Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions

Laird, John; Schneider, Peter A.; Jaff, Michael R.; Brodmann, Marianne; Zeller, Thomas; Metzger, D. Chris; Ramanathan, Krishnan; Scheinert, Dierk; Micari, Antonio; Wang, Hong; Masters, Michele; Tepe, Gunnar

doi:10.1161/circinterventions.118.007702

Cited by 132 publications

(103 citation statements)

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“…We acknowledge the presence of a transient mortality signal and this has been previously published within the SFA randomized trial data at years 2 and 3, 14,15 but is no longer evident beyond that period, 8 and is further diminished by obtaining more balanced and complete vital status data in this study. The lack of a correlation between paclitaxel exposure and mortality was further evident by the observation that there was no difference in cause of death in different treatment groups, and no specific patterns of non‐fatal events to suggest mechanism.…”

Section: Discussionmentioning

confidence: 65%

“…The IN.PACT SFA and IN.PACT Japan studies were similarly designed randomized trials of the IN.PACT Admiral paclitaxel drug‐coated balloon (DCB) that both met their primary efficacy endpoint of patency at 1 year 6,7 . In the IN.PACT SFA study, follow‐up at 2 and 3 years showed a higher mortality in the paclitaxel arm that diminished at years 4 and 5 of follow‐up 8 …”

Section: Introductionmentioning

confidence: 99%

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Paclitaxel exposure: Long‐term safety and effectiveness of a drug‐coated balloon for claudication in pooled randomized trials

Schneider

Brodmann

Mauri

et al. 2020

Cathet Cardio Intervent

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Background Paclitaxel drug‐coated balloons (DCB) prevent recurrent claudication after angioplasty, yet data from randomized trials with incomplete follow‐up have raised uncertainty regarding long‐term mortality. Objectives To evaluate the effect of paclitaxel exposure on the long‐term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials. Methods The IN.PACT randomized trials (SFA, N = 331 and Japan, N = 100) each compared the DCB with standard percutaneous transluminal angioplasty (PTA) for claudication, and consented patients for 5 and 3 years, respectively. To address long‐term safety, sites were requested to obtain vital status follow‐up. In the pooled, updated data set, we examined the association between randomized treatment and mortality by cumulative incidence and hazard ratio (HR), and freedom from clinically driven target lesion revascularization (CD‐TLR). Multivariable Cox regression with adjustment for baseline characteristics was used to evaluate the dose effect. Causes of death were adjudicated by a blinded clinical events committee that included oncologists with paclitaxel expertise. Results The rate of long‐term vital status ascertainment increased from 81% to 97% for DCB and from 85% to 97% for PTA in the IN.PACT SFA trial. The cumulative incidence of mortality was 14.7% DCB versus 12.0% PTA at 5 years, HR 1.39, log‐rank p = .286. Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p = .381), but was an independent predictor of reduced risk of CD‐TLR (HR 0.79; p < .001). Causes of death did not differ by treatment arm. Conclusions In pooled randomized trial data with updated vital status ascertainment, paclitaxel was associated with improved efficacy but was not associated with increased mortality.

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Section: Discussionmentioning

confidence: 65%

Section: Introductionmentioning

confidence: 99%

Paclitaxel exposure: Long‐term safety and effectiveness of a drug‐coated balloon for claudication in pooled randomized trials

Schneider

Brodmann

Mauri

et al. 2020

Cathet Cardio Intervent

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“…While the study evaluated mid-term outcomes through 3 years, other studies (eg, IN.PACT SFA, THUNDER, AcoArt I) have followed participants up to 5 years. 24,28,29…”

