Key result
Second-generation everolimus-eluting stents yield similar 3-year major event rates compared to first-generation sirolimus-eluting stents.
Why the study?
The long-term safety and efficacy of second-generation everolimus-eluting stents versus first-generation sirolimus-eluting stents in acute myocardial infarction patients required evaluation.
Do second-generation everolimus-eluting stents reduce the composite of cardiac death, non-fatal AMI, or target vessel revascularisation compared to first-generation sirolimus-eluting stents in patients with acute myocardial infarction?
RCT (n=625)
2:1
Yes
Do second-generation everolimus-eluting stents reduce the composite of cardiac death, non-fatal AMI, or target vessel revascularisation compared to first-generation sirolimus-eluting stents in patients with acute myocardial infarction?
Absolute Event Rate: 8% vs 10.5%
p-value: p=0.30
In patients with acute myocardial infarction undergoing primary PCI, second-generation everolimus-eluting stents demonstrated low and comparable event rates at three years compared to first-generation sirolimus-eluting stents.
Comparable 3-year MACE and stent thrombosis rates with EES versus SES in AMI; leaves open whether second-generation stents confer advantages in larger trials.
AIMS: Evaluation of the long-term safety and efficacy of second-generation everolimus-eluting stents (EES) versus first-generation sirolimus-eluting stents (SES) in acute myocardial infarction (AMI) patients. METHODS AND RESULTS: Six hundred and twenty-five patients were randomised (2:1) to EES or SES in the multicentre XAMI (XienceV stent vs. Cypher stent in Primary PCI for Acute Myocardial Infarction) trial. The primary endpoint was cardiac death, non-fatal AMI or any target vessel revascularisation (TVR) at one year, with a planned follow-up of three years. At three-year follow-up, the primary endpoint was 8.0% for EES and 10.5% for SES (p=0.30). Cardiac death was low and comparable in both groups (EES: 2.5% versus SES: 2.7%; p=0.86), as was definite/probable stent thrombosis (EES: 2.3% versus SES 3.2%; p=0.60). CONCLUSIONS: The event rate at three years in this all-comer, randomised, multicentre AMI trial was low, including stent thrombosis, with no significant difference between first- and second-generation DES. Registration of trial:http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1123 Candidate number: 2869; NTR number: NTR1123.
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Hofma et al. (2015) conducted an RCT in Acute myocardial infarction (AMI) (n=625). Second-generation everolimus-eluting stents (EES) vs. First-generation sirolimus-eluting stents (SES) was evaluated on Cardiac death, non-fatal AMI or any target vessel revascularisation (TVR) (p=0.30). Second-generation everolimus-eluting stents yielded similar 3-year rates of cardiac death, non-fatal AMI, or TVR compared to first-generation sirolimus-eluting stents (8.0% vs 10.5%; p=0.30).
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