Clinical trial NCT03392948: PERcutaneouS Coronary intErventions in Patients Treated With Oral Anticoagulant Therapy
Official title: PERcutaneouS Coronary intErventions in Patients Treated With Oral Anticoagulant Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Unstable Angina
Chronic Stable Angina
Keywords: atrial fibrillation
prosthetic valves
pulmonary embolism
venous thrombosis
percutaneous coronary interventions
chronic anticoagulant treatment
Lead sponsor: Italian Society of Invasive Cardiology
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 1080
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic disease requiring oral anticoagulant therapy (atrial fibrillation, prosthetic valves, previous pulmonary embolism, venous thrombosis) undergoing either elective, urgent or emergency percutaneous coronary interventions with stent implantation for acute or chronic coronary disease.

Brief summary: Approximately 5 to 8% of patients undergoing percutaneous coronary interventions requires chronic anticoagulant therapy due to atrial fibrillation or other clinical entities. There are many possible different combinations of the antithrombotic therapy after stent implantation in these patients.

Aim of this observational study is to evaluate the real world antithrombotic treatment in patients requiring anticoagulant therapy undergoing stent implantation and to compare the clinical outcome of patients treated with new oral anticoagulant drugs compared to warfarin.

The study is prospective, performed in different Italian hospitals and aimed to enroll 1080 patients with a 1 year follow up

Detailed description: Approximately 5 to 8% of patients undergoing percutaneous coronary interventions requires chronic anticoagulant therapy due to atrial fibrillation or other clinical entities. These patients pose particular problems when undergo percutaneous coronary intervention with stent implantation (PCI-S), because of the different antithrombotic and oral anticoagulant (OAC) strategies required after the procedure when dual antiplatelet therapy is recommended. Consequently, this scenario requires careful consideration balancing bleeding, stroke and acute coronary syndrome risks.

New oral anticoagulants (NOAC) have been compared to warfarin for stroke prevention in the setting of atrial fibrillation and all these drugs showed a similar or improved efficacy over warfarin in term of ischemic events as well as bleeding complications reduction. In particular, an important safety issue is the reduction of intracranial bleeding compared to warfarin. Currently, four different NOAC have been approved for the treatment of patients with atrial fibrillation: apixaban, edoxaban, rivaroxaban and dabigatran. The first three drugs are anti Xa inhibitors whereas the last one is a direct thrombin inhibitor.

Data regarding the combination of NOAC and antiplatelet therapy after PCI-S in patients requiring chronic anticoagulant therapy are currently scarce.

The aim of our study is to perform a prospective, multicenter, observational, controlled study on patients requiring chronic anticoagulant treatment with either vitamin K antagonists or NOAC undergoing PCI-S for concomitant coronary disease.

The primary objectives of the study are:

1. To describe the contemporary antithrombotic management during and post PCI-S in patients treated with oral anticoagulant therapy
2. To evaluate, in this context, the efficacy and safety of the different NAOC compared to warfarin regimens.

According to the observational design of the study, anticoagulant therapy (vitamin antagonists or new oral anticoagulant drugs), other pharmacological therapy as well as procedural device utilized, before, during the procedure and at follow-up will be left to the physician decision.

The events will be adjudicated by a clinical event committee (CEC) comprised of qualified physicians. The CEC is responsible for adjudicating all potential endpoint events, including death, bleeding, myocardial infarction, stent thrombosis, stroke, and coronary revascularization

Eligibility criteria: Inclusion Criteria:

* All patients undergoing percutaneous coronary interventions with stent and an indication for chronic anticoagulant therapy.

Exclusion Criteria:

* Patients of age \< 18 years old
* Lack of written informed consent to participate in the study

Primary outcomes:
measure: Net Adverse Clinical Event
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Ospedale Maggiore Carlo Alberto Pizzardi
state: BO
city: Catanzaro
country: Italy
facility: Azienda Ospedaliero - Universitaria "Mater Domini"
state: CZ
city: Grosseto
country: Italy
facility: Ospedale della Misericordia
state: GR
city: Messina
country: Italy
facility: A.O.U. Policlinico "G.Martino" - Messina
state: ME
city: Sassari
country: Italy
facility: Ospedale Civile SS Annunziata
state: SS
city: Avezzano
country: Italy
facility: Ospedale SS Filippo e Nicola
city: Lecce
country: Italy
facility: Ospedale "Vito Fazzi"
city: Rimini
country: Italy
facility: Ospedale "Infermi" di Rimini
city: Roma
country: Italy
facility: Ospedale S. Eugenio
city: Roma
country: Italy
facility: Ospedale Sandro Pertini
Study officials:
affiliation: Ospedale Sandro Pertini, ASL RM2, Rome
name: Alessandro Sciahbasi, MD
role: PRINCIPAL_INVESTIGATOR
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