Percutaneous left atrial appendage closure versus non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation and high bleeding risk

被引:37
作者
Godino, Cosmo [1 ]
Melillo, Francesco [1 ]
Bellini, Barbara [2 ]
Mazzucca, Mattia [1 ]
Pivato, Carlo Andrea [1 ]
Rubino, Francesca [1 ]
Figini, Filippo [2 ]
Mazzone, Patrizio [3 ]
Della Bella, Paolo [3 ]
Margonato, Alberto [1 ]
Colombo, Antonio [1 ]
Montorfano, Matteo [2 ]
机构
[1] Osped San Raffaele, Cardiol Unit, Milan, Italy
[2] Osped San Raffaele, Intervent Cardiovasc Unit, Milan, Italy
[3] Osped San Raffaele, Arrhythmia & Electrophysiol Unit, Milan, Italy
关键词
anticoagulant therapy; atrial fibrillation; bleeding risk; LAA closure; INTRACEREBRAL HEMORRHAGE; STROKE PREVENTION; WARFARIN; OCCLUSION; METAANALYSIS; EFFICACY; DEVICE; SAFETY;
D O I
10.4244/EIJ-D-19-00507
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Aims: A significant number of patients with non-valvular atrial fibrillation (NVAF) are ineligible for nonvitamin K oral anticoagulants (NOACs) due to previous major bleeding or because they are at high bleeding risk (HBR). In this setting the indication for percutaneous left atrial appendage closure (LAAO) is a valuable alternative. We aimed to evaluate the efficacy and safety of NOACs versus LAAO indication in NVAF patients at HBR (HAS-BLED >= 3). Methods and results: All consecutive patients who underwent successful LAAO (n=193) and those treated with NOACs (n=189) (dabigatran, apixaban or rivaroxaban) were included. A 1:1 propensity score matching (PSM) was used to match LAAO and NOACs patients. At baseline, patients in the LAAO group had higher HAS-BLED (4.2% vs 3.3%, p<0.001) and lower CHADS-VASc (4.3% vs 4.7%, p=0.005) scores. After 1:1 PSM, 192 patients were enrolled in the Fmal analysis (LAAO n=96; NOACs n=96). At two-year follow-up, no significant differences in thromboembolic (7.3% vs 6.3%, p=0.966) and ISTH major bleeding event rates (6.7% vs 4.8% p=0.503) were found between the two unmatched groups. All-cause death was significantly higher in the LAAO group (18.7% vs 10.6%; p=0.049). After PSM, all-cause death, thromboembolic and ISTH major bleeding event rates were similar between the groups. Significant independent predictors of all-cause death were dialysis (HR 5.65, 95% CI: 2.16-14.85, p<0.001) and age (BR 1.08, 95% CI: 1.05-1.13, p<0.001). Conclusions: In NVAF patients at HBR, LAAO and NOACs performed similarly in terms of thromboembolic and major bleeding events up to two-year follow-up. Our fmdings warrant further investigation in randomised trials and therefore can be considered as hypothesis-generating.
引用
收藏
页码:1548 / U91
页数:11
相关论文
共 26 条
[1]   Percutaneous Left Atrial Appendage Closure: Current Devices and Clinical Outcomes [J].
Asmarats, Lluis ;
Rodes-Cabau, Josep .
CIRCULATION-CARDIOVASCULAR INTERVENTIONS, 2017, 10 (11)
[2]   Optimal caliper widths for propensity-score matching when estimating differences in means and differences in proportions in observational studies [J].
Austin, Peter C. .
PHARMACEUTICAL STATISTICS, 2011, 10 (02) :150-161
[3]   Use and effectiveness of warfarin in medicare beneficiaries with atrial fibrillation [J].
Birman-Deych, E ;
Radford, MJ ;
Nilasena, DS ;
Gage, BF .
STROKE, 2006, 37 (04) :1070-1074
[4]   Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation [J].
Blackshear, JL ;
Odell, JA .
ANNALS OF THORACIC SURGERY, 1996, 61 (02) :755-759
[5]   Evaluating Real-World Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology Final 2-Year Outcome Data of the EWOLUTION Trial Focusing on History of Stroke and Hemorrhage [J].
Boersma, Lucas V. ;
Ince, Hueseyin ;
Kische, Stephan ;
Pokushalov, Evgeny ;
Schmitz, Thomas ;
Schmidt, Boris ;
Gori, Tommaso ;
Meincke, Felix ;
Protopopov, Alexey Vladimir ;
Betts, Timothy ;
Mazzone, Patrizio ;
Foley, David ;
Grygier, Marek ;
Sievert, Horst ;
De Potter, Tom ;
Vireca, Elisa ;
Stein, Kenneth ;
Bergmann, Martin W. ;
Al Nooryani, Arif ;
Meincke, Felix ;
Fiedler, Thomas ;
Senatore, Gaetano ;
Foley, David ;
Schmidt, Boris ;
Brigadeau, Francois ;
Defaye, Pascal ;
Teiger, Emmanuel ;
Bonnet, Jean-Louis ;
Wald, Christof ;
Schmitz, Thomas ;
Szili-Torok, Tamas ;
Tschishow, Wladimir ;
Mazzone, Patrizio ;
Crossland, David ;
Bergmann, Martin W. ;
Vahanian, Alec ;
Cruz-Gonzalez, Ignacio ;
Thambo, Jean-Benoit ;
Gori, Tommaso ;
Betts, Timothy ;
Al Smadi, Faisal ;
Mudra, Harald ;
Molitoris, Robin ;
Folkeringa, Richard ;
Stevenhagen, Yorick ;
Gras, Daniel ;
De Potter, Tom ;
Tamburino, Corrado ;
Molon, Giulio ;
Protopopov, Vladimir .
CIRCULATION-ARRHYTHMIA AND ELECTROPHYSIOLOGY, 2019, 12 (04)
[6]   Variable selection for propensity score models [J].
Brookhart, M. Alan ;
Schneeweiss, Sebastian ;
Rothman, Kenneth J. ;
Glynn, Robert J. ;
Avorn, Jerry ;
Sturmer, Til .
AMERICAN JOURNAL OF EPIDEMIOLOGY, 2006, 163 (12) :1149-1156
[7]   XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation [J].
Camm, A. John ;
Amarenco, Pierre ;
Haas, Sylvia ;
Hess, Susanne ;
Kirchhof, Paulus ;
Kuhls, Silvia ;
van Eickels, Martin ;
Turpie, Alexander G. G. .
EUROPEAN HEART JOURNAL, 2016, 37 (14) :1145-1153
[8]  
Cohen J., 1988, Statistical Power Analysis for the Behavioral Sciences., V2nd, DOI [DOI 10.1007/978-1-4684-5439-0_2, DOI 10.4324/9780203771587, 10.4324/9780203771587]
[9]   Real-world evidence of stroke prevention in patients with nonvalvular atrial fibrillation in the United States: the REVISIT-US study [J].
Coleman, Craig I. ;
Antz, Matthias ;
Bowrin, Kevin ;
Evers, Thomas ;
Simard, Edgar P. ;
Bonnemeier, Hendrik ;
Cappato, Riccardo .
CURRENT MEDICAL RESEARCH AND OPINION, 2016, 32 (12) :2047-2053
[10]   Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial [J].
Connolly, S. ;
Pogue, J. ;
Hart, R. ;
Pfeffer, M. ;
Hohnloser, S. ;
Chrolavicius, S. ;
Yusuf, S. .
LANCET, 2006, 367 (9526) :1903-1912