Heparin versus bivalirudin for carotid artery stenting using proximal endovascular clamping for neuroprotection: results from a prospective randomized study.

BACKGROUND: General recommendations indicate that, during a carotid artery stenting (CAS), sufficient unfractionated heparin (UFH) has to be given to maintain the activated clotting time between 250 to 300 seconds. Bivalirudin use is able to reduce postprocedural bleedings in percutaneous interventions when compared with UFH. The study purpose was to evaluate, in a randomized study, the safety and efficacy of bivalirudin versus heparin during CAS, using proximal endovascular occlusion (PEO) as a distal protection device. METHODS: From January 2006 to December 2009, 220 patients undergoing CAS using PEO have been randomly assigned to one of the study arms (control arm: 100 UI/kg UFH or bivalirudin arm: 0.75 mg/kg intravenous bolus and intraprocedural infusion at 1.75 mg/kg/h). RESULTS: Procedural success was achieved in all the patients. No episodes of intraprocedural thrombosis occurred. One major stroke occurred in the bivalirudin arm, and two minor strokes occurred, one in each group. A significant difference in the incidence of postprocedural bleedings was observed between the study groups; bivalirudin use was associated with reduced number of bleedings according to Thrombolysis In Myocardial Infarction criteria. CONCLUSIONS: The use of bivalirudin should be considered a safe and effective anticoagulation regimen during CAS, using PEO as a distal protection device. Bivalirudin use is associated with a reduced incidence of bleedings.

Carotid artery stenting in octogenarians using a proximal endovascular occlusion cerebral protection device: a multicenter registry.

BACKGROUND: Carotid stenting (CAS) has been proposed as an alternative to carotid endoarterectomy also in elderly patients with discrepant results. However, the use of proximal neuroprotection devices have not been evaluated in octogenarians. PURPOSE: The aim of this multicenter prospective registry was to demonstrate that CAS in octogenarians is safe and effective if performed in high-volume centers by experienced operators. METHODS: From July 2005 to May 2009, a total of 198 octogenarians patients, in three different institutions, were included in this registry. All patients underwent CAS using proximal endovascular occlusion device (Mo.Ma. device Invatec, Roncadelle, Italy). An independent neurologist evaluated all patients. The primary endpoint was death and stroke rate at 30 days. RESULTS: 198 octogenarians (135 men; mean age: 83.2 years) were included in the registry. 39.4% of the patients were symptomatic. Procedural success was 100%. In-hospital complications: Two minor and two major strokes (2.02%) occurred. No device-related complications and no serious access site complication were noted. Between discharge and 30-day follow-up, one patient died due to a cardiac arrest. The overall 30-day combined stroke/death rate was 2.52%, resulting in 1.61% event incidence in asymptomatic and 3.9% in symptomatic patients (P = ns). Logistic regression did not identify independent predictor of neurological events, except in the female gender. CONCLUSION: This multicenter prospective registry shows that CAS performed with proximal flow blockage is safe and feasible also in octogenarians. Thirty days death/stroke rates are similar to those of the overall population and within the International guidelines.

Renal artery stenting in patients with chronic ischemic heart disease.

