Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions (original) (raw)
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Jacc-cardiovascular Interventions, 2018
OBJECTIVES The IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. BACKGROUND Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of TransAtlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. METHODS The IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device-and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months. RESULTS Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo instent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months. CONCLUSIONS This real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (IN.PACT Global Clinical Study; NCT01609296).
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery, 2017
The aim was to assess 18 month outcomes of the paclitaxel eluting balloon (PEB) in patients with femoropopliteal (FP) in-stent restenosis (ISR). In a national prospective and multicentre cohort study, symptomatic patients with femoropopliteal in-stent restenosis were included from January 2012 to June 2013. Patients were treated by paclitaxel eluting balloon angioplasty (In Pact Admiral, Medtronic, Santa Rosa, CA, USA). Clinical and duplex scan follow-up evaluations were performed at 1, 3, 6, 9, 12, and 18 months. The primary endpoint was freedom from target lesion revascularisation (TLR) at 12 months. Secondary endpoints were major adverse cardiovascular events (MACE), Target extremity revascularisation (TER), primary and secondary sustained clinical improvement, recurrent restenosis rate, primary and secondary patency, quality of life assessed by EQ-5D questionnaire, technical success, clinical success, and length of stay RESULTS: A total of 53 patients were enrolled. After a blin...
Journal of the American College of Cardiology, 2019
BACKGROUND Randomized trials of drug-eluting stents (DES) and drug-coated balloons (DCB) for femoropopliteal interventions reported superior patency rates for both strategies compared to standard balloon angioplasty. To date, head-to-head comparisons are missing. OBJECTIVES The authors sought to compare DES versus DCB for femoropopliteal lesions through 36 months. METHODS Within a multicenter, randomized trial, 150 patients with symptomatic femoropopliteal disease were randomly assigned to primary DES implantation or DCB angioplasty with bailout stenting after stratification for lesion length (#10 cm, >10 cm to #20 cm, and >20 cm to #30 cm). The primary effectiveness endpoint was primary patency at 12 months assessed by Kaplan-Meier. Secondary endpoints comprised major adverse events including death, major amputations, and clinically driven target lesion revascularization, and clinical outcomes. RESULTS More than one-half of lesions were total occlusions, and the stenting rate was 25.3% in the DCB group. Kaplan-Meier estimates of primary patency were 79% and 80% for DES and DCB at 12 months (p ¼ 0.96) but decreased to 54% and 38% through 36 months (p ¼ 0.17), respectively. Freedom from clinically driven target lesion revascularization was >90% at 12 months but dropped to around 70% at 36 months in both groups. Overall, the mortality rate through 36 months was 7.3%, with 1 procedure-related death in the DCB group. Improvement of clinical outcomes was sustained through 36 months. CONCLUSIONS Patency rates at 12 months suggest comparable effectiveness and safety of DES versus DCB plus bailout stenting in femoropopliteal interventions; a trend in favor of the DES was observed up to 36 months.
Journal of Endovascular Therapy
To evaluate the performance of the Ranger paclitaxel-coated balloon vs uncoated balloon angioplasty for femoropopliteal lesions. Methods: Between January 2014 and October 2015, the prospective, randomized RANGER SFA study (ClinicalTrials.gov identifier NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2-4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68±8 years; 53 men) were enrolled in the Ranger drug-coated balloon (DCB) arm and 34 patients (mean age 67±9 years; 23 men) were assigned to the control group. Six-month analysis included angiographic late lumen loss and safety and clinical outcomes assessments. Results: Baseline characteristics of the DCB and control groups were similar, as were lesion lengths (68±46 vs 60±48 mm; p=0.731), severity of calcification (p=0.236), and the prevalence of occlusions (34% vs 34%; p>0.999). At 6 months, late lumen loss was significantly less for the DCB group vs controls (-0.16±0.99 vs 0.76±1.4; p=0.002). The DCB group had significantly greater freedom from binary restenosis (92% vs 64%; p=0.005) and primary patency rates (87% vs 60%; p=0.014). Target lesion revascularization rates were 5.6% in the DCB group and 12% in the control group (p=0.475). No target limb amputations or device-related deaths occurred in either group. Conclusion: Six-month results suggest that Ranger DCB treatment effectively inhibited restenosis in symptomatic femoropopliteal disease, resulting in improved vessel patency and a low revascularization rate in the short term compared with uncoated balloon angioplasty.
JACC: Cardiovascular Interventions, 2018
OBJECTIVES The authors sought to investigate the midterm efficacy and safety of drug-coated balloon (DCB) in the treatment of severe femoropopliteal artery disease (FPAD). BACKGROUND The midterm outcome of DCB versus uncoated balloon percutaneous transluminal angioplasty (PTA) for FPAD are still debated. METHODS A total of 200 Chinese patients with FPAD were prospectively randomized into treatment with DCB or with PTA. The primary efficacy endpoints were primary patency of the target lesion, freedom from clinically driven target lesion revascularization, improved ankle-brachial index, and improved Rutherford class at 24 months. The primary safety endpoint was the rate of major adverse events. RESULTS The DCB group and PTA group were comparable in demographic characteristics and clinical severity at baseline. At 24-month follow-up, primary patency was better in the DCB group versus PTA group (64.6% vs. 31.4%; p < 0.001). The DCB group had a higher rate of freedom from clinically driven target lesion revascularization than the PTA group (86.5% vs. 58.9%; p < 0.001). Rutherford class and ankle-brachial index also confirmed more improvements in the DCB group (p < 0.01 and p < 0.05, respectively). There was no significant difference in major adverse events.
Journal of Endovascular Therapy
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 proc...
The optimal endovascular treatment for femoropopliteal arterial occlusive disease has yet to be assessed. Patency rates after uncoated balloon angioplasty are disappointing. Although stents have better outcomes, they also have limitations. Intra-arterial stenting may lead to stent thrombosis and flow pattern disruption, which may result in stent fracture or in-stent restenosis. In the past decade, drug-eluting balloons (DEBs) and drug-eluting stents (DESs) have been introduced, and both have been proven to possess antirestenotic features compared with conventional techniques. The objective of this study is to perform a noninferiority analysis of DEBs with provisional bare-metal stenting and primary stenting with DESs in the treatment of femoropopliteal arterial occlusive disease. If DEB with provisional bare-metal stenting proves to be noninferior to primary stenting with DESs, DEBs may be the favorable technique because the postoperative long-term limitations of stents will be restricted. This is a prospective, randomized, controlled, single-blind, multicenter trial. The study population consists of volunteers aged $18 years, with chronic, symptomatic peripheral arterial occlusive disease (Rutherford-Baker classification 2 to 5) caused by de novo stenotic or occlusive atherosclerotic lesions of the superficial femoral artery or of the popliteal artery (only segment P1). Subjects will be treated with a DEB and provisional bare-metal stenting (if a stenosis >30% or a flow-limiting dissection persists after prolonged inflation with an uncoated balloon) or with primary stenting with a DES. The study will include 254 patients (ratio 1:1). The primary end point is 2-year freedom from binary restenosis, defined as a lumen diameter reduction of <50% assessed by duplex ultrasound imaging (peak systolic velocity ratio <2.5). Secondary end points are technical success, target lesion revascularization, target vessel revascularization, improvement in ankle-brachial index, improvement in Rutherford classification, amputation rate, and mortality rate. (J Vasc Surg 2017;66:1293-8.)