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EXPANDING THE INDICATIONS OF NOACs. DISSECTION OF THE COMPASS TRIAL IN PATIENTS WITH CORONARY AND/OR PERIPHERAL ARTERY DISEASE

Chairpersons: Deepak Bhatt (Boston, USA), Tabassome Simon (Paris, France)
9.30 am - 12.30 pm
 Peripheral artery disease (PAD) is considered to be a clinical manifestation of
systemic atherosclerosis. Most patients presenting with peripheral artery disease
are at high risk for myocardial infarction, ischemic stroke, and cardiovascular
death. Concomitant clinical evidence of coronary magnifies this risk.
 Antiplatelet therapy and statins, are the cornerstone of care for the prevention of
atherosclerotic events. However, the level of evidence in favor of aspirin in PAD is
modest and is mainly based on a meta-analysis involving approximately 5000
patients. In two large clinical trials, in patients with asymptomatic atherosclerosis
(which was defined as an abnormal ABI value) aspirin was not superior to
placebo in preventing cardiovascular events.
 In the CAPRIE trial, in a broadly defined stable population of patients with
atherosclerotic disease, including coronary artery disease, peripheral artery
disease, and cerebrovascular disease, clopidogrel was superior to aspirin. Benefit
was driven mainly by the subgroup of patients with PAD. These results from
CAPRIE established clopidogrel as the first therapy for peripheral artery disease
to be approved by the Food and Drug Administration.
 The CHARISMA trial, enrolling similar high-risk population of patients with
atherosclerosis found no significant benefit for clopidogrel over aspirin in the risk
of cardiovascular events in the overall population. However, there was a nonsignificant
trend in the subgroup of patients with PAD. Dual antiplatelet therapy
was associated with an increased risk of bleeding. On the basis of this evidence,
clopidogrel monotherapy has been the preferred therapy to manage the
atherothrombotic risk in patients with peripheral artery disease.
 In patients with symptomatic PAD enrolled in the EUCLID trial, ticagrelor was not
superior to clopidogrel for the reduction of cardiovascular events, and each drug
was associated with similar rates of major bleeding.
 The COMPASS trial randomized 27,402 patients with coronary artery disease or
peripheral artery disease (PAD) to receive the oral anticoagulant rivaroxaban at
2.5 mg twice daily plus aspirin at 100 mg/day, or rivaroxaban 5 mg twice daily
without aspirin, or aspirin 100 mg/day without rivaroxaban. The trial was stopped
prematurely more than a year ahead of its planned March 2018 completion
because, in an interim analysis, the primary end point of MI, stroke, or
cardiovascular death "has reached its pre-specified criteria for superiority."
COMPASS, Design, highlights of major results
Deepak Bhatt (Boston, USA)
Target patient population. To what patient do the COMPASS results apply?
Faiez Zannad (Nancy, FRA)

Stopping prematurely.
· Logistical considerations: Informing investigators, managing data backlog,
IRB considerations, transitioning patients to open label …
Jackie Bosch (Hamilton, CAN)
· Methodological and interpretation considerations. How should it impact the
interpretation, generalization of the results?
Stuart Pocock (London, GBR)
Mechanistic plausibility and potential for a class effect?
Deepak Bhatt (Boston, USA)
Patients with coronary artery disease and heart failure. Perspectives for
COMMANDER-HF trial
Faiez Zannad (Nancy, FRA)
Industry viewpoint
Peter DiBattiste (Janssen, USA); Nancy Cooks Bruns (Bayer, GER), Martin
Unverdorben (Daiichi Sankyo, USA)
Regulatory viewpoint
Kaori Shinagawa (PMDA, JPN), Ellis Unger (FDA, USA), Joseph Emmerich (EMA, FRA)
11.25 – 12.30 The Forum. Moderated discussion with the audience
Revisiting the Aspirin dogma in secondary prevention?
Chairpersons: Deepak Bhatt (Boston, USA), Faiez Zannad (Nancy, FRA)
Panelists: Deepak Bhatt (Boston, USA), Jackie Bosch (Hamilton, CAN), Nancy Cooks
Bruns (Bayer, GER), Peter DiBattiste (Janssen, USA), Joseph Emmerich (EMA, FRA),
Stuart Pocock (London, GBR), Kaori Shinagawa (PMDA, JPN), Tabassome Simon
(Paris, France), Ellis Unger (FDA, USA), Martin Unverdorben (Daiichi Sankyo, USA),
Faiez Zannad (Nancy, FRA)