Estudo duplo-cego, unicêntrico, randomizado, avaliando a eficácia o mononitrato de isossorbida na prevenção da oclusão de artéria radial comparado ao placebo em pacientes submetidos a procedimento coronariano percutâneo eletivo: protocolo de estudo
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Publicado:
Mar 13, 2021
Palavras-chave:
isossorbida, artéria radial, intervenção coronária percutânea
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Resumo
Objetivos: O objetivo primário deste estudo será avaliar a eficácia do mononitrato de isossorbida subcutâneo e peri-arterial na prevenção da oclusão da artéria radial (OAR) após procedimento coronariano percutâneo (PCP) realizado pela via transradial (VTR). Como objetivos secundários, definir a incidência de OAR em no serviço assim como avaliar variáveis relacionadas ao risco de oclusão.Métodos: Estudo unicêntrico, duplo-cego, randomizado, onde serão incluídos pacientes internados e eletivos de hospital de alta complexidade, que derem entrada para a realização de PCP, diagnóstico ou terapêutico, por VTR, em quadros coronarianos estáveis (eletivos) ou em síndromes coronarianas agudas. A amostra será dividida de forma randômica em grupo que receberá a medicação e um grupo controle. Todos os participantes serão submetidos a avaliação palpatória da patência da artéria radial e pelo teste inverso de Barbeau nas 24 horas e sete dias após o procedimento. Este será o primeiro estudo a avaliar o mononitrato de isossorbida como método farmacológico acessível e barato para prevenção da OAR após PCP por VTR.
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Janella BL, Matsuda CN, Pereira RD, Magalhães JM, Silva MA da. Estudo duplo-cego, unicêntrico, randomizado, avaliando a eficácia o mononitrato de isossorbida na prevenção da oclusão de artéria radial comparado ao placebo em pacientes submetidos a procedimento coronariano percutâneo eletivo: protocolo de estudo. Health Sci J [Internet]. 13º de março de 2021 [citado 12º de maio de 2024];11(1):61-8. Disponível em: https://portalrcs.hcitajuba.org.br/index.php/rcsfmit_zero/article/view/1047
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ARTIGO ORIGINAL
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Referências
Valgimigli M, Gagnor A, Calabró P, Frigoli E, Leonardi S, Zaro T, et al. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. Lancet. 2015;385(9986):2465-76. https://doi.org/10.1016/S0140-6736(15)60292-6
Agostoni P, Biondi-Zoccai GGL, de Benedictis ML, Rigattieri S, Turri M, Anselmi M, et al. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; Systematic overview and meta-analysis of randomized trials. J Am Coll Cardiol. 2004;44(2):349-56. https://doi.org/10.1016/j.jacc.2004.04.034 PMid:15261930
Jolly SS, Yusuf S, Cairns J, Niemelä K, Xavier D, Widimsky P, et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011;377(9775):1409-20. https://doi.org/10.1016/S0140-6736(11)60404-2
Lee MS, Wolfe M, Stone GW. Transradial versus transfemoral percutaneous coronary intervention in acute coronary syndromes: re-evaluation of the current body of evidence. JACC Cardiovasc Interv. 2013;6(11):1149-52. https://doi.org/10.1016/j.jcin.2013.08.003 PMid:24262614
Kolkailah AA, Alreshq RS, Muhammed AM, Zahran ME, Anas El-Wegoud M, Nabhan AF. Transradial versus transfemoral approach for diagnostic coronary angiography and percutaneous coronary intervention in people with coronary artery disease. Cochrane Database Syst Rev. 2018;4(4):CD012318. https://doi.org/10.1002/14651858.CD012318.pub2 PMid:29665617 PMCid:PMC6494633
