Prospective, multi-centre, randomized, open-label, parallel comparisons to evaluate * the incidence of bleedings (COSTA-Bleed) and * the incidence of ischemic and bleeding events (COSTA-Outcome) following a therapy with the abluminal sirolimus coated bio-engineered stent (COMBO stent) in association with short-term single antiplatelet therapy as compared to a guidelines-based strategy in patients with coronary artery disease with an indication for chronic oral anticoagulant therapy.
The COSTA trials are investigator-initiated studies aimed at comparing the clinical outcome after percutaneous coronary intervention (PCI) using a COMBO-stent based strategy associated with short-term antiplatelet therapy with a guidelines-based therapy in patients with an indication for chronic oral anticoagulation. The study is organized as a national, multi-centre prospective, randomized trial. The duration of the follow-up is 15 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
The OrbusNeich COMBO Bio-engineered Sirolimus Eluting Stent (COMBO Stent) consists of a 316L stainless steel alloy abluminally coated with a biocompatible, biodegradable poly-mer containing sirolimus. Covalently attached to the surface of the stent is a layer of murine, monoclonal, anti-human CD34 antibody. The antibody specifically targets circulatory CD34+ cells (endothelial progenitor cells) thus favoring endothelialization.
Anticoagulant medication after stent Implantation: (N)OAC and clopidogrel for 3 months followed by (N)OAC
MVZ am Kuechwald GmbH
Chemnitz, Germany
Elisabeth Krankenhaus
Essen, Germany
Universitaetsmedizin Mainz
Mainz, Germany
Theresienkrankenhaus und St. Hedwig GmbH
Mannheim, Germany
Number of patients with bleedings
any BARC (bleeding academic research consortium) bleeding at 6 weeks - superiority.
Time frame: 6 weeks
Number of patients with safety events
Strategy oriented composite safety endpoint, including death (unless proven not to be connected to the other endpoints), any MI, stroke or systemic embolism, definite or probable stent thrombosis, BARC 3-4 bleeding at 15 months post PCI - non-inferiority with reflex to superiority testing. Hierarchical testing: Endpoint II is only tested if null hypothesis of no difference in bleeding incidence can be rejected at final analysis.
Time frame: 15 months
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Implantation of traditional bare metal stents and/or drug eluting stents (any device approved on the market, implanted according to CE marking and IFU) and medication regimen in accordance with ESC Guidelines
A combination of antiplatelet and anticoagulant therapy according to ESC guidelines (2014)
Universitaetsmedizin Mannheim
Mannheim, Germany
St. Franziskus, Kliniken Maria Hilf GmbH
Mönchengladbach, Germany
Evangelisches Krankenhuas Muehlheim a.d. Ruhr GmbH
Muehlheim An Der Ruhr, Germany
Diakonissen-Stiftungs-Krankenhaus
Speyer, Germany
Herzklinik Ulm GbR
Ulm, Germany
Schwarzwald-Baar-Klinikum
Villingen-Schwenningen, Germany