TY  - JOUR
A1  - Just, Katja S.
A1  - Scholl, Catharina
A1  - Boehme, Miriam
A1  - Kastenmüller, Kathrin
A1  - Just, Johannes M.
A1  - Bleckwenn, Markus
A1  - Holdenrieder, Stefan
A1  - Meier, Florian
A1  - Weckbecker, Klaus
A1  - Stingl, Julia C.
T1  - Individualized versus standardized risk assessment in patients at high risk for adverse drug reactions (the IDrug randomized controlled trial) – never change a running system?
JF  - Pharmaceuticals
N2  - The aim of this study was to compare effects of an individualized with a standardized risk assessment for adverse drug reactions to improve drug treatment with antithrombotic drugs in older adults. A randomized controlled trial was conducted in general practitioner (GP) offices. Patients aged 60 years and older, multi-morbid, taking antithrombotic drugs and at least one additional drug continuously were randomized to individualized and standardized risk assessment groups. Patients were followed up for nine months. A composite endpoint defined as at least one bleeding, thromboembolic event or death reported via a trigger list was used. Odds ratios (OR) and 95% confidence intervals (CI) were calculated. In total, N = 340 patients were enrolled from 43 GP offices. Patients in the individualized risk assessment group met the composite endpoint more often than in the standardized group (OR 1.63 [95%CI 1.02–2.63]) with multiple adjustments. The OR was higher in patients on phenprocoumon treatment (OR 1.99 [95%CI 1.05–3.76]), and not significant on DOAC treatment (OR 1.52 [95%CI 0.63–3.69]). Pharmacogenenetic variants of CYP2C9, 2C19 and VKORC1 were not observed to be associated with the composite endpoint. The results of this study may indicate that the time point for implementing individualized risk assessments is of importance.
KW  - adverse drug reactions
KW  - pharmacogenetics
KW  - pharmacogenomics
KW  - personalized medicine
KW  - phenprocoumon
KW  - DOACs
KW  - older adults
KW  - bleeding
KW  - thromboembolism
Y1  - 2021
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-248557
SN  - 1424-8247
VL  - 14
IS  - 10
ER  - 
TY  - JOUR
A1  - Lock, J. F.
A1  - Ungeheuer, L.
A1  - Borst, P.
A1  - Swol, J.
A1  - Löb, S.
A1  - Brede, E. M.
A1  - Röder, D.
A1  - Lengenfelder, B.
A1  - Sauer, K.
A1  - Gremer, C. - T.
T1  - Markedly increased risk of postoperative bleeding complications during perioperative bridging anticoagulation in general and visceral surgery
JF  - Perioperative Medicine
N2  - Background 
Increasing numbers of patients receiving oral anticoagulants are undergoing elective surgery. Low molecular weight heparin (LMWH) is frequently applied as bridging therapy during perioperative interruption of anticoagulation. The aim of this study was to explore the postoperative bleeding risk of patients receiving surgery under bridging anticoagulation. 

Methods 
We performed a monocentric retrospective two-arm matched cohort study. Patients that received perioperative bridging anticoagulation were compared to a matched control group with identical surgical procedure, age, and sex. Emergency and vascular operations were excluded. The primary endpoint was the incidence of major postoperative bleeding. Secondary endpoints were minor postoperative bleeding, thromboembolic events, length of stay, and in-hospital mortality. Multivariate analysis explored risk factors of major postoperative bleeding. 

Results 
A total of 263 patients in each study arm were analyzed. The patient cohort included the entire field of general and visceral surgery including a large proportion of major oncological resections. Bridging anticoagulation increased the postoperative incidence of major bleeding events (8% vs. 1%; p < 0.001) as well as minor bleeding events (14% vs. 5%; p < 0.001). Thromboembolic events were equally rare in both groups (1% vs. 2%; p = 0.45). No effect on mortality was observed (1.5% vs. 1.9%). Independent risk factors of major postoperative bleeding were full-therapeutic dose of LMWH, renal insufficiency, and the procedure-specific bleeding risk. 

Conclusion 
Perioperative bridging anticoagulation, especially full-therapeutic dose LMWH, markedly increases the risk of postoperative bleeding complications in general and visceral surgery. Surgeons should carefully consider the practice of routine bridging.
KW  - low molecular heparin
KW  - atrial fibrillation
KW  - postoperative bleeding
KW  - thromboembolism
KW  - anticoagulation
KW  - bridging
KW  - antithrombotic therapy
KW  - warfarin interruption
KW  - oral anticoagulants
KW  - management
Y1  - 2020
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-230690
VL  - 9
ER  -