Original: title Long-Term Outcome After Drug-Eluting VersusBare-Metal Stent Implantation in Patients WithST-Segment Elevation Myocardial Infarction. 5 Years Follow-Up From the Randomized DEDICATION (Drug Elution and DistalProtection in Acute Myocardial Infarction) Trial. Reference: Lene Holmvang et al. J Am CollCardiolIntv 2013, article in press.
Primary angioplasty reduced mortality and reinfarction compared with thrombolytics in patients experiencing an ST segment elevation myocardial infarction. Two recent meta-analyses of randomized controlled trials evaluated the safety and efficacy of the first generation drug-eluting stents (DES) versus bare metal stents (BARE) and found an expected and significant difference in revascularization for DES and a nonsignificant trend to reduce deaths per year.
The DEDICATION study, (Drug Elution and Distal Protection in Acute Myocardial Infarction), randomized 626 patients experiencing ST segment elevation myocardial infarction to DES or BARE. Of the DES, 46% were sirolimus-eluting, 41% paclitaxel-eluting and 13% Zotarolimus-eluting. For BARE, 38% were cobalt alloy and 62% stainless steel. At five years the combined end point of death, MI and revascularization (MACE) tended to be lower in the DES group, (16.9% versus 23%, p = 0.07), mainly due to lower revascularization. However, when only considering cardiac death the difference favored the BARE group, (24 versus 10 events, P = .02).
Overall stent thrombosis at five years was low and similar in both groups, (5.4%), and none of the early cardiac deaths (before a month) can be clearly allocated to this complication. After the first month, 14 of the 18 cardiac deaths, (78%), can be allocated to stent thrombosis.
Conclusion:
The implantation of a drug-eluting stent in the context of primary angioplasty is associated with increased cardiac mortality at five years and this can only partially be explained by increased stent thrombosis. In this study, mortality with cardiac stents was significantly lower than in all previous reports.
Commentary:
The risk of thrombosis with the new generations of DES is shown to be lower than with the first generation devices evaluated in this study. The overwhelming advantage in terms of MACE in favor of DES (basically due to lower revascularization) during the first year was diluted over time. In fact, the difference after five years does not reach statistical significance. Note that the events (especially cardiac death) recorded in BARE were well below everything published so far, so we should expect long-term monitoring in other studies.
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