Dataset Information

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial.

ABSTRACT:

Purpose

This study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB).

Materials and methods

The EffPac trial was a prospective, multicenter, randomized controlled trial that enrolled 171 patients of Rutherford category 2 to 4 with medium length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor® 35 DCB angioplasty or plain old balloon angioplasty (POBA). Assessment at 5 years included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), clinical improvement, and target limb amputation. Long-term vital status was ascertained in 97.1% of the participants.

Results

Kaplan-Meier curves at 5 years demonstrate a primary patency of 61.4% after DCB angioplasty and 53.5% after POBA (log-rank p = 0.040) with a decreasing difference throughout the observation period. Freedom from TLR was 82.1% and 73.7%, respectively (log-rank p = 0.050). Incidence of primary clinical improvement was similar between groups (61% DCB vs. 64% POBA, p = 0.94). Major target limb amputation was necessary in one POBA-group participant. Freedom from all-cause death at 5 years was 88.5% after DCB and 86.0% after POBA (log-rank p = 0.34).

Conclusions

Primary patency after femoropopliteal DCB angioplasty remained superior to POBA throughout 5 years, however, with decreasing difference. Clinical improvement, freedom from TLR, and all-cause mortality were similar between groups over the long term. (Effectiveness of Paclitaxel-Coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral Artery [EffPac]; NCT02540018).

SUBMITTER: Teichgraber U

PROVIDER: S-EPMC9705448 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial.

Teichgräber Ulf U Lehmann Thomas T Ingwersen Maja M Aschenbach René R Zeller Thomas T Brechtel Klaus K Blessing Erwin E Lichtenberg Michael M von Flotow Peter P Heilmeier Britta B Sixt Sebastian S Brucks Steffen S Erbel Christian C Beschorner Ulrich U Werk Michael M Riambau Vicenç V Wienke Andreas A Klumb Christof C Thieme Markus M Scheinert Dierk D

Cardiovascular and interventional radiology 20220911 12

<h4>Purpose</h4>This study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB).<h4>Materials and methods</h4>The EffPac trial was a prospective, multicenter, randomized controlled trial that enrolled 171 patients of Rutherford category 2 to 4 with medium length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor® 35 DCB angioplasty or plain old balloon angioplasty (POBA). Assessment at 5 years included p ...[more]

PMID: 36088609

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Project description:PurposeAtherectomy has been reintroduced for debulking calcified atheroma to enhance the efficacy of drug-coated balloons (DCBs); however, its efficacy in severe calcification and related outcomes have not been fully evaluated. This study aimed to evaluate the outcomes of atherectomy and DCB angioplasty for treating femoropopliteal occlusive disease (FPOD).Materials and methodsFrom 2014 to July 2022, 85 limbs in 76 patients with FPOD underwent atherectomy with DCB angioplasty. We evaluated the efficacy of this procedure using primary patency (PP) and clinically driven target lesion revascularization (CD-TLR)-free survival. PP was defined as the duration of uninterrupted patency without occlusion or a peak systolic velocity ratio more than 2.5 at the target lesion. Lesion calcification was evaluated according to Peripheral Arterial Calcium Scoring System, and Grade 4 was classified as severe.ResultsSeventy-one (84%) cases were male, and 56 limbs (66%) were treated for claudication. Rotational and directional atherectomies were performed in 62 (73%) and 23 limbs, respectively. The improvement in the median ankle-brachial index was 0.36 (interquartile range, 0.25-0.48). Median follow-up duration was 19.4 months. The overall PP and CD-TLR-free survival rates were 77% and 93% at 1 year and 64% and 83% at 2 years, respectively. On multivariable analysis, female sex (adjusted hazard ratio [aHR], 3.77; 95% confidence interval (CI), 1.30-10.87, P=0.014), dialysis (aHR, 4.35; 95% CI, 1.33-13.22, P=0.015), and severe calcification (aHR, 2.42; 95% CI, 1.07-5.46, P=0.033) were independent risk factors for poor PP. Dialysis (aHR, 11.07; 95% CI, 3.72-32.92, P<0.001) and severe calcification (aHR, 3.19; 95% CI, 1.15-8.84, P=0.026) were identified as independent risk factors for CD-TLR.ConclusionAtherectomy with DCB angioplasty for FPOD did not work well in female patients, patients with lesions with severe calcification, and patients undergoing dialysis. Therefore, careful monitoring of these patients is crucial for patency loss and the requirement for revascularization. Additionally, for these patients requiring revascularization, surgical bypass may be appropriate for suitable candidates; whereas more proactive conservative management may be justified for claudicants.

