scholarly journals Impact of a Patient’s Baseline Risk on the Relative Benefit and Harm of a Preventive Treatment Strategy: Applying Trial Results in Clinical Decision Making

2021 ◽  
Author(s):  
Tamar I. de Vries ◽  
Manon C. Stam‐Slob ◽  
Ron J. G. Peters ◽  
Yolanda van der Graaf ◽  
Jan Westerink ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Major Bleeding ◽  
Treatment Effect ◽  
Significant Interaction ◽  
Risk Model ◽  
Baseline Risk ◽  
Systemic Embolism ◽  
Allocation Model ◽  
Linear Predictor ◽  
Relative Treatment Effect

Background For translating an overall trial result into an individual patient’s expected absolute treatment effect, differences in relative treatment effect between patients need to be taken into account. The aim of this study was to evaluate whether relative treatment effects of medication in 2 large contemporary trials are influenced by multivariable baseline risk of an individual patient. Methods and Results In 9361 patients from SPRINT (Systolic Blood Pressure Intervention Trial), risk of major adverse cardiovascular events was assessed using a newly derived risk model. In 18 133 patients from the RE‐LY (Randomized Evaluation of Long‐Term Anticoagulant Therapy) trial, risk of stroke or systemic embolism and major bleeding was assessed using the Global Anticoagulant Registry in the Field–Atrial Fibrillation risk model. Heterogeneity of trial treatment effect was assessed using Cox models of trial allocation, model linear predictor, and their interaction. There was no significant interaction between baseline risk and relative treatment effect from intensive blood pressure lowering in SPRINT ( P =0.92) or from dabigatran compared with warfarin for stroke or systemic embolism in the RE‐LY trial ( P =0.71). There was significant interaction between baseline risk and treatment effect from dabigatran versus warfarin in the RE‐LY trial ( P <0.001) for major bleeding. Quartile‐specific hazard ratios for bleeding ranged from 0.40 (95% CI, 0.26–0.61) to 1.04 (95% CI, 0.83–1.03) for dabigatran, 110 mg, and from 0.61 (95% CI, 0.42–0.88) to 1.20 (95% CI, 0.97–1.50) for dabigatran, 150 mg, compared with warfarin. Conclusions Effect modification of relative treatment effect by individual baseline event risk should be assessed systematically in randomized clinical trials using multivariate risk prediction, not only in terms of treatment efficacy but also for important treatment harms, as a prespecified analysis. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01206062.

6072Risk of stroke in hypertensive patients with atrial fibrillation treated with oral anticoagulants

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R E Harskamp ◽  
W A M Lucassen ◽  
R D Lopes ◽  
H C Van Weert
Keyword(s):  
Atrial Fibrillation ◽  
Blood Pressure ◽  
Vitamin K ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Haemorrhagic Stroke ◽  
Uncontrolled Hypertension ◽  
P Value ◽  
Systemic Embolism ◽  
History Of

Abstract Background Hypertension is common in patients with atrial fibrillation (AF) and carries an additional risk for complications, most notably stroke and bleeding. We assessed the history of hypertension, level of blood pressure control, and an interaction with the choice of oral anticoagulants on clinical outcomes. Purpose To gain insights into the risks of hypertension in the setting of AF and explore possible interactions with the safety and efficacy of non-vitamin K oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs). Methods We performed a systematic review and meta-analysis of studies that randomised patients to NOACs or VKAs and reported outcomes stratified by presence of hypertension. Collected outcomes included: ischaemic stroke or systemic embolism (SE), death from any cause, hemorrhagic stroke, major bleeding, and intracranial hemorrhage. Log adjusted hazard ratios (HR) and corresponding standard error were calculated, and HRs were compared using Mantel-Haenszel random effects. Quality of the evidence was assessed with Cochrane risk of bias tool. Results Five high-quality studies were eligible, including 71,602 participants who received NOACs (apixaban, dabigatran, edoxaban, rivaroxaban) or VKAs, with median follow-up of 1.8–2.8 years. 89.2% of participants had a history of hypertension. Compared with patients without hypertension, those with controlled and uncontrolled hypertension had higher risk for stroke/SE (HR: 1.21 [1.04–1.41] and HR: 1.50 [1.12–2.01], respectively) and haemorrhagic stroke (HR: 1.78 [1.06, 3.00] and HR: 1.66 [0.99–4.01], respectively). On a continuous scale, the risk of stroke increased 7% per 10mmHg increase in systolic blood pressure. As shown in the Table, no interactions were found between hypertension status and the efficacy or safety of NOACs versus VKAs. Table 1. Interaction of presence of hypertension on the comparative efficacy and safety of NOAC versus VKA Hypertension (n=63,869) No hypertension (n=7,733) P-value (int) Adjusted HR, 95% CI Adjusted HR, 95% CI Stroke or systemic embolism 080, 0.72–0.89 0.79, 0.53–1.19 0.98 Haemorrhagic stroke 0.55, 0.41–0.74 0.24, 0.04–1.37 0.36 Death from any cause 0.91, 0.84–0.98 0.89, 0.76–1.04 0.82 Major bleeding 0.90, 0.76–1.07 0.84, 0.69–1.01 0.57 Intracranial haemorrhage 0.41, 0.24-.068 0.48, 0.14–1.69 0.81 Major or clinically relevant non-major bleed 0.90, 0.68–1.18 0.91, 0.55–1.53 0.96 Conclusions Adequate blood pressure management is vital to optimally reduce the risk of stroke in patients with atrial fibrillation. The benefits of NOACs over VKAs, also apply to patients with elevated blood pressure.

