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Prevalence of bleeding secondary to anticoagulation and mortality in patients with atrial fibrillation admitted with SARS-CoV-2 infection

Rubini-Costa, Ricardo,Bermúdez Jiménez, Francisco José,Rivera López, Ricardo Francisco,Sola García, Elena,Nagib-Raya, Hadi,Moreno Escobar, Eduardo,Álvarez López, Miguel,Tercedor Sánchez, Luis,Molina Jiménez, María,Macías-Ruiz, Rosa,Jiménez Jáimez, Juan

Abstract

Supplementary data associated with this article can befound, in the online version, at https://doi.org/10.1016/j.medcli.2021.06.015

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Since Janua y 2020 Else ie has c ea ed a COVID-19 esou ce cen e wi h ee in o ma ion in English and Manda in on he no el co ona i us COVID- 19. The COVID-19 esou ce cen e is hos ed on Else ie Connec , he company's public news and in o ma ion websi e. Else ie he eby g an s pe mission o make all i s COVID-19- ela ed esea ch ha is a ailable on he COVID-19 esou ce cen e - including his esea ch con en - immedia ely a ailable in PubMed Cen al and o he publicly unded eposi o ies, such as he WHO COVID da abase wi h igh s o un es ic ed esea ch e-use and analyses in any o m o by any means wi h acknowledgemen o he o iginal sou ce. These pe missions a e g an ed o ee by Else ie o as long as he COVID-19 esou ce cen e emains ac i e. Medicina Clínica 158 (2022) 569–575 w w w.else ie .es/medicinaclinica O iginal a icle P e alence o bleeding seconda y o an icoagula ion and mo ali y in pa ien s wi h a ial fib illa ion admi ed wi h SARS-CoV-2 in ec ion Rica do Rubini-Cos aa,b,1, F ancisco Be múdez-Jiméneza,b,c,1, Rica do Ri e a-Lópeza,b, Elena Sola-Ga cíaa,b, Hadi Nagib-Rayab,d, Edua do Mo eno-Escoba b,d, Miguel Ángel López-Zú˜ nigae, Adela B iones-T a és , F ancisco Sanz-He e ag, Jose Miguel Sequí-Saba e h, Juan Luis Rome o-Cab e ai, Ja ie Maíllo-Secoj, Felipe Fe nández-Vázquezj, Ma ía Ri adenei a-Ruizk, Lucas López-Vale ol, Ca los Gómez-Na a om, Jose An onio Apa icio-Gómezm, Miguel Ál a ez Lópeza,b, Luis Te cedo a,b, Ma ía Molina-Jiméneza,b, Rosa Macías-Ruiza,b, Juan Jiménez-Jáimeza,b,∗ aSe icio de Ca diología, Hospi al Gene al Uni e si a io Vi gen de las Nie es, A da. de las Fue zas A madas 2, 18014 G anada, Spain bIns i u o de In es igación Biosani a ia IBS, Uni e sidad de G anada, Hospi al Real, A enida del Hospicio, s/n, 18010 G anada, Spain cCen o Nacional de In es igaciones Ca dio ascula es Ca los III (CNIC), Melcho Fe nández Almag o, 3, 28029 Mad id, Spain dSe icio de Ca diología, Hospi al Clínico San Cecilio, A . del Conocimien o, s/n, 18016 G anada, Spain eSe icio de Medicina In e na, Hospi al Uni e si a io de Jaén, A . del Ejé ci o Espa˜ nol, 10, 23007 Jaén, Spain Se icio de U gencias, Conso cio Hospi al Gene al Uni e si a io de Valencia, A . de les T es C eus, 2, 46014 Valencia, Spain gSe icio de Neumología, Conso cio Hospi al Gene al Uni e si a io de Valencia, A . de les T es C eus, 2, 46014 Valencia, Spain hSe icio de Reuma ología, Hospi al Uni e si a io Reina So ía, A . Menendez Pidal, s/n, 14004 Có doba, Spain iSe icio de Medicina In e na, Hospi al Uni e si a io Reina So ía, A . Menendez Pidal, s/n, 14004 Có doba, Spain jSe icio de Ca diología, Hospi al Uni e si a io de León, Al os de na a, s/n, 24071 León, Spain kSe icio de Ca diología, Hospi al Uni e si a io Vi gen Maca ena, D . Fed iani, 3, 41009 Se illa, Spain lHospi al Uni e si a io de Cas ellón, A inguda de Benicàssim, 128, 12004 Cas ellón, Spain mSe icio de Ca diología, Hospi al Uni e si a io To ecá denas, He mandad de Donan es de Sang e, s/n, 04009 Alme ía, Spain a i c l e i n o A icle his o y: Recei ed 27 Ap il 2021 Accep ed 21 June 2021 A ailable online 15 July 2021 Keywo ds: COVID-19 A ial fib illa ion Majo bleeding Mo ali y An icoagula ion a b s a c In oduc ion and pu pose: A ial fib illa ion (AF) is common in pa ien s admi ed wi h se e e COVID- 19. Howe e , he e is limi ed da a abou he managemen o ch onic an icoagula ion he apy in hese pa ien s. We assessed he an icoagula ion and incidence o majo ca dio ascula e en s in hospi alized pa ien s wi h AF and COVID-19. Me hods: We e ospec i ely in es iga ed all consecu i e pa ien s wi h AF admi