Section: Limitationsmentioning

confidence: 99%

Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty

et al. 2020

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Purpose: To evaluate the 3-year safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA) in a Japanese population with femoropopliteal occlusive disease. Materials and Methods: The multicenter, prospective, IN.PACT SFA Japan randomized controlled trial ( ClinicalTrials.gov identifier NCT01947478) was an independently adjudicated study evaluating Japanese participants randomized 2:1 to DCB (n=68) or PTA (n=32). The effectiveness endpoint was primary patency through 36 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis (by duplex ultrasound). The effectiveness endpoint was evaluated using the Kaplan-Meier method; estimates are presented with the 95% confidence intervals (CIs). The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 36 months. Results: Primary patency by Kaplan-Meier estimate was higher in the DCB group (68.9%, 95% CI 57.5% to 80.2%) vs the PTA group (46.9%, 95% CI 29.6% to 64.2%) at 36 months (log-rank p=0.001). The CD-TLR rates were 14.9% (10/67) for the DCB group and 20.7% (6/29) for PTA (p=0.554). The safety composite endpoint occurred in 83.6% (56/67) of DCB participants and 75.9% (22/29) of PTA participants (p=0.402). All-cause death was similar between groups at 36 months [DCB 6.0% (4/67) vs PTA 6.9% (2/29), p>0.999), with no device- or procedure-related deaths in either group. Conclusion: The final report of the IN.PACT SFA Japan trial showed that the IN.PACT Admiral DCB is safe and had durable outcomes through 3 years in Japanese participants with femoropopliteal occlusive disease.

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“…Drug-coated balloons (DCBs) were developed to overcome these limitations. Many randomized controlled trials(RCTs) [2][3][4][5][6] have shown consistent superior outcomes of DCBs over uncoated balloons in femoropopliteal lesions, with data up to 5 years for some studies [7][8][9][10]. But,their application in lower limbs is still insu cient.…”

Section: Introductionmentioning

confidence: 99%

Treatment of Infrainguinal Arterial Occlusive Disease by Acotec Drug-coated Balloon in 435 Patients

Ling

Cui

Chen

et al. 2020

Preprint

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Abstract Background: At present, there are many clinical trials of drug coated balloon in the treatment of lower extremity arterial occlusive diseases, but there are not many clinical data in the real world study. Here we aimed to evaluate the efficacy and safety ofAcotec drug-coated balloon (DCB) for chronic ischemic disease in lower extremity.Methods: Clinical data of 435 patientswith 564occlusive/stenotic lesions in 492lower extremities treated by DCB from April 2016 toApril2019 were retrospectively analyzed.The mean age was 63years.Rutherford stage 2, 3, 4, 5, and 6 were classified in 11, 167, 182, 109, and 23 limbs, respectively.The mean length of the targeted lesions was 179.6mm. Of all the lesions, 436 located at femoraland/or popliteal arteries, and 128 at infra-popliteal arteries. All the patients were followed up at 6-month intervals. The major evaluation endpoints included late lumen loss (LLL), target lesion restenosis, target lesion revascularization (TLR), and severe clinical events including mortality and major amputation.Results: The technique success rate was 96.1%.Stents were placed in 57 (13.1%) cases for flow-limited dissections or remnant stenosisgreater than 50% after DCB angioplasty.The mean follow-up time was 28.5 ± 12.1 months (12-48 months). The meanLLLwas 1.1 mm, 1.8mm, and 2.8 mm, respectively, 1, 2, and 3 years after operation. The rate ofrestenosis and TLRwas 17.3%and8.2%, respectively, 1 year after operation; 20.6% and 11.6%, respectively, 2 years after operation; 29.4% and 18.3%, respectively, 3 years after operation.Fourteenpatientsdiedand 25received amputation.Conclusion: AcotecDCBwas safe and effective in treating chronic ischemic diseases of lower extremities.A better clinical outcome was achieved in femoro-popliteal arteries, compared toinfrapopliteal arteries.

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Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions

Abstract: Supplemental Digital Content is available in the text.

Cited by 132 publications

References 30 publications

Paclitaxel exposure: Long‐term safety and effectiveness of a drug‐coated balloon for claudication in pooled randomized trials

Paclitaxel exposure: Long‐term safety and effectiveness of a drug‐coated balloon for claudication in pooled randomized trials

Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty

Treatment of Infrainguinal Arterial Occlusive Disease by Acotec Drug-coated Balloon in 435 Patients

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