- Email: [email protected]
Incidencia de trombosis de stents coronarios en el «mundo real»
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99
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,QFLGHQFLDGHWURPERVLVGHVWHQWVFRURQDULRVHQHO©PXQGRUHDOª ,QFLGHQFHRIFRURQDU\VWHQWWKURPERVLVLQWKH©UHDOZRUOGª %HUQDUGR/RPER0' ,YiQ5HQGyQ0' &ODXGLD6DWL]iEDO0' &DUROLQD5LYDV0' 'DQLHO6DUPLHQWR0' &DUORV&DUYDMDO0' -RUJH0RU0' -RVp*'LH]0' Bogotá, DC., Colombia. ANTECEDENTES: la evidencia disponible de stents liberadores de medicamento proviene de estudios controlados con estrictos criterios de inclusión, limitando sus conclusiones y haciendo difícil la aplicación de sus resultados en el mundo real. OBJETIVO: determinar la incidencia de trombosis de stents liberadores y no liberadores de medicamento en pacientes del «mundo real». METODOLOGÍA: estudio de incidencia para determinar el número de casos de trombosis de stents implantados, mediante información obtenida a partir de historias clínicas, bases de datos y seguimiento clínico, y con base en características demográficas, factores de riesgo, consumo de clopidogrel y casos de trombosis del stent con un seguimiento de cero días a un año. RESULTADOS: 640 stents implantados (69,2% no medicados, 30,8% medicados de los cuales 18,9% eran medicados con placlitaxel y 11,9% medicados con sirolimus). Se identificaron doce eventos de trombosis (siete stents medicados y cinco no medicados). La incidencia de trombosis con cualquier tipo de stent fue de 1,88% (IC 95% 0,97-3,28). La incidencia de trombosis con stent medicado fue 3,55% (IC 95% 1,43-7,32), y con stent no medicado 1,13% (IC 95% 0,37-2,64) p=0,000. El riesgo relativo de trombosis con stent medicado es de 3,14 (IC 95% 1,01-9,78) p=0,037. El riesgo relativo de presentar trombosis con stent medicado en infarto agudo del miocardio es 8,11 (IC 95% 2,32-28,31) p=0,001. CONCLUSIONES: la incidencia de trombosis del stent aumenta en el mundo real, y existe mayor riesgo de trombosis de stents medicados especialmente cuando son implantados en el contexto de un infarto agudo del miocardio. Es necesario realizar estudios futuros que involucren una población de pacientes más amplia y con seguimiento a largo plazo. PALABRAS CLAVE: trombosis, stents, cardiología intervencionista.
BACKGROUND: The existing evidence of drug-eluting stents comes from controlled studies done with strict inclusion criteria, limiting their conclusions and making difficult to apply their findings in the real world.
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OBJECTIVES: determine the incidence of thrombosis between bare metal stents versus drugeluting stents in patients in the «real world» METHODS: incidence study to determine the number of cases of thrombosis in implanted stents through information gathered from clinical records, data bases and clinical follow-up, based on demographic characteristics, risk factors, clopidogrel treatment and events of stent thrombosis with a 0 days to 1 year follow-up. RESULTS: 640 stents were implanted. 69.2% were bare metal stents and 30.8% drug-eluting stents, from which 18.9% were with placlitaxel and 11.9% with sirolimus. 12 thrombosis events were identified (7 with drug-eluting stents and 5 with bare metal stents). The incidence of thrombosis with any kind of stent was 1.88 %( CI 95% 0.97-3.28). The incidence of thrombosis with drug-eluting stents was 3.55% (CI 95%1.43-7.32), and with bare metal stents 1.13% (CI 95% 0.37-2.64) p=0.000. The relative risk of thrombosis with drug eluting stents is 3.14 (CI 95%1.01-9.78) p=0.037. The relative risk of thrombosis with drug eluting stents and acute myocardial infarction is 8.11 (CI 95%2.32-28.31) p=0,001. CONCLUSIONS: there is an increased incidence of thrombosis of coronary stents in the real world and a greater risk of thrombosis with drug eluting stents, especially when implanted in the context of an acute myocardial infarction. It is necessary to conduct further studies that may involve a higher sample of patients population and long-term follow-up. KEY WORDS: thrombosis, stents, interventional cardiology.
