Why the study?
Does the BuMA sirolimus-eluting stent reduce target lesion failure compared to the Excel sirolimus-eluting stent in patients with recent acute myocardial infarction?
Does the BuMA sirolimus-eluting stent reduce target lesion failure compared to the Excel sirolimus-eluting stent in patients with recent acute myocardial infarction?
In patients with recent AMI, the BuMA SES with faster elution kinetics resulted in similar 1-year target lesion failure but significantly lower rates of stent thrombosis and myocardial infarction compared to the Excel SES.
BuMA SES may be preferred over Excel SES in recent AMI for lower MI and thrombosis risk; extends comparative RCT data on sirolimus-eluting stents.
BACKGROUND: Implantation of early-generation metallic drug-eluting stents (DES) in patients with acute myocardial infarction (AMI) is associated with poor vessel wall healing. Use of biodegradable polymer (BP) DES might improve safety outcomes; however, the impact of varying drug elution and polymer absorption kinetics of BP-DES on clinical outcomes in the AMI population is unknown. METHODS: This subgroup analysis of the randomized PANDA III trial included 732 patients (366 in each group) presenting with recent (<1 month) AMI. Primary endpoint was 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (MI), or ischemia-driven target lesion revascularization. Secondary endpoints included a patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization; individual TLF and PoCE components; and definite/probable stent thrombosis (ST). RESULTS: There were no significant differences between-groups in baseline clinical, angiographic, or procedural characteristics other than the proportion of post-dilatation, which was performed more frequently with the BuMA stent (53.9% vs. 44.5%; P = 0.004). After 1 year, compared to Excel SES implantation in patients with AMI, BuMA was associated with similar incidences of TLF and PoCE (5.5% vs. 8.3%, P = 0.14; 8.8% vs. 9.9%, P = 0.61, respectively) but lower incidences of MI (2.5% vs. 6.1%, P = 0.02), target vessel MI (2.2% vs. 5.8%, P = 0.01), and definite/probable ST (0.3% vs. 2.2%, P = 0.04). CONCLUSIONS: BuMA SES, with faster drug elution rate and polymer absorption kinetics, might improve safety outcomes compared to Excel SES in the high-risk AMI population.
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Guan et al. (2017) studied this question.
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