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Microvascular and Macrovascular Disease and Risk for Major 1796 Diabetes Care Volume 39, October 2016 Microvascular and Macrovascular Kamel Mohammedi,1 Mark Woodward,1,2,3 Yoichiro Hirakawa,1 Disease and Risk for Major Sophia Zoungas,1,4 Bryan Williams,5 Liu Lisheng,6 Anthony Rodgers,1 Peripheral Arterial Disease in Giuseppe Mancia,7 Bruce Neal,1 Stephen Harrap,8 Michel Marre,9,10,11 and Patients With Type 2 Diabetes John Chalmers,1 on behalf of the ADVANCE Collaborative Group Diabetes Care 2016;39:1796–1803 | DOI: 10.2337/dc16-0588 OBJECTIVE Peripheral arterial disease (PAD) is a common manifestation of atherosclerosis in 1 type 2 diabetes, but the relationship between other vascular diseases and PAD has The George Institute for Global Health, University of Sydney, Sydney, New South Wales, Australia been poorly investigated. We examined the impact of previous microvascular and 2The George Institute for Global Health, Univer- macrovascular disease on the risk of major PAD in patients with type 2 diabetes. sity of Oxford, Oxford, U.K. 3Department of Epidemiology, Johns Hopkins RESEARCH DESIGN AND METHODS University, Baltimore, MD 4 We analyzed 10,624 patients with type 2 diabetes free from baseline major PAD in Monash Centre for Health Research and Imple- mentation, School of Public Health and Preven- the Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Con- tive Medicine, Monash University, Clayton, trolled Evaluation (ADVANCE) clinical trial. The primary composite outcome was Victoria, Australia major PAD defined as PAD-induced death, peripheral revascularization, lower- 5Institute of Cardiovascular Sciences, University limb amputation, or chronic ulceration. The secondary end points were the PAD College London (UCL) and National Institute of Health Research UCL Hospitals Biomedical Re- components considered separately. search Centre, London, U.K. 6The Chinese Hypertension League Institute, RESULTS Beijing, China Major PAD occurred in 620 (5.8%) participants during 5 years of follow-up. Base- 7The University of Milan-Bicocca and Istituto line microvascular and macrovascular disease were both associated with sub- Auxologico Italiano, Milan, Italy 8The University of Melbourne and Royal Mel- sequent risk of major PAD after adjustment for age, sex, region of origin, and bourne Hospital, Melbourne, Victoria, Australia randomized treatments. However, only microvascular disease remained signifi- 9INSERM, UMRS 1138, Centre de Recherche des cantly associated with PAD after further adjustment for established risk factors. Cordeliers, Paris, France 10 ˆ The highest risk was observed in participants with a history of macroalbuminuria Assistance Publique Hopitaux de Paris, Bichat PATHOPHYSIOLOGY/COMPLICATIONS Hospital, DHU FIRE, Department of Diabetology, (hazard ratio 1.91 [95% CI 1.38–2.64], P < 0.0001) and retinal photocoagulation Endocrinology and Nutrition, Paris, France therapy (1.60 [1.11–2.32], P = 0.01). Baseline microvascular disease was also 11Universite´ Paris Diderot, Sorbonne Paris Cite,´ associated with a higher risk of chronic lower-limb ulceration (2.07 [1.56–2.75], UFR de Medecine,´ Paris, France P < 0.0001) and amputation (1.59 [1.15–2.22], P = 0.006), whereas baseline macro- Corresponding author: John Chalmers, chalmers@ vascular disease was associated with a higher rate of angioplasty procedures (1.75 georgeinstitute.org.au. [1.13–2.73], P =0.01). Received 18 March 2016 and accepted 4 July 2016. CONCLUSIONS Clinical trial reg. no. NCT00145925, clinicaltrials .gov. Microvascular disease, particularly macroalbuminuria and retinal photocoagula- tion therapy, strongly predicts major PAD in patients with type 2 diabetes, but This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/ macrovascular disease does not. suppl/doi:10.2337/dc16-0588/-/DC1. © 2016 by the American Diabetes Association. Type 2 diabetes is associated with an increased risk of premature death (1). Cardio- Readers may use this article as long as the work is properly cited, the use is educational and not vascular disease is the leading cause of morbidity and mortality in patients with for profit, and the work is not altered. More infor- type 2 diabetes, who have two to three times the risk of developing myocardial mation is available at http://www.diabetesjournals infarction and stroke compared with people without diabetes (2). Peripheral arterial .org/content/license. care.diabetesjournals.org Mohammedi and Associates 1797 disease (PAD) is a common and severe ethics committee of each participating Malaysia, and India), established market clinical manifestation of atherosclerosis center, and all participants provided writ- economies (Australia, Canada, France, (3,4) and is especially frequent in pa- ten informed consent. All participants in