Project description:Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. 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 within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.

Project description:IntroductionThe combination of intravascular lithotripsy (IVL) and drug-coated balloon (DCB) angioplasty for calcified peripheral lesions is associated with promising short-term results. However, data regarding the 12 months performance of this treatment option is missing. This study reports on the outcomes of IVL and DCB angioplasty for calcified femoropopliteal disease.MethodsPatients treated with IVL and DCB for calcified femoropopliteal lesions between February 2017 and September 2020 were included into this study. The primary outcome measure of this analysis was primary patency. Secondary patency, freedom from target lesion revascularization (TLR) and overall mortality were additionally analyzed.ResultsFifty-five (n = 55) patients and 71 lesions were analyzed. Most patients presented with long-term limb-threatening ischemia (n = 31, 56%), 47% (n = 26) were diabetics, and 66% (n = 36) had long-term kidney disease. The median lesion length was 77 mm (interquartile range: 45-136), and 20% (n = 14) of the lesions were chronic total occlusions (CTOs). Eccentric calcification was found in 23% of the vessels (n = 16), and circumferential calcium (peripheral arterial calcium scoring system [PACSS] Class 3 and 4) was present in 78% (n = 55) of the treated lesions.The technical success after IVL amounted to 87% (n = 62) and the procedural success to 97% (n = 69). A flow-limiting dissection was observed in 2 cases (3%). Both the rates of target lesion perforation and distal embolization were 1% (n = 1). A bail-out scaffold was deployed in 5 lesions (7%). At 12 months the Kaplan-Meier estimate of primary patency was 81%, the freedom from TLR was 92% and the secondary patency 98%. The overall survival amounted to 89%, while the freedom from major amputation to 98%. The presence of eccentric disease, CTOs, or PACSS Class 4 did not increase the risk for loss of patency or TLR.ConclusionsIn this challenging cohort of patients, the use of IVL and DCB for calcified femoropopliteal lesions was associated with promising 12 months outcomes and an excellent safety profile.

Project description:ObjectivePrimary nitinol stenting (PNS) and drug-coated balloon (DCB) angioplasty are two of the most common endovascular interventions for femoropopliteal atherosclerotic disease. Although many prospective randomized controlled trials have compared PNS or DCB with plain balloon angioplasty (POBA), no studies have directly compared PNS against DCB therapy. The purpose of this network meta-analysis is to determine whether there is a significant difference in outcomes between PNS and DCB.MethodsThe primary outcome measure was binary restenosis, the secondary outcome measures were target lesion revascularization (TLR) and change in the ankle-brachial index (ABI). Outcomes were evaluated at 6, 12, and 24 months. A literature review identified all randomized controlled trials published before March 2020 that compared DCB with POBA or PNS with POBA in the treatment of native atherosclerotic lesions of the femoropopliteal artery. Studies were excluded if they contained in-stent stenosis or tibial artery disease that could not be delineated out in a subgroup analysis. Network meta-analysis was performed using the network and mvmeta commands in STATA 14.ResultsTwenty-seven publications covering 19 trials were identified; 8 trials compared PNS with POBA and 11 trials compared DCB with POBA. The odds of freedom from binary restenosis for patients treated with DCB compared with PNS at 6 months was 1.19 (95% confidence interval [CI], 0.63-2.22), at 12 months was 1.67 (95% CI, 1.04-2.68), and at 24 months was 1.36 (95% CI, 0.78-2.37). The odds of freedom from TLR for patients treated with DCB compared with PNS at 6 months was 0.66 (95% CI, 0.12-3.80), at 12 months was 1.89 (95% CI, 1.04-3.45), and at 24 months was 1.68 (95% CI, 0.82-3.44). The mean increase in ABI for patients treated with PNS compared with DCB at 6 months was 0.06 higher (95% CI, -0.03 to 0.15), at 12 months was 0.05 higher (95% CI, 0.00-0.09), and at 24 months was 0.07 higher (95% CI, -0.01 to 0.14).ConclusionsBoth DCB and PNS demonstrated a lower rate of binary restenosis compared with POBA at the 6-, 12-, and 24-month timepoints. When comparing DCB with PNS through network meta-analysis, DCB had a statistically lower rate of a binary restenosis and TLR at the 12-month timepoint. This network meta-analysis demonstrates that both DCB and PNS are superior to POBA, and that PNS is a satisfactory substitute for DCB when paclitaxel is not desirable.

