Clinical trial NCT02099617: Efficacy and Safety of New Generation Drug Eluting Stents Associated With an Ultra Short Duration of Dual Antiplatelet Therapy. Design of the Short Duration of Dual antiplatElet Therapy With SyNergy II Stent in Patients Older Than 75 Years Undergoing Percutaneous Coronary Revascularization.
Official title: Efficacy and Safety of New Generation Drug Eluting Stents Associated With an Ultra Short Duration of Dual Antiplatelet Therapy. Design of the Short Duration of Dual antiplatElet Therapy With SyNergy II Stent in Patients Older Than 75 Years Undergoing Percutaneous Coronary Revascularization.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Angina
Silent Myocardial Ischemia
Acute Coronary Syndrome
Lead sponsor: Ceric Sàrl
Sponsor class: INDUSTRY
Collaborators: name: Boston Scientific Corporation
First posted: 2014-03-31
Enrollment: 1200
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 1- Patient is ≥ 75 years old
* 2- One or more significant coronary artery stenosis is/are present (defined as ≥70% by visual assessment or ≥50% with Fractional Flow Reserve \<0.80) or a left main coronary stenosis ≥50% by visual assessment) suitable for PCI with one of the following present:
* a -Silent ischemia,
* stress-induced myocardial ischemia ≥ 10% of myocardium in a asymptomatic patient or
* stress-induced myocardial ischemia \< 10% of myocardium AND FFR (Fractional Flow Reserve) ≤0.80 or
* b - Stable angina, in a patient with objective ischemia despite optimal medical therapy or
* c - acute coronary syndrome including: unstable angina, non ST- and ST elevation myocardial infarction.
* 3- All patients must also sign informed consent as per local law and comply with all study process during follow up for at least one year.

Exclusion Criteria:

* 1- The subject is not eligible for randomization if ANY of the following is present:
* 2- Indication for myocardial revascularization by coronary artery bypass grafting,
* 3- Subjects unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one month (stable angina or silent ischemia) or at least six month (acute coronary syndrome),
* 4- Subjects requiring additional surgery (cardiac or non-cardiac) within one month,
* 5- Non cardiac co-morbidities with life expectancy less than 1 year,
* 6- Prior hemorrhagic stroke,
* 7- Known allergy to aspirin or P2Y12 inhibitors,
* 8- At least one contra indication to ALL the authorized P2Y12 inhibitors at the requested dose (in case of contra indication to only one of two of the P2Y12 inhibitors, the investigators are allowed to use the P2Y12 inhibitors for which no allergy is known).
* 9- Silent ischemia \<10% of the myocardium with FFR ≥0.80.
* 10- Participation in another clinical trial

Primary outcomes:
measure: Composite measure of MACCEs (Major Adverse Cardiac and Cerebrovascular Events)
timeFrame: 12 months
Secondary outcomes:
measure: Primary endpoint
timeFrame: 30 days, 180 days, 2 years
measure: All revascularizations
timeFrame: 30 days, 180 days, 1 year, 2 years
measure: Complete revascularization
timeFrame: Baseline procedure
measure: Net benefit
timeFrame: 30 days, 180 daysn 1 year, 2 years
measure: Major bleedings complications
timeFrame: 30 days, 180 days, 1 year, 2 years
measure: Stent thombosis
timeFrame: 30 days, 1 year, 2 years
measure: QoL
timeFrame: 12 months, 24 months
measure: Depression scale
timeFrame: 12 months, 24 months
measure: Cost effectiveness
timeFrame: 12 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU St Pierre
city: La Louvière
country: Belgium
facility: Centre Hospitalier de Jolimont
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège 1
country: Belgium
facility: CHU de Liège - Domaine Universitaire du Sart Tilman
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Pori
country: Finland
facility: Heary Center - Satakunta Centyral Hospital
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Marseille
country: France
facility: Hôpital de la Timone
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Ollioules
country: France
facility: Polyclinique les Fleurs
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital La Pitié-Salpêtrière
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Quincy sous Sénart
country: France
facility: Hôpital Privé Claude Galien
city: Toulouse
country: France
facility: CHU Toulouse Rangueil
city: Palermo
country: Italy
facility: ARNAS civico
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Skopje
country: North Macedonia
facility: University Clinic of Cardiology - Medical Faculty
city: Santander
country: Spain
facility: Hospital universitario Marquès de Valdecilla
state: Cantabria
city: Alicante
country: Spain
facility: Hospital San Juan de Alicante
state: Valencia
city: A Coruna
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
city: Badalona
country: Spain
facility: Hospital Universati Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant pau
city: Huelva
country: Spain
facility: Hospital Juan Roamon Jimenez
city: Murcia
country: Spain
facility: Hospital Universitario virgen de la arrixaca
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Toledo
country: Spain
facility: Hospital virgen de la salud.
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Vigo
country: Spain
facility: Hospital Meixoiero
city: Fribourg
country: Switzerland
facility: Hôpital Fribourgeois
city: Lausanne
country: Switzerland
facility: Centre hospitalier universitaire vaudois
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: St.Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Brighton
country: United Kingdom
facility: Brighton and Sussex Hospitals
city: Craigavon
country: United Kingdom
facility: Craigavon Cardiac Center
city: London
country: United Kingdom
facility: Guy's and St.Thomas'Hospitals
city: London
country: United Kingdom
facility: King's College London
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
References:
citation: Varenne O, Cook S, Sideris G, Kedev S, Cuisset T, Carrie D, Hovasse T, Garot P, El Mahmoud R, Spaulding C, Helft G, Diaz Fernandez JF, Brugaletta S, Pinar-Bermudez E, Mauri Ferre J, Commeau P, Teiger E, Bogaerts K, Sabate M, Morice MC, Sinnaeve PR; SENIOR investigators. Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial. Lancet. 2018 Jan 6;391(10115):41-50. doi: 10.1016/S0140-6736(17)32713-7. Epub 2017 Nov 1.