10/8/2012. Disclosures. Making Sense of AT9: Review of the 2012 ACCP Antithrombotic Guidelines. Goals and Objectives. Outline

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1 Disclosures Making Sense of AT9: Review of the 2012 ACCP Antithrombotic Guidelines No relevant conflicts of interest related to the topic presented. Cyndy Brocklebank, PharmD, CDE Chronic Disease Management and Anticoagulation Pharmacist Alberta Health Services October 20, 2012 Outline ACCP Antithrombotic Guidelines 2012 Important changes in methodology Antithrombotic Therapy and Prevention of Thrombosis: Orthopedic Nonsurgical patient Antithrombotic therapy for VTE disease Evidence-based management of anticoagulation Goals and Objectives Goals and Objectives: To inform pharmacists of some key changes in the ACCP Antithrombotic Guidelines 9th edition. To examine some of the controversies resulting from changes in the most recent antithrombotic guidelines. To assist pharmacists in applying the antithrombotic guideline recommendations to their patient care practice. New Developments in ACCP Antithrombotic Guidelines 2012 Jack Sparrow: I thought you were supposed to keep to the code. Gibbs: We figured they were more actual *guidelines* Methodologic Features Patient, Intervention, Comparison, and Outcome (PICO) questions foundation for lit review and formulation of final recommendations More methodologically rigorous scrutiny of all available evidence Included methodologists, subject matter experts, health economists, experts on patient values, and frontline clinicians Even more consideration of patient values and preferences Focus on improvement in patient-important outcomes Consideration of financial and intellectual conflict of interest Good quality evidence that effects important patient outcomes. 1

2 GRADE System Evaluating Quality of Evidence VTE Risk in Surgery without Prophylaxis CHEST. 2012;141(2_suppl):53S-70S. doi: /chest Risk Level Low risk Minor <40 yrs, no added risk factors Moderate risk Minor + added risk factors Surgery age yrs, no added risk factors High risk Surgery >60 yrs or with added risk factors, e.g cancer, prior VTE Highest Risk Surgery + multiple risk factors Hip or knee arthroplasty, hip fracture Calf Proximal Clinical PE Fatal PE 2% 0.4% 0.2% <0.01% 10 20% 2-4% 1-2% % 20-40% 4 8% 2-4% % 40 80% 10-20% 4 10% 0.2 5% Agnelli G. Circulation. 2004: 110 (suppl IV): IV4-12. Surgery: THA, TKA, HFS 2008 ACCP Guideline VTE is a serious but decreasing complication following orthopedic This guideline focuses on optimal prophylaxis to reduce patient-important outcomes such as PE and symptomatic Estimated nonfatal, symptomatic VTE rates after major orthopedic are: For patients undergoing THR or TKR, we recommend the routine use of one of the following: LMWH, fondaparinux, or adjusted dose VKA started pre-operatively or the evening of the surgical day (Grade 1A) For patients undergoing THR, TKR or HFS, we recommend thromboprophylaxis for at least 10 days (Grade 1A) For THR we recommend that thromboprophylaxis be extended beyond 10 days and up to 35 days after (Grade 1A) For TKR we suggest that thromboprophylaxis be extended beyond 10 days and up to 35 days after (Grade 2B) Geerts WH, Chest 2008;133:381S-453S. Surgery: THA, TKA In patients undergoing total hip arthroplasty (THA) or total knee arthroplasty (TKA), we recommend use of one of the following for a minimum of 10 to 14 days rather than no antithrombotic prophylaxis: LMWH, fondaparinux, apixaban, dabigatran, rivaroxaban, LDUH, adjusted-dose vitamin K antagonist (VKA), aspirin (all Grade 1B), or an intermittent pneumatic compression device (IPCD) (Grade 1C). Remarks: We recommend the use of only portable, battery-powered devices capable of recording and reporting proper wear time on a daily basis for inpatients and outpatients. Efforts should be made to achieve 18 h of daily compliance. One panel member believed strongly that aspirin alone should not be included as an option. Surgery: HFS In patients undergoing hip fracture (HFS), we recommend use of one of the following rather than no antithrombotic prophylaxis for a minimum of 10 to 14 days: LMWH, fondaparinux, LDUH, adjusted-dose VKA, aspirin (all Grade 1B), or an IPCD (Grade 1C).. For patients undergoing major orthopedic, we suggest extending thromboprophylaxis in the outpatient period for up to 35 days from the day of rather than for only 10 to 14 days (Grade 2B). 2

