Ongoing WARfarin and Coronary STENTing - Full Text View

Purpose

Patients on warfarin treatment pose particular problems when undergoing percutaneous coronary intervention with stent implantation (PCI-S), because of the poor definition of the optimal antithrombotic strategies to be adopted both peri-procedurally and during the 4 (or more) weeks after PCI-S, when dual antiplatelet therapy with aspirin and clopidogrel is recommended. In the absence of solid evidence-based data, no definite recommendations for the management of this patient subset are currently given in the guidelines on percutaneous coronary intervention issued by the most prominent Cardiology Associations. Indeed, a high variability has been reported in the current antithrombotic strategies, which may consist in either the temporary substitution of warfarin by dual antiplatelet treatment or the combination of warfarin and aspirin or clopidogrel or both. Peri-procedural bridging therapy with either intravenous unfractionated or subcutaneous low-molecular-weight heparin is also variably carried out. Purpose of this registry is to determine in patients on warfarin treatment undergoing PCI-S: 1) the contemporary peri-procedural and medium-term antithrombotic management; and 2) the relative safety and efficacy of the various antithrombotic regimens.

Condition
Acute Coronary Syndrome Atrial Fibrillation

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Ongoing WARfarin and Coronary STENTing. A Multi-center, Prospective Registry on Antithrombotic Treatment.

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation Blood Thinners Deep Vein Thrombosis Heart Attack

Drug Information available for: Warfarin Warfarin sodium

U.S. FDA Resources

Further study details as provided by War-Stent Investigators:

Primary Outcome Measures:

Incidence of major/minor bleeding + adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death) + arterial/venous thrombosis/thromboembolism [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of major/minor bleeding [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
Adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death) [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
Stent thrombosis [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
Arterial/venous thromboembolism; [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
Blood transfusions [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	March 2009
Estimated Study Completion Date:	October 2011
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
A Patients on long-term oral anticoagulation who are submitted to PCI-S because of acute coronary syndrome or stable angina. No further groups nor interventions are anticipated since the study is observational

Detailed Description:

Patients on oral anticoagulation with vitamin-K antagonists who undergo PCI-S will be prospectively included in the registry and follow up for 12 months

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients treated with warfarin who are hospitalized at tertiary centers all over the country to undergo percutaneous coronary intervention with stent implantation

Criteria

Inclusion Criteria:

Patients with ongoing warfarin treatment.

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722319

Locations

Italy
Division of Cardiology
Bologna, Italy, 40133

Sponsors and Collaborators

War-Stent Investigators

Investigators

Study Director:

Andrea Rubboli, MD

Division of Cardiology, Maggiore Hospital, Bologna

More Information

Publications:

Rubboli A, Halperin JL, Juhani Airaksinen KE, Buerke M, Eeckhout E, Freedman SB, Gershlick AH, Schlitt A, Fat Tse H, Verheugt FW, Lip GY. Antithrombotic therapy in patients treated with oral anticoagulation undergoing coronary artery stenting. An expert consensus document with focus on atrial fibrillation. Ann Med. 2008 May 2;:1-9 [Epub ahead of print]

Rubboli A, Verheugt FW. Antithrombotic treatment for patients on oral anticoagulation undergoing coronary stenting: a review of the available evidence and practical suggestions for the clinician. Int J Cardiol. 2008 Jan 24;123(3):234-9. Epub 2007 Apr 16. Review.

Rubboli A, Colletta M, Herzfeld J, Sangiorgio P, Di Pasquale G. Periprocedural and medium-term antithrombotic strategies in patients with an indication for long-term anticoagulation undergoing coronary angiography and intervention. Coron Artery Dis. 2007 May;18(3):193-9.

Rubboli A, Di Pasquale G. The combination of anticoagulant and anti-platelet therapy in patients with atrial fibrillation: a comment on the recent ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation. Eur Heart J. 2006 Dec;27(23):2908-9; author reply 2909-10. Epub 2006 Oct 30. No abstract available.

Rubboli A, Milandri M, Castelvetri C, Cosmi B. Meta-analysis of trials comparing oral anticoagulation and aspirin versus dual antiplatelet therapy after coronary stenting. Clues for the management of patients with an indication for long-term anticoagulation undergoing coronary stenting. Cardiology. 2005;104(2):101-6. Epub 2005 Jul 12.

Rubboli A, Colletta M, Di Pasquale G. Regarding antithrombotic treatment after coronary stenting in patients on chronic oral anticoagulation. Am Heart J. 2005 Feb;149(2):E1. No abstract available.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rubboli A, Sciahbasi A, Briguori C, Saia F, Palmieri C, Moroni LA, Calabrò P, Leone AM, Franco N, Valgimigli M, Varani E, Santi M, Pasqualini P, Capecchi A, Piccalò G, Margheri M, di Pasquale G, Galvani M, Bolognese L, Gonzini L, Maggioni AP; WARfarin and coronary STENTing registry. In-hospital management and outcome of patients on warfarin undergoing coronary stent implantation: results of the multicenter, prospective WARfarin and coronary STENTing (WAR-STENT) registry. J Invasive Cardiol. 2013 Apr;25(4):170-6.

Rubboli A, Bolognese L, Di Pasquale G, Galvani M, La Vecchia L, Maggioni AP. A prospective multicentre observational study on the management of patients on oral anticoagulation undergoing coronary artery stenting: rationale and design of the ongoing warfarin and coronary stenting (WAR-STENT) registry. J Cardiovasc Med (Hagerstown). 2009 Feb;10(2):200-3.

Responsible Party:	Aldo P. Maggioni, Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO)
ClinicalTrials.gov Identifier:	NCT00722319 History of Changes
Other Study ID Numbers:	WS-1
Study First Received:	July 23, 2008
Last Updated:	August 11, 2011
Health Authority:	Italy: Ethics Committee

Keywords provided by War-Stent Investigators:

oral anticoagulation
warfarin
percutaneous coronary intervention
stent
antiplatelet agents

Additional relevant MeSH terms:

Atrial Fibrillation
Acute Coronary Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Angina Pectoris
Vascular Diseases

Chest Pain
Pain
Signs and Symptoms
Platelet Aggregation Inhibitors
Warfarin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants

ClinicalTrials.gov processed this record on May 19, 2013

Ongoing WARfarin and Coronary STENTing (WAR-STENT)