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ePaper created 2014-10-06, 13:17:01 | version 1.33.00
Other bleeding manifestations such as conjunctival bleeds, hematuria, gastrointestinal bleeding indicated by black or bloody stool, and muscle bleeds were rarely observed. This indicates that VKA accompanied by self-testing not only improves the control of INR values but also leads to acceptable bleeding rates, indicating a high level of treatment safety. It should be mentioned that the distribution and prevalence of bleeding manifestations observed for patients performing self-testing with INRatio2 or CoaguChek XS were not significantly different for most bleeding manifestations, and only for hematuria and conjunctival bleeds, patients using CoaguChek XS experienced a statistically higher frequency than patients using INRatio2. The rate of patient-reported minor thrombotic events in the NTS data was low at 2% per patient year. Compared to the mentioned minor events, fatal events were even less frequent. In total, 71 events were reported, yielding a death rate of 1.9–2.1 per 100 patient-years. This is well below the rate of fatality observed in patients with clinic-based INR measurements, and compares favorably with the death rates for the warfarin groups reported in recent clinical trials in atrial fibrillation, 4.13%/year [32], 4.9%/year [33] and 3.94%/year [34]. The meta-analysis of Rose and colleagues [35] reported death rates of 2.3–8.1 per 100 patient-years based on 15 randomized controlled trials. Similarly, Heneghan et al. [12] found an average death rate of 3.9% while in self-monitoring this rate was reduced to 2.4%. It should be mentioned that the frequency in use of the CoaguChek XS and the INRatio2 did not differ significantly among patients experiencing fatal events, in either univariate or multivariate analysis. In the latter statistic approach, high target INR (3.0–4.0) and, most prominently, older age at the start of anticoagulation significantly influenced the risk, and 1 year of higher age increased the HR by 8%. Thus, self-testing was found to be efficient in reduction of fatal events, regardless of the monitor used for INR determination. Fig. 2 Forest plot showing multivariate Cox regression analysis of the effect of different parameters on patient survival. AF atrial fibrillation, DVT deep vein thrombosis, INR international normalized ratio, MHV mechanical heart valves. Therapeutic range is 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