Drug-eluting stents may be as safe a choice as bare metal stents when followed by a blood thinning regimen tailored to individual patients, based on the results of a research letter published March 31 in the JAMA.
The NOBORI Biolimus-Eluting vs. XIENCE/PROMUS Everolimus-Eluting Stent Trial (NEXT) trial compared biodegradable polymer biolimus-eluting stents (BP-BES) to durable polymer everolimus-eluting stents (DP-EES) for safety and efficacy in a population of more than 3,000 patients at 98 centers with target lesions scheduled for stenting. Investigators led by Masahiro Natsuaki, MD, of Saiseikai Fukuoka General Hospital in Fukuoka, Japan, randomized participants to receive either a BP-BES or a DP-EES.
After stenting, patients received a tailored course of dual antiplatelet therapy and were followed up for two years.
The primary efficacy outcome was target-lesion revascularization (TLR) at one year and the primary safety outcome was a composite of death and MI.
Of the 3,184 patients who completed the follow-up, dual antiplatelet therapy was sustained in both groups (69 percent of the BP-BES group and 70 percent of the DP-EES group). BP-BES stent treatment was noninferior to DP-EES for death or MI (7.8 percent vs. 7.7 percent) and TLR (6.2 percent vs. 6.0 percent). The cumulative incidence rates of death or MI and TLR did not differ significantly between the groups.
These data, the investigators noted, are different from meta-analyses that found biodegradable polymer drug-eluting stents associated with a higher risk of stent thrombosis or MI compared with DP-EES. But those studies differed from theirs for the follow-up period. They acknowledged that their two-year follow-up period is not sufficient to confirm long-term safety and the three-year follow-up data will be important.