[Clinical risk management: a new frontier for Italian Cardiology]. / La gestione del rischio clinico: una nuova frontiera per la Cardiologia italiana.

Patient safety is the moral and ethical responsibility of healthcare professionals, representing a constantly evolving field in industrialized countries whose key factors are sustainability, training and prevention. Clinical risk management is primarily concerned with systems issues, but people are of paramount importance to effective teamwork and leadership. Hospitals have recently been urged to adopt the methods of high-fidelity organizations to identify and change ineffective practice patterns: recognizing that little things that go wrong are early warning signs of trouble, near miss and errors become information about the health of systems and learn from them. Italian Cardiology will have to assume clinical risk as a common practice, through a rigorous examination of the causes of adverse events, staff training, sharing of validated adverse event analysis tools, identification of corrective actions and definition of shared procedures, the systematic control of the adoption of the planned interventions, the evaluation of the results of the measures implemented by applying stringency and scientific method in this area. The text tries to explain, in a pragmatic way, the main problems that hinder the diffusion of the culture of safety in Italian hospitals and in cardiology by proposing solutions.

Drug-Eluting Balloon for Below the Knee Angioplasty: Five-Year Outcome of the DEBATE-BTK Randomized Clinical Trial.

BACKGROUND: The aim of this study is to evaluate the 5-year clinical outcome of the DEBATE-BTK (Drug-eluting balloon for below-the-knee angioplasty evaluation) trial. METHODS: The DEBATE-BTK was a single-center, randomized trial that enrolled 132 diabetic patients with critical limb ischemia. Subjects were randomized 1:1 to DCB or plain old balloon angioplasty (POBA). Major clinical endpoints were, freedom from all-cause death, freedom from clinically driven target lesion revascularization (CDTLR) and the occurrence of major amputation. Additional analysis were conducted to assess overall survival in patients treated with DCB compared to those treated with only POBA in the entire 5-years period and to test the correlation between paclitaxel dose exposure (in terciles) and overall survival. RESULTS: Freedom from all-cause death at 5 years was 63.1% (41/65) in DCB vs. 53.7%(35/67) POBA patients (p = 0.4). Freedom from CDTLR was 82% in DCB and 63% in POBA patients (p = 0.002) at 1 year and 63 versus 54% at 5 years respectively P = 0.07. One patient in DCB and 2 patients in POBA underwent a major amputation of the target limb. During the 5-year follow-up, 24 patients originally randomized to POBA received DCB treatment for additional limb revascularization. According to DCB treatment in all the 5 years period, overall survival was 66.3.% (30/89) in DCB versus 40%(26/43) in POBA patients, p = 0.003. CONCLUSIONS: Overall survival at 5-year was similar in DCB treated patients compared to POBA. Moreover, survival was higher in patients that received DCB angioplasty at any time of the 5 years period. LEVEL OF EVIDENCE: Level 1b, Individual inception cohort study with > 80% follow-up.

Long-term mortality in patients undergoing lower-limb revascularization with Paclitaxel eluting devices.

BACKGROUND: Paclitaxel-eluting devices (PED) reduce restenosis and target lesion revascularization (TLR) in femoropopliteal intervention. Recent data suggest a two-fold increased long-term mortality in patients treated with PED. The aim of our study is to evaluate if endovascular therapy (EVT) with PED increases mortality risk in patients with symptomatic lower limb peripheral artery disease (PAD) compared to non-eluting devices (NED). METHODS: The study is a retrospective, single-center registry on patients undergoing EVT for PAD from January 2009 to June 2018. Propensity score analysis on logistic regression model for independent predictors of long-term mortality was used to match PED and NED patients. Mortality was assessed at 2, 5 and 7 years in the entired matched population and in a sub-group of patients ≤75 years. RESULTS: During the study period, 1294 patients, 718 NED and 576 PED, met the inclusion/exclusion criteria and entered in the study. Propensity score matching analysis identified 854 matched patients, 414 PED and 440 NED. The population was mainly characterized by diabetic patients with CLI (80%) and high prevalence of CAD (30%), heart failure (15%) and renal insufficiency (20%). Mean follow-up length was 58 ± 34 months, (median 52.5). Mortality was 18% in NED vs 12% in PED patients at two years (p = 0.01), 36% vs 30% at 5 years (p = 0.03) and 41% vs 39% at seven years (p = 0.2) respectively. In patients ≤75 years, mortality at 7-year was 28% in PED vs 36% in NED, p = 0.07. CONCLUSION: These results suggest a reduced mortality at 2 and 5 years with PED as compare to NED treatment in a real-world CLI scenario. At 7-year follow-up, the advantage was numerically evident only in patients ≤75 years.