Project description:BackgroundNumerous studies have reported favorable outcomes using drug-coated balloons (DCBs) for treatment of symptomatic peripheral artery disease of the superficial femoral and popliteal arteries. However, the treatment effect compared with an uncoated balloon has differed greatly among the randomized trials, with better outcomes observed with higher-dose DCBs. This European trial was designed to assess the safety and effectiveness of a next-generation low-dose (2-µg/mm2 surface dose of paclitaxel) DCB.MethodsThis was a prospective, randomized, multicenter, single-blinded trial. Patients were randomized (3:1) to treatment with a low-dose DCB or an uncoated percutaneous transluminal angioplasty (PTA) balloon. The primary safety end point was a composite of freedom from device- and procedure-related death through 30 days after the procedure and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months after the procedure. The primary effectiveness end point was primary patency at 12 months.ResultsPatients were randomized to treatment with a DCB (222 patients, 254 lesions) or uncoated PTA balloon (72 patients, 79 lesions) after successful predilatation. Mean lesion length was 7.2 and 7.1 cm, and 19.2% and 19.0% of lesions represented total occlusions, respectively. The primary safety end point was met, and superiority was demonstrated; freedom from a primary safety event was 94.1% (193 of 205) with DCB and 83.3% (50 of 60) with PTA, for a difference of 10.8% (95% confidence interval, 0.9%-23.0%). The primary effectiveness end point was met, and superiority of DCB over PTA was achieved (83.9% [188 of 224] versus 60.6% [40 of 66]; P<0.001). Outcomes with DCB were also superior to PTA per the Kaplan-Meier estimate for primary patency (89.0% versus 65.0% at 365 days; log-rank P<0.001) and for rates of clinically driven target lesion revascularization (5.9% versus 16.7%; P=0.014).ConclusionsSuperiority with a low-dose DCB for femoropopliteal interventions was demonstrated over PTA for both the safety and effectiveness end points.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01858363.

Project description:ObjectivesThe long-term data on the use of drug-coated balloons (DCBs) for femoropopliteal atherosclerotic lesions in the real-world setting are limited, even more so for racially and geographically distinct populations. The present analysis reports the 5-year safety and effectiveness outcomes of a DCB in the Asian subset of the prospective, real-world IN.PACT Global Study.MethodsThe IN.PACT Global Study was a prospective, multicenter, international, single-arm study designed to assess the long-term safety and effectiveness of the IN.PACT Admiral DCB in real-world participants with femoropopliteal artery disease. The present analysis included 114 Asian participants (138 lesions) treated in South Korea and Singapore. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the safety endpoint (a composite of freedom from device- and procedure-related mortality through 30 days; and freedom from major target limb amputation and clinically driven target vessel revascularization within 60 months after the index procedure) and major adverse events.ResultsIn this prespecified Asian subset, there was a high incidence of diabetes mellitus (54.4%), hypertension (78.1%), coronary artery disease (43.9%), and concomitant below-the-knee vascular disease of target leg (39.5%). Mean lesion length was 17.4 ± 12.4 cm; 26.8% were in-stent restenosis, and more than half of the lesions were totally occluded (51.4%) and calcified (54.3%). The 5-year Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization was 77.1% (95% confidence interval: 67.0%-84.5%). The safety composite endpoint was 76.0%; the cumulative incidence of all-cause mortality was 19.9%, and no major target limb amputations were reported through 5 years.ConclusionsThis subset analysis of Asian participants from the IN.PACT Global Study demonstrated consistent results with the previously reported data of the IN.PACT Admiral DCB. The data confirm the durable clinical effectiveness and safety profile of the DCB through 5 years for femoropopliteal atherosclerotic disease in this real-world population.

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.

Dataset Information

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial.

Purpose

Materials and methods

Results

Conclusions

Publications

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial.

Similar Datasets

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