TY - JOUR
T1 - Impact of established cardiovascular disease on 10-year death after coronary revascularization for complex coronary artery disease
AU - Wang, Rutao
AU - Garg, Scot
AU - Gao, Chao
AU - Kawashima, Hideyuki
AU - Ono, Masafumi
AU - Hara, Hironori
AU - van Geuns, Robert-Jan
AU - Morice, Marie-Claude
AU - Davierwala, Piroze M.
AU - Kappetein, Arie Pieter
AU - Holmes, David R.
AU - Wijns, William
AU - Tao, Ling
AU - Onuma, Yoshinobu
AU - Serruys, Patrick W.
N1 - Funding Information: The SYNTAX Extended Survival study was supported by the German Foundation of Heart Research (Frankfurt am Main, Germany). The SYNTAX trial, during 0- to 5-year follow-up, was funded by Boston Scientific Corporation (Marlborough, MA, USA). Both sponsors had no role in the study design, data collection, data analyses and interpretation of the study data, nor were involved in the decision to publish the final manuscript. The principal investigators and authors had complete scientific freedom. This work, RW, CG and WW are supported by Science Foundation Research Professorship Award (15/RP/2765). Funding Information: The design and the primary results of the SYNTAX trial have been published previously [–]. Briefly, the SYNTAX trial (NCT00114972) was an international, multi-centre, randomised controlled trial which randomised all-comers patients with de novo 3VD and/or LMCAD, deemed eligible for both PCI and CABG, in a 1:1 fashion to either CABG (n = 897) or PCI (n = 903) with the TAXUS Express paclitaxel-drug eluting stents (Boston Scientific Corporation, Marlborough, MA, USA). The SYNTAX trial completed patient follow-up at 5 years []. The SYNTAXES study (NCT03417050) was an investigator-driven initiative that extended follow-up and aimed to evaluate vital status up to 10 years [], funded by the German Heart Research Foundation (GHF; Frankfurt am Main, Germany). Follow-up was performed in accordance with local regulations of each participating centre and complied with the Declaration of Helsinki. Funding Information: Dr. Hara reports a grant for studying overseas from Japanese Circulation Society, a grant-in-Aid for JSPS Fellows and a grant from Fukuda Foundation for Medical Technology. Dr. van Geuns reports grants and personal fees from Boston Scientific, grants and personal fees from Abbott Vascular, grants and personal fees from Astra Zeneca, grants and personal fees from Amgen, grants from InfraRedx, outside the submitted work. Dr. Morice reports to work as the CEO of CERC, a CRO which was never involved in the SYNTAX trial at any level, except that submitted the 10-year additional follow-up (for free) to French authorities to get approval. Dr. Morice also reports to work as minor shareholder of electroducer. Dr. Kappetein reports to work as an employee of Medtronic, outside the submitted work. Dr. Wijns reports research grant and honoraria from MicroPort; medical advisor Rede Optimus Research and co-founder Argonauts, an innovation facilitator. Dr. Serruys reports personal fees from Biosensors, Micel Technologies, Sinomedical Sciences Technology, Philips/Volcano, Xeltis, and HeartFlow, outside the submitted work. All the other authors have no disclosures. Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/10
Y1 - 2021/10
N2 - Aims: To investigate the impact of established cardiovascular disease (CVD) on 10-year all-cause death following coronary revascularization in patients with complex coronary artery disease (CAD). Methods: The SYNTAXES study assessed vital status out to 10 years of patients with complex CAD enrolled in the SYNTAX trial. The relative efficacy of PCI versus CABG in terms of 10-year all-cause death was assessed according to co-existing CVD. Results: Established CVD status was recorded in 1771 (98.3%) patients, of whom 827 (46.7%) had established CVD. Compared to those without CVD, patients with CVD had a significantly higher risk of 10-year all-cause death (31.4% vs. 21.7%; adjusted HR: 1.40; 95% CI 1.08–1.80, p = 0.010). In patients with CVD, PCI had a non-significant numerically higher risk of 10-year all-cause death compared with CABG (35.9% vs. 27.2%; adjusted HR: 1.14; 95% CI 0.83–1.58, p = 0.412). The relative treatment effects of PCI versus CABG on 10-year all-cause death in patients with complex CAD were similar irrespective of the presence of CVD (p -interaction = 0.986). Only those patients with CVD in ≥ 2 territories had a higher risk of 10-year all-cause death (adjusted HR: 2.99, 95% CI 2.11–4.23, p < 0.001) compared to those without CVD. Conclusions: The presence of CVD involving more than one territory was associated with a significantly increased risk of 10-year all-cause death, which was non-significantly higher in complex CAD patients treated with PCI compared with CABG. Acceptable long-term outcomes were observed, suggesting that patients with established CVD should not be precluded from undergoing invasive angiography or revascularization. Trial registration: SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050. Graphic abstract: [Figure not available: see fulltext.]
AB - Aims: To investigate the impact of established cardiovascular disease (CVD) on 10-year all-cause death following coronary revascularization in patients with complex coronary artery disease (CAD). Methods: The SYNTAXES study assessed vital status out to 10 years of patients with complex CAD enrolled in the SYNTAX trial. The relative efficacy of PCI versus CABG in terms of 10-year all-cause death was assessed according to co-existing CVD. Results: Established CVD status was recorded in 1771 (98.3%) patients, of whom 827 (46.7%) had established CVD. Compared to those without CVD, patients with CVD had a significantly higher risk of 10-year all-cause death (31.4% vs. 21.7%; adjusted HR: 1.40; 95% CI 1.08–1.80, p = 0.010). In patients with CVD, PCI had a non-significant numerically higher risk of 10-year all-cause death compared with CABG (35.9% vs. 27.2%; adjusted HR: 1.14; 95% CI 0.83–1.58, p = 0.412). The relative treatment effects of PCI versus CABG on 10-year all-cause death in patients with complex CAD were similar irrespective of the presence of CVD (p -interaction = 0.986). Only those patients with CVD in ≥ 2 territories had a higher risk of 10-year all-cause death (adjusted HR: 2.99, 95% CI 2.11–4.23, p < 0.001) compared to those without CVD. Conclusions: The presence of CVD involving more than one territory was associated with a significantly increased risk of 10-year all-cause death, which was non-significantly higher in complex CAD patients treated with PCI compared with CABG. Acceptable long-term outcomes were observed, suggesting that patients with established CVD should not be precluded from undergoing invasive angiography or revascularization. Trial registration: SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050. Graphic abstract: [Figure not available: see fulltext.]
KW - CABG
KW - Cardiovascular disease
KW - Left main coronary artery disease
KW - PCI
KW - Three-vessel disease
UR - http://www.scopus.com/inward/record.url?scp=85113392733&partnerID=8YFLogxK
U2 - https://doi.org/10.1007/s00392-021-01922-y
DO - https://doi.org/10.1007/s00392-021-01922-y
M3 - Article
C2 - 34432113
SN - 1861-0684
VL - 110
SP - 1680
EP - 1691
JO - Clinical research in cardiology
JF - Clinical research in cardiology
IS - 10
ER -