Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic-Valve Implantation - POPular TAVI (antiplatelet therapy)

Contribution To Literature:

The POPular TAVI (antiplatelet therapy) trial showed that aspirin alone was preferential to aspirin plus clopidogrel after TAVR. 

Description:

The goal of the trial was to evaluate aspirin alone compared with aspirin plus clopidogrel among patients who underwent transcatheter aortic valve replacement (TAVR) and did not have a long-term indication for oral anticoagulation.


Study Design

  • Randomized
  • Parallel
  • Open-label

Eligible patients who underwent TAVR were randomized to aspirin alone (n = 331) versus aspirin and clopidogrel for 3 months (n = 334).

  • Total number of enrollees: 690
  • Duration of follow-up: 12 months
  • Mean patient age: 80 years
  • Percentage female: 50%
  • Percentage with diabetes: 24%

Inclusion criteria:

  • Patients who underwent TAVR and did not have an indication for anticoagulation therapy

Exclusion criteria:

  • Implantation of a drug-eluting stent within the last 3 months or bare-metal stent within the last month

Principal Findings:

The primary co-outcome, all bleeding (minor, major, and life-threatening or disabling bleeding) at 12 months, occurred in 15.1% of the aspirin alone group compared with 26.6% of the aspirin plus clopidogrel group (p = 0.001).

The primary co-outcome, nonprocedure-related bleeding at 12 months, occurred in 15.1% of the aspirin alone group compared with 24.9% of the aspirin plus clopidogrel group (p = 0.005).

Secondary outcomes:

  • Cardiovascular death, nonprocedure-related bleeding, stroke, or myocardial infarction at 12 months: 23.0% of the aspirin alone group compared with 31.1% of the aspirin plus clopidogrel group (p for noninferiority < 0.001, p for superiority 0.04)
  • Cardiovascular death, stroke, or myocardial infarction at 12 months: 9.7% of the aspirin alone group compared with 9.9% of the aspirin plus clopidogrel group (p for noninferiority = 0.004, p for superiority 0.93)
  • VARC major bleeding at 12 months: 2.4% of the aspirin alone group compared with 7.5% of the aspirin plus clopidogrel group (p < 0.05)
  • VARC major, life-threatening, or disabling bleeding at 12 months: 5.1% of the aspirin alone group compared with 10.8% of the aspirin plus clopidogrel group (p < 0.05)
  • Symptomatic aortic valve thrombosis at 12 months: 0.9% of the aspirin alone group compared with 0.3% of the aspirin plus clopidogrel group (p = nonsignificant)
  • Increased aortic valve gradient >10 mm Hg at 12 months: 3.0% of the aspirin alone group compared with 3.3% of the aspirin plus clopidogrel group (p < 0.05)

Interpretation:

Among patients who underwent TAVR and did not have an indication for anticoagulation, aspirin alone was associated with a reduction in all bleeding and nonprocedure-related bleeding compared with aspirin plus clopidogrel. This benefit was largely due to a significant reduction in major bleeding events. Aspirin alone compared with aspirin plus clopidogrel was also associated with noninferiority regarding adverse ischemic events (cardiovascular death, stroke, or myocardial infarction). Valve function appeared to remain similar within 12 months.

The results of this study are similar to the ARTE trial. A limitation of the trial is open-label design. This trial casts some doubt on the arbitrary practice of dual antiplatelet therapy after TAVR.

References:

Brouwer J, Nijenhuis VJ, Delewi R, et al. Aspirin With or Without Clopidogrel After Transcatheter Aortic-Valve Implantation. N Engl J Med Aug 30:[Epub ahead of print].

Presented by Dr. Jorn Brouwer at the European Society of Cardiology Virtual Congress, August 30, 2020.

Clinical Topics: Anticoagulation Management, Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and VHD, Interventions and Structural Heart Disease

Keywords: ESC Congress, ESC20, Anticoagulants, Aspirin, Geriatrics, Heart Valve Diseases, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Platelet Aggregation Inhibitors, Stroke, Transcatheter Aortic Valve Replacement, Thrombosis, Vascular Diseases


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