scholarly journals Cost-effectiveness of screening of coronary artery disease in patients with type 2 DIABetes at a very high cardiovascular risk (SCADIAB study) rational and design

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Kamel Mohammedi ◽  
Nathalie Préaubert ◽  
Tanguy Cariou ◽  
Vincent Rigalleau ◽  
Ninon Foussard ◽  
...  

Abstract Background Screening for coronary artery disease (CAD) remains broadly performed in patients with type 2 diabetes (T2DM), although the lack of evidence. We conduct a real-world evidence (RWE) study to assess the risk of major clinical outcomes and economic impact of routine CAD screening in T2DM individuals at a very high cardiovascular risk. Methods SCADIAB is a comparative nationwide cohort study using data from the French National Health Data System. The main inclusion criteria are: age ≥ 40 years, DT2 diagnosed for ≥ 7 years, with ≥ 2 additional cardiovascular risk factors plus a history of microvascular or macrovascular disease, except CAD. We estimated ≥ 90,000 eligible participants for our study. Data will be extracted from 01/01/2008 to 31/12/2019. Eligible participants will be identified during a first 7-year selection period (2008–2015). Each participant will be assigned either in experimental (CAD screening procedure during the selection period) or control group (no CAD screening) on 01/01/2015, and followed for 5 years. The primary endpoint is the incremental cost per life year saved over 5 years in CAD screening group versus no CAD screening. The main secondary endpoints are: total 5-year direct costs of each strategy; incidence of major cardiovascular (acute coronary syndrome, hospitalization for heart failure, coronary revascularization or all-cause death), cerebrovascular (hospitalization for transient ischemic attack, stroke, or carotid revascularization) and lower-limb events (peripheral artery disease, ischemic diabetic foot, lower-limb revascularization or amputation); and the budget impact for the French Insurance system to promote the cost-effective strategy. Analyses will be adjusted for a high-dimension propensity score taking into account known and unknown confounders. SCADIAB has been funded by the French Ministry of Health and the protocol has been approved by the French ethic authorities. Data management and analyses will start in the second half of 2021. Discussion SCADIAB is a large and contemporary RWE study that will assess the economic and clinical impacts of routine CAD screening in T2DM people at a very high cardiovascular risk. It will also evaluate the clinical practice regarding CAD screening and help to make future recommendations and optimize the use of health care resources. Trial registration ClinicalTrials.gov Identifier: NCT04534530 (https://clinicaltrials.gov/ct2/show/NCT04534530)

Diabetes Care ◽  
2015 ◽  
pp. dc142216 ◽  
Author(s):  
Jaana J. Karjalainen ◽  
Antti M. Kiviniemi ◽  
Arto J. Hautala ◽  
Olli-Pekka Piira ◽  
E. Samuli Lepojärvi ◽  
...  

2020 ◽  
Vol 72 (1) ◽  
Author(s):  
Mohd Iqbal Dar ◽  
Jahangir Rashid Beig ◽  
Iqra Jan ◽  
Tariq Rashid Shah ◽  
Muzaffar Ali ◽  
...  

Abstract Background Acute coronary syndrome (ACS) indicates the serious clinical manifestation of coronary artery disease (CAD) and is closely associated with cardiovascular prognosis in patients with ACS. This study was aimed to study the prevalence of type 2 diabetes mellitus (T2DM) and the relation of HbA1c with the severity of CAD in patients presenting as non-diabetic ACS. Diabetic status of the patients was assessed with fasting blood sugar (FBS) and HbA1c levels, and coronary artery disease burden was assessed by coronary angiography. Results Out of 208 patients, 85.1% were males, and 14.9% were females; 73.56% cases were hypertensive. 80.77% of cases had STEMI, 17.79% had NSTEMI, and 1.44% had unstable angina. Out of 168 STEMI patients, 64.3% were thrombolysed, 21.42% presented late, 2.38% had contraindications to thrombolysis, and 11.9% underwent primary PCI. FBS in diabetic range was found in 44.23% of cases, impaired FBS in 36.54%, and 19.23% of patients had FBS in non-diabetic range. According to HbA1c, 41.8% were diabetic, 39.4% were pre-diabetic, and 18.8% were non-diabetic. A significant positive correlation was found between HbA1c and Gensini score and between HbA1c and the number of vessels involved. Conclusion This study emphasises the importance of evaluating the presence of diabetes in patients presenting as non-diabetic acute coronary syndrome in developing countries. Acute coronary syndrome may be considered as one of the presentations of diabetes mellitus.


2020 ◽  
Vol 17 (5) ◽  
pp. 147916412095361
Author(s):  
Simone Battermann ◽  
Andrea Milzi ◽  
Rosalia Dettori ◽  
Kathrin Burgmaier ◽  
Nikolaus Marx ◽  
...  

