Author + information
- Received December 8, 1994
- Revision received April 28, 1995
- Accepted May 5, 1995
- Published online October 1, 1995.
- Nowamagbe A. Omoigui, MD, MPHa,
- Robert M. Califf, MD, FACCa,*,
- Karen Pieper, MSa,*,
- Gordon Keeler, MSa,*,
- Mary Ann O'Hanesian, MSa,*,
- Lisa G. Berdan, PA-C, MHSa,*,
- Daniel B. Mark, MD, MPHa,*,
- J. David Talley, MD, FACCa,†,
- Eric J. Topol, MD, FACCa,‡,*,
- for the CAVEAT-I Investigators
- ↵*Address for correspondence: Dr. Eric J. Topol, Department of Cardiology, Desk F25, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, Ohio 44195.
Objectives. In-hospital peripheral vascular complications of balloon angioplasty were compared with those of directional atherectomy in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I) to identify patients at risk and evaluate costs and outcomes.
Background. The incidence, costs and outcomes of peripheral vascular complications after coronary intervention have not been fully characterized as a function of randomly assigned therapy.
Methods. At 35 sites in the United States and Europe, 1,012 patients were randomized. Peripheral vascular complications were defined as the composite of pulse loss, pseudoaneurysm, hematoma >4 cm in diameter or groin hemorrhage necessitating blood transfusion. Logistic models were derived to 1) predict these complications from baseline and procedural characteristics, 2) test the relevance of randomization assignment, and 3) assess their impact on hospital costs and long-term outcomes.
Results. Sixty-seven patients (6.6%) developed peripheral vascular complications, of whom 15 (22.4%) required a blood transfusion, 14 (20.9%) underwent vascular surgery, and 2 (3.0%) died. Both in-hospital deaths occurred in patients with peripheral vascular complications. There was no difference in composite peripheral vascular complication rates among patients randomized to angioplasty or atherectomy. Greater age, female gender, postprocedural heparin and intraaortic balloon counterpulsation were predictive of increased risk. In a representative 60% subset, mean hospital costs increased from $9,583 in patients without to $18,350 in those with peripheral vascular complications (p = 0.0001). The unadjusted mortality rate at 1 year was 7.5% for patients with peripheral vascular complications compared with 1.1% for all others (p = 0.0001). These complications identified patients at greater risk of death, myocardial infarction or repeat revascularization at 30 days and 1 year. The atherectomy group had a trend toward more frequent deaths and myocardial infarction.
Conclusions. Directional atherectomy and balloon angioplasty had similar in-hospital peripheral vascular complication rates. Female gender, greater age, postprocedural heparin and intraaortic balloon counterpulsation were predictive of higher risk. The twofold increase in cost and sevenfold increase in long-term deaths highlight the need to prevent these periprocedural events and monitor patients closely.
This study was supported by grants from Devices for Vascular Intervention Inc., Redwood City, California and Eli Lilly and Company, Indianapolis, Indiana. A complete list of the CAVEAT-I investigators can be found in reference 21.
- Received December 8, 1994.
- Revision received April 28, 1995.
- Accepted May 5, 1995.
- American College of Cardiology