Periprocedural Outcomes of Direct Oral Anticoagulants Versus Warfarin in Nonvalvular Atrial Fibrillation

Abstract

The short-term safety and efficacy of DOACs and warfarin are not different in patients with nonvalvular atrial fibrillation periprocedurally. Under an uninterrupted anticoagulation strategy, DOACs are associated with a 38% lower risk of major bleeding compared with warfarin.

Scientific and Standardization Committee Communication: Guidance document on the periprocedural management of patients on chronic oral anticoagulant therapy: Recommendations for standardized reporting of procedural/surgical bleed risk and patient‐specific thromboembolic risk

“…Last, we acknowledge that this proposed procedural/surgical bleed risk and patient‐specific TE risk will be less useful in the design and interpretation of periprocedural studies of patients on chronic DOACs, where other factors such as DOAC pharmacokinetic profiles, procedural bleed risk, and patient renal function will play a more dominant role . In addition, the very low pooled ATE event rate of 0.5% (95% CI: 0.3‐0.6) in patients on chronic OAC needing temporary periprocedural interruption described in a recent large meta‐analysis of randomized trials would necessitate large sample sizes …”

“…Moreover, data from systematic reviews and observational studies of periprocedural VKA or DOAC continuation found low rates of procedure site bleeding of ~2.0 to 3.0% (95% CI: 1.1%‐5.8%) . Last, a recent meta‐analysis of 4519 procedures in patients with AF deemed at bleed risk low enough to warrant uninterrupted VKA or DOAC, including diagnostic gastrointestinal endoscopic procedures, dermatologic procedures, ophthalmological procedures (cataract removal), and dental/maxillofacial surgical procedures revealed pooled incidence rates of major bleed (MB) at 30 days of 3.3% (95% CI: 2.7‐4.0) and 2.0% (95% CI: 1.6‐2.4), respectively, which is higher than the perceived bleeding risk . Surgical and procedural societies have included non‐specific terms that include “not clinically relevant” and “very low bleed risk” to describe bleed risk in procedures associated with a 2‐day MB rate of <1% and, by definition, would not warrant OAC interruption .…”

“…[16][17][18] Last, a recent meta-analysis of 4519 procedures in patients with AF deemed at bleed risk low enough to warrant uninterrupted VKA or DOAC, including diagnostic gastrointestinal endoscopic procedures, dermatologic procedures, ophthalmological procedures (cataract removal), and dental/ maxillofacial surgical procedures revealed pooled incidence rates of major bleed (MB) at 30 days of 3.3% (95% CI: 2.7-4.0) and 2.0% (95% CI: 1.6-2.4), respectively, which is higher than the perceived bleeding risk. 19 Surgical and procedural societies have included non-specific terms that include "not clinically relevant" and "very low bleed risk" to describe bleed risk in procedures associated with a 2-day MB rate of <1% and, by definition, would not warrant OAC interruption. 11 Other guidance statements on the topic refer to the term "minimal bleed risk" to describe those procedures or surgeries at low enough bleed risk to warrant uninterrupted OAC (or at most a single interruption of DOAC on the day of procedure).…”

“…5 For patients on chronic OAC undergoing procedures or surgeries at high enough bleed risk to warrant OAC discontinuation, data from observational studies, substudies from randomized control trials (RCTs), RCTs, and meta-analyses suggest that the overall 30-day periprocedural background incidence of MB is ~1.0%-3.0%. 5,9,[19][20][21][22][23] A recent meta-analysis of substudies of RCTs in patients with AF undergoing 16 479 procedures necessitating warfarin or DOAC interruption found a 30-day incidence of MB of 2.0% (95% CI: 1.7-2.3) and 2.1% (95% CI: 1.8-2.4), respectively. 19 More recently, preliminary results from the large, multicenter PAUSE trial assessing standardized DOAC interruption for an elective procedure or surgery also found a 30-day MB rate of 1.43% (95% CI: 0-1.83).…”

“…5,9,[19][20][21][22][23] A recent meta-analysis of substudies of RCTs in patients with AF undergoing 16 479 procedures necessitating warfarin or DOAC interruption found a 30-day incidence of MB of 2.0% (95% CI: 1.7-2.3) and 2.1% (95% CI: 1.8-2.4), respectively. 19 More recently, preliminary results from the large, multicenter PAUSE trial assessing standardized DOAC interruption for an elective procedure or surgery also found a 30-day MB rate of 1.43% (95% CI: 0-1.83). 24 The bleed risk stratification of procedures and surgeries requiring OAC interruption into non-high bleed risk vs high bleed risk is important because the anticipated background event rates for bleeding would anchor the timing of periprocedural OAC management.…”