710-2 Coronary Stents Versus Balloon Angioplasty for Aorto-Coronary Saphenous Vein Bypass Graft Disease: Interim Results of a Randomized Trial

The purpose of this interim analysis of the SAVED Restenosis Trial was to assess the acute results of balloon angioplasty (PTCA) and elective PalmazSchatz coronary stent placement in the treatment of de novo venous bypass graft lesions. As of August 1, 1994, 128 patients (60 PTCA, 68 Stent) have been enrolled at 13 centers. Baseline demographics were similar in both groups. Mean graft ages in the PTCA and Stent groups were 9.8 ± 4.2 vs 9.7 ± 4.5 years (p = ns). Initial angiographic results by core laboratory analysis and clinical events from 0 to 30 days were as follows: Angiographic results PICA Stent Clinical Events (%) PICA Stent Vessel diameter (mm) 3.21 3.18 Death 3.3 5.9 Baseline mid (mm) 0.98 0.93 O-wave MI 1.7 1.5 Final mid (mm) 2.12 2.85 Bypass Surgery 6.7 0 ** Final % diam stenosis 33 12 * Closure: ≥24 hrs 33 2.9 Procedure success (%) 85 96 ** g24 hrs 1.7 0 * p l 0.01 ** p l 0.05 vs PICA One or more major clinical events occurred in 11.7% of PTCA patients vs 5.9% of Stent patients (p = ns). Crossover from assigned to alternative therapy (including bypass surgery) was 13.3% for the PTCA group vs 1.5% for the Stent group (p l 0.01). In conclusion, the preliminary findings of this prospective trial indicate: (1) Elective stent placement in de novo saphenous vein bypass graft lesions achieves a superior initial angiographic result compared to balloon angioplasty; (2) Stents confer a salutary effect on early clinical events with less frequent need for alterna1e therapies including coronary bypass surgery.