OBJECTIVES: To investigate the role of renal stenting in selected patients with chronic ischemic heart disease and renal artery stenosis. METHODS: Consecutive patients, with chronic ischemic heart disease and severe hypertension and/or impaired renal function undergoing renal stenting, were prospectively enrolled. Mid-term (at least 2 years) follow-up was performed to assess both changes in renal function [serum creatinine and estimated glomerular filtrate rate (eGFR)] and blood pressure (BP) control (number of required drugs) and to record the incidence of clinical major adverse events. Moreover, in the first consecutive 24 patients, out-of-range pressure values at 24-hr BP monitoring and GFR at renal scintigraphy were measured at baseline and 1 month after stenting. RESULTS: Seventy patients treated by stenting on 86 renal arteries entered the study. Procedural success rate was 99% and no major complication occurred. At 2-year follow-up, both mean serum creatinine (-0.1 +/- 0.7 mg/dl at follow-up compared to baseline, P = 0.6) and eGFR (+3.7 +/- 23.5 ml/min/1.73m(2) at follow-up compared to baseline, P = 0.2) did not significantly change while the number of drugs required to control BP significantly decreased (2.7 +/- 0.8 to 2.2 +/- 0.7, P < 0.0001). In the subset of 24 patients evaluated at 1 month, GFR significantly increased (62 +/- 20 ml/min to 67 +/- 21 ml/min; P = 0.008) and the rate of the out-of-range systolic pressure values at 24-hr monitoring significantly decreased (51-33%, P = 0.005). Elevated baseline creatinine values and the presence of global renal ischemia were identified as predictors of poor outcome at the multivariate analysis. CONCLUSIONS: In selected patients with chronic ischemic heart disease and hypertension and/or renal insufficiency, renal stenting may be performed with very low periprocedural complications and results in unchanged renal function and improved BP control.

Classification for carotid artery stenting complications: manifestation, management, and prevention.

Carotid artery stenting is a rapidly evolving method for treating carotid artery disease. Various intraprocedural and postprocedural complications have been reported in the literature. However, the absence of a unified classification scheme for these complications makes it difficult, if not impossible, to study their precise incidence, predictors, and management. The aim of this article is to propose the first joint classification of periprocedural complications, to analyze their incidence and etiology, and suggest possible ways to manage and prevent them. This classification is intended to be used as a common platform for prompt recognition, evaluation, treatment, and universal study of the complications during carotid stenting procedures. For this purpose, the opinions of the major experts on carotid interventions worldwide were merged with all the available information reported in the English-language literature to present as accurately as possible the management and prevention of carotid stenting complications according to this proposed classification.

Retrograde approach for complex popliteal and tibioperoneal occlusions.

PURPOSE: To describe the technical aspects of the retrograde approach for endovascular treatment of complex popliteal and/or tibioperoneal occlusions and determine its efficacy in minimizing failure rates. METHODS: An observational registry of retrograde revascularizations was maintained at our institution over 14 months (September 2006 to December 2007). During this time frame, antegrade revascularization failed in 62 (17.8%) of 343 limbs with complex total occlusions of the popliteal and/or infrapopliteal vascular territory. Of these antegrade failures, 51 (82.2%) limbs in 51 patients (32 men; mean age 72+/-8 years) were suitable for a retrograde attempt. From this subgroup, 45 (88.2%) were treated via a percutaneous transpedal access site and 6 (11.8%) via a transcollateral intra-arterial technique. RESULTS: The overall success rate was 86.3% (44/51); adjunctive stenting was needed in 21 (41.1%) to optimize results. Only 1 (1.9%) major complication (a pedal access site occlusion) and 4 (7.8%) minor sequelae (arterial perforation in 3 and a pedal hematoma without consequence) were documented. CONCLUSION: In complex popliteal to infrapopliteal occlusions, an antegrade recanalization attempt can fail in up to 20% of the cases. The additional use of a retrograde approach seems feasible and safe and can favorably modify this failure rate. This technique could be valuable for patients with critical limb ischemia due to popliteal and infrapopliteal occlusions once larger studies with follow-up confirm safety, efficacy, and clinical benefit.

Prevalence and clinical impact of stent fractures after femoropopliteal stenting.

