An Online Clinical Surveillance System to Assess the Clinical Effectiveness and Safety of Non-vitamin K Antagonist Oral Anticoagulants and Warfarin (Preprint)

2019 ◽  
Author(s):  
Fong-Ci Lin ◽  
Shih-Tsung Huang ◽  
Rung-Ji Shang ◽  
Chi-Chuan Wang ◽  
Fei-Yuan Hsiao ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Intracranial Hemorrhage ◽  
Surveillance System ◽  
Adverse Drug Events ◽  
Medical Center ◽  
Oral Anticoagulants ◽  
Critical Role ◽  
Clinical Effectiveness ◽  
University Hospital ◽  
Clinical Surveillance

BACKGROUND Active drug surveillance is the proactive process of assessing the adverse drug events (ADEs), but conventional systems lack a seamless workflow. OBJECTIVE This study aims to develop a seamless and online workflow for comparing the safety and effectiveness of drugs in a database of electronic medical records. METHODS We proposed a comprehensive integration process for clinical surveillance using the National Taiwan University Hospital Clinical Surveillance System (NCSS). We studied a practical application of the NCSS that evaluates the drug safety and effectiveness of novel oral-anticoagulants (NOACs) and warfarin by Cohort Tree Analysis in an efficient and interoperable platform. RESULTS We demonstrated a practical example of investigating the differences in effectiveness and safety between NOACs and warfarin in patients with non-valvular atrial fibrillation (AF) using the NCSS. We efficiently identified 2,357 non-valvular AF patients with newly prescribed oral anticoagulants between 2010 and 2015 and further developed one main cohort and two sub-cohorts for separately measuring ischemic stroke as the clinical effectiveness outcome and intracranial hemorrhage as the safety outcome. In the sub-cohort of ischemic stroke, NOACs users exhibited a significantly lower risk of ischemic stroke compared with warfarin users after adjusting for age, sex, comorbidity and co-medication in an intention-to-treat (ITT) analysis (P = 0.01) but exhibited a comparable risk in an as-treated (AT) analysis (P = 0.12) after the 2-year follow-up. In the sub-cohort of intracranial hemorrhage (ICH), NOACs users exhibited a comparable risk of ICH both in ITT (P = 0.68) and AT analyses (P = 0.15). CONCLUSIONS With a seamless and online workflow, the NCSS can serve the critical role of forming associations between evidence and the real world at a medical center in Taiwan.

scholarly journals A Web-Based Clinical System for Cohort Surveillance of Specific Clinical Effectiveness and Safety Outcomes: A Cohort Study of Non–Vitamin K Antagonist Oral Anticoagulants and Warfarin

10.2196/13329 ◽  
2019 ◽  
Vol 7 (3) ◽  
pp. e13329 ◽  
Author(s):  
Fong-Ci Lin ◽  
Shih-Tsung Huang ◽  
Rung Ji Shang ◽  
Chi-Chuan Wang ◽  
Fei-Yuan Hsiao ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Surveillance System ◽  
Adverse Drug Events ◽  
Medical Center ◽  
Oral Anticoagulants ◽  
Critical Role ◽  
Clinical Effectiveness ◽  
University Hospital ◽  
Drug Surveillance ◽  
Web Based

Background Conventional systems of drug surveillance lack a seamless workflow, which makes it crucial to have an active drug surveillance system that proactively assesses adverse drug events. Objective The aim of this study was to develop a seamless, Web-based workflow for comparing the safety and effectiveness of drugs in a database of electronic medical records. Methods We proposed a comprehensive integration process for cohort surveillance using the National Taiwan University Hospital Clinical Surveillance System (NCSS). We studied a practical application of the NCSS that evaluates the drug safety and effectiveness of novel oral anticoagulants (NOACs) and warfarin by cohort tree analysis in an efficient and interoperable platform. Results We demonstrated a practical example of investigating the differences in effectiveness and safety between NOACs and warfarin in patients with nonvalvular atrial fibrillation (AF) using the NCSS. We efficiently identified 2357 patients with nonvalvular AF with newly prescribed oral anticoagulants between 2010 and 2015 and further developed 1 main cohort and 2 subcohorts for separately measuring ischemic stroke as the clinical effectiveness outcome and intracranial hemorrhage (ICH) as the safety outcome. In the subcohort of ischemic stroke, NOAC users exhibited a significantly lower risk of ischemic stroke than warfarin users after adjusting for age, sex, comorbidity, and comedication in an intention-to-treat (ITT) analysis (P=.01) but did not exhibit a significantly distinct risk in an as-treated (AT) analysis (P=.12) after the 2-year follow-up. In the subcohort of ICH, NOAC users did not exhibit a different risk of ICH both in ITT (P=.68) and AT analyses (P=.15). Conclusions With a seamless and Web-based workflow, the NCSS can serve the critical role of forming associations between evidence and the real world at a medical center in Taiwan.