ed wi h COVID-19 be ween Ma ch and May 2020 in 9 Spanish hospi als. We selec ed a con ol g oup o non-AF pa ien s consecu i ely admi ed wi h COVID-19. We compa ed baseline cha ac e is ics, incidence o majo bleed- ing, h ombo ic e en s and mo ali y. We used p opensi y sco e ma ching (PSM) o minimize po en ial con ounding a iables, as well as a mul i a ia e analysis o p edic majo bleeding and dea h. Resul s: 305 pa ien s admi ed wi h AF and COVID-19 we e included. A e PSM, 151 AF pa ien s we e ma ched wi h 151 con ol g oup pa ien s. Du ing admission, low-molecula -weigh hepa in was he p incipal an icoagulan and he incidence o majo bleeding and mo ali y we e highe in he AF g oup [16 (10.6%) s 3 (2%), p = 0.003; 52 (34.4%) s 35 (23.2%), p = 0.03, espec i ely]. The mul i a ia e analysis showed he p esence o AF as independen p edic o o in-hospi al majo bleeding and mo ali y in COVID-19 pa ien s. In AF g oup, a seconda y mul i a ia e analysis iden ified high le els o D-dime as independen p edic o o in-hospi al majo bleeding. Conclusions: AF pa ien s admi ed wi h COVID-19 ep esen a popula ion a high isk o bleeding and mo ali y du ing admission. I seems ad isable o indi idualize an icoagula ion he apy du ing admission, conside ing pa ien specific bleeding and h ombo ic isk. © 2021 Else ie Espa˜ na, S.L.U. All igh s ese ed. Abb e ia ions: LMWH, low-molecula -weigh hepa in; PSM, p opensi y sco e ma ching; VTE, enous h omboembolism. ∗Co esponding au ho . E-mail add ess: [email p o ec ed] (J. Jiménez-Jáimez). 1Bo h au ho s con ibu ed equally. h ps://doi.o g/10.1016/j.medcli.2021.06.015 0025-7753/© 2021 Else ie Espa˜ na, S.L.U. All igh s ese ed. R. Rubini-Cos a, F. Be múdez-Jiménez, R. Ri e a-López e al. Medicina Clínica 158 (2022) 569–575 Palab as cla e: COVID-19 Fib ilación au icula Hemo agia mayo Mo alidad An icoagulación P e alencia de hemo agia secunda ia a an icoagulación y mo alidad en pacien es con fib ilación au icula ing esados po in ección po SARS-CoV-2 e s u m e n An eceden es y obje i os: La fib ilación au icula (FA) es ecuen e en pacien es ing esados po COVID-19 g a e. Sin emba go, los da os sob e el manejo de la an icoagulación c ónica en es os pacien es son escasos. Analizamos la an icoagulación y la incidencia de episodios ca dio ascula es mayo es en pacien es con FA ing esados po la COVID-19. Mé odos: Re ospec i amen e, se iden ifica on odos los pacien es con FA ing esados po la COVID-19 en e ma zo y mayo de 2020, en 9 hospi ales espa˜ noles. Se seleccionó un g upo con ol de pacien es ing esados consecu i amen e po la COVID-19 sin FA. Se compa a on las ca ac e ís icas basales, inci- dencia de hemo agias mayo es, episodios ombó icos y mo alidad. Pa a educi po enciales ac o es de con usión se ealizó un empa ejamien o po pun uación de p opensión, así como un análisis mul i a ian e pa a p edeci hemo agia mayo y mo alidad. Resul ados: Se incluye on 305 pacien es con FA ing esados po la COVID-19. T as el empa ejamien o po pun uación de p opensión, 151 pacien es con FA ue on empa ejados con 151 con oles. Du an e el ing eso, la hepa ina de bajo peso molecula ue el p incipal an icoagulan e y la incidencia de hemo agia mayo y mo alidad ue mayo en el g upo de FA (16[10,6%] s. 3[2%], p = 0,003; 52[34,4%] s. 35[23,2%], p = 0,03, espec i amen e). El análisis mul i a ian e demos ó la p esencia de FA como p edic o indepen- dien e de sang ados y mo alidad in ahospi ala ia en los pacien es con la COVID-19. En el g upo de FA, un segundo análisis mul i a ian e iden ificó alo es ele ados de díme o-D como p edic o independien e de hemo agia mayo in ahospi ala ia. Conclusiones: Los pacien es con FA ing esados po la COVID-19 ep esen an una población de al o iesgo de sang ado y mo alidad du an e el ing eso. Pa ece ecomendable indi idualiza la an icoagulación du an e el ing eso, conside ando el iesgo específico de sang ado y ombosis. © 2021 Else ie Espa˜ na, S.L.U. Todos los de echos ese ados. In oduc ion The co ona i us disease 2019 (COVID-19) pandemic caused by he se e e acu e espi a o y synd ome-co ona i us-2 (SARS-CoV- 2) has apidly sp ead h oughou he wo ld causing significan mo bidi y and mo ali y.1Se e al s udies ha e epea edly sugges ed ha p