ABSTRACT
Background : In January 2021, the Dutch vaccination programme against SARS-CoV-2 was started. Clinical studies have shown that systemic reactions including fever and chills occur in up to 50% of vaccine recipients. It is unclear whether these systematic reactions have an effect on anticoagulation control, potentially leading to an increased risk of thrombotic events and bleeding complications. Aims : To investigate whether COVID-19 vaccination with the Pfizer vaccine is associated with suboptimal anticoagulation control in patients using Vitamin K antagonists (VKAs). Methods : A case-crossover study was performed in a cohort of outpatients from three Dutch anticoagulation clinics who received a COVID-19 vaccination. All patients had their international normalized ratio (INR) measured 0-6 weeks before and 1-2 weeks after vaccination. INR results and VKA dosages before the first COVID-19 vaccination, the reference period, were compared with those after the first vaccination. Data extraction after the second vaccination will be performed in the near future, after which these analyses will be repeated and included in the final presentation at the congress. Results : A total of 2197 outpatient VKA-users were included, with a mean age of 86 years, of whom 38.5% were male and 71.7% used acenocoumarol (Table 1). There was no difference in mean INR level before and after vaccination (2.51 vs 2.54, mean difference 0.033 (95% CI, -0.071 to 0.0051). The mean dosage of phenprocoumon did not differ before and after vaccination (0.47 tablets/day (0.25)). Similarly, the mean dosage of acenocoumarol was comparable before and after vaccination (1.72 tablets/day (0.81) versus 1.71 tablets/ day (0.82). Most vaccine recipients remained in therapeutic range and INR > 5 was as likely to be reported after vaccination (1.0% and 2.6%) as it was before vaccination (1.0% and 1.6%) (Table 2). Conclusions : COVID-19 vaccination did not influence anticoagulation control in patients using VKAs.
ABSTRACT
Background : Excess mortality has been observed in the general population during the COVID-19 pandemic, but it is unknown whether preexisting anticoagulant treatment affects survival, given that COVID-19 associated hypercoagulability adversely impacts prognosis. Aims : To investigate whether preexisting vitamin K antagonist (VKA) treatment is associated with lower excess mortality during the first wave of the COVID-19 pandemic in the Netherlands when compared with excess mortality in the general population. Methods : All atrial fibrillation (AF) patients (≥60 years) receiving long-term VKA therapy before week 11, 2020 were included from three Dutch anticoagulation clinics. The corresponding patient population managed by the same clinics in 2019 (i.e., all AF patients (≥60 years) receiving long-term VKA therapy before week 11, 2019) was enrolled as a control cohort. Difference in survival within 9 weeks (i.e., week 11 to 19) between the two cohorts was evaluated by Cox regression analysis. This was compared with the difference in survival during the same time frame of the general elderly (≥60 years) Dutch populations in 2020 versus 2019. Results : The study included 22,730 VKA users for the cohort in 2019 and 19,476 for the cohort in 2020, of which baseline characteristics were comparable. The cumulative incidences for all-cause mortality of the VKA users and the general population are presented in Table 1. Conclusions : Elderly patients with AF receiving long-term VKA therapy in the Netherlands appeared to have a lower excess mortality during the first wave of the COVID-19 pandemic when compared to the general elderly population.
ABSTRACT
Background : Coagulopathy has been reported in severely ill patients with COVID-19, but data are lacking in outpatient settings. In patients treated with vitamin K antagonists (VKAs), whose anticoagulant effect is monitored through international normalized ratios (INRs), such coagulation abnormalities might lead to unstable control of anticoagulation. This could influence their thrombosis and bleeding risk. Aims : To assess stability of VKA therapy in COVID-19 patients through a case-crossover study. Methods : Between February-July 2020, we included patients with a positive COVID-19 test from two anticoagulant clinics in the Netherlands. We collected INRs between 26 weeks prior to diagnosis up to 12 weeks after. Time in Therapeutic Range (TTR), stability between INRs expressed as the Variance Growth Rate (VGR), and proportion of INR ≥ 5.0 were calculated and compared within patients with paired sample t -test (in the 26 weeks before infection, in the first 6 weeks after and between 6 and 12 weeks after diagnosis). Results : 51 COVID-19 patients (mean age 84) were included, of whom 15 (29%) were men. Mean TTR in the 26 weeks prior to COVID-19 infection was 80%(95%CI 75-85) compared to 59%(95%CI 51-68) in the 6 weeks after (Table 1). Mean TTR difference was -23%(95%CI -32 to -14) with a time above therapeutic range of 38% (95%CI 30-47) in the 6 weeks after diagnosis. The TTR rose again to 79% (95%CI 69-89) between 6 and 12 weeks after diagnosis (Figure 2). Also, VGR increased, with a mean increase of 4.8 (95%CI 2.1-7.5) in the first 6 weeks. The risk of INRs ≥ 5.0 was 4.4 (95%CI 2.7-7.3) times higher in the 6 weeks after diagnosis compared with the 26 weeks before. Conclusions : COVID-19 infection was associated with a strong decrease in TTR and INR stability in VKA users compared to their values before infection. Additional monitoring is advised to maintain therapeutic stability, particularly to prevent supratherapeutic INRs.
ABSTRACT
BACKGROUND: Short-term follow-up of COVID-19 patients reveals pulmonary dysfunction, myocardial damage and severe psychological distress. Little is known of the burden of these sequelae, and there are no clear recommendations for follow-up of COVID-19 patients.In this multi-disciplinary evaluation, cardiopulmonary function and psychological impairment after hospitalization for COVID-19 are mapped. METHODS: We evaluated patients at our outpatient clinic 6 weeks after discharge. Cardiopulmonary function was measured by echocardiography, 24-hours ECG monitoring and pulmonary function testing. Psychological adjustment was measured using questionnaires and semi-structured clinical interviews. A comparison was made between patients admitted to the general ward and Intensive care unit (ICU), and between patients with a high versus low functional status. FINDINGS: Eighty-one patients were included of whom 34 (41%) had been admitted to the ICU. New York Heart Association class II-III was present in 62% of the patients. Left ventricular function was normal in 78% of patients. ICU patients had a lower diffusion capacity (mean difference 12,5% P = 0.01), lower forced expiratory volume in one second and forced vital capacity (mean difference 14.9%; P<0.001; 15.4%; P<0.001; respectively). Risk of depression, anxiety and PTSD were 17%, 5% and 10% respectively and similar for both ICU and non-ICU patients. INTERPRETATION: Overall, most patients suffered from functional limitations. Dyspnea on exertion was most frequently reported, possibly related to decreased DLCOc. This could be caused by pulmonary fibrosis, which should be investigated in long-term follow-up. In addition, mechanical ventilation, deconditioning, or pulmonary embolism may play an important role.