Randomized Comparison of Percutaneous Coronary Intervention With Coronary Artery Bypass Grafting in Diabetic Patients 1-Year Results of the CARDia (Coronary Artery Revascularization in Diabetes) Trial

London Chest Hospital, Barts and The London NHS Trust, Imperial College, London, England.
Journal of the American College of Cardiology (Impact Factor: 16.5). 02/2010; 55(5):432-40. DOI: 10.1016/j.jacc.2009.10.014
Source: PubMed


The purpose of this study was to compare the safety and efficacy of percutaneous coronary intervention (PCI) with stenting against coronary artery bypass grafting (CABG) in patients with diabetes and symptomatic multivessel coronary artery disease.
CABG is the established method of revascularization in patients with diabetes and multivessel coronary disease, but with advances in PCI, there is uncertainty whether CABG remains the preferred method of revascularization.
The primary outcome was a composite of all-cause mortality, myocardial infarction (MI), and stroke, and the main secondary outcome included the addition of repeat revascularization to the primary outcome events. A total of 510 diabetic patients with multivessel or complex single-vessel coronary disease from 24 centers were randomized to PCI plus stenting (and routine abciximab) or CABG. The primary comparison used a noninferiority method with the upper boundary of the 95% confidence interval (CI) not to exceed 1.3 to declare PCI noninferior. Bare-metal stents were used initially, but a switch to Cypher (sirolimus drug-eluting) stents (Cordis, Johnson & Johnson, Bridgewater, New Jersey) was made when these became available.
At 1 year of follow-up, the composite rate of death, MI, and stroke was 10.5% in the CABG group and 13.0% in the PCI group (hazard ratio [HR]: 1.25, 95% CI: 0.75 to 2.09; p=0.39), all-cause mortality rates were 3.2% and 3.2%, and the rates of death, MI, stroke, or repeat revascularization were 11.3% and 19.3% (HR: 1.77, 95% CI: 1.11 to 2.82; p=0.02), respectively. When the patients who underwent CABG were compared with the subset of patients who received drug-eluting stents (69% of patients), the primary outcome rates were 12.4% and 11.6% (HR: 0.93, 95% CI: 0.51 to 1.71; p=0.82), respectively.
The CARDia (Coronary Artery Revascularization in Diabetes) trial is the first randomized trial of coronary revascularization in diabetic patients, but the 1-year results did not show that PCI is noninferior to CABG. However, the CARDia trial did show that multivessel PCI is feasible in patients with diabetes, but longer-term follow-up and data from other trials will be needed to provide a more precise comparison of the efficacy of these 2 revascularization strategies. (The Coronary Artery Revascularisation in Diabetes trial; ISRCTN19872154).

