Comparison of 2-year clinical outcomes with sirolimus and paclitaxel-eluting stents for patients with diabetes: results of the Registro Regionale AngiopLastiche Emilia-Romagna Registry.
BACKGROUND
Long-term outcomes of percutaneous coronary interventions (PCI) with sirolimus-eluting stents (SES) compared to paclitaxel-eluting-stents (PES) in unselected diabetics in routine practice is still debated.


OBJECTIVE
This study compared the 2-year incidence of MACE (all-cause mortality, nonfatal myocardial infarction and target vessel revascularization) of SES and PES in a real-world setting of patients with diabetes.


METHODS
Observational, multicenter, nonrandomized study.


METHODS
Prospective web-based registry (REAL Registry; study period, 2002-2005) comprising all 13 hospitals performing PCI.


METHODS
Among the 945 eligible patients treated with either SES alone (n = 606) or PES alone (n = 339), 29% were insulin-requiring, 72% had multivessel coronary disease, 26% had prior myocardial infarction and 10% had poor left ventricular function.


METHODS
Unadjusted and propensity score-adjusted 2-year clinical outcome.


RESULTS
After propensity score adjustment, 2-year MACE incidence in the SES and PES groups was equivalent (23.3% vs. 23.7%, HR 1.01, 95%CI 0.72-1.42, P = 0.96). Adjusted 2-year angiographic stent thrombosis occurred in 1.1% of the SES patients versus 2.6% of the PES patients (P = 0.15). In this large, real-world, diabetic population treated with DES, there was no difference in outcome between SES and PES. Further studies are needed to demonstrate the long-term safety of different types of DES in patients with diabetes.
Balducelli
Marco
M
Department of Cardiology, S. Maria delle Croci Hospital, Azienda Unitá Sanitaria Locale Ravenna, Viale Randi 5, Ravenna 48100, Italy. balducelli@libero.it
Ortolani
Paolo
P
Marzaroli
Paolo
P
Piovaccari
Giancarlo
G
Menozzi
Alberto
A
Manari
Antonio
A
Sangiorgio
Pietro
P
Tarantino
Fabio
F
Rossi
Rosario
R
Maresta
Aleardo
A
Tondi
Stefano
S
Passerini
Francesco
F
Guastaroba
Paolo
P
Grilli
Roberto
R
Marzocchi
Antonio
A
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000628:therapy*; D003920:Diabetes Mellitus; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D020407:Internet; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D057216:Propensity Score; D012042:Registries; D012189:Retrospective Studies; D020123:Sirolimus / Q000008:administration & dosage*
D007166:Immunosuppressive Agents; D017239:Paclitaxel; D020123:Sirolimus