Similar Overall Long-Term Outcomes, Less Stent Thrombosis with Newer DES in STEMI
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Among patients with ST-segment elevation myocardial infarction (STEMI), everolimus-eluting stents (EES) match the overall efficacy of older sirolimus-eluting stents (SES) through 3 years while carrying lower risk of stent thrombosis, according to results of a small randomized trial published in the August 2014 issue of JACC: Cardiovascular Interventions.
“Therefore, while waiting for the results of additional large studies with long-term follow-up data, EES may be safely considered for use” in this challenging subset, Giuseppe De Luca, MD, PhD, of Eastern Piedmont University (Novara, Italy), and colleagues write.
| Methods |
| The RACES-MI trial randomized 500 consecutive STEMI patients (mean age 59 years) who were admitted within 12 hours of symptom onset to a single tertiary center for primary PCI with either EES (n = 250) or SES (n = 250) from April 2007 to May 2009. All patients had chest pain for more than 30 minutes and either ST-segment elevation of 1 mm or more in at least 2 contiguous electrograph leads or new LBBB. |
| At the time of the procedure, patients were given a 70-U/kg IV bolus of unfractionated heparin, 500 mg of IV aspirin, and a 600-mg clopidogrel loading dose, with the GPI use left to the operator’s discretion. After the procedure, antiplatelet therapy included 100 mg/day of aspirin indefinitely and 75 mg of clopidogrel daily with a recommended duration of 12 months. |
Angiographic and procedural characteristics were generally similar in the SES and EES groups, with the exception of reference diameter—larger in the former (3.35 vs 3.25 mm; P = .001)—and the use of GPIs—more common in the latter (42.4% vs 54.4%; P = .006).
Overall Outcomes Similar, but Stent Thrombosis Lower With EES
Through 3 years of follow-up, the rate of MACE (cardiac death, reinfarction, definite/probable stent thrombosis, and TVR) was similar between the 2 groups, with no differences in any of the individual components except for a higher risk of stent thrombosis with SES (table 1).
Table 1. Three-Year Outcomes
|
EES |
SES |
Adjusted HR (95% CI) |
MACE |
16.0% |
20.8% |
0.73 (0.48-1.10) |
Cardiac Death |
4.4% |
5.6% |
0.75 (0.34-1.67) |
Reinfarction |
6.4% |
10.0% |
0.57 (0.30-1.07) |
TVR |
4.8% |
4.8% |
1.00 (0.44-2.25) |
Definite/Probable Stent Thrombosisa |
1.6% |
5.2% |
0.26 (0.08-0.80) |
a P = .036.
There were no differences between the groups in the use of recommended drugs at discharge or in the duration of dual antiplatelet therapy, and none of the stent thrombosis cases was tied to premature discontinuation of dual therapy in the first year.
First Long-Term DES Data in STEMI
Because of concerns about late stent thrombosis stemming from first-generation DES “the attention of research has been focused on new DES technologies with more biocompatible or bioabsorbable polymers,” Dr. De Luca and colleagues write. “Among elective patients, those stents have been shown to further improve outcome as compared with the outcomes of BMS and first-generation DES. Few studies have so far investigated the new generation of DES in the setting of STEMI.”
And 3 trials that have done just that—COMFORTABLE-AMI, EXAMINATION, and XAMI—reported results only out to 1 year. RACES-MI is the first trial comparing EES with SES in STEMI with 3-year results available.
“Together, these data support the preserved efficacy but improved safety of new-generation as compared to first-generation DES in the setting of STEMI,” the researchers write, acknowledging, however, that RACES-MI lacked the robust sample size and power needed to detect differences in mortality and other secondary endpoints.
Source:
Di Lorenzo E, Sauro R, Varricchio A, et al. Randomized
comparison of everolimus-eluting stents and sirolimus-eluting stent in patients
with ST elevation myocardial infarction: RACES-MI trial. J Am Coll Cardiol Intv. 2014;7:849-856.
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Todd Neale is the Associate News Editor for TCTMD and a Senior Medical Journalist. He got his start in journalism at …
Read Full BioDisclosures
- Dr. De Luca reports no relevant conflicts of interest.
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