Germany, Ireland, Italy, the Netherlands, tients with type 2 diabetes, with an ap- ADVANCE were included in the current New Zealand, and U.K.), and Eastern proximately threefold increased risk study except 516 for whom a history of Europe (Czech Republic, Estonia, Hun- compared with a population without di- PAD was established at baseline. PAD gary, Lithuania, Poland, Russia, and abetes (5). In the Action in Diabetes and was defined at baseline as a lower-limb Slovakia). Asia was considered the ref- Vascular Disease: Preterax and Diamicron amputation of at least one digit, chronic erence group on the basis of a previous MR Controlled Evaluation (ADVANCE) ulceration of a lower limb ($6 weeks) report of low prevalence of PAD in clinical trial, the incidence of PAD was believed to be due to arterial insuffi- Asians (13). Estimated glomerular filtra- comparable to the incidence of major ciency, or a peripheral revasculari- tion rate (eGFR) was computed using coronary events and stroke (6). PAD is zation procedure (surgery, angioplasty, the Chronic Kidney Disease Epidemiol- associated with poor outcomes, leading or emergency thrombolysis). ogy Collaboration equation. Cognitive to a high rate of amputation and death function was estimated by the Mini- (7), and has been associated with an in- Primary and Secondary End Points Mental State Examination (MMSE) score creased risk of cardiovascular morbidity The primary composite outcome for this and considered as normal (MMSE score fi and mortality (8,9). PAD mainly affects analysis was major PAD, de ned as at $28) or reduced (MMSE score ,28). the infrapopliteal arteries and may in- baseline, or death as a result of PAD. Educational accomplishment was de- duce more damage in small than in Each PAD outcome was considered sep- fined as age at completion of the highest large vessels in patients with type 2 di- arately as a secondary end point. PAD levelofformaleducationandcatego- abetes (7,10). The impact of prevalent outcomes were collected systematically rized as basic ($16 years) or low (#15 macrovascular or microvascular disease for all participants during the scheduled years). History of microvascular disease on the risk of developing PAD has not study visits every 2 years from case re- was defined as the presence at baseline yet been reliably compared in a contem- port forms and from reports of serious of at least macroalbuminuria (urinary porary cohort of patients with type 2 adverse events, without adjudication. albumin-to-creatinine ratio [ACR] .300 diabetes. The aim of the current study Information about the occurrence of mg/mg), retinal photocoagulation ther- was to determine the impact of micro- study outcomes and of all serious ad- apy, proliferative retinopathy, macular vascular and macrovascular disease at verse events was reported at the time edema, or blindness. History of macro- baseline on the development of major of occurrence between visits. When vascular disease was defined as the PAD during follow-up in the ADVANCE study outcomes or serious adverse presence at baseline of at least myocar- study. events occurred, the responsible inves- dial infarction, stroke, coronary artery tigator of each center ensured that the bypass graft, percutaneous transluminal RESEARCH DESIGN AND METHODS event was reported immediately by coronary angioplasty, hospital admis- completing a serious adverse events Participants sion for unstable angina, or transient ADVANCE was a large, multicenter, in- form. The data and safety monitoring ischemic attack. ternational randomized trial in patients committee regularly reviewed all such with type 2 diabetes (11). Its objectives events for each center. Statistical Analyses were to test the effects of intensive glu- Quantitative variables were expressed Selection of Candidate Risk Factors for cose control by using a gliclazide modi- as mean (SD) or median (interquartile Major PAD fi – ed release basedregimenandblood The initial set of candidate risk factors range) for those with skewed distribu- fi pressure treatment by using a xed- for the development of major PAD col- tions. Categorical parameters were ex- dose combination of perindopril and lected in ADVANCE at baseline were all pressed as numbers and percentages. indapamide on the incidence of major demographic, anthropometric, and clini- Characteristics of participants accord- microvascular and macrovascular events. cal parameters; risk factors for cardiovas- ing to the incidence of major PAD were The design and clinical characteristics of cular diseases; renal function biomarkers; compared at baseline in each individual x2 participants in ADVANCE have been cognitive function; and educational ac- region of origin by using ,ANOVA,or fl published previously (6,11,12). Brie y, complishment. Candidate risk
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