At five years, Cordis’ Cypher sirolimus-eluting stents (SES) had a safety record comparable to CABG and superior to bare-metal stents (BMS), and a major adverse cardiac and cerebrovascular event (MACCE) rate that was higher than in patients treated with CABG and lower than in those treated with BMS, based on the results of the randomized ARTS II trial.
The purpose of this study is to compare the five-year clinical outcomes, safety and efficacy of SES in ARTS II (Arterial Revascularization Therapies Study II), led by Patrick W. Serruys, MD, Thorax Center at Rotterdam, the Netherlands, with the outcomes of CABG and BMS from the ARTS I.
The ARTS I was a randomized trial of 1,205 patients with multivessel disease comparing CABG and BMS. The ARTS II study was a nonrandomized trial with the Cypher, applying the same inclusion and exclusion criteria, endpoints and protocol definitions. The ARTS II trial enrolled 607 patients, with an attempt to enroll at least one-third of patients with three-vessel disease.
At five years, the death/stroke/MI event-free survival rate was 87.1 percent in ARTS II SES, versus 86 percent and 81.9 percent in ARTS I CABG and BMS cohorts, respectively. The five-year MACCE rate in ARTS II (27.5 percent) was significantly higher than ARTS I CABG (21.1 percent), and lower than in ARTS I BMS (41.5 percent), according to the authors.
Serruys and colleagues said the long-term efficacy was mainly driven by the relatively higher rates of reintervention in patients in SES compared with CABG, such that the absolute difference in repeat revascularization between the two groups increased progressively from 4.2 percent at one year to 6.2 percent, 7.9 percent and 11.6 percent at two, three and five years, respectively.
“Therefore, the current trial confirms that surgical revascularization is more durable than percutaneous revascularization. It is noteworthy, however, that the freedom from surgical or percutaneous reintervention at five years increased from 69.1 percent in the BMS to 79.2 percent in the SES,” the authors wrote.
The researcher reported that the cumulative incidence of definite stent thrombosis was 3.8 percent. Thirty-two percent of major adverse cardiac events at five years were related to possible, probable or definite stent thrombosis.
Serruys and colleagues concluded that further assessment of the “distribution and clinical impact of the SYNTAX score in various populations is warranted; however, only a propensity-matched analysis based on SYNTAX score will allow a definitive comparison of outcomes between the SYNTAX randomized controlled trial and the ARTS II registry.”