Long-Term Survival Following Multivessel Revascularization in Patients With Diabetes: The FREEDOM Follow-On Study.
coronary artery disease
coronary revascularization
diabetes
Journal
Journal of the American College of Cardiology
ISSN: 1558-3597
Titre abrégé: J Am Coll Cardiol
Pays: United States
ID NLM: 8301365
Informations de publication
Date de publication:
19 02 2019
19 02 2019
Historique:
received:
13
10
2018
revised:
01
11
2018
accepted:
01
11
2018
pubmed:
15
11
2018
medline:
23
1
2020
entrez:
15
11
2018
Statut:
ppublish
Résumé
The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial demonstrated that for patients with diabetes mellitus (DM) and multivessel coronary disease (MVD), coronary artery bypass grafting (CABG) is superior to percutaneous coronary intervention with drug-eluting stents (PCI-DES) in reducing the rate of major adverse cardiovascular and cerebrovascular events after a median follow-up of 3.8 years. It is not known, however, whether CABG confers a survival benefit after an extended follow-up period. The purpose of this study was to evaluate the long-term survival of DM patients with MVD undergoing coronary revascularization in the FREEDOM trial. The FREEDOM trial randomized 1,900 patients with DM and MVD to undergo either PCI with sirolimus-eluting or paclitaxel-eluting stents or CABG on a background of optimal medical therapy. After completion of the trial, enrolling centers and patients were invited to participate in the FREEDOM Follow-On study. Survival was evaluated using Kaplan-Meier analysis, and Cox proportional hazards models were used for subgroup and multivariate analyses. A total of 25 centers (of 140 original centers) agreed to participate in the FREEDOM Follow-On study and contributed a total of 943 patients (49.6% of the original cohort) with a median follow-up of 7.5 years (range 0 to 13.2 years). Of the 1,900 patients, there were 314 deaths during the entire follow-up period (204 deaths in the original trial and 110 deaths in the FREEDOM Follow-On). The all-cause mortality rate was significantly higher in the PCI-DES group than in the CABG group (24.3% [159 deaths] vs. 18.3% [112 deaths]; hazard ratio: 1.36; 95% confidence interval: 1.07 to 1.74; p = 0.01). Of the 943 patients with extended follow-up, the all-cause mortality rate was 23.7% (99 deaths) in the PCI-DES group and 18.7% (72 deaths) in the CABG group (hazard ratio: 1.32; 95% confidence interval: 0.97 to 1.78; p = 0.076). In patients with DM and MVD, coronary revascularization with CABG leads to lower all-cause mortality than with PCI-DES in long-term follow-up. (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes [FREEDOM]; NCT00086450).
Sections du résumé
BACKGROUND
The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial demonstrated that for patients with diabetes mellitus (DM) and multivessel coronary disease (MVD), coronary artery bypass grafting (CABG) is superior to percutaneous coronary intervention with drug-eluting stents (PCI-DES) in reducing the rate of major adverse cardiovascular and cerebrovascular events after a median follow-up of 3.8 years. It is not known, however, whether CABG confers a survival benefit after an extended follow-up period.
OBJECTIVES
The purpose of this study was to evaluate the long-term survival of DM patients with MVD undergoing coronary revascularization in the FREEDOM trial.
METHODS
The FREEDOM trial randomized 1,900 patients with DM and MVD to undergo either PCI with sirolimus-eluting or paclitaxel-eluting stents or CABG on a background of optimal medical therapy. After completion of the trial, enrolling centers and patients were invited to participate in the FREEDOM Follow-On study. Survival was evaluated using Kaplan-Meier analysis, and Cox proportional hazards models were used for subgroup and multivariate analyses.
RESULTS
A total of 25 centers (of 140 original centers) agreed to participate in the FREEDOM Follow-On study and contributed a total of 943 patients (49.6% of the original cohort) with a median follow-up of 7.5 years (range 0 to 13.2 years). Of the 1,900 patients, there were 314 deaths during the entire follow-up period (204 deaths in the original trial and 110 deaths in the FREEDOM Follow-On). The all-cause mortality rate was significantly higher in the PCI-DES group than in the CABG group (24.3% [159 deaths] vs. 18.3% [112 deaths]; hazard ratio: 1.36; 95% confidence interval: 1.07 to 1.74; p = 0.01). Of the 943 patients with extended follow-up, the all-cause mortality rate was 23.7% (99 deaths) in the PCI-DES group and 18.7% (72 deaths) in the CABG group (hazard ratio: 1.32; 95% confidence interval: 0.97 to 1.78; p = 0.076).
