RE-DUAL PCI Real life Registry: Dual Therapy with dabigatran/clopidogrel versus Triple Therapy with dabigatran/clopidogrel/aspirin in ACS patients with indication for NOAC undergoing PCI.

Due to the increasing number of patients with atrial fibrillation undergoing
percutaneous coronary intervention (PCI), the optimal balance between
thromboembolic complications versus bleeding complications with the use of
anticoagulation and
anti-platelet therapy has been investigated. In recent studies mainly in stable
angina, dual therapy with novel oral anticoagulant (NOAC) based therapy and a
P2Y12-inhibitor seems to be the preferred choice of treatment compared to
triple therapy (vitamin K antagonist (VKA) or NOAC with P2Y12-inhibitor and
Aspirin) especially reducing the risk of bleeding. VKA seems to be omitted and
NOAC is the preferred choice, reducing bleeding risk and stroke. Especially in
ACS (acute coronary syndrome), real world data is missing. Subanalysis of
studies looking at ACS patient with NOAC undergoing PCI shows a trend toward
lower myocardial infarction rates in triple therapy NOAC-based, but the risk
difference was less using full dose NOAC in dual therapy and still
underpowered. In ACS the risk for thromboembolic events and ischemia is the
highest and the need for addition of aspirin to reduce this risk has to be
investigated. Is really needed to add aspirin to dual therapy in patients with
ACS undergoing PCI? Is the use of full dose NOAC with P2Y12 inhibitor the best
option?

A real world registry to compare dual therapy with Dabigatran/Clopidogrel to
Usual care (Triple Therapy) with Dabigatran/Clopidogrel/Aspirin in patients
with an indication for NOAC undergoing PCI in the setting of ACS.
Hypothesis: Dual therapy with Dabigatran/Clopidogrel (RE-DUAL PCI trial based)
will be superior in reducing the risk of bleeding compared to Triple therapy
with Dabigatran/Clopidogrel/Aspirin in patients with an indication for NOAC
undergoing PCI in the setting of ACS. Thromboembolic events, stent thrombosis
and death will be evaluated for estimation of events between both groups.

Open-label, multicenter, Regisry based Randomised controlled trial (RBRCT).

With regard to burden: I think the study is a little burden for patients with
regards to 2 short questionnaires. Rest is usual care. Possibly additionnal
information by telephone consultation.

With regard to risks: Dual therapy is already widely used in PCI patients, also
in ACS patients after consideration of bleeding versus thromboembolic risk.
This is a randomized setting to see whether the previous results in studies and
individual cases in daily practice actually show the same results. If patients
have the same outcome in both groups with regard to thromboembolic risk, they
can reduce bleeding risks with dual therapy and thus quality of life and
medical intervention.
I think that patients are not at any great risk compared to standard treatment
since in daily practice both therapies are applied based on insight of
(interventional) cardiologist and are individualized, which makes the standard
treatment choice for the whole group in general more difficult.