The main objective of the SENIOR study is to establish the efficacy and safety of the everolimus eluting stent with a biodegradable abluminal polymer (SYNERGY II) associated with a short dual antiplatelet therapy (DAPT) in patients ≥75 years old, suffering from stable angina, silent ischemia (1 month DAPT) or acute coronary syndromes (6 months DAPT) related to significant coronary artery disease and requiring percutaneous coronary intervention. The primary end point is to demonstrate that SYNERGY II in patients ≥75 years old is associated with a lower rate of the composite rate of major cardiovascular and cerebrovascular events (all-cause death, myocardial infarction, stroke, ischemia-driven target lesion revascularization) and a similar risk of stent thrombosis than bare metal stent at one year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,200
CHU St Pierre
Brussels, Belgium
Centre Hospitalier de Jolimont
La Louvière, Belgium
UZ Leuven
Leuven, Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège, Belgium
Oulu University Hospital
Oulu, Finland
Heary Center - Satakunta Centyral Hospital
Composite measure of MACCEs (Major Adverse Cardiac and Cerebrovascular Events)
all-cause death, non fatal myocardial infarction, non fatal stroke, ischemia-driven target lesion revascularization.
Time frame: 12 months
Primary endpoint
Time frame: 30 days, 180 days, 2 years
All revascularizations
All target lesion revascularization, all target vessel revascularization, all non target vessel revascularization
Time frame: 30 days, 180 days, 1 year, 2 years
Complete revascularization
anatomic and functional
Time frame: Baseline procedure
Net benefit
association of composite events (all cause mortality, myocardial infarction, stroke, ischemia driven target lesion revascularization, and major bleedings)
Time frame: 30 days, 180 daysn 1 year, 2 years
Major bleedings complications
type 2, 3 and 5 BARC definition)
Time frame: 30 days, 180 days, 1 year, 2 years
Stent thombosis
according to the definition of ARC symptomatic or asymptomatic (definite + probable)
Time frame: 30 days, 1 year, 2 years
QoL
Time frame: 12 months, 24 months
Depression scale
Time frame: 12 months, 24 months
Cost effectiveness
Time frame: 12 months
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Pori, Finland
Hôpital Ambroise Paré
Boulogne-Billancourt, France
Hôpital Henri Mondor
Créteil, France
Hôpital de la Timone
Marseille, France
Hôpital Privé Jacques Cartier
Massy, France
...and 34 more locations