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Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echo-V - DECREASE-V
Description:
The goal of the trial was to evaluate prophylactic coronary revascularization among patients with preoperative extensive stress-induced ischemia undergoing vascular surgery.
Study Design
Study Design:
Patients Screened: 1,880
Patients Enrolled: 101
Mean Follow Up: 1 year
Mean Patient Age: Median age, 70 years
Female: 12
Patient Populations:
Planned elective open abdominal aortic or infrainguinal arterial reconstruction; ≥3 cardiac risk factors, including age >70 years, angina pectoris, prior MI, compensated or a history of congestive heart failure, drug therapy for diabetes, renal dysfunction, and prior stroke or transient ischemic attack; and extensive stress-induced ischemia on stress testing
Primary Endpoints:
Death or nonfatal MI between screening and 30 days after the index surgical procedure
Secondary Endpoints:
Death or nonfatal MI by 1 year
Drug/Procedures Used:
Patients with planned elective open abdominal aortic or infrainguinal arterial reconstruction and three or more clinical cardiac risk factors underwent cardiac stress testing. Those with extensive stress-induced ischemia were randomized to coronary revascularization (n = 49) or no revascularization (n = 52). Method of revascularization (coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI] with stenting) was decided by the treating physicians.
Concomitant Medications:
All patients also received beta-blockers with a target heart rate of 60-65 bpm.
Principal Findings:
Of the patients who met the high-risk criteria and underwent stress testing, 23% (n = 101) had stress-induced ischemia and were randomized into the trial. The majority of patients had triple-vessel disease (67%). Nearly all of the patients in the trial had a prior myocardial infarction (MI) (98%). Of the revascularization cohort, PCI was performed in 65% of patients and CABG in 35%. Type of vascular surgery performed was femoro-popliteal (41%), bifurcated graft (25%), tube graft (25%), or thoraco-abdominal (10%).
The primary endpoint of death or MI by 30 days did not differ between the revascularization and no revascularization groups (42.9% vs. 32.7%, respectively, hazard ratio [HR] 1.4, p = 0.30), nor did death by 30 days (22.5% vs. 11.5%, HR 2.2, p = 0.14) or MI by 30 days (34.7% vs. 30.8%). Likewise, there was no difference in 1-year death or MI (49.0% vs. 44.2%, HR 1.2, p = 0.48), death (26.5% vs. 23.1%, HR 1.3, p = 0.58), or MI (36.7% vs. 36.5%).
Interpretation:
Among patients with preoperative extensive stress-induced ischemia undergoing elective vascular surgery, coronary revascularization prior to vascular surgery was not associated with a difference in death or MI at 30 days or 1 year compared with no revascularization.
The authors hypothesized that high-risk patients with coronary artery disease would benefit from prophylactic coronary revascularization prior to their vascular surgery since they would be at higher risk for adverse coronary events due to the potential strain of surgery. Results of the present study are similar to the CARP trial, which also showed that routine revascularization prior to elective vascular surgery was not associated with improved outcomes following vascular surgery.
While the patients in the current trial all had stress-induced ischemia and severe coronary disease on angiography, it is possible that the lesions were stable and the stress of the vascular surgery was not enough to cause plaque rupture. Current American College of Cardiology/American Heart Association guidelines suggest reserving revascularization only for high-risk, unstable patients preoperatively, and closely monitoring the patients for ischemia following vascular surgery.
References:
Poldermans D, Schouten O, Vidakovic R, et al. A clinical randomized trial to evaluate the safety of a noninvasive approach in high-risk patients undergoing major vascular surgery: the DECREASE-V Pilot Study. J Am Coll Cardiol 2007;49:1763-9.
Keywords: Myocardial Infarction, Stroke, Ischemic Attack, Transient, Heart Failure, Risk Factors, Coronary Artery Bypass, Diabetes Mellitus, Peripheral Vascular Diseases, Percutaneous Coronary Intervention
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