Cardiologists whose patients are not good candidates for dual antiplatelet therapy (DAPT) may have an option beyond a bare metal stent. Results from a trial presented March 31 at the American College of Cardiology (ACC) scientific session in Washington, D.C., showed that treatment with a drug-eluting stent (DES) in combination with a personalized DAPT approach appeared to be safe and effective at one year.
Bare-metal stents have an increased risk of restenosis and revascularization. DES address that limitation but they, in turn, have an increased risk of late and very late stent thrombosis, which requires DAPT. Current guidelines recommend at least one year of DAPT in patients treated with DES.
Marco Valgimigli, MD, PhD, of Erasmus Medical Center in Rotterdam, the Netherlands, said DAPT tolerance limits what type of stent to use in PCIs. “If you are concerned the patient is not compliant or cannot undergo one-year of DAPT, then this is a major reason for embracing a bare-metal stent,” he told Cardiovascular Business.
He and other researchers initiated the ZEUS (Zotarolimus-eluting Endeavor Sprint stent in Uncertain DES Candidates Study) trial to compare outcomes in patients who are at high risk of stent thrombosis, at high risk of bleeding or at low risk of in-stent restenosis who were treated with ether a zotarolimus-eluting Endeavor stent (Medtronic) or a thin-strut bare-metal stent and personalized DAPT duration. DAPT was based on clinical risk.
“For the first time, we are not allowing the type of device to drive the duration of DAPT,” he said. “We asked the clinician to judge by the bleeding risk or patient type what duration to go for. It is the patient driving the DAPT duration and not the device.”
They selected the zotarolimus-eluting Endeavor stent because the drug is eluted within 14 days after implantation and animal studies showed no traceable drug in coronary tissue at 28 days. “Based on this information, it makes sense to believe you can stop DAPT at one month,” Valgimigli explained.
The primary outcome was the rate of major cardiovascular adverse events (MACE) at 12 months.
The researchers enrolled and randomized 1,606 patients from sites in Italy, Switzerland and Portugal between 2011 and 2012. Of those patients, 52 percent were considered at high bleeding risk and 17 percent at high thrombosis risk.
The median DAPT duration was 31 days in the DES group and 33 days in the bare-metal stent group. At one year, the MACE rate in the DES group was 17.5 percent vs. 22.1 percent in the bare-metal stent group. The DES group also had lower rates for target vessel revascularization, MI and definite or probable stent thrombosis. Bleeding event rates were lower or equal to bare-metal stents, depending on the risk group.
“This good safety profile was observed in patients undergoing one month of DAPT or even no DAPT, which is quite remarkable,” he said. He added that the data also demonstrated effectiveness. “This patient population being denied the benefit of a DES should be in the position to at least get this DES type.”
Valgimigli said the study was open label, which was a limitation, and it may have been difficult to blind patients to the stent type. He added that the evidence applies only to the zotarolimus-eluting Endeavor stent.
The study was sponsored by University Hospital of Ferrara in Ferrara, Italy, where Valgimigli is also director of the catheterization laboratory, and supported by a grant from Medtronic.