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Tipo de stent Valor de p1 No medicado Medicado
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Tabla 2. CARACTERÍSTICAS DE LA ENFERMEDAD CORONARIA Y DEL PROCEDIMIENTO. Variables
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101
Tipo de stent No medicado Medicado
Valor de p1
Características de la población (QIHUPHGDGGHXQYDVR (QIHUPHGDGGHGRVYDVRV (QIHUPHGDGGHWUHVYDVRV $QJLQDHVWDEOH $QJLQDLQHVWDEOH ,QIDUWRDJXGRGHOPLRFDUGLR
Características del procedimiento
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102
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Tabla 3. ASOCIACIÓN DE TROMBOSIS Y OTRAS VARIABLES. Variables
Trombosis del stent Si No
Porcentaje
Valor de p
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103
Tabla 4. CASOS DE TROMBOSIS. DEFINICIONES DEL ACADEMIC RESEARCH CONSORTIUM (ARC). Tipo de trombosis
&DVR &DVR &DVR &DVR &DVR &DVR &DVR &DVR &DVR &DVR &DVR &DVR
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Tiempo
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Tipo de stent
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104
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Tabla 5. DEFINICIONES DE TROMBOSIS DEL STENT SEGÚN EL ACADEMIC RESEARCH CONSORTIUM. 7URPERVLV WHPSUDQD DJXGD VXEDJXGD
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,QFLGHQFLDGHWURPERVLVGHVWHQWVFRURQDULRVHQHO©PXQGRUHDOª ,QFLGHQFHRIFRURQDU\VWHQWWKURPERVLVLQWKH©UHDOZRUOGª %HUQDUGR/RPER0' ,YiQ5HQGyQ0' &ODXGLD6DWL]iEDO0' &DUROLQD5LYDV0' 'DQLHO6DUPLHQWR0' &DUORV&DUYDMDO0' -RUJH0RU0' -RVp*'LH]0' Bogotá, DC., Colombia. ANTECEDENTES: la evidencia disponible de stents liberadores de medicamento proviene de estudios controlados con estrictos criterios de inclusión, limitando sus conclusiones y haciendo difícil la aplicación de sus resultados en el mundo real. OBJETIVO: determinar la incidencia de trombosis de stents liberadores y no liberadores de medicamento en pacientes del «mundo real». METODOLOGÍA: estudio de incidencia para determinar el número de casos de trombosis de stents implantados, mediante información obtenida a partir de historias clínicas, bases de datos y seguimiento clínico, y con base en características demográficas, factores de riesgo, consumo de clopidogrel y casos de trombosis del stent con un seguimiento de cero días a un año. RESULTADOS: 640 stents implantados (69,2% no medicados, 30,8% medicados de los cuales 18,9% eran medicados con placlitaxel y 11,9% medicados con sirolimus). Se identificaron doce eventos de trombosis (siete stents medicados y cinco no medicados). La incidencia de trombosis con cualquier tipo de stent fue de 1,88% (IC 95% 0,97-3,28). La incidencia de trombosis con stent medicado fue 3,55% (IC 95% 1,43-7,32), y con stent no medicado 1,13% (IC 95% 0,37-2,64) p=0,000. El riesgo relativo de trombosis con stent medicado es de 3,14 (IC 95% 1,01-9,78) p=0,037. El riesgo relativo de presentar trombosis con stent medicado en infarto agudo del miocardio es 8,11 (IC 95% 2,32-28,31) p=0,001. CONCLUSIONES: la incidencia de trombosis del stent aumenta en el mundo real, y existe mayor riesgo de trombosis de stents medicados especialmente cuando son implantados en el contexto de un infarto agudo del miocardio. Es necesario realizar estudios futuros que involucren una población de pacientes más amplia y con seguimiento a largo plazo. PALABRAS CLAVE: trombosis, stents, cardiología intervencionista.