scholarly journals Intracranial Hemorrhage, Outcome, and Mortality After Intra-Arterial Therapy for Acute Ischemic Stroke in Patients Under Oral Anticoagulants

Stroke ◽  
2011 ◽  
Vol 42 (11) ◽  
pp. 3061-3066 ◽  
Author(s):  
Gian Marco De Marchis ◽  
Simon Jung ◽  
Giuseppe Colucci ◽  
Niklaus Meier ◽  
Urs Fischer ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Intracranial Hemorrhage ◽  
Oral Anticoagulants

scholarly journals Endovascular Treatment for Acute Ischemic Stroke in Patients on Oral Anticoagulants

Stroke ◽  
2020 ◽  
Vol 51 (6) ◽  
pp. 1781-1789 ◽  
Author(s):  
Robert-Jan B. Goldhoorn ◽  
Rob A. van de Graaf ◽  
Jan M. van Rees ◽  
Hester F. Lingsma ◽  
Diederik W.J. Dippel ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Prognostic Factors ◽  
Endovascular Treatment ◽  
Acute Ischemic Stroke ◽  
Functional Outcome ◽  
Intracranial Hemorrhage ◽  
Odds Ratio ◽  
Oral Anticoagulants ◽  
Common Odds Ratio ◽  
Symptomatic Intracranial Hemorrhage

Background and Purpose— The use of oral anticoagulants (OAC) is considered a contra-indication for intravenous thrombolytics as acute treatment of ischemic stroke. However, little is known about the risks and benefits of endovascular treatment in patients on prior OAC. We aim to compare outcomes after endovascular treatment between patients with and without prior use of OAC. Methods— Data of patients with acute ischemic stroke caused by an intracranial anterior circulation occlusion, included in the nationwide, prospective, MR CLEAN Registry between March 2014 and November 2017, were analyzed. Outcomes of interest included symptomatic intracranial hemorrhage and functional outcome at 90 days (modified Rankin Scale score). Outcomes between groups were compared with (ordinal) logistic regression analyses, adjusted for prognostic factors. Results— Three thousand one hundred sixty-two patients were included in this study, of whom 502 (16%) used OAC. There was no significant difference in the occurrence of symptomatic intracranial hemorrhage between patients with and without prior OACs (5% versus 6%; adjusted odds ratio, 0.63 [95% CI, 0.38–1.06]). Patients on OACs had worse functional outcomes than patients without OACs (common odds ratio, 0.57 [95% CI, 0.47–0.66]). However, this observed difference in functional outcome disappeared after adjustment for prognostic factors (adjusted common odds ratio, 0.91 [95% CI, 0.74–1.13]). Conclusions— Prior OAC use in patients treated with endovascular treatment for ischemic stroke is not associated with an increased risk of symptomatic intracranial hemorrhage or worse functional outcome compared with no prior OAC use. Therefore, prior OAC use should not be a contra-indication for endovascular treatment.

Abstract 1122‐000171: Unusual Multicompartmental Intracranial Hemorrhage After Tenecteplase Administration

2021 ◽  
Vol 1 (S1) ◽  
Author(s):  
Abdallah Amireh ◽  
Muhammad Nagy ◽  
Hassan Ali ◽  
Siddhart Mehta ◽  
Haralabos Zacharatos ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Intracranial Hemorrhage ◽  
Mechanical Thrombectomy ◽  
University Hospital ◽  
Vascular Lesions ◽  
Intracranial Hemorrhages ◽  
Conventional Angiography ◽  
Vessel Occlusion ◽  
Early Management ◽  
Ct Head

