AntiCoagulation versus AcetylSalicylic Acid after Transcatheter Aortic Valve Implantation

Conditions

Aortic stenosis

Brief summary

Hypo-attenuated leaflet thickening, superiority, Safety Composite, non-inferiority (bleeding, thromboembolic events and all-cause mortality)

Detailed description

Clinical efficacy, superiority (Composite of of Freedom from all-cause mortality, Freedom from all stroke, Freedom from hospitalization for procedure- or valve-related causes, Freedom from KCCQ overall summary score <45 or decline from baseline of >10 points), Safety Composite, superiority (bleeding, thromboembolic events and all-cause mortality), Thromboembolic events, superiority (Composite of myocardial infarction or stroke of any cause), Bleeding events, superiority (Bleeding events according to VARC-3 definitions), All-cause mortality, superiority, Safety outcomes in safety population (adverse events, serious adverse events, individual bleeding outcomes), Long-term outcomes at 5 and 10 years (Major Adverse Cardiovascular Events/MACE: The rate of the composite of Cardiac death, Aortic valve re-intervention, Stroke, Myocardial infarction, Heart failure hospitalization and Major, life-threatening, or disabling bleeding)

Related papers

No related papers found yet.

Interventions

DRUGRIVAROXABAN

DRUGAPIXABAN

DRUGACETYLSALICYLIC ACID

DRUGEDOXABAN

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Hypo-attenuated leaflet thickening, superiority, Safety Composite, non-inferiority (bleeding, thromboembolic events and all-cause mortality)	—

Secondary

Measure	Time frame
Clinical efficacy, superiority (Composite of of Freedom from all-cause mortality, Freedom from all stroke, Freedom from hospitalization for procedure- or valve-related causes, Freedom from KCCQ overall summary score <45 or decline from baseline of >10 points), Safety Composite, superiority (bleeding, thromboembolic events and all-cause mortality), Thromboembolic events, superiority (Composite of myocardial infarction or stroke of any cause), Bleeding events, superiority (Bleeding events according to VARC-3 definitions), All-cause mortality, superiority, Safety outcomes in safety population (adverse events, serious adverse events, individual bleeding outcomes), Long-term outcomes at 5 and 10 years (Major Adverse Cardiovascular Events/MACE: The rate of the composite of Cardiac death, Aortic valve re-intervention, Stroke, Myocardial infarction, Heart failure hospitalization and Major, life-threatening, or disabling bleeding)	—

Measure

Time frame

Clinical efficacy, superiority (Composite of of Freedom from all-cause mortality, Freedom from all stroke, Freedom from hospitalization for procedure- or valve-related causes, Freedom from KCCQ overall summary score <45 or decline from baseline of >10 points), Safety Composite, superiority (bleeding, thromboembolic events and all-cause mortality), Thromboembolic events, superiority (Composite of myocardial infarction or stroke of any cause), Bleeding events, superiority (Bleeding events according to VARC-3 definitions), All-cause mortality, superiority, Safety outcomes in safety population (adverse events, serious adverse events, individual bleeding outcomes), Long-term outcomes at 5 and 10 years (Major Adverse Cardiovascular Events/MACE: The rate of the composite of Cardiac death, Aortic valve re-intervention, Stroke, Myocardial infarction, Heart failure hospitalization and Major, life-threatening, or disabling bleeding)

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Countries

Norway

Outcome results

None listed