BACKGROUND: The existing evidence of drug-eluting stents comes from controlled studies done with strict inclusion criteria, limiting their conclusions and making difficult to apply their findings in the real world.
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OBJECTIVES: determine the incidence of thrombosis between bare metal stents versus drugeluting stents in patients in the «real world» METHODS: incidence study to determine the number of cases of thrombosis in implanted stents through information gathered from clinical records, data bases and clinical follow-up, based on demographic characteristics, risk factors, clopidogrel treatment and events of stent thrombosis with a 0 days to 1 year follow-up. RESULTS: 640 stents were implanted. 69.2% were bare metal stents and 30.8% drug-eluting stents, from which 18.9% were with placlitaxel and 11.9% with sirolimus. 12 thrombosis events were identified (7 with drug-eluting stents and 5 with bare metal stents). The incidence of thrombosis with any kind of stent was 1.88 %( CI 95% 0.97-3.28). The incidence of thrombosis with drug-eluting stents was 3.55% (CI 95%1.43-7.32), and with bare metal stents 1.13% (CI 95% 0.37-2.64) p=0.000. The relative risk of thrombosis with drug eluting stents is 3.14 (CI 95%1.01-9.78) p=0.037. The relative risk of thrombosis with drug eluting stents and acute myocardial infarction is 8.11 (CI 95%2.32-28.31) p=0,001. CONCLUSIONS: there is an increased incidence of thrombosis of coronary stents in the real world and a greater risk of thrombosis with drug eluting stents, especially when implanted in the context of an acute myocardial infarction. It is necessary to conduct further studies that may involve a higher sample of patients population and long-term follow-up. KEY WORDS: thrombosis, stents, interventional cardiology.
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(QHOJUXSRGHSDFLHQWHVFRQLPSODQWDFLyQGHVWHQW PHGLFDGR KXER PiV LQGLYLGXRV FRQ DQWHFHGHQWH GH HYHQWRFRURQDULRDJXGRSUHYLR (Q OD WDEOD VH PXHVWUDQ ODV FDUDFWHUtVWLFDV GH OD HQIHUPHGDGFRURQDULD\HOSURFHGLPLHQWRUHDOL]DGR Tabla 1. CARACTERÍSTICAS DEMOGRÁFICAS Y FACTORES DE RIESGO.