Outcomes in anticoagulated patients with atrial fibrillation and with mitral or aortic valve disease

Heart ◽  
2018 ◽  
Vol 104 (15) ◽  
pp. 1292-1299 ◽  
Author(s):  
Dragos Vinereanu ◽  
Alice Wang ◽  
Hillary Mulder ◽  
Renato D Lopes ◽  
Petr Jansky ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Major Bleeding ◽  
Treatment Effect ◽  
P Value ◽  
Efficacy And Safety ◽  
Systemic Embolism ◽  
Clinical Trial Registration ◽  
Safety Outcomes ◽  
Anticoagulated Patients

ObjectiveTo assess stroke/systemic embolism, major bleeding and other outcomes, and treatment effect of apixaban versus warfarin, in patients with atrial fibrillation (AF) and different types of valvular heart disease (VHD), using data from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial.MethodsThere were 14 793 patients with known VHD status, categorised as having moderate or severe mitral regurgitation (MR) (n=3382), aortic regurgitation (AR) (n=842) or aortic stenosis (AS) (n=324); patients with moderate or severe mitral stenosis were excluded from the trial. Baseline characteristics, efficacy and safety outcomes were compared between each type and no significant VHD. Treatment effect was assessed using an adjusted model.ResultsPatients with MR or AR had similar rates of stroke/systemic embolism and bleeding compared with patients without MR or AR, respectively. Patients with AS had significantly higher event rates (presented as rate per 100 patient-years of follow-up) of stroke/systemic embolism (3.47 vs 1.36; adjusted HR (adjHR) 2.21, 95% CI 1.35 to 3.63), death (8.30 vs 3.53; adjHR 1.92, 95% CI 1.41 to 2.61), major bleeding (5.31 vs 2.53; adjHR 1.80, 95% CI 1.19 to 2.75) and intracranial bleeding (1.29 vs 0.51; adjHR 2.54, 95% CI 1.08 to 5.96) than patients without AS. The superiority of apixaban over warfarin on stroke/systemic embolism was similar in patients with versus without MR (HR 0.69, 95% CI 0.46 to 1.04 vs HR 0.79, 95% CI 0.63 to 1.00; interaction P value 0.52), with versus without AR (HR 0.57, 95% CI 0.27 to 1.20 vs HR 0.78, 95% CI 0.63 to 0.96; interaction P value 0.52), and with versus without AS (HR 0.44, 95% CI 0.17 to 1.13 vs HR 0.79, 95% CI 0.64 to 0.97; interaction P value 0.19). For each of the primary and secondary efficacy and safety outcomes, there was no evidence of a different effect of apixaban over warfarin in patients with any VHD subcategory.ConclusionsIn anticoagulated patients with AF, AS is associated with a higher risk of stroke/systemic embolism, bleeding and death. The efficacy and safety benefits of apixaban compared with warfarin were consistent, regardless of presence of MR, AR or AS.Clinical trial registrationARISTOTLE clinical trial number NCT00412984.

