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Dual Anti Platelet Therapy and COUMADIN After PCI

Dual Anti Platelet Therapy and COUMADIN After PCI. Raed Abu Sham’a, M.D Internist and Cardiologist Cardiac Pacing and Electrophysiologist. Introduction. AF is the most common arrhythmia associat ed with stroke and thromboembolism

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Dual Anti Platelet Therapy and COUMADIN After PCI

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  1. Dual Anti Platelet Therapy and COUMADIN After PCI Raed Abu Sham’a, M.D Internist and Cardiologist Cardiac Pacing and Electrophysiologist

  2. Introduction • AF is the most common arrhythmiaassociated with stroke and thromboembolism • In high-risk patients with nonvalvular AF,anticoagulation with coumarins is recommended • Dual antiplatelet therapywith aspirin plus clopidogrel is advised following ACS or stenting

  3. Introduction • Therecommended duration of dual antiplatelet therapy varies,ranging from 4 weeks to at least 6 to12 months • A management problem arises when a patient in whomlong-term anticoagulation is recommendedbecause AF subsequentlypresents with ACS and/or undergoes PCI.

  4. Introduction • Coumarinmonotherapy is a poor therapeutic choice in post-stentpatients, with a high rate of adverse cardiac complications. • The useof “aspirin plus coumarins” or “triple therapy” is associated with more bleeding.

  5. Anticoagulation withcoumarins in CAD subjects may provide asimilar degree of “vascular protection” to antiplatelet therapy,at least in the post-ACS setting.

  6. 10 trials involving a total of 5,938patients

  7. Conclusion • Patients who are at low orintermediate risk for bleeding, the cardiovascular benefitsof coumarins outweigh the bleeding risks

  8. There is a lackof published evidence on the optimal antithrombotic managementstrategy in anticoagulated AF patients who presentwith an ACS and/or undergo PCI.

  9. Guidelines • The 2006 ACC/AHA/ESC guidelines on AF managementacknowledgethat no adequate studies specifically address this issue • These guidelines suggest that the maintenance regimen should bea combination of clopidogrel and coumarins for 9 to 12months, after which warfarin may be continued as monotherapyin the absence of a subsequent coronary event.

  10. Guidelines • Other authorities* have suggested an antithromboticmanagement schema based on ACS presentation,perceived bleeding risk, and the type of stent used. • Noneof these strategies have been tested in prospective randomizedtrials. * Lip GYH. Chest 2006;130:1823–7

  11. Objective of the trial • To present a case series of 426patients with AF undergoing PCI fromregistry data • Particular attention to: • Clinical characteristics • Demographic characteristics • Stroke risk factorsby the CHADS2 • Antithrombotics before PCI and at discharge • Bleedingat follow-up • Thromboembolismat follow-up • MACE at follow-up

  12. Methods • Retrospective 2-center registry ofPCI databaseof patients with AF that underwentPCI over a 5-year period(2001 to2006) • Patients with a preexisting diagnosis of AF and those who developed newonsetAF during their current admission were included.

  13. Methods • The type of stent implanted was recorded. Since May 2002, DES were routinely available for use. • Individual patient management decisionswere decided by the interventional cardiologistand/or responsible cardiologist. • The regimen of oralanticoagulation and/or antiplatelet drugs at discharge wasagain decided by the responsible clinical cardiologist.

  14. Methods • Patients were followed up as part of theusual routine. • Telephone follow-up wasalso performed to confirm the antithrombotic therapyregimen followed, and to ascertainany episodes of bleeding, stroke/thromboembolism, MACE. • Medical records and/or outpatient clinic interviews were alsoreviewed.

  15. End point definitions • Theprimary end point: • MACE: • Death • MI • TVR • Thesecondary safety end point: • MAE: • Any MACE • Major bleeding complications • Stroke

  16. Major bleeding was defined as • Decrease in the blood Hb level of more than 5.0g/dl (including the period around the PCI) • The need for the transfusion of ≥ 2 units of blood • The need for corrective surgery • The occurrenceof an intracranial or retroperitoneal hemorrhage • Any combination of these events

  17. Results

  18. (Cont.)