e-exis ing ca dio ascula como bidi ies a e asso- cia ed wi h a wo se p ognosis COVID-19.2–5 Specifically, a ial fib illa ion (AF) has been epo ed as a common condi ion in pa ien s admi ed wi h se e e o ms o COVID-19.3,6,7 I has been sugges ed ha AF migh be an independen p edic o o mo al- i y o hese pa ien s.8Howe e , unde lying ae iology o his high mo ali y a es a e no well es ablished. On he basis o possible d ug-d ug in e ac ions, he Ame ican Hea Associa ion (AHA) and he Eu opean Socie y o Ca diology (ESC) ag ee on he ecommenda ion o hepa in as he an icoagu- lan o choice in hospi alized COVID-19 pa ien s wi h AF who a e ecei ing p io an icoagula ion.9,10 Ce ainly, he sys ema ic an i- coagula ion wi h hepa in is he mos common s a egy adop ed by he physicians in his clinical scena io. Howe e , he e a e no da a ega ding he di e en an icoagula ion he apies in hese pa ien s and he incidence o po en ial ou comes, especially, h ombo ic and majo bleedings. The p ima y aim o his s udy was o assess he incidence haem- o hagic and h ombo ic e en s, mo ali y and he an icoagula ion egimen in a mul icen ic coho o pa ien s wi h AF admi ed wi h COVID-19. In addi ion, we p e end o iden i y clinical o analy i- cal independen p edic o s o majo bleeding and mo ali y du ing admission. Pa ien s and me hods Popula ion and s udy design A case–con ol mul icen ic s udy was pe o med in 9 e ia y e e al hospi als om Spain. All pa ien s wi h p e ious o newly diagnosed AF admi ed wi h confi med SARS-CoV-2 in ec ion be ween Ma ch 1s and May 31s , 2020, we e e ospec i ely iden ified. Confi med SARS-CoV-2 in ec ion was defined as a pos- i i e nasopha yngeal polyme ase chain eac ion and/o posi i e se ological es . Pa ien s wi hou a p e ious diagnosis o AF we e conside ed as newly diagnosed AF and all we e confi med by ECG a admission. We included a con ol g oup o COVID-19 pa ien s admi ed du ing he same pe iod wi hou AF. The con ol g oup was ob ained om he admi ed COVID-19 pa ien da abase o he coo dina o cen e, which was p o ided by he Medical Reco ds Depa men , and he pa ien s we e consecu i ely included by admission da e un il eaching he same numbe o AF g oup, 305 pa ien s. Pa ien s we e ollowed up a mean o 7 ± 1.6 mon hs a e hospi aliza ion, by e ision o medical digi al eco ds o by elephone con ac when necessa y. The Local E hics Commi ee o he coo dina o cen e app o ed he s udy p o ocol. Da a collec ion and ou comes Baseline cha ac e is ics, hospi aliza ion da a and ou comes du ing admission and ollow-up we e analyzed. Local elec onic medical eco ds se ed as sou ce da a, which we e ex ac ed by each cen e esea che and cen alized o he s udy coo dina o in an anonymized da abase. Baseline in es iga ions comp ised p e ious como bidi ies, including AF-ca dio ascula isk ac o s wi h a pa icula ocus on an i h ombo ic he apy (an icoagulan and an ipla ele ). The diag- nosis o p e ious AF was checked in medical eco ds and wi h ECG, and new onse AF cases we e iden ified wi h he admission ECG. Du ing admission, in e na ional no malized a io (INR), pla ele coun , se um biochemical pa ame e s, an i h ombo ic he apy, SARS-CoV-2 d ugs ea men (hyd oxychlo oquine, azi h omycin, lopina i / i ona i , da una i /cobicis a , emdesi i ) and in ensi e ca e uni (ICU) admission, we e eco ded. I di e en an icoagu- lan egimens we e p esc ibed du ing admission, we conside ed as he p incipal an icoagulan ha p esc ibed du ing >50% o he hospi aliza ion pe iod. 570 R. Rubini-Cos a, F. Be múdez-Jiménez, R. Ri e a-López e al. Medicina Clínica 158 (2022) 569–575 Table 1 Baseline and clinical cha ac e is ics du ing admission o AF and con ol g oup pa ien s, be o e and a e p opensi y sco e ma ching. Va iable To al (n = 610) Be o e PSM A e PSM AF (n = 305) No-AF (n = 305) p AF (n = 151) No-AF (n = 151) p Baseline cha ac e is ics – no. (%) Age, mean (SD) – y 72.9 (14.3) 79 (10.3) 66.8 (15.2) <0.001 74.6 (11.0) 75.1 (12.0) 0.086 Male sex 337 (55.2) 163 (53.4) 174 (57) 0.37 82 (54.3) 51 (53.6) 0.9 HBP 415 (68) 244 (80) 171 (56.1) <0.001 115 (76.2) 105 (69.5) 0.19 DM 194 (31.9) 117 (38.4) 77 (25.2) 0.001 46 (30.5) 46 (30.5) 1 Dyslipidemia 216 (35.4) 123 (40.3) 93 (30.5) 0.011 63 (41.7) 8 (38.4) 0.56 Obesi y 