ARTS II: Sirolimus-eluting stents safe, comparable to CABG, bare metal stents

Patients with multivessel disease who had sirolimus-eluting stents implanted for off-label indications had better event-free survival rates and a similar safety record after five years compared with those assigned to percutaneous coronary intervention with bare metal stents and CABG, study results indicated.

Although the results of trials including RAVEL, SIRIUS and TAXUS VI have already demonstrated the long-term benefits of drug-eluting stents, the results “are not applicable to the 60% to 70% of today’s PCI patients who receive drug-eluting stents for ‘off-label’ indications,” the researchers wrote.

They compared event-free survival rates, major adverse cardiac and cerebrovascular event rates and cumulative incidence of stent thrombosis among patients enrolled in the ARTS II trial who had sirolimus-eluting stents (Cypher, Cordis) implanted (n=607) between February and November 2003 with a historical cohort of patients who participated in the ARTS I trial and were assigned to bare metal stents (n=600) or CABG (n=605) between April 1997 and June 1998.

They found that five-year mortality was similar between patients assigned to sirolimus-eluting stents, CABG and bare metal stents, with a 94.5% survival observed among patients with sirolimus-eluting stents; 92.6% survival rate among those assigned to CABG; and a 92% survival rate among those who had bare metal stent implantation. Similarly, the five-year composite safety endpoint that consisted of death, cerebrovascular accident and MI event was similar between the sirolimus-eluting stent (87.1% event-free survival) and CABG groups (86%; P=.10) but significantly better in the sirolimus-eluting stent group compared with the bare metal stent cohort (81.9%). The occurrence of major adverse cardiac and cerebrovascular events after five years was higher among ARTS II patients (27.5%) compared with ARTS I patients undergoing CABG (21.1%; P=.02) but lower than patients assigned to receive bare metal stents (41.5%; P<.001).

“These results emphasize the importance of optimal stent implantation, development of less thrombogenic devices such as drug-eluting stents with biocompatible or bioabsorbable coatings, or fully bioabsorbable drug-eluting stents, and in addition, more effective antithrombotic therapies,” the researchers wrote. – by Nicole Blazek

Serruys PW. J Am Coll Cardiol. 2010;doi:10.1016/j.jacc.2009.11.049.

While not randomized, these late, five-year results of the ARTS II study showing persistent favorable outcomes for drug-eluting stents vs. bare metal stents in a patient population with complex multi-vessel CAD are exciting. In particular, these outcomes provide reassurance with regards to the consequences of late stent thrombosis in this population with the sirolimus-eluting stent utilized. The extent to which these results are transferable to other stents/drugs is unknown until more contemporary comparative studies are available.

An additional point to note is that adjunctive periprocedural medications such as statins were used much more aggressively in the ARTS II cohort compared with the ARTS I cohort, which emphasizes the potential impact of such medical treatment in conjunction with drug-eluting stent revascularization. In all, these are favorable results for drug-eluting stents in populations that are more representative of those seen in everyday practice.

– George Vetrovec, MD
Cardiology Today Editorial Board

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