Key result
Oral vitamin K1 added to acenocoumarine discontinuation increased over-reversal compared to discontinuation alone without improving target INR achievement.
Why the study?
Does 1 mg oral vitamin K1 added to acenocoumarine discontinuation improve INR reversal to therapeutic range in outpatients with excessive anticoagulation (INR >= 6.0)?
RCT (n=109)
Open-label
Randomized
Does 1 mg oral vitamin K1 added to acenocoumarine discontinuation improve INR reversal to therapeutic range in outpatients with excessive anticoagulation (INR >= 6.0)?
Answers are grounded in this paper and cite their sources.
Adding 1 mg oral vitamin K1 to acenocoumarine discontinuation offers no advantage for reversing excessive anticoagulation and increases the risk of over-reversal to subtherapeutic INR levels.
We performed a prospective, randomized, open study in 109 outpatients under chronic anticoagulation with acenocoumarine, presenting with International Normalized Ratios (INRs) > or = 6.0 and no or minor bleeding. All the patients withheld one dose of acenocoumarine; in addition, a treated group also received 1 mg oral vitamin K1. We aimed at a post-intervention INR < 6.0, with a target zone of 2.0-4.0. The INRs were lowered from a mean of 8.1 +/- 1.7 to 4.9 +/- 2.5 in the controls (P = 0.0000) and from 8.4 +/- 2.4 to 3.3 +/- 3 in the treated patients (P = 0.0000). There were no differences in the percentage of patients with post-intervention INRs < 6.0 or within the therapeutic zone. One-third of the treated patients and only 2% of the controls reached INRs < 2.0 (P = 0.0003). Oral vitamin K1 offered no advantage to the simple discontinuation of one dose of acenocoumarine. A substantial number of treated patients were consequently exposed to under-anticoagulation.
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Fondevila et al. (2001) conducted an RCT in Excessive oral anticoagulation (INR ≥ 6.0) (n=109). Oral vitamin K1 plus withholding one dose of acenocoumarine vs. Withholding one dose of acenocoumarine alone was evaluated on Post-intervention INR < 2.0 (p=0.0003). Oral vitamin K1 added to acenocoumarine discontinuation increased over-reversal compared to discontinuation alone without improving target INR achievement.
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