Procedural Characteristics

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Procedural Characteristics Impact of oral anticoagulation on clinical outcomes and hemodynamic parameters after successful TAVR P. Guedeney1, F. Huchet2, P. Overtchouk1, S. Rouanet3,E. Vicault4 T. Manigold2, P. Balagny1, P. Leprince1, L. De Decker2, G. Lebreton1, A.S. Boureau2, O. Barthelemy1, G. Montalescot1, P. Guerin2, J.P. Collet1 for the ACTION study group 1: ACTION study group, Sorbonne université, INSERM UMRS 1166, Institute of cardiology, Pitié Salpétrière Hospital, Paris France; 2: Nantes University Hospital, Cardiology department; 3:Statistician unit, StatEthic, Levallois-Perret, France; 4: ACTION study group, unité de recherche clinique, Lariboisière Hospital (AP-HP), Paris, France Results Introduction Results A total of 1,139 patients were enrolled, including 400 (35.1%) patients discharged with OAC. Figure 1. Correlates of the composite endpoints Transcatheter aortic valve replacement (TAVR), is validated therapeutic alternative to patients with symptomatic severe aortic stenosis Patients undergoing TAVR remain at high risk of both ischemic and bleeding events after the procedure Nonetheless, optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) is not yet established Table 1. Baseline characteristics   Overall (N=1139) No OAC (n=739) OAC (n=400) p-value Age (years) Male sex BMI (kg/m²) Previous non-CABG surgery Coronary artery disease Peripheral artery disease Chronic pulmonary disease Diabetes mellitus Systemic hypertension (N=1133) Chronic kidney disease History of atrial Fibrillation 82.4 ± 7.7 594 (52.2%) 26.7 ± 5.4 78 (6.8%) 512 (45%) 309 (27.1%) 224 (19.7%) 304 (26.7%) 894 (78.9%) 617 (54.2%) 422 (37.1%) 81.9 ± 8.1 381 (51.6%) 26.6 ± 5.4 42 (5.7%) 347 (47%) 201 (27.2%) 137 (18.5%) 198 (26.8%) 589 (80.2%) 382 (51.7%) 93 (12.6%) 83.2 ± 6.8 213 (53.3%) 26.8 ± 5.5 36 (9.0%) 165 (41.3%) 108 (27%) 87 (21.8%) 106 (26.5%) 305 (76.4%) 235 (58.8%) 329 (82.3%) 0.009 0.59 0.40 0.03 0.065 0.94 0.19 0.92 0.13 0.02 <0.001 Procedural Characteristics Transfemoral approach Balloon-expandable device Self-expanding device Valve-in-Valve procedure Device diameter>23mm 939 (82.4%) 691 (60.7%) 448 (39.3%) 54 (4.7%) 903 (79.3%) 602 (81.5%) 433 (58.6%) 306 (41.4%) 35 (4.7%) 584 (79.1%) 337 (84.3%) 258 (64.5%) 142 (35.5%) 19 (4.8%) 319 (79.8%) 0.44   0.051 0.99 0.81 Hospital discharge LVEF (%) LVEF ≤ 30% Mean gradient (mmHg) Severe Aortic regurgitation Antiplatelet therapy Single antiplatelet therapy Dual antiplatelet therapy No antiplatelet therapy  55.4 ± 10.5 46 (4%) 10.6 ± 5.4 7 (0.6%)  389 (34.2%) 488 (42.8%) 262 (23%)  55.8 ± 10.4 29 (3.9%) 10.9 ± 5.6 4 (0.6%)  264 (35.7%) 464 (62.8%) 11 (1.5%)  54.5 ± 10.6 17 (4.3%) 10 ± 5 3 (0.8%)  125 (31.3%) 24 (6%) 251 (62.8%)  0.047 0.79 0.70 Objective We evaluated the impact of oral anticoagulation (OAC) on clinical outcome and valvular hemodynamic deterioration (VHD) within the first year of TAVR Results A total of 1,139 patients were enrolled, including 400 (35.1%) patients discharged with OAC. Echocardiogram follow-up was available in 746 (66%) of the patients. Patients discharged with OAC were older, Objective Methods Methods Figure 2. Correlates of VHD All consecutive patients undergoing successful TAVR, in 2 large-volume French centers were prospectively enrolled. Clinical endpoint of interest was the composite of death, stroke, hospitalization for heart failure or major/life- threatening (MLT) bleeding within one-year of hospital discharge. Clinical events were defined according to the VARC-2 criteria. Echocardiographic follow-up, as performed by local physician, was collected. VHD was defined as mean transprothetic gradient≥20mmHg or an increase ≥10mmHg compared to baseline Determinants of clinical endpoint and VHD were assessed using Cox proportional Hazard model and Logistic regression model, respectively. All variables with p-value <0.2 in univariate analysis were considered, including both OAC at discharge and AF Echocardiogram follow-up was available with 746 (66%) of patients, with 58 (8%) presenting with VHD. Table 2. Clinical outcomes Overall OAC at discharge No OAC at discharge HR (95%CI) p-value Primary endpoint 21.5% 29.4% 17.3% 1.83 (1.42-2.35) <0.001 Death 12.9% 18.8% 9.6% 2.07 (1.49-2.87) Stroke 1.6% 2.0% 1.4% 1.35 (0.51-3.55) 0.54 Heart failure 9.2% 12.4% 7.5% 1.70 (1.14-2.52) 0.008 MLT bleeding 3.7% 5.3% 2.8% 1.9 (1.02-3.5) 0.041 Conclusions One-year clinical outcomes were mainly driven by patient baseline characteristics and not OAC prescription Occurrence of VHD, however, was driven by procedure- related variable and the prescription of OAC at discharge Source of funding: None