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. (SENIOR)

Ceric Sàrl

Status: Completed

Conditions: Silent Myocardial Ischemia; Acute Coronary Syndrome; Stable Angina

Treatments: 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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02099617

10-389

Details and patient eligibility

About

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.

Enrollment: 1,200 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 2 patient groups

Drug Eluting Stent

Experimental group

Description:

Synergy II

Treatment:

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

Bare Metal Stent

Active Comparator group

Description:

Omega or Rebel

Treatment:

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

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