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

NCT00032370 | Completed

• 1 other identifier: 411
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Cardiovascular Disease

Keywords

myocardial infarction; Prophylactic coronary artery revascularization

Outcome Measures

Primary Outcomes (1)

• Mortality

  3 months and 3.5 years post-op

Study Arms (2)

1

OTHER

Elective vascular surgery

Procedure: Vascular surgery with best medical treatment

2

OTHER

Cardiac revascularization prior to vascular surgery.

Procedure: Coronary artery bypass grafting (CABG); Procedure: Percutaneous transluminal coronary angioplasty (PTCA)

Interventions

Vascular surgery with best medical treatment PROCEDURE

Patients undergo scheduled vascular surgery

1

Coronary artery bypass grafting (CABG) PROCEDURE

Coronary artery bypass grafting prior to vascular surgery

Also known as: CABG

2

Percutaneous transluminal coronary angioplasty (PTCA) PROCEDURE

Cardiac revascularization via PTCA prior to vascular surgery

Also known as: PTCA

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• High risk patients scheduled for elective vascular surgery

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (18)

Southern Arizona VA Health Care System, Tucson

Tucson, Arizona, 85723, United States

Location

Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

No. Little Rock, Arkansas, 72114-1706, United States

Location

VA Medical Center, San Francisco

San Francisco, California, 94121, United States

Location

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, 90073, United States

Location

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, 80220, United States

Location

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

James A. Haley Veterans Hospital, Tampa

Tampa, Florida, 33612, United States

Location

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, 30033, United States

Location

Richard Roudebush VA Medical Center, Indianapolis

Indianapolis, Indiana, 46202-2884, United States

Location

VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

New Mexico VA Health Care System, Albuquerque

Albuquerque, New Mexico, 87108-5153, United States

Location

VA Medical Center, Durham

Durham, North Carolina, 27705, United States

Location

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

VA Pittsburgh Health Care System

Pittsburgh, Pennsylvania, 15240, United States

Location

VA North Texas Health Care System, Dallas

Dallas, Texas, 75216, United States

Location

VA South Texas Health Care System, San Antonio

San Antonio, Texas, 78229, United States

Location

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Related Publications (11)

• 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. doi: 10.1016/s0197-2456(99)00004-5.

  PMID: 10357501 RESULT

• Cina 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. doi: 10.1191/1358863x06vm655xx. No abstract available.

  PMID: 16669417 RESULT

• 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. doi: 10.1161/CIRCOUTCOMES.108.827683. Epub 2009 Mar 5.

  PMID: 20031818 RESULT

• 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. doi: 10.1002/ccd.22699.

  PMID: 20602474 RESULT

• 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. doi: 10.1016/j.athoracsur.2006.03.074.

  PMID: 16928485 RESULT

• 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. doi: 10.1016/j.jvs.2007.05.060.

  PMID: 17903649 RESULT

• 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. doi: 10.1093/eurheartj/ehm620.

  PMID: 18245121 RESULT

• 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. doi: 10.1016/j.amjcard.2008.05.022. Epub 2008 Jul 2.

  PMID: 18805102 RESULT

• 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. doi: 10.1111/j.1540-8183.2008.00391.x. Epub 2008 Aug 26.

  PMID: 18761563 RESULT

• 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. doi: 10.1016/j.jvs.2005.12.069.

  PMID: 16765234 RESULT

• 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. doi: 10.1016/j.amjcard.2004.07.077.

  PMID: 15518605 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Myocardial Infarction

Interventions

Vascular Surgical Procedures; Coronary Artery Bypass; Angioplasty, Balloon, Coronary

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Myocardial Revascularization; Cardiac Surgical Procedures; Vascular Grafting; Thoracic Surgical Procedures; Angioplasty, Balloon; Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Edward O. McFalls, MD

  VA Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: March 19, 2002
• First Posted: March 20, 2002
• Study Start: August 1, 1997
• Primary Completion: February 1, 2004
• Study Completion: May 1, 2004
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

US (18)