The prevalence of type 2 diabetes mellitus (DM) increased from 4.7 to 8.5% between 1980 and 2014 worldwide. Despite improvements in healthcare in many occidental countries in the last decades, all-cause mortality in DM patients is still higher than in the general population. Cardiovascular disease, and specifically coronary artery disease (CAD), is the leading cause of death nowadays [1,2]. The choice of the adequate coronary revascularization strategy in DM patients has been a matter of debate in the literature for over 2 decades, especially considering the multivessel nature of the CAD in this population [3,4]. In this review article, we will summarize the current evidence to support the decision-making process on how to choose the best coronary revascularization strategy in patients with DM and multivessel coronary disease (MVD).
EARLY EVIDENCE: EXPLORATORY ANALYZES AND INDIRECT COMPARISONS
In the early 2000s, BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) was the first trial explicitly designed to focus on coronary revascularization for DM patients . It was designed after a subanalysis of the DM population in the previous BARI trial, which showed a survival benefit favoring coronary artery bypass grafting (CABG) over balloon angioplasty in that population [6,7]. Although BARI 2D did not directly compare PCI versus CABG, those selected for CABG experienced a lower rate of major cardiovascular events when compared with optimal medical therapy (OMT) alone (69.5 versus 77.6%, P = 0.01). This was not observed in the PCI group (mostly performed with bare metal stents) .
A 1-year subanalysis of the DM patients from the SYNTAX (Synergy between percutaneous coronary intervention with Taxus and cardiac surgery) study showed a lower incidence of all-cause death, myocardial infarction (MI), stroke, and repeat revascularization in CABG patients when compared to PCI [14.2 versus 26.0%, relative risk 1.83, 95% confidence interval (95% CI) 1.22–2.73, P = 0.003, interaction P = 0.12], mainly in patients with higher SYNTAX scores . Subsequent analyses of randomized trials focusing on their DM population showed similar results, such as in ARTS, AWESOME, and MASS trials [9–11].
RANDOMIZED CLINICAL DATA
CARDia (Coronary Artery Revascularization in Diabetes) was the first trial to randomize DM patients to either CABG or PCI. A total of 510 diabetic patients were included (60% with MVD), with a 1-year follow-up. Although underpowered for its primary outcome, CARDia reported a rate of 10.5% for the composite of death, MI, and stroke in CABG patients, versus 13.0% in the PCI group (P = 0.39), concluding that PCI was not noninferior to CABG [12,13].
In 2012, Farkouh et al.  published the FREEDOM trial (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease). This was the first international multicenter randomized clinical trial properly powered to evaluate two different revascularization strategies (PCI with a drug-eluting stent (DES) – paclitaxel or sirolimus – versus CABG) in MVD patients with DM and stable ischemic heart disease and on top of current OMT. A total of 1900 patients were randomized, 83% with MVD. After a median follow-up of 3.8 years, CABG was associated with a reduction in the composite of all-cause mortality, nonfatal MI and nonfatal stroke (18.7 versus 26.6%, P = 0.005). Decreases in rates of both MI (6.0 versus 13.9%, P < 0.001) and death from any cause (10.9 versus 16.3%, P = 0.049) were observed. Of note, a slight increase in the number of strokes in the CABG group (5.2 versus 2.4%, P = 0.03) was also observed.
In a prespecified secondary analysis of the FREEDOM trial, CABG, when compared to PCI, was also associated with improvements in quality of life, angina frequency, and physical limitation, after a 2-year follow-up . Another FREEDOM subanalysis looked at the cost-effectiveness of CABG versus PCI, from the perspective of the U.S. healthcare system. CABG was associated with an increase in initial costs, but that was attenuated during the subsequent years, due to the need of repeat revascularization and the use of more cardiac medications in the PCI arm. When extrapolating FREEDOM results for a lifespan, CABG was found to be particularly cost-effective, compared to PCI .
Left ventricular dysfunction
Diabetes is considered a risk factor for heart failure and the association between those two conditions is being studied in some current clinical trials . Few data are available, though, regarding revascularization procedures in this subset of patients, as they were mostly excluded from the previous studies. On the other hand, in the landmark STICHES trial, that compared CABG plus OMT versus OMT alone in patients with left ventricular dysfunction, only 40% of the total 1212 patients had DM and no PCI arm was available for comparison .