3 ASA for VTE prophylaxis in orthopedics? ASA versus No prophylaxis 160 mg ASA x 35 days HFS patients, follow-up rate 99.6% 28% relative risk reduction in symptomatic VTE (RR 0.72; 95% CI, ) Trend towards more major nonfatal bleeding (RR 1.12, 95% CI, ) 7 fewer symptomatic VTE/ more major bleeds/1000 Surgery: THA, TKA, HFS In patients undergoing THA or TKA, irrespective of the concomitant use of an IPCD or length of treatment, we suggest the use of LMWH in preference to the other agents we have recommended as alternatives: fondaparinux, apixaban, dabigatran, rivaroxaban, LDUH (all Grade 2B), adjusted-dose VKA, or aspirin (all Grade 2C). Remarks: If started preoperatively, we suggest administering LMWH 12 h before. Patients who place a high value on avoiding the inconvenience of daily injections with LMWH and a low value on the limitations of alternative agents are likely to choose an alternative agent. Limitations of alternative agents include the possibility of increased bleeding (which may occur with fondaparinux, rivaroxaban, and VKA), possible decreased efficacy (LDUH, VKA, aspirin, and IPCD alone), and lack of long-term safety data (apixaban, dabigatran, and rivaroxaban). Furthermore, patients who place a high value on avoiding bleeding complications and a low value on its inconvenience are likely to choose an IPCD over the drug options. Lancet Apr 15;355(9212): Surgery: Miscellaneous In patients undergoing major orthopedic and who decline or are uncooperative with injections or an IPCD, we recommend using apixaban or dabigatran (alternatively rivaroxaban or adjusted-dose VKA if apixaban or dabigatran are unavailable) rather than alternative forms of prophylaxis (all Grade 1B). We suggest no prophylaxis rather than pharmacologic thromboprophylaxis in patients with isolated lower-leg injuries requiring leg immobilization (Grade 2C). Hospitalized Acutely Ill Medical Patients Hospitalization for acute medical illness associated with 8- fold increase in risk of VTE Among hospitalized patients, 50-75% of VTE events, including fatal PE, occur on the medical service Baseline risk for hospitalized medical patients estimated using the Padua Score Low-risk patients <4 points, VTE rate 0.3% High-risk patients 4 points, VTE rate 11% For patients undergoing knee arthroscopy without a history of prior VTE, we suggest no thromboprophylaxis rather than prophylaxis (Grade 2B). Bleeding Risk Factors: Hospitalized Medical Patients Independent risk factors for in-hospital bleeding: active gastroduodenal ulcer bleeding in 3 months before admission platelet count, 50 x 10 9 /L age >85 years, hepatic failure, severe renal failure, and ICU or critical care unit admission Hospitalized Acutely Ill Medical Patients For acutely ill hospitalized medical patients at increased risk of thrombosis, we recommend anticoagulant thromboprophylaxis with LMWH, LDUH bid, LDUH tid, or fondaparinux (Grade 1B). Remarks: In choosing the specific anticoagulant drug to be used for pharmacoprophylaxis, choices should be based on patient preference, compliance, and ease of administration (eg, daily vs bid vs tid dosing), as well as on local factors affecting acquisition costs (eg, prices of various pharmacologic agents in individual hospital formularies). For acutely ill hospitalized medical patients at low risk of thrombosis, we recommend against the use of pharmacologic prophylaxis or mechanical prophylaxis (Grade 1B). For acutely ill hospitalized medical patients who are bleeding or at high risk for bleeding, we recommend against anticoagulant thromboprophylaxis (Grade 1B). 3

