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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Eluting Stent | Experimental | Synergy II |
|
| Bare Metal Stent | Active Comparator | Omega or Rebel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent | Procedure |
| ||
| Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint | 30 days, 180 days, 2 years | |
| All revascularizations | All target lesion revascularization, all target vessel revascularization, all non target vessel revascularization | 30 days, 180 days, 1 year, 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU St Pierre | Brussels | 1150 | Belgium | |||
| Centre Hospitalier de Jolimont |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29102362 | Derived | 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. |
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| Procedure |
|
| Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent | Procedure |
|
| Complete revascularization | anatomic and functional | Baseline procedure |
| Net benefit | association of composite events (all cause mortality, myocardial infarction, stroke, ischemia driven target lesion revascularization, and major bleedings) | 30 days, 180 daysn 1 year, 2 years |
| Major bleedings complications | type 2, 3 and 5 BARC definition) | 30 days, 180 days, 1 year, 2 years |
| Stent thombosis | according to the definition of ARC symptomatic or asymptomatic (definite + probable) | 30 days, 1 year, 2 years |
| QoL | 12 months, 24 months |
| Depression scale | 12 months, 24 months |
| Cost effectiveness | 12 months |
| La Louvière |
| 7100 |
| Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| CHU de Liège - Domaine Universitaire du Sart Tilman | Liège | 4000 | Belgium |
| Oulu University Hospital | Oulu | 90220 | Finland |
| Heary Center - Satakunta Centyral Hospital | Pori | Finland |
| Hôpital Ambroise Paré | Boulogne-Billancourt | 92100 | France |
| Hôpital Henri Mondor | Créteil | 94000 | France |
| Hôpital de la Timone | Marseille | 13005 | France |
| Hôpital Privé Jacques Cartier | Massy | 91300 | France |
| Polyclinique les Fleurs | Ollioules | 83 190 | France |
| Hôpital Lariboisière | Paris | 75010 | France |
| Hôpital La Pitié-Salpêtrière | Paris | 75013 | France |
| Hôpital Cochin | Paris | 75014 | France |
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| Hôpital Privé Claude Galien | Quincy-sous-Sénart | 91480 | France |
| CHU Toulouse Rangueil | Toulouse | 31400 | France |
| ARNAS civico | Palermo | 90127 | Italy |
| Pauls Stradins Clinical University Hospital | Riga | LV-1002 | Latvia |
| University Clinic of Cardiology - Medical Faculty | Skopje | 1000 | North Macedonia |
| Hospital universitario Marquès de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital San Juan de Alicante | Alicante | Valencia | Spain |
| Complexo Hospitalario Universitario A Coruña | A Coruña | 08003 | Spain |
| Hospital Universati Germans Trias i Pujol | Badalona | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Clinic | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant pau | Barcelona | Spain |
| Hospital Juan Roamon Jimenez | Huelva | 21005 | Spain |
| Hospital Universitario virgen de la arrixaca | Murcia | 30107 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital virgen de la salud. | Toledo | 45071 | Spain |
| Hospital Clinico Universitario de Valladolid | Valladolid | 47005 | Spain |
| Hospital Meixoiero | Vigo | 36200 | Spain |
| Hôpital Fribourgeois | Fribourg | 1708 | Switzerland |
| Centre hospitalier universitaire vaudois | Lausanne | 1011 | Switzerland |
| Luzerner Kantonsspital | Lucerne | 6000 | Switzerland |
| Kantonsspital St. Gallen | Sankt Gallen | 9007 | Switzerland |
| Kantonsspital Winterthur | Winterthur | Switzerland |
| Brighton and Sussex Hospitals | Brighton | BN2 1ES | United Kingdom |
| Craigavon Cardiac Center | Craigavon | BT62 5QQ | United Kingdom |
| Guy's and St.Thomas'Hospitals | London | SE1 7EH | United Kingdom |
| King's College London | London | SE5 9PJ | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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