Acute Coronary Syndrome, Silent Myocardial Ischemia, Stable Angina
Conditions
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.
Interventions
PROCEDUREPercutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent
PROCEDUREPercutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent
PROCEDUREPercutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent
Sponsors
Boston Scientific Corporation
Ceric Sàrl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| All revascularizations | 30 days, 180 days, 1 year, 2 years | All target lesion revascularization, all target vessel revascularization, all non target vessel revascularization |
| Complete revascularization | Baseline procedure | anatomic and functional |
| 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) |
| Primary endpoint | 30 days, 180 days, 2 years | — |
| QoL | 12 months, 24 months | — |
| Depression scale | 12 months, 24 months | — |
| Cost effectiveness | 12 months | — |
| Stent thombosis | 30 days, 1 year, 2 years | according to the definition of ARC symptomatic or asymptomatic (definite + probable) |
Countries
Belgium, Finland, France, Italy, Latvia, North Macedonia, Spain, Switzerland, United Kingdom
Outcome results
None listed