BACKGROUND: The transition of patients with atherosclerotic vascular disease from the acute phase of the disease to the chronic stable atherosclerosis (CSA) phase has not been well characterized. We sought to compare ischemic and bleeding outcomes in hospitalized patients enrolled in clinical trials of non-ST-elevation acute coronary syndrome (ACS) with patients enrolled in outpatient trials of CSA. HYPOTHESIS: The risk for recurrent events will differ between the 2 populations. METHODS: Patient-level outcome data were evaluated from 3 consecutive trials of patients with ACS with long-term follow-up and 2 trials of patients with CSA. Kaplan-Meier curves were generated for ischemic and bleeding outcomes. RESULTS: In total, 37 370 patients were included in these analyses. Of these, 28 489 (76.2%) were from ACS trials and 8881 (23.8%) from chronic trials. During the first year of follow-up, 1353 deaths, 1081 cardiovascular (CV) deaths, 2113 myocardial infarctions (MIs), and 397 strokes occurred across the trials. Six-month Kaplan-Meier event rates for CV death, MI, or stroke were higher in the ACS trials compared with the CSA trials (8.6% vs 2.7%), as were the 1-year CV death rate (3.6% vs 1.7%) and 1-year rates for GUSTO moderate or severe bleeding (6.0% vs 1.3%). Qualitatively, the Kaplan-Meier curves appear to show an early increased risk as well as a continued increased risk over time. CONCLUSIONS: Patients with ACS enrolled while in the hospital appear to have different risk profiles for ischemic and bleeding outcomes compared with outpatients enrolled with CSA, including those patients with ACS after the acute phase.
BACKGROUND: The transition of patients with atherosclerotic vascular disease from the acute phase of the disease to the chronic stable atherosclerosis (CSA) phase has not been well characterized. We sought to compare ischemic and bleeding outcomes in hospitalized patients enrolled in clinical trials of non-ST-elevation acute coronary syndrome (ACS) with patients enrolled in outpatient trials of CSA. HYPOTHESIS: The risk for recurrent events will differ between the 2 populations. METHODS:Patient-level outcome data were evaluated from 3 consecutive trials of patients with ACS with long-term follow-up and 2 trials of patients with CSA. Kaplan-Meier curves were generated for ischemic and bleeding outcomes. RESULTS: In total, 37 370 patients were included in these analyses. Of these, 28 489 (76.2%) were from ACS trials and 8881 (23.8%) from chronic trials. During the first year of follow-up, 1353 deaths, 1081 cardiovascular (CV) deaths, 2113 myocardial infarctions (MIs), and 397 strokes occurred across the trials. Six-month Kaplan-Meier event rates for CV death, MI, or stroke were higher in the ACS trials compared with the CSA trials (8.6% vs 2.7%), as were the 1-year CV death rate (3.6% vs 1.7%) and 1-year rates for GUSTO moderate or severe bleeding (6.0% vs 1.3%). Qualitatively, the Kaplan-Meier curves appear to show an early increased risk as well as a continued increased risk over time. CONCLUSIONS:Patients with ACS enrolled while in the hospital appear to have different risk profiles for ischemic and bleeding outcomes compared with outpatients enrolled with CSA, including those patients with ACS after the acute phase.