96 (15.7) 68 (22.3) 28 (9.2) <0.001 24 (15.9) 19 (12.6) 0.41 CKD 105 (17.5) 73 (23.9) 34 (11.1) <0.001 28 (18.5) 25 (16.6) 0.65 DBADLa204 (33.4) 133 (43.6) 71 (23.3) <0.001 46 (30.5) 50 (33.1) 0.62 Alcoholism 29 (4.8) 18 (5.9) 11 (3.6) 0.183 8 (5.3) 8 (5.3) 1 PVD 100 (16.4) 54 (17.7) 46 (15.1) 0.382 29 (19.2) 23 (15.2) 0.36 Hepa opa hy 34 (5.6) 22 (7.2) 12 (3.9) 0.078 7 (4.6) 8 (5.3) 0.79 Recen s okeb5 (0.8) 5 (1.6) 0 0.06 2 (1.3) 0 0.49 S uc u al hea diseasec185 (30.5) 147 (48) 38 (12.5) 0.001 69 (46) 23 (15.3) 0.001 Mi al s enosisd3 (0.5) 3 (1) 0 0.24 1 (0.7) 0 1 Mechanical hea al e 6 (1) 5 (1.6) 1 (0.3) 0.21 3 (2) 1 (0.7) 0.62 P io majo bleeding 39 (6.4) 28 (9.2) 11 (3.6) 0.005 8 (5.3) 8 (5.3) 1 P io s oke 98 (16.1) 73 (23.9) 25 (8.2) <0.001 17 (11.3) 19 (12.6) 0.72 CHA2DS2-VASc (SD) 3.5 (2) 4.4 (1.7) 2.6 (1.9) <0.001 3.7 (1.6) 3.3 (1.8) 0.339 Admission – no. (%) C ea inine (SD)e1.3 (1.1) 1.4 (1.3) 1.2 (0.9) 0.01 1.3 (1.16) 1.3 (0.8) 0.699 D-dime (SD) 5028 (18501) 4280 (100001) 5744 (23963) 0.334 4733 (10192) 6150 (15308) 0.352 Pla ele coun (SD)e213529 (91165) 210767 (91299) 216291 (91098) 0.455 212490 (82950) 214880 (91239) 0.812 ICU admission 59 (9.7) 32 (10.5) 27 (8.9) 0.493 24 (15.9) 16 (10.6) 0.174 Hyd oxychlo oquine 542 (88.9) 246 (80.7) 296 (97) <0.001 131 (86.8) 144 (95.4) 0.009 Azi h omycin 511 (83.8) 217 (71.1) 294 (96.4) <0.001 108 (71.5) 147 (97.4) 0.001 Da una i /cobicis a 37 (6.1) 16 (5.2) 21 (6.9) 0.396 12 (7.9) 13 (8.6) 0.83 Lopina i / i ona i 327 (53.6) 130 (42.6) 197 (64.6) <0.001 79 (52.3) 82 (54.3) 0.72 PSM, p opensi y sco e ma ching; AF, a ial fib illa ion; SD, s anda d de ia ion; HBP, high blood p essu e; DM, diabe es melli us; CKD, ch onic kidney disease; DBADL, dependency o basic ac i i ies o daily li ing; PVD, pe iphe al ascula disease; ICU, in ensi e ca e uni . aDBADL was conside ed i i was desc ibed in he medical his o y o o ins i u ionalized pa ien s. bRecen s oke was conside ed i i occu ed in he las 6 mon hs. cNo e ha 60 (19.7%) (AF g oup) and 210 pa ien s (68.8%) (no-AF g oup) did no ha e p e ious echoca diog aphic s udy. dConside ed i mode a e o se e e mi al s enosis. eA admission. Maximum alue du ing admission. Majo ca dio ascula e en s du ing admission and a ollow- up we e collec ed. They included majo bleeding, dea h, s oke and enous h omboembolism (VTE). Majo bleeding was defined using In e na ional Classifica ion o Diseases-10 h Re ision codes (including lowe and uppe gas oin es inal bleeding, in ac anial haemo hage, hema u ia, hemop ysis and epis axis) and confi med by any o he ollowing c i e ia: (1) haemoglobin d op <7 g/dL in needing o any ed blood cell ans usion; (2) a leas wo uni s o ed blood cell ans usion wi hin 48 h. I bleeding was suspec ed wi hou confi ma ion o an ac i e bleeding sou ce, we conside ed i as majo bleeding i mee c i e ia (1) o (2). VTE included pulmona y embolism (PE) and deep ein h ombosis (DVT). Synch onously diagnosed DVT and PE in he same pa ien we e conside ed 1 VTE e en . S oke was conside ed in case o es ablished o ansien ischaemia in b ain. The p ima y ou come o his s udy was he incidence o in- hospi al majo bleeding. Key seconda y ou comes we e in-hospi al mo ali y and incidence o VTE and s oke. In discha ged pa ien s, addi ional seconda y ou comes eco ded du ing ollow-up we e ou pa ien mo ali y, majo haemo hage and h omboembolic e en s (VTE and s oke). S a is ical analysis Nume ical a iables a e exp essed as mean and s anda d de ia ion o , o non-no mally dis ibu ed a iables, as median [in e qua ile ange]. Ca ego ical a iables a e exp essed as abso- lu e and ela i e equencies and we e con as ed wi h he Pea son’s chi-squa e es o Fishe ’s exac es in cases whe e applicabili y condi ions we e no me . Fo he quan i a i e a i- ables, he S uden ’s - es was used o independen samples and he Mann–Whi ney es was used o hose a iables wi h a non- no mal dis ibu ion. A p alue o <0.05 was conside ed s a is ically significan . P opensi y sco e ma ching (PSM) was u ilized o con- ol o po en ial con ounding a iables. In o de o analyze he p ima y ou come and p edic o s o i , we pe o med bo h mul- i a ia e logis ic eg essions o in-hospi al majo bleeding: fi s , in all he COVID-19 