Antithrombotic Therapy After Transcatheter Aortic Valve Implantation in Patients With a Long-Term Indication for Oral Anticoagulation - POPular TAVI

Contribution To Literature:

The POPular TAVI trial showed that oral anticoagulation alone was associated with a reduction in bleeding compared with oral anticoagulation/clopidogrel.

Description:

The goal of the trial was to evaluate oral anticoagulation alone compared with oral anticoagulation plus clopidogrel among patients who underwent transcatheter aortic valve replacement (TAVR) and had a long-term indication for oral anticoagulation.

Study Design

  • Randomized
  • Parallel
  • Open-label

Patients who underwent TAVR and had a long-term indication for oral anticoagulation were randomized to oral anticoagulation alone (n = 164) versus oral anticoagulation plus clopidogrel for 3 months (n = 162).

  • Total number of enrollees: 326
  • Duration of follow-up: 3 months
  • Mean patient age: 81 years
  • Percentage female: 44%

Inclusion criteria:

  • Patients who underwent TAVR and had a long-term indication for oral anticoagulation

Exclusion criteria:

  • Drug-eluting stent within the last 3 months
  • Bare-metal stent within the last month
  • Allergy or contraindication to oral anticoagulation

Other salient features/characteristics:

  • Atrial fibrillation 96%
  • Type of anticoagulation: vitamin K antagonist, 75%; direct oral anticoagulant 24%
  • Access: transfemoral, 87%
  • Type of valve: Sapien 3, 41%; Evolut R, 29%; other, 30%
  • Embolic protection device: 2.5%

Principal Findings:

The co-primary outcome, all bleeding (Valve Academic Research Consortium-2 [VARC-2]), occurred in 21.7% of the oral anticoagulation alone group compared with 34.6% of the oral anticoagulation plus clopidogrel group (p = 0.01). Among those treated with a vitamin K antagonist, the relative risk  (95% confidence interval) for all bleeding for oral anticoagulation alone versus oral anticoagulation plus clopidogrel was 0.75 (0.5-1.14) and among those treated with a direct oral anticoagulant, the relative risk (95% confidence interval) was 0.28 (0.1-0.75).

The co-primary outcome, nonprocedural bleeding (Bleeding Academic Research Consortium [BARC]), occurred in 21.7% of the oral anticoagulation alone group compared with 34.0% of the oral anticoagulation plus clopidogrel group (p = 0.02).

Secondary outcomes:

  • Cardiovascular death, nonprocedural bleeding, myocardial infarction, or stroke: 31.2% of the oral anticoagulation alone group compared with 45.5% of the oral anticoagulation plus clopidogrel group (criteria for noninferiority met, p for superiority < 0.05)
  • Cardiovascular death, myocardial infarction, or stroke: 13.4% of the oral anticoagulation alone group compared with 17.3% of the oral anticoagulation plus clopidogrel group (criteria for noninferiority met, p for superiority = not significant)

Interpretation:

Among patients who underwent TAVR and had an indication for long-term anticoagulation, oral anticoagulation alone was associated with a reduction in all bleeding and procedural bleeding compared with oral anticoagulation plus clopidogrel. Oral anticoagulation alone compared with oral anticoagulation plus clopidogrel was noninferior with respect to major adverse ischemic events. A minority of patients (24%) were treated with a direct oral anticoagulant and there is still debate if this form of anticoagulation is safe compared with a vitamin K antagonist.

References:

Nijenhuis VJ, Brouwer J, Delewi R, et al. Anticoagulation With or Without Clopidogrel After Transcatheter Aortic-Valve Implantation. N Engl J Med 2020;382:1696-1707.

Editorial: Feit F. How Un-POPular Is Bleeding in Patients With TAVI? N Engl J Med 2020;382:1761-3.

Presented by Dr. Vincent Nijenhuis at the American College of Cardiology Virtual Annual Scientific Session Together With World Congress of Cardiology (ACC 2020/WCC), March 29, 2020.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Valvular Heart Disease, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease

Keywords: acc20, ACC Annual Scientific Session, Anticoagulants, Arrhythmias, Cardiac, Atrial Fibrillation, Cardiac Surgical Procedures, Embolic Protection Devices, Geriatrics, Heart Failure, Heart Valve Diseases, Hemorrhage, Myocardial Infarction, Risk, Secondary Prevention, Stroke, Transcatheter Aortic Valve Replacement, Vitamin K


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