| Literature DB >> 34063260 |
Patrizio Mazzone1, Alessandra Laricchia2, Giuseppe D'Angelo1, Giulio Falasconi1, Luigi Pannone1, Luca Rosario Limite1, David Zweiker1, Damiano Regazzoli3, Andrea Radinovic1, Alessandra Marzi1, Eustachio Agricola4, Luigia Brugliera5, Antonio Colombo3, Paolo Della Bella1, Matteo Montorfano2.
Abstract
BACKGROUND: Optimal antithrombotic therapy after left atrial appendage (LAA) occlusion is still not clear. The aim of this study was to investigate the role of different antithrombotic regimens after the procedure. METHODS ANDEntities:
Keywords: anticoagulant therapy; antithrombotic therapy; left atrial appendage occlusion; stroke
Year: 2021 PMID: 34063260 PMCID: PMC8124741 DOI: 10.3390/jcm10091959
Source DB: PubMed Journal: J Clin Med ISSN: 2077-0383 Impact factor: 4.241
Baseline characteristics. NIDDM: non-insulin dependent diabetes mellitus; IDDM: insulin dependent diabetes mellitus; TIA: transient ischemic attack; INR: international normalized ratio. GROUP A dual antiplatelet therapy; GROUP B anticoagulant therapy; GROUP C single antiplatelet therapy or no therapy; GROUP D combination of antiplatelet and anticoagulant therapy.
| OVERALL | GROUP A | GROUP B | GROUP C | GROUP D | ||
|---|---|---|---|---|---|---|
| Age, Mean ± SD | 72.7 ± 8.8 | 73 ± 8 | 73 ± 8 | 74 ± 9 | 72 ± 14 | 0.938 |
| Male, | 175 (67%) | 128 (69%) | 30 (60%) | 7 (58%) | 10 (83%) | 0.355 |
| NIDDM, | 53 (20%) | 34 (18.3%) | 11 (22%) | 6 (50%) | 2 (16.7%) | 0.117 |
| IDDM, | 22 | 18 (9.7%) | 3 | 1 (8.3%) | 0 | 0.603 |
| Hypertension, | 202 (77.7%) | 153 (82%) | 30 (60%) | 9 (75%) | 10 (83%) | 0.157 |
| Previous TIA, | 24 | 17 | 5 | 0 | 2 | 0.389 |
| Previous Stroke, | 66 (25.4%) | 44 (23.7%) | 12 (24%) | 6 (50%) | 4 (33.3%) | 0.255 |
| Previous Major Bleeding, | 147 | 103 (55.4%) | 31 | 8 | 5 | 0.514 |
| Congestive Heart Failure, | 74 (28.5%) | 60 (32%) | 10 (20%) | 1 (8.3%) | 3 (35%) | 0.137 |
| Coronary artery disease patients, | 84 | 71 | 4 | 2 | 7 | 0.005 |
| Ejection Fraction, | 52 ± 10 | 51 ± 10 | 54 ± 9 | 58 ± 3 | 53 ± 9 | 0.05 |
| Creatinine Clearance (mL/min), Mean ± SD | 59 ± 27 | 56 ± 27 | 68 ± 29 | 59 ± 32 | 64 ± 27 | 0.07 |
| Chronic Kidney Disease, | 83 (31.9%) | 64 (34.4%) | 11 (22%) | 4 (33.3%) | 4 (33.3%) | 0.593 |
| Dialysis, | 17 (6.5%) | 14 (7.5%) | 1 (2%) | 2 (16.7%) | 0 | 0.483 |
| Hepatic Failure, | 13 (5%) | 9 (4.8%) | 2 (4%) | 2 (17%) | 0 | 0.314 |
| Labile INR, | 27 (10.4%) | 23 (12.4%) | 2 (4%) | 0 | 2 (16.7%) | 0.190 |
| CHA2DS2-VASc score, | 3.8 ± 1.7 | 3.9 ± 1.7 | 3.3 ± 1.7 | 4.5 ± 1.8 | 4 ± 1.5 | 0.102 |
| HAS-BLED score, | 3.6 ± 1.4 | 3.7 ± 1.4 | 3 ± 1.3 | 4.2 ± 1.3 | 3.9 ± 1.4 | 0.005 |
Figure 1Figure (a) describes distribution of therapies at discharge based on indications to left atrial appendage (LAA) occlusion. Figure (b) shows therapies at discharge and after change after first follow-up evaluation (74 days, IQR 50-107). OAC = oral anticoagulation; INR = international normalized ratio; DAPT: double antiplatelet therapy; sAPT: single antiplatelet therapy.