Randomized Controlled Trial of Acotec Drug-Eluting Balloon Versus Plain Balloon for Below-the-Knee Angioplasty.

OBJECTIVES: The aim of this study was to investigate the efficacy and safety of the Litos drug-coated balloon (DCB) versus plain old balloon angioplasty (POBA) for reduction of late lumen loss (LLL) in patients with critical limb ischemia undergoing below-the-knee (BTK) intervention. BACKGROUND: Restenosis after balloon angioplasty of BTK arteries approximates 70%. Previous studies of DCBs in BTK arteries produced conflicting results. METHODS: ACOART-BTK (Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos® in Below-the-Knee Arteries to Treat Critical Limb Ischemia) is a randomized controlled single-center study. Inclusion criteria were critical limb ischemia (Rutherford class ≥4) and significant stenosis or occlusion >40 mm of at least 1 BTK vessel with distal runoff successfully treated with angioplasty. Six-month angiographic LLL was the primary endpoint. Occlusive restenosis at 6 months and clinically driven target lesion revascularization at 12 months were secondary endpoints. RESULTS: From January 2016 through January 2019, 105 patients with 129 BTK lesions were enrolled in the study. Mean lesion length was 168 ± 109 mm in the DCB group and 187 ± 113 mm in the POBA group (p = 0.30). Almost 70% of lesions were occluded at baseline in both groups. On 6-month angiography, mean LLL was 0.51 ± 0.60 mm in the DCB group and 1.31 ± 0.72 mm in the POBA group (p < 0.001); rates of occlusive restenosis were 8.6% and 48.4%, respectively (p < 0.001). Twelve-month clinically driven target lesion revascularization occurred in 6 of 62 DCB-treated lesions (10%) versus 27 of 66 POBA-treated lesions (41%) (p < 0.001). Complete healing at 12 months was observed in 42 of 47 DCB-treated limbs (89.4) versus 35 of 47 POBA-treated limbs (74.5%) (p = 0.05); no major amputations occurred. CONCLUSIONS: Litos DCBs strikingly reduced LLL, vessel reocclusion, and clinically driven target lesion revascularization compared with POBA in BTK angioplasty.

[Delirium in cardiology: an old problem, a new emergency]. / Il delirium in cardiologia: un vecchio problema, una nuova emergenza.

Delirium is a common cognitive behavioral disorder, with acute onset, frequent in elderly hospitalized patients. This condition has long been the subject of research in the critical area, with the development of targeted prevention and management protocols. In the cardiology field, however, awareness of delirium is poor. The problem of delirium has recently begun to involve practitioners since the publication of first studies showing the increase of adverse events in patients with this condition. The pathophysiology of delirium is unclear and the risk factors are based on clinical conditions and factors related to patient's care itself that need to be readily identified. Thus, delirium is a clinical manifestation that can easily be confused with other conditions. Notwithstanding, delirium can be prevented and treated when clinically evident, with a number of non-pharmacological interventions based on a multidisciplinary approach. Pharmacological therapy, due to its unclear effectiveness, should be reserved to patients with severe agitation or at risk of injuring themselves and others. The purpose of this review is to increase the awareness in healthcare professionals about the recent data on etiology, prevention, treatment and prognosis of delirium and to put the basis for a protocol that could be used in Cardiology departments.

