Should We Withdraw Anticoagulation Before TAVR?

Approximately one-third of patients undergoing transcatheter aortic valve replacement (TAVR) have atrial fibrillation and are on oral anticoagulant (OAC) therapy. This creates a complex clinical management scenario, as it is necessary to avoid both bleeding and embolic events.

Currently, there are no significant studies thoroughly assessing this scenario.

The POPular PAUSE TAVI study included 858 patients who underwent TAVR and were on anticoagulant therapy. Of these, 431 continued anticoagulation (OAC+), while the rest interrupted the treatment (OAC-).

The primary endpoint of the study was a composite of cardiovascular death, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days.

The groups were similar: the mean age was 80 years, approximately one-third of patients were women, and the average EuroSCORE was 3.8. All patients were symptomatic, 96% had atrial fibrillation, the average CHA2DS2-VASc score was 4.6, 79% had hypertension, 30% had diabetes, and 48% had coronary artery disease. Additionally, 33% had undergone previous myocardial revascularization surgery, 15% had had a heart attack, 11% had had a stroke, 10% had had a transient ischemic attack (TIA), 50% had impaired renal function, 18% had a prior pacemaker implanted, and 7% were cases of TAVI-in-TAVI (V-in-V).

Read also: MATTERHORN: Edge-to-Edge Repair vs. Surgery for Secondary Mitral Valve Regurgitation.

There were no significant differences in the primary endpoint between the two groups, with an incidence of 16.5% in the OAC+ group and 14.8% in the OAC- group (risk difference, 1.7 percentage points; 95% confidence interval [CI], −3.1 to 6.6; P=0.18 for non-inferiority). 

There were also no differences in the following events: cardiovascular death (2.1% in both groups; risk difference, 0.0 percentage points; 95% CI, −1.9 to 1.9), stroke (3.2% in OAC+ and 4.4% in OAC-; risk difference, −1.2 percentage points; 95% CI, −3.8 to 1.4), myocardial infarction (1.2% in OAC+ and 1.6% in OAC-; risk difference, −0.5 percentage points; 95% CI, −2.1 to 1.1), major vascular complications (10.2% in OAC+ and 7.7% in OAC-; risk difference, 2.5 percentage points; 95% CI, −1.3 to 6.3), and major bleeding (11.1% in OAC+ and 8.9% in OAC-; risk difference, 2.2 percentage points; 95% CI, −1.8 to 6.3).

Conclusion

In patients undergoing TAVR who had a concomitant indication for oral anticoagulation, continuation of such therapy was noninferior to the interruption of anticoagulation in terms of the incidence of cardiovascular death, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days.

Original Title: Continuation versus Interruption of Oral Anticoagulation during TAVI  for the POPular PAUSE TAVI Investigators.

Reference: D.J. van Ginkel, et al. NEJM.org. DOI: 10.1056/NEJMoa2407794.