A polymer-free, drug-coated stent was as safe and effective as a conventional drug-eluting stent at 5 years in the treatment of de novo coronary lesions, a first-in-man study has shown.
A stent coated with a lower dose of the drug Biolimus A9 did not reach the same efficacy rate as the higher dose.
The results may change practice when treating complex patients at high risk for bleeding, according to lead investigator, Dr. Ricardo A. Costa of the Instituto Dante Pazzanese de Cardiologia, São Paulo. The results were presented the results at this year’s Transcatheter Cardiovascular Therapeutics annual meeting, and simultaneously published online (JACC Cardiovasc Interv. 2015. doi: 10.1016/j.jcin.2015.09.008).
The lipophilic Biolimus A9 is intended for use with a proprietary polymer-free, stainless steel stent (BioFreedom, Biosensors International) that is structured to hold the drug on its abluminal surface. The drug was developed to avoid the chronic inflammation and local toxicity associated with the durable polymers used in first-generation drug-eluting stents. It was also intended to reduce the duration of dual-antiplatelet therapy, which often can surpass 6 months and is contraindicated in patients at high risk for bleeding.
In this first-in-man study conducted at four sites across Germany, 182 patients with de novo lesions were randomly assigned to treatment with a standard-dose drug-coated stent, a low-dose drug-coated stent, or to receive a first-generation paclitaxel-eluting stent.
About two-thirds of all study participants were men in their mid- to late-60s and 70s with stable angina. Prior percutaneous intervention had been performed in a third of the standard-dose drug-coated stent group, 44% of the low-dose group, and 46% of the control group.
Angiographic follow-up at 4-months showed that in-stent late lumen loss, a surrogate for neointimal hyperplasia, in both drug-coated cohorts was significantly lower than in the drug-eluting stent group (0.08 mm and 0.12 mm vs. 0.37 mm, respectively; P less than .0001 for regular dose vs. drug-eluting stent; P = .002 for low-dose vs. drug-eluting stent).
Angiographic follow-up at 1 year showed in-stent late lumen loss was 0.17 mm in the drug-coated stent group vs. 0.35 mm in the drug-eluting stent group (P = .001 for noninferiority; P = .11 for superiority); although at 0.22 mm, the low-dose group did not achieve noninferiority (P = .21).
At 5-year follow-up in 175 of the original 182 patients, there were no significant differences in major adverse cardiac events between the standard-dose (23.8%) and low-dose (26.4%) drug-coated stents and the drug-eluting stent (20.3%), or in clinically-indicated target lesion revascularization, at 10.8%, 13.4%, and 10.2%, respectively. In addition, there were no reported incidences of stent thrombosis across the cohorts.
The results of this trial support those from the LEADERS FREE trial, also presented at this year’s TCT annual meeting, which indicated that the drug-coated stent with only 1 month of dual antiplatelet therapy was safe and effective in complex patients at high risk for post-PCI bleeding.
Dr. Costa and his coinvestigators wrote that although their data were based on patients with simple, discrete lesions, they hope their findings lead to larger studies, and they concluded that the drug-coated stent “may offer less dependence on prolonged dual antiplatelet therapy than polymer-coated drug-eluting stents, while maintaining efficacy; thus, it may be suitable for those at high risk for bleeding.”
This trial was underwritten by Biosensors International. Dr. Costa has received speakers fees from Biosensors, Medtronic, and Daiichi-Sankyo. Three coinvestigators disclosed ties to Bristol-Myers Squibb/Sanofi, the Medicines Company, Lilly/Daiichi-Sankyo, Abbott Vascular, AstraZeneca, Regado Biosciences, and Johnson & Johnson.
wmcknight@frontlinemedcom.com
On Twitter @whitneymcknight