CONCLUSIONS
In patients with DM and MVD, coronary revascularization with CABG leads to lower all-cause mortality than with PCI-DES in long-term follow-up. (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes [FREEDOM]; NCT00086450).
Identifiants
pubmed: 30428398
pii: S0735-1097(18)38994-0
doi: 10.1016/j.jacc.2018.11.001
pmc: PMC6839829
mid: NIHMS1056818
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT00086450']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
629-638Subventions
Organisme : CSRD VA
ID : IK2 CX001074
Pays : United States
Investigateurs
Samin K Sharma
(SK)
Tanim N Zazif
(TN)
Hoang Thai
(H)
Binita Shah
(B)
Krishnan Ramanathan
(K)
Jean-François Tanguay
(JF)
Krishnan Ramanathan
(K)
Jeffrey R Burton
(JR)
Erick Schampaert
(E)
Jorge Escobedo
(J)
Jean-Luc Dubois-Rande
(JL)
Carlos Macaya
(C)
Didier Carrie
(D)
Gert Richardt
(G)
Ariel Roguin
(A)
Chaim Lotan
(C)
Ran Kornowski
(R)
Patrizia Presbitero
(P)
Whady Hueb
(W)
J Eduardo Sousa
(JE)
Jorge G Velásquez
(JG)
Alfredo Rodriguez
(A)
Gerry Devlin
(G)
John K French
(JK)
Upendra Kaul
(U)
Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2019. Published by Elsevier Inc.
Références
Am Heart J. 2013 Aug;166(2):250-7
pubmed: 23895807
Can J Cardiol. 2014 Dec;30(12):1482-91
pubmed: 25475448
Eur J Cardiothorac Surg. 2013 May;43(5):1006-13
pubmed: 23413014
J Am Coll Cardiol. 2017 May 2;69(17):2212-2241
pubmed: 28291663
N Engl J Med. 2012 Dec 20;367(25):2375-84
pubmed: 23121323
Am Heart J. 2012 Oct;164(4):591-9
pubmed: 23067919
N Engl J Med. 2009 Jun 11;360(24):2503-15
pubmed: 19502645
N Engl J Med. 2015 Nov 12;373(20):1937-46
pubmed: 26559572
J Am Coll Cardiol. 2010 Feb 2;55(5):432-40
pubmed: 20117456
Circulation. 2001 Jul 31;104(5):533-8
pubmed: 11479249
J Am Coll Cardiol. 2014 Nov 4;64(18):1929-49
pubmed: 25077860
Eur Heart J. 2019 Jan 7;40(2):87-165
pubmed: 30165437
Circulation. 1997 Sep 16;96(6):1761-9
pubmed: 9323059
J Am Coll Cardiol. 2000 Apr;35(5):1122-9
pubmed: 10758950
J Am Coll Cardiol. 2007 Apr 17;49(15):1600-1606
pubmed: 17433949
N Engl J Med. 2015 Nov 26;373(22):2117-28
pubmed: 26378978
J Am Coll Cardiol. 2013 Apr 16;61(15):1607-15
pubmed: 23500281
J Am Coll Cardiol. 2017 Dec 19;70(24):2995-3006
pubmed: 29241487
N Engl J Med. 2015 Mar 26;372(13):1204-12
pubmed: 25774645
J Am Coll Cardiol. 2017 Sep 19;70(12):1452-1454
pubmed: 28851543
J Am Coll Cardiol. 2010 Mar 16;55(11):1067-75
pubmed: 20079596
N Engl J Med. 2016 Jul 28;375(4):311-22
pubmed: 27295427
J Am Coll Cardiol. 2013 Feb 26;61(8):808-16
pubmed: 23428214
J Am Coll Cardiol. 2016 Sep 6;68(10):985-95
pubmed: 27585501
Lancet. 2018 Mar 10;391(10124):939-948
pubmed: 29478841
Am Heart J. 2008 Feb;155(2):215-23
pubmed: 18215589