0pWRGRV 6HXVyXQHVWXGLRGHLQFLGHQFLDSDUDEXVFDUHOQ~PHUR GHFDVRVQXHYRVGHWURPERVLVGHVWHQWVLPSODQWDGRVHQ ORVSDFLHQWHVTXHDVLVWLHURQDOVHUYLFLRGHKHPRGLQDPLD GHXQKRVSLWDOXQLYHUVLWDULRHQWUHORVDxRVD /DLQIRUPDFLyQVHREWXYRDSDUWLUGHODKLVWRULDFOtQLFD GLJLWDO \ EDVH GH GDWRV GHO VHUYLFLR GH KHPRGLQDPLD VHJXLPLHQWRFOtQLFR\FRQWDFWRWHOHIyQLFRLGHQWLILFDQGR GDWRVGHPRJUiILFRVDQWHFHGHQWHVSDWROyJLFRVKLVWRULD GHFRQVXPRGHFORSLGRJUHO\FDVRVGHWURPERVLVGHOVWHQW HQWUHFHURGtDV\XQDxR /DVFRPSOLFDFLRQHVWURPEyWLFDVVHGHILQLHURQFRPR WRGD RFOXVLyQ WURPEyWLFD GHO VWHQW REVHUYDGD SRU UHLQWHUYHQFLyQ DQJLRJUiILFD R PXHUWH QR DWULEXLEOH D FDXVDVH[WUDFDUGtDFDVXRQGD4 HOHFWURFDUGLRJUiILFD PHQWH HQHOWHUULWRULRGHOYDVRFRQLPSODQWDFLyQGHO VWHQW 3DUDHODQiOLVLVGHGDWRVVHXVyHOVRIWZDUH6366Y 6HGHVFULELyODSREODFLyQDHVWXGLRWHQLHQGRHQFXHQWD VXVFDUDFWHUtVWLFDVGHPRJUiILFDVDQWHFHGHQWHVFOtQLFRV\ IDFWRUHVGHULHVJRPHGLFDPHQWRV\FDUDFWHUtVWLFDVGHO SURFHGLPLHQWR/XHJRVHFDOFXOyODLQFLGHQFLDGHOQ~PH URGHHYHQWRVGHWURPERVLVGHOVWHQW\VHHVWLPyHOULHVJR UHODWLYRFUXGR\DMXVWDGR
Tipo de stent Valor de p1 No medicado Medicado
Variables Características de la población (GDGSURPHGLR '( *pQHUR 0DVFXOLQR )HPHQLQR $QWHFHGHQWHVFOtQLFRV\ IDFWRUHVGHULHVJR &RURQDULRJUDItDSUHYLD 'LVOLSLGHPLD 'LDEHWHVPHOOLWXV 7DEDTXLVPR +LSHUWHQVLyQDUWHULDO 3UHYLRLQIDUWRDJXGRGHO PLRFDUGLR 5HYDVFXODUL]DFLyQ PLRFiUGLFDSUHYLD 0HGLFDPHQWRV ,QKLELGRUGHJOLFRSURWHtQD ,,E,,,D ÉFLGRDFHWLOVDOLFtOLFR &ORSLGRJUHO +HSDULQD (QR[DSDULQD
6HLQFOX\HURQVWHQWVLPSODQWDGRVHQSD FLHQWHVFRQXQDHGDGSURPHGLRGH DxRV PXMHUHV KRPEUHV HQ OD WDEOD VH REVHUYDQODVFDUDFWHUtVWLFDVGHPRJUiILFDV\ORVIDFWR UHVGHULHVJR (O GH ORV SDFLHQWHV HQ HO JUXSR GH VWHQW PHGLFDGRHUDGLDEpWLFRPLHQWUDVHQHOJUXSRGHVWHQWQR PHGLFDGRKXERGHSDFLHQWHVFRQGLDJQyVWLFRGH GLDEHWHVPHOOLWXV GHRWUDSDUWH GHORVSDFLHQWHV FRQVWHQWPHGLFDGRWHQtDFRPRDQWHFHGHQWHGLVOLSLGHPLD IUHQWHDGHSDFLHQWHVFRQHVWHDQWHFHGHQWHHQHO JUXSRGHVWHQWVQRPHGLFDGRV
