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Drug-coated balloon in superficial femoral artery in-stent restenosis.

ABSTRACT: The femoropopliteal artery is one of the commonest sites of involvement in peripheral artery disease (PAD) leading to intermittent claudication and/or critical limb ischemia. Endovascular therapy for superficial femoral artery (SFA) disease has been recognized as a safe and efficient therapy and is recommended by current guidelines as the first-line approach. Although the widespread use of new-generation, self-expanding, nitinol stents in SFA stenosis has reduced the shortcomings associated with plain old balloon angioplasty (POBA), lumen renarrowing at the stented (in-stent restenosis - ISR) level still represents a relevant clinical problem, because of higher risk of recurrent ISR, occlusion and surgical revascularization compared to de-novo lesions. In this setting, different treatment options are available and drug-coated balloons (DCBs) have shown good results in terms of safety and effectiveness. In this review we examine the results of different trials exploring the outcome of using DCBs for the treatment of SFA ISR. The available data demonstrate that SFA ISR can be safely treated with percutaneous transluminal angioplasty with a DCB, with a reduction in recurrent restenosis and target lesion revascularization (TLR) at least at 1 year after POBA. The consistent and positive results of different registries and randomized trials support the use of DCB to reduce SFA ISR recurrence.

SUBMITTER: Gerardi D

PROVIDER: S-EPMC5939540 | biostudies-other | 2018

REPOSITORIES: biostudies-other

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Drug-coated balloon in superficial femoral artery in-stent restenosis.

Gerardi Donato D Alfani Arturo A Tesorio Tullio T Cioppa Angelo A Esposito Giovanni G Stabile Eugenio E

Postepy w kardiologii interwencyjnej = Advances in interventional cardiology 20180322 1

The femoropopliteal artery is one of the commonest sites of involvement in peripheral artery disease (PAD) leading to intermittent claudication and/or critical limb ischemia. Endovascular therapy for superficial femoral artery (SFA) disease has been recognized as a safe and efficient therapy and is recommended by current guidelines as the first-line approach. Although the widespread use of new-generation, self-expanding, nitinol stents in SFA stenosis has reduced the shortcomings associated with ...[more]

PMID: 29743899

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Project description:The purpose of this article was to compare the efficiency and safety of drug-coated balloon angioplasty (DCB) and atherectomy with percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal in-stent restenosis (ISR). Pubmed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) (all up to March 2019) were searched systematically. Trial sequential analysis (TSA) was conducted. 5 studies with 599 participants were included. Compared with PTA, DCB significantly increased the rate of patency (6 months: RR 1.65, 95% CI 1.30 to 2.09, P < 0.01; 12 months: RR 2.38, 95% CI 1.71 to 3.30, P < 0.01) and the rate freedom from target lesion revascularization (TLR) (6 months: RR 1.18, 95% CI 1.09 to 1.28, P < 0.01; 12 months: RR 1.56, 95% CI 1.33 to 1.82, P < 0.01) at 6 and 12 months follow-up, and the TSA results showed these outcomes were reliable. The rate of clinical improvement by ≥1 Rutherford category in the DCB group was higher than that in the PTA group (6 months: RR 1.35, 95% CI 1.03 to 1.75, P = 0.03; 12 months: RR 1.46, 95% CI 1.17 to 1.82, P < 0.01) at 6 and 12 months. There is no statistically difference of ABI, all-cause mortality, and incidence of amputation between DCB group and PTA group (MD 0.03, 95% CI -0.03 to 0.08, P = 0.40; RR 1.24, 95% CI 0.46 to 3.34, P = 0.67; RR 0.32, 95% CI 0.01 to 7.61, P = 0.48). Compared with PTA, the rate of patency and freedom from TLR in the laser atherectomy (LD) group was higher than that in the PTA group (patency: 6 months: RR 1.28, 95% CI 1.01 to 1.64, P < 0.05, 12 months: RR 2.25, 95% CI 1.14 to 4.44, P < 0.05; freedom from TLR: 6 months: RR 1.27, 95% CI 1.05 to 1.53, P = 0.01, 12 months: RR 1.59, 95% CI 1.12 to 2.25, P = 0.01) at 6 and 12 months follow-up. In conclusion, DCB and LD had superior clinical (freedom from TLR and clinical improvement) and angiographic outcomes (patency rate) compared with PTA for the treatment of femoropopliteal ISR. Moreover, DCB and LD had a low incidence of amputation and mortality and were relatively safe methods.

Project description:BackgroundSmall-vessel coronary artery disease (CAD) is frequently observed in coronary angiography and linked to a higher risk of lesion failure and restenosis. Currently, treatment of small vessels is not standardized while having drug-eluting stents (DES) or drug-coated balloons (DCBs) as possible strategies. We aimed to conduct a meta-analytic approach to assess the effectiveness of treatment strategies and outcomes for small-vessel CAD.MethodsComprehensive literature search was conducted using PubMed, Embase, MEDLINE, and Cochrane Library databases to identify studies reporting treatment strategies of small-vessel CAD with a reference diameter of ≤3.0 mm. Target lesion revascularization (TLR), target lesion thrombosis, all-cause death, myocardial infarction (MI), and major adverse cardiac events (MACE) were defined as clinical outcomes. Outcomes from single-arm and randomized studies based on measures by means of their corresponding 95% confidence intervals (CI) were compared using a meta-analytic approach. Statistical significance was assumed if CIs did not overlap.ResultsThirty-seven eligible studies with a total of 31,835 patients with small-vessel CAD were included in the present analysis. Among those, 28,147 patients were treated with DES (24 studies) and 3,299 patients with DCB (18 studies). Common baseline characteristics were equally distributed in the different studies. TLR rate was 4% in both treatment strategies [0.04; 95% CI 0.03-0.05 (DES) vs. 0.03-0.07 (DCB)]. MI occurred in 3% of patients receiving DES and in 2% treated with DCB [0.03 (0.02-0.04) vs. 0.02 (0.01-0.03)]. All-cause mortality was 3% in the DES group [0.03 (0.02-0.05)] compared with 1% in the DCB group [0.01 (0.00-0.03)]. Approximately 9% of patients with DES developed MACE vs. 4% of patients with DCB [0.09 (0.07-0.10) vs. 0.04 (0.02-0.08)]. Meta-regression analysis did not show a significant impact of reference vessel diameter on outcomes.ConclusionThis large meta-analytic approach demonstrates similar clinical and angiographic results between treatment strategies with DES and DCB in small-vessel CAD. Therefore, DES may be waived in small coronary arteries when PCI is performed with DCB.

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Drug-coated balloon in superficial femoral artery in-stent restenosis.

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Drug-coated balloon in superficial femoral artery in-stent restenosis.

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