Introduction : The 2019 AHA/ASA updated Guidelines for the Early Management of Patients with Acute Ischemic Stroke mention tenecteplase (TNK) as a reasonable therapy in patients without contraindications for IV fibrinolysis who are also eligible to undergo mechanical thrombectomy. We describe a case of acute left MCA ischemic stroke treated with IV TNK (IV bolus of 0.25 mg/kg) followed by mechanical thrombectomy with subsequent multicompartmental intracranial hemorrhages unrelated to area of infraction. Methods : A retrospective review at a single center university hospital was performed for all intravenous TNK administrations outside of a clinical trial setting from October 2020 to July 2021. Results : A 61‐year‐old male with history of HTN and cardiomyopathy (EF<20%). Presented with sudden onset right sided weakness, aphasia and left gaze. Presenting NIHSS was 28. CT head with hyperdense left MCA sign and ASPECTS score of 10. CTA confirmed proximal left MCA M1 segment occlusion. IV TNK was given within 01:23 hours of symptoms onset. Subsequently, patient underwent emergent mechanical thrombectomy for disabling large vessel occlusion stroke. Spontaneous near complete recanalization of left MCA occlusion was noted on initial angiography run with small non flow limiting distal thrombi visualized in the distal MCA territories. Immediate post procedure CT head was negative for any intracranial hemorrhage. Patient’s exam was noted to improve to NIHSS of 2. Approximately 6 hours after the TNK administration, patient became acutely unresponsive with NIHSS of 26. With Glasgow Coma Scale 7 patient required emergent intubation. CT head revealed bilateral cerebellar intraparenchymal hemorrhages, extensive subarachnoid hemorrhage in basal cisterns and within the sulci in bilateral frontotemporal regions, as well as subdural hemorrhages along the falx and tentorial dural folds. Hypertonic saline was administered followed by emergent extraventricular drain placement. Tranexamic acid 1000 mg was given as emergent reversal, fibrinogen level was 155 mg/dL. Despite aggressive medical management and over following 24 hours, exam worsened with loss of pupillary reflexes. Patient was terminally extubated 2 days after initial presentation in accordance with his advance directives. Conclusions : Tenecteplase was a reasonable choice in this case given LVO and disabling stroke. The patient’s neurological exam improved significantly after TNK with evidence of spontaneous recanalization. However, patient’s multicompartmental intracranial hemorrhages unrelated to area of infraction were unusual in the absence of any vascular lesions to predispose hemorrhage based on CT and conventional angiography. Further observational studies are warranted to evaluate similar complications of Tenecteplase administration and their occurrence rates.

scholarly journals Clinical Effectiveness of Direct Oral Anticoagulants vs Warfarin in Older Patients With Atrial Fibrillation and Ischemic Stroke

2019 ◽  
Vol 76 (10) ◽  
pp. 1192 ◽  
Author(s):  
Ying Xian ◽  
Haolin Xu ◽  
Emily C. O’Brien ◽  
Shreyansh Shah ◽  
Laine Thomas ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Older Patients ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Clinical Effectiveness

Evaluation of Potential Drug–Drug Interactions With Direct Oral Anticoagulants in a Large Urban Hospital

2018 ◽  
Vol 33 (2) ◽  
pp. 136-141 ◽  
Author(s):  
Yoonsun Mo ◽  
Ayse Karakas-Torgut ◽  
Antony Q. Pham
Keyword(s):  
Drug Interactions ◽  
Medical Center ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Hospital Setting ◽  
Retrospective Chart Review ◽  
University Hospital ◽  
Potential Drug ◽  
Urban Hospital ◽  
Combined Use

Objective: The aim of this study is to assess patterns of potential drug–drug interactions (DDIs) with direct oral anticoagulants (DOACs) in an inpatient hospital setting. Methods: A retrospective chart review was conducted at the Brookdale University Hospital and Medical Center (BUHMC) from January 2014 to November 2016. All adult patients admitted to the BUHMC who were treated with a DOAC for at least 3 days were screened. Among them, those who received selected interacting drugs at any time during the course of DOAC therapy were included in this study. Results: This study included 165 patients with an average of 73 years (standard deviation [SD] = 12.3) and 233 cases. The most commonly used concomitant drug with a DOAC was aspirin (58%), followed by amiodarone (16%) and P2Y12 inhibitors (11%). The combined use of dual antiplatelet therapy and a DOAC was identified in 18 (6%) cases. Approximately one-third of the cases encountered were classified as the “avoidance” category. Conclusions: Despite computerized DDI alerts, potentially significant DDIs with DOACs still occur. While the present study provides insight into the current patterns of DDIs, further studies are needed to evaluate clinical outcomes of the potential DDIs with DOACs in practice.