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    • "(10 years); individual end points Hueb et al 2010 39 MASSIII Circ 2010 308 Off-pump CABG On-pump CABG Composite: mortality, MI, CVA, revasc. (5 years) Kapur et al 2010 40 CARDia JACC 2010 510 PCI CABG Composite: mortality, MI, CVA (1 year) Moller et al 2010 41 Best Bypass Surgery Circ 2010 341 Off-pump CABG On-pump CABG Composite: mortality, MI, CVA, cardiac arrest, low CO syndrome, revasc. (30 days) Omran et al 2010 42 — JTCS 2010 220 CABG with ventral cardiac denervation CABG AF (in hospital) Veeger et al 2010 43 CABADAS ATS 2010 726 Aspirin/dipyridamole or warfarin after CABG Aspirin after CABG Composite: mortality CV, MI, revasc. "
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    ABSTRACT: Background: There is currently no accepted standard for reporting outcomes following cardiac surgery. The objective of this paper was to systematically review the literature to evaluate the current use and definition of perioperative outcomes reported in cardiac surgery trials. Methods and results: We reviewed 5 prominent medical and surgical journals on Medline from January 1, 2010, to June 30, 2014, for randomized controlled trials involving coronary artery bypass grafting and/or valve surgery. We identified 34 trials meeting inclusion criteria. Sample sizes ranged from 57 to 4752 participants (median 351). Composite end points were used as a primary outcome in 56% (n=19) of the randomized controlled trials and as a secondary outcome in 12% (n=4). There were 14 different composite end points. Mortality at any time (all-cause and/or cardiovascular) was reported as an individual end point or as part of a combined end point in 82% (n=28), myocardial infarction was reported in 68% (n=23), and bleeding was reported in 24% (n=8). Patient-centered outcomes, such as quality of life and functional classification, were reported in 29% (n=10). Definition of clinical events such as myocardial infarction, stroke, renal failure, and bleeding varied considerably among trials, particularly for postoperative myocardial infarction and bleeding, for which 8 different definitions were used for each. Conclusions: Outcome reporting in the cardiac surgery literature is heterogeneous, and efforts should be made to standardize the outcomes reported and the definitions used to ascertain them. The development of standardizing outcome reporting is an essential step toward strengthening the process of evidence-based care in cardiac surgery.
    Full-text · Article · Aug 2015 · Journal of the American Heart Association
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    • "In the pre-DES era, no specific trials were done on diabetic patients. After the introduction of DESs, multiple trials were done that either included patients with diabetes [11] [12] or were done specifically on this high-risk group [13] [14] [15]. "
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    ABSTRACT: OBJECTIVES: Coronary artery bypass grafting (CABG) was found to be the preferred strategy of revascularization in patients with diabetes in the bare-metal stent (BMS) era. The introduction of drug-eluting stents (DESs) led to a significant reduction in the rates of repeat revascularization (RRV) when compared with BMSs. We did a collaborative analysis of data from randomized controlled trials in the contemporary era to compare CABG versus percutaneous coronary intervention using DESs in diabetic patients. METHODS: We performed a systematic review and meta-analysis from randomized trials in the contemporary era comparing PCI with DESs with CABG in diabetic patients with multivessel disease. A comprehensive literature search (1 January 2003 to 18 May 2013) identified randomized controlled trials that reported long-term outcomes comparing PCI using DESs with CABG in 2974 diabetic patients. RESULTS: At 1 year, PCI was associated with a significant increase in the incidence of RRV [2.48 (1.56-3.94); P ≤0.0001], lower incidence of stroke [relative risk (RR) = 0.43 (0.19-0.81); P = 0.017], and no difference in death or myocardial infarction (MI). At 5 years, PCI was still associated with a lower incidence of stroke, but was associated with a significant increase in the incidence of death [RR = 1.36 (1.11-1.66); P = 0.0033] and MI [RR = 2.01 (1.54-2.62); P ≤0.0001]. CONCLUSIONS: In patients with diabetes, PCI was associated with no difference in death and MI at 1 year. However, at 5 years, PCI was associated with a higher incidence of death and MI. PCI was associated with a higher incidence of RRV but a lower incidence of stroke.
    Full-text · Article · Sep 2014 · Interactive Cardiovascular and Thoracic Surgery
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    • "Data abstraction from studies selected for pooled analyses of effectiveness of CABG versus PCI-DES in patients with DM-MVD. Study Dominguez-Franco et al (2009) Tarantini et al (2009) Yamagata et al (2010) Kim et al (2012) Onuma et al (2011) Mack et al (2011) Farkouh et al (2012) Kamalesh et al (2013) Kapur et al (2010) Country (source of data) "
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    ABSTRACT: Background: Currently, the appropriateness of percutaneous coronary intervention (PCI) using drug-eluting stents (DES) versus coronary artery bypass grafting (CABG) for patients with diabetes (DM) and multi-vessel disease (MVD) is uncertain due to limited evidence from few randomised controlled trials (RCTs). We aimed to compare the clinical effectiveness of CABG versus PCI-DES in DM-MVD patients using an evidence-based approach. Methods: A systematic review and meta-analyses were conducted to compare the risk of all-cause mortality, myocardial infarction (MI), repeat revascularisation, cerebrovascular events (CVE), and major adverse cardiac or cerebrovascular events (MACCE). Results: A total of 1,837 and 3,052 DM-MVD patients were pooled from four RCTs (FREEDOM, SYNTAX, VA CARDS, and CARDia) and five non-randomised studies. At mean follow-up of 3 years, CABG compared with PCI-DES was associated with a lower risk of all-cause mortality and MI in RCTs. By contrast, no significant differences were observed in the mean 3.5-year risk of all-cause mortality and MI in non-randomised trials. However, the risk of repeat revascularisations following PCI-DES compared with CABG was 2.3 (95% CI=1.8-2.8) and 3.0 (2.3-4.2)-folds higher in RCTs and non-randomised trials, respectively. Accordingly, the risk of MACCE at 3 years following CABG compared with PCI-DES was lower in both RCTs and non-randomised trials [0.65 (: 0.55-0.77); and 0.77 (0.60-0.98), respectively]. Conclusions: Based on our pooled results, we recommend CABG compared with PCI-DES for patients with DM-MVD. Although non-randomised trials suggest no additional survival-, MI-, and CVE- benefit from CABG over PCI-DES, these results should be interpreted with care.
    Full-text · Article · Jul 2014 · International journal of cardiology
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