Trick or Treat 2: A New Era of Stroke Prevention in AF? WATCHMAN and LARIAT?
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1 Trick or Treat 2: A New Era of Stroke Prevention in AF? WATCHMAN and LARIAT?
2 Disclosure SentreHeart, Inc Consultant Equity holder
3 A cardiac disease that kills by producing emboli The most severe consequence of AF is potentially life threatening embolic events
4 Should we use LAA closure as an option to prevent stroke Medical rationale Efficacy Safety Reimbursement
5 In the US, WATCHMAN is an investigational device, limited by applicable law to investigational use only and not available for sale. CE Mark 2005 WATCHMAN Clinical History PROTECT-AF 800 pts, 59 sites CAP Registry 566 pts, 26 sites PREVAIL 400 pts, < 50 sites PROTECT-AF Long-term F/U WATCHMAN device was non-inferior to warfarin in preventing strokes; FDA concerned with acute safety events Significantly improved safety results Improved success and procedural safety confirmed with new and experienced operators Superior to warfarin for primary efficacy, CV death, and all-cause mortality at 4 years
6 PROTECT AF 4 Year: CV and All-Cause Mortality Reddy, VY et al. JAMA. 2014; 312(19):
7 WATCHMAN FDA Approval INDICATIONS FOR USE This device is indicated to reduce the risk of thromboembolism from the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation who: Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy Are deemed by their physicians to be suitable for warfarin Have an appropriate rationale to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin
8 Proponents of device therapy to prevent embolic stroke: WATCHMAN device as an alternative to Warfarin
9 *2.5 mg twice daily if two or more: age >80, weight <60 kg or Cr > 1.5 (25% renal excretion). Excluded if Cr > 2.5. Dabigatran Rivaroxaban Apixaban Mechanism Direct Thrombin Inhibitor Factor Xa Inhibitor Factor Xa Inhibitor Dose 110 mg or 150 mg 2x/ day 20 mg/day 5 mg 2x/ day *2.5 mg 2x/day Efficacy in preventing embolic events Superior (150 mg) Noninferior (110 mg) noninferior superior Hemorrhagic stroke Significantly less (110 mg) More (150 mg) less less GI bleeding Not specified (110 mg) Major GI bleeding Epistaxis and hematuria less All bleeding events Less (at 110 mg) Similar (at 150mg) less
10 Potential Incidence of Major Bleeding Anticoagulant Dabigatran 150 mg 2x/day Rivaroxaban mg/day Apixaban 5 mg 2x/day Annual Rate for Major Bleed *Potential number of patients >65 yo with major bleeding/year (x1000) 3.32% % % 38.8 Warfarin 3.09% % *Assumes 50% of AF patients treated with AF on OAC Wallentin, L., et al. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet, 2010, 376(9745), Patel, M. R., et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med, 2011, 365(10), Granger, C.B., et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med, (11): p
11 Oral Anticoagulants DISCONTINUATION RATES NOAC Warfarin RE-LY ARISTOTLE ROCKET-AF Dabigatran Apixaban Rivaroxaban NEJM 2009;361: NEJM 2011;365: NEJM 2011;365:883-91
12 Long term follow-up from the PREVAIL Trial Greater event rate of embolic stroke and systemic embolism in the WATCHMAN arm compared to the control The new ischemic strokes in the updated PREVAIL dataset occurred more than 1 year post-watchman implantation, raising questions about long-term device effectiveness.
13 Long term follow-up from the PREVAIL Trial The results of PROTECT AF and PREVAIL appear to be diverging, which introduces challenges in the interpretation of results of the pre-specified Bayesian analysis. PROTECT AF demonstrated a benefit of the WATCHMAN device driven by a reduction in hemorrhagic stroke rate; however, the Control group hemorrhagic stroke rate was substantially higher than observed in contemporary anticoagulation trials, and there are questions regarding the robustness of this potential benefit.
14 Role of implants? Warfarin eligible (need transition OAC therapy) Warfarin intolerant Consider WATCHMAN a Class IIB?
15 Patients with Limited to NO options Patients with contraindications to OAC therapy 82 year old woman with paroxysmal AF History of both ICH and cardioembolic stroke, hypertension TEE reveals LAA thrombus
16 AF patients with contraindication to OAC therapy Under studied population No OAC or device trials have included this cohort of patients All previous studies have been in warfarin eligible patients
17 AVERROES Exclusion Criteria Serious bleeding event in the previous 6 months High risk of bleeding (e.g., active PUD) Blood dyscrasias Platelet count of <100,000 per cubic millimeter Hemoglobin level of <10 g per deciliter Stroke within the previous 10 days Documented IC hemorrhagic tendencies Severe renal insufficiency Abnormal LFT s Sensitivity to ASA
18 WATCHMAN FDA Approval CONTRAINDICATIONS Intracardiac thrombus is visualized by echocardiographic imaging. An ASD repair or closure device or a PFO repair or closure device is present. The LAA anatomy will not accommodate a device. Any of the customary contraindications for other percutaneous catheterization procedures (e.g., patient size too small to accommodate TEE probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present. There are contraindications to the use of warfarin, aspirin, or clopidogrel. The patient has a known hypersensitivity to any portion of the device material or the individual components.
