Dataset Information

Design of the FP-RESTORE study: a protocol for prospective, observational study of real-world treatments with endovascular therapy in patients with femoropopliteal artery Tosaka III in-stent restenosis.

ABSTRACT:

Introduction

Femoropopliteal artery in-stent restenosis (FP-ISR) represents one of the main obstacles for stent implantation in peripheral artery disease patients, especially Tosaka III FP-ISR, which is also referred to as in-stent occlusion. Diverse endovascular treatments of Tosaka III FP-ISR are available, and the results are unequivocal. However, real-world data are limited. This study aims to evaluate the efficacy, safety and health economics evaluation of various endovascular procedures in the treatment of Tosaka III FP-ISR.

Method and analysis

This study is a prospective, multicentre, real-world, observational clinical study. Patients diagnosed with Tosaka III FP-ISR and treated with endovascular procedures in nine centres from 1 April 2021 to 31 December 2022 will be recruited. The relevant clinical information, Ankle-Brachial Index and CT angiography will be collected. All the participants will undergo follow-up at 1, 6, 12, 18 and 24 months after the operation. The primary outcome is freedom from clinically driven target lesion revascularisation at 24 months. Safety and health economics issues will also be reported.

Ethics and dissemination

The FP-RESTORE clinical trial has been registered at ClinicalTrials.gov (http://clinicaltrials.gov/). This study was also approved by the Institutional Review Board and Human Research Ethics Committee of Zhongshan Hospital, Fudan University (approval number: B2021-427). Moreover, written informed consent will be obtained at the time of recruitment. The study outcomes will be disseminated by publication in a peer-reviewed journal to provide information for further clinical practice.

Trial registration number

NCT04801004.

SUBMITTER: Li X

PROVIDER: S-EPMC9730372 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Design of the FP-RESTORE study: a protocol for prospective, observational study of real-world treatments with endovascular therapy in patients with femoropopliteal artery Tosaka III in-stent restenosis.

Li Xu X Zhou Min M Ding Yong Y Wu Ziheng Z Feng Zibo Z Guo Lianrui L Li Qiang Q Fang Xin X Sang Hongfei H Ye Meng M Shi Zhenyu Z

BMJ open 20221206 12

<h4>Introduction</h4>Femoropopliteal artery in-stent restenosis (FP-ISR) represents one of the main obstacles for stent implantation in peripheral artery disease patients, especially Tosaka III FP-ISR, which is also referred to as in-stent occlusion. Diverse endovascular treatments of Tosaka III FP-ISR are available, and the results are unequivocal. However, real-world data are limited. This study aims to evaluate the efficacy, safety and health economics evaluation of various endovascular proce ...[more]

PMID: 36600357

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Project description:To estimate the clinical and economic impact of drug-eluting endovascular treatment strategies for femoropopliteal artery disease compared with current standard of care.Systematic literature search to pool target lesion revascularisations (TLR). Model-based per-patient cost impact and quasi-cost-effectiveness projection over 24 months based on pooled TLRs and current reimbursement.The UK's National Health Service (NHS).Patients presenting with symptomatic femoropopliteal disease eligible for endovascular treatment.Current National Institute for Health and Care Excellence (NICE) guideline-recommended treatment with percutaneous transluminal balloon angioplasty (PTA) and bailout bare metal stenting (BMS) versus primary BMS placement, or drug-coated balloon (DCB), or drug-eluting stent (DES) treatment.24-month per-patient cost impact to NHS (primary outcome).pooled 24-month TLR rates; numbers needed to treat (NNTs); cost per TLR avoided and estimated incremental cost-effectiveness ratio (ICER) in £ per quality-adjusted life year (QALY).N=28 studies were identified, reporting on 5167 femoropopliteal lesions. Over 24 months, DCB, DES and BMS reduced TLRs of de novo lesions from 36.2% to 17.6%, 19.4% and 26.9%, respectively, at an increased cost of £43, £44 and £112. NNTs to avoid 1 TLR in 24 months were 5.4, 6.0 and 10.8, resulting in cost per TLR avoided of £231, £264 and £1204. DCB was estimated to add 0.011 QALYs, DES 0.010 QALYs and BMS 0.005 QALYs, resulting in estimated ICERs of £3983, £4534 and £20 719 per QALY gained. A subset analysis revealed more favourable clinical and economic outcomes for a 3.5 µg/mm(2) DCB with urea excipient, compared with the rest of DCBs. A modest reduction of 10% in DCB and DES prices made drug-eluting treatments dominant.Widespread adoption of drug-eluting endovascular therapies for femoropopliteal disease would add meaningful clinical benefit at reasonable additional costs to the NHS. Based on currently available data, DCBs offer the highest clinical and economic value.

Project description:AimsOptimal endovascular management of intermittent claudication (IC) remains disputed. This systematic review and meta-analysis compares efficacy and safety outcomes for balloon angioplasty (BA), bare-metal stents (BMS), drug-coated balloons (DCB), drug-eluting stents (DES), covered stents, and atherectomy.Methods and resultsElectronic databases were searched for randomized, controlled trials (RCT) from inception through November 2021. Efficacy outcomes were primary patency, target-lesion revascularization (TLR), and quality-of-life (QoL). Safety endpoints were all-cause mortality and major amputation. Outcomes were evaluated at short-term (<1 year), mid-term (1-2 years), and long-term (≥2 years) follow-up. The study was registered on PROSPERO (CRD42021292639). Fifty-one RCTs enrolling 8430 patients/lesions were included. In femoropopliteal disease of low-to-intermediate complexity, DCBs were associated with higher likelihood of primary patency [short-term: odds ratio (OR) 3.21, 95% confidence interval (CI) 2.44-4.24; long-term: OR 2.47, 95% CI 1.93-3.16], lower TLR (short-term: OR 0.33, 95% CI 0.22-0.49; long-term: OR 0.42, 95% CI 0.29-0.60) and similar all-cause mortality risk, compared with BA. Primary stenting using BMS was associated with improved short-to-mid-term patency and TLR, but similar long-term efficacy compared with provisional stenting. Mid-term patency (OR 1.64, 95% CI 0.89-3.03) and TLR (OR 0.50, 95% CI 0.22-1.11) estimates were comparable for DES vs. BMS. Atherectomy, used independently or adjunctively, was not associated with efficacy benefits compared with drug-coated and uncoated angioplasty, or stenting approaches. Paucity and heterogeneity of data precluded pooled analysis for aortoiliac disease and QoL endpoints.ConclusionCertain devices may provide benefits in femoropopliteal disease, but comparative data in aortoiliac arteries is lacking. Gaps in evidence quantity and quality impede identification of the optimal endovascular approach to IC.

Dataset Information

Design of the FP-RESTORE study: a protocol for prospective, observational study of real-world treatments with endovascular therapy in patients with femoropopliteal artery Tosaka III in-stent restenosis.

Introduction

Method and analysis

Ethics and dissemination

Trial registration number

Publications

Design of the FP-RESTORE study: a protocol for prospective, observational study of real-world treatments with endovascular therapy in patients with femoropopliteal artery Tosaka III in-stent restenosis.

Similar Datasets

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