Objective: This study sought to compare two strategies of revascularization in patients obtaining a good immediate angiographic result after percutaneous transluminal coronary angioplasty (PTCA): elective stenting versus optimal PTCA. A 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-PTCA 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 PTCA have a 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 PTCA (n=59). After randomization in the PTCA 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 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 stent 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< or =0.3 vs. 1.24+/-0.29 mm for the stent and the PTCA 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 PTCA group (p=NS). Overall costs (hospital 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 delay angiogram and provisional stent if early loss occurs had similar restenosis rate and TVR, but lower cost than primary stenting after PTCA.