Recently, a retrospective registry data analysis combined all revascularization procedures performed in patients with DM, MVD and left ventricular dysfunction in the province of Alberta, Canada, from 2004 to 2016. Propensity-matched DM patients (n = 1738) were categorized according to their revascularization procedure (CABG or PCI). In these patients, 56% had left ventricular ejection fraction (LVEF) between 35 and 49%, and 44% had LVEF lower than 34%. After 5.5 years, CABG patients experienced a lower incidence of the primary outcome, a composite of death, stroke, MI, and repeat revascularization (MACCE). Specifically, this finding was demonstrated in both LVEF strata, where the hazard ratio for MACCE in the 35–49% LVEF stratum was 1.97 (95% CI 1.64–2.35, P < 0.001) and for the LVEF less than 35% stratum, the hazard ratio was 2.28 [95% confidence interval (CI) 1.79–2.90, P < 0.001]. Importantly, there was also a reduction in death in both strata, while no increase in the rates of stroke was noted [19▪▪].
Few data are available about revascularization procedures in patients with DM, MVD, and chronic kidney disease (CKD), since most studies on coronary revascularization in patients with CKD usually do not focus specifically on diabetic patients [20,21].
In a recently reported subanalysis of the MASS II trial, authors studied outcomes of 493 DM patients with MVD and mild [estimated Glomerular Filtration Rate (eGFR) 60-89ml/min] or moderate (eGFR 30–59 ml/min) CKD according to the treatment group (PCI, CABG, or OMT only). OMT was associated with an increase in the composite of all-cause mortality, MI, and need for additional revascularization in patients with mild CKD, in comparison to CABG (hazard ratio 2.55, 95% CI 1.01–6.45, P = 0.04). This effect was not observed when comparing PCI to OMT or PCI versus CABG .
A FREEDOM as-treated analysis published in 2016 presented outcomes for 451 patients with CKD (mean eGFR was 47 ml/min/1.73 m2, excluding patients requiring dialysis). CABG effect on a composite end-point of death, MI, and stroke was consistent among those with or without CKD, with no evidence of interaction (hazard ratio between CABG and PCI in patients with CKD: 0.73, 95% CI 0.5–1.05, P for interaction = 0.83) [23▪]. Also, after performing their revascularization procedure, 210 patients in the FREEDOM trial developed acute kidney injury (AKI). AKI was more frequently observed in the CABG group (14.3% in CABG versus 8.5% in PCI, P < 0.001), and it doubled the risk of 5-year MACCE in both treatment arms (30% of risk in patients with AKI versus 17% in patients without AKI, P < 0.001) .
Type 1 diabetes mellitus
Type 1 DM is usually underrepresented in clinical trials, due to its lower prevalence in the overall population compared to type 2 DM [25,26]. Recently, a research group from Sweden published a registry-based analysis with all type 1 DM patients who underwent a revascularization procedure in that country, from 1995 through 2013. In total, 663 patients underwent CABG and 1863 PCI. After a mean follow-up of 10.6 years, the risk for all-cause mortality was the same in the CABG and in the PCI group (hazard ratio 1.14, 95% CI 0.99–1.32), as well the risk of stroke (hazard ratio 1.00, 95% CI 0.76–1.31) or heart failure (hazard ratio 1.10, 95% CI 0.91–1.32). On the other hand, the risks for death from coronary heart disease (hazard ratio 1.45, 95% CI 1.21–1.74), MI (hazard ratio 1.47, 95% CI 1.23–1.78), and repeat revascularization (hazard ratio 5.64, 95% CI 4.67–6.82) were higher with PCI. Of note, patients in the PCI arm had more comorbidities including a higher prevalence of prior stroke, heart failure, active cancer, and end-stage CKD [27▪▪,28].
Revascularization following an acute coronary syndrome
Despite the fact that around 35% of DM patients with non-ST segment elevation MI in the US end up undergoing CABG [29▪], this practice is based mainly on the evidence for stable populations (Fig. 1) [30,31]. No large randomized trial has adequately studied this question .