  19. Antithrombotic drugs at discharge • There was wide variability in the antithrombotic therapy regimen and duration of treatment. • Patients discharged with triple therapy, there was noconsistency in the duration of treatment, with either coumarinsor 1 antiplatelet agent

  20. Complete follow-up was achieved in88% of the cohort (median 595 days; range 0 to 2,190days).

  21. Anticoagulation No Anticoagulation Kaplan-Meier Survival Curves inRelation to Anticoagulation Use at Discharge p= 0.6

  22. Anticoagulation No Anticoagulation Kaplan-Meier Survival Curves inRelation to Anticoagulation Use at Discharge p= 0.02

  23. Anticoagulation No Anticoagulation Kaplan-Meier Survival Curves inRelation to Anticoagulation Use at Discharge p= 0.03

  24. Discussion • This is the largest dataset of AF patientsundergoing PCI where antithrombotic therapymanagement strategies have been related to clinical outcomes. • These patients represent a high-risk population owing to: • Age • Comorbidities • The presence of stroke risk factors • High incidence of ACS as the indication for PCI

  25. Discussion • This data confirmthe protective effect of the coumarins in patients with AFtreated with PCI by decreasing the incidence ofMACE. • The beneficial effect of coumarins isconfirmed in the multiple regression analysis as an independentpredictors of MACE.

  26. Discussion • The present study illustrates that various antithromboticdrug combinations are used in everyday practice. • Suchvariability is due to the lack of availableguidelines.

  27. The combination of Coumarins plus Aspirin after PCI haspreviously been shown to be less effective compared toTiclopidine plus Aspirin in preventing stent thrombosis. • There is clear superiority of oral anticoagulationover dual antiplatelet therapy with Aspirin plusClopidogrelin stroke prevention in AF * * The ACTIVE Writing Group.Clopidogrel plus aspirin versus oralanticoagulation for atrialfibrillation in the ACTIVEtrial. Lancet 2006;367:1903–12.

  28. Discussion • Although thecombination of aspirin and clopidogrel (40.7%) or tripletherapy (50.0%) accounted for the majority of patients, theduration of their use still varied widely among patients. • Thisvariability was due essentially to the use of DES

  29. Tripletherapy is currently the best option for the majority of thepatients, although this predisposes to an increased risk ofbleeding, which may require stopping anticoagulationand/or antiplatelet therapy Such therapy cessation exposesthese patients to stent thrombosis or stroke/thromboembolism

  30. Complications during 12-month follow-up with various drug regimens The long-term prognosis of warfarintreatedpatients is unsatisfactory irrespective of the drugcombinations used

  31. DES subgroup • 174 patients (40.1%)were treated with ≥ 1 DES. • A higher prevalence ofdiabetes was observed in these patients (46% vs. 35%: p 0.03), but no other differences • The characters of the implanted stents: • Number of stents higher (2.17 vs. 1.59; p 0.01) • Smaller (2.78 mm vs. 2.99 mm; p 0.01) • Longer(39 mm vs. 35 mm; p 0.01)

  32. DES subgroup • In a univariate analysis, alower incidence of MACE was observed in the DES group(29.0% vs. 40.5%; p 0.032) • This difference didnot persist in a multivariate analysis. • Patients treated withDES had a higher rate of stent thrombosis (2.8% vs. 0%;p 0.034)

  33. The implantationof DES should probably be discouraged in anticoagulatedAF patients due to the need for prolonged dual antiplateletadministration

  34. Limitation of the Study • This large study is limited by its registry design. • Many confounders/biases are possible, although they have tried to address mostin a multivariate analysis. • The changesof antithrombotic regiment in these patients during thefollow-up period, sometimes in relation to the presence ofthrombotic or hemorrhagic complications.

  35. Conclusion • Treatment with coumarins atdischarge shows a beneficial effect on prognosis by reducingthe incidence of death and MACE • Such benefits do notappear to be associated with a substantial increase in majorbleeding events. • Patients with low risk of bleeding complications, atriple-therapy regimen should be used • Further large studies are required

  36. Editorial Comment • Consider the imperative of preventing ischemicstroke in patients with AF. • Warfarin reduces thromboembolismby about one-half while increasing major bleeding to1% to 2% per year. • For the highest-risk AF patients, the benefit of anticoagulation outweighsthe bleeding risk.

  37. Editorial Comment • AlthoughAspirin is the prophylactic antiplatelet drug of choice, itreduces the risk of recurrent stroke, MI, and vascular deathby only 13%. • Clopidogrel was 8% better than aspirin and associated with fewer GI bleeding * * CAPRIE Steering Committee.Lancet 1996;348:1329 –39.

  38. Characteristics and Outcomes of Patients Taking Warfarin Prior to Percutaneous Coronary Intervention Atul Aggarwal,1 David Dai,2 John S. Rumsfeld,3 Lloyd W. Klein,4 and Matthew T. Roe,2 on behalf of the American College of Cardiology – National Cardiovascular Data Registry (NCDR) Nebraska Heart Institute, Hastings, NE,1 Duke Clinical Research Institute, Durham, NC,2 Denver VA Medical Center/ University of Colorado, Denver, CO3 and Rush Medical College, Chicago, IL4 ACC 2007

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