Initial Experience With Novel Oral Anticoagulants During the First 45 Days After Left Atrial Appendage Closure With the Watchman Device

Abstract

Background: The use of oral anticoagulation or dual antiplatelet therapy (DAPT) is recommended within the first 45 days after left atrial appendage (LAA) closure using the Watchman device because of incomplete device endothelialization. This study reports for the first time the feasibility of novel oral anticoagulants (NOAC) in these patients.

Hypothesis: NOAC therapy is safe and effective after LAA closure.

Methods: Interventional LAA closure was performed successfully in 45 patients. Of these, 18 patients received NOAC during the first 45 days after implantation and 27 patients received DAPT. Transesophageal echocardiography was conducted 45 days after implantation. The primary study endpoint was abnormal thrombus apposition 45 days after implantation. Secondary study endpoints were death from any cause, major adverse cardiac and cerebrovascular events (MACCE), and major bleedings.

Results: After 45 days, transesophageal echocardiography revealed no abnormal thrombus apposition. During a follow-up of 417 ± 323 days, 7 patients died. No stroke or transient ischemic attack occurred. Nonfatal myocardial infarction occurred in 1 patient. There was a nonsignificant trend for lower all-cause mortality (P = 0.159) and occurrence of MACCE (P = 0.096) in the NOAC group compared with the DAPT group. Overall, 6 patients suffered from a major bleeding (NOAC, n = 3; DAPT, n = 3). In NOAC group, major bleedings (at day 205, 688, and 736) occurred long after termination of NOAC therapy. There was no significant difference in the frequency of major bleedings in different groups.

Conclusions: Our pilot study suggests that NOAC therapy within the first 45 days after interventional LAA closure is safe and effective.

© 2015 Wiley Periodicals, Inc.

Figures

Figure 1

(A) Kaplan‐Meier estimates of freedom from all‐cause mortality based on the use of DAPT or NOAC. (B) Kaplan‐Meier estimates of freedom from MACCE based on the use of DAPT or NOAC. Abbreviations: DAPT, dual antiplatelet therapy; MACCE, major adverse cardiac and cerebrovascular events; NOAC, novel oral anticoagulants.

Figure 2

Kaplan‐Meier estimates of freedom from major bleeding based on the use of DAPT or NOAC. Abbreviations: DAPT, dual antiplatelet therapy; NOAC, novel oral anticoagulants.