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Randomized Controlled Trial
. 2021 Dec 28;43(1):56-67.
doi: 10.1093/eurheartj/ehab441.

Ten-year all-cause death after percutaneous or surgical revascularization in diabetic patients with complex coronary artery disease

Rutao Wang  1   2   3 , Patrick W Serruys  2   4 , Chao Gao  1   2   3 , Hironori Hara  2   5 , Kuniaki Takahashi  5 , Masafumi Ono  2   5 , Hideyuki Kawashima  2   5 , Neil O'leary  2 , David R Holmes  6 , Adam Witkowski  7 , Nick Curzen  8 , Francesco Burzotta  9 , Stefan James  10 , Robert-Jan van Geuns  3 , Arie Pieter Kappetein  11 , Marie-Angele Morel  2 , Stuart J Head  11 , Daniel J F M Thuijs  11 , Piroze M Davierwala  12 , Timothy O'Brien  13 , Valentin Fuster  14 , Scot Garg  15 , Yoshinobu Onuma  2
Affiliations
Randomized Controlled Trial

Ten-year all-cause death after percutaneous or surgical revascularization in diabetic patients with complex coronary artery disease

Rutao Wang et al. Eur Heart J. .

Abstract

Aims: The aim of this article was to compare rates of all-cause death at 10 years following coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) in patients with or without diabetes.

Methods and results: The SYNTAXES study evaluated up to 10-year survival of 1800 patients with three-vessel disease (3VD) and/or left main coronary artery disease (LMCAD) randomized to receive either PCI or CABG in the SYNTAX trial. Ten-year all-cause death according to diabetic status and revascularization strategy was examined. In diabetics (n = 452), the risk of mortality was numerically higher with PCI compared with CABG at 5 years [19.6% vs. 13.3%, hazard ratio (HR): 1.53, 95% confidence interval (CI): 0.96, 2.43, P = 0.075], with the opposite seen between 5 and 10 years (PCI vs. CABG: 20.8% vs. 24.4%, HR: 0.82, 95% CI: 0.52, 1.27, P = 0.366). Irrespective of diabetic status, there was no significant difference in all-cause death at 10 years between patients receiving PCI or CABG, the absolute treatment difference was 1.9% in diabetics (PCI vs. CABG: 36.4% vs. 34.5%, difference: 1.9%, 95% CI: -7.6%, 11.1%, P = 0.551). Among insulin-treated patients (n = 182), all-cause death at 10 years was numerically higher with PCI (47.9% vs. 39.6%, difference: 8.2%, 95% CI: -6.5%, 22.5%, P = 0.227).

Conclusions: The treatment effects of PCI vs. CABG on all-cause death at 10 years in patients with 3VD and/or LMCAD were similar irrespective of the presence of diabetes. There may, however, be a survival benefit with CABG in patients with insulin-treated diabetes. The association between revascularization strategy and very long-term ischaemic and safety outcomes for patients with diabetes needs further investigation in dedicated trials.

Trial registration: SYNTAX: ClinicalTrials.gov reference: NCT00114972 and SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050.

Keywords: All-cause death; Coronary artery bypass grafting; Diabetes; Percutaneous coronary intervention; SYNTAX.

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Figures

None
The treatment effects of PCI versus CABG on all-cause death at 10 years in 3VD/LMCAD patients with pharmacologically treated diabetes and insulin-treated diabetes.
Figure 1
Figure 1
Kaplan–Meier curves for all-cause death at 10 years according to diabetes. (A) All-cause death at 10 years according to diabetes in the overall cohort. (B) All-cause death at 10 years according to diabetes in the percutaneous coronary intervention arm. (C) All-cause death at 10 years according to diabetes in the coronary artery bypass grafting arm. Event rates represent Kaplan–Meier estimates. Note: As Kaplan–Meier estimates, the rate is not the same as the ratio of the numerator and denominator.
Figure 2
Figure 2
Kaplan–Meier curves for all-cause death at 10 years according to treatment strategies in patients with (A) and without (B) diabetes. (A) All-cause death at 10 years according to treatment strategies in patients with diabetes. (B) All-cause death at 10 years according to treatment strategies in patients without diabetes. Event rates represent Kaplan–Meier estimates. Note: As Kaplan–Meier estimates, the rate is not the same as the ratio of the numerator and denominator.
Figure 3
Figure 3
All-cause death at 10 years in the percutaneous coronary intervention and coronary artery bypass grafting arms among diabetic or non-diabetic patients stratified by subgroups.
Figure 4
Figure 4
Kaplan–Meier plots showing the observed vs. predicted treatment benefit of coronary artery bypass grafting over percutaneous coronary intervention according to the SYNTAX score II 2020 in predicted benefit quarters in non-diabetic population (A) and diabetic population (B), and calibration plot (C) showing the observed vs. predicted treatment benefit (absolute difference in mortality between coronary artery bypass grafting and percutaneous coronary intervention) in patients with diabetes (red line) and without diabetes (blue line). The percentages in red or blue figuring in the illustration are the absolute risk differences between coronary artery bypass grafting and percutaneous coronary intervention in each quarter for the diabetic and non-diabetic population. Vertical dashed lines represent quartiles, and the solid red or blue lines represent the mean value and 95% CI of the observed absolute risk differences between coronary artery bypass grafting and percutaneous coronary intervention in each quartile. (D) The individual difference between the predicted mortality (solid lines) by SYNTAX Score II 2020 after either percutaneous coronary intervention or coronary artery bypass grafting as well as the individual observed mortality (dashed lines) in diabetic patients. Blue solid line represents the predicted mortality after percutaneous coronary intervention; Red solid line represents the predicted mortality after coronary artery bypass grafting; Blue dashed line represents the observed mortality after percutaneous coronary intervention; Red dashed line represents the observed mortality after coronary artery bypass grafting.
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