Long-term clinical outcomes after drug eluting stent implantation in women with de novo coronary lesions. Results from the REAL (REgistro Regionale AngiopLastiche Emilia-Romagna) multicenter registry.
BACKGROUND
The long-term effectiveness of drug eluting stents (DESs) in a real-world setting of female patients is currently unclear.


RESULTS
We analyzed long-term follow-up (up to 3 years) data from all female patients with de novo lesions enrolled in a prospective web-based multicenter registry (REAL Registry; study period, July 2002-June 2006) including all 15 hospitals performing PCI in the Emilia-Romagna region of Italy. Among the 3549 women without ST elevation myocardial infarction, 2434 were treated with BMSs alone and 1115 with DESs alone. At 3 years, use of DESs was associated with a lower propensity score adjusted incidence of MACE [cardiac mortality, non-fatal myocardial infarction and target vessel revascularization (TVR); 19.5% vs. 24.4%; HR 0.75, p=0.006)] and TVR (11.6% vs. 15.6%; HR 0.68, p=0.004) compared with BMSs. No difference was apparent in terms of adjusted 3-year cardiac mortality or myocardial infarction. Nevertheless, after the first 6 months of follow-up, a non significantly increased risk of myocardial infarction and stent thrombosis was found in the DES group.


CONCLUSIONS
In this real-world female registry, the use of DESs was associated with a 3-year reduction of TVR and MACE in comparison with the use of BMSs. However, the observed (non-significant) increment of late AMI makes performing larger studies to clarify the long-term safety of DESs mandatory.
Ortolani
Paolo
P
Istituto di Cardiologia, Università di Bologna, Policlinico S. Orsola-Malpighi, Italy. paortol@tin.it
Solinas
Emilia
E
Guastaroba
Paolo
P
Casella
Gianni
G
Manari
Antonio
A
Piovaccari
Giancarlo
G
Balducelli
Marco
M
Tondi
Stefano
S
Percoco
Gianfranco
G
Tarantino
Fabio
F
Passerini
Francesco
F
Rossi
Rosario
R
Vignali
Luigi
L
De Palma
Rossana
R
Grilli
Roberto
R
Marzocchi
Antonio
A
D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000401:mortality*; D023903:Coronary Restenosis / Q000401:mortality; D054855:Drug-Eluting Stents / Q000009:adverse effects / Q000706:statistics & numerical data*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality* / Q000628:therapy*; D016016:Proportional Hazards Models; D012042:Registries / Q000706:statistics & numerical data*; D012307:Risk Factors; D016896:Treatment Outcome