Sandoval Y, Bell MR, Gulati R. Transradial artery access complications. Circ Cardiovasc Interv. 2019;12(11):e007386. https://doi.org/10.1161/CIRCINTERVENTIONS.119.007386
Bhat FA, Changal KH, Raina H, Tramboo NA, Rather HA. Transradial versus transfemoral approach for coronary angiography and angioplasty - A prospective, randomized comparison. BMC Cardiovasc Disord. 2017;17(1):23. https://doi.org/10.1186/s12872-016-0457-2 PMid:28077091 PMCid:PMC5225509
Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, et al. Defining high bleeding risk in patients undergoing percutaneous coronary intervention. Circulation. 2019;140(3):240-61. https://doi.org/10.1161/CIRCULATIONAHA.119.040167 PMid:31116032 PMCid:PMC6636810
Redfors B, Généreux P, Witzenbichler B, Kirtane AJ, Mcandrew T, Weisz G, et al. Bleeding Severity After Percutaneous Coronary Intervention. Circ Cardiovasc Interv [Internet]. 2018;11(3):e005542. https://doi.org/10.1161/CIRCINTERVENTIONS.117.005542
Généreux P, Giustino G, Witzenbichler B, Weisz G, Stuckey TD, Rinaldi MJ, et al. Incidence, predictors, and impact of post-discharge bleeding after percutaneous coronary intervention. J Am Coll Cardiol. 2015;66(9):1036-45. https://doi.org/10.1016/j.jacc.2015.06.1323 PMid:26314532
Cantor WJ, Mahaffey KW, Huang Z, Das P, Gulba DC, Glezer S, et al. Bleeding complications in patients with acute coronary syndrome undergoing early invasive management can be reduced with radial access, smaller sheath sizes, and timely sheath removal. Catheter Cardiovasc Interv. 2007;69(1):73-83. https://doi.org/10.1002/ccd.20897 PMid:17139670
Mason PJ, Shah B, Tamis-Holland JE, Bittl JA, Cohen MG, Safirstein J, et al. An update on radial artery access and best practices for transradial coronary angiography and intervention in acute coronary syndrome: A scientific statement from the American Heart Association. Circ Cardiovasc Interv. 2018;11(9):e000035. https://doi.org/10.1161/HCV.0000000000000035 PMid:30354598
van Leeuwen MAH, Hollander MR, van der Heijden DJ, van de Ven PM, Opmeer KHM, Taverne YJHJ, et al. The ACRA Anatomy Study (Assessment of Disability After Coronary Procedures Using Radial Access): A comprehensive anatomic and functional assessment of the vasculature of the hand and relation to outcome after transradial catheterization. Circ Cardiovasc Interv. 2017;10(11): e005753. https://doi.org/10.1161/CIRCINTERVENTIONS.117.005753 PMid:29127118
van Leeuwen MAH, van der Heijden DJ, Hollander MR, Mulder MJ, van de Ven PM, Ritt MJPF, et al. ACRA Perfusion Study. Circ Cardiovasc Interv. 2019;12(4):e007641. https://doi.org/10.1161/CIRCINTERVENTIONS.118.007641 PMid:30929508
Rao S V, Cohen MG, Kandzari DE, Bertrand OF, Gilchrist IC. The transradial approach to percutaneous coronary intervention: historical perspective, current concepts, and future directions. J Am Coll Cardiol. 2010 May;55(20):2187-95. https://doi.org/10.1016/j.jacc.2010.01.039 PMid:20466199
Bernat I, Aminian A, Pancholy S, Mamas M, Gaudino M, Nolan J, et al. Best practices for the prevention of radial artery occlusion after transradial diagnostic angiography and intervention: an international consensus paper. JACC Cardiovasc Interv. 2019;12(22):2235-46. https://doi.org/10.1016/j.jcin.2019.07.043 PMid:31753298