Ticagrelor versus clopidogrel in patients undergoing implantation of paclitaxel-eluting stent in the femoropopliteal district: A randomized pilot study using frequency-domain optical coherence tomography.

OBJECTIVES: Aim of this study was to evaluate different response in platelet reactivity and vessel healing using high-resolution frequency-domain optical coherence tomography (FD-OCT) in patients with femoropopliteal artery disease treated with ZILVER PTX drug eluting stents (DES), and randomly assigned to clopidogrel or ticagrelor for 12 months. BACKGROUND: The optimal antithrombotic regimen for long-term management of patients with peripheral artery disease (PAD) after revascularization is poorly defined and often extrapolated from trials performed on patients undergoing percutaneous coronary intervention. METHODS: In this single center randomized trial 40 patients with femoropopliteal artery disease treated with ZILVER PTX DES stents, were randomized to Ticagrelor (T) + Aspirin for 3 months, subsequently continuing Ticagrelor alone for another 9 months or Clopidogrel (C) + Aspirin for 3 months, subsequently continuing Clopidogrel alone for 9 months. Platelet reactivity via the P2Y12 pathway was evaluated at baseline and at 3 months follow-up, angiographic and FD-OCT follow-up along the entire stented segment was performed at 12 months. RESULTS: No significant difference between T and C group was found concerning net percentage volume obstruction (29.7% ± 17.6% vs. 31.2% ± 10.7%; p = 0.78). FD-OCT at 12 months showed a high percentage of uncovered stent struts in both groups: 24.2% ± 32.8% in the T group vs 15.3% ± 15.8% in the C group (p = 0.4). Mean values of platelet reactivity units (PRU) at 3 month follow-up were 81 ± 72 in the T group and 200 ± 61 in the C group (p < 0.001). CONCLUSIONS: Significantly higher platelet reactivity remains in patients treated with clopidogrel as compared to ticagrelor 3 months after PTA and stent implantation. Ticagrelor does not reduce neointimal proliferation in patients treated with DES in the femoropopliteal district as compared with clopidogrel. A large amount of uncovered stent struts at 12-month follow-up was found in these patients regardless of the antiplatelet treatment assumed.

Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions: The DRASTICO Study.

BACKGROUND: Drug-eluting technologies improve 12-month angiographic results of femoropopliteal (FP) interventions, but few data on the comparison between drug-coated balloons (DCBs) and drug-eluting stents (DES) are available. OBJECTIVES: The aim of this study was to compare, after balloon pre-dilation, a strategy of DCB followed by provisional self-expanding nitinol bare-metal stent implantation with a strategy of systematic DES implantation in patients at high risk for FP restenosis. METHODS: Patients presenting with either intermittent claudication or critical limb ischemia undergoing FP intervention were randomly assigned 1:1 to DCB or DES after successful target lesion pre-dilation. The primary endpoint was 12-month target lesion binary restenosis, assessed using Doppler ultrasound. Secondary endpoints were freedom from target lesion revascularization and from major amputation. RESULTS: A total of 192 patients, 96 in the DCB group and 96 in the DES group, with 240 lesions in 225 limbs, were included. Diabetes and critical limb ischemia were present in >50% in both groups. Mean lesion length was 14 cm, and baseline target lesion occlusion reached about 60% of cases in both groups. The systematic DES strategy yielded larger post-procedural minimal luminal diameter and a lower incidence of residual dissection compared to DCB, in which nitinol stents were used in only 21% of the lesions. Twelve-month target lesion restenosis was observed in 22% of DCB-treated versus 21% of DES-treated patients (p = 0.90). Clinically driven target lesion revascularization was necessary in 14% of DCB patients versus 17% of DES patients (p = 0.50). CONCLUSIONS: DCB was not superior to DES in the treatment of complex FP lesions in a high-risk population, yielding similar rate of restenosis and clinically driven target lesion revascularization. (Paclitaxel-Eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-Eluting Stent for the Treatment of Femoropopliteal De Novo Lesions; NCT01969630).

