Background: The optimal antithrombotic treatment
after MitraClip implantation is a matter of debate. Although dual antiplatelet
therapyis 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 MitraClip
implantation 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 percutaneous leaflet-based mitral valve repair 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: 1,035 patients with MitraClip
implantation 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= 301, 29.1 %), followed
by OAC duo (n = 279, 26.9 %), OAC mono (n = 261, 25.2 %), dual antiplatelet
therapy (n = 157, 15.2 %) and OAC triple (n = 37, 3.6 %). Of patients with OAC
therapy, 2.1 % had new OAC compared to pre-procedural without a justifying
diagnosis of atrial fibrillation or venous thromboembolism. Event rates for
ischemic stroke/systemic embolism were very low in all groups. Mortality was
higher in patients with single antiplatelet therapy compared to OAC duo and OAC
mono. Bleeding events were highest in patients receiving dual antiplatelet
therapy.
Conclusion: Antithrombotic treatment after MitraClip implantation 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 MitraClip implantation.
|
|
Aspirin or Clopidogrel
|
Dual platelet inhibition
|
OAC mono
|
OAC duo
|
OAC triple
|
|
Total N (% of all patients)
|
301 (29.1%)
|
157 (15.2%)
|
261 (25.2%)
|
27 (26.9%)
|
37 (3.6%)
|
|
Mortality*
|
16.1
|
10.5
|
12.8
|
15.8
|
n.r.±
|
|
Combined bleeding*
|
5.5
|
10.7
|
n.r.±
|
3.7
|
n.r.±
|
± not reported due to small
number of cases (<5)
* event rates (per 100 person-years)