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Evevident
Original paper
2019JAMACardiology

PAUSE

Perioperative Management of Patients With Atrial Fibrillation Receiving a Direct Oral Anticoagulant

CohortPeriprocedural anticoagulation

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Overview

A standardized DOAC interruption/resumption strategy without heparin bridging produced low rates of major bleeding and arterial thromboembolism.

Clinical takeaway

PAUSE provides a practical perioperative DOAC playbook based on drug, renal function, and procedural bleeding risk.

Key result

With standardized interruption and no bridging, 30-day major bleeding was ~1-2% and arterial thromboembolism <1%.

Practice impact

Use structured DOAC hold times rather than bridging in most elective procedures.

Evidence

Study design

Prospective, single-arm management cohort study.

Enrollment

3,007

Follow-up

30 days after the procedure.

Geography

Canada, United States, Europe

Clinical question

Can standardized perioperative DOAC interruption be used safely without bridging or coagulation testing?

Population

  • Patients with atrial fibrillation taking apixaban, dabigatran, or rivaroxaban who required an elective procedure.

Intervention

Standardized DOAC interruption and resumption protocol (hold interval by drug, renal function, and procedural bleeding risk) without heparin bridging.

Comparator

No randomized comparator; outcomes assessed prospectively within each DOAC cohort.

Primary outcome

Major bleeding and arterial thromboembolism at 30 days.

A simple, drug- and renal-function-based interruption protocol without bridging or coagulation testing yielded low rates of major bleeding and arterial thromboembolism.

30-day major bleeding rate / 1.35 / CI 95% CI ~0.0-2.0 (apixaban cohort)

Key results

  • 30-day major bleeding: 1.35% (apixaban), 0.90% (dabigatran), and 1.85% (rivaroxaban).
  • 30-day arterial thromboembolism: 0.16% (apixaban), 0.60% (dabigatran), and 0.37% (rivaroxaban).
  • Most patients had an undetectable or minimal residual anticoagulant level at surgery without preoperative testing.

Harms

  • Major bleeding remained low (roughly 1-2%) across the three DOACs.
  • As a single-arm cohort, PAUSE cannot directly compare strategies, only demonstrate the safety of the protocol.

Clinical Use

When to cite

  • When planning perioperative DOAC interruption based on bleeding risk and renal function without routine bridging.

Practice impact

  • Use structured DOAC hold times rather than bridging in most elective procedures.

Applicability

  • Most applicable to patients with atrial fibrillation taking apixaban, dabigatran, or rivaroxaban who require elective procedures.

Limitations

  • Prospective single-arm cohort rather than a randomized comparison.
  • Applies to the studied DOACs, procedure types, and renal-function strata.
  • Excluded severe renal impairment and some high-bleeding-risk procedures.

Common misinterpretations

  • PAUSE validates a simple hold-and-resume protocol; it does not compare DOACs head-to-head.
  • No preoperative coagulation testing or bridging is needed for most patients following the protocol.

Related evidence

BRIDGE - Earlier Trial

Citation

Douketis JD, Spyropoulos AC, Duncan J, et al. Perioperative Management of Patients With Atrial Fibrillation Receiving a Direct Oral Anticoagulant. JAMA Intern Med. 2019;179(11):1469-1478. doi:10.1001/jamainternmed.2019.2431

In patients with AF who had DOAC therapy interruption for an elective surgery or procedure, a perioperative management strategy without heparin bridging or coagulation function testing was associated with low rates of major bleeding and arterial thromboembolism.