Impact of Persistent Medication Adherence and Compliance with Lifestyle Recommendations on Major Cardiovascular Events and One-Year Mortality in Patients with Type 2 Diabetes and Advanced Stages of Atherosclerosis: Results From a Prospective Cohort Study.

Background: The aim of this study was to evaluate the impact of single and combined effects of persistent medication adherence and compliance with lifestyle recommendations on the incidence of major adverse cardiovascular events (MACE) and one-year all-cause mortality in patients with type 2 diabetes (T2D) and peripheral artery disease (PAD) after partial foot amputation (PFA), representing a unique cohort of patients with advanced stages of atherosclerosis. Methods: This is a prospective cohort study of 785 consecutive patients (mean age 60.9 ± 9.1 years; 64.1% males). Medication adherence was evaluated by using the proportion of days covered (PDC) measure calculation and was defined as a PDC ≥80%. It derived as an average of PDCs of the following four classes of drugs: a) antidiabetics (oral hypoglycemic medications and/or insulin); b) ACEI or ARBs; c) Statins; d) antiplatelet drugs. Lifestyle compliance was defined as a PDC ≥80% comprising of PDCs of a) physical activity of ≥30 minutes per day; b) healthy nutrition and weight management; c) non-smoking. Cox proportional hazard models adjusted for confounders were used. Results: Total all-cause mortality was 16.9% (n = 133) at one-year follow-up. After adjusting for confounders, compared to adherent/compliant patients (n = 432), non-adherent and/or non-compliant patients had an increased risk of one-year mortality: HR = 8.67 (95% CI [5.29, 14.86] in non-adherent/non-compliant patients (n = 184), p < 0.001; HR = 3.81 (95% CI [2.03, 7.12], p < 0.001) in adherent/non-compliant patients (n = 101) and HR = 3.14 (95% CI [1.52, 6.45] p = 0.002) in non-adherent/compliant patients (n = 184). The incidence of MACE followed similar pattern (HR = 9.66 (95% CI [6.55, 14.25] for non-adherence/non-compliance; HR = 3.48 (95% CI [2.09, 5.77] and HR = 3.35 (95% CI [1.89, 5.91], p < 0.001 for single adherence or compliance. Conclusions: Medication adherence and compliance to lifestyle recommendations have shown to be equally effective to reduce the incidence of MACE and one-year mortality in patients with diabetes and PAD after PFA representing a population with highly advanced stages of atherosclerotic disease. Our findings underline the necessity to give lifestyle intervention programs a high priority and that costs for secondary prevention medications should be covered for patients under these circumstances. Lay Summary: This study analyzed the single and combined effects of medication adherence and compliance with lifestyle recommendations on cardiovascular events and mortality in patients with type 2 diabetes and advances stages of atherosclerosis over a period of one year.Evaluation of medication adherence included antidiabetics, statins, dual antiplatelets and ACEI/ARBs, whereas lifestyle recommendations included healthy nutrition, physical activity and smoking cessation.Persistent medication adherence and lifestyle changes have shown to be equally effective to reduce the incidence of MACE and one-year mortality in patients representing a population with highly advanced stages of atherosclerotic disease, and positive effects added up to a double effect if patients were persistently adherent and compliant with both interventions.

Coronary artery calcium score and coronary computed tomography angiography predict one-year mortality in patients with type 2 diabetes and peripheral artery disease undergoing partial foot amputation.

METHODS: This is a single-center prospective cohort study including 199 consecutive patients with T2D, PAD (mean age 62.3 ± 7.2 years; 62.8% males), and preoperative CACS and CCTA undergoing PFA and followed-up over 1 year. RESULTS: Over a period of 1 year follow-up, a total of 35 (17.6%) participants died. The area under ROC curve to predict mortality for the CACS was 0.835 (95% CI:0.769-0.900), for CCTA 0.858 (95% CI:0.788-0.927). After adjustment for confounders, compared to no-stenosis on CCTA (reference), the risk of all-cause mortality in non-obstructive coronary atery disease (CAD) increased (HR = 1.38, 95% CI [0.75-12.86], p = .284), 1-vessel obstructive CAD (HR = 8.13, 95% CI [0.87-75.88], p = .066), 2-vessels (HR = 10.94, 95% CI [1.03-115.8], p = .047), and 3-vessels (HR = 45.73, 95% CI [4.6-454.7], p = .001) respectively. Increasing levels of CACS tended to be associated with increased risk of all-cause mortality (HR = 1.002, 95% CI [1.0-1.003], p = .061). 61/95 patients with obstructive CAD underwent coronary revascularization. CONCLUSIONS: Coronary artery calcium score and CCTA have a high predictive value for 1-year all-cause mortality in T2D patients undergoing minor amputations and may be considered for preoperative risk assessment allowing timely preventive interventions.