4 Patients With Cancer In outpatients with cancer who have no additional risk factors for VTE, we suggest against routine prophylaxis with LMWH or LDUH (Grade 2B) and recommend against the prophylactic use of vitamin K antagonists (Grade 1B). In outpatients with solid tumors who have additional risk factors for VTE and who are at low risk of bleeding, we suggest prophylactic dose LMWH or LDUH over no prophylaxis (Grade 2B). Remarks: Additional risk factors for venous thrombosis in cancer outpatients include previous venous thrombosis, immobilization, hormonal therapy, angiogenesis inhibitors, thalidomide, and lenalidomide. In outpatients with cancer and indwelling central venous catheters, we suggest against routine prophylaxis with LMWH or LDUH (Grade 2B) and suggest against the prophylactic use of vitamin K antagonists (Grade 2C). Chronically Immobilized Outpatients In chronically immobilized persons residing at home or at a nursing home, we suggest against the routine use of thromboprophylaxis (Grade 2C). Estimated annual incidence of symptomatic VTE in nursing home patients ~1% retrospectively assessment of 132,018 nursing home patients across five states found symptomatic VTE incidence of 0.91 per 100 person-years 18,661 nursing home patients in Kansas reported VTE incidence of 1.30 per 100 person-years postacute care patients (e.g. rehab facility) have an incidence of symptomatic VTE of % during their stay at the facility This estimate is closer to the rate for hospitalized medical patients Unclear from available data if the benefits outweigh the risk in this population VTE Prophylaxis ACCP 2008 Procedure LMWH Fondaparinux Warfarin LDUH Dabigatran Rivaroxaban Apixaban Compression Total hip replacement Hip fracture Knee arthroplasty General Medical patients Long distance travel ± ± ± LMWH = low molecular weight heparin, LDUH = low dose unfractionated heparin, ASA is not recommended for sole agent in prophylaxis Adapted from: Geerts W et al. CHEST. 2008; 133: 381S-453S. VTE Prophylaxis ACCP 2012 Patient Group Total hip replacement Hip fracture Knee arthroplasty General Medical patients Long distance travel LMWH Fonda Warfarin LDUH Dabigatran Rivaroxaban Apixaban Compression/ Mechanical prophylaxis preferred preferred preferred * * (IPC) (IPC) * * (IPC) ** low-mod VTE risk or high bleed risk bid or tid Recommended for medical patients at increased risk of thrombosis; low risk medical patients no prophylaxis NR NR mmhg GCS high VTE risk only Critical Care LMWH = low molecular weight heparin, LDUH = low dose unfractionated heparin, Fonda = fondaparinux *if patient declines injections and/or IPC VTE risk, unable to have LMWH or LDUH **high NR = not recommended ASA ** NR MK Gould CHEST. February 2012;141(2_suppl):e227S-e277S Evidence-Based Management of Anticoagulant Therapy Loading Dose for Initiation of Vitamin K Antagonist (VKA) Therapy Includes initiation, maintenance, dosing, drug interactions, bleeding, organization of care Systematic reviews revealed sufficient but usually low-quality evidence to provide guidance Only two questions had sufficient evidence to support a strong recommendation. INR therapeutic range 2-3 avoidance of routine pharmacogenetic testing to guide VKA dosing) For patients sufficiently healthy to be treated as outpatients, we suggest initiating VKA therapy with warfarin 10 mg daily for the first 2 days followed by dosing based on international normalized ratio (INR) measurements rather than starting with the estimated maintenance dose (Grade 2C). Two case series with 1,054 outpatients suggest that a nomogram specifying a 10-mg loading dose is safe Recurrent VTE rate of 1.9% major bleeding rate of 1.0% at 3 months follow-up only 49.3% of participants followed the nomogram completely. 4

