The INR was adjusted by home monitoring; all patients received 81 mg aspirin daily. Adverse events were independently adjudicated.
RESULTS:
A total of 375 aortic valve replacement patients were randomized into control (n = 190)
and test (n = 185) groups from September 2006 to December 2009.
The mean age ± standard deviation was 55.2 ± 12.5 years;
79% were men; and 93% were in sinus rhythm preoperatively.
... The follow-up duration averaged 3.82 years
(755.7 patient-years [pt-yrs] for control; 675.2 pt-yrs for test).
The mean INR was 2.50 ± 0.63 for the control and 1.89 ± 0.49 for the test groups (P < .0001).
The test group experienced significantly lower major (1.48% vs 3.26%/pt-yr; P = .047) and minor (1.32% vs 3.41%/pt-yr; P = .021) bleeding rates.
The incidence of stroke, transient ischemic attack, total neurologic events, and all-cause mortality were similar between the 2 groups.
CONCLUSIONS:
INR can be safely maintained between 1.5 and 2.0 after aortic valve replacement with this approved bileaflet mechanical prosthesis. With low-dose aspirin, this resulted in a significantly lower risk of bleeding, without a significant increase in thromboembolism.
