Does Prophylactic Coronary Artery Revascularization for High Risk Patients Reduce Long-term Risk of Mortality - Full Text View

Sponsor:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00032370

Purpose

Although a number of sophisticated diagnostic tests have been shown to be helpful in identifying patients at high risk for perioperative cardiac complications, no study has addressed the most important question: Should prophylactic coronary revascularization be performed prior to elective vascular surgery? This study is designed to answer this question.

Condition	Intervention
Cardiovascular Disease	Procedure: Vascular surgery with best medical treatment Procedure: Coronary artery bypass grafting (CABG) Procedure: Percutaneous transluminal coronary angioplasty (PTCA)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	CSP #411 - The Coronary Artery Revascularization Prophylaxis (CARP) Trial

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Mortality [ Time Frame: 3 months and 3.5 years post-op ] [ Designated as safety issue: No ]

Enrollment:	510
Study Start Date:	August 1997
Study Completion Date:	May 2004
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 1 Elective vascular surgery	Procedure: Vascular surgery with best medical treatment Patients undergo scheduled vascular surgery
2 Cardiac revascularization prior to vascular surgery.	Procedure: Coronary artery bypass grafting (CABG) Coronary artery bypass grafting prior to vascular surgery Other Name: CABG Procedure: Percutaneous transluminal coronary angioplasty (PTCA) Cardiac revascularization via PTCA prior to vascular surgery Other Name: PTCA

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

High risk patients scheduled for elective vascular surgery

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032370

Locations

United States, Arizona
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States, 85723
United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States, 72114-1706
United States, California
VA Medical Center, San Francisco
San Francisco, California, United States, 94121
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
United States, Colorado
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States, 80220
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, United States, 33612
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States, 30033
United States, Indiana
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States, 46202-2884
United States, Minnesota
VA Medical Center
Minneapolis, Minnesota, United States, 55417
United States, New Mexico
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, United States, 87108-5153
United States, North Carolina
VA Medical Center, Durham
Durham, North Carolina, United States, 27705
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
United States, Pennsylvania
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States, 15240
United States, Texas
VA North Texas Health Care System, Dallas
Dallas, Texas, United States, 75216
VA South Texas Health Care System, San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Study Chair:

Edward O. McFalls, MD

Department of Veterans Affairs

More Information

Publications:

McFalls EO, Ward HB, Krupski WC, Goldman S, Littooy F, Eagle K, Nyman JA, Moritz T, McNabb S, Henderson WG. Prophylactic coronary artery revascularization for elective vascular surgery: study design. Veterans Affairs Cooperative Study Group on Coronary Artery Revascularization Prophylaxis for Elective Vascular Surgery. Control Clin Trials. 1999 Jun;20(3):297-308.

Cinà CS, Devereaux PJ. Coronary-artery revascularization before elective major vascular surgery. McFalls EO, ward HB, Moritz TE, Goldman S, Krupski WC, Littooy F, Pierpont G, Santilli S, Rapp J, Hattler B, Shunk K, Jaenicke C, Thottapurathu L, Ellis N, Reda DJ, Henderson WG. N Engl J Med. 2004; 351: 2795-804. Vasc Med. 2006 Feb;11(1):61-3. No abstract available.

Garcia S, Moritz TE, Goldman S, Littooy F, Pierpont G, Larsen GC, Reda DJ, Ward HB, McFalls EO. Perioperative complications after vascular surgery are predicted by the revised cardiac risk index but are not reduced in high-risk subsets with preoperative revascularization. Circ Cardiovasc Qual Outcomes. 2009 Mar;2(2):73-7. Epub 2009 Mar 5.

Garcia S, Rider JE, Moritz TE, Pierpont G, Goldman S, Larsen GC, Shunk K, Littooy F, Santilli S, Rapp J, Reda DJ, Ward HB, McFalls EO. Preoperative coronary artery revascularization and long-term outcomes following abdominal aortic vascular surgery in patients with abnormal myocardial perfusion scans: a subgroup analysis of the coronary artery revascularization prophylaxis trial. Catheter Cardiovasc Interv. 2011 Jan 1;77(1):134-41.

Ward HB, Kelly RF, Thottapurathu L, Moritz TE, Larsen GC, Pierpont G, Santilli S, Goldman S, Krupski WC, Littooy F, Reda DJ, McFalls EO. Coronary artery bypass grafting is superior to percutaneous coronary intervention in prevention of perioperative myocardial infarctions during subsequent vascular surgery. Ann Thorac Surg. 2006 Sep;82(3):795-800; discussion 800-1.

McFalls EO, Ward HB, Moritz TE, Littooy F, Santilli S, Rapp J, Larsen G, Reda DJ. Clinical factors associated with long-term mortality following vascular surgery: outcomes from the Coronary Artery Revascularization Prophylaxis (CARP) Trial. J Vasc Surg. 2007 Oct;46(4):694-700.

McFalls EO, Ward HB, Moritz TE, Apple FS, Goldman S, Pierpont G, Larsen GC, Hattler B, Shunk K, Littooy F, Santilli S, Rapp J, Thottapurathu L, Krupski W, Reda DJ, Henderson WG. Predictors and outcomes of a perioperative myocardial infarction following elective vascular surgery in patients with documented coronary artery disease: results of the CARP trial. Eur Heart J. 2008 Feb;29(3):394-401.

Garcia S, Moritz TE, Ward HB, Pierpont G, Goldman S, Larsen GC, Littooy F, Krupski W, Thottapurathu L, Reda DJ, McFalls EO. Usefulness of revascularization of patients with multivessel coronary artery disease before elective vascular surgery for abdominal aortic and peripheral occlusive disease. Am J Cardiol. 2008 Oct 1;102(7):809-13. Epub 2008 Jul 2.

Garcia S, McFalls EO, Goldman S, Larsen GC, Littooy F, Moritz TE, Reda DJ, Ward HB, Shunk K, Hattler B. Diagnostic coronary angiography in patients with peripheral arterial disease: a sub-study of the Coronary Artery Revascularization Prophylaxis Trial. J Interv Cardiol. 2008 Oct;21(5):369-74. Epub 2008 Aug 26.

Raghunathan A, Rapp JH, Littooy F, Santilli S, Krupski WC, Ward HB, Thottapurathu L, Moritz T, McFalls EO; CARP Investigators. Postoperative outcomes for patients undergoing elective revascularization for critical limb ischemia and intermittent claudication: a subanalysis of the Coronary Artery Revascularization Prophylaxis (CARP) trial. J Vasc Surg. 2006 Jun;43(6):1175-82.

Pierpont GL, Moritz TE, Goldman S, Krupski WC, Littooy F, Ward HB, McFalls EO; Current Opinion On Revascularization Study Investigators. Disparate opinions regarding indications for coronary artery revascularization before elective vascular surgery. Am J Cardiol. 2004 Nov 1;94(9):1124-8.

Responsible Party:	McFalls, Edward - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00032370 History of Changes
Other Study ID Numbers:	411
Study First Received:	March 19, 2002
Last Updated:	May 3, 2011
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

myocardial infarction
Prophylactic coronary artery revascularization

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 12, 2012