Efficacy and Saftey of 38 mm Long Stent Treatment for Diffuse Coronary Disease: A Multicenter Evaluation by Angiography and OCT Analysis at One Year After Implantation

Background: Very long lesions treatment usually contemplates the use of DES but the implantation of multiple overlapping DES for diffuse disease increases the risk of restenosis and stent thrombosis. Methods: We prospectively evaluated the performance of 38mm-long DES in terms of feasibility, efficacy and safety in elective patients undergoing stent implantation for de novo diffuse (>33 mm) coronary disease. Endpoint of the study was the occurrence of MACE (cardiac death, myocardial infarction, TLR and stent thrombosis at one year FU). Secondary endpoints were OCT struts coverage, and malapposed struts at followup. Results: 68 pts with 79 lesions were enrolled, 83.8% male, mean age of 67.2 ±10 yrs. All 79 lesions were type C, 23.5% C3. Lesions were treated with Taxus Libertè®, 14 with Endeavor Resolute®, and 10 with Xience® stents all post-dilated at high atmosphere (>20 atm) with NC balloons. Mean stent size was 3.0±0.2, mean stent per lesion was 1.1, mean stent length was 42.18 mm. No adverse in-hospital events were observed. Mean follow-up of 8.2±3.7 months was done for all pts. No MACE but 2 not cardiac deaths (2.9%) occurred, no TLR detected. OCT was randomly performed in 5 patients of each group at 8 mo FU angiography. Mean neointimal thickness was 140±72 μm, 223±107 μm and 254.5±82.5 μm and percentage of neointimal hyperplasia was 15.7±9.4%, 20.7±11.9%, and 30.7±9.4% for the Resolute®, Taxus Libertè®, and Xience® groups respectively, with a significant difference between Resolute® and the other 2 groups (P= 0.0001 with Taxus®, P=0.024 with Xience®). Percentage of IIIb+IV stent struts were 15.7%, 9.89%, and 0.87% of total struts analysed. Frames with RUTTS > 30% were 23.1%, 16.2%, and 1.3% of total analyzed for Resolute®, Taxus Libertè®, and Xience® groups respectively with a significant difference between Xience® and the other 2 groups (P=0.0001 for both Resolute® and Taxus®) Conclusion: Dedicated 38mm-long DES for treatment of complex diffuse disease can be achieved with high success rate and excellent mid term safety profile. OCT analysis revealed that second generation stents may perform significantly better than first generation in terms of safety parameters.