scholarly journals 24-hour blood pressure variability and treatment effect of intravenous alteplase in acute ischaemic stroke

2021 ◽  
Vol 6 (2) ◽  
pp. 168-175
Author(s):  
Ewgenia Barow ◽  
Florent Boutitie ◽  
Bastian Cheng ◽  
Tae-Hee Cho ◽  
Martin Ebinger ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Ischaemic Stroke ◽  
Acute Ischaemic Stroke ◽  
Treatment Effect ◽  
Blood Pressure Variability ◽  
Significant Interaction ◽  
Primary Outcome Measure ◽  
Favourable Outcome ◽  
Stroke Severity ◽  
Intravenous Alteplase

Introduction To assess the association between 24 h blood pressure variability (BPV) on functional outcome and treatment effect of intravenous alteplase in acute ischaemic stroke. Patients and methods In all patients with acute ischaemic stroke of unknown onset randomised in the WAKE-UP (Efficacy and Safety of magnetic resonance imaging [MRI]-based Thrombolysis in Wake-Up Stroke) trial, blood pressure (BP) was measured before randomisation and after initiation of treatment at regular intervals up to 24 hours. Individual BPV was measured by coefficient of variation (CV) of all BP values. Primary outcome measure was favourable outcome defined by a modified Rankin Scale (mRS) score 0 or 1 at 90 days after stroke. Results BP measurements were available for 498 of 503 patients randomised (177 women [35.5%], mean age [SD] of 65.2 [11.5] years). Systolic BPV was not associated with the treatment effect of thrombolysis (test for interaction, p = 0.46). The adjusted odds ratio (aOR) for favourable outcome with alteplase, adjusted for age, stroke severity and baseline BP on admission, did not show an association across the quintiles of increasing systolic BPV with an aOR 1.89 (95% confidence interval [CI], 0.76–4.70) in the lowest quintile to aOR 1.05 (95% CI, 0.43–2.56) in the highest quintile. Higher mean systolic BP was associated with a smaller treatment effect of thrombolysis with a significant interaction (p = 0.033). The aOR for favourable outcome with alteplase decreased with quintiles of increasing mean systolic BP from aOR 3.16 (95% CI, 1.26–7.93) in the lowest quintile to aOR 0.84 (95% CI, 0.34–2.10) in in the highest quintile. Conclusions There was a significant interaction between mean systolic BP and treatment effect of thrombolysis with higher mean systolic BP being associated with poorer outcome. BPV was not associated with outcome after thrombolysis. ClinicalTrials.gov identifier NCT01525290.

scholarly journals Apixaban versus Warfarin in Patients with Left Ventricular (LV) Thrombus, a prospective randomized trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R Alcalai ◽  
R Rashad ◽  
A Butnaru ◽  
G Moravsky ◽  
D Leibowitz
Keyword(s):  
Major Bleeding ◽  
Thrombus Formation ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Left Ventricular ◽  
Systemic Embolism ◽  
Bleeding Events ◽  
Open Label ◽  
Warfarin Group ◽  
Acute Mi

Abstract Background Patients with acute myocardial infarction (MI) have an elevated risk of stroke, mostly due to left ventricular (LV) thrombus formation, which typically occur within the first 2 weeks following an anterior MI. Currently the recommended management of LV thrombus after acute MI is anticoagulation with vitamin K antagonist. To date, there are no prospective data on the use of direct oral anticoagulants (DOACS) for stroke prevention in the setting of LV thrombus. Aim To assess the efficacy of apixaban vs. warfarin in treating LV thrombus after MI. Methods The study is a prospective, randomized, multi-center open label trial comparing apixaban (at a dose of 5 mg twice daily) with s.c enoxaparin 1mg/kg BID followed by dose-adjusted warfarin to achieve a target international normalized ratio (INR) of 2.0 to 3.0 for 3 months in patients with LV thrombus detected by echocardiography 3 to 14 days after acute MI. The primary outcome was the presence and size of LV thrombus 3 months after initiation of anticoagulation as assessed by 2D echocardiogram. Secondary outcomes were stroke or systemic embolism, major bleeding and death from any cause. Results 25 patients have been enrolled to date in 3 medical centers, 13 were randomized to apixaban and 12 to warfarin. Mean age was 59.8±10.7 and 19 (76%) were males with no difference between the study groups. Mean LV thrombus size at enrollment was 24X15 mm in the apixaban group and 19X14 in the warfarin group (p=NS). After 3 months of treatment thrombus completely resolved in all patients in the warfarin group and in 12 of 13 in the apixaban group. In one patient in the apixaban group who had a very large thrombus of 40x20mm size upon enrollment the thrombus size was reduced significantly to 20x12 after 3 months. No death, stroke or systemic embolism was documented in either group. There were two patients with major bleeding in the warfarin group, one had sub-arachnoid hemorrhage after 2 months and anticoagulation was stopped, and another had GI bleeding after 1 month and was switched to enoxaparin. One patient in the warfarin group refused to continue the treatment after 3 weeks. No major bleeding events were recorded in the apixaban group and all patients completed 3 months of treatment. Conclusions Our preliminary results indicate that apixaban is a safe and effective treatment for patients with LV thrombus post anterior wall MI. Funding Acknowledgement Type of funding source: None