5 Monitoring Frequency for VKAs For patients taking VKA therapy with consistently stable INRs, we suggest an INR testing frequency of up to 12 weeks rather than every 4 weeks (Grade 2B). stable INRs = at least 3 months of consistent results with no need to adjust VKA dosing 3 studies reviewed for the guideline examined the usual 4 week INR testing interval with testing frequencies out to 4 weeks: None found a difference in rates of thromboembolism, bleeding, or INR control appropriate length of the INR recall interval depends on duration of prior stability and foreseeable future changes in medications or disorders that affect the INR Therapeutic Dose of LMWH in Patients With Decreased Renal Function For patients receiving therapeutic LMWH who have severe renal insufficiency (calculated creatinine clearance < 30 ml/min), we suggest a reduction of the dose rather than using standard doses (Grade 2C). no RCTs comparing a standard, body-weight-adjusted LMWH dose to reduced dose in severe renal insufficiency (creatinine clearance <30 ml/min) Observational studies with enoxaparin suggest lowering doses for severe renal impairment may reduce bleeding incidence dose adjustment was either empirical or to 0.5 vs the standard 1 mg/kg bid of enoxaparin other LMWHs unknown (insufficient data) no advice on how LMWH should be reduced if the decision is to reduce Vitamin K for Patients Taking VKAs With High INRs Without Bleeding Vitamin K for Patients Taking VKAs With High INRs Without Bleeding (a) For patients taking VKAs with INRs between 4.5 and 10 and with no evidence of bleeding, we suggest against the routine use of vitamin K (Grade 2B). vitamin K may reverse supratherapeutic INRs more rapidly, there is no evidence of benefit for patient-important outcomes Similar rates of major bleeding and thromboembolic events compared to just with-holding VKA (b) For patients taking VKAs with INRs > 10.0 and with no evidence of bleeding, we suggest that oral vitamin K be administered (Grade 2C). 2.5 mg of oral vitamin K resulted in a low rate of observed major bleeding by 90 days (3.9%; 95% CI, ) Patients with INR > 10 given oral vitamin K 2 mg were less likely to still have an INR >5 by day 3 compared with those who had warfarin withheld (11.1% vs 46.7%) Duration of Anticoagulation /PE Treatment ACCP 2008 Indication Reversible provoking risk factor*, first event Unprovoked or PE, first event proximal PE Unprovoked isolated distal Unprovoked or PE second event INR Target range Risk of Recurrence Duration < 5%/year 3 months ~ 10%/year 3 months then assess for chronic warfarin, longterm therapy if proximal or PE and low bleed risk after first 3 months in patients with preference for less frequent monitoring (vs no treatment) < 5%/year 3 months >12%/year Chronic warfarin or PE and Cancer >20%/year LMWH for first 3-6 months then warfarin or LMWH indefinitely or until cancer resolved *Major risk factors: major, hospitalization, plaster cast immobilization within 1 month of event Minor risk factors: estrogen therapy, pregnancy, prolonged travel >8 hrs, or major factors above occurring 1 3 months prior to VTE diagnosis. Blood. 2002; 100: Blood. 2002; 99: Chest 2008; 133: 454S-545S. Duration of Anticoagulation /PE Treatment 2012 Indication Surgical transient provoking risk factor Non-surgical transient provoking risk factor Unprovoked or PE, first event Isolated distal proximal PE Isolated distal : surgical or non-surgical risk factor Unprovoked or PE second event INR Target range Risk of Recurrence yr 5 yrs yr 5 yr yr 5 yr Duration 3 months 3 months < 5%/year 3 months 3 months then assess risk benefit of extended therapy Patients with low-moderate bleeding risk suggest extended therapy High bleed risk patients recommend 3 months >12%/year Extended anticoagulation in patients with lowmoderate bleed risk Patients with high bleed risk suggest 3 months or PE and Cancer >15%/year Extended anticoagulation if bleed risk is not high Suggest LMWH over VKA therapy Superficial vein thrombosis lower limb (at least 5 cm) N/A *Nonsurgical risk factors: estrogen therapy, pregnancy, prolonged travel >8 hrs, leg injury 45 days prophylactic dose fondaparinux or LMWH 5

