Michael R Jones1, George Howard2, Gary S Roubin3, Joseph L Blackshear4, David J Cohen5, Donald E Cutlip6, Pierre P Leimgruber7, David Rhodes2, Ronald J Prineas8, Stephen P Glasser9, Brajesh K Lal10, Jenifer H Voeks11, Thomas G Brott12. 1. Department of Cardiology, Baptist Health Lexington, KY (M.R.J.). 2. School of Public Health, Department of Biostatistics, University of Alabama at Birmingham, Birmingham AL (G.H., D.R.). 3. Cardiovascular Associates of the Southeast, Birmingham, AL (G.S.R.). 4. Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Jacksonville, FL (J.L.B.). 5. St. Luke's Mid America Heart Institute, University of Missouri, Kansas City School of Medicine, Kansas City, MO (D.J.C.). 6. Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (D.E.C.). 7. University of Washington School of Medicine, Washington State University Elson S. Floyd College of Medicine, Spokane, WA (P.P.L.). 8. Department of Public Health Services, Wake Forest School of Medicine, Winston Salem, NC (R.J.P.). 9. Division of Cardiology, Department of Medicine, University of Kentucky School of Medicine, Lexington, KY (S.P.G.). 10. Division of Vascular Surgery, Department of Surgery, University of Maryland School of Medicine, Baltimore, MD (B.K.L.). 11. Department of Neurology, College of Medicine, Medical University of South Carolina, Charleston, SC (J.H.V.). 12. Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).
Abstract
BACKGROUND: The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) previously reported increased mortality in patients who sustained a periprocedural stroke or cardiac event (myocardial infarction [MI] or biomarker only) in follow-up to 4 years. We now extend these observations to 10 years. METHODS AND RESULTS: CREST is a randomized controlled trial designed to compare the outcomes of carotid stenting versus carotid endarterectomy. Proportional hazards models were used to assess the association between mortality and periprocedural stroke, MI, or biomarker-only events. For 10-year follow-up, patients with periprocedural stroke were at 1.74× the risk of death compared with those without stroke (adjusted hazard ratio [HR]=1.74; 95% CI, 1.21-2.50; P<0.003). This increased risk was driven by increased early (between 0 and 90 days) mortality (adjusted HR=14.41; 95% CI, 5.33-38.94; P<0.0001), with no significant increase in late (between 91 days and 10 years) mortality (adjusted HR=1.40; 95% CI, 0.93-2.10; P=0.11). Patients with a protocol MI were at 3.61× increased risk of death compared with those without MI (adjusted HR=3.61; 95% CI, 2.28-5.73; P<0.0001), with an increased hazard both early (adjusted HR=8.20; 95% CI, 1.86-36.2; P=0.006) and late (adjusted HR=3.40; 95% CI, 2.09-5.53; P<0.0001). Patients with a biomarker-only event were at 2.04× increased risk overall (adjusted HR=2.04; 95% CI, 1.09-3.84; P=0.03) than those without MI, with an increased early hazard (adjusted HR=8.44; 95% CI, 1.09-65.5; P=0.04) and a suggestive but nonsignificant association toward higher 91-day to 10-year risk (1.88; 95% CI, 0.97-3.64; P=0.062) contributing to the increased risk. CONCLUSIONS: In the CREST trial, patients with periprocedural events demonstrate a substantial increase in future mortality to 10 years. For stroke, this risk is largely confined to an early time frame while periprocedural MI or biomarker-only events confer a continuous increased mortality for 10 years. Strategies to reduce periprocedural events and to optimize the evaluation and management of patients with cardiac events should be considered in efforts to reduce not only early but also long-term mortality. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00004732.
RCT Entities:
BACKGROUND: The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) previously reported increased mortality in patients who sustained a periprocedural stroke or cardiac event (myocardial infarction [MI] or biomarker only) in follow-up to 4 years. We now extend these observations to 10 years. METHODS AND RESULTS: CREST is a randomized controlled trial designed to compare the outcomes of carotid stenting versus carotid endarterectomy. Proportional hazards models were used to assess the association between mortality and periprocedural stroke, MI, or biomarker-only events. For 10-year follow-up, patients with periprocedural stroke were at 1.74× the risk of death compared with those without stroke (adjusted hazard ratio [HR]=1.74; 95% CI, 1.21-2.50; P<0.003). This increased risk was driven by increased early (between 0 and 90 days) mortality (adjusted HR=14.41; 95% CI, 5.33-38.94; P<0.0001), with no significant increase in late (between 91 days and 10 years) mortality (adjusted HR=1.40; 95% CI, 0.93-2.10; P=0.11). Patients with a protocol MI were at 3.61× increased risk of death compared with those without MI (adjusted HR=3.61; 95% CI, 2.28-5.73; P<0.0001), with an increased hazard both early (adjusted HR=8.20; 95% CI, 1.86-36.2; P=0.006) and late (adjusted HR=3.40; 95% CI, 2.09-5.53; P<0.0001). Patients with a biomarker-only event were at 2.04× increased risk overall (adjusted HR=2.04; 95% CI, 1.09-3.84; P=0.03) than those without MI, with an increased early hazard (adjusted HR=8.44; 95% CI, 1.09-65.5; P=0.04) and a suggestive but nonsignificant association toward higher 91-day to 10-year risk (1.88; 95% CI, 0.97-3.64; P=0.062) contributing to the increased risk. CONCLUSIONS: In the CREST trial, patients with periprocedural events demonstrate a substantial increase in future mortality to 10 years. For stroke, this risk is largely confined to an early time frame while periprocedural MI or biomarker-only events confer a continuous increased mortality for 10 years. Strategies to reduce periprocedural events and to optimize the evaluation and management of patients with cardiac events should be considered in efforts to reduce not only early but also long-term mortality. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00004732.
