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.

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome; Silent Myocardial Ischemia; Stable Angina
• Interventions: Procedure: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent; Procedure: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent; Procedure: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent

• Registration Number: NCT02099617
• Lead Sponsor: Ceric Sàrl

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-03-26
• Study First Posted: 2014-03-31
• Study Start: 2014-05
• Status Verified: 2017-05
• Primary Completion: 2017-07
• Study Completion: 2018-06
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug Eluting Stent	Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent	Synergy II
Bare Metal Stent	Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent	Omega or Rebel
Bare Metal Stent	Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent	Omega or Rebel

Primary Outcome Measures

Name	Time	Method
Composite measure of MACCEs (Major Adverse Cardiac and Cerebrovascular Events)	12 months	all-cause death, non fatal myocardial infarction, non fatal stroke, ischemia-driven target lesion revascularization.

Secondary Outcome Measures

Name	Time	Method
Cost effectiveness	12 months
Primary endpoint	30 days, 180 days, 2 years
Complete revascularization	Baseline procedure	anatomic and functional
Stent thombosis	30 days, 1 year, 2 years	according to the definition of ARC symptomatic or asymptomatic (definite + probable)
QoL	12 months, 24 months
All revascularizations	30 days, 180 days, 1 year, 2 years	All target lesion revascularization, all target vessel revascularization, all non target vessel revascularization
Net benefit	30 days, 180 daysn 1 year, 2 years	association of composite events (all cause mortality, myocardial infarction, stroke, ischemia driven target lesion revascularization, and major bleedings)
Major bleedings complications	30 days, 180 days, 1 year, 2 years	type 2, 3 and 5 BARC definition)
Depression scale	12 months, 24 months

Trial Locations

Locations (44)

Centre Hospitalier de Jolimont; 🇧🇪 La Louvière, Belgium

Heary Center - Satakunta Centyral Hospital; 🇫🇮 Pori, Finland

Hôpital Ambroise Paré; 🇫🇷 Boulogne-Billancourt, France

Hôpital de la Timone; 🇫🇷 Marseille, France

Hôpital Privé Jacques Cartier; 🇫🇷 Massy, France

Polyclinique les Fleurs; 🇫🇷 Ollioules, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Hôpital La Pitié-Salpêtrière; 🇫🇷 Paris, France

Hôpital Cochin; 🇫🇷 Paris, France

Hôpital Privé Claude Galien; 🇫🇷 Quincy sous Sénart, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Pauls Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

CHU Toulouse Rangueil; 🇫🇷 Toulouse, France

Hospital universitario Marquès de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

University Clinic of Cardiology - Medical Faculty; 🇲🇰 Skopje, North Macedonia

ARNAS civico; 🇮🇹 Palermo, Italy

Hospital del Mar; 🇪🇸 Barcelona, Spain

Complexo Hospitalario Universitario A Coruña; 🇪🇸 A Coruna, Spain

Hospital Universati Germans Trias i Pujol; 🇪🇸 Badalona, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospital de la Santa Creu i Sant pau; 🇪🇸 Barcelona, Spain

Hospital Juan Roamon Jimenez; 🇪🇸 Huelva, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitario virgen de la arrixaca; 🇪🇸 Murcia, Spain

Hospital virgen de la salud.; 🇪🇸 Toledo, Spain

Hospital Meixoiero; 🇪🇸 Vigo, Spain

Hospital Clinico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Hôpital Fribourgeois; 🇨🇭 Fribourg, Switzerland

Centre hospitalier universitaire vaudois; 🇨🇭 Lausanne, Switzerland

Luzerner Kantonsspital; 🇨🇭 Luzern, Switzerland

Kantonsspital St. Gallen; 🇨🇭 St.Gallen, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland

Brighton and Sussex Hospitals; 🇬🇧 Brighton, United Kingdom

Guy's and St.Thomas'Hospitals; 🇬🇧 London, United Kingdom

Craigavon Cardiac Center; 🇬🇧 Craigavon, United Kingdom

King's College London; 🇬🇧 London, United Kingdom

Freeman Hospital; 🇬🇧 Newcastle upon Tyne, United Kingdom

New Cross Hospital; 🇬🇧 Wolverhampton, United Kingdom

Hospital San Juan de Alicante; 🇪🇸 Alicante, Valencia, Spain

Oulu University Hospital; 🇫🇮 Oulu, Finland

CHU de Liège - Domaine Universitaire du Sart Tilman; 🇧🇪 Liège 1, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

CHU St Pierre; 🇧🇪 Brussels, Belgium

Hôpital Henri Mondor; 🇫🇷 Créteil, France