9DORUGHSSDUDHYDOXDUGLIHUHQFLDVHQWUHHOWLSRGHVWHQWLPSODQWDGR /RVUHVXOWDGRVVHSUHVHQWDQHQWpUPLQRVGHSRUFHQWDMHH[FHSWRSDUD ODHGDGTXHVHPXHVWUDFRPRSURPHGLR GHVYLDFLyQHVWiQGDU
Tabla 2. CARACTERÍSTICAS DE LA ENFERMEDAD CORONARIA Y DEL PROCEDIMIENTO. Variables
5HVXOWDGRV
101
Tipo de stent No medicado Medicado
Valor de p1
Características de la población (QIHUPHGDGGHXQYDVR (QIHUPHGDGGHGRVYDVRV (QIHUPHGDGGHWUHVYDVRV $QJLQDHVWDEOH $QJLQDLQHVWDEOH ,QIDUWRDJXGRGHOPLRFDUGLR
Características del procedimiento
6HJPHQWR &RURQDULDGHUHFKDSUR[LPDO &RURQDULDGHUHFKDPHGLDO 'HVFHQGHQWHDQWHULRUSUR[LPDO 'HVFHQGHQWHDQWHULRUPHGLDO %LIXUFDFLyQ 3UHGLODWDFLyQFRQEDOyQ
9DORUGHSSDUDHYDOXDUGLIHUHQFLDVHQWUHHOWLSRGHVWHQWLPSODQWDGR 6HSUHVHQWDQORVVHJPHQWRVLQWHUYHQLGRVFRQPD\RUIUHFXHQFLD
102
,QFLGHQFLDGHWURPERVLVGHVWHQWVFRURQDULRVHQHOPXQGRUHDO /RPER\FROV
+XERXQDSURSRUFLyQVLPLODUHQDPERVJUXSRVGH HQIHUPHGDGFRURQDULDGHWUHVYDVRVDOUHGHGRUGH VHREVHUYDHQHOJUXSRFRQVWHQWQRPHGLFDGRGH FDVRVFRQGLDJQyVWLFRGHLQIDUWRDJXGRGHOPLRFDUGLR IUHQWHDGHSDFLHQWHVFRQHVWHGLDJQyVWLFRHQHOJUXSR GHVWHQWPHGLFDGR$VtPLVPRKXERPD\RUSRUFHQWDMH GHOHVLRQHVHQELIXUFDFLyQHQHOJUXSRGHSDFLHQWHVFRQ VWHQWPHGLFDGR\XQDSURSRUFLyQVLPLODUGHFDVRVHQORV TXHVHSUHGLODWyFRQEDOyQDOUHGHGRUGH 6HDQDOL]yODSRVLEOHDVRFLDFLyQHQWUHWURPERVLV\ODV GLIHUHQWHVYDULDEOHVPHGLDQWHSUXHEDGH&KLFXDGUDGR GH3HDUVRQ 7DEOD /DVYDULDEOHVLQIDUWRDJXGRGHOPLRFDUGLR\WLSRGH VWHQWWXYLHURQGLIHUHQFLDVVLJQLILFDWLYDVFRQUHODFLyQDO ULHVJRGHWURPERVLV(OULHVJRUHODWLYRGHWURPERVLVFRQ VWHQW PHGLFDGR HV GH ,& FRQ S 'HVSXpVGHXQDUHJUHVLyQORJtVWLFDFRQXQPRGHOR DMXVWDGRHOULHVJRUHODWLYRGHSUHVHQWDUWURPERVLVGH VWHQWPHGLFDGRHQXQLQIDUWRDJXGRGHOPLRFDUGLRHVGH ,& S (QODWDEODVHSUHVHQWDFDGDXQRGHORVFDVRVGH WURPERVLV GH VWHQW VHJ~Q OD GHILQLFLyQ GHO $FDGHPLF 5HVHDUFK&RQVRUWLXP $5& )XHURQLGHQWLILFDGRVGRFHHYHQWRVGHWURPERVLVVLHWH VWHQWVPHGLFDGRV FXDWURSDFOLWD[HOWUHVVLUROLPXV \FLQFR QRPHGLFDGRV/DLQFLGHQFLDGHWURPERVLVFRQFXDOTXLHU WLSRGHVWHQWIXHGH ,& ,QFLGHQ FLDGHWURPERVLVFRQVWHQWPHGLFDGRIXH ,& \FRQVWHQWQRPHGLFDGR ,& S +XER GLH] WURPERVLV WHPSUDQDV HQWUH GtDV GHODVFXDOHVQXHYHIXHURQVXEDJXGDV \XQDDJXGDVHLVWURPERVLVWHPSUDQDVGHILQLWLYDVIXH URQHQLQIDUWRDJXGRGHOPLRFDUGLR\GHpVWDVWUHVVH