***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Purpose : To evaluate the safety and efficacy of the novel Passeo-18 Lux paclitaxel-coated balloon compared with the Passeo-18 uncoated balloon in patients with symptomatic de novo or restenotic femoropopliteal lesions . Methods : Sixty patients ( 34 men ; mean age 70.7±10.1 years ) in 5 European centers were enrolled in the BIOLUX P-I trial ( Clinical Trials.gov identifier NCT01056120 ) and r and omized 1:1 to either the paclitaxel-coated balloon or the uncoated balloon . The primary endpoint was late lumen loss at 6 months . Secondary endpoints were binary restenosis at 6 months , clinical ly driven target lesion revascularization ( TLR ) , change in ankle-brachial index and Rutherford classification , and major adverse events at 6 and 12 months . Results : At 6 months , patients treated with paclitaxel-coated balloons had a significantly lower late lumen loss ( 0.51±0.72 vs. 1.04±1.00 mm , p=0.033 ) and binary restenosis ( 11.5 % vs. 34.6 % , p=0.048 ) than the control group . Correspondingly , clinical ly driven TLR was lower in the paclitaxel-coated balloon group at 12 months [ 15.4 % vs. 41.7 % ( p=0.064 ) for the intention-to-treat population and 16.0 % vs. 52.9 % , ( p=0.020 ) for the as-treated population ] . No death and one minor amputation were observed compared with two deaths and two minor amputations in the control group . No major amputations or thrombosis were reported . Conclusion : The Passeo-18 Lux paclitaxel-coated balloon has been proven to be safe and effective in patients with femoropopliteal lesions , with superior performance outcomes compared with treatment with an uncoated balloon Background —Peripheral percutaneous transluminal angioplasty is fraught with a substantial risk of restenosis and reintervention . A drug-eluting balloon ( DEB ) based on a novel coating was compared with uncoated balloons in patients undergoing femoro-popliteal percutaneous transluminal angioplasty .  Methods and Results — Patients with symptomatic femoro-popliteal atherosclerotic disease undergoing percutaneous transluminal angioplasty  were r and omized to paclitaxel-coated IN.PACT Pacific or uncoated Pacific balloons . The primary end point was late lumen loss at 6 months assessed by blinded angiographic corelab quantitative analyses . Secondary end points were binary restenosis and Rutherford class change at 6 months , and target lesion revascularization plus major adverse clinical events ( major adverse events = death , target limb amputation , or target lesion revascularization ) at 6 and 12 months . Eighty-five patients ( 91 cases = interventional procedures ) were r and omized in 3 hospitals ( 44 to DEB and 47 to uncoated balloons ) .  Average lesion length was 7.0±5.3 and 6.6±5.5 cm for DEB and control arm , respectively . Procedural success was obtained in all cases . Six-month quantitative angiography showed that DEB were associated with significantly lower late lumen loss ( −0.01 mm [ 95 % CI , −0.29 ; 0.26 ] versus 0.65 mm [ 0.37 ; 0.93 ] , P=0.001 ) and fewer binary restenoses ( 3 [ 8.6 % ] versus 11 [ 32.4 % ] , P=0.01 ) . This translated into a clinical ly relevant benefit with significantly fewer major adverse events for DEB versus uncoated balloons up to 12 months ( 3 [ 7.1 % ] versus 15 [ 34.9 % ] , P<0.01 ) as well as target lesion revascularizations ( 3 [ 7.1 % ] versus 12 [ 27.9 % ] , P=0.02 ) . Conclusions —Use of IN.PACT Pacific DEB is associated with significant reductions in late lumen loss and restenoses at 6 months , and re interventions after femoro-popliteal percutaneous transluminal angioplasty up to 1 year of follow-up . Clinical Trial Registration —URL http://www . clinical trials.gov . Unique identifier : NCT01083030 BACKGROUND Evidence from large , r and omized , controlled peripheral artery disease trials reporting long-term outcomes using drug-coated balloons ( DCBs ) is limited . Previously , the DCB showed favorable 1-year outcomes compared with conventional percutaneous transluminal angioplasty ( PTA ) , yet durability of the treatment effect with DCBs remains unknown . OBJECTIVES This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions . METHODS We enrolled 331 patients with symptomatic ( Rutherford 2 to 4 ) femoropopliteal lesions up to 18 cm in length . Patients were r and omly assigned in a 2:1 ratio to treatment with DCB or PTA .  The 24-month assessment s included primary patency , freedom from clinical ly driven target lesion revascularization ( CD-TLR ) , major adverse events , and quality of life and functional outcomes as assessed by the EuroQOL-5D quality -of-life question naire , walking impairment question naire , and 6-min walk test . RESULTS At 24 months , patients treated with DCB showed significantly higher primary patency when compared with PTA ( 78.9 % vs. 50.1 % ; p < 0.001 ) . The rates of CD-TLR were 9.1 % and 28.3 % ( p < 0.001 ) for the DCB and PTA groups , respectively . The overall mortality rate in the DCB group was 8.1 % versus 0.9 % in the PTA group ( p = 0.008 ) . There were no device- or procedure-related deaths and no major amputations in either group through 24-month follow-up . The rate of vessel thrombosis was low ( 1.5 % DCB vs. 3.8 % PTA ; p = 0.243 ) , with no new events reported between 1 and 2 years . Both groups showed similar functional improvement at 2 years , although DCB patients achieved this level of function with 58 % fewer re interventions . CONCLUSIONS The 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency , lower CD-TLR , and similar functional status improvement with fewer repeat interventions . ( R and omized Trial of IN.PACT Admiral Drug Eluting Balloon vs St and ard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [ INPACT SFA I ] ; NCT01175850 ; and IN.PACT Admiral Drug-Coated Balloon vs. St and ard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [ SFA ] and Proximal Popliteal Artery [ PPA ] [ INPACT SFA II ] ; NCT01566461 ) Purpose The previously reported 6-month angiographic and 12-month clinical outcomes of the CONSEQUENT trial demonstrated the safety and efficacy of a novel paclitaxel – resveratrol-coated balloon for the treatment of lesions in the femoropopliteal segment . The purpose of this report is to present the 2-year results including a cost-benefit analysis for Germany . Material s and Methods Patients with symptomatic peripheral artery occlusive disease in femoropopliteal lesions were r and omized either to drug-coated balloon ( DCB , n = 78 ) or plain old balloon angioplasty ( POBA , n = 75 ) . As secondary endpoints , the 2-year clinical results consisting of target lesion revascularization ( TLR ) , patency and increase in walking distance were recorded . Based on the Kaplan – Meier analyses for TLR and other adverse events , a cost-benefit analysis was conducted for the German DRG system . Results There were no additional TLRs in both groups between 14 and 24 months so that the corresponding rates remained significantly different between the treatment groups ( DCB : 19.1 vs. POBA 40.6 % , p = 0.007 ) . At 2 years , the patency rate was significantly higher in the DCB group ( 72.3 vs. 48.4 % , p = 0.006 ) . The walking distance increase was also significantly higher after DCB angioplasty ( 172 ± 103 vs. 52 ± 136 m , p = 0.001 ) . We estimated 2-year cost savings of € 1111.97 per patient treated with DCB instead of POBA . Conclusions The use of paclitaxel – resveratrol matrix-coated peripheral balloons compared to POBA was associated with a significantly reduced TLR rate , superior patency and substantial cost savings at 2 years . Clinical Trials.gov Identifier NCT01970579 BACKGROUND The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis . Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery , potentially improving vessel patency by reducing restenosis . METHODS In this single-blind , r and omized trial conducted at 54 sites , we assigned , in a 2:1 ratio , 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to st and ard angioplasty . The primary efficacy end point was primary patency of the target lesion at 12 months ( defined as freedom from binary restenosis or from the need for target-lesion revascularization ) . The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death ( i.e. , death from a medical complication related to a limb ) , amputation , and reintervention . RESULTS The two groups were well matched at baseline ; 42.9 % of the patients had diabetes , and 34.7 % were current smokers . At 12 months , the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty ( 65.2 % vs. 52.6 % , P=0.02 ) . The proportion of patients free from primary safety events was 83.9 % with the drug-coated balloon and 79.0 % with st and ard angioplasty ( P=0.005 for noninferiority ) . There were no significant between-group differences in functional outcomes or in the rates of death , amputation , thrombosis , or reintervention . CONCLUSIONS Among patients with symptomatic femoropopliteal peripheral artery disease , percutaneous transluminal angioplasty with a paclitaxel-coated balloon result ed in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a st and ard balloon . The drug-coated balloon was noninferior to the st and ard balloon with respect to safety . ( Funded by Lutonix-Bard ; LEVANT 2 Clinical Trials.gov number , NCT01412541 . ) BACKGROUND Drug-eluting stents reduce restenosis in coronary arteries , but clinical trials have failed to prove their efficacy in peripheral arteries . We investigated the use of paclitaxel-coated angioplasty balloons and paclitaxel dissolved in the angiographic contrast medium during angioplasty of the leg . METHODS In a small , multicenter trial , we r and omly assigned 154 patients with stenosis or occlusion of a femoropopliteal artery to treatment with st and ard balloon catheters coated with paclitaxel , uncoated balloons with paclitaxel dissolved in the contrast medium , or uncoated balloons without paclitaxel ( control ) . The primary end point was late lumen loss at 6 months . RESULTS The mean ( + /-SD ) age of the patients was 68+/-8 years , 24 % were smokers , and 49 % had diabetes . Twenty-seven percent of the lesions were total occlusions , and 36 % were restenotic lesions . The mean lesion length was 7.4+/-6.5 cm . There were no significant differences in baseline characteristics between the groups . There were no adverse events attributable to the paclitaxel-coated balloons . At 6 months , the mean late lumen loss was 1.7+/-1.8 mm in the control group , as compared with 0.4+/-1.2 mm ( P<0.001 ) in the group treated with paclitaxel-coated balloons and 2.2+/-1.6 mm ( P=0.11 ) in the group treated with paclitaxel in the contrast medium . The rate of revascularization of target lesions at 6 months was 20 of 54 ( 37 % ) in the control group , 2 of 48 ( 4 % ) in 
    Output:
    
Interpretation Efficacy of DCB differs substantially across studies .
Effect size depends on the type of DCB , treatment strategy , and lesion complexity .
The risk of 2-year all-cause mortality at 2 years was increased , but without evidence of causation