A propensity score matched comparative study between paclitaxel-coated balloon and everolimus-eluting stents for the treatment of small coronary vessels.

OBJECTIVES: To compare the long-term clinical outcomes of paclitaxel drug-coated-balloons (DCB) and everolimus-eluting-stents (EES) following the treatment of de novo small vessel coronary artery disease. BACKGROUND: It is currently unclear whether treatment of de novo small vessel coronary disease with DCB is comparable to second generation drug-eluting stents, which are the current standard of care. METHODS: The present study enrolled 90 patients with small vessel coronary disease from the DCB treatment arm of the BELLO (Balloon Elution and Late Loss Optimization) trial and 2,000 patients treated with EES at the San Raffaele Scientific Institute. Propensity score matching was performed to adjust for differences in baseline clinical and angiographic characteristics, yielding a total of 181 patients: 90 patients with 94 lesions receiving DCB and 91 patients with 94 lesions receiving EES. Major adverse cardiac events (MACE) were defined as the composite of cardiac death, recurrent non-fatal myocardial infarction, and target vessel revascularization. RESULTS: After propensity score matching, baseline clinical and angiographic characteristics were similar between the two groups. The cumulative MACE rate at 1-year was 12.2% with DCB and 15.4% with EES (P = 0.538). Patients in the DCB group had similar TLR rates as compared to EES over the same interval (4.4% vs. 5.6%; P = 0.720). There were no cases of definite or probable stent or vessel thrombosis. CONCLUSIONS: The use of paclitaxel-DCB appears to be associated with similar clinical outcomes when compared to second-generation-EES in small coronary artery disease. The findings of this study should be confirmed with larger prospective randomized studies with longer follow-up. © 2017 Wiley Periodicals, Inc.

Stellarex drug-coated balloon: a technology evaluation.

The Stellarex® drug-coated balloon (DCB) is an over-the-wire dual lumen catheter with a distally premounted semi-compliant balloon, which has a low dose (2 µg/mm2 of the expanded balloon surface) paclitaxel coating. Its hybrid formulation, made of amorphous and crystalline paclitaxel combined with a polyethylene glycol excipient, provides maintenance of coating integrity and adequate drug release. This balanced combination of amorphous and crystalline paclitaxel is able to maintain drug on the surface during handling and balloon tracking, with an effective drug transfer to vessel wall in the lesion site. Clinical data associated with Stellarex balloon are growing and confirm clinical effectiveness over a long-term follow-up without any possible signal of a reduced safety for treated patients.

2-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease: Evidence From the SFA-Long Study.

OBJECTIVES: The aim of this study was to appraise 2-year outcomes after percutaneous transluminal angioplasty of long femoropopliteal artery disease using paclitaxel-coated balloons (PCBs). BACKGROUND: Percutaneous transluminal angioplasty with PCBs for TransAtlantic Inter-Society Consensus types C and D femoropopliteal artery disease has provided favorable results ≤12 months but no prospective studies performed longer term follow-up assessment. METHODS: Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency (i.e., freedom from the combined endpoint of clinically driven target lesion revascularization and >50% restenosis in the treated lesion as appraised by a duplex ultrasound peak systolic velocity ratio of >2.4) at 24 months. Secondary endpoints included major adverse events (the composite of death, target limb amputation, thrombosis at the target lesion, or clinically driven nontarget lesion revascularization), changes in Rutherford class, and quality of life ≤24 months post-procedure. RESULTS: A total of 105 patients (age 68 ± 9 years; 81.9% men) successfully treated with PCBs were included (treated lesion length was 251 ± 71 mm; 49.5% total occlusions). The 24-month follow-up data were available in 98 patients; they showed a primary patency rate of 70.4%, with major adverse events occurred in 10 patients (10.2%, 5 non-procedure-related deaths) and persistently significant clinical benefits in Rutherford class (51% of asymptomatic patients at 24 months). CONCLUSIONS: PCBs benefits on primary patency and target vessel revascularization satisfactorily extend over 24 months in patients undergoing percutaneous transluminal angioplasty for symptomatic femoropopliteal disease.

Comparison of paclitaxel drug-eluting balloon and paclitaxel-eluting stent in small coronary vessels in diabetic and nondiabetic patients - results from the BELLO (balloon elution and late loss optimization) trial.

