Uncertainty on the effectiveness and safety of rivaroxaban in premenopausal women with atrial fibrillation: empirical evidence needed

Table 1 Outcomes of the Monte Carlo simulation in which rivaroxaban (RVX) is compared to vitamin K antagonists (VKAs) for the prevention of stroke in a hypothetical cohort of premenopausal women with atrial fibrillation over their lifetime

	Rivaroxaban (RVX)		Vitamin K antagonists (VKAs)		Increment of RVX vs. VKAs		Chance RVX performs better
	Mean	95% CI^a	Mean	95% CI^a	Mean	95% CI^a	Chance RVX performs better
Benefit/Risk profile
Clinical events, per 1000 subjects over the lifetime
Ischemic stroke or TIA	567	408 to 759	611	428 to 832	−44	−318 to +222	61%
Systemic embolism	87	36 to 169	102	47 to 182	−15	−110 to +84	63%
Myocardial infarction	319	190 to 496	362	228 to 533	−43	−141 to +49	84%
Intracranial hemorrhage	136	74 to 226	210	146 to 290	−74	−140 to −8	98%
Extracranial hemorrhage (ECH)
Major AUB	928	57 to 1990	429	21 to 894	499	−5.83 to +1690	24%
Major other ECH	1023	685 to 1458	832	639 to 1060	191	−65 to +536	9%
Minor AUB	3872	2194 to 5739	1868	1442 to 2314	2004	227 to +3929	1%
Minor other ECH	3763	2670 to 5137	3401	2716 to 4188	362	−513 to +1436	23%
QALYs, per subject	30.48	26.89 to 33.86	29.91	26.31 to 33.34	0.57	−0.80 to 2.15	78%
Cost-effectiveness (×€1000, per subject)
Healthcare costs	63.7	45.2 to 91.4	47.5	32.5 to 66.7	16.3	−6.1 to 43.1	8%
Costs per QALY gained^b	–	–	–	–	28.5	–	60%^c
Net monetary benefit^c	1460	1276 to 1637	1448	1265 to 1625	12	−75 to 109	60%

^aThe lower bound of the range equals the 2.5th percentile, and the upper bound equals the 97.5th percentile
^bOtherwise defined as the incremental cost-effectiveness ratio (ICER)
^cThe net monetary benefit (NMB) is the monetary value assigned to the total amount of QALYs that is associated with a treatment, subtracted by the costs of the treatment. We assumed that one QALY was valued with €50,000. The treatment with the highest NMB is considered cost-effective

ISSN: 1471-2261