Procedural data. GROUP A dual antiplatelet therapy; GROUP B anticoagulant therapy; GROUP C single antiplatelet therapy or no therapy; GROUP D combination of antiplatelet and anticoagulant therapy.
| OVERALL | GROUP A | GROUP B | GROUP C | GROUP D | ||
|---|---|---|---|---|---|---|
| Devices implanted, | 82 (31%) | 57 (30%) | 19 (38%) | 3 (25%) | 3 (25%) | 0.641 |
| 5 (2%) | 1 (0.5%) | 4 (8%) | 0 | 0 | 0.028 | |
| 55 (21%) | 44 (23%) | 2 (4%) | 5 (42%) | 4 (33%) | 0.002 | |
| 118 (45%) | 84 (45%) | 25 (50%) | 4 (33%) | 5 (42%) | 0.709 | |
| Size Change, | 5 (2%) | 4 (2.1%) | 0 | 0 | 1 (8.3%) | 0.312 |
| Repositioning, | 14 | 10 | 1 | 2 | 1 | 0.235 |
| Procedural success, | 260 | 186 | 50 | 12 | 12 | N/A |
Clinical follow up at three months. TIA: transient ischemic attack; CV: cardiovascular. GROUP A dual antiplatelet therapy; GROUP B anticoagulant therapy; GROUP C single antiplatelet therapy or no therapy; GROUP D combination of antiplatelet and anticoagulant therapy.
| Events, | OVERALL | GROUP A | GROUP B | GROUP C | GROUP D | |
|---|---|---|---|---|---|---|
| Device-related thrombosis | 3 (1.2%) | 2 (1.1%) | 1 (2.1%) | 0 | 0 | 0.892 |
| Ischemic Stroke | 1 (0.4%) | 0 | 1 (2.1%) | 0 | 0 | 0.232 |
| TIA | 1 (0.4%) | 0 | 0 | 0 | 1 (9.1%) | 0.005 |
| Stroke and TIA | 2 (0.8%) | 0 | 1 (2.1%) | 0 | 1 (9.1%) | 0.07 |
| Intracranial Bleeding | 2 (0.8%) | 0 | 2 (4.2%) | 0 | 0 | 0.08 |
| Major Bleeding | 5 (2%) | 2 (1.1%) | 1 (2.1%) | 1 (8.3%) | 1 (9.1%) | 0.107 |
| Minor Bleeding | 10 (4%) | 7 (3.8%) | 3 (6.3%) | 0 | 0 | 0.655 |
| Mortality | 1 (0.4%) | 1 (0.5%) | 0 | 0 | 0 | 0.942 |
| CV Mortality | 1 (0.4%) | 1 (0.5%) | 0 | 0 | 0 | 0.942 |
Figure 2Kaplan–Meier for event free survival at 3-months (A) and 2-year (B) FU for each group: composite endpoint of left atrial thrombus on transesophageal echocardiography, ischemic stroke, transient ischemic attack, intracranial bleeding, major and minor bleeding, and all-cause mortality. GROUP A dual antiplatelet therapy; GROUP B anticoagulant therapy; GROUP C single antiplatelet therapy or no therapy; GROUP D combination of antiplatelet and anticoagulant therapy.
Long term clinical follow-up. FU: follow-up; TEE: transesophageal echocardiography; TIA: transient ischemic attack. GROUP A dual antiplatelet therapy; GROUP B anticoagulant therapy; GROUP C single antiplatelet therapy or no therapy; GROUP D combination of antiplatelet and anticoagulant therapy.
| OVERALL | GROUP A | GROUP B | GROUP C | GROUP D | ||
|---|---|---|---|---|---|---|
| Clinical FU, | 253 (97.3%) | 182 (97.8%) | 48 (96%) | 12 (100%) | 11 (91.7%) | 0.508 |
| Clinical FU (days) | 420 | 434 | 382 | 554 | 347 | 0.706 |
| 3 months TEE FU, | 194 (74.6%) | 148 (79.6%) | 32 (64%) | 8(66.7%) | 6(50%) | 0.022 |
| TEE data, n (%): | ||||||
| leaks (any) | 41 (21%) | 30 (20%) | 8 (24%) | 1 (2.4%) | 2 (4.9%) | 0.753 |
| major leaks (>5 mm) | 3 (1.1%) | 1 (0.5%) | 1 (2%) | 1 (8.3%) | 0 | 0.090 |
| device related thrombosis | 4 (1.6%) | 2 (1%) | 1 (2%) | 0 | 1 (8.3%) | 0.092 |
| Events, n (%): | ||||||
| Ischemic Stroke | 5 (2%) | 3 (1.6%) | 2 (4%) | 0 | 0 | 0.926 |
| TIA | 3 (1.2%) | 0 | 1 (2%) | 0 | 2 (16.6%) | 0.005 |
| Stroke and TIA | 8 (3.1%) | 3 (1.6%) | 3 (6%) | 0 | 2 (16.6%) | 0.014 |
| Intracranial Bleeding | 3 (1.2%) | 1 (0.5%) | 2 (4%) | 0 | 0 | 0.217 |
| Major Bleeding | 7 (2.7%) | 3 (1.6%) | 1 (2%) | 2 (16.6%) | 1 (8.3%) | 0.016 |
| Minor Bleeding | 13 (5%) | 10 (5.4%) | 3 (6%) | 0 | 0 | 0.639 |
| Mortality | 15 (5.7%) | 12 (6.5%) | 0 | 0 | 3 (25%) | 0.059 |
| CV Mortality | 8 (3.1%) | 7 (3.8%) | 0 | 0 | 1 (8.3%) | 0.631 |
The fields “Stroke and TIA”, “Major Bleeding” and “Mortality” respectively report the cumulative incidence in the overall population and in the patients belonging to each group of: stroke and TIA, intracranial bleeding and major bleeding of other districts, CV mortality and mortality due to other reasons.