OBJECTIVES: To evaluate the impact of diabetes on the efficacy of drug-eluting balloon (DEB) as compared to paclitaxel-eluting stent (PES) for the reduction of restenosis in small vessels according to the presence of diabetes in patients enrolled in the BELLO (Balloon Elution and Late Loss Optimization) trial. BACKGROUND: Small vessel disease is common in diabetic patients but currently there are no available data regarding DEB in these patients. METHODS: In the BELLO trial, 182 patients with lesions in small vessels were randomized 1:1 to receive DEB or PES. In the current sub analysis, patients were stratified according to the presence of diabetes. The diabetic group consisted of 74 patients (DEB=39, PES=35) and the nondiabetic group of 108 patients (DEB=51, PES=57). Angiographic endpoints examined were in-stent/in-balloon and in-segment late loss and binary restenosis at 6 months. Clinical endpoints were major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 1 year. RESULTS: In-stent/in-balloon late loss was significantly less with DEB as compared to PES in both diabetic (0.05±0.41 vs. 0.30±0.51mm, p=0.033) and nondiabetic patients (0.10±0.36 vs. 0.29±0.40mm, p=0.015). In patients with diabetes, angiographic restenosis and in-segment late loss were significantly lower with DEB as compared to PES (respectively, 6.3% vs. 25.0%; p=0.039 and -0.013±0.39 vs. 0.25±0.53; p=0.023), with no differences noted in nondiabetic patients. The cumulative MACE rate at 1 year was similar between DEB and PES in both the diabetic (13.2% vs. 25%, p=0.194) and nondiabetic groups (11.8% vs. 14.3%, p=0.699). CONCLUSIONS: Diabetes does not appear to have a negative impact on the efficacy of DEB in small vessels, which were associated with better angiographic outcomes at 6 months in this complex subgroup. Larger studies are needed to confirm these findings.

1-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease: Evidence From the SFA-Long Study.

OBJECTIVES: The aim of this study was to appraise 1-year outcomes after percutaneous treatment of long femoropopliteal artery disease using paclitaxel-coated balloons. BACKGROUND: Percutaneous transluminal angioplasty with paclitaxel-coated balloons for TransAtlantic Inter-Society Consensus types A and B femoropopliteal artery disease has provided favorable results. METHODS: Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long and with 4- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency at 12 months. Secondary endpoints included major adverse events (the composite of death, major target limb amputation, thrombosis at the target lesion site, or clinically driven non-target lesion target vessel revascularization), changes in Rutherford class, ankle-brachial index, and quality of life up to 24 months post-procedure. RESULTS: A total of 105 patients (mean age 68 ± 9 years, 81.9% men) treated with paclitaxel-coated balloons and provisional stenting were enrolled, and final procedural success was obtained in all. The mean treated lesion length was 251 ± 71 mm, including 63.4% moderate to severely calcified lesions and 49.5% total occlusions. The bailout stent rate was 10.9%. Follow-up after 12 months was obtained in 101 patients (96.2%), showing that primary patency was maintained in 84 (83.2%), and major adverse events had occurred in 7 (6.2%), with persistently significant clinical benefits in Rutherford class. CONCLUSIONS: Paclitaxel-coated balloons are associated with favorable functional and clinical outcomes at 1 year in patients with long femoropopliteal artery disease requiring percutaneous revascularization. (Drug Eluting Balloon [DEB] and Long Lesions of Superficial Femoral Artery [SFA] Ischemic Vascular Disease [DEB-SFA-LONG]; NCT01658540).

2-year results of paclitaxel-eluting balloons for femoropopliteal artery disease: evidence from a multicenter registry.

OBJECTIVES: This study aimed to appraise 2-year outcomes after percutaneous treatment of femoropopliteal artery disease with paclitaxel-eluting balloons. BACKGROUND: Percutaneous transluminal angioplasty with paclitaxel-eluting balloons for femoropopliteal artery disease has provided favorable 1-year results. METHODS: Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions ≤15 mm long and with 3- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter registry. Endpoints of interest included primary patency, major adverse events (the composite of death, amputation, or target lesion revascularization), changes in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life after ≥24 months. RESULTS: A total of 105 patients (114 lesions) treated with paclitaxel-eluting balloons and provisional stenting were enrolled, and final procedural success was obtained in all. Follow-up after 27 ± 3 months was obtained in 98 (93.3%) patients, showing that primary patency was maintained in 71 (72.4%), and major adverse events had occurred in 17 (17.5%), with persistently significant benefits in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life (all p < 0.001). Secondary patency rate was achieved in 89 cases (84.7%). CONCLUSIONS: PEBs are associated with favorable functional and clinical outcomes at 2 years in patients with femoropopliteal artery disease requiring percutaneous revascularization.

Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter Italian registry.