pa ien s; and second, only in he AF coho . In addi ion, we conduc ed a mul i a ia e analysis o he key sec- onda y ou come in-hospi al mo ali y in COVID-19 pa ien s. All he mul i a ia e logis ic eg essions we e pe o med be o e he PSM. Baseline di e ences (p < 0.10) we e in oduced in he eg ession model. Kaplan–Meie su i al analysis was pe o med o mo al- i y du ing ollow-up in he discha ged pa ien s and compa ed wi h he Log-Rank es . Indi iduals who expe ienced he e en we e cen- so ed a hei e en ime. All analyses we e conduc ed using SPSS S a is ics (IBM SPSS 24.0, A monk, NY, USA). Resul s Basal clinical ea u es Th ee hund ed and fi e pa ien s wi h p e ious o newly diag- nosed AF admi ed wi h confi med COVID-19 we e included and ma ched wi h a con ol g oup o COVID-19 pa ien s wi hou AF. Baseline cha ac e is ics o bo h g oups a e summa ized in Table 1. Be o e ma ching, pa ien s wi h AF we e significan ly olde han con ols, wi h a simila sex dis ibu ion and mo e p e alence o 571 R. Rubini-Cos a, F. Be múdez-Jiménez, R. Ri e a-López e al. Medicina Clínica 158 (2022) 569–575 p e ious ca dio ascula isk ac o s. In he AF coho , mos o he pa ien s had pe manen AF (61%), wi h lowe p opo ions o pa oxysmal (22%), pe sis en (5.2%) o newly diagnosed (11.8%). Be o e admission, mos o he pa ien s we e on o al an icoagu- lan s (Table A.1). Du ing admission, low-molecula -weigh hepa in (LMWH) was he mos commonly used an icoagulan in AF pa ien s (83%), while DOAC (7.5%) and VKA (2.6%) we e used in a mino i y o pa ien s (Table A.2). A e con olling o possible con ounding ac o s using PSM, 151 pa ien s wi h AF we e ma ched wi h 151 pa ien s wi hou AF (Table 1). Simila p opo ions o AF sub ypes and ca dio ascula isk ac o s we e ob ained a e ma ching in he AF coho , bu a highe p opo ion o ca diac disease in AF pa ien s s ill emained s a is ically significan (Table 1). Rega ding an icoag- ulan egimen du ing admission, he e we e expec ed di e ences a e PSM, wi h a highe p opo ion o AF pa ien s ecei ing he a- peu ic doses o LMWH han non-AF pa ien s. Ou comes du ing admission The p ima y ou come in-hospi al majo bleeding occu ed in 37 (6%) pa ien s: 30 (9.8%) and 7 (2.3%) in he AF and con ol g oups, espec i ely (OR: 4.64, 95% CI 2.00–10.74, p < 0.001). This finding was consis en a e he PSM [16 (10.6%) s 3 (2%), OR: 5.85, 95% CI 1.67–20.51, p = 0.003] ega dless o baseline and clinical como - bidi ies (Fig. 1). The lis o majo bleeding episodes in AF pa ien s is summa ized in Table A.3. AF pa ien s wi h a majo bleeding e en du ing admission we e compa ed wi h hose wi h no majo bleeding (Table 2). Dyslipidemia and obesi y we e mo e common in AF pa ien s wi h in-hospi al majo bleeding (OR: 2.43, 96% CI 1.12–5.24, p = 0.021; OR: 2.61, 95% CI 1.19–5.73, p = 0.014, espec- i ely). No majo bleeding occu ed in pa ien s ea ed wi h DOACs. The mul i a ia e analysis iden ified AF as independen p edic o o in-hospi al majo bleeding in all he COVID-19 pa ien s o he s udy Table 2 Baseline, clinical cha ac e is ics and endpoin s du ing admission o AF pa ien s depending on he p esence o majo bleeding du ing admission. Va iable To al (n = 305) No bleeding(n = 275) Bleeding (n = 30) p Baseline cha ac e is ics – no. (%) Age, mean (SD) – y 79 (10.3) 79.2 (10.3) 77 (9.2) 0.263 Male sex 163 (53.4) 144 (52.4) 19 (63.3) 0.253 HBP 244 (80) 216 (78.5) 28 (93.3) 0.055 DM 117 (38.4) 102 (37.1) 15 (50) 0.167 Dyslipidemia 123 (40.3) 105 (38.2) 18 (60) 0.021 Obesi y 68 (22.3) 56 (20.4) 12 (40) 0.014 CKD 73 (23.9) 62 (22.5) 11 (36.7) 0.085 DBADLa133 (43.6) 123 (44.7) 10 (33.3) 0.232 Alcoholism 18 (5.9) 15 (5.5) 3 (10) 0.402 PVD 54 (17.7) 47 (17.1) 7 (23.3) 0.448 Hepa opa hy 22 (7.2) 19 (6.9) 3 (10) 0.464 Recen s okeb5 (1.6) 4 (1.5) 1 (3.3) 0.406 S uc u al hea diseasec147 (48) 131 (47.6) 16 (53.3) 0.462 Mi al s enosisd3 (1) 2 (0.7) 1 (3.3) 0.268 Mechanical hea al e 5 (1.6) 4 (1.5) 1 (3.3) 0.406 P io majo bleeding 28 (9.2) 23 (8.4) 5 (16.7) 0.173 P io s oke 73 (23.9) 65 (23.6) 8 (26.7) 0.712 CHA2DS2-VASc (SD) 4.4 (1.7) 4.3 (1.7) 4.6 (1.4) 0.423 An icoagulan 234 (76.7) 207 (75.3) 27 (90) 0.07 An ipla ele 38 (12.5) 33 (12) 5 (16.7) 0.557 A ial fib illa ion Newly diagnosed 36 (11.8) 34 (12.4) 2 (6.7) 