Feres F, Costa RA, Siqueira D, Costa JRJ, Chamié D, Staico R, et al. Diretriz da Sociedade Brasileira de Cardiologia e da Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista sobre intervenção coronária percutânea. Arq Bras Cardiol. 2017;109(1 Suppl 1):1-81. [Portuguese] https://doi.org/10.5935/abc.20170111 PMid:28792984
Neumann F-J, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019;40(2):87-165. https://doi.org/10.1093/eurheartj/ehy394 PMid: 30165437
Barbeau GR, Arsenault F, Dugas L, Simard S, Larivière MM. Evaluation of the ulnopalmar arterial arches with pulse oximetry and plethysmography: comparison with the Allen's test in 1010 patients. Am Heart J. 2004;147(3):489-93. https://doi.org/10.1016/j.ahj.2003.10.038 PMid:14999199
Chen Y, Ke Z, Xiao J, Lin M, Huang X, Yan C, et al. Subcutaneous injection of nitroglycerin at the radial artery puncture site reduces the risk of early radial artery occlusion after transradial coronary catheterization: a randomized, placebo-controlled clinical trial. Circ Cardiovasc Interv. 2018;11(7):e006571. https://doi.org/10.1161/CIRCINTERVENTIONS.118.006571
Rashid M, Kwok CS, Pancholy S, Chugh S, Kedev SA, Bernat I, et al. Radial artery occlusion after transradial interventions: a systematic review and meta-analysis. J Am Heart Assoc. 2016;5(1):e002686. https://doi.org/10.1161/JAHA.115.002686 PMid:26811162 PMCid:PMC4859386
Ul Haq MA, Rashid M, Kwok CS, Wong CW, Nolan J, Mamas MA. Hand dysfunction after transradial artery catheterization for coronary procedures. World J Cardiol. 2017;9(7):609-19.
https://doi.org/10.4330/wjc.v9.i7.609 PMid:28824791 PMCid:PMC5545145
Voudris K V, Georgiadou P, Charitakis K, Marmagkiolis K. Radial interventions: present and future indications. Curr Treat Options Cardiovasc Med. 2016;18(1):2. https://doi.org/10.1007/s11936-015-0429-3 PMid:26712065
Shroff AR, Fernandez C, Vidovich MI, Rao S V, Cowley M, Bertrand OF, et al. Contemporary transradial access practices: Results of the second international survey. Catheter Cardiovasc Interv. 2019;93(7):1276-87. https://doi.org/10.1002/ccd.27989 PMid:30456913
Kerawala CJ, Martin IC. Palmar arch backflow following radial forearm free flap harvest. Br J Oral Maxillofac Surg. 2003;41(3):157-60. https://doi.org/10.1016/s0266-4356(03)00023-8
Jirous S, Bernat I, Slezak D, Miklik R, Rokyta R. Post-procedural radial artery occlusion and patency detection using duplex ultrasound vs. the reverse Barbeau test. Eur Heart J Suppl. 2020;22(Suppl F):F23-9. https://doi.org/10.1093/eurheartj/suaa095 PMid:32694950 PMCid:PMC7361668
Ognerubov D V, Sedaghat A, Provatorov SI, Tereshchenko AS, Bertrand OF, Bernat I, et al. A randomized trial comparing short versus prolonged hemostasis with rescue recanalization by ipsilateral ulnar artery compression: impact on radial artery occlusion-The RESCUE-RAO Trial. J Interv Cardiol. 2020;2020:7928961. https://doi.org/10.1155/2020/7928961 PMid:33149729 PMCid:PMC7603610
Pancholy S, Coppola J, Patel T, Roke-Thomas M. Prevention of radial artery occlusion-patent hemostasis evaluation trial (PROPHET study): a randomized comparison of traditional versus patency documented hemostasis after transradial catheterization. Catheter Cardiovasc Interv. 2008;72(3):335-40. https://doi.org/10.1002/ccd.21639 PMid:18726956
Pancholy SB, Bernat I, Bertrand OF, Patel TM. Prevention of radial artery occlusion after transradial catheterization: The PROPHET-II Randomized Trial. JACC Cardiovasc Interv. 2016;9(19):1992-9. https://doi.org/10.1016/j.jcin.2016.07.020 PMid:27712733
