Timothy P Murphy1, Christopher J Cooper2, Donald E Cutlip3, Alan Matsumoto4, Kenneth Jamerson5, John Rundback6, Kenneth A Rosenfield7, William Henrich8, Joseph Shapiro9, Joseph Massaro10, Chen-Hsing Yen11, Holly Burtch2, Claudia Thum11, Diane Reid12, Lance Dworkin13. 1. Vascular Disease Research Center, Rhode Island Hospital, Gerry 337, 593 Eddy Street, Providence, RI 02903. Electronic address: tmurphy@lifespan.org. 2. Division of Cardiology, University of Toledo, Toledo, Ohio. 3. Division of Cardiology, Beth Israel Deaconess Hospital, Boston; Harvard Clinical Research Institute, Boston. 4. Department of Radiology, University of Virginia, Charlottesville, Virginia. 5. Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan. 6. Interventional Institute, Holy Name Medical Center, Teaneck, New Jersey. 7. Division of Cardiology, Massachusetts General Hospital, Boston. 8. University of Texas Health Sciences at San Antonio, San Antonio, Texas. 9. Joan C. Edwards School of Medicine, Marshall University, Huntington, West Virginia. 10. Harvard Clinical Research Institute, Boston; Department of Biostatistics, Boston University, Boston, Massachusetts. 11. Harvard Clinical Research Institute, Boston. 12. National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland. 13. Division of Nephrology, Rhode Island Hospital, Gerry 337, 593 Eddy Street, Providence, RI 02903.
Abstract
PURPOSE: To describe the experience and results from the roll-in phase of the Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) study. MATERIALS AND METHODS: The CORAL roll-in database was used to describe the baseline characteristics of the patients in the roll-in cohort, all of whom underwent renal artery stent placement; to evaluate CORAL site performance; to compare estimates of lesion (stenosis) severity made by site interventionalists with the central CORAL angiographic core laboratory readings; and to report outcomes after renal artery stent placement. During the roll-in phase, 239 patients (mean age, 70.2 y ± 9.0; 49% male) underwent renal artery stent procedures. Angiographic core laboratory analysis of renal arteriograms was done, and participants were followed at 1 month and 9 months. RESULTS:Major angiographic complications were identified in 28 (13%) subjects. Kidney function remained unchanged at the short (2-4 weeks) follow-up interval. Improvement in systolic blood pressure with use of distal embolic protection devices (n = 161) did not show any clinical benefit over nonuse of such devices (n = 78) in this small series. At 9 months, there were significantly more endpoints reported by site in subjects with bilateral renal artery stenosis (P = .01) and prior history of stroke (P = .03). CONCLUSIONS: In the roll-in phase of the CORAL study, a significant number of angiographic complications were identified. No effect was seen on estimated glomerular filtration rate after renal artery stent placement, but systolic blood pressure decreased significantly.
RCT Entities:
PURPOSE: To describe the experience and results from the roll-in phase of the Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) study. MATERIALS AND METHODS: The CORAL roll-in database was used to describe the baseline characteristics of the patients in the roll-in cohort, all of whom underwent renal artery stent placement; to evaluate CORAL site performance; to compare estimates of lesion (stenosis) severity made by site interventionalists with the central CORAL angiographic core laboratory readings; and to report outcomes after renal artery stent placement. During the roll-in phase, 239 patients (mean age, 70.2 y ± 9.0; 49% male) underwent renal artery stent procedures. Angiographic core laboratory analysis of renal arteriograms was done, and participants were followed at 1 month and 9 months. RESULTS: Major angiographic complications were identified in 28 (13%) subjects. Kidney function remained unchanged at the short (2-4 weeks) follow-up interval. Improvement in systolic blood pressure with use of distal embolic protection devices (n = 161) did not show any clinical benefit over nonuse of such devices (n = 78) in this small series. At 9 months, there were significantly more endpoints reported by site in subjects with bilateral renal artery stenosis (P = .01) and prior history of stroke (P = .03). CONCLUSIONS: In the roll-in phase of the CORAL study, a significant number of angiographic complications were identified. No effect was seen on estimated glomerular filtration rate after renal artery stent placement, but systolic blood pressure decreased significantly.
Authors: B C van Jaarsveld; P Krijnen; H Pieterman; F H Derkx; J Deinum; C T Postma; A Dees; A J Woittiez; A K Bartelink; A J Man in 't Veld; M A Schalekamp Journal: N Engl J Med Date: 2000-04-06 Impact factor: 91.245
Authors: Christopher J Cooper; Timothy P Murphy; Alan Matsumoto; Michael Steffes; David J Cohen; Michael Jaff; Richard Kuntz; Kenneth Jamerson; Diane Reid; Kenneth Rosenfield; John Rundback; Ralph D'Agostino; William Henrich; Lance Dworkin Journal: Am Heart J Date: 2006-07 Impact factor: 4.749
Authors: Aram V Chobanian; George L Bakris; Henry R Black; William C Cushman; Lee A Green; Joseph L Izzo; Daniel W Jones; Barry J Materson; Suzanne Oparil; Jackson T Wright; Edward J Roccella Journal: Hypertension Date: 2003-12-01 Impact factor: 10.190
Authors: Christopher J Cooper; Steven T Haller; William Colyer; Michael Steffes; Mark W Burket; William J Thomas; Robert Safian; Bhagat Reddy; Pamela Brewster; Mary Ann Ankenbrandt; Renu Virmani; Eric Dippel; Krishna Rocha-Singh; Timothy P Murphy; David J Kennedy; Joseph I Shapiro; Ralph D D'Agostino; Michael J Pencina; Sadik Khuder Journal: Circulation Date: 2008-05-19 Impact factor: 29.690
Authors: J Webster; F Marshall; M Abdalla; A Dominiczak; R Edwards; C G Isles; H Loose; J Main; P Padfield; I T Russell; B Walker; M Watson; R Wilkinson Journal: J Hum Hypertens Date: 1998-05 Impact factor: 3.012
Authors: Liesbeth Bax; Arend-Jan J Woittiez; Hans J Kouwenberg; Willem P T M Mali; Erik Buskens; Frederik J A Beek; Branko Braam; Frans T M Huysmans; Leo J Schultze Kool; Matthieu J C M Rutten; Cornelius J Doorenbos; Johannes C N M Aarts; Ton J Rabelink; Pierre-François Plouin; Alain Raynaud; Gert A van Montfrans; Jim A Reekers; Anton H van den Meiracker; Peter M T Pattynama; Peter J G van de Ven; Dammis Vroegindeweij; Abraham A Kroon; Michiel W de Haan; Cornelis T Postma; Jaap J Beutler Journal: Ann Intern Med Date: 2009-05-04 Impact factor: 25.391
Authors: Usha S Govindarajulu; Marco Stillo; David Goldfarb; Michael E Matheny; Frederic S Resnic Journal: Stat Med Date: 2017-05-03 Impact factor: 2.373
Authors: Jacek Kadziela; Ilona Michalowska; Jerzy Pregowski; Hanna Janaszek-Sitkowska; Katarzyna Lech; Marek Kabat; Adam Staruch; Andrzej Januszewicz; Adam Witkowski Journal: Postepy Kardiol Interwencyjnej Date: 2016-05-11 Impact factor: 1.426
Authors: Jaber Abboud; Albrecht Römer; Wolfgang Kasper; Bernhard M Kaess; Stefan Haack; Thomas Mettang; Oliver Vonend; Joachim R Ehrlich Journal: Int J Cardiol Heart Vasc Date: 2020-01-30