0.519 Pa oxysmal 67 (22) 61 (22.2) 6 (20) Pe sis en 16 (5.2) 13 (4.7) 3 (10) Pe manen 186 (61) 167 (60.7) 19 (63.3) Admission – no. (%) C ea inine (SD)e1.06 (0.8–1.48) 1.4 (1.3) 1.6 (1.1) 0.347 D-dime (SD) 4280 (10001) 3936 (8281) 7657 (20255) 0.065 Pla ele coun (SD)e210767 (91299) 210145 (90115) 216466 (103030) 0.719 ICU admission 32 (10.5) 27 (9.8) 5 (16.7) 0.222 Hyd oxychlo oquine 246 (80.7) 223 (81.1) 23 (76.7) 0.56 Azi h omycin 217 (71.1) 194 (70.5) 23 (76.7) 0.482 Da una i /cobicis a 16 (5.2) 15 (5.5) 1 (3.3) 1 Lopina i / i ona i 130 (42.6) 118 (42.9) 12 (40) 0.76 LMWH 253 (82.9) 228 (82.9) 25 (83.3) 0.953 The apeu ic dose 79 (25.9) 71 (25.8) 8 (26.7) 0.92 P ophylac ic dose 174 (57) 157 (57.1) 17 (56.7) 0.964 DOAC 23 (7.5) 23 (8.4) 0 0.145 VKA 8 (2.6) 7 (2.5) 1 (3.3) 0.568 No an icoagula ion 21 (6.9) 17 (6.2) 4 (13.3) 0.138 Endpoin s du ing admission S oke 1 (0.3) 1 (0.4) 0 1 Venous h omboembolism 4 (1.3) 3 (1.1) 1 (3.3) 0.341 Exi us 116 (38) 103 (37.5) 13 (43.3) 0.529 SD, s anda d de ia ion; HBP, high blood p essu e; DM, diabe es melli us; CKD, ch onic kidney disease; DBADL, dependency o basic ac i i ies o daily li ing; PVD, pe iphe al ascula disease; ICU, in ensi e ca e uni ; LMWH, low-molecula -weigh hepa in; DOAC, di ec o al an icoagulan ; VKA, i amin K an agonis . aDBADL was conside ed i i was desc ibed in he medical his o y o o ins i u ionalized pa ien s. bRecen s oke was conside ed i i occu ed in he las 6 mon hs. cNo e ha 56 (20.4%) (no bleeding g oup) and 4 pa ien s (13.3%) (bleeding g oup) did no ha e p e ious echoca diog aphic s udy. dConside ed i mode a e o se e e mi al s enosis. eA admission. Maximum alue du ing admission. 572 R. Rubini-Cos a, F. Be múdez-Jiménez, R. Ri e a-López e al. Medicina Clínica 158 (2022) 569–575 Fig. 1. Incidence o majo ca dio ascula e en s. Incidence o majo ca dio ascula e en s in pa ien s wi h and wi hou AF in he whole sample (panel A) and a e p opensi y sco e ma ching analysis (panel B). No e he significan di e ence be ween bo h g oups in majo bleeding, wi h a simila a e o AF- ela ed h omboembolic complica ions. (ns: non significan ; *** means p < 0.001; ** means p < 0.01 and * means p < 0.05). Table 3 Mul i a ia e analysis. Independen p edic ing ac o s o in-hospi al majo bleeding in COVID-19 pa ien s. Va iable Odds a io 95% CI p Lowe Uppe A ial fib illa ion 3.51 1.49 8.32 0.004 P io majo bleeding 2.83 1.06 7.56 0.038 ICU admission 3.06 1.27 7.37 0.013 DM 2.01 1.01 4.03 0.048 CI, confidence in e al; DM, diabe es melli us; ICU: in ensi e ca e uni . (OR: 3.51, 95% CI 1.49–8.32, p = 0.004), as well as p io majo bleed- ing, ICU admission and diabe es melli us (Table 3). The a iable “p io an icoagulan he apy” was closely ela ed o he p esence o AF and he e o e was excluded o he eg ession model. A sec- onda y mul i a ia e analysis was pe o med only in he AF coho , showing high D-dime le els as an independen p edic ing ac o o majo bleeding du ing admission (OR: 1.03, 95% CI 1.003–1.06, p = 0.03) (Table A.4). The incidence o he key seconda y ou come in-hospi al mo - ali y was 165 (27%) and i was significan ly highe in he AF g oup be o e and a e PSM [116 (38%) s 49 (16.1%), OR: 3.21, 95% CI 2.19–4.70, p < 0.001; 52 (34.4%) s 35 (23.2%), OR: 1.74, 95% CI 1.05–2.87, p = 0.03, espec i ely] (Fig. 2A and Table A.5). Mul i a ia e analysis showed he p esence o AF as an indepen- den p edic ing ac o o in-hospi al mo ali y (OR: 1.88, 95% CI 1.19–2.94, p = 0.006) as well as male sex, olde age, ch onic kid- ney disease (CKD), D-dime and absence o an icoagula ion du ing admission (Table 4). Howe e , he p esence o majo bleeding du - ing admission as well as he an icoagulan he apy wi h LMWH we e no independen ly associa ed wi h he inc eased mo ali y in AF pa ien s. Finally, he e we e no di e ences be ween bo h g oups in he o he key seconda y ou comes o s oke and VTE e en s du ing admission. Ne e heless, he e was a end owa ds a lowe inci- dence in AF g oup (Fig. 1). E en s a ollow up Respec i ely, 189 (62%) and 256 (83.9%) pa ien s wi h and wi h- ou AF we e discha ged a e he COVID-19 admission. In he AF g oup, DOAC he apy was he mos equen an icoagulan p e- sc ibed a discha ge (45.7%), ollowed by AVK (14.5%) and