Background-The 1-year restenosis rate after balloon angioplasty of long lesions in below-the-knee arteries may be as high as 70%. Our aim was to investigate the efficacy of a paclitaxel drug-eluting balloons versus conventional percutaneous transluminal angioplasty (PTA) for the reduction of restenosis in diabetic patients with critical limb ischemia undergoing endovascular intervention of below-the-knee arteries. Methods and Results-The Drug-Eluting Balloon in Peripheral Intervention for Below the Knee Angioplasty Evaluation(DEBATE-BTK) is a randomized, open-label, single-center study comparing drug-eluting balloons and PTA. Inclusion criteria were diabetes mellitus, critical limb ischemia (Rutherford class 4 or higher), significant stenosis or occlusion >40 mm of at least 1 below-the-knee vessel with distal runoff, and life expectancy >1 year. Binary in-segment restenosis at a 1-year angiographic or ultrasonographic follow-up was the primary end point. Clinically driven target lesion revascularization, major amputation, and target vessel occlusion were the secondary end points. One hundred thirty-two patients with 158 infrapopliteal atherosclerotic lesions were enrolled. Mean length of the treated segments was 129±83 mm in the drugeluting balloon group compared with 131±79 mm in the PTA group (P=0.7). Binary restenosis, assessed by angiography in >90% of patients, occurred in 20 of 74 lesions (27%) in the drug-eluting balloon group compared with 55 of 74 lesions (74%) in the PTA group (P<0.001); target lesion revascularization, in 12 (18%) versus 29 (43%; P=0.002); and target vessel occlusion, in 12 (17%) versus 41 (55%; P<0.001). Only 1 major amputation occurred, in the PTA group (P=0.9). Conclusions-Drug-eluting balloons compared with PTA strikingly reduce 1-year restenosis, target lesion revascularization, and target vessel occlusion in the treatment of below-the-knee lesions in diabetic patients with critical limb ischemia. Clinical Trial Registration-URL: http://ClinicalTrials.gov. Unique identifier: NCT01558505. Received February 6, 2013; accepted June 12, 2013. From the Cardiovascular and Neurological Department (F.L., I.P., P.A., S.G., K.D., G.F., G.V., F.T., G.B., L.B.) and Diabetes Unit (L.R.), San Donato Hospital, Arezzo, Italy; and Department of Cardiovascular Diseases, University of Siena, Le Scotte Hospital, Siena, Italy (S.G.).Correspondence to Francesco Liistro, MD, Cardiovascular and Neurological Department, San Donato Hospital, Via Pietro Nenni 20, 52100, Arezzo, Italy. E-mail francescoliistro@hotmail.com We designed a prospective, randomized trial to compare the performance of a novel DEB (IN.PACT Amphirion, Medtronic, Santa Rosa, CA) with conventional PTA in diabetics with de novo, long atherosclerotic lesions of the BTK area using 1-year binary restenosis rate as the primary end point. Drug-Eluting Balloon in Peripheral Intervention for Below the Knee Angioplasty Evaluation (DEBATE-BTK) A Randomized Trial in Diabetic Patients With Critical Limb Ischemia Methods Study DesignThe Drug-Eluting...

Using DEB for treating femoropopliteal ISR led to a significant reduction in recurrent restenosis and repeat angioplasty at 1-year follow-up as compared to historical controls.

Background-Distal unprotected left main coronary artery (ULMCA) stenosis represents a technical challenge for interventional cardiologists. In this study, we compared 2-year clinical outcomes of different stenting strategies in patients with distal ULMCA stenosis treated with drug-eluting stents. Methods and Results-The survey promoted by the Italian Society of Invasive Cardiology on ULMCA stenosis was an observational study on patients with ULMCA stenosis treated with percutaneous coronary intervention. In this study, we selected patients with distal ULMCA stenosis treated with drug-eluting stents. Seven hundred seventy-three patients were eligible for this study: 456 were treated with 1 stent (group 1) and 317 with 2 stents (group 2). The primary end point of the study was the incidence of major adverse cardiac events (MACEs), defined as the occurrence of mortality, myocardial infarction, and target lesion revascularization. During a 2-year follow-up, risk-adjusted survival free from MACE was significantly higher in patients in group 1 than in patients in group 2. The propensity-adjusted hazard ratio for the risk of 2-year MACE in patients in group 1 versus group 2 was 0.53 (95% CI, 0.37 to 0.76). The propensity-adjusted hazard ratio for the risk of 2-year cardiac mortality and myocardial infarction in patients in group 1 versus group 2 was 0.38 (95% CI, 0.17 to 0.85). Conclusions-Compared with the 2-stent technique, the 1-stent technique is associated with a better 2-year MACE-free survival. The stenting strategy is a prognostic factor that should be taken into account when deciding the optimal revascularization treatment.

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Background-Failure to achieve myocardial reperfusion often occurs during percutaneous coronary intervention (PCI) in patients with myocardial infarction with ST-segment elevation. We hypothesized that manual thrombus aspiration during primary PCI would favorably influence tissue-level myocardial perfusion and left ventricular (LV) functional recovery and remodeling. Methods and Results-We prospectively randomized 111 patients with ST-segment elevation myocardial infarction to either standard or thrombus-aspiration PCI. Primary end point of the study was postprocedural incidence of ST-segment resolution Ն70%. Secondary end points included Thrombolysis in Myocardial Infarction (TIMI) myocardial perfusion grade Ն2, the combination of TIMI myocardial perfusion grade Ն2 and ST-segment resolution Ն70%, post-PCI TIMI grade 3 flow, corrected TIMI frame count, myocardial contrast echocardiography score index, the absence of persistent ST-segment deviation, and time course of wall-motion score index, LV ejection fraction, and LV volume in the 2 groups. The incidence of ST-segment resolution Ն70% was 71% and 39% in the thrombus-aspiration and standard PCI groups, respectively (odds ratio, 3.7; 95% CI, 1.7 to 8.3; Pϭ0.001). TIMI myocardial perfusion grade Ն2 was attained in 93% in the thrombus-aspiration group compared with 71% in the standard PCI group (Pϭ0.006). The percentage of patients with ST-segment resolution Ն70% and TIMI myocardial perfusion grade Ն2 was significantly greater in the thrombus-aspiration group compared with the standard PCI group (69% versus 36%, Pϭ0.0006). Myocardial contrast echocardiography score index was significantly higher in the thrombus-aspiration group compared with the standard PCI group (0.86Ϯ0.20 versus 0.65Ϯ0.31; PϽ0.0001). A significantly greater improvement in LV ejection fraction and in wall-motion score index from baseline to 6-month follow-up was observed in the thrombus-aspiration group compared with the standard PCI group (LV ejection fraction from 48Ϯ6% to 55Ϯ6% versus 48.7Ϯ7% to 49Ϯ8%, PϽ0.0001; wall-motion score index from 1.59Ϯ0.13 to 1.31Ϯ0.19 versus 1.64Ϯ0.20 to 1.51Ϯ0.26, Pϭ0.008). Twelve patients (11%) developed LV remodeling at 6 months, 2 (4%) in the thrombus-aspiration group and 10 (18%) in the standard PCI group (Pϭ0.02). Conclusions-Manual