[The dawn era in the management of acute ischemic stroke and its health policy implications. Should interventional cardiologists be involved?] / La nuova era nel trattamento dell'ictus e le sue implicazioni socio-sanitarie. I cardiologi interventisti dovrebbero essere coinvolti?

Similarly to what happened for myocardial infarction treatment during the two previous decades, ischemic stroke therapy has radically changed in recent years after the encouraging clinical results on the use of mechanical revascularization systems. The ever-increasing use of thrombectomy, which is now the first-choice approach for achieving rapid reperfusion of the ischemic brain, inaugurates a new era in the treatment of ischemic stroke, with important social and healthcare implications and the need for effective integrated stroke networks on a regional basis.Given the high annual rates of stroke and that approximately 35% of strokes are caused by the thrombotic occlusion of a large cerebral vessel, with a treatment window reaching up to 24 h after onset in selected cases, the resources of interventional neuroradiology are not enough to meet treatment needs in terms of performing centers and number of operators. The possibility of using centers already active for the treatment of acute myocardial infarction has therefore been taken into consideration. This article presents objective data to support the validity of this strategy and discusses how to create treatment networks using the interventional skills of cardiologists with the implementation of multidisciplinary functional structures.

Long-term prognostic value of delirium in elderly patients with acute cardiac diseases admitted to two cardiac intensive care units: a prospective study (DELIRIUM CORDIS).

BACKGROUND: Delirium is a frequent in-hospital complication in elderly patients, and is associated with poor clinical outcome. Its clinical impact, however, has not yet been fully addressed in the setting of the cardiac intensive care unit (CICU). The present study is a prospective, two-centre registry aimed at assessing the incidence, prevalence and significance of delirium in elderly patients with acute cardiac diseases. METHODS: Between January 2014 and March 2015, all consecutive patients aged 65 years or older admitted to the CICU of our institutions were enrolled and followed for 6 months. Delirium was defined according to the confusion assessment method. RESULTS: During the study period, 726 patients were screened for delirium. The mean age was 79.1±7.8 years. A total of 111 individuals (15.3%) were diagnosed with delirium; of them, 46 (41.4%) showed prevalent delirium (PD), while 65 (58.6%) developed incident delirium (ID). Patients 85 years or older showed a delirium rate of 52.3%. Hospital stay was longer in delirious versus non-delirious patients. Patients with delirium showed higher in-hospital, 30-day and 6-month mortality compared to non-delirious patients, irrespective of the onset time (overall, ID or PD). Six-month re-hospitalisation was significantly higher in overall delirium and the PD group, as compared to non-delirious patients. Kaplan-Meier analysis showed a significant reduction of 6-month survival in patients with delirium compared to those without, irrespective of delirium onset time (i.e. ID or PD). A positive confusion assessment method was an independent predictor of short and long-term mortality. CONCLUSIONS: Delirium is a common complication in elderly CICU patients, and is associated with a longer and more complicated hospital stay and increased short and long-term mortality. Our findings suggest the usefulness of a protocol for the early identification of delirium in the CICU. Clinicaltrials.gov: NCT02004665.

Invasive strategy in non-ST-segment elevation acute coronary syndrome: What should be the benchmark target in the real world patients? Insights from BLITZ-4 Quality Campaign.

AIMS: To define a benchmark target for an invasive strategy (IS) rate appropriate for performance assessment in intermediate-to-high risk non-ST-segment elevation acute coronary syndromes (NSTE-ACS). METHODS AND RESULTS: During the BLITZ-4 campaign, which aimed at improving the quality of care in 163 Italian coronary care units, 4923/5786 (85.1%) of consecutive patients admitted with NSTE-ACS with troponin elevation and/or dynamic ST-T changes on the electrocardiogram were managed with IS. The reasons driving the choice (RDC) for a conservative strategy (CS) in the remaining 863 patients were prospectively recorded. In 33.8%, CS was mandatory because of patients refusal, known coronary anatomy or death before coronary angiography; in 52.8% it was clinically justified because of active stroke, bleeding, advanced frailty, severe comorbidities, contraindication to antiplatelet therapy or because they were considered to be at low risk; only in 13.4% the reasons, such as renal failure, advanced age or other, were less stringent. As compared to patients undergoing IS, those in the CS were 12years older and had significantly more severe comorbidities. The in-hospital and 6-month all-cause mortality were 9.0% vs 0.9% and 22.0% vs 3.9% in CS and IS groups respectively (p<0.0001 for both). CONCLUSION: As the RDC for CS were clinically correct in vast majority of cases the observed 85% invasive strategy rate may be considered as the desirable benchmark target in patients with NSTE-ACS. For the same reason, it remains questionable if the higher rate of IS could have improved the prognosis in CS patients, despite their highly unfavorable prognosis.

