combo-stent in patients on chronic anticoagulant therapy (costa) costa-bleed and costa-outcome trials

Conditions: Stable Angina; Unstable Angina; STEMI; NSTEMI; Coronary Disease

Summary: 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.

Eligibility criteria:
inclusion criteria: * age 18 and older; * willingness to comply with the study protocol; subject or a legally authorized representative must provide written informed consent prior to any study related procedure, in accordance with international conference on harmonization of good clinical practice (ich-gcp) guidelines and per site requirements. * patients on anticoagulant therapy or treatment-naive pa-tients with an indication to chronic anticoagulant therapy. indications to oral anticoagulation may include atrial fibrillation, prosthetic valve disease, peripheral by-pass surgery, lung embolism or deep vein thrombosis or any other indication according to the investigator´s opinion. * single or multiple de novo lesion in a native coronary artery, all amenable to treatment with the combo stent; exclusion criteria: * patients who, in the investigator's opinion, should not be treated with (n)oac. these may include, for instance: history of barc 3-5 bleeding \<12 months; patients with a haemorrhagic disorder or bleeding diathesis (e.g. von willebrand disease, haemophilia a or b or other hereditary bleeding disorder, history of spontaneous intra-articular bleeding, history of prolonged bleeding after surgery/intervention); patients with recent major surgery; history of intraocular, spinal, retroperitoneal, intra-articular or recent gastrointestinal bleeding unless the causative factor has been permanently eliminated or repaired; (reduction in the haemoglobin level of at least 2g/dl, transfusion of at least two units of blood, or symptomatic bleeding in a critical area or organ) including life-threatening bleeding episode (symptomatic intracranial bleeding, bleeding with a decrease in the haemoglobin level of at least 5g/dl or bleeding requiring transfusion of at least 4 units of blood or inotropic agents or necessitating surgery); anaemia (haemoglobin \<10g/dl) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count \<100e9/l) at screening; * pregnant or nursing patients. female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test; * other medical illness with a life expectancy \<2 years (e.g. known malignancy) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol or confound the data in-terpretation or is associated with a limited life expectancy; * patient has received an organ transplant or is on a wait-ing list for an organ transplant; * known hypersensitivity or contraindication to antiplate-let or anticoagulant agents that does not allow guide-lines-compliant therapy and that cannot be adequately pre-medicated; * previously received murine therapeutic antibodies and exhibited sensitization through the production of human anti-murine antibodies (hama); * any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study; * current participation in another investigational drug or device study except for non-interventional registries; * patients not willing or able to comply with the protocol requirements or considered unreliable by the investigator concerning the requirements for follow up during the study and/or compliance with study drug administration; angiographic exclusion criteria: * vessel diameter \ 5mm; * target lesion with characteristics that make it unsuitable for stent delivery and deployment; * planned use of a stent or another coronary device in the same or another session (target vessel or non-target vessel), precluding a combo-only strategy.

Keywords: stent , combo stent, anticoagulation