ARTS II: Drug-eluting stents as effective as bypass surgery

One-year trial results indicate that drug-eluting stents are promising for treatment of complex, multivessel disease.

ORLANDO — Drug-eluting stents compared well with bypass surgery in the ARTS II trial, reported here at the recent American College of Cardiology Scientific Session 2005.

Investigator Patrick Serruys, MD, chief of interventional cardiology at the Thoraxcenter-Erasmus University, Rotterdam, presented the ARTS II one-year results. “We can conclude at a 0.05 level of significance that patients in ARTS II who were treated with the drug-eluting stents performed better than patients treated with bypass surgery in ARTS I.”

In commenting on the significance of the results, Valentin Fuster, MD, PhD, said that the trial represents a “breakthrough” in that the “data are so obviously important,” setting the stage for advances in nonsurgical treatment of multivessel disease in patients with diabetes.

Fuster, professor of cardiology at the Mt. Sinai School of Medicine, said that the results suggest that drug-eluting stents may “have more of an impact on the hard endpoints of MI and mortality than even CABG.”

Multivessel lesions

ARTS II (Arterial Revascularization Therapies Study part II: sirolimus-eluting stents for the treatment of patients with multivessel do novo coronary artery lesions) included 607 registry patients who were treated with the sirolimus-eluting stent (Cypher, Cordis Johnson&Johnson). Their results were compared to historical controls from the ARTS I trial, which included 602 patients treated with CABG and 600 treated with a bare metal stent.

Serruys said that 26.2% of the ARTS II registry population had diabetes; 54% had three-vessel disease and 13.9% had type C lesions. The average number of drug-eluting stents used per patient was 3.7; the average total stent length was 73 mm. Thirty-three percent of the ARTS II patients were also treated with a GPIIb/IIIa agent, which was not available when the ARTS I trial was conducted in the late 1980s.

In comparison, 18.2% of the ARTS I patients had diabetes; 28% had three-vessel disease and 7.5% had type C lesions. The average number of stents per patient in the bare metal stent group was 2.8; the average total length was 48 mm.

Primary endpoints in ARTS II were major adverse cardiac and cerebrovascular events, including death, nonfatal MI and revascularization at one year when comparing patients treated with the Cypher stent vs. patients treated with CABG in ARTS I. Secondary endpoints were adverse events at 30 days, six months, three and five years; the total cost; and the cost, cost effectiveness and quality of life at six months and at one, three and five years.

Patients included in ARTS II had not undergone CABG or angioplasty, had stable or unstable angina or silent ischemia, and had de novo lesions.

One-year results

At one year, the incidence of major cardiac and cerebrovascular events was not significantly different between the patients who received a drug-eluting stent in ARTS II (10.4%) and the patients undergoing bypass surgery in ARTS I (11.6%, P=.46). The patients treated with a bare metal stent in ARTS I had a significantly higher rate of adverse events at one year (26.5%), Serruys said.

The bare metal stent group had a significantly higher rate of revascularization with PCI compared to the drug-eluting stent group in ARTS II.

There were no significant differences between the ARTS II patients and the ARTS I patients treated with CABG in one-year mortality (1% vs. 2.7%, respectively); or in the incidence of cerebrovascular events (0.8% vs. 1.8%, respectively); MI (1.2% vs. 3.5% respectively); or revascularization with CABG (2% vs. 0.7%, respectively); or PCI (5.4% vs. 3%, respectively).

Serruys and Fuster both said that a randomized trial is needed before the either type of therapy — drug-eluting stent or bypass surgery — can be considered superior to the other. – by Kathy Holliman

For more information:

• Serruys PW, Ong AT, Colombo A, et al. Arterial Revascularization Therapies Part II: sirolimus-eluting stent for the treatment of patients with multivessel do novo coronary artery lesions. Late-breaking trial presented at the American College of Cardiology Scientific Session 2005. March 6-9, 2005. Orlando.