OBJECTIVES: The aim of this study was to investigate the occurrence and the clinical impact of stent fractures after femoropopliteal stenting. BACKGROUND: The development of femoral stent fractures has recently been described; however, there are no data about the frequency and the clinical relevance. METHODS: A systematic X-ray screening for stent fractures was performed in 93 patients. In total, 121 legs treated by implantation of self-expanding nitinol stents were investigated after a mean follow-up time of 10.7 months. The mean length of the stented segment was 15.7 cm. RESULTS: Overall, stent fractures were detected in 45 of 121 treated legs (37.2%). In a stent-based analysis, 64 of 261 stents (24.5%) showed fractures, which were classified as minor (single strut fracture) in 31 cases (48.4%), moderate (fracture of >1 strut) in 17 cases (26.6%), and severe (complete separation of stent segments) in 16 cases (25.0%). Fracture rates were 13.2% for stented length < or =8 cm, 42.4% for stented length >8 to 16 cm, and 52.0% for stented length >16 cm. In 21 cases (32.8%) there was a restenosis of >50% diameter reduction at the site of stent fracture. In 22 cases (34.4%) with stent fracture there was a total stent reocclusion. According to Kaplan-Meier estimates, the primary patency rate at 12 months was significantly lower for patients with stent fractures (41.1% vs. 84.3%, p < 0.0001). CONCLUSIONS: There is a considerable risk of stent fractures after long segment femoral artery stenting, which is associated with a higher in-stent restenosis and reocclusion rate.

Effect of two different neuroprotection systems on microembolization during carotid artery stenting.

OBJECTIVES: This study sought to compare the efficacy of two different cerebral protection systems for the prevention of embolization during carotid artery stenting (CAS) using a transcranial Doppler (TCD) monitoring with the detection of microembolic signals (MES). BACKGROUND: Despite the introduction of cerebral protection systems, neurologic complications during CAS cannot completely be prevented. Transcranial Doppler and detection of MES may aid in assessing the efficacy of different neuroprotection systems. METHODS: A total of 42 patients with internal carotid artery stenoses were treated by CAS using either a filter (E.P.I. FilterWire, Boston Scientific Corp., Santa Clara, California) (n = 21) or a proximal endovascular clamping device (MO.MA system, Invatec s.r.l., Roncadelle, Italy) (n = 21). Microembolic signal counts were compared during five phases: placement of the protection device, passage of the stenosis, stent deployment, balloon dilation, and retrieval of the protection device. RESULTS: There were no significant differences in clinical or angiographic outcomes between the two groups. Compared to the filter device, the MO.MA system significantly reduced MES counts during the procedural phases of wire passage of the stenosis, stent deployment, balloon dilation, and in total (MES counts for the filter device were 25 +/- 22, 73 +/- 49, 70 +/- 31, and 196 +/- 84 during the three phases and in total, MES counts for the MO.MA system were 1.8 +/- 3.2, 11 +/- 19, 12 +/- 21, and 57 +/- 41, respectively; p < 0.0001). CONCLUSIONS: In comparison to a filter device the MO.MA system led to significantly lower MES counts during CAS. The detection of MES by TCD may facilitate the evaluation and comparison of different neuroprotection systems.

[Carotid artery stenting with different cerebral protection systems]. / Stentowanie tetnic szyjnych z uzyciem róznych systemów protekcji mózgu.

Carotid angioplasty with stent implantation (CAS) has become an alternative for carotid endarterectomy in treatment of carotid arteries atherosclerosis due to low procedural injury and comparable procedural risk. Wide application of cerebral protection devices decreased the procedural risk. The aim of the study was to estimate the procedural safety of CAS procedures with application of different cerebral protection systems. CAS procedures were performed in 48 patients. One procedure was unsuccessful, in this patient stroke occurred. Distal occlusion balloon system was used in 5 patients, proximal occlusion balloons for common carotid artery was used in 21 pts and filter systems in 22 pts. During 6-months follow-up, we observed no death nor stroke (40 pts). In one patient we revealed TIA. Moreover we found restenosis in one patient 6 months after CAS (total occlusion). In our experience CAS procedures were safe and incidence of major cerebro-vascular complications comparable to other centers.

Evaluation of the biodegradable peripheral Igaki-Tamai stent in the treatment of de novo lesions in the superficial femoral artery: the GAIA study.

