Clinical Randomized Trial Evaluating Novel, Microcrystalline, and Biocompatible Polymer Paclitaxel-Coated Balloon for the Treatment of Femoropopliteal Occlusive Disease

Buszman, Piotr P.; Nowakowski, Przemysław; Milewski, Krzysztof; Orlik, Bartłomiej; Żurakowski, Aleksander; Ludyga, Tomasz; Polczyk, Filip; Dębiński, Marcin; Jelonek, Michał; Kachel, Mateusz; Gąsior, Mariusz; Granada, Juan F.; Kiesz, R. Stefan

doi:10.1016/j.jcin.2018.07.029

Cited by 10 publications

(7 citation statements)

References 4 publications

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“…The primary endpoint was reported previously. 16 Briefly, LLL was significantly lower (by 63%) in the study group compared to the control (0.52 ± 1.2 mm vs 1.39 ± 1.1; absolute difference: 0.87, 95% CI for the difference: 0.29-1.44), thus confirming the superiority of mcPCB (p < 0.01). The binary restenosis was over twofold lower in the mcPCB group (odds ratio (OR): 0.27; 95% CI: 0.09-0.81; p = 0.02).…”

Section: Angiographic Outcome At 6 Monthsmentioning

confidence: 52%

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Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial

et al. 2021

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The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and serious adverse events (SAE: death, amputation, repeated revascularization) were considered a composite secondary endpoint. Routine angiography was scheduled for all study subjects at 6-month follow-up; outpatient appointments were scheduled at 12 and 36 months after intervention. At 6 months, the LLL was 63% lower in the mcPCB group compared to the POBA group (0.52 ± 1.2 vs 1.39 ± 1.1 mm; psup < 0.01). Binary restenosis occurred in 23% vs 52% of patients ( p = 0.02). At 3 years, the prevalence of SAE was significantly lower in the mcPCB group (33.3 vs 63.3%; p = 0.02), which mainly resulted from a twofold reduction in target vessel revascularization rate (28.6 vs 59.3%; p = 0.02). The difference in mortality was nonsignificant (7.4 vs 14.3%; p = 0.42). Patients with mcPCB were less symptomatic and less likely to adhere to secondary prevention measures. In this pivotal trial, a novel mcPCB proved superior to POBA concerning LLL at 6-month follow-up, and SAE at 12 months. This result was sustained up to 3 years. There was no difference between groups regarding mortality. ClinicalTrials.gov Identifier: NCT02145065

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Section: Angiographic Outcome At 6 Monthsmentioning

confidence: 52%

“…The study hypothesis and 6- and 12-month results have already been published. 16 Normally distributed parametric data were expressed as a mean and SD. In cases of skewed distribution, data were expressed as median and interquartile range.…”

Section: Methodsmentioning

confidence: 99%

Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial

et al. 2021

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“…Finally, 52 articles reporting 38 trials were included (Figure 1). 6–8,18–66 All trials were 2-armed RCTs with a total of 6026 patients. The characteristics of the eligible studies are shown in Table 1.…”

Section: Resultsmentioning

confidence: 99%

“…Data on TLR as clinical endpoint at various time points were reported by 36 articles. Seventeen articles reporting 15 trials with 1936 patients reported TLR at 6 months, 18–20,29,31,33,35,39,40,43,51,52,56,57,60,62,65 29 trials with 4749 patients reported TLR at 12 months, 6,7,18,20,21,23,24,26,28,31,33,35,39,40,43,46–49,51,52,55–58,60,62,65,66 and 15 trials with 2043 patients reported TLR at more than 24 months. 18,20,28,31,34,35,37,41,42,45,51,60,63,64,66 The network plot for these trials is presented by Stata in Figure 2D-2...…”

Section: Resultsmentioning

confidence: 99%

“…Data on primary patency measured by quantitative vascular angiography or DUS follow-up imaging at various time points were reported by 39 articles. Twenty-two trials reported primary patency at 6 months, 6,[18][19][20]22,26,27,29,30,33,[36][37][38][39][40]43,47,51,52,56,60,62,65 30 trials reported primary patency at 12 months, [6][7][8]18,[20][21][22][23][24]26,27,32,33,[38][39][40]43,[46][47][48][49][50][51]55,56,58,60,61,...…”

Section: Bayesian Network Meta-analysesmentioning

confidence: 99%

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Network Analysis of Endovascular Treatment Strategies for Femoropopliteal Arterial Occlusive Disease