WUDWDURQ FRQ VWHQWV PHGLFDGRV \ WUHV FRQ VWHQW QR PHGLFDGR6HLGHQWLILFDURQGRVWURPERVLVWDUGtDV DPEDVFRQVWHQWPHGLFDGRXQRFRQVLUROLPXV\ RWURFRQSDFOLWD[HOVLHQGRHVWH~OWLPRVWHQWLPSODQWDGR HQHOFRQWH[WRGHXQLQIDUWRDJXGRGHOPLRFDUGLRGLH] IXHURQ WURPERVLV GHILQLWLYDV \ GRV IXHURQ WURPERVLV SUREDEOHV /RVGRFHFDVRVGHWURPERVLVVHSUHVHQWDURQHQWUHFHUR GtDV\XQDxR 1RKXERFDVRVGHPXHUWH HQORVSDFLHQWHVFRQWURPERVLVWDUGtDGHOVWHQW
9RO1R ,661
Tabla 3. ASOCIACIÓN DE TROMBOSIS Y OTRAS VARIABLES. Variables
Trombosis del stent Si No
Porcentaje
Valor de p
*pQHUR 0DVFXOLQR )HPHQLQR &RURQDULRJUDItDSUHYLD 1R 6L 'LVOLSLGHPLD 1R 6L 'LDEHWHVPHOOLWXV 1R 6L 7DEDTXLVPR 1R 6L +LSHUWHQVLyQ 1R 6L 3UHYLRLQIDUWRDJXGRGHOPLRFDUGLR 1R 6L 3UHYLDUHYDVFXODUL]DFLyQPLRFiUGLFD 1R 6L (QIHUPHGDGGHXQYDVR 1R 6L (QIHUPHGDGGHGRVYDVRV 1R 6L (QIHUPHGDGGHWUHVYDVRV 1R 6L ,QKLELGRUGHJOLFRSURWHtQD,,E,,,D 1R 6L $VSLULQD 1R 6L &ORSLGRJUHO 1R 6L +HSDULQD 1R 6L (QR[DSDULQD 1R 6L 6HJPHQWR 6WHQWXWLOL]DGR 3DFOLWD[HO 6LUROLPXV 1RPHGLFDGR ,QIDUWRDJXGRGHOPLRFDUGLR 1R 6L $QJLQDLQHVWDEOH 1R 6L
5HYLVWD&RORPELDQDGH&DUGLRORJtD 0D\R-XQLR
9RO1R ,661
103
Tabla 4. CASOS DE TROMBOSIS. DEFINICIONES DEL ACADEMIC RESEARCH CONSORTIUM (ARC). Tipo de trombosis
&DVR &DVR &DVR &DVR &DVR &DVR &DVR &DVR &DVR &DVR &DVR &DVR
7HPSUDQD 7DUGtD 7HPSUDQD 7HPSUDQD 7HPSUDQD 7HPSUDQD 7DUGtD 7HPSUDQD 7HPSUDQD 7HPSUDQD 7HPSUDQD 7HPSUDQD
6XEDJXGD 1$ 6XEDJXGD 6XEDJXGD 6XEDJXGD 6XEDJXGD 1$ 6XEDJXGD 6XEDJXGD $JXGD 6XEDJXGD 6XEDJXGD
Tiempo
'HILQLWLYD 'HILQLWLYD 'HILQLWLYD 3UREDEOH 'HILQLWLYD 3UREDEOH 'HILQLWLYD 'HILQLWLYD 'HILQLWLYD 'HILQLWLYD 'HILQLWLYD 'HILQLWLYD
GtDV GtDV GtDV GtDV GtDV GtDV PHVHV GtDV GtDV GtD GtDV GtDV
Tipo de stent
3DFOLWD[HO 3DFOLWD[HO 1R PHGLFDGR 1R PHGLFDGR 1R PHGLFDGR 3DFOLWD[HO 6LUROLPXV 6LUROLPXV 3DFOLWD[HO 6LUROLPXV 1R PHGLFDGR 1R PHGLFDGR
Desenlace
0XHUWR 9LYR 9LYR 0XHUWR 9LYR 0XHUWR 9LYR 9LYR 9LYR 0XHUWR 0XHUWR 0XHUWR
1$ QR DSOLFD
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Figura 1.&RQVXPRGHFORSLGRJUHODPEXODWRULRSRVWHULRUDODLPSODQ WDFLyQ GHO VWHQWSRU XQ DxR
