M.A.R.T® vascular stent system (Cordis Corporation, Milpitas, CA) for femoropopliteal lesions up to 15 cm in length .…”

Section: Introductionmentioning

confidence: 99%

Long‐term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3‐year results from the STROLL study

Bunte

Cohen

Jaff

et al. 2018

Cathet Cardio Intervent

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Section: Introductionmentioning

confidence: 99%

Long‐term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3‐year results from the STROLL study

Bunte

Cohen

Jaff

et al. 2018

Cathet Cardio Intervent

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“…There continues to be uncertainty regarding the optimal endovascular treatment of patients with severe lifestyle limiting claudication associated with superficial femoral artery (SFA) and proximal popliteal artery peripheral artery disease (PAD) . Previous clinical trials have reported inconsistent data on the benefits of nitinol self‐expanding stents compared to percutaneous transluminal angioplasty for lesions in this challenging arterial segment .…”

Section: Introductionmentioning

confidence: 99%

A single stent strategy in patients with lifestyle limiting claudication: 3‐year results from the Durability II trial

Rocha‐Singh

Bosiers

Schultz

et al. 2015

Cathet Cardio Intervent

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ObjectivesTo evaluate longer‐term safety and efficacy of a single self‐expanding stent up to 20 cm in length in patients with atherosclerotic disease of the superficial femoral (SFA) and proximal popliteal arteries.BackgroundAngioplasty and stenting are options for revascularization of symptomatic peripheral artery disease. While angioplasty alone is effective in short lesions, outcomes in longer lesions (i.e., mean 8.7 cm) show suboptimal patency rates of 33% at one year.MethodsTwo hundred eighty‐seven patients (mean age 68 years, 66% male) were treated with the EverFlex™ Self‐Expanding Peripheral Stent System. Patients were followed through 3 years with yearly core lab adjudicated duplex ultrasonography for patency, radiographic assessment of stent fractures, and resting ankle brachial indices.ResultsOverall freedom from loss of primary patency at 3 years was 60.0%. Patency was significantly higher for lesions ≤8 cm compared with lesions >8 cm (71.0 vs. 50.5%, P < 0.0001). There was no significant difference in patency between single‐stent and multistent recipients (60.4 vs. 52.4%, P = 0.343). The three‐year freedom from clinically driven target lesion revascularization was 70.0%. At 3 years, the overall stent fracture rate was 0.9%.ConclusionsDURABILITY II is the first investigational device exemption trial to report 3‐year duplex Doppler defined stent patency and CD‐TLR outcomes in long SFA and proximal popliteal lesions and demonstrated acceptable stent patency and freedom from CD‐TLR with a low fracture rate. These data suggest that use of a single long stent provides reasonable long‐term outcomes when intervention is required for symptomatic SFA and proximal popliteal arterial disease. © 2015 Wiley Periodicals, Inc.

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Antithrombotic therapy after femoropopliteal artery stenting: 12-month results from Japan Postmarketing Surveillance

et al. 2019

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ObjectiveTo investigate the effects of antithrombotic therapy on target lesion revascularisation (TLR) and major adverse cardiovascular and cerebrovascular events (MACCEs) at 12 months after femoropopliteal intervention with second-generation bare metal nitinol stents.MethodsA total of 277 lesions in 258 limbs of 248 patients with de novo atherosclerosis in the above-the-knee femoropopliteal segment were analysed from the Japan multicentre postmarketing surveillance.ResultsAt discharge, dual antiplatelet therapy (DAPT) was prescribed in 68.5% and cilostazol in 30.2% of patients. At 12 months of follow-up, prescriptions of DAPT significantly (p=0.0001) decreased to 51.2% and prescription of cilostazol remained unchanged (p=0.592) at 28.0%. Prescription of warfarin also remained unchanged (14.5% at discharge, 13.3% at 12 months, p=0.70). At 12 months, freedoms from TLR and MACCE were 89.4% and 89.7%, respectively. In a multivariate Cox proportional hazards model, neither DAPT nor cilostazol at discharge was associated with both TLR and MACCE at 12 months. However, warfarin at discharge was only independently associated with TLR at 12 months. Kaplan-Meier estimates demonstrated that warfarin at discharge yielded a significantly (p=0.013) lower freedom from TLR at 12 months than no warfarin at discharge. Freedom from TLR at 12 months by the Kaplan-Meier estimates was 77.8% (95% CI 59.0% to 88.8%) in patients with warfarin at discharge and 91.2% (95% CI 86.3% to 94.3%) in those without warfarin at discharge.ConclusionsClinical benefits of DAPT or cilostazol might be small in terms of TLR and MACCE at 12 months. Anticoagulation with warfarin at discharge might increase TLR at 12 months.

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Commentary: The Pitfalls of Femoropopliteal Stenting Trials

Cited by 3 publications

References 19 publications

Long‐term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3‐year results from the STROLL study

Long‐term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3‐year results from the STROLL study

A single stent strategy in patients with lifestyle limiting claudication: 3‐year results from the Durability II trial

Antithrombotic therapy after femoropopliteal artery stenting: 12-month results from Japan Postmarketing Surveillance

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