Is Stroke Frequency Declining?

Transcription

1 Is Stroke Frequency Declining? Etiologic Factors Clinical, Anatomic, Technique-related, and Device-specific Samir Kapadia, MD Professor of Medicine Section head, Interventional Cardiology Director, Cardiac Catheterization Laboratories

2 Disclosure Co PI for sentinel

3 Outline Risk of Stroke During TAVR Clinical Silent Brain Infarction Timing and mechanism of Stroke Risk Factors for Stroke

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5 Stroke (%) All Stroke : PARTNER A (ITT) TAVR SAVR ALL TF TA ALL TF TA 30 Days 1 Year Smith et al, NEJM, June 2011

6 CoreValve Trial : All Stroke Adams, NEJM, 2014

7 What is the risk of stroke with surgery? 2.6% PARTNER -SAVR 6.2% CoreValve - SAVR

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9 Stroke Detection and Reporting Strokes = 34 patients (17%; 95% CI, 12-23%) TIA = 4 patients (2%; 95% CI, 0-4%) 25 strokes were not included in STS database STS database reported 13 patients (6.6%) with stroke but 4 did not have stroke by DeNOVO (alcohol withdrawal, no deficit by day 7) Masse, circulation, 2014

10 Stroke : TAVR versus SAVR P1A 2.6 P2A S3i Days TAVR SAVR TAVR SAVR TAVR SAVR

11 Superiority Analysis Components of Primary Endpoint (VI) Mortality Favors TAVR Favors Surgery Weighted Difference -5.2% Upper 2-sided 95% CI -2.4% Superiority Testing p-value < Stroke Weighted Difference -3.5% Upper 2-sided 95% CI -1.1% Superiority Testing p-value = AR > Moderate Weighted Difference +1.2% Lower 2-sided 95% CI +0.2% Superiority Testing p-value =

12 Stroke Risk With Second Generation TAVR valves Meta-analysis of ~20 non-randomized, mostly FIM, valve-company sponsored studies 2.4% major stroke at 30-days Athappan, et al. A systematic review on the safety of second-generation transcatheter aortic valves. EuroIntervention 2016; 11:

13 TVT Stroke Rate % 30 Day Stroke

14 TVT Registry Experience and Risk of Stroke Over 53,000 US TAVR patients from >350 US centers No significant decline in stroke rate as centers gain experience Self-reported rates without prospective neurologist exams pre and post-procedure likely underestimate true rates Carroll J, et al. ACC 2016

15 Timing of Neurological Event TAVR EARLY SAVR LATE 3 2 Tay et al, J Am Coll Cardiol Intv 2011;4: TA-TAVR SAVR TF-TAVR Miller et al, 2012;143:

16 Updated PARTNER Analysis Kapadia et al, Circ Int 2016

17 Mortality After Stroke and TIA TF TAVR PARTNER Trial Stroke TIA Kapadia et al, Circ Int 2016

18 Mortality after Stroke : TAVR Patients CoreValve High Risk Trial No. at Risk Major Stroke No Major Stroke

19 Predictors of Stroke, Neuro events or MRI findings Author N Event rate Approach Clinical predictors Anatomical predictors Tay et al % TA/TF H/O stroke/tia Carotid stenosis* Nuis et al % TF New onset AF Baseline AR >3+ Amat Santos et al % TA/TF New onset AF None Franco et al % TA/TF None Post-dilation Miller et al % TA/TF History of stroke Non TF-TAVR candidate Smaller AVA Cabau et al % (MRI) TA/TF Male, History of CAD Higher AVG Fairbairn et al % (MRI) TF Age Aortic atheroma Nombela-Franco et al % TA/TF Balloon postdilatation, valve dislodgement, New onset AF, PVD, Prior CVA

20 Pre-dilatation

21 Predictors of Late CVEs (>30-day) UNIVARIATE Chronic atrial fibrillation Peripheral vascular disease Cerebrovascular disease Anticoagulation treatment at hospital discharge 2.83 ( ) p= ( ) p= ( ) p= ( ) p=0.005 MULTIVARIATE Chronic atrial fibrillation Peripheral vascular disease Cerebrovascular disease Anticoagulation treatment at hospital discharge 2.84 ( ) p= ( ) p= ( ) p= ( ) p= Hazard ratio (95% Confidence Interval) Nombela-Franco et al. Circulation Dec 18;126(25):

22 Association of warfarin therapy with clinical events after bioprosthetic AVR: STS database 25,656 patients undergoing bioprosthetic AVR at 797 hospitals in the STS database Warfarin plus aspirin associated with a reduced risk of death and embolic events, compared to aspirin alone Death Thromboembolism Brennan M. et al. JACC 2012

23 GALILEO (Global multicenter, open-label, randomized, event-driven, active-controlled study comparing a rivaroxaban-based antithrombotic strategy to an antiplatelet-based strategy after transcatheter aortic valve replacement (TAVR) to Optimize clinical outcomes will compare rivaroxaban-based) 1520 patients after successful TAVI procedure Rivaroxaban 10 mg OD and Aspirin mg OD R 1:1 Clopidogrel 75 mg OD Aspirin mg OD Drop of aspirin Rivaroxaban 10 mg OD Drop of clopi Aspirin mg OD Primary end-point is death, MI, stroke, non-cns systemic emboli, symptomatic valve thrombosis, deep vein thrombosis or pulmonary embolism,major bleedings over 720 days of treatment exposure.

24 ATLANTIS (Anti-Thrombotic Strategy to Lower All cardiovascular and Neurologic Ischemic and Hemorrhagic Events after Trans-Aortic Valve Implantation for Aortic Stenosis) 1509 patients after successful TAVI procedure Stratum 1 Indication for OAT R 1:1 Stratum 2 No indication for OAT R 1:1 VKA Apixaban 5mg bid* DAPT/SAPT Primary end-point is a composite of death, MI, stroke, systemic emboli, intracardiac or bioprosthesis thrombus, episode of deep vein thrombosis or pulmonary embolism,major bleedings over one year follow-up.

25 Conclusion Stroke after TAVR is an important problem. Stroke rate after TAVR is better than stroke after SAVR Stroke and TIA are associated with increased mortality and morbidity. Risk of stroke is predominantly procedural. If TAVR stroke risk can be reduced further, it can be a differentiated feature from SAVR. Procedural variations, emboli prevention devices, and post procedural treatment may help to reduce stroke risk.