Tenfold risk increase of major cardiovascular events after high limb amputation with non-compliance for secondary prevention measures.

Background The aim of the study was to evaluate the impact of compliance with lifestyle recommendations and medication on 1-year prevention of major adverse cardiovascular events (MACE) in patients with type 2 diabetes (T2D) after trans-femoral amputation (TFA). Methods In this prospective single-center interventional cohort study, 179 consecutive T2D patients with symptomatic coronary artery disease (CAD) underwent 1-year follow-up examination after TFA in 2013. Lower limb and coronary artery CT angiography were provided before surgery; physical examination and laboratory tests were performed at baseline and every month after TFA for 1 year. A total of 77 patients (43%) were defined as compliant. They followed all recommendations, including >80% drug intake (anti-diabetic, antihypertensive drugs, dual antiplatelet and statin treatment), healthy diet, smoking cessation, physical exercise ≥30 min/day. A total of 102 patients (57%) were non-compliant (drug intake ≤80%, and did not fully follow lifestyle change recommendations). Results There were no significant differences at baseline between the two groups. Fuster-BEWAT score in 1 year was 9.83 ± 3.1 in compliant and 7.74 ± 2.9 in non-compliant patients ( p = 0.0001). At 1-year follow-up, there were 43 myocardial infarctions (40 patients (93%) were non-compliant) and 28 deaths (26 cases (92.8%) were non-compliant). Patients from the non-compliant group with three- and two-vessel obstructive CAD had higher 1-year MACE rate than those with one-vessel obstructive and non-obstructive CAD (95.24% and 70.5% versus 17.2% and 8.6%; p < 0.0001); more proximal coronary lesions were related to a worse prognosis. Conclusions Non-compliant diabetic patients had a tenfold increased risk for MACE within 1 year after TFA.

Coronary artery calcium score and coronary computed tomographic angiography for major perioperative cardiovascular complications in symptomatic diabetic patients undergoing trans-femoral amputation.

OBJECTIVE: Perioperative risk for major cardiovascular events (MACE) is particularly high in patients with type 2 diabetes undergoing surgery for trans-femoral amputation (TFA). The aim of this study was to identify prognostic value of coronary calcium score (CACS) and coronary computed tomographic angiography (CCTA) for perioperative MACE in these patients. METHODS: In this prospective single center interventional cohort study, we evaluated 331 consecutive symptomatic patients with diabetes and without history of coronary intervention or myocardial infarction (MI) undergoing TFA in 2013. 179/331 patients (54%) had no contraindications for CCTA and were included in the study cohort. RESULTS: All patients had revised cardiac risk index score of 3 or more points (class IV with MACE rate of 11%). Increasing calcium score was associated with increasing severity of CAD by CCTA and incidence of cardiovascular complications. During 25weeks of follow-up, there were 43 MACE (24%), 28(15.6%) of them cardiac death. Post-operative event rate increased in patients with increasing CACS from 10% with CACS 1-99 to 84% with CACS>1000 (p<0.001). Similarly, there were more post-operative events in patients with 3- and 2-vessels disease compared to 1-vessel obstructive and non-obstructive CAD (74.1% and 34.1% vs. 10.5% and 6.5%, p<0.001). CONCLUSIONS: Predicative value of CCTA and CACS is high for perioperative MI and death in patients with type 2 diabetes undergoing non-cardiac surgery for TFA. It may be considered as a valuable tool for preoperative risk assessment in these patients, where stress tests are not feasible and more sophisticated technical equipment is not available.