Safety and efficacy of drug‐coated balloon for peripheral artery revascularization—A systematic review and meta‐analysis

Ullah, Waqas; Zghouzi, Mohamed; Sattar, Zeeshan; Ahmad, Bachar; Zahid, Salman; Suleiman, Abdul-Rahman M.; Sattar, Yasar; Khan, Muhammad Zia; Paul, Timir K.; Bagur, Rodrigo; Qureshi, Mohammad Imran; Fischman, David L.; Banerjee, Subhash; Prasad, Anand; Alraies, M. Chadi

doi:10.1002/ccd.30074

Cited by 5 publications

(2 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Concerns that local endovascular therapy with paclitaxel-coated devices might be associated with higher mortality rates were first voiced some years ago [ 34 ]. In several randomized trials and large bodies of real-world data, these concerns were not confirmed [ 1 , 6 , 35 – 40 ].…”

Section: Discussionmentioning

confidence: 99%

Improvement of Outcome for Treatment of ‘Restenosis-prone’ Vascular Lesions? Potential Impact of the Paclitaxel dose on Late Lumen Loss in Porcine Peripheral Arteries

Gemeinhardt

Haase

Schnorr

et al. 2022

Cardiovasc Intervent Radiol

View full text Add to dashboard Cite

Purpose Clinical data indicate that the drug density on drug-coated balloons (DCBs) might have a role on treatment effect and durability. The aim of the current study was to investigate inhibition of neointimal formation and potential adverse effects after treatment with a novel double-dose DCB in swine. Material and methods A four-week study was performed in peripheral arteries of 12 domestic pigs after vessel injury and stent implantation. The novel double-dose DCB with 6-lg paclitaxel (Ptx)/mm 2 balloon surface (1 9 6) was compared to a standard DCB with 3.5 lg Ptx/mm 2 (3.5) and uncoated balloons (POBA). Potential adverse effects were stimulated by using three fully overlapping DCBs with 6 lg Ptx/mm 2 each (3 9 6). Quantitative angiography, histomorphometry and histopathological analyses were performed. Results Higher paclitaxel doses per square millimeter of treated arteries were associated with reduced late lumen loss (LLL) in quantitative angiography 4 weeks after treatment (POBA: 0.91 ± 0.75 mm; 3.5: 0.45 ± 0.53 mm; 1 9 6: 0.21 ± 0.41 mm; 3 9 6: -0.38 ± 0.65 mm). In histomorphometry, maximal neointimal thickness and neointimal area were the lowest for the 1 9 6 group (0.15 ± 0.06 mm/1.5 ± 0.4 mm 2 ), followed by 3 9 6 (0.20 ± 0.07 mm/1.8 ± 0.4 mm 2 ), 3.5 (0.22 ± 0.12 mm/ 2.2 ± 1.1 mm 2 ) and POBA (0.30 ± 0.07 mm/3.2 ± 0.7 mm 2 ). Downstream tissue showed histopathological changes in all groups including POBA, in larger number and different quality (e.g., edema, inflammation, vessel wall necrosis, vasculitis and perivasculitis) in the 3 9 6 group, which did not cause clinical or functional abnormalities throughout the study. Conclusion Treatment with the double-dose DCB (6 lg Ptx/mm 2 ) tended to increase inhibition of in-stent neointimal formation and to diminish LLL after peripheral intervention in the porcine model compared to a marketapproved DCB with 3.5 lg Ptx/mm 2 .

show abstract

Section: Discussionmentioning

confidence: 99%

Improvement of Outcome for Treatment of ‘Restenosis-prone’ Vascular Lesions? Potential Impact of the Paclitaxel dose on Late Lumen Loss in Porcine Peripheral Arteries

Gemeinhardt

Haase

Schnorr

et al. 2022

Cardiovasc Intervent Radiol

View full text Add to dashboard Cite

show abstract

“…Recently, DCB technology has become increasingly prevalent for more complex lesions. This technology has provided favorable outcomes in relevant randomized controlled trials (RCTs) and short-or mid-term observational studies 3,4) . However, patency after DCB treatment, especially in complex lesions with great length, small vessel diameter, severe calcification, and chronic total occlusion, remains challenging in real-world clinical practice 5) .…”

Section: See Article Vol 30: 000-000mentioning

confidence: 99%

Intravascular Ultrasound–Guided Femoropopliteal Endovascular Intervention: Could it Become a Standard Procedure?

Murata

2023

JAT

View full text Add to dashboard Cite

Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study

Brodmann

Lansink

Guetl

et al. 2022

Cardiovasc Intervent Radiol

View full text Add to dashboard Cite

Purpose Data on the long-term safety and effectiveness of drug-coated balloons (DCBs) for the treatment of long femoropopliteal atherosclerotic lesions in the real-world setting are rare. This study reports 3 year and 5 year outcomes of the pre-specified 150 mm balloon sub-cohort of the IN.PACT Global Study. Methods The IN.PACT Global Study was a prospective, multicentre, international, single-arm study evaluating the performance of the IN.PACT Admiral DCB in real-world patients with femoropopliteal atherosclerotic disease. This pre-specified 150 mm DCB cohort analysis comprised 107 participants (111 lesions) with all target lesions treated with at least one 150 mm DCB. Results Mean lesion length was 20.3 ± 9.2 cm; 18.0% had in-stent restenosis, 58.6% were totally occluded, and 17.1% were severely calcified. Through 60 months, the Kaplan–Meier estimate of freedom from clinically driven target lesion revascularization (CD-TLR) was 72.7% [95% confidence interval (CI):62.4%–80.5%]. The safety composite endpoint (freedom from device/procedure-related death through 30 days; freedom from target limb major amputation and clinically driven target vessel revascularization through 5 years) was 70.5%. The cumulative incidence of major amputation was 1.0% and all-cause mortality was 18.4%. Freedom from CD-TLR rates in the provisional stented and non-stented subgroups through 36 months were 64.0% [95% CI: 46.1%–77.3%] and 81.9% [95% CI: 69.7%–89.6%] (log-rank p = 0.074), respectively. Conclusions The results demonstrate sustained long-term safety of the 150 mm IN.PACT Admiral DCB for long femoropopliteal atherosclerotic lesions in real-world patients. In particular, the results show that DCB angioplasty is an effective revascularization modality in long complex lesions. ClinicalTrials.gov identifier: NCT01609296. Level of Evidence. Level 3, Cohort Study.

show abstract

Safety and efficacy of drug‐coated balloon for peripheral artery revascularization—A systematic review and meta‐analysis

Cited by 5 publications

References 29 publications

Improvement of Outcome for Treatment of ‘Restenosis-prone’ Vascular Lesions? Potential Impact of the Paclitaxel dose on Late Lumen Loss in Porcine Peripheral Arteries

Improvement of Outcome for Treatment of ‘Restenosis-prone’ Vascular Lesions? Potential Impact of the Paclitaxel dose on Late Lumen Loss in Porcine Peripheral Arteries

Intravascular Ultrasound–Guided Femoropopliteal Endovascular Intervention: Could it Become a Standard Procedure?

Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study

Contact Info

Product

Resources

About