tct october 20th, 2007 (washington d.c.)

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Temporal Improvement in Carotid Stent Outcomes: Achievement of AHA Target Goals in Abbott Vascular Post-Marketing Trials. William A. Gray MD, Ronald Fairman MD, Rod Raabe MD, L. Nelson Hopkins MD, Jay S. Yadav MD, Richard Atkinson MD, Mark Wholey MD, Richard Green MD, Stan Barnwell MD. - PowerPoint PPT Presentation

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  • Carotid Stenting Post-Marketing Studies: Temporal relationshipsOct 04Oct 06Oct 05Dec 06144 sitesCAPTUREEnrollment completedFirst Generation Post Approval Study1 year follow-up to be completed Q4 07128 sitesEXACTSecond Generation Post Approval StudyNov 05Mar 06195 sitesCAPTURE 2Enrollment ongoingTemporal Second Generation Post Market StudyApr 07

  • Post-Market Multicenter Study: Quantity Sample sizesEXACT and CAPTURE/CAPTURE 2 were initiated independently by two sponsors (ABT, GDT) and use 2 different device systems (Xact/Emboshield and Acculink/Accunet).

    Large sample size, large # of sites Total patients: 83364225 patients/144 sites (CAPTURE), 1987 patients/167 sites (CAPTURE 2), 2124 patients/126 sites (EXACT) 8334 total patientsLargest prospective, multi-center, neurologically-controlled, independently-adjudicated data set for carotid intervention ever assembled

  • AHA 1998 CEA Guidance DocumentPatients With Asymptomatic Carotid Artery Disease

    For patients with a surgical risk

  • CAPTURE 2 and EXACT: All stroke/death and major stroke/death by symptom statusHierarchical Events Includes only the most serious event for each patient and includes only each patients first occurrence of each event.Clinical Studies are not directly comparable by methodology presented. -Data from respective studies are presented for Educational purposesEXACT: n=2124 CAPTURE 2: n=1987EXACT: n=204 CAPTURE 2: n=197EXACT: n=1917 CAPTURE 2: n=1788All patientsSymptomaticAsymptomatic

  • CAPTURE 2 and EXACT: Asymptomatics 30 day Outcomes by Octogenarian StatusHierarchical Events Includes only the most serious event for each patient and includes only each patients first occurrence of each eventClinical Studies are not directly comparable by methodology presented. -Data from respective studies are presented for educational purposesEXACT: n=1454 CAPTURE 2: n=1372EXACT: n=463 CAPTURE 2: n=41680 years3%

  • CAPTURE 2 and EXACT: ConclusionsOngoing improvement in outcomes in