Timir K Paul1, Samit Bhatheja2, Hemang B Panchal2, Shimin Zheng2, Subhash Banerjee2, Sunil V Rao2, Luis Guzman2, Nirat Beohar2, David Zhao2, Roxana Mehran2, Debabrata Mukherjee2. 1. From the Division of Cardiology, Department of Internal Medicine (T.K.P., H.B.P.) and Department of Biostatistics and Epidemiology, College of Public Health (S.Z.), East Tennessee State University, Johnson City; The Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (S.B., R.M.); VA North Texas Health Care System, University of Texas Southwestern Medical Center at Dallas (S.B.); The Duke Clinical Research Institute, Durham, NC (S.V.R.); Virginia Commonwealth University, Richmond (L.G.); Nirat Beohar, Columbia University Division of Cardiology at the Mount Sinai Medical Center, Miami Beach, FL (N.B.); Wake Forest University, Winston-Salem, NC (D.Z.); and Division of Cardiology, Department of Internal Medicine, Texas Tech University, El Paso (D.M.). pault@etsu.edu. 2. From the Division of Cardiology, Department of Internal Medicine (T.K.P., H.B.P.) and Department of Biostatistics and Epidemiology, College of Public Health (S.Z.), East Tennessee State University, Johnson City; The Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (S.B., R.M.); VA North Texas Health Care System, University of Texas Southwestern Medical Center at Dallas (S.B.); The Duke Clinical Research Institute, Durham, NC (S.V.R.); Virginia Commonwealth University, Richmond (L.G.); Nirat Beohar, Columbia University Division of Cardiology at the Mount Sinai Medical Center, Miami Beach, FL (N.B.); Wake Forest University, Winston-Salem, NC (D.Z.); and Division of Cardiology, Department of Internal Medicine, Texas Tech University, El Paso (D.M.).
Abstract
BACKGROUND: Current guidelines give a class I recommendation to use of embolic protection devices (EPD) for saphenous vein graft (SVG) intervention; however, studies have shown conflicting results. The objective of this meta-analysis is to compare all-cause mortality, major adverse cardiovascular events, myocardial infarction (MI), or target vessel revascularization in SVG intervention with and without EPD. METHODS AND RESULTS: Literature was searched through October 2016. Eight studies (n=52 893) comparing SVG intervention performed with EPD (n=11 506) and without EPD (n=41 387) were included. There was no significant difference in all-cause mortality (odds ratio [OR], 0.79; confidence interval [CI], 0.55-1.12; P=0.19), major adverse cardiovascular events (OR, 0.73, CI, 0.51-1.05; P=0.09), target vessel revascularization (OR, 1.0; CI, 0.95-1.05; P=0.94), periprocedural MI (OR, 1.12; CI, 0.65-1.90, P=0.69), and late MI (OR, 0.80; CI, 0.52-1.23; P=0.30) between the 2 groups. Sensitivity analysis excluding CathPCI Registry study showed no difference in periprocedural MI, late MI, and target vessel revascularization; however, it favored EPD use in all-cause mortality and major adverse cardiovascular events. Further sensitivity analysis including only observational studies revealed no difference in all-cause mortality, major adverse cardiovascular events, target vessel revascularization, and late MI. Additional analysis after excluding CathPCI Registry study revealed no difference in outcomes. CONCLUSIONS: This study including 52 893 patients suggests no apparent benefit in routine use of EPD during SVG intervention in the contemporary real-world practice. Further randomized clinical trials are needed in current era to evaluate long-term outcomes in routine use of EPD, and meanwhile, current guideline recommendations on EPD use should be revisited.
BACKGROUND: Current guidelines give a class I recommendation to use of embolic protection devices (EPD) for saphenous vein graft (SVG) intervention; however, studies have shown conflicting results. The objective of this meta-analysis is to compare all-cause mortality, major adverse cardiovascular events, myocardial infarction (MI), or target vessel revascularization in SVG intervention with and without EPD. METHODS AND RESULTS: Literature was searched through October 2016. Eight studies (n=52 893) comparing SVG intervention performed with EPD (n=11 506) and without EPD (n=41 387) were included. There was no significant difference in all-cause mortality (odds ratio [OR], 0.79; confidence interval [CI], 0.55-1.12; P=0.19), major adverse cardiovascular events (OR, 0.73, CI, 0.51-1.05; P=0.09), target vessel revascularization (OR, 1.0; CI, 0.95-1.05; P=0.94), periprocedural MI (OR, 1.12; CI, 0.65-1.90, P=0.69), and late MI (OR, 0.80; CI, 0.52-1.23; P=0.30) between the 2 groups. Sensitivity analysis excluding CathPCI Registry study showed no difference in periprocedural MI, late MI, and target vessel revascularization; however, it favored EPD use in all-cause mortality and major adverse cardiovascular events. Further sensitivity analysis including only observational studies revealed no difference in all-cause mortality, major adverse cardiovascular events, target vessel revascularization, and late MI. Additional analysis after excluding CathPCI Registry study revealed no difference in outcomes. CONCLUSIONS: This study including 52 893 patients suggests no apparent benefit in routine use of EPD during SVG intervention in the contemporary real-world practice. Further randomized clinical trials are needed in current era to evaluate long-term outcomes in routine use of EPD, and meanwhile, current guideline recommendations on EPD use should be revisited.
Authors: Wojciech Wańha; Maksymilian Mielczarek; Natasza Gilis-Malinowska; Tomasz Roleder; Marek Milewski; Szymon Ładziński; Dariusz Ciećwierz; Paweł Gąsior; Tomasz Pawłowski; Rafał Januszek; Adam Kowalówka; Michalina Kolodziejczak; Stanisław Bartuś; Marcin Gruchała; Grzegorz Smolka; Eliano Pio Navarese; Dariusz Dudek; Andrzej Ochała; Elvin Kedhi; Miłosz Jaguszewski; Wojciech Wojakowski Journal: J Clin Med Date: 2020-04-22 Impact factor: 4.241