Steven P Sedlis1, Pamela M Hartigan, Koon K Teo, David J Maron, John A Spertus, G B John Mancini, William Kostuk, Bernard R Chaitman, Daniel Berman, Jeffrey D Lorin, Marcin Dada, William S Weintraub, William E Boden. 1. From the New York Veterans Affairs (VA) Healthcare Network, New York (S.P.S., J.D.L.), and Upstate New York VA Healthcare Network and Albany Medical College, Albany (W.E.B.) - all in New York; VA Connecticut Healthcare System, West Haven (P.M.H.) and Hartford Hospital, Hartford (M.D.) - both in Connecticut; McMaster University Medical Center, Hamilton, ON (K.K.T.), Vancouver Hospital and Health Sciences Center, Vancouver, BC (G.B.J.M.), and London Health Sciences Centre, London, ON (W.K.) - all in Canada; Stanford University Medical Center, Stanford, CA (D.J.M.); Mid-America Heart Institute, University of Missouri, Kansas City, Kansas City (J.A.S.); Saint Louis University School of Medicine, St. Louis (B.R.C.); Cedars-Sinai Medical Center, Los Angeles (D.B.); and Christiana Care Health System, Newark, DE (W.S.W.).
Abstract
BACKGROUND:Percutaneous coronary intervention (PCI) relieves angina in patients with stable ischemic heart disease, but clinical trials have not shown that it improves survival. Between June 1999 and January 2004, we randomly assigned 2287 patients with stable ischemic heart disease to an initial management strategy ofoptimal medical therapy alone (medical-therapy group) or optimal medical therapy plus PCI (PCI group) and did not find a significant difference in the rate of survival during a median follow-up of 4.6 years. We now report the rate of survival among the patients who were followed for up to 15 years. METHODS: We obtained permission from the patients at the Department of Veterans Affairs (VA) sites and some non-VA sites in the United States to use their Social Security numbers to track their survival after the original trial period ended. We searched the VA national Corporate Data Warehouse and the National Death Index for survival information and the dates of death from any cause. We calculated survival according to the Kaplan-Meier method and used a Cox proportional-hazards model to adjust for significant between-group differences in baseline characteristics. RESULTS:Extended survival information was available for 1211 patients (53% of the original population). The median duration of follow-up for all patients was 6.2 years (range, 0 to 15); the median duration of follow-up for patients at the sites that permitted survival tracking was 11.9 years (range, 0 to 15). A total of 561 deaths (180 during the follow-up period in the original trial and 381 during the extended follow-up period) occurred: 284 deaths (25%) in the PCI group and 277 (24%) in the medical-therapy group (adjusted hazard ratio, 1.03; 95% confidence interval, 0.83 to 1.21; P=0.76). CONCLUSIONS: During an extended-follow-up of up to 15 years, we did not find a difference in survival between an initial strategy of PCI plus medical therapy and medical therapy alone in patients with stable ischemic heart disease. (Funded by the VA Cooperative Studies Program and others; COURAGE ClinicalTrials.gov number, NCT00007657.).
RCT Entities:
BACKGROUND: Percutaneous coronary intervention (PCI) relieves angina in patients with stable ischemic heart disease, but clinical trials have not shown that it improves survival. Between June 1999 and January 2004, we randomly assigned 2287 patients with stable ischemic heart disease to an initial management strategy of optimal medical therapy alone (medical-therapy group) or optimal medical therapy plus PCI (PCI group) and did not find a significant difference in the rate of survival during a median follow-up of 4.6 years. We now report the rate of survival among the patients who were followed for up to 15 years. METHODS: We obtained permission from the patients at the Department of Veterans Affairs (VA) sites and some non-VA sites in the United States to use their Social Security numbers to track their survival after the original trial period ended. We searched the VA national Corporate Data Warehouse and the National Death Index for survival information and the dates of death from any cause. We calculated survival according to the Kaplan-Meier method and used a Cox proportional-hazards model to adjust for significant between-group differences in baseline characteristics. RESULTS: Extended survival information was available for 1211 patients (53% of the original population). The median duration of follow-up for all patients was 6.2 years (range, 0 to 15); the median duration of follow-up for patients at the sites that permitted survival tracking was 11.9 years (range, 0 to 15). A total of 561 deaths (180 during the follow-up period in the original trial and 381 during the extended follow-up period) occurred: 284 deaths (25%) in the PCI group and 277 (24%) in the medical-therapy group (adjusted hazard ratio, 1.03; 95% confidence interval, 0.83 to 1.21; P=0.76). CONCLUSIONS: During an extended-follow-up of up to 15 years, we did not find a difference in survival between an initial strategy of PCI plus medical therapy and medical therapy alone in patients with stable ischemic heart disease. (Funded by the VA Cooperative Studies Program and others; COURAGE ClinicalTrials.gov number, NCT00007657.).
