Impact of the 1-year angioscopic findings on long-term clinical events in 504 patients treated with first-generation or second-generation drug-eluting stents: The DESNOTE-X Study.

Aims: We aimed to test the hypothesis that the presence of in-stent yellow plaque (YP) assessed by angioscopy would be a risk of very late stent failure (VLSF) of the cobalt-chromium everolimus-eluting stent (CoCr-EES) in comparison with first-generation drug-eluting stents (DES). Methods and results: DESNOTE-X was a prospective cohort study, an extended study of the DESNOTE study (UMIN000013515). All patients who received successful angioscopic examination at planned one-year follow-up of DES were clinically followed. The primary endpoint was VLSF defined as a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularisation. A total of 504 patients with 549 lesions were enrolled over a period of 12.5 years. At one-year follow-up, the incidence of YP was significantly higher in the first-generation DES than in the CoCr-EES (199/292 [68%] vs 80/257 [31%], p<0.001). Maximum yellow colour grade on coronary angioscopy at one-year follow-up was an independent predictor of future VLSF in the first-generation DES (HR 2.604 [95% CI: 1.265-5.361], p=0.009), whereas it was not in the CoCr-EES (p for interaction 0.022). Conclusions: The incidence of in-stent atherosclerosis identified as YP on angioscopy was lower and its impact on late clinical events appeared smaller in the CoCr-EES than in the first-generation DES.