Abstract 003: Personalizing the Intensity of Blood Pressure Control: Modeling the Heterogeneity of Risks and Benefits From the SPRINT Trial

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Krishna K Patel ◽  
Suzanne V Arnold ◽  
Paul S Chan ◽  
Yuanyuan Tang ◽  
Yashashwi Pokharel ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Cardiovascular Risk ◽  
Prediction Models ◽  
Risk Model ◽  
Treatment Strategies ◽  
Intensive Treatment ◽  
Major Adverse Cardiovascular Events ◽  
Diabetic Patients ◽  
High Cardiovascular Risk ◽  
Serious Adverse Events

Introduction: In SPRINT (Systolic blood PRessure INtervention Trial), non-diabetic patients with hypertension at high cardiovascular risk treated with intensive blood pressure (BP) control (<120mmHg) had fewer major adverse cardiovascular events (MACE) and all-cause deaths but higher rates of serious adverse events (SAE) compared with patients treated with standard BP control (<140mmHg). However, the degree of benefit or harm for an individual patient could vary due to heterogeneity in treatment effect. Methods: Using patient-level data from SPRINT, we developed predictive models for benefit (freedom from death or MACE) and harm (increased SAE) to allow for individualized BP treatment goals based on projected risk-benefit for each patient. Interactions between candidate variable and treatment were evaluated in the models to identify differential treatment effects. We performed 10 fold cross-validation for both the models. Results: Among 9361 patients, 8606 (92%) patients had no MACE or death event (benefit) and 3529 (38%) patients had a SAE (harm) over a median follow-up of 3.3 years. The benefit model showed good discrimination (c-index= 0.72; cross-validated c-index= 0.72) with treatment interactions of age, sex, and baseline systolic BP (Figure A), with more benefit of intensive BP treatment in patients who are older, male, and have lower baseline SBP. The SAE risk model showed moderate discrimination (c-index=0.66; cross-validated c-index= 0.65) with a treatment interaction of baseline renal function (Figure B), indicating less harm of intensive treatment in patients with a higher baseline creatinine. The mean predicted absolute benefit of intensive BP treatment was of 2.2% ± 2.5% compared with standard treatment, but ranged from 10.7% lower benefit to 17% greater benefit in individual patients. Similarly, mean predicted absolute harm with intensive treatment was 1.0% ± 1.9%, but ranged from 15.9% lesser harm to 4.9% more harm. Conclusion: Among non-diabetic patients with hypertension at high cardiovascular risk, we developed prediction models using basic clinical data that can identify patients with higher likelihood of benefit vs. harm with BP treatment strategies. These models could be used to tailor the treatment approach based on the projected risk and benefit for each unique patient.

