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ePaper created 2014-10-06, 13:17:01 | version 1.33.00
Serious clinical events were even less frequent. In total, 71 fatal events were observed, of which 31 patients used INRatio2 and 40 used CoaguChek XS. The Kaplan–Meier survival estimate curves are shown in Fig. 1 demonstrating no difference between the groups using different monitors. The 1-year death rate was 1.9% for patients using INRatio2 and 2.1% for CoaguChek XS. The hazard ratio (HR) of 0.95 was not statistically significant in the univariate analysis, i.e., without correction for other influencing factors (P = 0.844, Table 3). Consequently, the Kaplan–Meier estimation showed mostly identical curves (Fig. 1). However, as the risk profile was different between these two populations, a multivariate analysis was subsequently performed for verification. Multivariate Analysis for Surrogate Parameters The multivariate analysis (Table 4), considering all patient characteristics, only had a small Table 3 Clinical events Total CoaguChek XS INRatio2 P # events % of total (%) # events % of total (%) # events % of total (%) Bruises 1,804 45 951 45 853 44 0.211 Nose bleeds 774 19 387 18 387 20 0.239 Blood in urine 233 6 150 7 83 4 0.012 Blood in stool 215 5 101 5 114 6 0.783 Black stool 111 3 43 2 68 4 0.207 Muscle bleeds 96 2 46 2 50 3 0.607 Joint bleeds 39 1 12 1 27 1 0.130 Conjunctival bleeds 433 11 235 11 198 10 0.044 Impaired vision 266 7 161 8 105 5 0.149 Thromboembolism 72 2 31 1 41 2 0.169 All minor events 4,043 2,117 1,926 All fatal events 71 40 31 0.844 Observed minor and major clinical events, all observations. Statistical significance for the univariate differences of the mean events per time observed between the two monitors P values in bold are below the threshold for significance (0.05) Fig. 1 Kaplan–Meier survival estimate curves of event- free survival for the two monitors Adv Ther