Triple Antithrombotic Therapy in Patients With Atrial Fibrillation and Coronary Artery Stents
2010; Lippincott Williams & Wilkins; Volume: 121; Issue: 18 Linguagem: Inglês
10.1161/circulationaha.109.924944
ISSN1524-4539
AutoresJeremy S. Paikin, Douglas Wright, Mark Crowther, Shamir R. Mehta, John W. Eikelboom,
Tópico(s)Cardiac Imaging and Diagnostics
ResumoHomeCirculationVol. 121, No. 18Triple Antithrombotic Therapy in Patients With Atrial Fibrillation and Coronary Artery Stents Free AccessReview ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessReview ArticlePDF/EPUBTriple Antithrombotic Therapy in Patients With Atrial Fibrillation and Coronary Artery Stents Jeremy S. Paikin, Douglas S. Wright, Mark A. Crowther, Shamir R. Mehta and John W. Eikelboom Jeremy S. PaikinJeremy S. Paikin From McMaster University, Hamilton, Ontario, Canada. , Douglas S. WrightDouglas S. Wright From McMaster University, Hamilton, Ontario, Canada. , Mark A. CrowtherMark A. Crowther From McMaster University, Hamilton, Ontario, Canada. , Shamir R. MehtaShamir R. Mehta From McMaster University, Hamilton, Ontario, Canada. and John W. EikelboomJohn W. Eikelboom From McMaster University, Hamilton, Ontario, Canada. Originally published11 May 2010https://doi.org/10.1161/CIRCULATIONAHA.109.924944Circulation. 2010;121:2067–2070Case presentation: A 76-year-old man with rate-controlled atrial fibrillation (AF), diabetes mellitus, and prior stroke who is receiving warfarin to prevent recurrent stroke presents to the emergency department with chest pain, elevated serum troponin, and an ECG that demonstrates ST depression in the precordial leads. Cardiac catheterization reveals an ulcerated plaque and partially obstructive thrombus in the left circumflex coronary artery. Percutaneous coronary intervention is performed with placement of 2 bare-metal stents. What is the optimal antithrombotic therapy? What is the optimal antithrombotic therapy if the patient receives drug-eluting stents instead of bare-metal stents?Efficacy of Antithrombotic Therapy in Patients With AFMeta-analyses of randomized controlled trials in patients with nonvalvular AF indicate that oral vitamin K antagonist (VKA) therapy reduces the risk of stroke or systemic embolism by 64% compared with placebo and by 39% compared with aspirin.1,2 In the ACTIVE trials (Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events), warfarin reduced the risk of stroke or systemic embolism by 42% compared with dual-antiplatelet therapy with the combination of aspirin and clopidogrel,3 whereas dual-antiplatelet therapy reduced the risk by 28% compared with aspirin alone.4 Recently, the RE-LY trial (Randomized Evaluation of Long-term anticoagulant therapY) showed that compared with warfarin the oral direct thrombin inhibitor, dabigatran etexilate given at a dose of 150 mg twice daily reduces stroke with less intracranial bleeding, and dabigatran 110 mg twice daily has similar efficacy with less bleeding.5 Dabigatran etexilate is not yet approved for stroke prevention in AF.The 2006 American College of Cardiology/American Heart Association/European Society of Cardiology and the 2008 American College of Chest Physicians guidelines both recommend stratification of patients with AF according to their risk of stroke to guide the choice of antithrombotic therapy. The guidelines recommend VKA therapy for patients with a CHADS2 score >1, either aspirin or VKA therapy for patients with a CHADS2 score of 1 (with the American College of Chest Physicians giving preference to VKA), and aspirin for patients with a CHADS2 score of 0.6,7Efficacy of Antithrombotic Therapy in Patients With Coronary Artery StentsIn patients undergoing percutaneous coronary intervention with stent insertion, dual-antiplatelet therapy reduces the risk of cardiovascular death or myocardial infarction compared with aspirin alone or aspirin plus warfarin.8 Concerns about the risk of stent thrombosis prompted the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions to recommend dual-antiplatelet therapy for a minimum of 1 month and ideally for 1 year in patients with a bare-metal stent and for a minimum of 1 year in those with a drug-eluting stent.9 For patients at high risk of bleeding, the guidelines recommend dual-antiplatelet therapy for a minimum of 2 weeks in those with a bare-metal stent. Under circumstances that prevent the use of clopidogrel for 1 year, the duration of dual-antiplatelet therapy studied for Food and Drug Administration approval was 3 months for sirolimus-eluting stents and 6 months for paclitaxel-eluting stents.9The antithrombotic management of patients with AF