Münzel T, Steven S, Daiber A. Organic nitrates: update on mechanisms underlying vasodilation, tolerance and endothelial dysfunction. Vascul Pharmacol. 2014;63(3):105-13. https://doi.org/10.1016/j.vph.2014.09.002 PMid:25446162
Kwok CS, Rashid M, Fraser D, Nolan J, Mamas M. Intra-arterial vasodilators to prevent radial artery spasm: a systematic review and pooled analysis of clinical studies. Cardiovasc Revasc Med. 2015;16(8):484-90. https://doi.org/10.1016/j.carrev.2015.08.008 PMid:26365608
Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123(23):2736-47. https://doi.org/10.1161/circulationaha.110.009449 PMid: 21670242
Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115(17):2344-51. https://doi.org/10.1161/circulationaha.106.685313 PMid:17470709
Cox LS, Sanchez-Borges M, Lockey RF. World Allergy Organization Systemic Allergic Reaction Grading System: Is a modification needed? J Allergy Clin Immunol Pract. 2017;5(1):58-62.e5. https://doi.org/10.1016/j.jaip.2016.11.009 PMid:28065342
Agostoni P, Biondi-Zoccai GGL, de Benedictis ML, Rigattieri S, Turri M, Anselmi M, et al. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; Systematic overview and meta-analysis of randomized trials. J Am Coll Cardiol. 2004;44(2):349-56. https://doi.org/10.1016/j.jacc.2004.04.034 PMid:15261930
Jolly SS, Yusuf S, Cairns J, Niemelä K, Xavier D, Widimsky P, et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011;377(9775):1409-20. https://doi.org/10.1016/S0140-6736(11)60404-2
Lee MS, Wolfe M, Stone GW. Transradial versus transfemoral percutaneous coronary intervention in acute coronary syndromes: re-evaluation of the current body of evidence. JACC Cardiovasc Interv. 2013;6(11):1149-52. https://doi.org/10.1016/j.jcin.2013.08.003 PMid:24262614
Kolkailah AA, Alreshq RS, Muhammed AM, Zahran ME, Anas El-Wegoud M, Nabhan AF. Transradial versus transfemoral approach for diagnostic coronary angiography and percutaneous coronary intervention in people with coronary artery disease. Cochrane Database Syst Rev. 2018;4(4):CD012318. https://doi.org/10.1002/14651858.CD012318.pub2 PMid:29665617 PMCid:PMC6494633
Sandoval Y, Bell MR, Gulati R. Transradial artery access complications. Circ Cardiovasc Interv. 2019;12(11):e007386. https://doi.org/10.1161/CIRCINTERVENTIONS.119.007386
Bhat FA, Changal KH, Raina H, Tramboo NA, Rather HA. Transradial versus transfemoral approach for coronary angiography and angioplasty - A prospective, randomized comparison. BMC Cardiovasc Disord. 2017;17(1):23. https://doi.org/10.1186/s12872-016-0457-2 PMid:28077091 PMCid:PMC5225509
Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, et al. Defining high bleeding risk in patients undergoing percutaneous coronary intervention. Circulation. 2019;140(3):240-61. https://doi.org/10.1161/CIRCULATIONAHA.119.040167 PMid:31116032 PMCid:PMC6636810
Redfors B, Généreux P, Witzenbichler B, Kirtane AJ, Mcandrew T, Weisz G, et al. Bleeding Severity After Percutaneous Coronary Intervention. Circ Cardiovasc Interv [Internet]. 2018;11(3):e005542. https://doi.org/10.1161/CIRCINTERVENTIONS.117.005542
Généreux P, Giustino G, Witzenbichler B, Weisz G, Stuckey TD, Rinaldi MJ, et al. Incidence, predictors, and impact of post-discharge bleeding after percutaneous coronary intervention. J Am Coll Cardiol. 2015;66(9):1036-45. https://doi.org/10.1016/j.jacc.2015.06.1323 PMid:26314532
