Long-term follow-up of second-generation everolimus-eluting stents versus first-generation sirolimus-eluting stents in acute myocardial infarction: three-year results of the XAMI trial
Selected in EuroIntervention by S. Brugaletta
Sjoerd H. Hofma, Pieter C. Smits, Jan Brouwer, Matthijs A. Velders, Arnoud W.J. van ’t Hof, Michel Queré, Cornelis Jan de Vries, Adrianus J. van Boven
EuroIntervention 2015;10:1280-1283 published online ahead of print January 2015
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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).
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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What is known
Despite the proven efficacy and safety of drug-eluting stents (DES) in the treatment of coronary artery disease, increased very late stent thrombosis (VLST) rate is still a major concern, especially in first-generation DES. Second-generation DES with more biocompatible coatings and newer anti-proliferative drugs have shown increased efficacy and reduced risk of VLST comparable to bare metal stents (BMS) in stable patients. The XAMI (Xience V stent vs. Cypher stent in Primary PCI for Acute Myocardial Infarction) trial was designed to evaluate the efficacy and safety of the second-generation XIENCE V (Abbott Vascular, Santa Clara, CA, USA) everolimus-eluting stent (EES) compared to the first-generation sirolimus-eluting CYPHER stent (SES) (Cordis Corporation, Bridgewater, NJ, USA) in acute myocardial infarction (AMI) patients undergoing primary angioplasty. This article reports the three-year follow-up of this trial.
- Six hundred and twenty-five patients were randomised (2:1) to EES or SES in the multicentre XAMI (Xience V 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 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).
Recent trials and meta-analysis have supported the use of second-generation DES in STEMI patients over BMS in terms of efficacy and safety. First generation DES had previously showed better efficacy as compared to BMS in STEMI patients, but VLST was a matter of concern. Few data are currently available on VLST of second-generation DES in STEMI, and the XIMA trial is one of the trials available with a long follow-up. It shows that at 3-year there are no concern on VLST of second generation DES. However, it should be taken into account the small sample size for this endpoint, which will probably needs a large metanalysis of those trials with long-term follow-up.