Antithrombotic Strategies Post-TAVR Amit N. Vora, MD MPH Structural - - PowerPoint PPT Presentation

antithrombotic strategies post tavr
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Antithrombotic Strategies Post-TAVR Amit N. Vora, MD MPH Structural - - PowerPoint PPT Presentation

Antithrombotic Strategies Post-TAVR Amit N. Vora, MD MPH Structural Interventional Cardiologist UPMC Pinnacle, Harrisburg PA Disclosures Research funding BMS Education funding: Medtronic Background The initial pivotal trials used


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SLIDE 1

Antithrombotic Strategies Post-TAVR

Amit N. Vora, MD MPH Structural Interventional Cardiologist UPMC Pinnacle, Harrisburg PA

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SLIDE 2

Disclosures

  • Research funding BMS
  • Education funding: Medtronic
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SLIDE 3

Background

  • The initial pivotal trials used DAPT for 3-6 months following TAVR

(borrowed from PCI)

– Prevent device-related thromboembolic complications during endothelialization

  • f the valve frame

– Many patients had CAD / arch atheroma

  • But, need to balance:

– Thromboembolic risk (stroke, MI, clinical and sub-clinical valve leaflet thrombosis) – Bleeding risk (especially in elderly, frail patients)

  • Especially challenging in patients with atrial fibrillation burden
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SLIDE 4

Ischemic and Bleeding Risks Post-TAVR

Vranckx, EHJ 2017

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SLIDE 5

Variability in worldwide practice

Cerrato et. al, IJC 2017

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SLIDE 6

Neither ASA or P2Y12 14% ASA or P2Y12 alone 25% Dual Therapy 61% Neither ASA or P2Y12 11% ASA or P2Y12 alone 73% Dual Therapy 16%

No Antic icoagula

  • agulati

tion

  • n

Antic icoagula

  • agulati

tion

  • n

Combination therapy

Courtesy of M. Sherwood

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SLIDE 7

No real consensus guidelines

ACC/AHA

  • Clopidogrel 75mg daily for 6 months

after TAVR in addition to lifelong aspirin (IIb, LOE C)

  • Anticoagulation with VKA to achieve

INR of 2.5 for at least 3 months in low bleeding risk patients (IIa, LOE B-NR)

  • DAPT for 3-6 months, then SAPT

lifelong (IIa, LOE C)

  • Consider SAPT for high bleeding risk

patients

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SLIDE 8
  • N=222 patients randomized to ASA + clopidogrel vs SAPT

(mostly ASA)

  • Primary endpoint: Composite of death/MI/stroke, major/life-

threatening bleeding at 90d

  • Trial stopped early (slow enrollment, 74% of inclusion)

Rodes-Cabau, JACC Intv 2017

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SLIDE 9

Results

  • Primary endpoint:

– 15.3% vs 7.2% (OR 2.31, 95% CI 0.95-5.62, p=0.065)

  • No significant differences in:

– Death (6.3% vs 3.6%, p=0.37) – MI (3.6% vs 0.9% p=0.18) – Stroke/TIA (2.7% vs 0.9%, p=0.31)

  • Higher bleeding with DAPT

(10.8% vs 3.6% OR 3.16, p=0.038)

Rodes-Cabau, JACC Intv 2017 DAPT SAPT

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SLIDE 10

Future Trials

Guedeney, Circ Intv 2019

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SLIDE 11

POPular-TAVR Trial Design

  • Primary endpoint:

– Freedom from non-procedure related bleeding complications at 1 year

  • Secondary endpoints:

– Net clinical benefit at 1 year:

  • CV mortality
  • Non-procedure-related bleeding
  • Stroke
  • MI

Nijenhuis, AHJ 2016

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SLIDE 12

GALILEO

Windecker, AHJ 2017

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SLIDE 13

The ATLANTIS Trial

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SLIDE 14

At our institution

No OAC Indicated

  • DAPT for 3 months for most but

transitioning to SAPT for high bleeding risk patients

  • DAPT for 6-12 months if recent PCI
  • Consideration of OAC alone for

patients at higher risk for valve leaflet thrombosis OAC Indicated

  • OAC with no antiplatelet agent if high

bleeding risk

– Preference for DOACs (rivaroxaban, apixaban)

  • OAC with short term SAPT (1-3

months) if lower bleeding risk

  • Almost never triple antithrombotic

therapy

  • Strong consideration of WATCHMAN

device

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SLIDE 15

Conclusions

  • Paucity of current data, but more recent data supporting less

aggressive antithrombotic therapy

  • Consider SAPT in many patients, OAC in patients at higher risk

for valve leaflet thrombosis

  • Wealth of new data will be available 2019-2020