COMFORTABLE-AMI (Comparison ofBiomatrix Versus Gazelle in STEMI)
COMFORTABLE-AMI (Comparison of BiomatrixVersus Gazelle in STEMI)L Räber (Berne University Hospital, Switzerland)EuroPCR 2012• A prospective, multicenter, randomized, controlled superiority trial in patients with acute ST-elevation myocardial infarction• Population and design: 1161 STEMI patients Randomized 1:1 to a biolimus-eluting stent (BES) or a bare-metal stent• Primary outcome: MACE defined as the composite of cardiac death, target-vessel related myocardial infarction (Q-wave and non-Q-wave), or ischemia-driven target lesion revascularization within 12 monthsSTEMI=ST-elevation myocardial infarction; MACE=Major adverse cardiac events
COMFORTABLE-AMI: Results• At one year: MACE rate was 8.7% in the bare-metal-stent arm, compared with just 4.3% in the BES arm (p=0.004) TVR (2.7% vs 0.5%, p=0.01) and target lesion revascularization (5.7% vs 1.6%, p<0.001) also significantly lower in the BES group Stent-thrombosis rates were twice as high in the bare-metal-stent group; not statistically significant (2.1% vs 0.9%, p=0.10)• In an analysis that looked only at target-vessel MI due to restenosis or stent thrombosis, only three BES patients had an event over one year vs 14 in the bare-metal-stent group; statistically significant (p=0.01)• Patients in both arms of the study took dual antiplatelet therapy for one yearTVR=target vessel revascularization
COMFORTABLE-AMI: Commentary*"None of the previous trials enrolling STEMI patients have shown a safetyadvantage with respect to myocardial infarction." - Dr Lorenz Räber"When you meet the patient the first time as they get on the table, you dont know alot about their history—the worry is, if you put in DES, you find out when they comeoff the table that they are scheduled for some near-future surgery. So a lot ofinterventionalists balance the risk of restenosis vs possible bleeding complications.Theres also a concern about endothelial healing with DES and possible stentthrombosis." - Dr Kari Niemelä*All comments from COMFORTABLE-AMI: Bioerodable polymer DES trumps bare metal in STEMI(http://www.theheart.org/article/1401109.do)
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