What is the clinical evidence from this study?

Study design: RCT. Population: Transcatheter Aortic-Valve Implantation (n=665). Intervention: Aspirin vs. Aspirin plus Clopidogrel. Primary outcome: All bleeding (RR 0.57, 95% CI 0.42 to 0.77, p=0.001).

What does this research mean for the field?

Aspirin alone reduces all bleeding events by 42.9% compared to aspirin plus clopidogrel in patients undergoing TAVI at 12 months follow-up. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.CHALLENGES_CONSENSUS.

August 30, 2020Open Access

Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation

Key Result

Aspirin alone reduced all bleeding events by 42.9% compared to aspirin plus clopidogrel in patients undergoing TAVI at 12 months follow-up.

Study Design

Type

RCT (n=665)

Blinding

null

Randomization

1:1 ratio

Multicenter

Yes

Structured PICO

Does aspirin alone reduce bleeding and thromboembolic events compared to aspirin plus clopidogrel in patients undergoing TAVI without an indication for oral anticoagulation?

Population

Patients undergoing transcatheter aortic-valve implantation (TAVI) who did not have an indication for oral anticoagulation

Intervention

Aspirin

Comparator

Aspirin plus clopidogrel administered for 3 months

Outcome

Incidence of bleeding and the composite of bleeding or thromboembolic events at 1 yearcomposite

In patients undergoing TAVI without an indication for oral anticoagulation, aspirin alone significantly reduces bleeding and composite bleeding/thromboembolic events at 1 year compared to dual antiplatelet therapy with aspirin and clopidogrel.

Main Result

Effect estimate: RR 0.57 (95% CI 0.42 to 0.77)

Absolute Event Rate: 15.1% vs 26.6%

p-value: p=0.001

Limitations

Open-label design; potential bias
Powered for composite outcomes rather than solitary thromboembolic events
No mandated imaging for subclinical valve thrombosis
Utilized BARC type 4 definition for procedure-related bleeding, which may not fully apply to TAVI patients.

Abstract

Among patients undergoing TAVI who did not have an indication for oral anticoagulation, the incidence of bleeding and the composite of bleeding or thromboembolic events at 1 year were significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.).