6 Initial Anticoagulant Regimen in Patients With Proximal In patients with acute of the leg, we suggest LMWH or fondaparinux over IV UFH (Grade 2C) and over SC UFH (Grade 2B for LMWH; Grade 2C for fondaparinux). Remarks: Local considerations such as cost, availability, and familiarity of use dictate the choice between fondaparinux and LMWH. LMWH and fondaparinux are retained in patients with renal impairment, whereas this is not a concern with UFH. Anticoagulant Regimen for Longterm VTE Therapy In patients with of the leg or PE and no cancer, we suggest VKA therapy over LMWH for long-term therapy (Grade 2C). For patients with and no cancer who are not treated with VKA therapy, we suggest LMWH over dabigatran or rivaroxaban for long-term therapy (Grade 2C). In patients with acute of the leg treated with LMWH, we suggest once- over twice-daily administration (Grade 2C). Remarks: This recommendation only applies when the approved once-daily regimen uses the same daily dose as the twice-daily regimen (ie, the once-daily injection contains double the dose of each twice-daily injection). It also places value on avoiding an extra injection per day. Long-term Treatment of Patients With VTE and Cancer In patients with PE or of the leg and cancer, we suggest LMWH over VKA therapy (Grade 2B). In patients with PE and cancer who are not treated with LMWH, we suggest VKA over dabigatran or rivaroxaban for long-term therapy (Grade 2C). Remarks: Choice of treatment in patients with and without cancer is sensitive to the individual patient's tolerance for daily injections, need for laboratory monitoring, and treatment costs. Treatment of VTE with dabigatran or rivaroxaban, in addition to being less burdensome to patients, may prove to be associated with better clinical outcomes than VKA and LMWH therapy. When these guidelines were being prepared (October 2011), postmarketing studies of safety were not available. Given the paucity of currently available data and that new data are rapidly emerging, we give a weak recommendation in favor of VKA and LMWH therapy over dabigatran and rivaroxaban, and we have not made any recommendation in favor of one of the new agents over the other. ASA for Primary Prevention of Cardiovascular Disease For persons aged 50 years or older without symptomatic cardiovascular disease, we suggest low-dose aspirin 75 to 100 mg daily over no aspirin therapy (Grade 2B). Recommendation largely based on data from a meta-analysis with 95,000 individuals comparing long-term ASA ( mg) vs control aspirin use in patients at low risk: 6 fewer MIs and 4 more major bleeds events per 1,000 treated 6 fewer total deaths, but the 95% CI includes 0 fewer deaths aspirin use in patients at moderate risk: 19 fewer nonfatal MIs/1000 treated vs 16 more major bleeds/1000 treated aspirin use in patients at high risk: 31 fewer nonfatal MIs/1000 treated vs 22 more major bleeds/1000 treated 6 fewer total deaths in the moderate and high risk groups P Vandvik CHEST. February 2012;141(2_suppl):e637S-68S References Guyatt GH, Akl EA, Crowther MA, et al. Executive Summary: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Guidelines. CHEST. 2012;141(2)(Suppl):7S-47S Guyatt GH, Akl EA, Crowther MA, et al. Introduction to the 9 th Edition. Chest Feb;141(2 Suppl):48S- 52S. Kahn SR. Prevention of VTE in nonsurgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest Feb;141(2 Suppl):e195S-226S. Vandvik PO. Primary and secondary prevention of cardiovascular disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest Feb;141(2 Suppl):e637S-68S. You JJ. Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest Feb;141(2 Suppl):e531S-75S. Holbrook A. Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest Feb;141(2 Suppl):e152S-84S. Kearon C, Akl EA, Comerota AJ, et al. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest Feb;141(2 Suppl):e419S-94S. 6

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