At the end of 2017, Ramanathan et al. [33▪▪] published a registry-based analysis, including all revascularization procedures performed in patients with DM and MVD in the province of British Columbia, Canada, between 2007 and 2014. Both acute (n = 3017) and stable (n = 1802) patients were included, yielding a total of 2888 PCIs and 1931 CABGs. CABG was associated with a reduction in overall MACCE (all-cause death, nonfatal MI, and stroke; 29.8% for PCI versus 16.7% for CABG; P < 0.01), including all-cause mortality (19.0% versus 10.3%, P < 0.01), after a mean follow-up of 3.3 years. When analyzing acute coronary syndrome patients only, CABG also conveyed lower rates of MACCE (33.4 versus 20.8%; P < 0.01), death (22.3 versus 12.4; P < 0.01), MI (17.6 versus 9.9; P < 0.01) and repeat revascularization (22.6 versus 8.2; P < 0.01). Importantly, even in the initial 30 days following the revascularization procedures, rates for MACCE, death, and MI were significantly lower in the CABG group from the ACS population, which was not observed in other revascularization studies that predominantly targeted patients with stable ischemic coronary disease.
New generation stents
Newer stent generations have been developed in the recent years, but that is unlikely to change the overall clinical benefits offered by CABG in the DM population . Considering the chronological sequence of results from BARI (comparing CABG versus PCI with balloon angioplasty), BARI 2D (PCI with bare metal stents) and FREEDOM (PCI with first-generation DES) trials, CABG has been consistently related to lower rates of adverse outcomes in DM patients [5,6,14]. In two recently reported cohort studies from Japan and China, comparing CABG versus PCI with DES (mainly first-generation DES), CABG was also superior in patients with DM [35,36].
The use of second-generation DES, on the other hand, was not yet tested against CABG in a clinical trial within the DM population. A meta-analysis published in 2014 reported similar mortality rates when making indirect comparisons of CABG versus second-generation everolimus DES (hazard ratio 1.11, 95% CI 0.67–1.84) . In the following year, everolimus DES was also compared against CABG in a registry-based analysis, comprising 8096 propensity-score matched DM patients with MVD. Although the observed lower risk of death with everolimus DES PCI within the first month (hazard ratio 0.58, 95% CI 0.34–0.98, P = 0.04), in the long-term follow-up (up to 4 years), the occurrence of death was similar between treatments (hazard ratio 1.12, 95% CI 0.96–1.30, P = 0.16). A higher rate of MI (hazard ratio 1.64, 95% CI 1.32–2.04, P < 0.0001) and repeat revascularization (hazard ratio 2.42, 95% CI 2.12–2.76, P < 0.0001) was observed with PCI. Of note, only 20% of the PCI patients attained complete revascularization. For the remaining 80% (n = 6600) patients, the long-term survival with CABG was still superior than with PCI (hazard ratio 1.20, 95% CI 1.01–1.42, P = 0.03; P for interaction = 0.05) .
Finally, the BEST trial (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) also attempted to compare PCI with everolimus DES and CABG in 880 patients with MVD, 40% of them with DM. Although BEST was underpowered (due to slow enrollment) and with overall neutral result, the DM subgroup experienced significantly lower rates of the composite of death, MI and target-vessel revascularization when submitted to CABG (19.2 versus 9.1%, P = 0.007), at 2 years after randomization, with a borderline P value for interaction (0.06) .
RESULTS FROM META-ANALYSIS
Several recently published meta-analysis have compared revascularization outcomes in the DM population [40–42]. We will briefly highlight the findings of the key papers.
In 2013, Verma et al.  reported the pooled results of 3612 DM patients from eight randomized trials. CABG was associated with a decrease in all-cause mortality at 5 years when compared to PCI (risk ratio 0.67, 95% CI 0.52–0.86, P = 0.002), lower repeat revascularization (risk ratio 0.41, 95% CI 0.29–0.59), higher stroke rate (risk ratio 1.72, 95% CI 1.18–2.53) and comparable rate of MI (risk ratio 0.76, 95% CI 0.44–1.29). Similar results were also found in another meta-analysis published in 2014 .