Authors: David J Maron; William E Boden; Robert A O'Rourke; Pamela M Hartigan; Karen J Calfas; G B John Mancini; John A Spertus; Marcin Dada; William J Kostuk; Merril Knudtson; Crystal L Harris; Steven P Sedlis; Robert G Zoble; Lawrence M Title; Gilbert Gosselin; Shah Nawaz; Gerald T Gau; Alvin S Blaustein; Eric R Bates; Leslee J Shaw; Daniel S Berman; Bernard R Chaitman; William S Weintraub; Koon K Teo Journal: J Am Coll Cardiol Date: 2010-03-30 Impact factor: 24.094
Authors: G B John Mancini; Pamela M Hartigan; Eric R Bates; Bernard R Chaitman; Steven P Sedlis; David J Maron; William J Kostuk; John A Spertus; Koon K Teo; Marcin Dada; Merril Knudtson; Daniel S Berman; David C Booth; William E Boden; William S Weintraub Journal: Am Heart J Date: 2013-08-02 Impact factor: 4.749
Authors: Stephan D Fihn; James C Blankenship; Karen P Alexander; John A Bittl; John G Byrne; Barbara J Fletcher; Gregg C Fonarow; Richard A Lange; Glenn N Levine; Thomas M Maddox; Srihari S Naidu; E Magnus Ohman; Peter K Smith Journal: Circulation Date: 2014-07-28 Impact factor: 29.690
Authors: G B John Mancini; Pamela M Hartigan; Leslee J Shaw; Daniel S Berman; Sean W Hayes; Eric R Bates; David J Maron; Koon Teo; Steven P Sedlis; Bernard R Chaitman; William S Weintraub; John A Spertus; William J Kostuk; Marcin Dada; David C Booth; William E Boden Journal: JACC Cardiovasc Interv Date: 2014-01-15 Impact factor: 11.195
Authors: Shamir R Mehta; Christopher P Cannon; Keith A A Fox; Lars Wallentin; William E Boden; Rudolf Spacek; Petr Widimsky; Peter A McCullough; David Hunt; Eugene Braunwald; Salim Yusuf Journal: JAMA Date: 2005-06-15 Impact factor: 56.272
Authors: Peter K Smith; Robert M Califf; Robert H Tuttle; Linda K Shaw; Kerry L Lee; Elizabeth R Delong; R Eric Lilly; Michael H Sketch; Eric D Peterson; Robert H Jones Journal: Ann Thorac Surg Date: 2006-10 Impact factor: 4.330
Authors: David J Maron; John A Spertus; G B John Mancini; Pamela M Hartigan; Steven P Sedlis; Eric R Bates; William J Kostuk; Marcin Dada; Daniel S Berman; Leslee J Shaw; Bernard R Chaitman; Koon K Teo; Robert A O'Rourke; William S Weintraub; William E Boden Journal: Am J Cardiol Date: 2009-08-28 Impact factor: 2.778
Authors: Stephan Windecker; Stefan Stortecky; Giulio G Stefanini; Bruno R da Costa; Bruno R daCosta; Anne Wilhelmina Rutjes; Marcello Di Nisio; Maria G Silletta; Maria G Siletta; Ausilia Maione; Fernando Alfonso; Peter M Clemmensen; Jean-Philippe Collet; Jochen Cremer; Volkmar Falk; Gerasimos Filippatos; Christian Hamm; Stuart Head; Arie Pieter Kappetein; Adnan Kastrati; Juhani Knuuti; Ulf Landmesser; Günther Laufer; Franz-Joseph Neumann; Dimitri Richter; Patrick Schauerte; Miguel Sousa Uva; David P Taggart; Lucia Torracca; Marco Valgimigli; William Wijns; Adam Witkowski; Philippe Kolh; Peter Jüni; Peter Juni Journal: BMJ Date: 2014-06-23
Authors: Georg M Fröhlich; Simon Redwood; Roby Rakhit; Philip A MacCarthy; Pitt Lim; Tom Crake; Steven K White; Charles J Knight; Christoph Kustosz; Guido Knapp; Miles C Dalby; Iqbal S Mali; Andrew Archbold; Andrew Wragg; Adam D Timmis; Pascal Meier Journal: JAMA Intern Med Date: 2014-08 Impact factor: 21.873
Authors: Leslee J Shaw; Joe X Xie; Lawrence M Phillips; Abhinav Goyal; Harmony R Reynolds; Daniel S Berman; Michael H Picard; Balram Bhargava; Gerard Devlin; Bernard R Chaitman Journal: Heart Asia Date: 2016-06-01