Reduced Leaflet Motion after Transcatheter Aortic-Valve Replacement

Abstract

BACKGROUNDSubclinical 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. METHODSIn 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. RESULTSA 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). CONCLUSIONSIn 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 leafletmotion 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. (Funded by Bayer; GALILEO-4D ClinicalTrials.gov number, NCT02833948.

Noncanonical Effects of Oral Thrombin and Factor Xa Inhibitors in Platelet Activation and Arterial Thrombosis

“…46 Interestingly, subclinical leaflet-motion, as potential surrogate marker for thrombotic valve alteration, was reduced under rivaroxaban as shown in an accompanying imaging study. 47 Similar findings were made in an earlier animal study that suggested that rivaroxaban might be superior to standard therapy after mechanical valve surgery in terms of valve thrombus and platelet deposition. 48 Unexpected results came also from the Re-Align study, that aimed to investigate dabigatran in patients after mechanical heart valve surgery.…”

Anticoagulation after Transcatheter Aortic Valve Implantation: Current Status

“…Recently, the GALILEO-4D sub-study demonstrated that dual pathway inhibition (rivaroxaban 10 mg plus ASA) is more effective than DAPT (ASA plus clopidogrel) in preventing subclinical leaflet abnormalities as documented using 4D CT. 107 However, these results should be cautiously interpreted due to the higher risk of adverse outcomes found with the rivaroxaban-based strategy in the parental trial. In conclusion, while European guidelines did not provide specific recommendations supporting anticoagulant pathways in patients without a coexisting indication for OAC, American guidelines were published at a time when new evidence from large registries and the AUREA and GALILEO trials that showed a definite increase in the bleeding rate without significant benefits with OAC, was not available.…”

Known–Unknowns in Geriatric Cardiology

“…The etiology of MR plays an important role in the therapy, particularly in old patients. In developed countries, the etiology of MR in geriatric patients is usually secondary [54,61,79,80]; in this clinical setting, the clinical benefit of surgery remains uncertain. The ESC Guidelines [79] provide no recommendations for the therapy of secondary MR, while the American Guidelines [80] propose individualized approaches.…”

“…In developed countries, the etiology of MR in geriatric patients is usually secondary [54,61,79,80]; in this clinical setting, the clinical benefit of surgery remains uncertain. The ESC Guidelines [79] provide no recommendations for the therapy of secondary MR, while the American Guidelines [80] propose individualized approaches. Currently, mitral valve repair (MVR) is the generally accepted "gold standard" treatment for degenerative MR [81][82][83], while surgical mitral valve replacement (SMVR) is indicated only in cases where the expected clinical improvements exceed the increased operative risk associated with aging and comorbidities [80][81][82][83][84][85].…”