LMWH (9.6%); up o 30.2% we e no p esc ibed any an icoagulan . In he con ol g oup, mos o he pa ien s we e no an icoagula ed a e discha ge (97.3%). Table 4 Mul i a ia e analysis. Independen p edic ing ac o s o in-hospi al mo ali y in COVID-19 pa ien s. Va iable Odds a io 95% CI p Lowe Uppe A ial fib illa ion 1.88 1.19 2.94 0.006 Age 1.06 1.04 1.08 0.01 Male sex 1.74 1.14 2.64 0.01 D-dime 1.02 1.01 1.04 0.002 CKD 2.31 1.43 3.72 0.001 An icoagula ion du ing admission 0.026 LMWHa1 – – – No an icoagula ion 3.80 1.40 10.30 0.01 DOAC 1.59 0.62 4.06 0.33 VKA 0.27 0.03 2.36 0.24 CI, confidence in e al; CKD, ch onic kidney disease; DOAC, di ec o al an icoagu- lan ; VKA, i amin K an agonis . aAn icoagula ion wi h low-molecula -weigh hepa in was he e e ence o com- pa isons wi h o he an icoagulan s. Du ing a mean ollow-up pe iod o 7 ± 1.6 mon hs, incidence o ou pa ien majo bleeding was simila in he AF g oup compa ed wi h con ol g oup (4.8% s 2.7%, p = 0.256), as well as s oke (1.6% s 1%, p = 0.65) and VTE e en s (0% s 0.8%, p = 0.51). In e es ingly, a significan ly highe ou pa ien mo ali y a e was s ill p esen among pa ien s wi h AF (Fig. 2B). A seconda y mul i a ia e analysis was pe o med in he AF coho o 6-mon h mo ali y, showing he male sex, age, dependency o basic ac i i ies o daily li ing and CKD as independen p edic o s o highe mo ali y in AF pa ien s (Table A.6). Discussion Pa ien s wi h p e ious o newly diagnosed AF, admi ed wi h SARS-CoV-2 in ec ion, p esen an inc eased isk o majo bleeding, as well as an ex emely high a e o mo ali y du ing admission and a ollow up a e discha ge, wi h a low a e o h omboem- bolic e en s, which was simila o he con ol g oup. These wo s ou comes seem o be independen o p e ious clinical s a us, ca - dio ascula isk ac o s o p io ca dio ascula and bleeding e en s. Al hough in ou s udy we desc ibe a high incidence o majo bleeding in pa ien s wi h AF, we did no iden i y a s a is ical asso- cia ion be ween any an icoagulan and majo bleeding e en s. Howe e , we ecognize ha a ele an p opo ion o hese pa ien s ecei ed he apeu ical doses o LMWH, wi h a esidual use o DOACs. In ac , we did no obse e majo bleeding episodes in pa ien s ea ed du ing admission wi h DOACs, al hough significan 573 R. Rubini-Cos a, F. Be múdez-Jiménez, R. Ri e a-López e al. Medicina Clínica 158 (2022) 569–575 Fig. 2. Mo ali y in pa ien s wi h AF espec o he con ol g oup. Panel A shows he di e ence in he in-hospi al mo ali y in he whole sample o pa ien s. Panel B ep esen s he Kaplan–Mei analysis o dea h a e discha ge in bo h g oups. di e ences could no be demons a ed due o he e ospec i e and no andomized design o ou s udy. Rega ding mo ali y, he e we sugges ha AF in ol es an inde- penden poo p ognosis in COVID-19 pa ien s in he same way o o he ecen s udies.8,11 Howe e , due o he p e iously men- ioned limi a ions, we canno confi m i he high p opo ion o majo bleeding obse ed in AF pa ien s wi h COVID-19 is ela ed o hei high mo ali y a e. Se e al s udies ha e been epo ed AF as a equen condi ion in pa ien s admi ed wi h se e e o ms o COVID-193,6–8 and i has la ely been associa ed wi h an inc eased isk o un a ou able ou - comes in COVID-19 pa ien s.11 A ema kable finding o ou esea ch was ha he absence o an icoagula ion du ing admission was independen ly associa ed wi h a highe mo ali y in pa ien s wi h COVID-19, bu no wi h h ombo ic e en s. Al hough a p ope an i- coagula ion and a lowe mo ali y in COVID-19 pa ien s has been es ablished be o e,12–14 ou da a sugges ha some o hese dea hs migh be a ibu able o an ad anced COVID-19 disease o ex eme agili y ha p e en physicians om an icoagula ing hem. Al hough pa ien s wi h AF a e a popula ion a high isk o wo se ou comes o COVID-19, he isk o bleeding e en s and he sa es an icoagula ion he apy has no been es ablished ye . On he basis o possible d ug-d ug in e ac ions be ween DOAC and VKA wi h empi ic COVID-19 pha maco he apy and hei po en ial con- sequences, he AHA and he ESC bo h ag ee on he ecommenda ion o hepa in as he an icoagulan o choice in hospi alized COVID- 19 pa ien s wi h AF, who a e ecei ing p io an icoagula ion.9,10 In he p esen s udy, mos o he pa ien s wi h AF we e ea ed wi h he apeu ic