AIM: Severe highly-calcified de-novo lesions of carotid arteries are important predictors of haemodynamic depression (HD) after carotid artery stenting (CAS). Cutting-balloon angioplasty (CBA) using low-inflation pressures has been described as an effective method to achieve important luminal gain and avoid HD. METHODS:from January 2005 to December 2007 102 consecutive patients (mean age 76.36+/-7.54 years) with severe highly-calcified de novo lesions of carotid artery undergoing CAS were prospectively observed and randomized in two groups: group 1 (N=50) underwent standard CAS, group 2 (N=52) underwent CAS with CBA. Patients with prior ipsilateral carotid endarterectomy (CEA), betablockers therapy or arrhytmias were excluded. HD was defined as periprocedural hypotension (systolic blood pressure <90 mmHg) or bradycardia (heart rate <60 beats/min). CBA angioplasty was carried out using CB coronary device, 0.014 inch compatible, from 3 to 4 mm or CB peripheral device, 0.018 inch compatible, from 5 to 6 mm in diameter, inflated at a mean-maximum value of 8.6 atmospheres; the average number of cuts per lesion was 2.7. RESULTS: Demographic and clinical characteristic of both groups at the basal conditions were comparable. HD occurred in 18/50 (36%) procedures in group 1, and in 3/52 (5.76%) in group 2. The difference between the two groups concerning HD incidence was statistically significant (P<0.001). There was a strong (P<0.001) association between HD and CBA and the OR=0.109 (95%CI 0.019-0.425) confirmed the protective role of CBA. No major intraprocedural complications were observed in this series. Postprocedural Doppler ultrasound scan showed one case (2%) of in-stent restenosis in group 1 representing early failure due to recoil, and only 1 (1.92%) neurological adverse event (transient ischemic attack, TIA) in group 2. CONCLUSIONS:HD is a common occurrence after CAS, especially in patients with both long and calcified plaque. Only a tailored procedure with a correct remodelling of the plaque allows to avoid both HD and elastic recoil of the target lesion.
RCT Entities:
AIM: Severe highly-calcified de-novo lesions of carotid arteries are important predictors of haemodynamic depression (HD) after carotid artery stenting (CAS). Cutting-balloon angioplasty (CBA) using low-inflation pressures has been described as an effective method to achieve important luminal gain and avoid HD. METHODS: from January 2005 to December 2007 102 consecutive patients (mean age 76.36+/-7.54 years) with severe highly-calcified de novo lesions of carotid artery undergoing CAS were prospectively observed and randomized in two groups: group 1 (N=50) underwent standard CAS, group 2 (N=52) underwent CAS with CBA. Patients with prior ipsilateral carotid endarterectomy (CEA), betablockers therapy or arrhytmias were excluded. HD was defined as periprocedural hypotension (systolic blood pressure <90 mmHg) or bradycardia (heart rate <60 beats/min). CBA angioplasty was carried out using CB coronary device, 0.014 inch compatible, from 3 to 4 mm or CB peripheral device, 0.018 inch compatible, from 5 to 6 mm in diameter, inflated at a mean-maximum value of 8.6 atmospheres; the average number of cuts per lesion was 2.7. RESULTS: Demographic and clinical characteristic of both groups at the basal conditions were comparable. HD occurred in 18/50 (36%) procedures in group 1, and in 3/52 (5.76%) in group 2. The difference between the two groups concerning HD incidence was statistically significant (P<0.001). There was a strong (P<0.001) association between HD and CBA and the OR=0.109 (95%CI 0.019-0.425) confirmed the protective role of CBA. No major intraprocedural complications were observed in this series. Postprocedural Doppler ultrasound scan showed one case (2%) of in-stent restenosis in group 1 representing early failure due to recoil, and only 1 (1.92%) neurological adverse event (transient ischemic attack, TIA) in group 2. CONCLUSIONS:HD is a common occurrence after CAS, especially in patients with both long and calcified plaque. Only a tailored procedure with a correct remodelling of the plaque allows to avoid both HD and elastic recoil of the target lesion.