Authors: Thomas G Brott; Robert W Hobson; George Howard; Gary S Roubin; Wayne M Clark; William Brooks; Ariane Mackey; Michael D Hill; Pierre P Leimgruber; Alice J Sheffet; Virginia J Howard; Wesley S Moore; Jenifer H Voeks; L Nelson Hopkins; Donald E Cutlip; David J Cohen; Jeffrey J Popma; Robert D Ferguson; Stanley N Cohen; Joseph L Blackshear; Frank L Silver; J P Mohr; Brajesh K Lal; James F Meschia Journal: N Engl J Med Date: 2010-05-26 Impact factor: 91.245
Authors: Michael J Wolk; Steven R Bailey; John U Doherty; Pamela S Douglas; Robert C Hendel; Christopher M Kramer; James K Min; Manesh R Patel; Lisa Rosenbaum; Leslee J Shaw; Raymond F Stainback; Joseph M Allen Journal: J Am Coll Cardiol Date: 2013-12-16 Impact factor: 24.094
Authors: Joseph L Blackshear; Donald E Cutlip; Gary S Roubin; Michael D Hill; Pierre P Leimgruber; Richard J Begg; David J Cohen; John F Eidt; Craig R Narins; Ronald J Prineas; Stephen P Glasser; Jenifer H Voeks; Thomas G Brott Journal: Circulation Date: 2011-05-23 Impact factor: 29.690
Authors: P J Devereaux; Denis Xavier; Janice Pogue; Gordon Guyatt; Alben Sigamani; Ignacio Garutti; Kate Leslie; Purnima Rao-Melacini; Sue Chrolavicius; Homer Yang; Colin Macdonald; Alvaro Avezum; Luc Lanthier; Weijiang Hu; Salim Yusuf Journal: Ann Intern Med Date: 2011-04-19 Impact factor: 25.391
Authors: Michael D Hill; William Brooks; Ariane Mackey; Wayne M Clark; James F Meschia; William F Morrish; J P Mohr; J David Rhodes; Jeffrey J Popma; Brajesh K Lal; Mary E Longbottom; Jenifer H Voeks; George Howard; Thomas G Brott Journal: Circulation Date: 2012-11-16 Impact factor: 29.690
Authors: William J Powers; Colin P Derdeyn; José Biller; Christopher S Coffey; Brian L Hoh; Edward C Jauch; Karen C Johnston; S Claiborne Johnston; Alexander A Khalessi; Chelsea S Kidwell; James F Meschia; Bruce Ovbiagele; Dileep R Yavagal Journal: Stroke Date: 2015-06-29 Impact factor: 10.170
Authors: Robert J Beaulieu; Danielle C Sutzko; Jeremy Albright; Erin Jeruzal; Nicholas H Osborne; Peter K Henke Journal: JAMA Surg Date: 2020-02-01 Impact factor: 14.766
Authors: Jon S Matsumura; Bret M Hanlon; Kenneth Rosenfield; Jenifer H Voeks; George Howard; Gary S Roubin; Thomas G Brott Journal: J Vasc Surg Date: 2021-10-22 Impact factor: 4.860
Authors: Adam Mazurek; Krzysztof Malinowski; Kenneth Rosenfield; Laura Capoccia; Francesco Speziale; Gianmarco de Donato; Carlo Setacci; Christian Wissgott; Pasqualino Sirignano; Lukasz Tekieli; Andrey Karpenko; Waclaw Kuczmik; Eugenio Stabile; David Christopher Metzger; Max Amor; Adnan H Siddiqui; Antonio Micari; Piotr Pieniążek; Alberto Cremonesi; Joachim Schofer; Andrej Schmidt; Piotr Musialek Journal: J Clin Med Date: 2022-08-17 Impact factor: 4.964