Nonemergency PCI at hospitals with or without on-site cardiac surgery
Alice K Jacobs, Sharon-Lise T Normand, Joseph M Massaro, Donald E Cutlip, Joseph P Carrozza Jr, Anthony D Marks, Nancy Murphy, Iyah K Romm, Madeleine Biondolillo, Laura Mauri, MASS COMM Investigators, Don E Cutlip, Jenifer Kaufman, Alice K Jacobs, Denise Fine, Frederic S Resnic, Kevin J Croce, Kelly O'Neill, Jean-Pierre Geagea, Kathi Benjamino, Clifford J Berger, Darlene Gareri, Eric Joubert, Sunit Mukherjee, Gail Ganem, Sergio Waxman, Judy Pendleton, Seth Bilazarian, Kathy Caredeo, James D Waters, Allayne Mendys, Nadine Belanger, Ik-Kyung Jang, Iris McNulty, Carl J Turissini, Deb Accardi, Kathy Minahan, James Alderman, Marian Gurry Stanton, Paul T Schwerdt, Susan Riley, James D Waters, Carla Hayden-Muse, Anthony D Marks, Angela Cahill, Joseph P Carrozza Jr, Mary Perianayagam, Andrew R Weintraub, Vilma Castaneda, Frederick S Ling, Jennifer Gassman, Harold Dauerman, David R Holmes Jr, Donald E Cutlip, Robert Piana, John Lopez, Paul Gordon, Alice K Jacobs, Sharon-Lise T Normand, Joseph M Massaro, Donald E Cutlip, Joseph P Carrozza Jr, Anthony D Marks, Nancy Murphy, Iyah K Romm, Madeleine Biondolillo, Laura Mauri, MASS COMM Investigators, Don E Cutlip, Jenifer Kaufman, Alice K Jacobs, Denise Fine, Frederic S Resnic, Kevin J Croce, Kelly O'Neill, Jean-Pierre Geagea, Kathi Benjamino, Clifford J Berger, Darlene Gareri, Eric Joubert, Sunit Mukherjee, Gail Ganem, Sergio Waxman, Judy Pendleton, Seth Bilazarian, Kathy Caredeo, James D Waters, Allayne Mendys, Nadine Belanger, Ik-Kyung Jang, Iris McNulty, Carl J Turissini, Deb Accardi, Kathy Minahan, James Alderman, Marian Gurry Stanton, Paul T Schwerdt, Susan Riley, James D Waters, Carla Hayden-Muse, Anthony D Marks, Angela Cahill, Joseph P Carrozza Jr, Mary Perianayagam, Andrew R Weintraub, Vilma Castaneda, Frederick S Ling, Jennifer Gassman, Harold Dauerman, David R Holmes Jr, Donald E Cutlip, Robert Piana, John Lopez, Paul Gordon
Abstract
Background: Emergency surgery has become a rare event after percutaneous coronary intervention (PCI). Whether having cardiac-surgery services available on-site is essential for ensuring the best possible outcomes during and after PCI remains uncertain.
Methods: We enrolled patients with indications for nonemergency PCI who presented at hospitals in Massachusetts without on-site cardiac surgery and randomly assigned these patients, in a 3:1 ratio, to undergo PCI at that hospital or at a partner hospital that had cardiac surgery services available. A total of 10 hospitals without on-site cardiac surgery and 7 with on-site cardiac surgery participated. The coprimary end points were the rates of major adverse cardiac events--a composite of death, myocardial infarction, repeat revascularization, or stroke--at 30 days (safety end point) and at 12 months (effectiveness end point). The primary end points were analyzed according to the intention-to-treat principle and were tested with the use of multiplicative noninferiority margins of 1.5 (for safety) and 1.3 (for effectiveness).
Results: A total of 3691 patients were randomly assigned to undergo PCI at a hospital without on-site cardiac surgery (2774 patients) or at a hospital with on-site cardiac surgery (917 patients). The rates of major adverse cardiac events were 9.5% in hospitals without on-site cardiac surgery and 9.4% in hospitals with on-site cardiac surgery at 30 days (relative risk, 1.00; 95% one-sided upper confidence limit, 1.22; P<0.001 for noninferiority) and 17.3% and 17.8%, respectively, at 12 months (relative risk, 0.98; 95% one-sided upper confidence limit, 1.13; P<0.001 for noninferiority). The rates of death, myocardial infarction, repeat revascularization, and stroke (the components of the primary end point) did not differ significantly between the groups at either time point.
Conclusions: Nonemergency PCI procedures performed at hospitals in Massachusetts without on-site surgical services were noninferior to procedures performed at hospitals with on-site surgical services with respect to the 30-day and 1-year rates of clinical events. (Funded by the participating hospitals without on-site cardiac surgery; MASS COM ClinicalTrials.gov number, NCT01116882.).
Source: PubMed