Reduced leaflet motion after transcatheter aortic-valve replacement
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Reduced leaflet motion after transcatheter aortic-valve replacement. / de Backer, Ole; Dangas, George D.; Jilaihawi, Hasan; Leipsic, Jonathon A.; Terkelsen, Christian J.; Makkar, Raj; Kini, Annapoorna S.; Veien, Karsten T.; Abdel-Wahab, Mohamed; Kim, Won Keun; Balan, Prakash; van Mieghem, Nicolas; Mathiassen, Ole N.; Jeger, Raban V.; Arnold, Martin; Mehran, Roxana; Guimarães, Ana H.C.; Nørgaard, Bjarne L.; Kofoed, Klaus F.; Blanke, Philipp; Windecker, Stephan; Søndergaard, Lars; GALILEO-4D Investigators.
I: New England Journal of Medicine, Bind 382, Nr. 2, 2020, s. 130-139.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Reduced leaflet motion after transcatheter aortic-valve replacement
AU - de Backer, Ole
AU - Dangas, George D.
AU - Jilaihawi, Hasan
AU - Leipsic, Jonathon A.
AU - Terkelsen, Christian J.
AU - Makkar, Raj
AU - Kini, Annapoorna S.
AU - Veien, Karsten T.
AU - Abdel-Wahab, Mohamed
AU - Kim, Won Keun
AU - Balan, Prakash
AU - van Mieghem, Nicolas
AU - Mathiassen, Ole N.
AU - Jeger, Raban V.
AU - Arnold, Martin
AU - Mehran, Roxana
AU - Guimarães, Ana H.C.
AU - Nørgaard, Bjarne L.
AU - Kofoed, Klaus F.
AU - Blanke, Philipp
AU - Windecker, Stephan
AU - Søndergaard, Lars
AU - GALILEO-4D Investigators
PY - 2020
Y1 - 2020
N2 - BACKGROUND Subclinical leaflet thickening and reduced leaflet motion of bioprosthetic aortic valves have been documented by four-dimensional computed tomography (CT). Whether anticoagulation can reduce these phenomena after transcatheter aortic-valve replacement (TAVR) is not known. METHODS In a substudy of a large randomized trial, we randomly assigned patients who had undergone successful TAVR and who did not have an indication for long-term anticoagulation to a rivaroxaban-based antithrombotic strategy (rivaroxaban [10 mg] plus aspirin [75 to 100 mg] once daily) or an antiplatelet-based strategy (clopidogrel [75 mg] plus aspirin [75 to 100 mg] once daily). Patients underwent evaluation by four-dimensional CT at a mean (±SD) of 90±15 days after randomization. The primary end point was the percentage of patients with at least one prosthetic valve leaflet with grade 3 or higher motion reduction (i.e., involving >50% of the leaflet). Leaflet thickening was also assessed. RESULTS A total of 231 patients were enrolled. At least one prosthetic valve leaflet with grade 3 or higher motion reduction was found in 2 of 97 patients (2.1%) who had scans that could be evaluated in the rivaroxaban group, as compared with 11 of 101 (10.9%) in the antiplatelet group (difference, -8.8 percentage points; 95% confidence interval [CI], -16.5 to -1.9; P=0.01). Thickening of at least one leaflet was observed in 12 of 97 patients (12.4%) in the rivaroxaban group and in 33 of 102 (32.4%) in the antiplatelet group (difference, -20.0 percentage points; 95% CI, -30.9 to -8.5). In the main trial, the risk of death or thromboembolic events and the risk of life-threatening, disabling, or major bleeding were higher with rivaroxaban (hazard ratios of 1.35 and 1.50, respectively). CONCLUSIONS In a substudy of a trial involving patients without an indication for long-term anticoagulation who had undergone successful TAVR, a rivaroxaban-based antithrombotic strategy was more effective than an antiplatelet-based strategy in preventing subclinical leaflet-motion abnormalities. However, in the main trial, the rivaroxaban-based strategy was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than the antiplatelet-based strategy.
AB - BACKGROUND Subclinical leaflet thickening and reduced leaflet motion of bioprosthetic aortic valves have been documented by four-dimensional computed tomography (CT). Whether anticoagulation can reduce these phenomena after transcatheter aortic-valve replacement (TAVR) is not known. METHODS In a substudy of a large randomized trial, we randomly assigned patients who had undergone successful TAVR and who did not have an indication for long-term anticoagulation to a rivaroxaban-based antithrombotic strategy (rivaroxaban [10 mg] plus aspirin [75 to 100 mg] once daily) or an antiplatelet-based strategy (clopidogrel [75 mg] plus aspirin [75 to 100 mg] once daily). Patients underwent evaluation by four-dimensional CT at a mean (±SD) of 90±15 days after randomization. The primary end point was the percentage of patients with at least one prosthetic valve leaflet with grade 3 or higher motion reduction (i.e., involving >50% of the leaflet). Leaflet thickening was also assessed. RESULTS A total of 231 patients were enrolled. At least one prosthetic valve leaflet with grade 3 or higher motion reduction was found in 2 of 97 patients (2.1%) who had scans that could be evaluated in the rivaroxaban group, as compared with 11 of 101 (10.9%) in the antiplatelet group (difference, -8.8 percentage points; 95% confidence interval [CI], -16.5 to -1.9; P=0.01). Thickening of at least one leaflet was observed in 12 of 97 patients (12.4%) in the rivaroxaban group and in 33 of 102 (32.4%) in the antiplatelet group (difference, -20.0 percentage points; 95% CI, -30.9 to -8.5). In the main trial, the risk of death or thromboembolic events and the risk of life-threatening, disabling, or major bleeding were higher with rivaroxaban (hazard ratios of 1.35 and 1.50, respectively). CONCLUSIONS In a substudy of a trial involving patients without an indication for long-term anticoagulation who had undergone successful TAVR, a rivaroxaban-based antithrombotic strategy was more effective than an antiplatelet-based strategy in preventing subclinical leaflet-motion abnormalities. However, in the main trial, the rivaroxaban-based strategy was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than the antiplatelet-based strategy.
U2 - 10.1056/NEJMoa1911426
DO - 10.1056/NEJMoa1911426
M3 - Journal article
C2 - 31733182
AN - SCOPUS:85076054728
VL - 382
SP - 130
EP - 139
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 2
ER -
ID: 261165023