&RQHODGYHQLPLHQWRGHORVVWHQWPHGLFDGRVHOLQWHUpV VHKDHQIRFDGRHQODRFOXVLyQWURPEyWLFDWDUGtD $ ILQDOHVGHVHUHXQLyXQDFRPLVLyQGHH[SHUWRV EDMRHOQRPEUH$FDGHPLF5HVHDUFK&RQVRUWLXP $5& TXH XQLILFy ODV GHILQLFLRQHV GH WURPERVLV GH VWHQWV WDQWRWHPSUDQDFRPRWDUGtD 7DEOD ([LVWHQIDFWRUHV TXHSUHGLVSRQHQDOGHVDUUROORGHWURPERVLVWHPSUDQD FRQODXWLOL]DFLyQGHVWHQWVPHGLFDGRV\QRPHGLFDGRV LQWHUYHQFLyQHQVtQGURPHDJXGRFDUJDWURPEyWLFDGH OD OHVLyQ WUDWDGD UHODFLyQ GHO WDPDxR VWHQWYDVR SUHVHQFLD GH IHQyPHQR GH QR UHIOXMR \ GLVHFFLyQ FRURQDULD /DRFOXVLyQWURPEyWLFDWDUGtDGHVFULWDHV SHFLDOPHQWHFRQHOXVRGHVWHQWPHGLFDGRVDXQTXHQR DXVHQWHFRQHOXVRGHVWHQWQRPHGLFDGRVVHUHODFLRQD FRQHOUHWDUGRRODIDOWDGHHQGRWHOL]DFLyQPHGLDGRV SRUHOGLVSRVLWLYR 'HVGHVXGLVSRQLELOLGDGVHFRPSUREyTXHORVVWHQWV OLEHUDGRUHVGHPHGLFDPHQWRSULQFLSDOPHQWHHOOLEHUDGRU GHUDSDPLFLQD DQWLELyWLFRGHODIDPLOLDGHORVPDFUyOLGRV HOFXDOWLHQHSRWHQFLDODQWLSUROLIHUDWLYRDQWLLQIODPDWRULRH LQPXQRVXSUHVRU \HOVWHQWOLEHUDGRUGHSDFOLWD[HO DJHQWH FLWRVWiWLFR TXH HYLWD OD GLVRFLDFLyQ GH ORV PLFURW~EXORVHQHOHVWDGLR0GHOFLFORFHOXODUSHUSHWXiQ GRORHQHVWDIDVH UHGXFHQORVHYHQWRVFOtQLFRVUHODFLR QDGRVFRQODUHHVWHQRVLVHVSHFLDOPHQWHHQHOVHJXLPLHQWR DODUJRSOD]RHQFRPSDUDFLyQFRQORVVWHQWVQRPHGLFDGRV VLQLPSRUWDUHOWLSRXWLOL]DGRDGHPiVGHUHGXFLUGHPDQHUD VLJQLILFDWLYDODQHFHVLGDGGHIXWXURVSURFHGLPLHQWRVGH UHYDVFXODUL]DFLyQ HQ ORV SDFLHQWHV FRQ HQIHUPHGDG FRURQDULD (Q6DEDWH\FRODERUDGRUHVSXEOLFDURQXQHVWX GLRPXOWLFpQWULFRDOHDWRUL]DGRTXHFRPSDUDEDODHILFD FLDGHORVVWHQWVOLEHUDGRUHVGHUDSDPLFLQDYHUVXVORV VWHQWVQROLEHUDGRUHVGHPHGLFDPHQWRHQODSUHYHQFLyQ
104
,QFLGHQFLDGHWURPERVLVGHVWHQWVFRURQDULRVHQHOPXQGRUHDO /RPER\FROV
9RO1R ,661
Tabla 5. DEFINICIONES DE TROMBOSIS DEL STENT SEGÚN EL ACADEMIC RESEARCH CONSORTIUM. 7URPERVLV WHPSUDQD DJXGD VXEDJXGD
0HQRURLJXDOD WUHLQWD GtDV
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2FOXVLyQ WURPEyWLFD GHO VHJPHQWR LQWUDVWHQW REVHUYDGR HQ HO PRPHQWR GHO HVWXGLR DQJLRJUiILFR 3UHVHQFLDGHRQGD4HQHOWHUULWRULRSHUIXQGLGRSRUODDUWHULD FRQ VWHQW &XDOTXLHU PXHUWH DWULEXLGD TXH QR KD\D VLGR LPSXWDGD D XQD FDXVD QR FDUGLDFD
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