Drug-coated balloon in peripheral artery disease

Shanmugasundaram, Madhan; Murugapandian, Sangeetha; Truong, Huu Tam; Lotun, Kapildeo; Banerjee, Subhash

doi:10.1016/j.carrev.2018.04.017

Cited by 12 publications

(6 citation statements)

References 43 publications

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“…Numerous randomized controlled trials have reported on paclitaxel DCB in both de novo and restenotic femoropopliteal lesions with satisfactory results. 14 However, most trials have mainly included patients with claudication and lower Rutherford classes. The real-world outcomes after DCB angioplasty in femoropopliteal lesions were inferior to what has been reported in previous studies, particularly for complex lesions (eg, the heavily calcified and long CTO lesion).…”

Section: Discussionmentioning

confidence: 99%

One-Year Clinical Outcome and Risk Factor Analysis of Directional Atherectomy Followed With Drug-Coated Balloon for Femoropopliteal Artery Disease

et al. 2021

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Purpose: This study investigated the 1-year clinical outcomes of directional atherectomy combined with drug-coated balloon (DA + DCB) in femoropopliteal artery disease (FPAD) from real-world experience. Materials and Methods: A retrospective study was conducted of patients treated between July 2016 and June 2019 using DA + DCB for FPAD. Patients’ demographics, comorbidities, clinical characteristics and outcomes, and angiography and duplex ultrasound findings were analyzed. The 6-month and 1-year primary patency, primary assisted patency, secondary patency, and freedom from clinically-driven target lesion revascularization (CD-TLR) were evaluated. Univariate and multivariate analyses were performed to identify risk factors of primary patency loss or CD-TLR. Results: Seventy-nine consecutive patients (83 lesions, mean age 70.9 years, 52 men) were included. Twenty-seven limbs had lifestyle-limiting claudication and 56 limbs had critical limb ischemia. There were 73 and 10 limbs with de novo lesion and in-stent restenosis, respectively. The mean lesion length of all the patients was 22.1 cm. The mean length of chronic total occlusions (CTOs) was 8.3 cm. Severe calcification was found in 32.5% cases. The 1-year primary patency rate was 80.8% and freedom from CD-TLR was 92.2%. The bailout stenting rate was 2.4%. Patients with CTO >10 cm had significantly lower 1-year primary patency rate and freedom from CD-TLR than did patients with CTO ≤10 cm. Total length of CTO (stratified as ≤5 cm, 5–10 cm, >10 cm) was identified as an independent risk factor of 1-year primary patency loss and CD-TLR. Conclusion: DA + DCB appears to be a safe and effective endovascular therapy to treat FPAD in real-world clinical practice, with a promising 1-year patency rate with a low rate of bailout stenting.

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Section: Discussionmentioning

confidence: 99%

One-Year Clinical Outcome and Risk Factor Analysis of Directional Atherectomy Followed With Drug-Coated Balloon for Femoropopliteal Artery Disease

et al. 2021

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“…To identify all relevant studies published in the last 10 years (from 3 July 2010 to 3 July 2020), the search strategy was first developed in the PubMed database and then was applied to the other databases. This 10-year period was chosen because the technology has remained the same over this time span with no significant evolution (10). The search term combined a descriptor of the device (MeSH or not) and a term related to economics (MeSH or not) (Supplementary File 2, Study Protocol).…”

Section: Methodsmentioning

confidence: 99%

“…For endovascular surgery, plain old balloon angioplasty (POBA), drug-coated balloon (DCB) angioplasty, stent placement (bare-metal stent, drug-eluting stent [DES], or covered stent), and atherectomy may all be reasonable options in specific circumstances and for specific lesion anatomy (7). DCBs and DESs contain medications that inhibit vessel restenosis and have been shown to result in notable improvements in clinical outcomes in several studies (8–10). However, this point is controversial, as a recent study found an increased risk of death following the use of paclitaxel-coated balloons and stents in PAD (11).…”

Section: Introductionmentioning

confidence: 99%

Quality of economic evaluations of drug-coated balloons and drug-eluting stents in peripheral artery disease: a systematic review