A patient-level analysis included data of 5034 DM patients (77% with MVD) from FREEDOM, BARI-2D, and COURAGE trials. During a median 4.5-year follow-up, CABG was associated with lower rates of death (hazard ratio 0.76, 95% CI 0.60–0.96, P = 0.024) and MI (hazard ratio 0.50, 95% CI 0.38–0.67, P = 0.0001), with a similar rate of stroke (hazard ratio 1.54, 95% CI 0.96–2.48, P = 0.074) (Fig. 2) [45▪▪].
Finally, in 2018, Head et al. reported patient-level data from 11 trials, comparing CABG and PCI in patients with stable ischemic coronary disease. Importantly, 34.2% of the PCI procedures were done with a newer generation DES. In the subgroup with DM (n = 4386 patients), there was a 15.5% mortality event-rate in the PCI group compared to 10.0% in CABG group (hazard ratio 1.44, 95% CI 1.20–1.74, P = 0.0001) after a 5-year follow-up. No previous trials had enough power to evaluate mortality in this population individually (see Fig. 2) [46▪▪,47].
The recommendations from contemporary guidelines favor CABG over PCI as the optimal revascularization strategy in patients with DM and MVD. Needless to say, any specific patient decision should consider whether coronary anatomy and clinical conditions are suitable or not for CABG, as well as patient preferences and local resources and expertise.
The 2017 Appropriate Use Criteria for Coronary Revascularization in Patients With Stable Ischemic Heart Disease from the American College of Cardiology, American Heart Association (and other societies) state that, among other indications, it is appropriate to use CABG :
- In DM patients with three-vessel disease with intermediate or high disease complexity (SYNTAX score >22), irrespective of the risk findings on noninvasive tests.
- In DM patients with three-vessel disease with low disease complexity (SYNTAX score ≤22), with intermediate or high-risk findings on noninvasive testing.
- In DM patients with two-vessel disease and left anterior descending artery (LAD) involvement, associated to intermediate or high risk findings on noninvasive tests and/or an invasive fractional flow reserve ≤0.80 in both vessels.
- In highly symptomatic DM patients with two-vessel disease and LAD involvement, even with low risk findings on noninvasive tests.
Recommendations from European Society of Cardiology, Canadian Cardiovascular Society, and American College of Cardiology/American Heart Association guidelines can be found in Table 1 [49–51].
In light of the most recent clinical evidence, CABG should be the preferable revascularization strategy in patients with DM and MVD, especially with LAD involvement. In this population, CABG reduces the long-term occurrence of MI, repeat revascularization and, eventually, death, with a similar risk of stroke, when compared to PCI. Given the multivessel nature of the coronary disease in patients with DM, it is not expected that a localized intervention, namely PCI, will be able to reduce those clinical outcomes at the long-term. Bypassing the remaining lesions, preferably with an arterial graft, is more likely to prevent the occurrence of future events.
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Conflicts of interest
There are no conflicts of interest.
REFERENCES AND RECOMMENDED READING
Papers of particular interest, published within the annual period of review, have been highlighted as:
- ▪ of special interest
- ▪▪ of outstanding interest
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In this paper, authors report a FREEDOM trial analysis including 451 patients with DM, MVD, and CKD. Effects of CABG and PCI are studied in this population. Particular attention should be drawn at the survival curves (Fig. 2 in the article). By examining those curves, it is possible to analyze the impact of both revascularization method and CKD on each major outcome in this population.
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In this registry-based analysis from British Columbia, Canada, authors tracked all revascularization procedures performed in DM patients with MVD in that province over an 8-year period. The authors reported outcomes separately for acute coronary syndrome patients, and this gives us an excellent perspective on how CABG and PCI perform in this setting, not yet evaluated in a randomized trial.
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This is a patient-level analysis of 5034 DM patients from three US federally funded trials: FREEDOM, BARI-2D, and COURAGE. A central figure of this article is partially reproduced in this review (view Fig. 2). The authors were able to delineate a triple comparison among CABG, PCI, and also OMT alone.
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This is one of the largest pooled analysis focusing on cardiovascular outcomes following revascularization procedures published to date. The authors were able to include contemporary trials, incorporating the most recent improvements in medical and intervention therapy. It is worth comparing how hazard ratios for mortality increased when analyzing data for the whole population, then for multivessel patients only, and finally for diabetic patients. In an accompanying editorial (reference ), the findings are put into perspective and suggestions are given on how to incorporate them into clinical practice.
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