***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: OBJECTIVES The intention of the PEPCAD China ISR ( A Prospect i ve , Multicenter , R and omized Trial of Paclitaxel-Coated versus Paclitaxel-Eluting Stent for the Treatment of Drug-Eluting Stent In-Stent Restenosis ) was to demonstrate the efficacy of paclitaxel-coated balloon ( PCB ) angioplasty in a non-European patient population with coronary drug-eluting stent in-stent restenosis ( DES-ISR ) . BACKGROUND The treatment of DES-ISR is still challenging with no established best strategy . Moreover , there is no study on the effect of PCB in the treatment of ISR in the Chinese population . METHODS PEPCAD China ISR was a 220-patient r and omized ( 1:1 ) , single-blind prospect i ve multicenter trial conducted in China . Patients with coronary DES-ISR received either PCB ( SeQuent Please , B. Braun Melsungen AG , Melsungen , Germany ) or paclitaxel-eluting stent ( Taxus Liberté , Boston Scientific , Natick , Massachusetts ) treatment . The primary endpoint was in-segment late lumen loss at 9 months . RESULTS There were no significant baseline differences between both treatment groups in terms of patient , lesion , or procedural characteristics . At 9 months , in-segment late lumen loss in the PCB group was noninferior to that of the paclitaxel-eluting stent group ( 0.46 ± 0.51 mm vs. 0.55 ± 0.61 mm ; difference : -0.06 mm with 95 % confidence interval : -0.23 to 0.10 ; p for noninferiority = 0.0005 ) . The 9-month rate of binary restenosis and 12-month composite clinical event rates were not significantly different between groups . CONCLUSIONS In a r and omized trial of 220 patients , angioplasty with a PCB was noninferior to paclitaxel-eluting stent implantation when used to treat DES-ISR . On the basis of these , as well as previous r and omized trial data , PCB angioplasty offers an effective treatment for DES-ISR without the necessity of implanting additional metal layers for drug release . ( A Safety and Efficacy Study of Paclitaxel-Eluting Balloon to Paclitaxel-Eluting Stent [ PEPCAD ] ; NCT01622075 ) OBJECTIVES This study sought to define the impact of paclitaxel-coated balloon angioplasty for treatment of drug-eluting stent restenosis compared with uncoated balloon angioplasty alone . BACKGROUND Drug-coated balloon angioplasty is associated with favorable results for treatment of bare-metal stent restenosis . METHODS In this prospect i ve , single-blind , multicenter , r and omized trial , the authors r and omly assigned 110 patients with drug-eluting stent restenoses located in a native coronary artery to paclitaxel-coated balloon angioplasty or uncoated balloon angioplasty . Dual antiplatelet therapy was prescribed for 6 months . Angiographic follow-up was scheduled at 6 months . The primary endpoint was late lumen loss . The secondary clinical endpoint was a composite of cardiac death , myocardial infa rct ion attributed to the target vessel , or target lesion revascularization . RESULTS There was no difference in patient baseline characteristics or procedural results . Angiographic follow-up rate was 91 % . Treatment with paclitaxel-coated balloon was superior to balloon angioplasty alone with a late loss of 0.43 ± 0.61 mm versus 1.03 ± 0.77 mm ( p < 0.001 ) , respectively . Restenosis rate was significantly reduced from 58.1 % to 17.2 % ( p < 0.001 ) , and the composite clinical endpoint was significantly reduced from 50.0 % to 16.7 % ( p < 0.001 ) , respectively . CONCLUSIONS Paclitaxel-coated balloon angioplasty is superior to balloon angioplasty alone for treatment of drug-eluting stent restenosis . ( PEPCAD DES-Treatment of DES-In-Stent Restenosis With SeQuent ® Please Paclitaxel Eluting PTCA Catheter [ PEPCAD-DES ] ; NCT00998439 ) INTRODUCTION The paclitaxel-coated balloon catheter ( DCB ) based on the PACCOCATH ( ® ) technology has yielded angiographic and clinical results superior to drug-eluting stents ( DES ) in