Jonathan D Newman1, Karen P Alexander2, Xiangqiong Gu2, Sean M O'Brien2, William E Boden3, Sajeev C Govindan4, Roxy Senior5, Nagaraja Moorthy6, Paulo C Rezende7, Marcin Demkow8, Jose Luis Lopez-Sendon9, Olga Bockeria10, Neeraj Pandit11, Gilbert Gosselin12, Peter H Stone13, John A Spertus14, Gregg W Stone15, Jerome L Fleg16, Judith S Hochman1, David J Maron17. 1. New York University School of Medicine (J.D.N., J.S.H.). 2. Duke Clinical Research Institute, Durham, NC (K.P.A., X.G., S.M.O.). 3. VA New England Healthcare System, Boston, MA (W.E.B.). 4. Government Medical College, Kerala, India (S.C.G.). 5. Northwick Park Hospital-Royal Brompton Hospital, London, United Kingdom (R.S.). 6. Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, Karnataka, India (N.M.). 7. Heart Instituto do Coracao, University of Sao Paulo, Brazil (P.C.R.). 8. Coronary and Structural Heart Diseases Department, Institute of Cardiology, Warsaw, Poland (M.D.). 9. Hospital Universitario La Paz, Idipaz, Madrid, Spain (J.L.L.-S.). 10. National Research Center for Cardiovascular Surgery, Moscow, Russia (O.B.). 11. Ram Manohar Lohia Hospital, Delhi, India (N.P.). 12. Montreal Heart Institute, QC, Canada (G.G.). 13. Brigham and Women's Hospital, MA (P.H.S.). 14. Saint Luke's Mid America Heart Institute/UMKC, MO (J.A.S.). 15. Columbia University Medical Center and the Cardiovascular Research Foundation, NY (J.W.S.). 16. National Institute of Health, NHLBI, MD (J.L.F.). 17. Stanford University School of Medicine, CA (D.J.M.).
Abstract
BACKGROUND: Risk factor control is the cornerstone of managing stable ischemic heart disease but is often not achieved. Predictors of risk factor control in a randomized clinical trial have not been described. METHODS AND RESULTS: The ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) randomized individuals with at least moderate inducible ischemia and obstructive coronary artery disease to an initial invasive or conservative strategy in addition to optimal medical therapy. The primary aim of this analysis was to determine predictors of meeting trial goals for LDL-C (low-density lipoprotein cholesterol, goal <70 mg/dL) or systolic blood pressure (SBP, goal <140 mm Hg) at 1 year post-randomization. We included all randomized participants in the ISCHEMIA trial with baseline and 1-year LDL-C and SBP values by January 28, 2019. Among the 3984 ISCHEMIA participants (78% of 5179 randomized) with available data, 35% were at goal for LDL-C, and 65% were at goal for SBP at baseline. At 1 year, the percent at goal increased to 52% for LDL-C and 75% for SBP. Adjusted odds of 1-year LDL-C goal attainment were greater with older age (odds ratio [OR], 1.11 [95% CI, 1.03-1.20] per 10 years), lower baseline LDL-C (OR, 1.19 [95% CI, 1.17-1.22] per 10 mg/dL), high-intensity statin use (OR, 1.30 [95% CI, 1.12-1.51]), nonwhite race (OR, 1.32 [95% CI, 1.07-1.63]), and North American enrollment compared with other regions (OR, 1.32 [95% CI, 1.06-1.66]). Women were less likely than men to achieve 1-year LDL-C goal (OR, 0.68 [95% CI, 0.58-0.80]). Adjusted odds of 1-year SBP goal attainment were greater with lower baseline SBP (OR, 1.27 [95% CI, 1.22-1.33] per 10 mm Hg) and with North American enrollment (OR, 1.35 [95% CI, 1.04-1.76]). CONCLUSIONS: In ISCHEMIA, older age, male sex, high-intensity statin use, lower baseline LDL-C, and North American location predicted 1-year LDL-C goal attainment, whereas lower baseline SBP and North American location predicted 1-year SBP goal attainment. Future studies should examine the effects of sex disparities, international practice patterns, and provider behavior on risk factor control.
