Ongoing WARfarin and Coronary STENTing

NCT ID: NCT00722319

Last Updated: 2011-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-10-31

Brief Summary

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.

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

Conditions

Acute Coronary Syndrome; Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients with ongoing warfarin treatment.

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

War-Stent Investigators

OTHER

Sponsor Role: lead

Responsible Party

Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO)

Principal Investigators

Andrea Rubboli, MD

Role: STUDY_DIRECTOR

Division of Cardiology, Maggiore Hospital, Bologna

Locations

Division of Cardiology

Bologna, , Italy

Countries

Italy

References

Rubboli A, Halperin JL, Airaksinen KE, Buerke M, Eeckhout E, Freedman SB, Gershlick AH, Schlitt A, Tse HF, 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;40(6):428-36. doi: 10.1080/07853890802089786.

Reference Type: BACKGROUND

PMID: 18608125 (View on PubMed)

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. doi: 10.1016/j.ijcard.2007.02.017. Epub 2007 Apr 16.

Reference Type: BACKGROUND

PMID: 17434621 (View on PubMed)

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. doi: 10.1097/MCA.0b013e328012a964.

Reference Type: BACKGROUND

PMID: 17429293 (View on PubMed)

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. doi: 10.1093/eurheartj/ehl348. Epub 2006 Oct 30. No abstract available.

Reference Type: BACKGROUND

PMID: 17074773 (View on PubMed)

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. doi: 10.1159/000086918. Epub 2005 Jul 12.

Reference Type: BACKGROUND

PMID: 16020950 (View on PubMed)

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. doi: 10.1016/j.ahj.2004.08.019. No abstract available.

Reference Type: BACKGROUND

PMID: 15846242 (View on PubMed)

Rubboli A, Saia F, Sciahbasi A, Leone AM, Palmieri C, Bacchi-Reggiani ML, Calabro P, Bordoni B, Piccalo G, Franco N, Nicolino A, Magnavacchi P, Vignali L, Mameli S, Dallago M, Maggiolini S, Steffanon L, Piovaccari G, Di Pasquale G; WARfarin and Coronary STENTing (WAR-STENT) Study group. Twelve-month outcome of patients with an established indication for oral anticoagulation undergoing coronary artery stenting and stratified by the baseline risk of bleeding: Insights from the Warfarin and Coronary Stenting (War-Stent) Registry. Cardiovasc Revasc Med. 2017 Sep;18(6):425-430. doi: 10.1016/j.carrev.2017.03.015. Epub 2017 Mar 19.

Reference Type: DERIVED

PMID: 28363682 (View on PubMed)

Rubboli A, Saia F, Sciahbasi A, Bacchi-Reggiani ML, Steffanon L, Briguori C, Calabro P, Palmieri C, Rizzi A, Imperadore F, Sangiorgi GM, Valgimigli M, Carosio G, Steffenino G, Galvani M, Di Pasquale G, La Vecchia L, Maggioni AP, Bolognese L; WARfarin and Coronary STENTing (WAR-STENT) Study Group. Outcome of patients on oral anticoagulation undergoing coronary artery stenting: data from discharge to 12 months in the Warfarin and Coronary Stenting (WAR-STENT) Registry. J Invasive Cardiol. 2014 Nov;26(11):563-9.

Reference Type: DERIVED

PMID: 25363997 (View on PubMed)

Rubboli A, Sciahbasi A, Briguori C, Saia F, Palmieri C, Moroni LA, Calabro P, Leone AM, Franco N, Valgimigli M, Varani E, Santi M, Pasqualini P, Capecchi A, Piccalo 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.

Reference Type: DERIVED

PMID: 23549489 (View on PubMed)

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. doi: 10.2459/JCM.0b013e3283212f07.

Reference Type: DERIVED

PMID: 19377385 (View on PubMed)

Other Identifiers

WS-1

Identifier Type: -

Identifier Source: org_study_id