receiving warfarin who undergo percutaneous coronary intervention with stent insertion requires clinicians to weigh the risk of thromboembolism against the risk of bleeding. Possible approaches include "triple therapy" using a VKA in combination with dual-antiplatelet therapy or dual-antiplatelet therapy alone.Efficacy of Triple TherapyNo randomized controlled trials have evaluated the efficacy and safety of the combination of warfarin and dual-antiplatelet therapy compared with either therapy alone. There is no reason to expect loss of efficacy when a VKA and dual-antiplatelet therapy are used in combination. It is likely, however, that combination therapy increases the risk of major bleeding, which in patients with an acute coronary syndrome is associated with a 5-fold increased risk of death within 30 days.10Safety of Triple TherapyObservational studies of patients receiving triple therapy have reported 30-day major bleeding rates of 0% to 15%, although the upper limit of this range is from a small study and is probably an outlier. Our meta-analysis of 10 studies involving 1349 patients receiving triple therapy revealed a weighted mean incidence of major bleeding at 30 days of 2.2% (95% confidence interval 0.7% to 3.7%; Table).11–20 Most patients in these studies were receiving warfarin for AF and dual-antiplatelet therapy for a coronary artery stent. Although the studies contributing to these estimates were small, involved heterogeneous patient populations, employed different cointerventions, and used various definitions of major bleeding, they provide the best available estimates of bleeding risk associated with triple therapy. Patients and healthcare providers are likely to accept a 2.2% rate of major bleeding at 30 days in patients with a bare-metal stent as an acceptable tradeoff when weighed against the possible consequences of warfarin withdrawal (an increase in the risk of stroke)3 or dual-antiplatelet withdrawal (an increase in the risk of stent thrombosis).9 By contrast, the 1-year bleeding rate is 12%, which highlights the importance of minimizing the exposure to triple therapy.21Table. Results of a Meta-Analysis of Observational Studies Reporting 30-Day Bleeding Rates in Patients Receiving "Triple Therapy"StudyPatients on TT, nMean Age, yIndication forBleeding Events at 30 Days, nBleeding Rate at 30 Days, %Dual-Antiplatelet TherapyWarfarinStent, nACS, nAF, nTT indicates triple therapy; ACS, acute coronary syndrome.Orford et al1165N/A65262523.1Konstantino et al127664.17676N/A22.6Porter et al13180651801506721.1Lip et al14671.366600.0Khurram et al1510769107n /a8600.0Rubboli et al162068.920N/A8315.0Nguyen et al1758064580580267345.9Nguyen et al1886N/AN/A86N/A11.2Rogacka et al1912769.91271277543.2Rossini et al2010267.91021026811.0Total13491263115360249Pooled rate2.2 (0.7–3.7)Treatment DecisionsThe Figure presents an algorithm to help physicians select the optimal antithrombotic therapy for patients with AF and a recent coronary artery stent. Because dual-antiplatelet therapy is indicated for all stent patients, the challenge is to identify patients who should also receive warfarin therapy. Dual-antiplatelet therapy alone is likely to be adequate for AF patients undergoing stent insertion who are at low risk of stroke (CHADS2 risk score 0 to 1) and in those at high risk of stroke who are deemed to be at unacceptably high risk of bleeding with triple therapy. Major risk factors for bleeding include advanced age (eg, >75 years), severe renal dysfunction (eg, creatinine clearance 160 mm Hg, diastolic blood pressure >110 mm Hg).22 Patients at high risk of stroke (CHADS2 risk score >1) who are not at high risk of bleeding should be considered for warfarin in addition to dual-antiplatelet therapy. Exposure to triple therapy should be limited by using a bare-metal stent in preference to a drug-eluting stent where possible, thereby restricting the duration of dual-antiplatelet therapy to 1 month. We believe that for patients who receive a drug-eluting stent and who require triple therapy, the duration of treatment should be limited to 3 months for those with a sirolimus stent and 6 months for those with a paclitaxel stent. Download figureDownload PowerPointFigure. Decision algorithm for antithrombotic therapy in patients with AF and a coronary artery stent. All patients undergoing percutaneous coronary intervention with stent insertion require dual-antiplatelet therapy. The decision to combine warfarin with dual-antiplatelet therapy requires assessment of the patient's risk of stroke and risk of bleeding. Dual-antiplatelet therapy alone is likely to be sufficient in