SAFETY, SUCCESS, AND RESTENOSIS AFTER ELECTIVE CORONARY IMPLANTATION OF THE PALMAZ-SCHATZ STENT IN 100 PATIENTS AT A SINGLE CENTER

We report the immediate safety, efficacy, and 6-month angiographic follow-up after elective implantation of the Palmaz-Schatz stent (Johnson & Johnson Interventional Systems, Warren, N.J.) in the first 100 consecutive patients at a single center. Patients with suitable cardiac anatomy and no contraindications to anticoagulation were prospectively entered into the study. One hundred two stents were successfully implanted in 99 patients. The mean diameter stenosis was 70% +/- 11% before implantation and was reduced to 20% +/- 11% after stent implantation. There were no deaths, Q-wave myocardial infarcts, urgent bypass operations, or strokes during the procedure or follow-up period. Stent thrombosis occurred in two patients; in both vessel patency was successfully accomplished by balloon angioplasty. There were three gastrointestinal hemorrhages, two of which required transfusion. Angiographic follow-up was performed in 98% of patients at 6.3 +/- 2.6 months after the procedure. Restenosis (greater-than-or-equal-to 50% stenosis within or immediately adjacent to the stent) occurred in 32%. Stent restenosis was associated with male sex (36% vs 7% for female subjects; p = 0.03) and stent implantation in a restenosis lesion (47% vs 25% for de novo lesions; p = 0.03); it was inversely associated with current cigarette smoking (0% vs 36% for nonsmokers; p = 0.02). In conclusion, the Palmaz-Schatz stent can be electively implanted with high success and low complication rates. The restenosis rate appears to be similar to that of balloon angioplasty.