Authors: Pierluigi Tricoci; Zhen Huang; Claes Held; David J Moliterno; Paul W Armstrong; Frans Van de Werf; Harvey D White; Philip E Aylward; Lars Wallentin; Edmond Chen; Yuliya Lokhnygina; Jinglan Pei; Sergio Leonardi; Tyrus L Rorick; Ann M Kilian; Lisa H K Jennings; Giuseppe Ambrosio; Christoph Bode; Angel Cequier; Jan H Cornel; Rafael Diaz; Aycan Erkan; Kurt Huber; Michael P Hudson; Lixin Jiang; J Wouter Jukema; Basil S Lewis; A Michael Lincoff; Gilles Montalescot; José Carlos Nicolau; Hisao Ogawa; Matthias Pfisterer; Juan Carlos Prieto; Witold Ruzyllo; Peter R Sinnaeve; Robert F Storey; Marco Valgimigli; David J Whellan; Petr Widimsky; John Strony; Robert A Harrington; Kenneth W Mahaffey Journal: N Engl J Med Date: 2011-11-13 Impact factor: 91.245
Authors: David A Morrow; Eugene Braunwald; Marc P Bonaca; Sebastian F Ameriso; Anthony J Dalby; Mary Polly Fish; Keith A A Fox; Leslie J Lipka; Xuan Liu; José Carlos Nicolau; A J Oude Ophuis; Ernesto Paolasso; Benjamin M Scirica; Jindrich Spinar; Pierre Theroux; Stephen D Wiviott; John Strony; Sabina A Murphy Journal: N Engl J Med Date: 2012-03-24 Impact factor: 91.245
Authors: Stephan D Fihn; Julius M Gardin; Jonathan Abrams; Kathleen Berra; James C Blankenship; Apostolos P Dallas; Pamela S Douglas; Joanne M Foody; Thomas C Gerber; Alan L Hinderliter; Spencer B King; Paul D Kligfield; Harlan M Krumholz; Raymond Y K Kwong; Michael J Lim; Jane A Linderbaum; Michael J Mack; Mark A Munger; Richard L Prager; Joseph F Sabik; Leslee J Shaw; Joanna D Sikkema; Craig R Smith; Sidney C Smith; John A Spertus; Sankey V Williams Journal: J Am Coll Cardiol Date: 2012-11-19 Impact factor: 24.094
Authors: John H Alexander; Renato D Lopes; Stefan James; Rakhi Kilaru; Yaohua He; Puneet Mohan; Deepak L Bhatt; Shaun Goodman; Freek W Verheugt; Marcus Flather; Kurt Huber; Danny Liaw; Steen E Husted; Jose Lopez-Sendon; Raffaele De Caterina; Petr Jansky; Harald Darius; Dragos Vinereanu; Jan H Cornel; Frank Cools; Dan Atar; Jose Luis Leiva-Pons; Matyas Keltai; Hisao Ogawa; Prem Pais; Alexander Parkhomenko; Witold Ruzyllo; Rafael Diaz; Harvey White; Mikhail Ruda; Margarida Geraldes; Jack Lawrence; Robert A Harrington; Lars Wallentin Journal: N Engl J Med Date: 2011-07-24 Impact factor: 91.245
Authors: Deepak L Bhatt; Kim A Eagle; E Magnus Ohman; Alan T Hirsch; Shinya Goto; Elizabeth M Mahoney; Peter W F Wilson; Mark J Alberts; Ralph D'Agostino; Chiau-Suong Liau; Jean-Louis Mas; Joachim Röther; Sidney C Smith; Geneviève Salette; Charles F Contant; Joseph M Massaro; Ph Gabriel Steg Journal: JAMA Date: 2010-08-30 Impact factor: 56.272
Authors: Deepak L Bhatt; Keith A A Fox; Werner Hacke; Peter B Berger; Henry R Black; William E Boden; Patrice Cacoub; Eric A Cohen; Mark A Creager; J Donald Easton; Marcus D Flather; Steven M Haffner; Christian W Hamm; Graeme J Hankey; S Claiborne Johnston; Koon-Hou Mak; Jean-Louis Mas; Gilles Montalescot; Thomas A Pearson; P Gabriel Steg; Steven R Steinhubl; Michael A Weber; Danielle M Brennan; Liz Fabry-Ribaudo; Joan Booth; Eric J Topol Journal: N Engl J Med Date: 2006-03-12 Impact factor: 91.245
Authors: Lars Wallentin; Richard C Becker; Andrzej Budaj; Christopher P Cannon; Håkan Emanuelsson; Claes Held; Jay Horrow; Steen Husted; Stefan James; Hugo Katus; Kenneth W Mahaffey; Benjamin M Scirica; Allan Skene; Philippe Gabriel Steg; Robert F Storey; Robert A Harrington; Anneli Freij; Mona Thorsén Journal: N Engl J Med Date: 2009-08-30 Impact factor: 91.245
Authors: Eric J Topol; Donald Easton; Robert A Harrington; Pierre Amarenco; Robert M Califf; Carmen Graffagnino; Stephen Davis; Hans-Christophe Diener; James Ferguson; Desmond Fitzgerald; Jeffrey Granett; Ashfaq Shuaib; Peter J Koudstaal; Pierre Theroux; Frans Van de Werf; Kristina Sigmon; Karen Pieper; Marc Vallee; James T Willerson Journal: Circulation Date: 2003-07-21 Impact factor: 29.690