Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation - POPular PAUSE TAVI

Aug 31, 2024
Font Size
A
A
A
Author/Summarized by Author:
Amit Saha, MD
Summary Reviewer:
Dharam J. Kumbhani, MD, SM, FACC
Trial Sponsor:
St. Antonius Hospital and the Netherlands Organization for Health Research and Development
Date Presented:
08/31/2024
Date Published:
08/31/2024
Original Posted Date:
08/31/2024
References

Contribution To Literature:

The POPular PAUSE TAVI trial showed that in patients who take oral anticoagulation and undergo TAVI, periprocedural continuation of oral anticoagulation was not noninferior to interruption of therapy with respect to the composite of major adverse cardiovascular and bleeding events at 30 days.

Description:

The goal of the trial was to determine whether, in patients undergoing transcatheter aortic valve implantation (TAVI) who also take oral anticoagulation for a comorbid condition, continuation of anticoagulant therapy is noninferior to periprocedural interruption of anticoagulation with respect to major adverse cardiovascular and bleeding events.

Study Design

  • International
  • Open-label
  • Randomized

Patients taking oral anticoagulation undergoing TAVI were randomized in a 1:1 fashion to continue (n = 431) or interrupt (n = 427) oral anticoagulation during the periprocedural period. Timing of pre-TAVI interruption of oral anticoagulation ranged from 48 hours for most direct oral anticoagulants to up to 120 hours for vitamin K antagonists, and no heparin bridging was performed. Post-TAVI resumption of anticoagulation was at the discretion of the treating physician.

  • Total number of enrollees: 858
  • Duration of follow-up: 30 days
  • Mean patient age: 81 years
  • Percentage female: 35%

Inclusion criteria:

  • Planned transfemoral or trans-subclavian TAVI
  • Oral anticoagulant use

Exclusion criteria:

  • Mechanical heart valve prosthesis
  • Intracardiac thrombus
  • Venous thromboembolism <3 months prior
  • Atrial fibrillation with stroke or transient ischemic attack <6 months prior

Other salient features/characteristics:

  • Oral anticoagulation due to atrial fibrillation: 95%
  • Mean CHA2DS2-VASc score: 4.5
  • Direct oral anticoagulant therapy: 82%
  • Median time to resumption of oral anticoagulation in the interruption group: 1 day

Principal Findings:

The primary outcome, composite of 30-day cardiovascular death, stroke, myocardial infarction, major vascular complications, or major bleeding, for continuation vs. interruption of oral anticoagulation, was: 16.5% vs. 14.8%, risk difference 1.7% (95% confidence interval [CI] -3.1 to 6.6, p for noninferiority = 0.18).

Secondary outcomes for continuation vs. interruption of oral anticoagulation:

  • Cardiovascular death: 2.1% vs. 2.1%, risk difference 0% (95% CI -1.9% to 1.9%)
  • Stroke: 3.2% vs. 4.4%, risk difference -1.2% (95% CI -3.8% to 1.4%)
  • Major vascular complications: 10.2% vs. 7.7%, risk difference 2.5% (95% CI -1.3% to 6.3%)
  • Major bleeding: 11.1% vs. 8.9%, risk difference 2.2% (95% CI -1.8 to 6.3)

Interpretation:

In patients undergoing TAVI while on chronic oral anticoagulation, continuation of anticoagulant therapy failed to meet the noninferiority margin of an absolute risk difference of 4% compared with interruption of anticoagulation in the periprocedural period. This was driven primarily by a numeric increase in both vascular complications and major bleeding events, which were defined as Valve Academic Research Consortium 3 (VARC-3) type 2 or greater. Rates of stroke and other thromboembolic events were numerically similar between groups. This is in contrast to prior observational data, which have suggested decreased stroke risk without increased bleeding in nonrandomized comparisons of continuation versus interruption of oral anticoagulation. Subgroup analyses suggested that a high CHA2DS2-VASc score or history of prior stroke may slightly affect the primary composite endpoint, but these remain hypothesis-generating. The current data therefore do not support continuing oral anticoagulation in the general population undergoing TAVI, although special consideration could be given to patients at much higher risk of thromboembolic events.

References:

van Ginkel DJ, Bor WL, Aarts HM, et al., for the POPular PAUSE TAVI Investigators. Continuation versus Interruption of Oral Anticoagulation during TAVI. N Engl J Med 2024;Aug 31:[Epub ahead of print].

Presented by Dr. Dirk Jan van Ginkel at the European Society of Cardiology Congress, London, UK, August 31, 2024.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Anticoagulation Management and Atrial Fibrillation, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias

Keywords: Anticoagulants, Atrial Fibrillation, Transcatheter Aortic Valve Replacement, ESC Congress, ESC24


< Back to Listings