Comparison of six-month outcomes for primary percutaneous revascularization for acute myocardial infarction with drug-eluting versus bare metal stents (from the APEX-AMI study).
We evaluated the use and outcomes of drug-eluting stents (DESs) and bare metal stents (BMSs) in a large primary percutaneous coronary intervention (PCI) acute ST-elevation myocardial infarction (MI) trial. Recently concerns have been raised with "off-label" use of DESs for short- and long-term clinical outcomes. Limited randomized data exist evaluating DESs versus BMSs in ST-elevation MI. Patients (n=5,745) in the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial were categorized by stent type used. Baseline variables and clinical outcomes were collected at 90 days and 6 months. Outcomes by stent type were adjusted for using conventional multivariable predictors of 90-day mortality (age, anterior location, total ST-segment deviation, and Killip class), time to PCI, and Thrombolysis In Myocardial Infarction grade flow. Stents were deployed (at the investigator's discretion) in 5,124 patients (89.2%) with acute MI, with DES use in 2,221 (43.3%) and BMS use in 2,903 (56.7%). Patients receiving DESs were younger (median 59 vs 63 years of age, p<0.001), had left anterior descending coronary artery PCI (57.9% vs 48.1%, p<0.001), and often were treated in the United States (58.2%). DES-treated patients had a lower adjusted mortality at 90 days (hazard ratio 0.73, 95% confidence interval [CI] 0.54 to 0.99, p=0.046) and trended toward lower mortality (hazard ratio 0.77, 95% CI 0.58 to 1.03, p=0.084) and recurrent MI (hazard ratio 0.81, 95% CI 0.59 to 1.11, p=0.186) at 6 months compared with BMSs. In conclusion, in this observational analysis of stent use from a large primary percutaneous intervention for acute MI trial, DESs appear as safe as BMSs with similar 6-month clinical outcomes with regard to death and recurrent MI.
Patel
Manesh R
MR
Duke Clinical Research Institute, Durham, North Carolina, USA. patel017@mc.duke.edu
Pfisterer
Matthias E
ME
Betriu
Amadeo
A
Widmisky
Petr
P
Holmes
David R
DR
O'Neill
William W
WW
Stebbins
Amanda
A
Van de Werf
Frans
F
Armstrong
Paul W
PW
Granger
Christopher B
CB
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D003627:Data Interpretation, Statistical; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy*; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D012008:Recurrence; D012307:Risk Factors; D057127:Single-Chain Antibodies; D015607:Stents; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D057127:Single-Chain Antibodies; C402724:pexelizumab