OBJECTIVES: This study sought to evaluate the safety and performance of the Igaki-Tamai (Igaki Medical Planning Company, Kyoto, Japan) biodegradable stent in patients with occlusive superficial femoral artery (SFA) disease. BACKGROUND: Poly-L-lactic acid (PLLA) biodegradable stents have been shown to be effective in the coronaries, but no data are available regarding their efficacy in the femoral artery. METHODS: A prospective, multicenter, nonrandomized study enrolled 30 patients with symptomatic de novo SFA disease undergoing implantation of Igaki-Tamai bioresorbable stents. Clinical examinations and duplex ultrasound were prospectively performed after 1, 6, 9, and 12 months. The main study endpoints were technical success, restenosis rate, rate of target lesion revascularization (TLR), changes in ankle-brachial index (ABI), and quality of life by evaluating the walking impairment questionnaire (WIQ). Safety was assessed by monitoring the occurrence of major adverse clinical events and serious adverse events. RESULTS: The mean age of the patients was 67.7 years, and 77% were male. The mean lesion length was 5.9 cm. Mean diameter stenosis was reduced from 89.9% to 6.2%, after stent implantation. Technical success was 96.7%. Binary restenosis rate for the 6 and 12 months follow-up was 39.3% and 67.9%, respectively. The TLR rate was 25.0% after 6 months and 57.1% after 12 months. All TLR were successful; the secondary patency rate after 1 year was 89.3%. Between baseline and 12 months, ABI increased in 53.6% of patients. Functional endpoints (WIQ), even if affected by a relatively high reintervention rate, showed improvement in most of the patients. CONCLUSIONS: The GAIA (Evaluation of the Biodegradable Peripheral Igaki-Tamai Stent in the Treatment of De Novo Lesions in the Superficial Femoral Artery) study shows that when using biodegradable PLLA stents (Igaki-Tamai), the immediate angiographic results are comparable to the results of metal stents, achieving a high secondary patency rate after 1 year. Modifications of stent characteristics and technical modifications are needed with the goal to reduce the restenosis rate during the reabsorption period.

Drug-eluting balloons for the treatment of the superficial femoral artery in-stent restenosis: 2-year follow-up.

OBJECTIVES: The aim of this prospective registry was to evaluate the safety and efficacy at 2-year follow-up of the use of drug-eluting balloons (DEBs) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR). BACKGROUND: The use of DEBs for the treatment of SFA ISR is associated with a satisfactory primary patency rate at 1 year, but no data are available for longer follow-up. Unfortunately, when DEBs were used to treat SFA de novo lesions, the occurrence of restenosis increased by 50% between the first and the second years of follow-up. METHODS: From December 2009 to December 2010, 39 consecutive patients underwent percutaneous transluminal angioplasty of SFA ISR at our institution (Clinica Montevergine, Mercogliano, Italy). All patients underwent conventional SFA percutaneous transluminal angioplasty and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic Inc., Minneapolis, Minnesota). Patients were evaluated for up to 24 months. RESULTS: During follow-up, 1 patient died of heart failure and another of sudden death, for a 2-years rate of cardiovascular mortality rate of 5.12 %. The primary patency rate at 2 years was 70.3% (11 of 37 patients experienced restenosis recurrence at 2-year follow-up). The treatment of complex ISR lesions (classes II and III) was associated with an increased rate of recurrent restenosis compared with class I (33.3 % and 36.3 % vs. 12.5%; p = 0.05). CONCLUSIONS: The data suggest that adjunctive use of DEBs for the treatment of SFA ISR is a safe and effective therapeutic strategy up to 2 years of follow-up.

Predictors of carotid occlusion intolerance during proximal protected carotid artery stenting.

