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

Cardiovascular Disease Clinical Trial

— CARP  

Official title:

CSP #411 - The Coronary Artery Revascularization Prophylaxis (CARP) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032370
• Other study ID #: 411
• Status: Completed
• Phase: N/A
• First received: March 19, 2002
• Last updated: June 25, 2015
• Start date: August 1997
• Est. completion date: May 2004

Study information

• Verified date: June 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

Primary Hypothesis: Prophylactic coronary artery revascularization in high risk patients scheduled for elective vascular surgery reduces long-term risk of mortality.

Secondary Hypotheses: Prophylactic coronary artery revascularization in high risk patients scheduled for elective vascular surgery reduces long-term risk of myocardial infarction and improves both cost-effectiveness of treatment and quality of life of the patients.

Intervention: 1) Medical therapy. This is the current, conservative practice. Each local investigator will decide the best medical treatment consistent with that given to any patient scheduled for elective vascular surgery. In patients with coronary artery disease, long-term treatment would be expected to include a combination of antiplatelet agents, beta-blockers, calcium channel blockers, and nitrates. Vascular surgery should occur as soon as possible but no later than three months after randomization. 2) Coronary artery revascularization. Repair of the heart in patients with coronary artery disease may aid in the protection of these patients when they undergo vascular surgery. The surgeon is free to choose between coronary artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA). Coronary artery revascularization should occur as soon as possible after randomization. Vascular surgery should occur between one and three months following CABG or between three to four days and three months following PTCA.

Primary Outcomes: Long-term mortality, MI, and quality of life.

Study Abstract: Cardiovascular disease accounts for one million deaths per year and is the major cause of mortality among Americans. Studies have shown that in patients scheduled for elective vascular surgery, the prevalence of coronary artery disease exceeds 50%. It is not surprising, therefore, that "perioperative cardiac morbidity" defined as the occurrence of MI, unstable angina, CHF, arrhythmias, and cardiac death, is the leading cause of perioperative complications. 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.

STUDY DESIGN This proposal utilizes a prospective, randomized trial to test whether prophylactic coronary revascularization reduces perioperative cardiac complications and long term mortality in patients who undergo elective vascular surgery. All VA patients requiring elective vascular surgery will be screened for enrollment. Patients will be excluded from enrollment if they need urgent/emergent vascular surgery; have had previous coronary artery revascularization with no current ischemia; or have one or more serious medical conditions such as COPD (FEV1<1.0), renal dysfunction (creatinine >3.5 mg/dl), liver failure, metastatic cancer, severe dementia, stroke, or unstable angina. Eligibility for the study is based on results from coronary angiography. Patients having clinical risk factors (including history of MI, pathologic Q-waves, ventricular ectopy requiring antiarrhythmic therapy, diabetes, angina, and CHF); and/or a positive stress test; should be candidates for coronary angiography. Specific angiographic criteria will exclude individuals from subsequent randomization. These include normal coronary arteries, severe LV dysfunction (EF<20%), aortic valve area <1 cm2, and left main disease (or equivalent). Patients considered nonintervenable by the cardiologist or cardiac surgeon will also be excluded. Enrolled patients who do not meet any of the exclusion criteria will then be randomized to either medical treatment or prophylactic revascularization. The decision to proceed with either PTCA or CABG will be based on institutional experiences. The study design does not compare PTCA versus CABG, but rather tests whether any revascularization procedure proves beneficial. The stratification factors will be the participating hospital and the type of vascular procedure that has been proposed (intraabdominal or infrainguinal). The randomization scheme is stratified by type of vascular surgery because aortic procedures (intraabdominal) may carry more risk than peripheral procedures (infrainguinal).

STATISTICAL CONSIDERATIONS For this trial, a sample size of 560 randomized patients will be required. This will provide 90% power to detect a difference in 3.5 year survival rates of 85% for patients receiving prophylactic coronary artery revascularization versus 75% for patients receiving medical treatment. Allowing for a 10% post randomization dropout rate, the target sample size will be 620 patients. Assuming an average intake of one patient per hospital per month, 18 participating hospitals will be required.

STUDY PHASES The study originally was funded for a one year pilot phase. The purpose of this phase was to determine the feasibility of randomizing one patient per hospital per month. In order for the study to enter the main phase, five pilot hospitals, ranging in number of vascular surgery cases from low to high, had to achieve at least 90% of patient accrual expectations (54 out of an expected 60 patients randomized in one year). After successful completion of the pilot phase, the main study was approved. During the main phase, 18 participating hospitals will accrue patients for four years and continue postvascular surgery follow-up for one year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: May 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

High risk patients scheduled for elective vascular surgery

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Procedure:
• Vascular surgery with best medical treatment
Patients undergo scheduled vascular surgery
• Coronary artery bypass grafting (CABG)
Coronary artery bypass grafting prior to vascular surgery
• Percutaneous transluminal coronary angioplasty (PTCA)
Cardiac revascularization via PTCA prior to vascular surgery

Locations

Country	Name	City	State
United States	New Mexico VA Health Care System, Albuquerque	Albuquerque	New Mexico
United States	VA Medical Center, Cleveland	Cleveland	Ohio
United States	VA North Texas Health Care System, Dallas	Dallas	Texas
United States	Atlanta VA Medical and Rehab Center, Decatur	Decatur	Georgia
United States	VA Eastern Colorado Health Care System, Denver	Denver	Colorado
United States	VA Medical Center, Durham	Durham	North Carolina
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida
United States	Richard Roudebush VA Medical Center, Indianapolis	Indianapolis	Indiana
United States	VA Medical Center	Minneapolis	Minnesota
United States	Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock	No. Little Rock	Arkansas
United States	VA Pittsburgh Health Care System	Pittsburgh	Pennsylvania
United States	VA Medical Center, Portland	Portland	Oregon
United States	VA South Texas Health Care System, San Antonio	San Antonio	Texas
United States	VA Medical Center, San Francisco	San Francisco	California
United States	VA Puget Sound Health Care System, Seattle	Seattle	Washington
United States	James A. Haley Veterans Hospital, Tampa	Tampa	Florida
United States	Southern Arizona VA Health Care System, Tucson	Tucson	Arizona
United States	VA Greater Los Angeles Healthcare System, West LA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (11)

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, Re — View Citation

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 — View Citation

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 r — View Citation

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 — View Citation

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 pat — View Citation

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 Ar — View Citation

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 el — View Citation

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. 2 — View Citation

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 — View Citation

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 claudicati — View Citation

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 myoca — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		3 months and 3.5 years post-op	No