Author + information
- Tania Rodriguez-Gabella, MD,
- Luis Nombela-Franco, MD, PhD,
- Ander Regueiro, MD,
- Pilar Jiménez-Quevedo, MD, PhD,
- Jean Champagne, MD,
- Gilles O’Hara, MD,
- Mathieu Bernier, MD,
- Carlos Macaya, MD, PhD and
- Josep Rodés-Cabau, MD∗ ()
- ↵∗Quebec Heart & Lung Institute, Laval University, 2725 Chemin Sainte-Foy, G1V 4GS Quebec City, Quebec, Canada
Left atrial appendage closure (LAAC) has emerged as an alternative to warfarin for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). Optimal antithrombotic therapy following LAAC is an unresolved issue and current anticoagulation and antiplatelet strategies after LAAC remain empirical. In the PROTECT-AF (Watchman left atrial appendage system for embolic protection in patients with atrial fibrillation) trial, patients received short-term (45 days) anticoagulation followed by dual antiplatelet therapy (DAPT) for a period of 6 months and then lifelong aspirin (1). In patients with a contraindication to oral anticoagulation, DAPT with lifelong aspirin and clopidogrel for 1 to 6 months has been recommended (2,3). The purpose of DAPT post-LAAC is to prevent device thrombus formation and cardioembolic events within the months following the procedure. However, most patients with a contraindication to anticoagulation have already experienced episodes of major or life-threatening bleeding and DAPT may be associated with a high risk of bleeding events in this population (4). Single antiplatelet therapy post-LAAC may provide similar thromboembolic protection with a lower risk of bleeding episodes. However, there is a lack of data regarding the use of a single antiplatelet agent following LAAC. We aimed to evaluate the feasibility and preliminary safety and efficacy of single antiplatelet therapy after LAAC in patients with a contraindication to anticoagulation therapy and high risk of bleeding.
This pilot study included 31 patients with NVAF, contraindication to long-term anticoagulation, and high risk of bleeding determined by a HAS-BLED score ≥3. All patients had an annual stroke risk >2% as determined by a CHADS2 score ≥1 or CHA2DS2-VASC score ≥2. Details of the procedure have been previously reported (1–3). The antithrombotic treatment following LAAC consisted of single antiplatelet therapy with either aspirin (80 to 100 mg/24 h) or clopidogrel (75 mg/24 h) indefinitely. Clinical follow-up was obtained at 45 days, 6 months, 12 months, and yearly thereafter. A transesophageal echocardiography (TEE) examination was performed 45 days after the procedure.
Baseline and procedural characteristics of the study population are shown in Table 1. All patients but 1 had TEE at 45 ± 6 days post-LAAC. One patient (3.3%) had a device-related thrombus on the surface of the device, without clinical consequences. The patient received low molecular weight heparin for 4 weeks, and repeat TEE showed the disappearance of the thrombus.
Median follow-up was 19 (interquartile range: 12 to 24) months and no patient was lost to follow-up. Five patients (16.1%) died during the follow-up period, none of them related to the device or to cardioembolic or bleeding causes. There was no stroke or systemic embolism during the follow-up period (expected annual rates of stroke or thromboembolism according to CHA2DS2-VASC score of 8.1% and 11.2%, respectively). One patient (3.2%) had a major gastrointestinal bleeding (expected annual rate of bleeding according to HAS-BLED score of 8.6%).
The present study showed the preliminary safety and efficacy of single antiplatelet therapy following LAAC. In addition to the absence of thromboembolic events at close to 2-year follow-up, the rate of device-related thrombus at 45 days post-LAAC (3.3%) was similar to that found in the PROTECT-AF trial (4.2%) (1), and ASAP (ASA Plavix feasibility study with Watchman left atrial appendage closure technology) trial (4%) (2) using short-term anticoagulation and DAPT, respectively. The patients in the present study had a high risk of bleeding determined by a mean HAS-BLED score >4. The bleeding rate in the present study was lower than expected based on the HAS-BLED score, suggesting that single antiplatelet therapy could be the optimal therapy for patients at high risk of bleeding undergoing LAAC.
In conclusion, single antiplatelet therapy after LAAC in patients with a high risk of bleeding is associated with a low rate of cardioembolic and bleeding complications at a median follow-up of 19 months. Future randomized trials should be carried out to confirm the safety and efficacy of single antiplatelet therapy following LAAC.
Please note: Drs. Rodriguez-Gabella and Regueiro are supported by a grant from the Fundación Alfonso Martin Escudero (Madrid, Spain). The authors have reported that they have no relationships relevant to the contents of this paper to disclose. Deepak L. Bhatt, MD, MPH, served as Guest Editor for this article.
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