situations like in-stent restenosis ( ISR ) and a trend towards superior results in small coronary vessels and side branches of coronary bifurcations . Using the DCB followed by cobalt-chromium stent ( CoCr ) deployment or with a reverse sequence may yield different outcomes in terms of late loss . METHODS 97 patients with de-novo coronary stenosis ( 55.6 ± 10.7 years , 79.4 % male , ≥70 % , length : ≤25 mm , vessel diameter : 2.5 - 4.0 mm ) were r and omly treated with the DCB ( 3 μg/mm² ) followed by a CoCr-stent or stent first and DCB later . Six-month angiographic and one-year clinical follow-up intention-to-treat analyses were performed . RESULTS Angiographic and demographic baseline data was comparable between the two groups . When comparing balloon first versus stent first technique , the primary outcome variables were not statistically different for mean in-segment ( 0.51 ± 0.56 mm vs. 0.36 ± 0.55 mm , p = 0.23 ) and in-stent ( 0.52 ± 0.55 mm vs. 0.46 ± 0.52 mm , p = 0.65 ) late lumen loss . The lesion related 12-month MACE rates were 5/49 ( 10.2 % ) and 2/48 ( 4.2 % ) ( p = 0.44 ) . Lesion related thrombotic events occurred in three patients in balloon first and in one patient in stent first group , two of which were associated with early discontinuation of continuous dual anti-platelet therapy , two with suboptimal PCI , and one each were performed in a thrombotic lesion and a bifurcation type 1.1.0 . CONCLUSION Drug-coated balloon first followed by cobalt chromium stent deployment versus a reverse sequence is not associated with statistically significantly different 6-month angiographic or 12-month clinical outcomes Background — Treatment of in-stent restenosis with paclitaxel-coated balloon catheter as compared with plain balloon angioplasty has shown surprisingly low late lumen loss at 6 months and fewer major adverse cardiac events up to 2 years . We compared the efficacy and safety of a paclitaxel-coated balloon with a paclitaxel-eluting stent as the current st and ard of care . Methods and Results — One hundred thirty-one patients with coronary in-stent restenosis were r and omly assigned to treatment by a paclitaxel-coated balloon  ( 3 & mgr;g/mm2 ) or a paclitaxel-eluting stent . The main inclusion criteria encompassed diameter stenosis of ≥70 % and ≤22 mm in length , with a vessel diameter of 2.5 to 3.5 mm . The primary end point was angiographic in-segment late lumen loss . Quantitative coronary angiography revealed no differences in baseline parameters . At 6 months follow-up , in-segment late lumen loss was 0.38±0.61 mm in the drug-eluting stent group versus 0.17±0.42 mm ( P=0.03 ) in the drug-coated balloon group , result ing in a binary restenosis rate of 12 of 59 ( 20 % ) versus 4 of 57 ( 7 % ; P=0.06 ) . At 12 months , the rate of major adverse cardiac events were 22 % and 9 % , respectively ( P=0.08 ) . This difference was primarily due to the need for target lesion revascularization in 4 patients ( 6 % ) in the coated-balloon group , compared with 10 patients ( 15 % ) in the stent group ( P=0.15 ) . Conclusions — Treatment of coronary in-stent restenosis with the paclitaxel-coated balloon was at least as efficacious and as well tolerated as the paclitaxel-eluting stent . For the treatment of in-stent restenosis , inhibition of re-restenosis does not require a second stent implantation Background Treatment of lesions in small coronary arteries by percutaneous transluminal coronary intervention is limited by a high recurrence rate . We assessed the use of a paclitaxel-coated balloon in this indication . Methods One-hundred eighteen patients with stenoses in small coronary vessels were treated by a paclitaxel-coated balloon ( 3 μg/mm2 ) . The main inclusion criteria encompassed diameter stenosis of ≥70 % and ≤22 mm in length with a vessel diameter of 2.25–2.8 mm .  