Jay Giri1, Sahil A Parikh2, Kevin F Kennedy3, Ido Weinberg4, Cameron Donaldson4, Beau M Hawkins5, Daniel J McCormick6, Benjamin Jackson7, Ehrin J Armstrong8, Preethi Ramchand9, Christopher J White10, Michael R Jaff4, Kenneth Rosenfield4, Robert W Yeh4. 1. Cardiovascular Medicine Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. Electronic address: Giri.jay@gmail.com. 2. University Hospitals Harrington Heart and Vascular Institute and Case Western Reserve University School of Medicine, Cleveland, Ohio. 3. St. Luke's Mid-America Heart Institute, University of Missouri - Kansas City, Kansas City, Missouri. 4. The Institute for Heart, Vascular, & Stroke Care, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. 5. Cardiovascular Section, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma. 6. Cardiovascular Medicine Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. 7. Division of Vascular Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. 8. Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado. 9. Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. 10. John Ochsner Heart and Vascular Institute, Ochsner Medical Center, New Orleans, Louisiana.
Abstract
OBJECTIVES: The aim of this study was to compare the stroke/death rates between proximal embolic protection devices (P-EPDs) and distal filter embolic protection devices (F-EPDs) in elective carotid artery stenting (CAS). BACKGROUND: P-EPDs have theoretical advantages that may make them superior to F-EPDs for stroke prevention during CAS. METHODS: We examined 10,246 consecutive elective CAS procedures performed with embolic protection in the NCDR CARE registry between January 2009 and March 2013. We analyzed crude and propensity-matched rates of in-hospital combined death/stroke in patients treated with P-EPDs versus F-EPDs. Secondary analyses included 30-day adverse event rates and stroke rates by the involved cerebrovascular territory. RESULTS: P-EPDs were used in 590 of 10,246 cases (5.8%). Patients treated with P-EPDs had higher rates of symptomatic lesion status (46.8% vs. 39.7%, p<0.001), atrial fibrillation/flutter (16.1% vs. 13.0%, p=0.03), and history of a neurological event (51.2% vs. 46.6%, p=0.03). In unadjusted and propensity-matched analyses, differences in in-hospital stroke/death between P-EPD and F-EPD cohorts were nonsignificant (1.5% vs. 2.4%, p=0.16 and 1.6% vs. 2.0%, p=0.56, respectively). For patients with available data (n=7,693, 75.1%), 30-day adverse events rates were similar for P-EPDs and F-EPDs before (2.5% vs. 4.2%, p=0.07) and after (2.7% vs. 4.0%, p=0.22) propensity matching. CONCLUSIONS: Use of a P-EPD during CAS was associated with low rates of in-hospital stroke/death similar to those with an F-EPD in the first comparative effectiveness study of the devices. An adequately powered randomized trial comparing clinical outcomes between these devices is unlikely to be feasible.
OBJECTIVES: The aim of this study was to compare the stroke/death rates between proximal embolic protection devices (P-EPDs) and distal filter embolic protection devices (F-EPDs) in elective carotid artery stenting (CAS). BACKGROUND: P-EPDs have theoretical advantages that may make them superior to F-EPDs for stroke prevention during CAS. METHODS: We examined 10,246 consecutive elective CAS procedures performed with embolic protection in the NCDR CARE registry between January 2009 and March 2013. We analyzed crude and propensity-matched rates of in-hospital combined death/stroke in patients treated with P-EPDs versus F-EPDs. Secondary analyses included 30-day adverse event rates and stroke rates by the involved cerebrovascular territory. RESULTS: P-EPDs were used in 590 of 10,246 cases (5.8%). Patients treated with P-EPDs had higher rates of symptomatic lesion status (46.8% vs. 39.7%, p<0.001), atrial fibrillation/flutter (16.1% vs. 13.0%, p=0.03), and history of a neurological event (51.2% vs. 46.6%, p=0.03). In unadjusted and propensity-matched analyses, differences in in-hospital stroke/death between P-EPD and F-EPD cohorts were nonsignificant (1.5% vs. 2.4%, p=0.16 and 1.6% vs. 2.0%, p=0.56, respectively). For patients with available data (n=7,693, 75.1%), 30-day adverse events rates were similar for P-EPDs and F-EPDs before (2.5% vs. 4.2%, p=0.07) and after (2.7% vs. 4.0%, p=0.22) propensity matching. CONCLUSIONS: Use of a P-EPD during CAS was associated with low rates of in-hospital stroke/death similar to those with an F-EPD in the first comparative effectiveness study of the devices. An adequately powered randomized trial comparing clinical outcomes between these devices is unlikely to be feasible.
Authors: Thomas G Brott; George Howard; Gary S Roubin; James F Meschia; Ariane Mackey; William Brooks; Wesley S Moore; Michael D Hill; Vito A Mantese; Wayne M Clark; Carlos H Timaran; Donald Heck; Pierre P Leimgruber; Alice J Sheffet; Virginia J Howard; Seemant Chaturvedi; Brajesh K Lal; Jenifer H Voeks; Robert W Hobson Journal: N Engl J Med Date: 2016-02-18 Impact factor: 91.245
Authors: Victoria Mayoral Campos; José Andrés Guirola Órtiz; Carlos Tejero Juste; María José Gimeno Peribáñez; Carolina Serrano; Cristina Pérez Lázaro; Ignacio de Blas Giral; Miguel Ángel de Gregorio Ariza Journal: CVIR Endovasc Date: 2018-07-17