Background: Patients with type 2 diabetes (T2DM) are at high risk for cardiovascular events and present more severe coronary artery disease (CAD). The Gensini and COURAGE scores are established angiographic instruments to assess CAD severity, which may also predict future cardiovascular risk. However, it is unclear if these scores are able to depict the increased risk of patients with T2DM and stable CAD (T2DM-SAP). Methods: We performed quantitative coronary angiography and assessed the Gensini and COURAGE scores in 124 patients with T2DM-SAP. Angiographic data were compared to patients with stable angina without T2DM (Non-DM-SAP, n = 74), and to patients with acute coronary syndrome and T2DM (T2DM-ACS, n = 53). Results: T2DM-SAP patients had similar Gensini and COURAGE-scores compared to Non-DM-SAP-patients (Gensini: 14.44 ± 27.34 vs 11.49 ± 26.99, p = 0.465; COURAGE: 3.48 ± 4.49 vs 3.60 ± 4.72, p = 0.854). In contrast, T2DM-SAP patients had significantly lower Gensini (14.44 ± 27.34 vs 30.94 ± 48.74, p = 0.003) and lower COURAGE (3.48 ± 4.49 vs 5.30 ± 4.63, p = 0.016) scores compared to T2DM-ACS-patients. Conclusion: Both the Gensini and the COURAGE score fail to predict the high cardiovascular risk of patients with T2DM-SAP. Therefore, these scores should be used with caution in the assessment of future risk of patients with T2DM. However, among T2DM-ACS patients, both scores are increased, reflecting the high cardiovascular risk in this patient population.


2021 ◽  
Vol 9 (2) ◽  
pp. e002407
Author(s):  
Lukas Sprenger ◽  
Arthur Mader ◽  
Barbara Larcher ◽  
Maximilian Mächler ◽  
Alexander Vonbank ◽  
...  

IntroductionThe prevalence of type 2 diabetes mellitus (T2DM) is higher in peripheral artery disease (PAD) than in coronary artery disease (CAD) patients, and PAD overall confers higher cardiovascular risk than CAD. How cardiovascular risk compares between PAD and CAD patients when analyses are stratified by the presence of type 2 diabetes is unclear and is addressed in the present study.Research design and methodsWe prospectively recorded major cardiovascular events (MACE; ie, cardiovascular death, myocardial infarction or stroke) over 10.0±4.7 years in 923 patients with stable CAD, of whom 26.7% had T2DM and in 292 patients with PAD, of whom 42.1% had T2DM. Four groups were analyzed: CAD patients without diabetes (CAD/T2DM−; n=677), CAD patients with T2DM (CAD/T2DM+; n=246), PAD patients without diabetes (PAD/T2DM−; n=169) and PAD patients with T2DM (PAD/T2DM+; n=123).ResultsThe event rate for MACE increased over our four investigated groups: it was lowest in CAD/T2DM− patients (2.52 events per 100 person-years). It was significantly higher in CAD/T2DM+ patients (3.96 events per 100 person-years; p<0.001), in PAD/T2DM− patients (3.68 events per 100 person-years; p=0.022), and in PAD/T2DM+ patients (7.10 events per 100 person-years; p<0.001), who in turn were at a higher risk than CAD/T2DM+ or PAD/T2DM− patients (p=0.001 and p<0.001, respectively). Cox regression analysis after multivariate adjustment showed that the presence of T2DM (HR=1.44 (95% CI 1.09 to 1.92); p=0.012) and the presence of PAD versus CAD (HR=1.48 (95% CI 1.15 to 1.91); p=0.002) were mutually independent predictors of cardiovascular events.ConclusionsIn conclusion, our data show that T2DM as well as the presence of PAD versus CAD are mutually independent predictors of MACE. Patients with both PAD and T2DM are at an exceedingly high risk of cardiovascular events.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Lukas Sprenger ◽  
Alexander Vonbank ◽  
Barbara Larcher ◽  
Arthur Mader ◽  
Maximilian Maechler ◽  
...  

Introduction: The prevalence of type 2 diabetes (T2DM) is higher in peripheral artery disease (PAD) than in coronary artery disease (CAD) patients, and PAD overall confers higher cardiovascular risk than CAD. Hypothesis: We hypothesize that there is a difference in cardiovascular risk between PAD and CAD patients when analyses are stratified by the presence of T2DM. Methods: We prospectively recorded cardiovascular events over 7.6±5.0 years in 253 patients with PAD, of whom 41.9% had T2DM and in 923 patients with stable CAD, of whom 26.7% had T2DM. Four groups were analyzed: CAD patients without diabetes (CAD/T2DM-; n=677), CAD patients with T2DM (CAD/T2DM+; n=246), PAD patients without diabetes (PAD/T2DM-; n=147) and PAD patients with T2DM (PAD/T2DM+; n=106). Results: The cardiovascular event rate was lowest in CAD/T2DM- patients (40.5%). It was significantly higher in CAD/T2DM+ patients (50.2%; p=0.007), in PAD/T2DM- patients (55.2%; p<0.001), and in PAD/T2DM+ patients (67.6%; p<0,001), who in turn were at a higher risk than CAD/T2DM+ or PAD/T2DM- patients (p<0.001 and p=0.013, respectively). Further, cardiovascular risk was significantly higher in PAD/T2DM- than in CAD/T2DM+ patients (p<0.001). Cox regression analysis after multivariate adjustment confirmed that PAD versus CAD (HR=2.58 [2.12-3.15]; p<0.001) more strongly than the presence of T2DM (HR=1.55 [1.30- 1.85]; p<0.001) predicted cardiovascular events. Conclusions: We conclude that even when compared to CAD PAD confers a higher risk than T2DM. PAD patients without diabetes are at a higher risk than the extremely high risk patients with the combination of CAD and T2DM; risk is exceedingly high in PAD patients with T2DM.


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