OBJECTIVES: The aim of this study was to identify predictors of occlusion intolerance (OI) developing during proximal protected carotid artery stenting (CAS). BACKGROUND: The use of proximal embolic protection devices, such as endovascular occlusion, during CAS has been demonstrated to be particularly safe and effective. However, endovascular occlusion can expose the ipsilateral hemisphere to hypoperfusion and produce transient neurological symptoms (OI). METHODS: From March 2010 to March 2012, 605 consecutive patients underwent proximal protected CAS at our institution. To identify independent predictors of OI, a multivariate logistic regression model was developed that included all patients' clinical/angiographic and procedural characteristics. RESULTS: OI developed in a total of 184 patients (30.4%). Compared with patients in whom OI did not develop, those who experienced OI had lower occlusion pressure (OP) (42.3 ± 12.7 mm Hg vs. 61.9 ± 15.4 mm Hg, p < 0.001). Receiver-operating characteristic curve analysis demonstrated that OP was the most consistent predictor of OI with a C-statistic of 0.85 (95% confidence interval [CI]: 0.82 to 0.88) with best cutoff being ≤40 mm Hg (sensitivity, 68.5%; specificity, 93.3%). By logistic regression analysis, the most powerful independent predictor of OI developing was an OP ≤40 mm Hg (odds ratio: 33.2, 95% CI: 19.1 to 57.7) and the most powerful clinical predictor of such OP was the presence of contralateral internal carotid artery occlusion (odds ratio: 3.1, 95% CI: 1.5 to 6.2). CONCLUSIONS: OI may occur in as many as one-third of the patients undergoing proximal protected CAS. This event is more common in those patients with an OP ≤40 mm Hg. Patients presenting with concomitant occlusion of the contralateral internal carotid artery more frequently have an OP ≤40 mm Hg.

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.

[SICI-GISE position paper on the requirements for diagnostic and interventional procedures in patients with peripheral arterial disease]. / Documento di posizione SICI-GISE sui requisiti di processo diagnostico ed interventistico riferiti a pazienti affetti da patologia vascolare periferica.

Interventional procedures on peripheral vessels are the field of a novel specialty dedicated to the diagnosis and minimally invasive endovascular treatment of diseases involving the cerebral, thoracic and abdominal arteries (including renal and visceral arteries), as well as the peripheral arteries (femoro-popliteal arteries and the arteries below the knee). At present, physicians with three different types of medical training, each involving particular strengths and characteristics, specialize in endovascular treatment of patients with peripheral arterial disease: vascular surgeons, interventional radiologists and interventional cardiologists. Treatment of high-risk patients in terms of anatomical and clinical (serious comorbidities) complexity raised the need for the interventional cardiologist to face issues related to technical aspects of the procedure, multilevel pathology management and adequate indication. To achieve this goal, interventional cardiologists require particular facilities and clinical skills. The objectives of this position paper from the Italian Society of Interventional Cardiology (SICI-GISE) are (i) to define the theoretical background and practical training required to ensure that interventional cardiologists maintain high-quality standards also in the field of treatment of peripheral arterial disease, by establishing shared rules and drafting papers; (ii) to standardize the procedures of interventional cardiology operational units that treat patients with peripheral arterial disease in Italy on the basis of scientific evidence, and (iii) to establish common requirements in terms of facilities and regulations.

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.

Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: One-year single centre clinical results.

BACKGROUND: The use of directional atherectomy (DA) for the treatment of calcified femoro-popliteal lesions seems to improve the acute procedural success, however without reducing the long term restenosis rate. Drug coated balloons (DCB) reduced restenosis rate in non heavy calcified lesions. Aim of this study was to demonstrate safety and efficacy of a combined endovascular approach using DA and DCB for the treatment of heavy calcified lesions of the femoro-popliteal tract. METHODS: From January 2010 to November 2010, 240 patients underwent PTA of the femoro-popliteal tract in our institution. Within this cohort a total of 30 patients had life limiting claudication (LLC) (n=18) and 12 a critical limb ischemia (CLI) with baseline Rutherford class 4.2±1.2 underwent PTA of heavy calcified lesions with intravascular ultrasound guided DA and DCB. All procedures have been performed using a distal protection device. Stent implantation was allowed only in case of flow limiting dissections or suboptimal result (residual stenosis>50%) by visual estimation. After the intervention patients were followed up to 12 months. RESULTS: Procedural and clinical success, was achieved in all cases. Bail-out stenting was necessary in only two (6.5%). At twelve month follow up median Rutherford class was 2.2±1.2, ABI was 0.8±0.1 and Limb salvage rate was 100%. Two minor, foot finger or forefoot amputations, were performed to reach complete wound healing and/or preserve deambulation. Duplex control was performed in all the cases (n=30). In three cases duplex scan showed a significant target lesion restenosis requiring a reintervention (TLR=10%) leading a total one-year secondary patency rate of 100%. All the three restenosed patients were insulin dependent diabetics and none of them were stented during the procedure. CONCLUSION: The data suggest that combined use of DA and DCB may represent a potential alternative strategy for the treatment of femoro-popliteal severely calcified lesions. These very promising data and the considered hypothesis have to be confirmed in a multicentre randomised trial.