OBJECTIVES: This study evaluated the use of a paclitaxel-eluting balloon (PEB) for treatment of femoropopliteal arterial disease. BACKGROUND: Conventional balloon angioplasty and stenting in this setting is associated with high restenosis rates within 12 months. Recent data suggest that PEB use may reduce restenosis. Twelve-month outcomes following PEB use with provisional stenting are described. METHODS: This prospective registry enrolled patients (Rutherford class 2 to 4) with reference vessel diameter of 3 to 7 mm and lesion/occlusion length ≤ 15 cm. Endpoints included primary patency rate, target lesion revascularization, and changes in Rutherford class and ankle-brachial index. Walking capacity, absolute claudication distance, and quality of life were also assessed. RESULTS: The registry enrolled 105 patients. Baseline ankle-brachial index was 0.56 ± 0.15. Baseline Rutherford classification was class 2 or 3 for most patients (91.5%). Most lesions were located in the superficial femoral artery (77.1%). Mean lesion length was 76.3 ± 38.3 mm; 29.8% of lesions were total occlusions. The device was successfully used in all patients and only 12.3% of lesions required stenting. At 12-month follow-up, 92 of 105 patients (87.6%) were evaluable; the primary patency rate was 83.7%; the target lesion revascularization rate was 7.6%; 85.6% of patients were Rutherford class 0 or 1; and mean ankle-brachial index was 0.86 ± 0.15. Quality of life and absolute claudication distance showed significant improvement from baseline to 12-month follow-up. CONCLUSIONS: PEB treatment of femoropopliteal arterial disease resulted in consistent clinical improvement across multiple endpoints with a low rate of stenting and target lesion revascularization.

A new paclitaxel-eluting balloon for angioplasty of femoropopliteal obstructions: acute and midterm results.

AIMS: To evaluate safety and results of the Freepac drug-eluting balloon (DEB) technology for the treatment of chronic femoropopliteal steno-occlusions. METHODS AND RESULTS: In a multicentre registry we enrolled 66 patients with symptomatic femoropopliteal stenosis and/or occlusion <15 cm (Rutherford stages 2 to 4). Patients were treated first with an undersized uncoated balloon and then with an appropriate sized DEB. In case of unsatisfactory results, nitinol stents were implanted. Clinical evaluations and echo-duplex were performed at baseline, at discharge, and at three months after intervention. Procedural success was 100%. Stents were implanted in 10.8% of the patients. At three months follow-up, the mean ankle-brachial index (ABI) significantly improved from 0.58 ± 0.13 to 0.82 ± 0.25, thus resulting in a Rutherford class improvement (p <0.01) and amelioration of the claudication distance (102 ± 87 vs. 403 ± 160 meters) (p<0.001). No serious adverse events occurred during the follow-up. CONCLUSIONS: The results of this registry demonstrate the safety of mediated paclitaxel elution for the prevention of restenosis in the superficial femoral and popliteal arteries after angioplasty. This technique was associated with encouraging results in terms of clinical improvement as well as a lack of adverse events, including target lesion revascularisation, at three months.

Multicenter experience with a new "hybrid" carotid stent.

PURPOSE: To report the results from a prospective multicenter registry evaluating the safety and performance of a new hybrid stent specifically engineered for carotid indications. METHODS: Between October 18, 2006, and March 28, 2007, 124 patients (88 men; mean age 71.8+/-7.3 years, range 52-87) underwent Cristallo Ideale stent implantation at 4 expert sites in Italy and Germany. Eligibility criteria included >60% symptomatic and >80% asymptomatic carotid stenosis. Different cerebral protection devices were utilized (proximal protection and distal filters). The primary endpoint was the rate of 30-day major adverse neurological events, defined as major and minor stroke and neurological death by independent neurological assessment. All adverse events were adjudicated by an independent clinical event committee. RESULTS: Stent deployment was completed successfully in all the cases without documented technical failure. There were no neurological events during the procedures. Thirty-day follow-up was available for 119 (96.0%) patients [2 (1.6%) were lost to follow-up and 3 (2.4%) died from non-neurological causes unrelated to the device or procedure]. There were no major adverse neurological events within 30 days, but 2 (1.6%) device-/procedure-related transient ischemic attacks were reported (both resolved completely in <24 hours). Four (3.2%) other non-neurological events (anemia requiring transfusion, worsening of pre-existing chronic renal failure, acute access site thrombosis, and monocular vision disturbance) were reported in the study period. CONCLUSION: The Cristallo Ideale carotid stent is safe and effective in the periprocedural period. Its newly designed hybrid structure seems to support the rationale of combining adequate plaque scaffolding with high vessel adaptability.

Efficacy of a nitinol filter device in the prevention of embolic events during carotid interventions.

PURPOSE: To evaluate the feasibility, safety, and efficacy of the TRAP Vascular Filtration System (VFS) during carotid interventions as a deterrent to embolic complications. METHODS: Thirty-one consecutive patients (18 men; mean age 72 +/- 8 years) gave informed consent to undergo elective percutaneous angioplasty and stenting of the extracranial carotid artery protected by the TRAP VFS, a nitinol basket filter system. RESULTS: The TRAP VFS was delivered and retrieved safely in all patients; procedural success for carotid stenting was 100%. In 3 (9.7%) cases, the filters were positioned after lesion predilation. Nearly half (13, 41.9%) of the retrieved filters contained visible plaque debris that histology identified as cholesterol crystals, fibrin material, atheromatous plaque, and macrophage foam cells. There were no symptomatic major or minor neurological complications encountered in this cohort during hospitalization. CONCLUSIONS: Our data indicate that percutaneous dilation and stenting of the carotid artery protected by TRAP VFS appears to be feasible, safe, and effective in preventing cerebral embolization.