HOW TO PREDICT THE LONG-TERM OUTCOME OF NEW STENTS?



Yasunori Ueda, M.D., Ph.D., Osaka National Hospital, Osaka, Japan

It is well known that the short-term clinical outcome cannot predict the long-term outcome of drug-eluting stents (DES) from the experience of head-to-head comparison between Cypher and Endeavor stents, in which 1-year results were better for Cypher but 5-year results were extremely better for Endeavor stent. On the other hand, angioscopy revealed the terrible appearance of Cypher stent at 1-year follow-up having unhealed ruptured plaque, thrombus, and poor neointima coverage. Furthermore, the early formation of yellow plaque (neoatherosclerosis) at 1 year was also detected after Cypher stent implantation, which was not detected after bare metal stent (BMS) implantation. However, Endeavor stent had adequate white neointima coverage that was similar with BMS. Recently, DESNOTE study demonstrated that the presence of yellow plaque in the stented segment at 1-year follow-up was associated with the higher risk of very-late stent failure (VLSF). The use of statin and the larger reduction of serum LDL-cholesterol were associated with the lower risk of VLSF. Therefore, the DES with adequate neointima coverage without yellow plaque at 1-year follow-up would have a good long-term outcome. Aggressive LDL-cholesterol lowering therapy may also contribute to reduce the incidence of VLSF. Taking these into consideration, we should judge if a new DES is better than the previous ones by both the early clinical outcomes and early findings from the intra-coronary imaging and pathological studies. We should regard the findings from imaging and pathological studies as of same or of more important value as the early results of clinical trials. The long-term clinical outcome over 30 or 50 years may be real evidence, but 1-year clinical outcome may not worth surrogate endpoint. Looking for the imaging or pathological findings at short-term period to speculate the future clinical outcome should be more important than satisfying with the good short-term clinical outcome.