doses o LMWH du ing admission, wi h low le - els o con inua ion o p io an icoagula ion wi h DOAC and VKA. This s a egy has been p e iously named as b idging he apy and is associa ed wi h highe isk o bleeding wi h no significan di e - ence in mo ali y o h ombo ic e en s, especially in he se ing o pe iope a i e in asi e p ocedu es.15–18 In line wi h his in o ma ion, he e we desc ibe a high incidence o majo bleeding in AF pa ien s ecei ing ull LMWH dosing du ing admission, be o e and a e con olling o con ounde s wi h PSM, wi h low le els o h ombo ic e en s. In con as , con ol g oup pa ien s wi hou AF showed lowe incidence o majo bleeding be o e and a e PSM, wi h a highe p opo ion o pa ien s ecei ing a p ophylac ic LMWH dose. Ano he impo an finding o ou s udy was he independen associa ion o AF wi h in-hospi al majo bleeding in COVID- 19 pa ien s, some hing ha has no been p e iously desc ibed. This no el finding should be aken in o accoun and i sugges s ha p ecise managemen o an icoagula ion migh educe he isk o bleeding. Addi ionally, we obse ed ha high le els o D-dime we e s ongly associa ed wi h high isk o majo bleed- ing in AF pa ien s. In e es ingly, a common clinical app oach in COVID-19 pa ien s wi h ele a ed D-dime le els is o in ensi y he an icoagulan doses o hepa in, some hing ha migh agg a a e haemo hagic complica ions, especially in AF pa ien s. DOACs ha e epea edly been ound o be sa e and mo e e ec- i e han VKA an agonis s in he ea men o non al ula AF, especially in olde pa ien s.19,20 Taking hese da a in o accoun , and he low and simila a e o h omboembolic e en s amongs ou s udy g oups, a change in he an icoagula ion s a egy in he COVID-19 pa ien s wi h AF migh be conside ed, gi ing a mo e impo an ole o DOACs. Mo eo e , mos o he d ugs wi h po en- ial in e ac ion wi h DOACs ha e been p o en o be ine ec i e agains COVID-19, so a e used less and less. Al-Samka i e al.21 analyzed he a e o bleeding and h om- bo ic complica ions in a la ge mul icen e coho o c i ically ill and nonc i ically ill COVID-19 pa ien s, showing a majo bleeding a e o 2.3%. He e, we desc ibe a highe incidence o majo bleed- ing e en s among pa ien s wi h AF. Al hough he con ol g oup pa ien s o he p esen s udy we e e y simila o he pa ien s o hei s udy, ce ainly, pa ien s wi h AF in ou s udy we e olde , had mo e como bidi ies and he majo i y o hem we e ea ed wi h LMWH a he apeu ic dose, han hose o Al-Samka i s udy. All hese ac s a e likely ela ed wi h his highe bleeding a e. Any- way, hese po en ial con ounding a iables we e con olled wi h PSM; hence, he an icoagula ion egimen seems o be playing an impo an ole. In summa y, pa ien s wi h p io o newly diagnosed AF admi - ed wi h COVID-19 ep esen a popula ion a high isk o majo bleeding and mo ali y du ing he hospi aliza ion. I seems c i ical o indi idualize an icoagula ion he apy du ing admission, consid- e ing pa ien specific isks o bleeding and VTE. Limi a ions The non- andomized na u e o he s udy limi s he conclusions abou he influence o he an icoagula ion he apy and ou comes. This bias is pa ially con olled wi h p opensi y sco e ma ching s udy ha ha e achie ed e y simila s udy g oups. La ge and an- domized s udies a e equi ed o be e cla i y his issue. Da a on he se e i y o he SARS-CoV-2 in ec ion we e no ully collec ed. The high mo ali y a e is in many cases mo e due o he COVID-19 in ec ion a he han ca dio ascula e en s. Howe e , his is simi- la o bo h PSM g oups and di e ences ela ed o he AF condi ion a e s ill p esen . 574 R. Rubini-Cos a, F. Be múdez-Jiménez, R. Ri e a-López e al. Medicina Clínica 158 (2022) 569–575 Au ho s’ con ibu ions All o he au ho s had access o he da a and pa icipa ed in he p epa a ion o he manusc ip . E hical conside a ions The s udy p o ocol was app o ed by he Local E hics Commi ee o he coo dina o cen e. Funding None decla ed. Conflic o in e es s The au ho s decla e ha he e is no conflic o in e es . Appendix A. Supplemen a y da a Supplemen a y da a associa ed wi h his a icle can be ound, in he online e sion, a h ps://doi.o g/10.1016/j. medcli.2021.06.015. Re e ences 1. Johns Hopkins Co ona i us Resou ce Cen e . COVID-19 map. 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