TREATMENT OF STROKE PATIENTS THAT ARE TAKING NOVEL ANTICOAGULANTS. Jesse Weinberger, MD The Icahn School of Medicine at Mount Sinai

Transcription

1 TREATMENT OF STROKE PATIENTS THAT ARE TAKING NOVEL ANTICOAGULANTS Jesse Weinberger, MD The Icahn School of Medicine at Mount Sinai

2 Acknowledgement Many of the slides for this presentation were obtained from the AAN Stroke Section Website, compiled by Dr. Anthony Culebras, with permission given to use the slides from the website as long as an acknowledgement is made in the presentation.

3 1. Jesse Weinberger, MD Faculty Disclosure 2. Treatment of Patients That Are Taking Novel Anticoagulants 3. Boehringer -Ingelheim 4. Consultant 2013, no longer, speaking and teaching, membership on advisory committees or review panels and board membership).

4 Atrial Fibrillation A Substantial Threat to the Brain Affects ~4% of people aged >60 years ~9% of those aged >80 years 5%/year stroke rate 35% lifetime risk of stroke 12%/year for those with prior stroke $ billions annual cost for stroke care AF identifies millions of people with a five-fold increased risk of stroke

5 Anticoagulation in Atrial Fibrillation Stroke Risk Reductions Warfarin Better Control Better AFASAK SPAF BAATAF CAFA SPINAF EAFT Aggregate 100% 50% 0-50% -100% Hart R, et al. Ann Intern Med 1999;131:492.

6 Warfarin vs. Aspirin in AF 4052 Patients Pooled from 6 Trials van Walraven C, Hart RG.JAMA 2002; 288: Stroke Rate Stroke Rate RRR NNT Aspirin Warfarin All participants 4%/yr 2%/yr 55% 43 Prior stroke/tia 10%/yr 4%/yr 60% 17 Primary prevention 3%/yr 1.5%/yr 45% 83

7 SPAF-II Rates of Disabling Stroke 6 Ischemic Hemorrhagic Event Rate (%/year) Aspirin Warfarin < 75 years Aspirin Warfarin > 75 years SPAF Investigators. Lancet 1994; 343: 687.

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12 Cumulative Hazard Rates for the Primary Outcome of Stroke or Systemic Embolism, According to Treatment Group Connolly SJ et al. N Engl J Med 2009;361:

13 Cumulative Rates of the Primary End Point (Stroke or Systemic Embolism) in the Per- Protocol Population and in the Intention-to-Treat Population. Patel MR et al. N Engl J Med 2011;365:

14 Kaplan Meier Curves for the Primary Efficacy and Safety Outcomes. Granger CB et al. N Engl J Med 2011;365:

15 Types of stroke by treatment group. Giugliano R P et al. Stroke. 2014;45: Copyright American Heart Association, Inc. All rights reserved.

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18 Clinical Problems with New Agents Difficult to monitor efficacy of dose in an individual patient. Management of hemorrhagic complications Rebound from withdrawal of new agents increases risk of thromboembolic complications Evaluation for thrombolytic therapy in acute stroke patient.

19 EFFICACY OF DOSE IN INDIVIDUAL PATIENT

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24 MANAGEMENT OF BLEEDING COMPLICATIONS

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40 REBOUND FROM WITHDRAWAL OF NEW ORAL ANTICOAGULANTS

41 IMPORTANT SAFETY INFORMATION ABOUT PRADAXA WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. If anticoagulation with PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant

42 EVALUATION FOR THROMBOLYTIC THERAPY IN ACUTE STROKE PATIENTS

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46 CT Perfusion Imaging in a Patient with Stroke, before and after Thrombolysis with Recombinant Tissue Plasminogen Activator (rt-pa). Wechsler LR. N Engl J Med 2011;364:

47 Modified Rankin Score at 3 Months According to Treatment Group. Ciccone A et al. N Engl J Med 2013;368:

48 Second Primary Endpoint Device 18-Month Rate Control 18-Month Rate 18-Month Rate Ratio (95% CI) Similar 18-month event rates in both groups 1.07 (0.57, 1.88) Upper 95% CI bound slightly higher than allowed to meet success criterion (<1.75%) Limited number of patients with follow-up through 18 months thus far (Control = 30 pts, Device = 58 pts) Results are preliminary; final validation not yet complete

49 % of Patients Pericardial Effusions Requiring Intervention 3.0% 2.5% 2.0% 1.5% 1.0% 0.5% 0.0% 1.6% n=7 PROTECT AF CAP PREVAIL p = % p = % n=1 0.4% n=1 Cardiac perforation requiring surgical repair n=11 1.2% n=7 1.5% n=4 Pericardial effusion with cardiac tamponade requiring pericardiocentesis or window PROTECT AF and CAP data from Reddy, VY et al. Circulation. 2011;123:

50 CONCLUSIONS New oral anticoagulants (NOACS)have benefit of immediate action, no question of whether to bridge with heparin. NOACS do not have to be monitored, but may be helpful in some cases, ie drug interactions. Question if NOACS are reversible. Risk for thrombolytic therapy in acute stroke.