Patients at high risk for bleeding who underwent PCI had better outcomes if they received a polymer-free umirolimus-coated stent compared with a bare-metal stent, according to a randomized, double blind trial.
After 390 days of follow up, the primary safety end point of the composite of cardiac death, MI or stent thrombosis occurred in 9.4 percent of patients in the umirolimus-coated stent group and 12.9 percent of patients in the bare-metal stent group.
Further, 5.1 percent and 9.8 percent of patients, respectively needed clinically driven target-lesion revascularization, which was the primary efficacy end point.
Lead author Philip Urban, MD, director of invasive cardiology at Hôpital de la Tour in Geneva, Switzerland, presented the findings on Oct. 14 in a late-breaking clinical trials session at the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco.
Results of the ongoing LEADERS FREE trial were simultaneously published online in The New England Journal of Medicine. The study was funded by Bisensors Europe, the manufacturer of the stents used in this trial.
The umirolimus-coated BioFreedom stent is not yet FDA-approved, but it is available in Europe.
“There are preliminary talks with the FDA,” Urban said. “The intention is to bring this stent to the U.S. It may take some time and probably some more trials.”
An estimated 15 percent to 20 percent of patients undergoing PCI are at high risk for bleeding, according to Urban. He added that the percentage of high bleeding risk patients is increasing. He also noted that guidelines recommend these patients use a second-generation drug-eluting stent with a shortened course of dual antiplatelet therapy or a bare-metal stent followed by a month of dual antiplatelet therapy.
Urban said patients with high blood pressure are typically excluded from device and antiplatelet trials and have never been studied as a group.
In this trial, 2,466 patients with coronary artery disease and high blood pressure were randomized at 68 sites in four countries to receive the umirolimus-coated BioFreedom stent or the bare-metal Gazelle stent. All patients received aspirin and a P2Y12 inhibitor once daily for 30 days followed by a single antiplatelet agent for the remainder of the study.
“The advantages [of the BioFreedom stent] are there is no polymer at all, so you obviously can have no side effect from a polymer early or late, and the drug transfers rapidly to the vessel wall – 98 percent within a month,” Urban said. “Those two elements combined made us consider it as a potential candidate for safe, short [dual antiplatelet therapy].”
At baseline, the groups were well balanced. The mean age was approximately 76, and approximately 70 percent of patients were males.
During the study, cardiac death occurred in 4.2 percent of patients in the drug-coated stent group and 5.3 percent of patients in the bare-metal stent group, while MI occurred in 6.1 percent and 8.9 percent of patients, respectively. Stent thrombosis occurred in 2.0 percent and 2.2 percent of patients, respectively.
At the 12-month follow up, 18.1 percent of patients in the drug-coated stent group and 19.1 percent of patients in the bare-metal stent group had bleeding. Major bleeding occurred in 7.2 percent and 7.3 percent of patients, respectively.
“You could imagine down the road if it’s really demonstrated to be equivalent to a drug-eluting stent, you might consider that this could become a workhorse stent for everybody and then you just use the [dual antiplatelet therapy] duration that you think is right for the individual patient,” Urban said. “This is the first trial, but we’ve got such a wealth of evidence with fantastic drug-eluting stents out there with biodegradable polymers. I think for the moment it’s sensible to keep this device for [high bleeding risk] patients and wait and see.”