Cardiovascular risk model performance in women with and without hypertensive disorders of pregnancy

Heart ◽  
2018 ◽  
Vol 105 (4) ◽  
pp. 330-336 ◽  
Author(s):  
Veerle Dam ◽  
N Charlotte Onland-Moret ◽  
W M Monique Verschuren ◽  
Jolanda M A Boer ◽  
Laura Benschop ◽  
...  
Keyword(s):  
Risk Model ◽  
Model Performance ◽  
Predictive Performance ◽  
Baseline Risk ◽  
Hypertensive Disorders Of Pregnancy ◽  
Cvd Risk ◽  
Hypertensive Disorders ◽  
Framingham Risk ◽  
History Of ◽  
Score Model

ObjectivesCompare the predictive performance of Framingham Risk Score (FRS), Pooled Cohort Equations (PCEs) and Systematic COronary Risk Evaluation (SCORE) model between women with and without a history of hypertensive disorders of pregnancy (hHDP) and determine the effects of recalibration and refitting on predictive performance.MethodsWe included 29 751 women, 6302 with hHDP and 17 369 without. We assessed whether models accurately predicted observed 10-year cardiovascular disease (CVD) risk (calibration) and whether they accurately distinguished between women developing CVD during follow-up and not (discrimination), separately for women with and without hHDP. We also recalibrated (updating intercept and slope) and refitted (recalculating coefficients) the models.ResultsOriginal FRS and PCEs overpredicted 10-year CVD risks, with expected:observed (E:O) ratios ranging from 1.51 (for FRS in women with hHDP) to 2.29 (for PCEs in women without hHDP), while E:O ratios were close to 1 for SCORE. Overprediction attenuated slightly after recalibration for FRS and PCEs in both hHDP groups. Discrimination was reasonable for all models, with C-statistics ranging from 0.70-0.81 (women with hHDP) and 0.72–0.74 (women without hHDP). C-statistics improved slightly after refitting 0.71–0.83 (with hHDP) and 0.73–0.80 (without hHDP). The E:O ratio of the original PCE model was statistically significantly better in women with hHDP compared with women without hHDP.ConclusionsSCORE performed best in terms of both calibration and discrimination, while FRS and PCEs overpredicted risk in women with and without hHDP, but improved after recalibrating and refitting the models. No separate model for women with hHDP seems necessary, despite their higher baseline risk.

scholarly journals Impacts of off-label dosing noacs on clinical outcomes in very elderly patients with atrial fibrillation

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
T Chao ◽  
Y.H Chan ◽  
G.Y.H Lip ◽  
S.A Chen
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Systemic Embolism ◽  
Very Elderly ◽  
Off Label ◽  
Funding Sources ◽  
Clinical Events

Abstract Background Studies about the comparisons of on-label and off-label dosing non-vitamin K antagonist oral anticoagulants (NOACs) regarding the risks of clinical outcomes among atrial fibrillation (AF) patients have been published. However, data among the very elderly AF patients were limited. In the present study, we aimed to investigate the impacts of inappropriate dosing of NOACs on clinical outcomes in AF patients aged ≥85 years of age. Methods We used medical data from a multi-center healthcare system in Taiwan enrolling 1,836 and 268 AF patients aged ≥85 years treated with NOACs and warfarin, respectively. Among 1,836 patients receiving NOACs, underdosing, overdosing and on-label dosing NOACs were prescribed in 248, 149 and 1439 patients, respectively. The risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding were compared between warfarin and NOACs in different dosing groups. Also, the risks of clinical events of underdosing and overdosing NOACs were comapred to on-labeling dosing. Results Compared to warfarin, underdosing NOACs were associated with a higher risk of IS/SE (aHR 2.39; p=0.048) without a lower risk of major bleeding; while overdosing NOACs were not associated with a lower risk of IS/SE (aHR 0.74, p=0.604) (Figure 1). Compared to on-label dosing NOACs, underdosing NOACs were associated with a higher risk of IS/SE, while the risk was not lower for overdoing NOACs (Figure 2). Conclusions Even for very elderly AF patients aged ≥85 years, NOACs should still be prescribed at the dosing following the criteria defined in clinical trials and guideline recommendations. FUNDunding Acknowledgement Type of funding sources: None. Figure 1 Figure 2

scholarly journals Rivaroxaban for Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation and Active Cancer

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2621-2621 ◽  
Author(s):  
Eva Simona Laube ◽  
Anthony Yu ◽  
Dipti Gupta ◽  
Yimei Miao ◽  
Patrick Samedy ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
General Population ◽  
Competing Risks ◽  
Major Bleeding ◽  
Cumulative Incidence ◽  
Research Funding ◽  
Chronic Phase ◽  
Systemic Embolism ◽  
Safety And Efficacy ◽  
Active Cancer

