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ePaper created 2014-10-06, 13:17:01 | version 1.33.00
(1%; 39 events). The differences in frequencies of minor clinical events between the two monitors was not statistically significant for most minor clinical events in the univariate comparison. For hematuria and conjunctival bleeds, patients on CoaguChek XS experienced a statistically significant higher frequency of events than patients on INRatio2 (without correcting for multiple testing, Table 3), although the number of events was low for both groups. Table 2 Univariate comparison of the monitor used Group Difference: CoaguChek vs. INRatio2 Patient distribution (%) TTR (%) P All 0.0 1.1 0.079 Gender Male 0.8 1.1 0.199 Female -0.8 1.2 0.199 Age (years) \45 -0.4 0.7 0.969 45–64 5.2 1.5 0.157 65–74 2.9 2.0 0.033 75–79 -1.1 0.2 0.724 80–84 -3.0 -2.0 0.451 C85 -3.5 -3.1 0.714 Indication AF, no MHV 3.6 1.2 0.404 AF and MHV 0.0 4.6 0.046 MHV, no AF -1.8 3.7 0.540 DVT -3.1 1.3 0.040 Other 1.2 -0.3 0.252 Therapeutic range 2.0–3.5 2.8 1.4 0.037 2.5–4.0 -2.6 2.3 0.049 Others -0.2 -4.7 0.027 Table 2 continued Group Difference: CoaguChek vs. INRatio2 Patient distribution (%) TTR (%) P Medication Acenocoumarol -3.5 1.4 0.005 Phenprocoumon 3.6 0.8 0.514 Others (warfarin) -0.1 0.0 Univariate comparison of the effect of the coagulometer (P for TTR comparison using a ranksum test, without Bonferroni adjustment) P values in bold are below the threshold for significance (0.05) AF atrial fibrillation, DVT deep vein thrombosis, INR international normalized ratio, MHV mechanical heart valves, TTR time in therapeutic range, defined in this setting to include an additional 0.5 INR units (e.g. therapeutic range 2.0–3.5 for an international target range of 2.0–3.0) Adv Ther