Unexpected, late cardiovascular effects of surgery for peripheral artery disease. Veterans Affairs Cooperative Study 199.

In reviewing late morbidity of a multicenter clinical trial comparing balloon angioplasty (percutaneous transluminal angioplasty) with bypass surgery for lower-extremity ischemia, an unexpectedly high incidence of adverse systemic events in surgical patients was uncovered. The study was prospective and randomized, and included a total of 263 patients, with follow-up from 2 to 6 years. When end points of related deaths, amputations, and intervention failures were summed, surgery was favored over percutaneous transluminal angioplasty at 4 years. Progression of cardiac and renal dysfunction and mortality differed between groups. A total of 42 deaths were in the group who underwent surgery and 27 in those who underwent percutaneous transluminal angioplasty. The percentage difference in death rate between the two groups increased each year to reach 10% at 5 years. A significant difference in renal function was noted in nine patients who underwent surgery and zero who underwent percutaneous transluminal angioplasty. Myocardial infarctions were greater on follow-up of surgical patients. After 6 years, congestive heart failure had occurred in 19 patients who underwent surgery and eight who underwent percutaneous transluminal angioplasty. The trends in this study of patients with only moderately severe peripheral arterial disease suggest an increased rate of deterioration of cardiac and renal function in patients who have arterial operations. In surgical patients, mortality was 13.1% per year, whereas it was 8.4% for patients treated with percutaneous transluminal angioplasty. Future intervention studies should include long-term follow-up of such cardiovascular events.

RCT Entities:   Population Interventions Outcomes