Variation in Antithrombotic Therapy and Clinical Outcomes in Patients With Preexisting Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Preexisting atrial fibrillation undergoing transcatheter aortic valve replacement (TAVR) (n=11382). Intervention: OAC+APT (oral anticoagulant plus antiplatelet therapy) vs. APT (antiplatelet therapy) alone. Primary outcome: Bleeding at 1 year (HR 1.16, 95% CI 1.05-1.27).

Matthew W. Sherwood; Aakriti Gupta; Sreekanth Vemulapalli; Zhuokai Li; Jonathan P. Piccini; J. Kevin Harrison; David Dai; Amit N. Vora; Michael J. Mack; David R. Holmes; John S. Rumsfeld; David J. Cohen; Vinod H. Thourani; Ajay J. Kirtane; Eric D. Peterson

doi:10.1161/circinterventions.120.009963

April 1, 2021Circulation Cardiovascular InterventionsOpen Access

Variation in Antithrombotic Therapy and Clinical Outcomes in Patients With Preexisting Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement

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Key result

In TAVR patients with preexisting atrial fibrillation, discharge on OAC+APT increased bleeding risk compared with APT alone (HR 1.16) without reducing the risk of stroke or mortality.

Why the study?

Optimal antithrombotic management in patients with preexisting AF undergoing TAVR is challenging because of the need to balance bleeding and thromboembolism risks, prompting evaluation of practice variations and 1-year clinical outcomes.

Does OAC+APT therapy improve 1-year outcomes of stroke, bleeding, and mortality compared with APT alone or OAC alone in patients with preexisting atrial fibrillation undergoing TAVR?

Study Design

Type

Cohort (n=11,382)

Multicenter

Yes

Structured PICO

Does OAC+APT therapy improve 1-year outcomes of stroke, bleeding, and mortality compared with APT alone or OAC alone in patients with preexisting atrial fibrillation undergoing TAVR?

P

Population

11,382 patients with preexisting atrial fibrillation who underwent transcatheter aortic valve replacement across 387 US hospitals, followed for 1 year.

E

Exposure

Combination of oral anticoagulants and antiplatelet therapies (OAC+APT) at discharge.

C

Comparator

Antiplatelet therapy (APT) alone or oral anticoagulant (OAC) alone at discharge.

O

Outcome

1-year outcomes of stroke, bleeding, and all-cause mortality.hard clinical

Main Result

Hazard Ratio: 1.16 (95% CI 1.05–1.27)

Absolute Event Rate: 21.1% vs 19.5%

Limitations

Observational design with potential confounding by indication
Data from 2011-2015 may not reflect current practice with DOACs
Results may not apply to patients with new-onset atrial fibrillation following TAVR
Observational nature inherently carries risk of confounding by indication
Extrapolation to patients with concomitant coronary artery disease or percutaneous coronary intervention should be made with caution
Based on data from 2011-2015 which may not reflect recent expansion of DOAC use
Excludes new-onset AF following TAVR

Implication

Discharging TAVR patients with preexisting AF on a combination of OAC and APT does not reduce mortality or stroke but significantly increases bleeding risk compared to APT alone, challenging its routine use.

Abstract

BACKGROUND: Optimal antithrombotic management of patients with preexisting atrial fibrillation undergoing transcatheter aortic valve replacement is challenging given the need to balance the risk of bleeding and thromboembolism. We aimed to examine variation in care and association of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality in patients undergoing transcatheter aortic valve replacement with concomitant atrial fibrillation in the United States. METHODS: Patients who underwent transcatheter aortic valve replacement with preexisting atrial fibrillation from November 2011 through September 2015 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry linked to the Medicare database were examined according to receipt of oral anticoagulants (OACs) or antiplatelet therapies (APTs) or a combination of these (OAC+APT) at discharge. To assess the associations of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality, we utilized inverse probability weighting for antithrombotic therapies and multivariable regression modeling to adjust for patient- and hospital-level variables. RESULTS: In the 11 382 patients included in our study, 5833 (51.2%) were discharged on OAC+APT, 4786 (42.0%) on APT alone, and 763 (6.7%) on OAC alone. There was significant variability in discharge medication patterns, including 42% of patients discharged without OAC therapy. In adjusted analyses, the risk for all-cause mortality and stroke was not significantly different when comparing the 3 different antithrombotic strategies. Risk of bleeding was higher with OAC+APT compared with APT alone (hazard ratio, 1.16 [95% CI, 1.05–1.27]) and similar compared with OAC alone (hazard ratio, 1.17 [95% CI, 0.93–1.47]). CONCLUSIONS: There was significant variability in discharge medication patterns across US sites in patients with atrial fibrillation undergoing transcatheter aortic valve replacement, including significant underuse of OAC in this high-risk cohort. The use of OAC+APT (versus OAC alone or APT alone) was not associated with a lower risk of stroke or mortality but was associated with increased risk of bleeding complications at 1 year compared with APT alone.

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Cite This Study

Sherwood et al. (2021) conducted a cohort in Preexisting atrial fibrillation undergoing transcatheter aortic valve replacement (TAVR) (n=11,382). OAC+APT (oral anticoagulant plus antiplatelet therapy) vs. APT (antiplatelet therapy) alone was evaluated on Bleeding at 1 year (HR 1.16, 95% CI 1.05-1.27). In TAVR patients with preexisting atrial fibrillation, discharge on OAC+APT increased bleeding risk compared with APT alone (HR 1.16) without reducing the risk of stroke or mortality.

synapsesocial.com/papers/6a4af1904e2f04c47c814636 https://doi.org/10.1161/circinterventions.120.009963