Abstract 63: Three-month Outcomes in Japanese Stroke /TIA Patients With Non-valvular Atrial Fibrillation After Initiating Oral Anticoagulants: The SAMURAI-NVAF Study

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Shoji Arihiro ◽  
Kenichi Todo ◽  
Masatoshi Koga ◽  
Hiroshi Yamagami ◽  
Tadashi Terasaki ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Intracranial Hemorrhage ◽  
Recurrent Stroke ◽  
Oral Anticoagulants ◽  
Bleeding Events ◽  
Nonvalvular Atrial Fibrillation ◽  
Fatal Bleeding ◽  
Index Stroke ◽  
Ischemic Events

Backgound and Purpose: Recently, three non-vitamin K antagonist oral anticoagulants (NOACs) became available for patients with nonvalvular atrial fibrillation (NVAF) in Japan. We aimed to determine 3-month outcomes in ischemic stroke/TIA patients receiving NOACs or warfarin from a multicenter prospective registry (SAMURAI-NVAF registry, NCT01581502). Methods: Among 1,191 acute ischemic stroke /TIA patients enrolled between September 2011 and March 2014, we studied 916 patients (389 women, 77±10 y) who took oral anticoagulants (OACs) after index stroke and completed 3-month follow-up survey. Primary outcome measures were ischemic events, including recurrent stroke/TIA and thromboembolism, and major bleedings events, such as fatal bleeding and/or symptomatic bleeding in a critical area or organ according to the International Society on Thrombosis and Haemostasis statement. We assessed the incidence and clinical factors associated with primary outcomes within 90 days after initiating OACs. Results: NOACs were given for 370 patients (126 women, 74±9 y; dabigatran 168, rivaroxaban 183 and apixaban 19) and warfarin for 546 (263 women, 79±10 y). NOAC users had lower scores of CHADS2 (median 3 in NOAC, 4 in warfarin, p<0.001) and HAS-BLED (3, 3, p<0.001) than warfarin users. Ischemic events occurred in 14 NOAC users (3.8%; 2 women, 76±6 y, including 8 lower dose users between two approved dose for each NOAC) and 25 warfarin users (4.6%; 13 women, 81±9 y). Of these, 13 NOAC users (3.5%) and 16 warfarin users (2.9%) developed ischemic stroke/TIA. Among NOAC users, patients with ischemic events had lower body weights (53±11 vs 60±11kg, p= 0.017), more frequently had congestive heart failure (36 vs 10%, p = 0.003) and intracardiac thrombus (27 vs 4%, p < 0.001) than those without. Major bleeding events occurred in 5 NOAC users (1.4%, all using lower dose), and 14 warfarin users (2.6%). Of these, one NOAC user (0.3%) and 4 warfarin users (0.7%) developed intracranial hemorrhage. Conclusion: The 3-month incidence of ischemic events in stroke/TIA patients with NVAF was approximately 4% in both NOAC and warfarin users. Intracranial hemorrhage was relatively infrequent in NOAC users.

P4787Use of direct oral anticoagulants in patients with atrial fibrillation having a history of intracranial hemorrhage

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T F Chao ◽  
S A Chen
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Intracranial Hemorrhage ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Research Database ◽  
Bleeding Events ◽  
Risk Of Mortality ◽  
Taiwan National Health Insurance ◽  
History Of

Abstract Background Patients with atrial fibrillation (AF) having a history of intracranial hemorrhage (ICH) were excluded from the pivotal randomized trials comparing direct oral anticoagulants (DOACs) and warfarin. We aimed to compare the effectiveness and safety of DOACs and warfarin among AF patients having a history of ICH. Method A total of 4,540 AF patients having a CHA2DS2-VASc score ≥1 for males and ≥2 for females who had a history of ICH and received oral anticoagulants (DOACs in 3,493 and warfarin in 1,047) were identified from the Taiwan National Health Insurance Research Database. A propensity matching analysis was performed to balance the baseline differences, and 973 patients were finally identified in each groups. Results The risk of ischemic stroke did not differ significantly between warfarin and DOACs (4.41%/yr vs 4.87%/yr; HR 0.985, p=0.927). The risks of bleeding events were lower with DOACs compared to warfarin with a HR (95% CI) of 0.752 (0.573–0.986, p=0.040) for major bleeding and 0.614 (0.379–0.995, p 0.048) for ICH. The risk of mortality was also lower in patients treated with DOACs (HR = 0.539; 95% CI = 0.453–0.642, p<0.001). The cumulative incidence curves of each events for 2 groups are shown in Figure. Conclusion Compared to warfarin, DOACs were associated with a similar risk of ischemic stroke and better safety profiles among AF patient with a history of ICH.

Sign in / Sign up

Export Citation Format

Share Document