Nejvíce citovaný článek - PubMed ID 37345804
The influence of atrial high-rate episodes on stroke and cardiovascular death: an update
AIMS: Apixaban was superior to aspirin for the prevention of stroke or systemic embolism in participants with subclinical atrial fibrillation (SCAF) in the Apixaban for the Reduction of Thromboembolism in Patients With Device-Detected Subclinical Atrial Fibrillation trial. This was especially true for those with CHA2DS2-VASc score > 4. Understanding the cost-effectiveness of treating SCAF is important for decision-makers. METHODS AND RESULTS: Canadian, UK, German, and US direct healthcare costs [in 2023 US dollars (USD)] were applied to hospitalized events (including strokes and bleeds) and study drugs for all participants with a CHA2DS2-VASc score > 4 to determine the mean cost per participant during the trial (mean follow-up 3.5 years). A daily cost of $0.63, $0.11, $2.26, and $6.06 for apixaban in Canada, the UK, Germany, and the USA was used. If in-trial results were not cost-saving (below $0), the prospective plan was to perform a lifetime cost-effectiveness analysis using a Markov model and a willingness-to-pay of 50 000 USD per quality-adjusted life year (QALY). After considering the cost of study medication and clinical events over 3.5 years, apixaban was dominant (cost-saving and more effective) in Canada (-$2301) and the UK (-$902) but cost more in Germany and the USA ($600 and $1990, respectively). Over a lifetime, treatment with apixaban produced a net gain of 0.107 QALYs, but with costs in both Germany ($2623 more) and the USA ($9110 more), yielding an incremental cost-effectiveness ratio of $24 514 per QALY for Germany and $85 140 for the USA. CONCLUSION: In patients with SCAF and a CHA2DS2-VASc score > 4, apixaban is cost saving in Canada and the UK and cost-effective in Germany. Apixaban was not cost-effective in the USA under the base cost assumption but would be cost-effective at a daily cost of $4.35 and cost saving at $3.59.
- Klíčová slova
- Apixaban, Cost-effectiveness, Stroke prevention, Subclinical atrial fibrillation,
- MeSH
- analýza nákladů a výnosů MeSH
- Aspirin * ekonomika terapeutické užití škodlivé účinky MeSH
- časové faktory MeSH
- cévní mozková příhoda prevence a kontrola ekonomika etiologie MeSH
- ekonomické modely MeSH
- fibrilace síní * ekonomika diagnóza komplikace farmakoterapie MeSH
- fibrinolytika ekonomika terapeutické užití škodlivé účinky MeSH
- inhibitory agregace trombocytů * ekonomika terapeutické užití škodlivé účinky MeSH
- inhibitory faktoru Xa ekonomika terapeutické užití škodlivé účinky MeSH
- kvalitativně upravené roky života MeSH
- lidé MeSH
- náklady na léky * MeSH
- pyrazoly * ekonomika terapeutické užití škodlivé účinky MeSH
- pyridony * ekonomika terapeutické užití škodlivé účinky MeSH
- rizikové faktory MeSH
- senioři MeSH
- tromboembolie * prevence a kontrola ekonomika etiologie diagnóza MeSH
- úspory nákladů MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Geografické názvy
- Kanada MeSH
- Spojené státy americké MeSH
- Názvy látek
- apixaban MeSH Prohlížeč
- Aspirin * MeSH
- fibrinolytika MeSH
- inhibitory agregace trombocytů * MeSH
- inhibitory faktoru Xa MeSH
- pyrazoly * MeSH
- pyridony * MeSH
BACKGROUND AND AIMS: Patients with long atrial high-rate episodes (AHREs) ≥24 h and stroke risk factors are often treated with anticoagulation for stroke prevention. Anticoagulation has never been compared with no anticoagulation in these patients. METHODS: This secondary pre-specified analysis of the Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High-rate episodes (NOAH-AFNET 6) trial examined interactions between AHRE duration at baseline and anticoagulation with edoxaban compared with placebo in patients with AHRE and stroke risk factors. The primary efficacy outcome was a composite of stroke, systemic embolism, or cardiovascular death. The safety outcome was a composite of major bleeding and death. Key secondary outcomes were components of these outcomes and electrocardiogram (ECG)-diagnosed atrial fibrillation. RESULTS: Median follow-up of 2389 patients with core lab-verified AHRE was 1.8 years. AHRE ≥24 h were present at baseline in 259/2389 patients (11%, 78 ± 7 years old, 28% women, CHA2DS2-VASc 4). Clinical characteristics were not different from patients with shorter AHRE. The primary outcome occurred in 9/132 patients with AHRE ≥24 h (4.3%/patient-year, 2 strokes) treated with anticoagulation and in 14/127 patients treated with placebo (6.9%/patient-year, 2 strokes). Atrial high-rate episode duration did not interact with the efficacy (P-interaction = .65) or safety (P-interaction = .98) of anticoagulation. Analyses including AHRE as a continuous parameter confirmed this. Patients with AHRE ≥24 h developed more ECG-diagnosed atrial fibrillation (17.0%/patient-year) than patients with shorter AHRE (8.2%/patient-year; P < .001). CONCLUSIONS: This hypothesis-generating analysis does not find an interaction between AHRE duration and anticoagulation therapy in patients with device-detected AHRE and stroke risk factors. Further research is needed to identify patients with long AHRE at high stroke risk.
- Klíčová slova
- Atrial fibrillation, Atrial high-rate episodes, NOAH-AFNET 6, Stroke,
- MeSH
- antikoagulancia terapeutické užití MeSH
- cévní mozková příhoda * etiologie prevence a kontrola diagnóza MeSH
- fibrilace síní * komplikace farmakoterapie diagnóza MeSH
- lidé MeSH
- pyridiny * MeSH
- rizikové faktory MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- srdeční síně MeSH
- thiazoly * MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- antikoagulancia MeSH
- edoxaban MeSH Prohlížeč
- pyridiny * MeSH
- thiazoly * MeSH