NORSTENT and BASKET-SAVAGE Trials Offer New Insights on Use of DES and BMS
There were no significant differences in mortality and nonfatal spontaneous myocardial infarction (MI) between patients undergoing percutaneous coronary intervention (PCI) who received drug-eluting stents (DES) and those receiving bare-metal stents (BMS), according to results from the NORSTENT Trial presented Aug. 30 during ESC Congress 2016 in Rome and simultaneously published in the New England Journal of Medicine. However, rates of repeat revascularization were lower in patients that received DES.
The study out of Norway randomly assigned approximately 9,000 PCI patients with stable or unstable coronary artery disease between Sept. 15, 2008 and Feb. 14, 2011, to receive either a DES or a BMS. Of the patients in the DES group, 96 percent received everolimus or zotarolimus-eluting stents.
Overall results after a median of five years follow up showed the rates of death from any cause and nonfatal spontaneous MI were 16.6 percent in the DES group and 17.1 percent in the BMS group (P=0.66). Study investigators did note that the rates of repeat revascularization were higher in the DES group (16.5 percent) compared to the BMS group (19.8 percent). Quality of life measures did not vary significantly between the two groups, while the rates of definite stent thrombosis were slightly higher in the BMS group (1.2 percent) compared to the DES group (0.8 percent).
In an accompanying editorial, Eric R. Bates, MD, FACC, writes that the “use of BMS remains an important option for PCI in some patients, including those with a large vessel diameter in whom restenosis rates are low; those who cannot complete the longer duration of dual-antiplatelet therapy (DAPT) recommended for DES because of noncompliance or need for noncardiac surgery; those who cannot pay for DES or longer duration of DAPT because of increased cost; and those at increased risk for bleeding.” He notes that the results of the NorStent trial are important and “should increase confidence in choosing to implant BMS in selected patient if clinical indications favor that decision and should support guideline recommendations endorsing that option.”
Meanwhile, the BASKET-SAVAGE Trial, also presented Aug. 30 during ESC Congress 2016 in Rome, did find DES to have a clear advantage over BMS in patients undergoing revascularization of saphenous vein grafts (SVG). The trial randomized 173 patients with SVG disease (median age of 72 years) to undergo PCI with either BMS or paclitaxel DES.
While terminated due to limited enrollment, results showed a significantly lower percentage of major adverse cardiac events in the DES group (2 percent) compared to the BMS group (18 percent, P<0.001). Investigators noted the difference was driven largely by a 12 percent rate of repeat procedures in the target graft among patients receiving BMS, compared to none in the DES group. Additionally, data showed a significantly higher rate of nonfatal MI in the BMS group (12 percent) compared to the DES group (2 percent, P=0.025).
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