OPTIMAL CORONARY BALLOON ANGIOPLASTY WITH PROVISIONAL STENTING VERSUSPRIMARY STENT (OCBAS) - IMMEDIATE AND LONG-TERM FOLLOW-UP RESULTS

Objective. This study sought to compare two strategies of revasculariz ation in patients obtaining a good immediate angiographic result after percutaneous transluminal coronary angioplasty (PTCA): elective stent ing versus optimal PTCA. A good immediate angiographic result with pro visional stenting was considered to occur only if early loss in minima l luminal diameter (MLD) was documented at 30 min post-PTCA angiograph y. Background. Coronary stenting reduces restenosis in lesions exhibit ing early deterioration (>0.3 mm) in MLD within the first 24 hours (ea rly loss) after successful PTCA, Lesions with no early loss after PTCA have a low restenosis rate. Methods. To compare angiographic restenos is and target vessel revascularization (TVR) of lesions treated with c oronary stenting versus those treated with optimal PTCA, 116 patients were randomized to stent (n = 57) or to optimal PTCA (n = 59). After r andomization in the PTCA group, 13.5% of the patients crossed over to stent due to early loss (provisional stenting). Results. Baseline demo graphic and angiographic characteristics were similar in both groups o f patients. At 7.6 months, 96.6% of the entire population had a follow -up angiographic study: 98.2% in the stent and 94.9% in the PTCA group . Immediate and follow up angiographic data showed that acute gain was significantly higher in the stent than in the PTCA group (1.95 vs. 1. 5 mm; p < 0.03), However, late loss was significantly higher in the st ent than the PTCA group (0.63 +/- 0.59 vs. 0.26 +/- 0.44, respectively ; p = 0.01). Hence, net gain with both techniques was similar (1.32 +/ - 0.3 vs. 1.23 +/- 0.29 mm for the stent and the PTCA groups, respecti vely; p = NS). Angiographic restenosis rate at follow-up (19.2% in ste nt vs, 16.4% in PTCA; p = NS) and TVR (17.5% in stent vs. 13.5% in PTC A; p = NS) were similar. Furthermore, event-free survival was 80.8% in the stent versus 83.1% in the PTCA group (p = NS). Overall costs (hos pital and follow-up) were US $591,740 in the stent versus US $398,480 in the PTCA group (p < 0.02). Conclusions. The strategy of PTCA with d elay angiogram and provisional stent if early loss occurs had similar restenosis rate and TVR, but lower cost than primary stenting after PT CA, (C) 1998 by the American College of Cardiology.