19 WATCHMAN device in AF patients with contraindications to OAC Expected rate: 7.3% Observed ischemic stroke rate 1.7% 77% reduction in stroke rate Reddy and Sievert et al., JACC 61: , 2013
20 % LARIAT device in AF patients with contraindications to OAC Effectiveness in Stroke Reduction vs. Estimated 5.62% -58% Estimated based on CHA2DS2-VASc score Observed rate in study % 1.0 Tzikas et al EuroIntervention 2015
21 Available devices in US for contraindicated patients Epicardial LAA closure Devices Surgical Percutaneous Atriclip Tiger Paw LARIAT
22 Event Rate (% patient-years) 20% 18% LAA ligation in patients with contraindications to OAC therapy National Registry of AF Stroke rate National Registry of AF Stroke rate with ASA 16% 14% 12% 10% 6.2% Expected ER Observed ER: 1% Reduction of 80% 8% 6% 4% 2% 0% CHADS2 score of the LARIAT Population N=139 patients Mean F/U 2.9 +/- 1.1 years 405 patient-years CHADS2 score Sievert et al., JACC EP 2015 (In press)
23 Figure 2: Kaplan-Meier Curves Kaplan-Meier Curves A Survival B Stroke
24 Summary of adverse events and clinical endpoints Follow up (years) 2.9 +/- 1.1 Patient-years Total Adverse events Procedural Related Pericardial effusion (requiring surgical intervention) Pericardial effusion (no intervention required) Pulmonary embolus resulting in death Inflammation Related Pericarditis (>2 days) LA thrombus Delayed pleural effusion Delayed pericardial effusion Death rate Stroke/Systemic Embolism rate Death/Stroke/Systemic Embolism rate 16 (11.5%) 2 (1.4%) 1 (0.7%) 1 (0.7%) 8 (5.9%) 2 (1.4%) 1 (0.7%) 1 (0.7%) 1.8% (n=7) 1.0% (n=4) 2.8% (n=11)
25 WATCHMAN Reddy et al JACC 2013 ACP Tzikas et al EuroIntervention 2015 Number of patients 150 1, Age 72.5 ± ± 8 67 ± 11 Mean CHADS2 score 2.8 ± ± 1.2 LARIAT Sievert et al JACC EP 2015 Mean follow-up 14.4 ± 8.6 months 13 months 35 ± 12 months Patient-years , Absolute # strokes/systemic embolism Event rate (patientyears) 4 (stroke) 9 (strokes), 9 (TIA) 31 (systemic embolism) 2.3% 0.7% stroke 0.7% TIA 2.3% systemic embolism 4 (strokes) 1%
26 Is the LARIAT Safe? Use of LARIAT Suture Delivery Device for Left Atrial Appendage Closure: FDA Safety Communication Date Issued: July 13, 2015
27 LARIAT MDRs March June serious MDRs 6 deaths LAA Perforations LAA Lacerations LAA Avulsions RV Perforations Serious WATCHMAN MDRs 2015 (Total 32) Perforations (8) Air embolism (2) Thrombus (11) Stroke (2) Device embolization (6) Death (3) Serious TactiCath MDRs 2015 (Total 52) Pericardial effusions No intervention (4) Pericardiocentesis (36) Surgery (2) Esophageal fistula (2) Coronary ischemia (2) TIA/stroke (3) Death (3)
28 LARIAT Safety Summary # of LARIAT cases Serious Injury to cardiac / related structure >2 PRBC in 2 days post Organ / structure requiring intervent. Fatal Pericarditi s requiring Hemothora Pneumothor hosp or surg tx x ax Vascular injury requiring surg treatment, hospitalizatio n, transfusion Afzal % 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 4.00% Han % 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% Miller % 0.00% 0.00% 0.00% 2.40% 0.00% 0.00% 0.00% Price % 8.40% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% Massumi % 0.00% 5.00% 0.00% 0.00% 0.00% 0.00% 0.00% Stone % 0.00% 0.00% 0.00% 3.70% 0.00% 0.00% 0.00% Bartus % 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 1.10% Bartus % 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% Sievert % 0.00% 0.00% 0.00% 0.00% 0.00% 0.70% 0.00% Lakkireddy % 0.00% 0.00% 0.00% 0.00% 0.00% 1.40% 1.40% Pilliarisetti % 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% Range 0-7.3% 0-8.4% 0-5.0% 0.00% 0-3.7% 0.00% 0-1.4% 0-4.0% Wtd Avg % 0.45% 0.27% 0.00% 0.33% 0.00% 0.11% 0.35% 3.83% Full references part of IDE submission file; SentreHEART, Inc.
29 Patient Selection Criteria 1. Diagnosed non-valvular atrial fibrillation 2. Current CHADS 2 score 2 or CHA 2 DS 2 VASc 3 3. Currently contraindicated to or intolerant of standard long-term oral anticoagulation (OAC) therapy (i.e., warfarin, dabigatran, apixaban, and rivaroxaban) due to a history of internal or external bleeding. Examples: a) Neurological: intracranial, subdural, subarachnoid, parenchymal b) Intraocular bleeding c) GI: diverticulosis, ulcerative colitis, Crohn s disease, recurrent gastric or duodenal ulcer, erosive gastritis, esophageal tears, AV malformations, frequent nose bleeds d) Urological: hemorrhagic cystitis, urolithiasis with recurrent bleeding e) Pulmonary: hemoptysis, arterial-venous malformations 4. Contraindication to long-term OAC due to high risk for bleeding Examples: a) Recurrent syncope and traumatic falls b) High-risk occupations (ie. professional athletes, soldiers, fire fighters) c ) Intracranial aneurysms d) Dual antiplatelet therapy with high risk of bleeding 5. Failure of OAC (e.g. embolic event despite OAC) 6. Intolerance or difficulty in using OAC Koneru et al., Heart Rhythm 2014
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