RCT Entities:
BACKGROUND: Risk factor control is the cornerstone of managing stable ischemic heart disease but is often not achieved. Predictors of risk factor control in a randomized clinical trial have not been described. METHODS AND RESULTS: The ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) randomized individuals with at least moderate inducible ischemia and obstructive coronary artery disease to an initial invasive or conservative strategy in addition to optimal medical therapy. The primary aim of this analysis was to determine predictors of meeting trial goals for LDL-C (low-density lipoprotein cholesterol, goal <70 mg/dL) or systolic blood pressure (SBP, goal <140 mm Hg) at 1 year post-randomization. We included all randomized participants in the ISCHEMIA trial with baseline and 1-year LDL-C and SBP values by January 28, 2019. Among the 3984 ISCHEMIAparticipants (78% of 5179 randomized) with available data, 35% were at goal for LDL-C, and 65% were at goal for SBP at baseline. At 1 year, the percent at goal increased to 52% for LDL-C and 75% for SBP. Adjusted odds of 1-year LDL-C goal attainment were greater with older age (odds ratio [OR], 1.11 [95% CI, 1.03-1.20] per 10 years), lower baseline LDL-C (OR, 1.19 [95% CI, 1.17-1.22] per 10 mg/dL), high-intensity statin use (OR, 1.30 [95% CI, 1.12-1.51]), nonwhite race (OR, 1.32 [95% CI, 1.07-1.63]), and North American enrollment compared with other regions (OR, 1.32 [95% CI, 1.06-1.66]). Women were less likely than men to achieve 1-year LDL-C goal (OR, 0.68 [95% CI, 0.58-0.80]). Adjusted odds of 1-year SBP goal attainment were greater with lower baseline SBP (OR, 1.27 [95% CI, 1.22-1.33] per 10 mm Hg) and with North American enrollment (OR, 1.35 [95% CI, 1.04-1.76]). CONCLUSIONS: In ISCHEMIA, older age, male sex, high-intensity statin use, lower baseline LDL-C, and North American location predicted 1-year LDL-C goal attainment, whereas lower baseline SBP and North American location predicted 1-year SBP goal attainment. Future studies should examine the effects of sex disparities, international practice patterns, and provider behavior on risk factor control.
Authors: Kornelia Kotseva; Guy De Backer; Dirk De Bacquer; Lars Rydén; Arno Hoes; Diederick Grobbee; Aldo Maggioni; Pedro Marques-Vidal; Catriona Jennings; Ana Abreu; Carlos Aguiar; Jolita Badariene; Jan Bruthans; Almudena Castro Conde; Renata Cifkova; Jim Crowley; Kairat Davletov; Jaap Deckers; Delphine De Smedt; Johan De Sutter; Mirza Dilic; Marina Dolzhenko; Vilnis Dzerve; Andrejs Erglis; Zlatko Fras; Dan Gaita; Nina Gotcheva; Peter Heuschmann; Hosam Hasan-Ali; Piotr Jankowski; Nebojsa Lalic; Seppo Lehto; Dragan Lovic; Silvia Mancas; Linda Mellbin; Davor Milicic; Erkin Mirrakhimov; Rafael Oganov; Nana Pogosova; Zeljko Reiner; Stefan Stöerk; Lâle Tokgözoğlu; Costas Tsioufis; Dusko Vulic; David Wood Journal: Eur J Prev Cardiol Date: 2019-02-10 Impact factor: 7.804
Authors: Marc A Pfeffer; Brian Claggett; Susan F Assmann; Robin Boineau; Inder S Anand; Nadine Clausell; Akshay S Desai; Rafael Diaz; Jerome L Fleg; Ivan Gordeev; John F Heitner; Eldrin F Lewis; Eileen O'Meara; Jean-Lucien Rouleau; Jeffrey L Probstfield; Tamaz Shaburishvili; Sanjiv J Shah; Scott D Solomon; Nancy K Sweitzer; Sonja M McKinlay; Bertram Pitt Journal: Circulation Date: 2014-11-18 Impact factor: 29.690