Paclitaxel-Eluting Balloon vs Standard Angioplasty to Reduce Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: Three-Year Results of the DEBATE-ISR Study.

PURPOSE: To report the 3-year safety and effectiveness outcomes from the prospective all-comers DEBATE-ISR study (ClinicalTrials.gov identifier NCT01558531) of symptomatic diabetic patients with femoropopliteal in-stent restenosis (ISR) undergoing treatment with paclitaxel-eluting balloons compared with historical diabetic controls. METHODS: From January 2010 to December 2011, 44 consecutive diabetic patients (mean age 74±11 years; 32 men) were treated with drug-eluting balloons (DEBs) and enrolled in the study. The control group comprised 42 consecutive diabetic patients (age 76±7 years; 23 men) treated with conventional balloon angioplasty (BA) from 2008 to 2009. RESULTS: No significant differences in terms of clinical, angiographic, or procedural characteristics were observed between the study groups. Critical limb ischemia was present in the majority of patients. Tosaka class III ISR was observed in more than half of the patients. Mean lesion length was 132±86 and 137±82 mm in the DEB and BA groups, respectively (p=0.7). At 3-year follow-up, the rate of target lesion revascularization (TLR) was 40% in the DEB group vs 43% in the BA group (p=0.8); Kaplan-Meier analysis showed no significant differences in terms of freedom from TLR. The presence of a Tosaka class III occlusion was associated with a worse outcome in both study groups (odds ratio 3.96, 95% confidence interval 1.55 to 10.1, p=0.004). CONCLUSION: Using DEBs for femoropopliteal ISR yielded similar results to BA in terms of TLR at 3-year follow-up. The treatment of more complex ISR lesions was associated with an increased rate of TLR, irrespective of the technology used.

Paclitaxel-eluting balloon vs. standard angioplasty to reduce recurrent restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: the DEBATE-ISR study.

PURPOSE: To test the ability of a drug-eluting balloon (DEB) to reduce recurrent in-stent restenosis (ISR) in diabetic patients with femoropopliteal stents. METHODS: A prospective all-comers study [Drug-Eluting Balloon in Peripheral Intervention for In-Stent Restenosis (DEBATE-ISR); ClinicalTrials.gov identifier NCT01558531] of symptomatic diabetic patients with femoropopliteal ISR undergoing treatment with paclitaxel-eluting balloons was designed to compare their 12-month recurrent restenosis rate with that of historical diabetic controls. From January 2010 to December 2011, 44 consecutive diabetic patients (32 men; mean age 74±11 years) were treated with DEBs and enrolled in the study. The control group comprised 42 diabetic patients (23 men; mean age 76±7 years) treated with a conventional balloon for femoropopliteal ISR from 2008 to 2009. RESULTS: No significant differences in terms of clinical, angiographic, or procedural characteristics were observed between the study groups. Lesion length was 132±86 mm in the DEB group vs. 137±82 mm in the BA group. Procedural success, defined as a residual stenosis <30% in the restenotic segment (stent +5 mm at proximal and distal edges), was obtained in all treated lesions. At 1-year follow-up, 6 patients died (3 in each group), and 1 patient in the BA group underwent major amputation. Recurrent restenosis, assessed by angiography (66%) or ultrasound (34%), occurred in 8/41 (19.5%) patients in the DEB group vs. 28/39 (71.8%) in the BA group (p<0.001). Target lesion revascularization for symptomatic recurrent restenosis was performed in 6/44 (13.6%) patients in the DEB vs.13/42 (31.0%) in the BA group (p=0.045). CONCLUSION: 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.

Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery).

OBJECTIVES: This study sought to compare paclitaxel-eluting balloon (PEB) with conventional percutaneous transluminal angioplasty (PTA), followed by systematic implantation of a self-expanding nitinol bare-metal stent (BMS) in patients at risk for restenosis. BACKGROUND: PTA is an effective strategy for treating atherosclerosis of the femoropopliteal axis (FPA). Whereas PEB have shown advantage over uncoated balloons in the treatment of simple lesions, it is unknown whether these results are applicable to complex degrees of FPA atheroma. METHODS: A total of 104 patients (110 FPA lesions in 110 limbs) were randomly assigned to either PEB + BMS or PTA + BMS. The primary endpoint was 12-month binary restenosis. Secondary endpoints were freedom from target lesion revascularization and major amputation. Post hoc subanalyses were performed for the comparison of long (≥100 mm) versus short lesions and true lumen versus subintimal approach. RESULTS: Mean lesion length was 94 ± 60 versus 96 ± 69 mm in the PEB + BMS and PTA + BMS groups (p = 0.8), respectively. The primary endpoint occurred in 9 (17%) versus 26 (47.3%) of lesions in the PEB + BMS and PTA + BMS groups (p = 0.008), respectively. A near-significant (p = 0.07) 1-year freedom from target lesion revascularization advantage was observed in the PEB + BMS group. No major amputation occurred. No significant difference was observed according to lesion characteristics or technical approach. CONCLUSIONS: Pre-dilation with PEB angioplasty prior to BMS implantation, as compared to PTA + BMS in complex FPA lesions, reduces restenosis and target lesion revascularization at 12-month follow-up. Restenosis reduction is maintained irrespective of lesion length and recanalization technique. (Drug Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery [DEBATE-SFA]; NCT01556542).

Elutax paclitaxel-eluting balloon followed by bare-metal stent compared with Xience V drug-eluting stent in the treatment of de novo coronary stenosis: a randomized trial.

BACKGROUND: Paclitaxel-eluting balloons (PEBs) are a promising alternative to drug-eluting stent (DES) in the treatment of coronary stenoses. The aim of our study was to compare the 9-month restenosis rates of a strategy of predilatation with PEB followed by bare-metal CoCr stent (PEB + BMS group) versus implantation of everolimus DES (DES group). METHODS: This randomized, single-center study planned to enroll 366 patients with stable angina (183 patients per arm) undergoing percutaneous coronary intervention of a de novo, native coronary artery stenosis ≤ 15 mm in length. Primary end point, in a noninferiority study design, was 9-month binary angiographic restenosis. A frequency-domain optical coherence tomography substudy investigated the percentage of uncovered stent struts per lesion, the percentage of malapposed/uncovered struts per lesion, and the percentage of net volume obstruction at 9-month follow-up among the first consecutive 30 patients enrolled in the PEB + BMS group. RESULTS: The study was prematurely halted after enrollment of 125 patients, 59 in the PEB + BMS group and 66 in the DES group, because of excess of ischemia-driven target lesion revascularization in the PEB + BMS group. When all the enrolled patients completed their follow-up, IDLTR rates were 14% in the PEB + BMS versus 2% in DES group (P = .001). Binary restenosis, either in-stent or in-segment, was significantly higher in the PEB + BMS compared with DES group (17% vs 3% [P = .01] and 25% vs 4% [P = .009] respectively). Frequency-domain optical coherence tomography demonstrated important neointimal regrowth in the PEB + BMS group, similar to historical BMS data. CONCLUSION: In the treatment of de novo coronary stenosis, a strategy of predilatation with PEB before BMS implantation was significantly inferior to implantation of an everolimus DES stent in terms of 9-month target lesion revascularization. Frequency-domain optical coherence tomography data confirm the lack of efficacy of this strategy.

Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia.

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 drug-eluting 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.