Abstract BACKGROUND: The link between aging, cancer and atrial fibrillation is well known and the appropriate anticoagulation management of non-valvular atrial fibrillation (NVAF) in patients with active cancer is of growing clinical concern. Rivaroxaban has been broadly used for the primary prevention of stroke and systemic embolism in the general population of patients with NVAF. However, individuals with a serious concomitant illness associated with a life expectancy of less than 2 years were excluded from pivotal trials including the ROCKET-AF study, limiting the generalizability of results to patients with active cancer. There is little published evidence on the safety and efficacy of rivaroxaban for NVAF in this specific subgroup. OBJECTIVES: The aim of this study was to assess the safety and efficacy of rivaroxaban in patients with active cancer and NVAF. METHODS: The use of rivaroxaban in cancer patients at Memorial Sloan Kettering Cancer Center (MSKCC) was monitored in the setting of a Quality Assessment Initiative. Patients with active cancer and NVAF treated with rivaroxaban from 1/1/2014 through 3/31/2016 are included in this analysis. Endpoints of interest were defined a priori and include stroke, systemic embolism, major bleeding and clinically-relevant non-major bleeding leading to discontinuation of rivaroxaban for at least 7 days (CRNMB). Clinical events were assessed through text searches of medical records. The analysis was performed respecting different times on previous anticoagulation, considering the first 90 days as the acute phase of treatment and contrasting it with the subsequent chronic phase. RESULTS: A total of 163 evaluable patients were included in the analysis, with a median age of 72.0 years (interquartile range=67.0-77.5 years) and 56% of these individuals being men. The majority had a solid tumor (85%), with stage IV disease reported in 50% of cases. The mean CHA2DS2-Vasc score was 3.2 (standard deviation=1.5) and 64% of patients were already in the chronic phase of anticoagulation. Results for the acute, chronic and combined phases of anticoagulation are presented in the Table and plotted in the Figure. The estimated cumulative incidence of ischemic stroke, major bleeding, and CRNMB at 1 year were 1.4% (95% CI=0-3.4%), 1.2% (95% CI=0-2.9%) and 14.0% (95% CI=4.2-22.7%) respectively, after adjusting for competing risks. Interestingly, the cumulative incidence of major bleeding in our cohort is lower than the value reported for the ORBIT-AF registry of cancer patients on dabigatran or a vitamin K antagonist for NVAF, in which the estimated rate of this complication was 5.1/100 patient-years. Lastly, the 1-year cumulative incidence of mortality was 22.6% (95% CI=12.2-31.7%). This high risk of death was present throughout the observation period and reflects the cancer population. One patient died after developing an acute ischemic cerebrovascular insult and a myocardial infarction. There were no deaths related to bleeding and no recorded systemic embolism episodes. CONCLUSIONS: The safety and efficacy profile of rivaroxaban treatment for NVAF in patients with active cancer seems comparable to what was observed for the general population in the ROCKET-AF study, but ideally a prospective study would be required to confirm these findings. Table Cumulative Incidence of Competing risks for Patients in the Acute, Chronic and Combined Phases of Anticoagulation* *Cumulative incidence estimates for the chronic phase are conditional to reaching day 90 of anticoagulation without sustaining an event. The chronic phase was defined as lasting 275 days and the combined period encompasses 365 days. CRNMB: Clinically-relevant non-major bleeding leading to discontinuation of rivaroxaban for at least 7 days. *Clinically-relevant non-major bleeding leading to discontinuation of rivaroxabanfor at least7 days. Table. Cumulative Incidence of Competing risks for Patients in the Acute, Chronic and Combined Phases of Anticoagulation*. / *Cumulative incidence estimates for the chronic phase are conditional to reaching day 90 of anticoagulation without sustaining an event. The chronic phase was defined as lasting 275 days and the combined period encompasses 365 days. / CRNMB: Clinically-relevant non-major bleeding leading to discontinuation of rivaroxaban for at least 7 days. / *Clinically-relevant non-major bleeding leading to discontinuation of rivaroxabanfor at least7 days. Figure Figure. Disclosures Yu: Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees. Soff:Janssen Scientific Affairs, LLC: Consultancy, Research Funding. Mantha:Janssen Scientific Affairs, LLC: Research Funding.

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