Biolimus-Eluting Stents More Effective Than Bare-Metal Stents in AMI Patients
The use of biolimus-eluting stents with a biodegradable polymer resulted in fewer adverse cardiac events at one year compared to bare-metal stents (BMS) in STEMI patients undergoing primary percutaneous coronary intervention (PCI), according to a new study published in The Journal of the American Medical Association (JAMA) on Aug. 21.
Overall results from the randomized trial, known as COMFORTABLE AMI, showed a significant 4.4 percent absolute reduction and a 51 percent relative reduction in the risk of major adverse cardiac events at one year with biolimus-eluting stents with a biodegradable polymer. According to the study authors, the difference was driven by a lower risk of target vessel–related reinfarction (3 [0.5 percent] vs. 15 [2.7 percent]; HR, 0.20; 95 percent CI, 0.06-0.69; P=.01) and ischemia-driven target-lesion revascularization (9 [1.6 percent] vs. 32 [5.7 percent]; HR, 0.28; 95 percent CI, 0.13-0.59; P_.001) with the biolimus-eluting stents.
Compared with the use of BMS, study authors also noted robust findings for the "more comprehensive patient-oriented composite of any death, reinfarction, or revascularization." For example, biolimus-eluting stents were associated with a 4.9 percent absolute reduction and a 72 percent relative reduction in the risk of ischemia-driven target-lesion revascularization.
Data did show that rates of cardiac death were not significantly different (2.9 percent vs. 3.5 percent) between BMS and biolimus-eluting stents. There was also a lower absolute rate of repeat revascularization in both treatment groups.
It's important to note that the biolimus-eluting stent used in the study is currently not approved by the Food and Drug Administration and not considered as standard of care in the U.S. According to the study authors, "it remains to be determined how this stent platform performs compared with newer-generation durable polymer-based drug-eluting stents." They also suggest that future research is needed to establish the optimal duration of dual antiplatelet therapy after implantation of biolimus-eluting stents with a biodegradable polymer.
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