Cantor WJ, Mahaffey KW, Huang Z, Das P, Gulba DC, Glezer S, et al. Bleeding complications in patients with acute coronary syndrome undergoing early invasive management can be reduced with radial access, smaller sheath sizes, and timely sheath removal. Catheter Cardiovasc Interv. 2007;69(1):73-83. https://doi.org/10.1002/ccd.20897 PMid:17139670
Mason PJ, Shah B, Tamis-Holland JE, Bittl JA, Cohen MG, Safirstein J, et al. An update on radial artery access and best practices for transradial coronary angiography and intervention in acute coronary syndrome: A scientific statement from the American Heart Association. Circ Cardiovasc Interv. 2018;11(9):e000035. https://doi.org/10.1161/HCV.0000000000000035 PMid:30354598
van Leeuwen MAH, Hollander MR, van der Heijden DJ, van de Ven PM, Opmeer KHM, Taverne YJHJ, et al. The ACRA Anatomy Study (Assessment of Disability After Coronary Procedures Using Radial Access): A comprehensive anatomic and functional assessment of the vasculature of the hand and relation to outcome after transradial catheterization. Circ Cardiovasc Interv. 2017;10(11): e005753. https://doi.org/10.1161/CIRCINTERVENTIONS.117.005753 PMid:29127118
van Leeuwen MAH, van der Heijden DJ, Hollander MR, Mulder MJ, van de Ven PM, Ritt MJPF, et al. ACRA Perfusion Study. Circ Cardiovasc Interv. 2019;12(4):e007641. https://doi.org/10.1161/CIRCINTERVENTIONS.118.007641 PMid:30929508
Rao S V, Cohen MG, Kandzari DE, Bertrand OF, Gilchrist IC. The transradial approach to percutaneous coronary intervention: historical perspective, current concepts, and future directions. J Am Coll Cardiol. 2010 May;55(20):2187-95. https://doi.org/10.1016/j.jacc.2010.01.039 PMid:20466199
Bernat I, Aminian A, Pancholy S, Mamas M, Gaudino M, Nolan J, et al. Best practices for the prevention of radial artery occlusion after transradial diagnostic angiography and intervention: an international consensus paper. JACC Cardiovasc Interv. 2019;12(22):2235-46. https://doi.org/10.1016/j.jcin.2019.07.043 PMid:31753298
Feres F, Costa RA, Siqueira D, Costa JRJ, Chamié D, Staico R, et al. Diretriz da Sociedade Brasileira de Cardiologia e da Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista sobre intervenção coronária percutânea. Arq Bras Cardiol. 2017;109(1 Suppl 1):1-81. [Portuguese] https://doi.org/10.5935/abc.20170111 PMid:28792984
Neumann F-J, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019;40(2):87-165. https://doi.org/10.1093/eurheartj/ehy394 PMid: 30165437
Barbeau GR, Arsenault F, Dugas L, Simard S, Larivière MM. Evaluation of the ulnopalmar arterial arches with pulse oximetry and plethysmography: comparison with the Allen's test in 1010 patients. Am Heart J. 2004;147(3):489-93. https://doi.org/10.1016/j.ahj.2003.10.038 PMid:14999199
Chen Y, Ke Z, Xiao J, Lin M, Huang X, Yan C, et al. Subcutaneous injection of nitroglycerin at the radial artery puncture site reduces the risk of early radial artery occlusion after transradial coronary catheterization: a randomized, placebo-controlled clinical trial. Circ Cardiovasc Interv. 2018;11(7):e006571. https://doi.org/10.1161/CIRCINTERVENTIONS.118.006571
Rashid M, Kwok CS, Pancholy S, Chugh S, Kedev SA, Bernat I, et al. Radial artery occlusion after transradial interventions: a systematic review and meta-analysis. J Am Heart Assoc. 2016;5(1):e002686. https://doi.org/10.1161/JAHA.115.002686 PMid:26811162 PMCid:PMC4859386
Ul Haq MA, Rashid M, Kwok CS, Wong CW, Nolan J, Mamas MA. Hand dysfunction after transradial artery catheterization for coronary procedures. World J Cardiol. 2017;9(7):609-19.