patients at low risk of stroke (CHADS2 score of 0 to 1) and in those at high risk of stroke (CHADS2 score >1) who have an unacceptably high risk of bleeding (eg, age >75 years, severe renal dysfunction, recent gastrointestinal bleeding, prior stroke, uncontrolled hypertension). Patients at high risk of stroke (CHADS2 score >1) who are not at high risk of bleeding should be considered for "triple therapy."Strategies that may further reduce the risk of bleeding in patients who receive triple therapy include the following: Using the lowest proven effective dose of aspirin: Aspirin should be used at the lowest proven effective dose to reduce the risk of gastrointestinal bleeding. The Antithrombotic Trialists' Collaboration analyses showed that aspirin doses of 75 to 100 mg/d were no less effective than higher doses in secondary prevention of major cardiovascular events.23 The CURRENT OASIS-7 (Clopidogrel optimal loading dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS) investigators showed in invasively managed patients with acute coronary syndrome that aspirin 75 to 100 mg/d was similarly effective to 300 to 325 mg/d, with no difference in bleeding.24Adding acid-suppressive therapy to prevent gastrointestinal bleeding: The 2008 consensus statement by the American College of Cardiology Foundation/American College of Gastroenterology/American Heart Association recommended a proton pump inhibitor as prophylaxis against gastrointestinal bleeding in patients receiving dual-antiplatelet therapy or in those requiring the combination of antiplatelet and anticoagulant therapy.25 The Food and Drug Administration has issued a warning about the potential for a negative interaction between clopidogrel and proton pump inhibitors based on observational data,26,27 but recent evidence from randomized controlled trials questions whether this interaction is relevant for patients.28,29Ensuring optimal control of international normalized ratio (INR): The risk of bleeding increases sharply when the INR is above the target therapeutic range. The American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions guidelines recommend targeting an INR of 2 to 2.5 for patients receiving triple therapy,9 but the effectiveness and safety of this approach compared with the conventional INR range of 2 to 3 are unproven. Evidence-based methods to optimize anticoagulant control include specialist anticoagulation clinics, self-monitoring with a point-of-care device, and computerized dosing algorithms.30Case ResolutionBecause of the patient's very high risk of recurrent stroke, he was treated with aspirin 81 mg once daily, clopidogrel 75 mg once daily, and warfarin, targeting an INR of 2.0 to 2.5 for 4 weeks, at which time clopidogrel was discontinued. The same patient receiving a drug-eluting stent instead of a bare-metal stent would continue with triple therapy for 3 or 6 months, at which time clopidogrel would be discontinued. Warfarin was managed by a specialist anticoagulation clinic, and the patient received acid-suppressive therapy to reduce his risk of gastrointestinal bleeding.DisclosuresDr Crowther is co-principal investigator on a grant currently before the Canadian Institutes of Health Research examining whether aspirin withdrawal in patients with coronary artery disease and AF results in less bleeding. Dr Crowther holds a Career Investigator Award from the Heart and Stroke Foundation of Canada. Dr Mehta is an investigator for the CURRENT OASIS-7 trial, has received honoraria from Sanofi-Aventis and BMS, and has served as a consultant/advisory board member for Sanofi-Aventis and BMS. Dr Eikelboom is a Coinvestigator for the CURRENT OASIS-7 trial, has received honoraria from Sanofi-Aventis and BMS, and has served as a consultant/advisory board member for Sanofi-Aventis and BMS. The remaining authors report no conflicts.FootnotesCorrespondence to Jeremy S. Paikin, McMaster University, Hamilton General Hospital, 237 Barton St E, Hamilton, Ontario, L8L2X2, Canada. E-mail [email protected] References 1 McNamara RL, Tamariz LJ, Segal JB, Bass EB. Management of atrial fibrillation: review of the evidence for the role of pharmacologic therapy, electrical cardioversion, and echocardiography. Ann Intern Med. 2003; 139: 1018–1033.CrossrefMedlineGoogle Scholar2 Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007; 146: 857–867.CrossrefMedlineGoogle Scholar3 Connolly S, Pogue J, Hart R, Pfeffer M, Hohnloser S, Chrolavicius S, Yusuf S. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial Fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial. 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