Incidence of bleeding and compliance on prolonged dual antiplatelet therapy (aspirin + thienopyridine) following drug-eluting stent implantation.
Prolonged periods of dual antiplatelet therapy (DAT), i.e., aspirin plus a thienopyridine, are currently recommended to prevent late drug-eluting stent (DES) thrombosis. The aim of our study was to determine the risk and predictors of bleeding and compliance associated with such prolongation of DAT. In this observational study we examined 2,355 consecutive patients undergoing successful DES implantation at 4 hospitals in Italy from June 2002 to December 2004. Bleeding events occurring on DAT and warfarin or in the first 30 days after stent implantation were excluded. Median duration of DAT was 209 days (interquartile range 178 to 444) and only 158 patients (6.7%) prematurely discontinued DAT. The overall bleeding rate was 1.9% (45), with major bleeding in 19 (0.8%) and minor bleeding in 26 (1.1%). Independent predictors of bleeding were DAT (hazard ratio 19.8, 95% confidence interval [CI] 3.69 to 106.34, p <0.001) and age >65 years (hazard ratio 2.15, 95% CI 1.16 to 4.00, p = 0.02). In patients on DAT, the incidence rate (30 days to 18 months) of any bleeding event was 2.57 per 100 person-years (95% CI 1.85 to 3.48) and major bleeding was 1.10 per 100 person-years (95% CI 0.65 to 1.74). In conclusion, DAT after DES implantation is well tolerated and associated with a very low risk of major bleeding.
Latib
Azeem
A
Division of Cardiology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Morici
Nuccia
N
Cosgrave
John
J
Airoldi
Flavio
F
Godino
Cosmo
C
Brambilla
Nedy
N
Chieffo
Alaide
A
Bonizzoni
Erminio
E
Carlino
Mauro
M
Bedogni
Francesco
F
Montorfano
Matteo
M
Sangiorgi
Giuseppe M
GM
Briguori
Carlo
C
Colombo
Antonio
A
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects*; D001241:Aspirin / Q000009:adverse effects*; D016001:Confidence Intervals; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced* / Q000209:etiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects; D015994:Incidence; D007558:Italy; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction; D010349:Patient Compliance; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects*; D011446:Prospective Studies; D011725:Pyridines / Q000009:adverse effects*; D012307:Risk Factors; D020123:Sirolimus / Q000009:adverse effects*; D013997:Time Factors
D007166:Immunosuppressive Agents; D010975:Platelet Aggregation Inhibitors; D011725:Pyridines; C446540:thienopyridine; D001241:Aspirin; D020123:Sirolimus