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1.
Stroke ; 45(11): 3320-4, 2014 Nov.
Article in English | MEDLINE | ID: mdl-25256180

ABSTRACT

BACKGROUND AND PURPOSE: Evidence indicates that center volume of cases affects outcomes for both carotid endarterectomy and stenting. We evaluated the effect of enrollment volume by site on complication rates in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). METHODS: The primary composite end point was any stroke, myocardial infarction, or death within 30 days or ipsilateral stroke in follow-up. The 477 approved surgeons performed >12 procedures per year with complication rates <3% for asymptomatic patients and <5% for symptomatic patients; 224 interventionists were certified after a rigorous 2 step credentialing process. CREST centers were divided into tertiles based on the number of patients enrolled into the study, with Group 1 sites enrolling <25 patients, Group 2 sites enrolling 25 to 51 patients, and Group 3 sites enrolling >51 patients. Differences in periprocedural event rates for the primary composite end point and its components were compared using logistic regression adjusting for age, sex, and symptomatic status within site-volume level. RESULTS: The safety of carotid angioplasty and stenting and carotid endarterectomy did not vary by site-volume during the periprocedural period as indicated by occurrence of the primary end point (P=0.54) or by stroke and death (P=0.87). A trend toward an inverse relationship between center enrollment volume and complications was mitigated by adjustment for known risk factors. CONCLUSIONS: Complication rates were low in CREST and were not associated with center enrollment volume. The data are consistent with the value of rigorous training and credentialing in trials evaluating endovascular devices and surgical procedures. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.


Subject(s)
Angioplasty/trends , Carotid Stenosis/epidemiology , Cerebral Revascularization/trends , Endarterectomy, Carotid/trends , Postoperative Complications/epidemiology , Stents/trends , Aged , Angioplasty/adverse effects , Carotid Stenosis/surgery , Cerebral Revascularization/adverse effects , Endarterectomy, Carotid/adverse effects , Female , Follow-Up Studies , Humans , Male , Middle Aged , Postoperative Complications/diagnosis , Prospective Studies , Risk Factors , Single-Blind Method , Stents/adverse effects , Treatment Outcome
2.
EuroIntervention ; 6(8): 920-7, 1-2, 2011 Mar.
Article in English | MEDLINE | ID: mdl-21330238

ABSTRACT

AIMS: Small reference vessel diameter predicts adverse outcomes following coronary stenting. TAXUS Express and TAXUS Liberté paclitaxel-eluting stents (PES) reduce restenosis compared to bare metal stents (BMS) in small diameter vessels. TAXUS Element is a novel thin-strut, platinum chromium stent designed to enhance visibility, conformability, and drug delivery in small diameter vessels. METHODS AND RESULTS: The PERSEUS Small Vessel (SV) prospective, single-arm, superiority trial evaluates the TAXUS Element PES in 224 subjects with target lesion length≤20 mm and vessel diameter≥2.25 to <2.75 mm, compared to 125 lesion-matched historical Express BMS control subjects from the TAXUS V trial. The primary endpoint was nine-month in-stent late loss. The secondary endpoint was 12-month target lesion failure (TLF) compared to a pre-specified performance goal (PG). Outcomes were analysed with and without propensity-score adjustment. TAXUS Element was superior to the Express BMS for late loss (0.38±0.51 versus 0.80±0.53 mm respectively; P<0.001), and TLF (7.3%) was significantly less than the 19.5% PG (P<0.001). No differences in mortality, myocardial infarction, or stent thrombosis were observed through 12 months. Results were similar after adjustment. CONCLUSIONS: PERSEUS SV supports the efficacy and safety of the platinum chromium, thin-strut TAXUS Element stent in small coronary vessels.


Subject(s)
Angioplasty, Balloon, Coronary , Coronary Artery Disease/therapy , Drug-Eluting Stents/adverse effects , Myocardial Infarction/therapy , Paclitaxel/therapeutic use , Aged , Angioplasty, Balloon, Coronary/mortality , Chromium Compounds , Coronary Artery Disease/mortality , Coronary Restenosis/mortality , Coronary Vessels/drug effects , Equipment Failure Analysis , Female , Humans , Male , Middle Aged , Myocardial Infarction/mortality , Platinum Compounds , Prospective Studies
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