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Antithrombotic therapy and oral surgery

Antithrombotic therapy and oral surgery. Michael B Streiff, MD FACP Professor of Medicine and Pathology Medical Director, Johns Hopkins Anticoagulation Service Chairman, VTE Guideline Committee ,National Comprehensive Cancer Network

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Antithrombotic therapy and oral surgery

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  1. Antithrombotic therapy and oral surgery Michael B Streiff, MD FACP Professor of Medicine and Pathology Medical Director, Johns Hopkins Anticoagulation Service Chairman, VTE Guideline Committee ,National Comprehensive Cancer Network President, Medical and Scientific Advisory Board, National Blood Clot Alliance

  2. Disclosures- Michael B. Streiff, MD • Research support • AHRQ • Boehringer-Ingelheim • Janssen • NIH/NHLBI • PCORI • Portola • Roche • Consulting • Bayer • CSL Behring • Daiichi-Sankyo • Janssen • Pfizer • Portola • Educational Grants • Covidien

  3. Scope of the Problem • In 2009 548 million dental procedures performed annually • Over 50% of Americans take daily aspirin • Over 2 million MI and stroke annually in US • More than 30 million warfarin prescriptions each year Manski, R.J. and Brown, E. AHRQ Statistical Brief #368. April 2012.. Williams CD et al Am J Prev Med 2015; AHA/ASA Annual stats 2018; Wysowski DK et al Arch Intern Med 2007

  4. Plan for Procedures: Thromboembolism Risk Stratification Spyropoulos AC et al. J ThrombHaemost 2016

  5. Plan for Procedures: Procedural Bleeding Risk Stratification NCCN Guidelines 2018

  6. A Systematic Review of Peri-procedural Anticoagulation • Review of 34 studies (21 prospective, 1 RCT) • Therapeutic AC in 20 studies (57%) • Last pre-op LMWH dose 24+ hrs. before surgery (36%), 12-23 hrs. (36%) • LMWH restart within 24 hrs (55%), > 24 hrs (16%) • Bridging increases bleeding complications Siegal D et al. Circulation 2012

  7. The Bridge Trial (Standard Risk AF) Warfarin- restart POD 1 Warfarin Dalteparin 100 units/kg q12h N=950 Low risk-within 24 hrs. R High Risk-with 48-72 hrs. Day - 5 Placebo N=934 Procedure Follow up 30 days Pre-op Bridge Day -3 Randomized double-blind placebo controlled trial 6445 AF pts screened, 1884 (29%) enrolled Mean age 72 yrs. , Male 1382 (73%) Mean CHADS2 score 2.35 Low bleeding risk procedures N=1539 (81.7%) Douketis JD et al. NEJM 2015

  8. Bridging did not improve outcomes Douketis JD et al. NEJM 2015

  9. Perioperative Management of AC for VTE • Retrospective cohort of 1178 pts. and 1812 procedures • VTE risk: Low 79%, Med 18%, High 3% • Therapeutic bridge 73% • Conclusion: Bridge therapy associated with excess bleed risk, no benefit Clark NP et al. JAMA Internal Med 2015

  10. Who should be considered for perioperative bridging? • Mechanical mitral valve • Afib with stroke (especially within 3 months) • Afib with CHADS2 score 5 or 6 • Venous thromboembolism with 3 months • Active cancer with unprovoked VTE • Recurrent unprovoked VTE • Previous thromboembolism with therapy interruption or subtherapeutic AC • High risk thrombophilia (Antiphospholipid syndrome, protein C or S or antithrombin deficiency)

  11. When to stop warfarin and apixaban • Warfarin (INR 2-3): at least 5 days prior to procedure • Apixaban (Half-life): • CrCl > 80 ml/min (12 hrs.) • CrCl 50-79 ml/min (15 hrs.) • CrCl 30-49 ml/min (18 hrs.) • Low risk surgery (4 half-lives = 6.3% drug left) • Stop 2-3 days before surgery • CrCl > 80 = 48 h, CrCl 50-79 = 60 h, CrCl 30-49 = 72 h • High risk surgery (6 half-lives = 1.6% drug left) • Stop 3-4.5 days before surgery • CrCl > 80 = 72 h, CrCl 50-79 = 90 h, CrCl = 30-49 = 108 h University of Washington Anticoagulation Service; NCCN Guideline 2018

  12. When to stop dabigatran • Half-life • CrCl > 80 ml/min (14 h) • CrCl 50-79 ml/min (17 h) • CrCl 30-49 ml/min (19 h) • Low risk surgery (4 half-lives = 6.3% drug left) • Stop 2.5-3 days before surgery • CrCl > 80 = 56 h, CrCl 50-79 = 68 h, CrCl 30-49 = 76 h • High risk surgery (6 half-lives = 1.6% drug left) • Stop 4-5 days before surgery • CrCl > 80 = 84 h, CrCl 50-79 = 102 h, CrCl = 30-49 = 114 h Van Ryn J et al. ThrombHaemost 2010; NCCN Guideline 2018;

  13. When to stop edoxaban • Half-life 10-14 hours • Low risk surgery (4 half-lives = 6.3% drug left) • Stop 2 days before surgery • High risk surgery (6 half-lives = 1.6% drug left) • Stop 4 days before surgery NCCN Guideline 2018; Edoxaban PI

