|Image Source: Cordis|
Washington, D.C.—In the first six-year follow-up of a drug-eluting stent (DES), the clinical benefits of the Cordis Cypher sirolimus DES compared to a bare-metal stent (BMS) were sustained, according to a scientific poster presented here at the Cardiovascular ResearchTherapies (CRT) conference.
At the six-year follow-up, patients in the Cypher stent arm of the SIRIUS trial experienced lower rates of target vessel failure (TVF)—the primary endpoint of the trial—than those who received the BMS (26.1 percent vs.39.9 percent, respectively). The researchers defined TVF as a composite of cardiac death, MI and target vessel revascularization.
The Cypher DES also demonstrated lower rates of target lesion revascularization (TLR) and major adverse cardiac events (MACE), which included MI and death, compared to the BMS. The researchers reported that the TLR rate for the Cypher stent was 11.9 percent versus 27.9 percent for the BMS; and the MACE rate for the Cypher stent was 22.6 percent versus 37.2 percent for the BMS. The six-year outcomes support the previously reported results of the trial and showed "no signs of late catch-up."
Also, there was no significant difference in the mortality or the MI rates between the Cypher stent and the BMS at six-year follow-up. The mortality rate was 8.9 percent for those receiving the Cypher DES compared to 9.4 percent for those receiving BMS (p=0.974). The MI rate for the Cypher stent was 6.4 percent, compared to 7.0 percent for the BMS (p=0.774).
There was no significant difference in the overall rate of stent thrombosis between the Cypher stent and the BMS, regardless of the definition of stent thrombosis employed. The definitions include the original SIRIUS trial protocol definition and the ARC definition, according to the researchers.
At six years, the protocol definition identified a rate of 1.2 percent stent thrombosis for the Cypher stent versus 0.8 percent for the BMS (p=0.536). The definite/probable ARC definition identified a stent thrombosis rate of 1.2 percent for the Cypher stent vs. 2.1 percent for the BMS (p=0.304).
Finally, there was no trend for an increase in ARC-defined definite or probable very late stent thrombosis rates between one and six years (0.8 percent in Cypher stent arm vs. 1 percent in the BMS arm).