MIAMI—Second-generation drug-eluting stents are feasible and effective in the treatment of unprotected left main coronary artery lesions, according to findings presented Oct. 24 at the late-breaking trials at the Transcatheter Cardiovascular Therapeutics conference.
Julinda Mehilli, MD, co-director of clinical research and data coordination in the Intracoronary Stenting and Anti-Thrombosis Research (ISAR) Center at the German Heart Center in Munich, and colleagues initiated the trial without industry funding. Their intent was to determine whether the second-generation stents were inferior to first-generation stents in the treatment of unprotected left main artery disease and to evaluate the relative performance of zotarolimus-eluting stents (ZES) and everolimus-eluting stents (EES).
“There is a large body of scientific evidence showing that the risk of death of myocardial infarction in patients with unprotected left main artery disease who undergo PCI and CABG is very similar, even in long-term cohorts," Mehilli said. "But repeat revascularization is two to three times higher after PCI than after CABG. That is why we are looking for the drug-eluting stent that is the best performing in these patients.”
The randomized, multicenter trial enrolled 650 patients at three centers in Germany and one in Italy. One group of 324 patients received ZES (Endeavor Resolute, Medtronic) and the other group of 326 patients received EES (Xience, Abbott). All of the patients either refused surgery or were not surgical candidates.
The primary endpoints were major adverse cardiovascular events (MACE) at one year post-procedure. Secondary endpoints were definite or probable stenosis at one year follow-up, and angiographic restenosis at six to nine months post-procedure.
Among the ZES group, 69 percent had multivessel coronary artery disease, compared to 74 percent of the EES patients. Eighty-three percent of the patients in the ZES group had distal lesions compared to 77 percent of the EES patients; 62 percent of ZES patients received a single stent compared to 66 percent of the EES patients.
The two groups experienced similar outcomes. At the one-year point, 17.5 percent of the ZES patients and 14.3 percent of the Xience patients met the primary endpoint; this difference was not statistically significant. Among the ZES group, 0.6 percent experienced stent thrombosis and 0.3 percent experienced probable thrombosis. Among the EES group, 0.6 percent experienced stent thrombosis. The ZES groups experienced angiographic restenosis at the rate of 21.5 percent compared to 16.8 percent among the EES group. Clinical restenosis was experienced by 11.7 percent of the ZES group and 9.4 percent of the EES group.
Noting that the patient cohort was extremely high risk, Mehilli’s team concluded that the second-generation stents performed well and were safe and feasible treatments for patients with unprotected left main artery disease. The study findings further stated that neither the ZES nor EES stent was inferior to the other in the treatment of these patients.