Follow-up angiography was performed at scheduled 6-month post-intervention or whenever driven by clinical or electrocardiographic signs of ischemia . The primary endpoint was angiographic in-segment late lumen loss . Results Eighty-two of 118 patients ( 70 % ) with a vessel diameter of 2.35 ± 0.19 mm were treated with the drug-coated balloon only , while 32 patients required additional stent deployment . The mean in-segment late lumen loss was 0.28 ± 0.53 mm . In patients treated with the drug-coated balloon only , the in-segment late lumen loss was 0.16 ± 0.38 mm . At 12 months , the rate of major adverse cardiac events was 15 % which was primarily due to the need for target lesion revascularization in 14 patients ( 12 % ) . In those with additional bare metal stent implantation geographical mismatch between coated-balloon dilatation and stent implantation was significantly associated with the occurrence of restenosis . Conclusion Treatment of coronary stenosis in small coronary vessels with the paclitaxel-coated balloon was well tolerated . It may offer an alternative to the implantation of a drug-eluting stent ( Clinical Trials.gov Identifier : NCT00404144 ) BACKGROUND The best way to manage restenosis in patients who have previously received a drug-eluting stent is unknown . We investigated the efficacy of paclitaxel-eluting balloons ( PEB ) , paclitaxel-eluting stents ( PES ) , and balloon angioplasty in these patients . METHODS In this r and omised , open-label trial , we enrolled patients older than 18 years with restenosis of at least 50 % after implantation of any limus-eluting stent at three centres in Germany between Aug 3 , 2009 , and Oct 27 , 2011 . Patients were r and omly assigned ( 1:1:1 ; stratified according to centre ) to receive PEB , PES , or balloon angioplasty alone by means of sealed , opaque envelopes containing a computer-generated sequence . Patients and investigators were not masked to treatment allocation , but events and angiograms were assessed by individuals who were masked . The primary endpoint was diameter stenosis at follow-up angiography at 6 - 8 months . Primary analysis was done by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00987324 . FINDINGS We enrolled 402 patients , of whom 137 ( 34 % ) were assigned to PEB , 131 ( 33 % ) to PES , and 134 ( 33 % ) to  balloon angioplasty . Follow-up angiography at 6 - 8 months was available for 338 ( 84 % ) patients . PEB was non-inferior to PES in terms of diameter stenosis ( 38·0 % [ SD 21·5 ] vs 37·4 % [ 21·8 ] ; difference 0·6 % , one-sided 95 % CI 4·9 % ; p(non-inferiority)=0·007 ; non-inferiority margin of 7 % ) . Findings were consistent in per- protocol analysis ( p(non-inferiority)=0·011 ) . PEB and PES were superior to balloon angioplasty alone ( 54·1 % [ 25·0 ] ; p(superiority)<0·0001 for both comparisons ) . Frequency of death , myocardial infa rct ion , or target lesion thrombosis did not differ between groups . INTERPRETATION By obviating the need for additional stent implantation , PEB could be a useful treatment for patients with restenosis after implantation of a drug-eluting stent . FUNDING Deutsches Herzzentrum OBJECTIVES The aim of this study was to investigate the efficacy of a paclitaxel-eluting balloon ( PEB ) for the treatment of sirolimus-eluting stent ( SES ) restenosis . BACKGROUND Because drug-eluting stents ( DES ) are being used in increasingly complicated setting s , DES restenosis is no longer an uncommon phenomenon , and its optimal treatment is unknown . METHODS This study was a prospect i ve single-blind r and omized trial conducted in 50 patients with SES restenosis . Patients were r 
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Results : In the UK , Germany , Switzerl and , South Africa , Japan and Brazil , DCB angioplasty is cost-effective when compared with drug-eluting stents to treat either BMS-ISR or DES-ISR .
Conclusions : DCB angioplasty ought to be the preferred treatment option for patients with BMS-ISR and DES-ISR from the payers ’ point of view