Zhao

Cui

2022

J Endovasc Ther

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Purpose: Endovascular treatment of femoropopliteal arterial diseases remains controversial. We conducted a Bayesian network meta-analysis of randomized controlled trials aiming to investigate the efficacy differences between paclitaxel- or sirolimus-eluting stents, covered stents, drug-coated balloons, bare metal stents, and percutaneous transluminal angioplasty. Method: MEDLINE, Embase, Ovid, and other relevant online material were searched up to October 21, 2020. Primary endpoints were primary patency and target lesion revascularization at 6, 12, and more than 24 months. Results: Thirty-eight eligible trials included 6026 patients. In terms of primary patency, drug eluting stents were ranked as the most effective treatment based on the surface under the cumulative ranking curve values at 6 (80.6), 12 (78.4), and more than 24 months (96.5) of follow-ups. In terms of target lesion revascularization, drug eluting stents were ranked as the most effective treatment based on the surface under the cumulative ranking curve values at 6 (90.3), 12 (71.3), and more than 24 months (82.1) of follow-ups. Covered stents and bare metal stents had higher ranks in target lesion revascularization than those in primary patency. Sirolimus stents had a higher rank than paclitaxel stents. Conclusion: Drug eluting stents showed encouraging results in primary patency rates and freedom from target lesion revascularization at all phases of follow-up for femoropopliteal arterial diseases. Sirolimus stents appear to be more effective in femoropopliteal segment than paclitaxel stent.

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Restenosis Prevention With Drug Eluting or Covered Stents in Femoropopliteal Arterial Occlusive Disease: Evidence From a Comprehensive Network Meta-analysis

et al. 2019

European Journal of Vascular and Endovascular Surgery

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WHAT THIS PAPER ADDS This comprehensive network meta-analysis used data from 28 randomised controlled trials of commonly used endovascular treatments for femoropopliteal lesions. It was found that drug eluting stents were significantly more effective than drug coated balloons for the treatment of short lesions. However, the overall analysis did not demonstrate any significant difference in the efficacy of drug eluting stents, covered stents, drug coated balloons, and bare metal stent. Percutaneous transluminal angioplasty alone does not constitute an effective choice. These outcomes may contribute to clinical decision making. Background/objective: Endovascular interventions for femoropopliteal (FP) arterial diseases are limited by the development of restenosis. Current drug coated devices are capable of preventing restenosis by releasing antiproliferative agents to the vessel wall. However, default strategies for the treatment of FP diseases remain controversial. The aim of this study was to investigate the efficacy differences between drug eluting stents (DES), covered stents (CS), and other commonly used endovascular treatments in FP lesions, including drug coated balloons (DCBs), bare metal stents (BMS), and percutaneous transluminal angioplasty (PTA). Methods: A comprehensive network meta-analysis was conducted using data from relevant randomised control trials published up to 16 December 2018. Primary patency and target lesion revascularisation (TLR) at 12 months were set as the primary and secondary end points, respectively. Results: Twenty-eight eligible trials including 4728 patients were selected. DES was ranked as the most effective treatment in the multidimensional analysis of primary patency; however, there was no significant difference in the efficacy of DES and that of CS, DCB, and BMS. However, in short lesions (<10 cm), DES was significantly more effective than DCB (odds ratio 0.35; 95% confidence interval 0.15e0.83). Primary patency at 12 months was significantly lower with PTA. In terms of preventing TLR, DCB was ranked first, followed by DES, CS, BMS, and PTA. TLR was significantly higher with PTA than with other treatment strategies. Conclusion: The findings of this network meta-analysis suggest that this is not the appropriate time to identify the best endovascular treatment strategy for the FP segment. DES is effective in maintaining mid-term patency, especially in short lesions, whereas DCB seems more suitable for clinical use.

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Clinical Randomized Trial Evaluating Novel, Microcrystalline, and Biocompatible Polymer Paclitaxel-Coated Balloon for the Treatment of Femoropopliteal Occlusive Disease

Cited by 10 publications

References 4 publications

Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial

Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial

Network Analysis of Endovascular Treatment Strategies for Femoropopliteal Arterial Occlusive Disease

Restenosis Prevention With Drug Eluting or Covered Stents in Femoropopliteal Arterial Occlusive Disease: Evidence From a Comprehensive Network Meta-analysis

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