https://doi.org/10.4330/wjc.v9.i7.609 PMid:28824791 PMCid:PMC5545145
Voudris K V, Georgiadou P, Charitakis K, Marmagkiolis K. Radial interventions: present and future indications. Curr Treat Options Cardiovasc Med. 2016;18(1):2. https://doi.org/10.1007/s11936-015-0429-3 PMid:26712065
Shroff AR, Fernandez C, Vidovich MI, Rao S V, Cowley M, Bertrand OF, et al. Contemporary transradial access practices: Results of the second international survey. Catheter Cardiovasc Interv. 2019;93(7):1276-87. https://doi.org/10.1002/ccd.27989 PMid:30456913
Kerawala CJ, Martin IC. Palmar arch backflow following radial forearm free flap harvest. Br J Oral Maxillofac Surg. 2003;41(3):157-60. https://doi.org/10.1016/s0266-4356(03)00023-8
Jirous S, Bernat I, Slezak D, Miklik R, Rokyta R. Post-procedural radial artery occlusion and patency detection using duplex ultrasound vs. the reverse Barbeau test. Eur Heart J Suppl. 2020;22(Suppl F):F23-9. https://doi.org/10.1093/eurheartj/suaa095 PMid:32694950 PMCid:PMC7361668
Ognerubov D V, Sedaghat A, Provatorov SI, Tereshchenko AS, Bertrand OF, Bernat I, et al. A randomized trial comparing short versus prolonged hemostasis with rescue recanalization by ipsilateral ulnar artery compression: impact on radial artery occlusion-The RESCUE-RAO Trial. J Interv Cardiol. 2020;2020:7928961. https://doi.org/10.1155/2020/7928961 PMid:33149729 PMCid:PMC7603610
Pancholy S, Coppola J, Patel T, Roke-Thomas M. Prevention of radial artery occlusion-patent hemostasis evaluation trial (PROPHET study): a randomized comparison of traditional versus patency documented hemostasis after transradial catheterization. Catheter Cardiovasc Interv. 2008;72(3):335-40. https://doi.org/10.1002/ccd.21639 PMid:18726956
Pancholy SB, Bernat I, Bertrand OF, Patel TM. Prevention of radial artery occlusion after transradial catheterization: The PROPHET-II Randomized Trial. JACC Cardiovasc Interv. 2016;9(19):1992-9. https://doi.org/10.1016/j.jcin.2016.07.020 PMid:27712733
Münzel T, Steven S, Daiber A. Organic nitrates: update on mechanisms underlying vasodilation, tolerance and endothelial dysfunction. Vascul Pharmacol. 2014;63(3):105-13. https://doi.org/10.1016/j.vph.2014.09.002 PMid:25446162
Kwok CS, Rashid M, Fraser D, Nolan J, Mamas M. Intra-arterial vasodilators to prevent radial artery spasm: a systematic review and pooled analysis of clinical studies. Cardiovasc Revasc Med. 2015;16(8):484-90. https://doi.org/10.1016/j.carrev.2015.08.008 PMid:26365608
Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123(23):2736-47. https://doi.org/10.1161/circulationaha.110.009449 PMid: 21670242
Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115(17):2344-51. https://doi.org/10.1161/circulationaha.106.685313 PMid:17470709
Cox LS, Sanchez-Borges M, Lockey RF. World Allergy Organization Systemic Allergic Reaction Grading System: Is a modification needed? J Allergy Clin Immunol Pract. 2017;5(1):58-62.e5. https://doi.org/10.1016/j.jaip.2016.11.009 PMid:28065342