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.

NCT02099617 | Completed DMC

• 1 other identifier: 10-389
• Study Type: interventional
• Target: 1,200
• Locations: 9 countries
• Sites: 44

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.

Conditions

Stable Angina; Silent Myocardial Ischemia; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (9)

• Primary endpoint

  30 days, 180 days, 2 years

• All revascularizations

  30 days, 180 days, 1 year, 2 years

• Complete revascularization

  Baseline procedure

• Net benefit

  30 days, 180 daysn 1 year, 2 years

• Major bleedings complications

  30 days, 180 days, 1 year, 2 years

Study Arms (2)

Drug Eluting Stent

EXPERIMENTAL

Synergy II

Procedure: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent

Bare Metal Stent

ACTIVE COMPARATOR

Omega or Rebel

Procedure: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent; Procedure: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent

Interventions

Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent PROCEDURE

Drug Eluting Stent

Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent PROCEDURE

Bare Metal Stent

Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent PROCEDURE

Bare Metal Stent

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient is ≥ 75 years old
• 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.
• 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.

You may not qualify if:

• The subject is not eligible for randomization if ANY of the following is present:
• Indication for myocardial revascularization by coronary artery bypass grafting,
• 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),
• Subjects requiring additional surgery (cardiac or non-cardiac) within one month,
• Non cardiac co-morbidities with life expectancy less than 1 year,
• Prior hemorrhagic stroke,
• Known allergy to aspirin or P2Y12 inhibitors,
• 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).
• Silent ischemia \<10% of the myocardium with FFR ≥0.80.
• Participation in another clinical trial

Sponsors & Collaborators

• Ceric Sàrl: lead
• Boston Scientific Corporation: collaborator

Study Sites (44)

CHU St Pierre

Brussels, 1150, Belgium

Location

Centre Hospitalier de Jolimont

La Louvière, 7100, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHU de Liège - Domaine Universitaire du Sart Tilman

Liège, 4000, Belgium

Location

Oulu University Hospital

Oulu, 90220, Finland

Location

Heary Center - Satakunta Centyral Hospital

Pori, Finland

Location

Hôpital Ambroise Paré

Boulogne-Billancourt, 92100, France

Location

Hôpital Henri Mondor

Créteil, 94000, France

Location

Hôpital de la Timone

Marseille, 13005, France

Location

Hôpital Privé Jacques Cartier

Massy, 91300, France

Location

Polyclinique les Fleurs

Ollioules, 83 190, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Hôpital La Pitié-Salpêtrière

Paris, 75013, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location

CHU Toulouse Rangueil

Toulouse, 31400, France

Location

ARNAS civico

Palermo, 90127, Italy

Location

Pauls Stradins Clinical University Hospital

Riga, LV-1002, Latvia

Location

University Clinic of Cardiology - Medical Faculty

Skopje, 1000, North Macedonia

Location

Hospital universitario Marquès de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital San Juan de Alicante

Alicante, Valencia, Spain

Location

Complexo Hospitalario Universitario A Coruña

A Coruña, 08003, Spain

Location

Hospital Universati Germans Trias i Pujol

Badalona, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant pau

Barcelona, Spain

Location

Hospital Juan Roamon Jimenez

Huelva, 21005, Spain

Location

Hospital Universitario virgen de la arrixaca

Murcia, 30107, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital virgen de la salud.

Toledo, 45071, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47005, Spain

Location

Hospital Meixoiero

Vigo, 36200, Spain

Location

Hôpital Fribourgeois

Fribourg, 1708, Switzerland

Location

Centre hospitalier universitaire vaudois

Lausanne, 1011, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Kantonsspital Winterthur

Winterthur, Switzerland

Location

Brighton and Sussex Hospitals

Brighton, BN2 1ES, United Kingdom

Location

Craigavon Cardiac Center

Craigavon, BT62 5QQ, United Kingdom

Location

Guy's and St.Thomas'Hospitals

London, SE1 7EH, United Kingdom

Location

King's College London

London, SE5 9PJ, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29102362 DERIVED

MeSH Terms

Conditions

Angina, Stable; Acute Coronary Syndrome

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 31, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: June 1, 2018
• Last Updated: January 16, 2024

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1); NO (1); FR (11); GB (6); CH (5); ES (13); FI (2); BE (4); IT (1)