Authors: Paul K Whelton; Robert M Carey; Wilbert S Aronow; Donald E Casey; Karen J Collins; Cheryl Dennison Himmelfarb; Sondra M DePalma; Samuel Gidding; Kenneth A Jamerson; Daniel W Jones; Eric J MacLaughlin; Paul Muntner; Bruce Ovbiagele; Sidney C Smith; Crystal C Spencer; Randall S Stafford; Sandra J Taler; Randal J Thomas; Kim A Williams; Jeff D Williamson; Jackson T Wright Journal: J Am Coll Cardiol Date: 2017-11-13 Impact factor: 24.094
Authors: Christopher M O'Connor; Mona Fiuzat; Karl Swedberg; Michael Caron; Bruce Koch; Peter E Carson; Wendy Gattis-Stough; Gordon W Davis; Michael R Bristow Journal: J Am Coll Cardiol Date: 2011-08-23 Impact factor: 24.094
Authors: Chiara Melloni; Bimal R Shah; Fang-Shu Ou; Matthew T Roe; Sidney C Smith; Charles V Pollack; Magnus Ohman; W Brian Gibler; Eric D Peterson; Karen P Alexander Journal: Am Heart J Date: 2010-12 Impact factor: 4.749
Authors: Scott M Grundy; James I Cleeman; C Noel Bairey Merz; H Bryan Brewer; Luther T Clark; Donald B Hunninghake; Richard C Pasternak; Sidney C Smith; Neil J Stone Journal: Circulation Date: 2004-07-13 Impact factor: 29.690
Authors: David J Maron; G B John Mancini; Pamela M Hartigan; John A Spertus; Steven P Sedlis; William J Kostuk; Daniel S Berman; Koon K Teo; William S Weintraub; William E Boden Journal: J Am Coll Cardiol Date: 2018-11-06 Impact factor: 24.094
Authors: Michelle F Magee; Jacqueline E Tamis-Holland; Jiang Lu; Vera A Bittner; Maria Mori Brooks; Neuza Lopes; Alice K Jacobs Journal: Int J Endocrinol Date: 2015-03-19 Impact factor: 3.257
Authors: Earl S Ford; Umed A Ajani; Janet B Croft; Julia A Critchley; Darwin R Labarthe; Thomas E Kottke; Wayne H Giles; Simon Capewell Journal: N Engl J Med Date: 2007-06-07 Impact factor: 91.245
Authors: Mandeep S Sidhu; Karen P Alexander; Zhen Huang; Sean M O'Brien; Bernard R Chaitman; Gregg W Stone; Jonathan D Newman; William E Boden; Aldo P Maggioni; Philippe Gabriel Steg; Thomas B Ferguson; Marcin Demkow; Jesus Peteiro; Gurpreet S Wander; Denis C Phaneuf; Mark A De Belder; Rolf Doerr; Erick Alexanderson-Rosas; Carisi A Polanczyk; Peter A Henriksen; Dwayne S G Conway; Vicente Miro; Tali Sharir; Renato D Lopes; James K Min; Daniel S Berman; Frank W Rockhold; Stephen Balter; David Borrego; Yves D Rosenberg; Sripal Bangalore; Harmony R Reynolds; Judith S Hochman; David J Maron Journal: Am Heart J Date: 2022-02-09 Impact factor: 5.099
Authors: Jonathan D Newman; Rebecca Anthopolos; G B John Mancini; Sripal Bangalore; Harmony R Reynolds; Dennis F Kunichoff; Roxy Senior; Jesus Peteiro; Balram Bhargava; Pallav Garg; Jorge Escobedo; Rolf Doerr; Tomasz Mazurek; Jose Gonzalez-Juanatey; Grzegorz Gajos; Carlo Briguori; Hong Cheng; Andras Vertes; Sandeep Mahajan; Luis A Guzman; Matyas Keltai; Aldo P Maggioni; Gregg W Stone; Jeffrey S Berger; Yves D Rosenberg; William E Boden; Bernard R Chaitman; Jerome L Fleg; Judith S Hochman; David J Maron Journal: Circulation Date: 2021-09-15 Impact factor: 29.690
Authors: Michael Foley; Christopher A Rajkumar; Matthew Shun-Shin; Sashiananthan Ganesananthan; Henry Seligman; James Howard; Alexandra N Nowbar; Thomas R Keeble; John R Davies; Kare H Tang; Robert Gerber; Peter O'Kane; Andrew S P Sharp; Ricardo Petraco; Iqbal S Malik; Sukhjinder Nijjer; Sayan Sen; Darrel P Francis; Rasha Al-Lamee Journal: J Am Heart Assoc Date: 2021-01-26 Impact factor: 5.501