Background: The optimal antithrombotic treatment
after transcatheter aortic valve replacement (TAVR) is a matter of debate. Although
dual antiplatelet therapy is recommended in guidelines, uncertainty exists due
to a lack of evidence particularly in the context of comorbidity with
indication for oral anticoagulation (OAC).
Purpose: To assess the frequency, efficacy and safety of
different antithrombotic regimes in patients after TAVR using real-world data.
Methods: In a retrospective cohort study
using a German claims database we analyzed anticoagulation treatment during the
first 90 days after TAVR using drug prescription claims. Frequency of treatment
regimes (ASS or Clopidogrel, dual platelet inhibition, single OAC [OAC mono],
OAC plus aspirin or clopidogrel [OAC duo] and OAC plus aspirin and clopidogrel
[OAC triple]) and effectiveness (ischemic stroke/systemic embolism, all-cause
mortality) and safety (intracranial bleeding, major extracranial bleeding and
gastrointestinal bleeding) events up to 6 months after the procedure were
assessed.
Results: 3,828 patients with TAVR between
2014 and 2018 and a pre- and post-procedural follow-up time of 6 months were
included into the study. After the procedure, the majority of patients received
single antiplatelet therapy (N= 1414, 36.9 %) followed by dual antiplatelet
therapy (N= 854, 22.3 %), OAC duo (n = 837, 21.9 %), OAC mono (n = 619, 16.2 %)
and OAC triple (n = 104, 2.7 %). Of patients with OAC therapy, 2.5 % had new
OAC compared to pre-procedural without a justifying diagnosis of atrial
fibrillation or venous thromboembolism. Bleeding events were highest in
patients receiving triple therapy and mortality was highest in patients
receiving any OAC therapy. Event rates for ischemic
stroke/systemic embolism did not differ between patients with single and dual
antiplatelet inhibition and were lower in patients receiving any OAC treatment.
Conclusion: Antithrombotic treatment
after TAVR shows large variety in clinical routine, and a substantial number of
patients had regimes not in accordance with current guidelines. Since
antithrombotic regimes are associated with considerable differences in the risk
of mortality and safety outcomes, these findings support the need for prospective
evidence regarding antithrombotic therapy after TAVR.
|
|
Aspirin or Clopidogrel
|
Dual platelet inhibition
|
OAC mono
|
OAC duo
|
OAC triple
|
|
Total N (% of all patients)
|
1414 (36.9 %)
|
854 (22.3 %)
|
619 (16.2 %)
|
837 (21.9 %)
|
104 (2.7 %)
|
|
Ischemic stroke/systemic embolism*
|
2.32
|
2.39
|
n.r.±
|
2.21
|
n.r.±
|
|
Mortality*
|
10.57
|
7.71
|
22.57
|
14.77
|
17.97
|
|
Combined bleeding*
|
2.77
|
7.04
|
6.37
|
6.49
|
18.23
|
* event rates (per 100 person-years)
± not reported due to small
number of cases (<5)