Optimal coronary balloon angioplasty with provisional stenting versus primary stent (OCBAS): Immediate and long-term follow-up results

Objective. This study sought to compare two strategies of revascularization in patients obtaining good immediate angiographic result after percutaneous transluminal coronary angioplasty (PTCA): elective stenting versus optimal PTCA. good immediate angiographic result with provisional stenting was considered to occur only if early loss in minimal luminal diameter (MLD) was documented at 30 min post-PTC angiography. Background. Coronary stenting reduces restenosis in lesions exhibiting early deterioration (>0.3 mm) in MLD within the first 24 hours (early loss) after successful PTCA. Lesions with no early loss after PTC have low restenosis rate. Methods. To compare angiographic restenosis and target vessel revascularization (TVR) of lesions treated with coronary stenting versus those treated with optimal PTCA, 116 patients were randomized to stent (n = 57) or to optimal PTC (n = 59). After randomization in the PTC group, 13.5% of the patients crossed over to stent due to early loss (provisional stenting). Results. Baseline demographic and angiographic characteristics were similar in both groups of patients. At 7.6 months, 96.6% of the entire population had follow-up angiographic study: 98.2% in the stent and 94.9% in the PTC group. Immediate and follow-up angiographic dat showed that acute gain was significantly higher in the stent than in the PTC group (1.95 vs. 1.5 mm; p < 0.03). However, late loss was significantly higher in the stent than the PTC 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. 1.24 ± 0.29 mm for the stent and the PTC groups, respectively; p = NS). Angiographic restenosis rate at follow-up (19.2% in stent vs. 16.4% in PTCA; p = NS) and TVR (17.5% in stent vs. 13.5% in PTCA; p = NS) were similar. Furthermore, event-free survival was 80.8% in the stent versus 83.1% in the PTC group (p = NS). Overall costs (hospital and follow-up) were US $591,740 in the stent versus US $398,480 in the PTC group (p < 0.02). Conclusions. The strategy of PTC with delay angiogram and provisional stent if early loss occurs had similar restenosis rate and TVR, but lower cost than primary stenting after PTCA.