Clinical trial NCT00722319: Ongoing WARfarin and Coronary STENTing
Official title: Ongoing WARfarin and Coronary STENTing. A Multi-center, Prospective Registry on Antithrombotic Treatment.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Atrial Fibrillation
Keywords: oral anticoagulation
warfarin
percutaneous coronary intervention
stent
antiplatelet agents
Lead sponsor: War-Stent Investigators
Sponsor class: OTHER
First posted: 2008-07-25
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: Inclusion Criteria:

* Patients with ongoing warfarin treatment.

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of major/minor bleeding + adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death) + arterial/venous thrombosis/thromboembolism
timeFrame: 1, 3, 6 and 12 months
Secondary outcomes:
measure: Incidence of major/minor bleeding
timeFrame: 1, 3, 6 and 12 months
measure: Adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death)
timeFrame: 1, 3, 6 and 12 months
measure: Stent thrombosis
timeFrame: 1, 3, 6 and 12 months
measure: Arterial/venous thromboembolism;
timeFrame: 1, 3, 6 and 12 months
measure: Blood transfusions
timeFrame: 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Division of Cardiology
Study officials:
affiliation: Division of Cardiology, Maggiore Hospital, Bologna
name: Andrea Rubboli, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.