Key result
CarboMedics valve shows similar 5-year survival compared to the St. Jude Medical valve.
Why the study?
Comparative clinical outcomes of CarboMedics and St. Jude Medical valve implantations with low-dose anticoagulation were not well established.
Does CarboMedics valve implantation compared to St. Jude Medical valve implantation improve survival or reduce complications in patients undergoing valve replacement?
Cohort (n=697)
No
Does CarboMedics valve implantation compared to St. Jude Medical valve implantation improve survival or reduce complications in patients undergoing valve replacement?
Absolute Event Rate: 90.4% vs 91.3%
CarboMedics and St. Jude Medical valves demonstrated similar 5-year survival and low complication rates when managed with low-dose anticoagulation (target INR 1.5).
Similar survival supports clinical equipoise; leaves open whether randomized data would reveal differences in complications or durability.
Three hundred and twenty-six patients underwent CarboMedics valve implantation (CM) in the aortic (119 patients), mitral (148 patients) or aortic and mitral (59 patients) positions while 371 patients underwent St. Jude Medical valve implantation (SJ) in the aortic (113 patients), mitral (184 patient), or aortic and mitral (74 patients) positions at National Taiwan University Hospital from August 1991 through 1995. All patients received warfarin (Coumadin) anticoagulation with the target international normalized ratio around 1.5. The hospital mortality was 3.7% in the CM group and 4.3% in the SJ group. In the CM group at 5 years, the actuarial freedom from thromboembolism, valve thrombosis, and anticoagulant-related hemorrhage was 89.91 +/- 2.66%, 95. 23 +/- 1.50%, and 99.62 +/- 0.37%, respectively, and the actuarial survival rate was 90.4 +/- 1.6%. In the SJ group at 5 years, the actuarial freedom from thromboembolism, valve thrombosis, and anticoagulant-related hemorrhage was 94.79% +/- 1.70%, 98.80 +/- 0.72%, and 99.68 +/- 0.31%, respectively, and the actuarial survival rate was 91.3 +/- 1.7%. We therefore concluded that a similar survival rate was noted in the CM and SJ groups. With low dose anticoagulation, the complications of thromboembolism, valve thrombosis, and anticoagulant-related hemorrhage were low in the SJ group.
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Wang et al. (1996) conducted a cohort in Valvular heart disease requiring valve replacement (n=697). CarboMedics valve implantation vs. St. Jude Medical valve implantation was evaluated on 5-year actuarial survival rate. CarboMedics valve implantation demonstrated a similar 5-year actuarial survival rate compared to St. Jude Medical valve implantation (90.4% vs 91.3%).
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