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COMFORTABLE AMI: Biodegradable polymer DES improved rate of MACE at 1 year vs. BMS
Use of biolimus-eluting stents with a biodegradable polymer resulted in a lower rate of MACE at 1 year among patients with STEMI undergoing primary PCI compared with bare-metal stents, according to results of the COMFORTABLE AMI trial.
The prospective, randomized, single blind, controlled trial, which was published in The Journal of the American Medical Association, was designed to compare biolimus-eluting stents with a biodegradable polymer (BioMatrix, Biosensors Europe SA; n=575) with BMS of otherwise identical design (Gazelle, Biosensors Europe SA; n=582) in patients with STEMI at 11 sites in Europe and Israel who underwent primary PCI.
At 1 year, major adverse cardiac events — a composite of cardiac death, target vessel-related reinfarction and ischemia-driven target lesion revascularization — occurred in 24 patients (4.3%) receiving biolimus-eluting stents with a biodegradable polymer and 49 patients (8.7%) receiving BMS (HR=0.49; 95% CI, 0.30-0.80). Researchers reported a lower risk for target vessel-related reinfarction (0.5% vs. 2.7%; HR=0.20; 95% CI, 0.06-0.69) and ischemia-driven TLR (1.6% vs. 5.7%; HR=0.28; 95% CI, 0.13-0.59) in patients receiving biolimus-eluting stents compared with those receiving BMS.
Cardiac death rates were not significantly different (biolimus-eluting stents, 2.9% vs. BMS, 3.5%; P=.53). Stent thrombosis occurred in five patients (0.9%) treated with biolimus-eluting stents and 12 patients (2.1%; P=.10) treated with BMS.
“Differences in favor of biolimus-eluting stents over BMS in our study with respect to the primary endpoint were not limited to efficacy but also driven by an 80% lower risk of target vessel–related reinfarction,” the researchers wrote. “This difference in safety has not been observed in previous randomized trials comparing drug-eluting and bare-metal stents among patients with STEMI, but is consistent with the findings of a recent meta-analysis reporting a lower risk of reinfarction during the first year with a number needed to treat of 79 compared with 45 in our study.”