Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 220
Mean Follow Up: 240 days
Mean Patient Age: 66
Female: 19

Patient Populations:

New lesions in aortocoronary venous bypass grafts
Angina pectoris, objective evidence of myocardial ischemia, or both
Stenosis of 60 percent or more of the luminal diameter
Vessels from 3.0 to 5.0 mm in diameter

Exclusions:

Myocardial infarction within the previous seven days
Contraindication to aspirin, dipyridamole, or warfarin
Ejection fraction less than 25 percent
Diffuse disease that would require more than two stents
Evidence of thrombus
Outflow obstruction of the graft due to distal anastomotic stenosis or poor runoff in the recipient native vessel

Primary Endpoints:

Angiographic restenosis, defined as stenosis of 50 percent or more of the luminal diameter at follow-up.

Secondary Endpoints:

Rate of procedural success
Change in the minimal luminal diameter from the baseline value immediately after the procedure and at six months
Duration of hospitalization
Frequency of bleeding and peripheral vascular complications

Drug/Procedures Used:

Palmaz-Schatz coronary stent vs balloon angioplasty

Concomitant Medications:

Patients assigned to stent placement received aspirin (325 mg qd) and dipyridamole (75 mg tid), beginning at least 24 hours before the procedure. During the procedure, patients received intravenous dextran 40 and heparin to maintain an activated clotting time of more than 300 seconds. Warfarin therapy was begun on the day of the procedure, and heparin therapy was continued until a therapeutic prothrombin time (international normalized ratio, 2.0 to 3.5) was achieved. Dipyridamole and warfarin were continued for one month, and aspirin indefinitely.