  14. When to stop rivaroxaban • Half Life • CrCl > 80 ml/min (8 hrs.) • CrCl 50-79 ml/min (9 hrs.) • CrCl 30-49 ml/min (9 hrs.) • Age 60+ (11-13 hrs.) • Low risk surgery (4 half-lives = 6.3% drug left) (about 2 days) • Stop 2 days before surgery • CrCl > 80 = 32 h, CrCl 50-79 = 36 h, CrCl 30-49 = 36 h, Age 60+ = 52 hours • High risk surgery (6 half-lives = 1.6% drug left)(about 2-3 days) • Stop 3 days before surgery • CrCl > 80 = 48 h, CrCl 50-79 = 54 h, CrCl = 30-49 = 54 h), Age 60+ = 78 hours University of Washington Anticoagulation Service; NCCN Guideline 2018; Rivaroxaban PI

  15. When to restart AC • Tentative based upon post-op course • Collaborative decision with surgeon • VTE prophylaxis dosing prior to therapeutic • Low risk surgery • Restart no sooner than 24-48 hours • High risk surgery • Restart no sooner than 72 hours • Very high risk surgery • Restart no sooner than 5-7 days

  16. Perioperative Management of AC • Step 1: Assess the bleeding risk of the procedure • Step 2: Assess the risk of recurrent thromboembolism • Step 3: Determine the elimination half-life of the anticoagulants and review the list of medication and supplements • Step 4: Review the pre-op labs (CBC, CMP, PT) • Step 5: Design a tentative perioperative AC management plan and discuss with surgeon

  17. Pre-operative AC Time line • Pre-op day 10-14 • CBC, CMP (Calculate creatinine clearance!), PT/INR • Assess thromboembolic and bleeding risk • Discuss tentative bridging plan with patient and surgeon and disseminate plan • Pre-op day 5-6 stop warfarin and start enoxaparin 1mg/kg q12h 36-48 hrs. after last dose of warfarin • Pre-op day 3-5 stop DOAC and start enoxaparin 12-24 hours after last dose of DOAC • Last dose of enoxaparin 24-48 hours pre-operation • Very high thrombotic risk consider UFH IV

  18. Warfarin and Oral Surgery • Literature review ( Wahl MJ JADA 2000) • 950 pts. with >2400 surgeries (extractions, alveolar or gingival surgery) • Only 12 pts. (1.3%) required more than local measures for hemostasis • Nine (75%) had supra-therapeutic INR; 5 of 526 pts (0.95%) who held AC had thrombotic event,4 died • Single-center Retrospective study (Eichhorn W et al. Clin Oral Invest 2012) • 637 pts., 934 procedures (osteotomy, extractions) continued warfarin (INR 2.44) • Local hemostasis with collagen fleece, suture, compression, fibrin glue • 47 pts. (7.4%) had bleeding treated with local measures vs. 2 of 285 (0.7%) control pts.

  19. Warfarin and Oral Surgery • Prospective single center study of warfarin (INR 2-3) plus aspirin (N=71) versus warfarin (N=71) or aspirin alone (N=71) (Bajkin BV JADA 2012) • Risk of bleeding tended to be more with combined warfarin INR 2-3 and aspirin therapy (4.2%) than warfarin INR 2-3 (2.8%) or aspirin (0%) • Bleeding manageable with local measures • Prospective open randomized study of warfarin (N=109) v. warfarin-LMWH bridge (N=105) (Bajkin B J Oral MaxillofacSurg 67:990-995, 2009) • No difference in bleeding (7.3% v. 4.8%) , all treated with local measures, No thromboembolism

  20. Warfarin and LMWH bridging • Prospective randomized study of simple extractions with or without LMWH bridging • Warfarin INR 2.45 (N=109) vs. LMWH bridging (INR 1.26) • Post-op bleeding: 8 warfarin (7.3%) vs. 5 LMWH (4.8%). Treated with local measures, no transfusions • Conclusion- Bridging unnecessary for simple extractions Bajkin BV et al J Oral MaxilofacSurg 2009

  21. DOACs and Dental Surgery • Prospective observational study of 367 pts. (119 DOACs, 248 warfarin) • DOAC held morning of the procedure; warfarin continued • Bleeding: 4 DOAC (3.1%) vs. 23 warfarin (8.8%). • Bleeding controlled with local measures or holding AC dose Yoshikawa H et al. J Oral MaxillofacSurg 2019

  22. Plan for Procedures: Procedural Bleeding Risk Stratification for Oral Surgery University of Washington Anticoagulation Service

  23. Oral Surgery Recommendations • Discussion between oral surgeon, physician and patient prior to procedure to outline management • For routine oral surgery (simple extractions < 3, 3 implants, etc.) warfarin (INR < 3.5 on day prior to surgery), single or dual APA or DOAC may be continued with local hemostatic measures (collagen, TXA rinse, topical fibrin, sutures) • For DOACs do not take daily dose morning of surgery • For AC + dual APA or warfarin INR >3.5 or more extensive surgery individualized management Aframian DJ, et al Oral SurgOral Med 2007; van Diermen DE et al. Oral Surg Oral Med 2013

  24. Questions ?

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