Periprocedural Complication Clinical Trial
Official title:
Prospective Observational Study of the Direct Oral Anticoagulants Periprocedural Management
Direct oral anticoagulants (DOAC) are a new drug group that has been approved for chronic
anticoagulation of patients in atrial fibrillation or suffering acute thrombosis, between
others. The need of surgery of a patient in atrial fibrillation is round 10% per year.
Due to DOAC short time of commercialization and the lack of experience, the proper management
of DOAC when a patient in this treatment needs a scheduled or urgent procedure, has not yet
been established. This fact may mean both the decrease of the anticoagulant treatment
efficacy and the increase of the haemorrhage complications in the perioperative period.
With the aim of gaining additional information about this aspect, a multicentre, prospective
and observational study (classified by the spanish drug society, AEMPS, as non-interventional
trial, EPA-SP) about the DOAC management, before a scheduled or urgent surgery, in normal
clinical practice, is proposed.
When an anticoagulated patient is scheduled for surgery or an invasive procedure, the
physician's worry is how to achieve needing an optimal haemostasis without increasing the
risk of thrombosis. For decades, the main drug for chronic anticoagulation has been
antivitamin-k (warfarin or acenocoumarol). In the majority of patients, the periprocedural
management proposal has been stopping the drug and giving a short acting anticoagulant for
some days before surgery, known as bridging therapy strategy, mostly done with a
low-molecular weight heparin (LMWH).
The debate about the best perioperative management of the anticoagulated patients has
increased with the arrival on the market of direct oral anticoagulants (DOAC), by the moment
approved for long-term anticoagulation in patients with atrial fibrillation and for the
treatment of pulmonary embolism. DOAC could be classified in two groups: direct inhibitors of
thrombin (the only current available drug is dabigatran) and direct inhibitors of factor Xa
(rivaroxaban, apixaban, edoxaban, and others soon to come). DOAC have pharmacokinetic
characteristics that seem to favour stopping the drug for some days without substitution in
the vast majority of the patients. Nevertheless, current lack of experience in the management
of high doses of DOAC during the perioperative period, the absence of effective antagonists
to reverse the anticoagulation, the unsuitable standardized laboratory monitoring and, also,
the different pharmacokinetics between patients receiving these drugs, have made challenging
to standardize the optimal management in the perioperative period. Some proposals have been
published in last years from expert consensus, based on pharmacokinetic data, but DOAC short
time of commercialization and the difficulties to interpret the post-hoc analysis from the
randomized trials, for the heterogeneity of the included population and the wide kind of
surgeries, most of them with low bleeding risk, have moved the spanish working group on
perioperative management of haemostasis to plan a multi-institutional registry to gain
experience and information in the periprocedural (urgent or scheduled) management of DOAC.
The authors designed an observational, prospective, multicentre study including patients
under long-term DOAC treatment for atrial fibrillation or treatment of venous thromboembolism
who are scheduled or need an urgent procedure. Data collected were demographic, related with
the DOAC management and with the possible haemorrhagic or thrombotic events with a follow-up
of 30 day. A univariable analysis and a multivariate regression model were applied using all
the available co-variables. Bilateral hypothesis contrast were considered significant if α <
0.05.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05241821 -
Acute STROke Complicating TAVI - Management and Outcomes
|