Etangsale

Nunno

Pineau

et al. 2021

Int J Technol Assess Health Care

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Objective We aimed to perform a systematic review of economic evaluations of drug-coated balloons (DCBs) and drug-eluting stents (DESs) in peripheral artery disease (PAD) and to assess the level of evidence of relevant studies. The purpose was not to present economic findings. Methods A systematic review was performed using four electronic databases to identify health economic evaluation studies reporting on the use of DCBs and DESs in PAD. The methodological and reporting quality of the studies was assessed using three different tools, the Drummond, Cooper, and CHEERS (Consolidated Health Economic Evaluation Reporting Standards) checklists. Results Six articles were included in this review of the 1,728 publications identified. Four studies were cost-effectiveness analyses and two cost–utility analyses. According to the Cooper hierarchy scale, the studies used good-quality data sources. The level of evidence used for clinical effect sizes, safety data, baseline clinical data, and costs was of high quality in general. In contrast, an evaluation of the reporting quality suggested that essential information was lacking. Conclusion The present study demonstrates that clinical data used in economic evaluations of DCBs and DESs in PAD are from clinical studies of high quality in general. However, the quality of reporting represents a concern when interpreting the results provided by these economic studies.

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“…The heart springs are designed to reduce restenosis [ 6 ]. Genuine pure metal stents, reduce the chance of restenosis by up to 20% while pharmaceutical stents reduce it by less than 10% [ 7 ]. The diagnostic and therapeutic procedure is an ambiguity of interventional cardiology for those with coronary stenosis whose severity cannot be clearly stated.…”

Section: Introductionmentioning

confidence: 99%

Cost-effectiveness analysis of fractional flow reserve versus angiography among patients with coronary artery disease undergoing borderline coronary lesions treatment in Iran

Keshavarz

Rezaee

Esmaili

et al. 2022

Cost Eff Resour Alloc

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Background The present study aimed to examine the cost-effectiveness of fractional flow reserve (FFR) versus angiography in treating borderline coronary lesions in patients with coronary artery stenosis in Iran. Cardiovascular disease is a leading cause of morbidity, mortality, readmission and the most important cause of disability in many countries, including Iran. Methods This was a cost-effectiveness study conducted from the perspective of the Ministry of Health in 2019. The effectiveness was determined using four indicators: Quality Adjusted Life Years (QALYs), major adverse cardiac events (MACE), angina, and number of used stents (mean). Only direct medical costs (DMC) were estimated. To evaluate the cost-effectiveness of FFR versus angiography, A decision tree model was built by patient’s level data.To coping with uncertainty Probabilistic sensitivity analysis (PSA) was performed. Results Totally, 98 cases of FFR and 238 cases of angiography were included in the analysis. The average of QALY in FFR and angiography were 0.853 and 0.787, respectively. The cost of these methods were $6128 and $8388, correspondingly. Therefore, FFR was dominant compared to angiography. Results of the scatter plots and acceptability curve showed that FFR was more cost-effective than angiography in 94% and 96% of simulations for a threshold lower than $11,000 PPP. The PSA analysis confirmed the robustness of the study results. Conclusion The results indicated that FFR was more cost-effective than angiography in the cases studied in Iran. Consequently, FFR can be used as a high-priority diagnostic method and it is recommendable to be included in insurance coverage.

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Drug-coated balloon in peripheral artery disease

Cited by 12 publications

References 43 publications

One-Year Clinical Outcome and Risk Factor Analysis of Directional Atherectomy Followed With Drug-Coated Balloon for Femoropopliteal Artery Disease

One-Year Clinical Outcome and Risk Factor Analysis of Directional Atherectomy Followed With Drug-Coated Balloon for Femoropopliteal Artery Disease

Quality of economic evaluations of drug-coated balloons and drug-eluting stents in peripheral artery disease: a systematic review

Cost-effectiveness analysis of fractional flow reserve versus angiography among patients with coronary artery disease undergoing borderline coronary lesions treatment in Iran

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