Drug-eluting balloon for treatment of superficial femoral artery in-stent restenosis.

OBJECTIVES: The purpose of this prospective registry was to evaluate the safety and efficacy, at 1 year, of the use of drug-eluting balloons (DEB) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR). BACKGROUND: The use of the self-expanding nitinol stent has improved the patency rate of SFA after percutaneous transluminal angioplasty (PTA). As the population with SFA stenting continues to increase, occurrence of ISR has become a serious problem. The use of DEB has showed promising results in reducing restenosis recurrence in coronary stents. METHODS: From December 2009 to December 2010, 39 consecutive patients underwent PTA of SFA-ISR in our institution. All patients underwent conventional SFA PTA and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic, Minneapolis, Minnesota). Patients were evaluated up to 12 months. RESULTS: Technical and procedural success was achieved in every patient. No in-hospital major adverse cardiac and cerebrovascular events occurred. At 1 year, 1 patient died due to heart failure. Primary endpoint, primary patency rate at 12 months, was obtained in 92.1% (35 patients). At 1 year, patients were asymptomatic for claudication, and duplex assessment demonstrated lack of recurrent restenosis (100% rate of Secondary patency). The presence of an occlusive restenosis at the time of treatment was not associated with an increased restenosis rate, when compared with non-occlusive restenosis, at 1 year. CONCLUSIONS: The data suggest that adjunctive use of DEB for the treatment of SFA-ISR represents a potentially safe and effective therapeutic strategy. These data should be considered hypothesis-generating to design a randomized trial.

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.

Proximal endovascular occlusion for carotid artery stenting: results from a prospective registry of 1,300 patients.

OBJECTIVES: This single-center registry presents the results of proximal endovascular occlusion (PEO) use in an unselected patient population. BACKGROUND: In published multicenter registries, the use of PEO for carotid artery stenting (CAS) has been demonstrated to be safe and efficient in patient populations selected for anatomical and/or clinical conditions. METHODS: From July 2004 to May 2009, 1,300 patients underwent CAS using PEO. Patients received an independent neurological assessment before the procedure and 1 h, 24 h, and 30 days after the procedure. RESULTS: Procedural success was achieved in 99.7% of patients. In hospital, major adverse cardiac or cerebrovascular events included 5 deaths (0.38%), 6 major strokes (0.46%), 5 minor strokes (0.38%), and no acute myocardial infarction. At 30 days of follow-up, 2 additional patients died (0.15%), and 1 patient had a minor stroke (0.07%). The 30-day stroke and death incidence was 1.38% (n = 19). Symptomatic patients presented a higher 30-day stroke and death incidence when compared with asymptomatic patients (3.04% vs. 0.82%; p < 0.05). No significant difference in 30-day stroke and death rate was observed between patients at high (1.88%; n = 12) and average surgical risk (1.07; n = 7) (p = NS). Operator experience, symptomatic status, and hypertension were found to be independent predictors of adverse events. CONCLUSIONS: The use of PEO for CAS is safe and effective in an unselected patient population. Anatomical and/or clinical conditions of high surgical risk were not associated with an increased rate of adverse events.