Fabrizio Turrini1, Stefania Scarlini2, Caterina Mannucci2, Roberto Messora2, Paolo Giovanardi2, Paolo Magnavacchi3, Carlo Cappelli3, Valeria Evandri4, Andrea Zanasi4, Stefania Romano5, Rita Cavani5, Italo Ghidoni6, Stefano Tondi3, Marco Bondi2. 1. Cardiovascular Medicine Clinic, Department of Internal Medicine, Nuovo Ospedale Civile Sant'Agostino Estense, AUSL Modena, Via Giardini 1355, 41125 Modena, Italy. Electronic address: f.turrini@ausl.mo.it. 2. Cardiovascular Medicine Clinic, Department of Internal Medicine, Nuovo Ospedale Civile Sant'Agostino Estense, AUSL Modena, Via Giardini 1355, 41125 Modena, Italy. 3. Cardiology Clinic, Department of Cardiovascular Disease, Nuovo Ospedale Civile Sant'Agostino Estense, AUSL Modena, Via Giardini 1355, 41125 Modena, Italy. 4. Geriatrics Clinic, Department of Internal Medicine, Endocrinology, Metabolism and Geriatrics, University of Modena, Via Giardini 1355, 41125 Modena, Italy. 5. Diabetology Service, AUSL Modena, Via del Pozzo 71, 41124 Modena, Italy. 6. Department of Cardiovascular and Thoracic Surgery, Hesperia Hospital, Modena, Via Arquà 80, 41125 Modena, Italy.
Abstract
OBJECTIVES: To evaluate if screening and treatment of asymptomatic coronary artery disease (CAD) are effective in preventing first cardiac event in diabetics. METHODS:Diabetic patients without known CAD were randomly assigned to undergo a screening for silent myocardial ischemia followed by revascularization or to continue follow-up. The reduction of cardiac death (CD) or nonfatal myocardial infarction (MI) represented the primary aim; secondary aim was the prevention of heart failure (HF). RESULTS:From September 2007 to May 2012, 520 patients (62 years; 104 female) were enrolled. Silent CAD was found in 20 of 262 patients (7.6%), revascularization was performed in 12 (4.6%). After a mean follow-up of 3.6 years 12 events (4.6%) occurred in the study group and 14 (5.4%) in the follow-up (HR=0.849, 95% CI: 0.393-1.827, P=0.678). The occurrence of first HF episode did not differ between groups: 2 (0.8%) in screened and 7 (2.7%) in follow-up (HR=0.273, 95% CI: 0.057-1.314, P=0.083). Subgroup analysis revealed a significantly lower HF episodes among patients with intermediate cardiovascular risk (Log rank P=0.022). Additionally, when CD and MI were analysed within subgroups, a significant lower number of CDs was observed among older than 60 years (P=0.044). CONCLUSION: Screening and revascularization of silent CAD in diabetics, failed to demonstrate a significant reduction in cardiac events and HF episodes. However, our data indicate that further research is warranted in patients older than 60 years and those with an intermediate cardiovascular risk. CLINICALTRIALS.GOV: NCT00547872.
RCT Entities:
OBJECTIVES: To evaluate if screening and treatment of asymptomatic coronary artery disease (CAD) are effective in preventing first cardiac event in diabetics. METHODS:Diabeticpatients without known CAD were randomly assigned to undergo a screening for silent myocardial ischemia followed by revascularization or to continue follow-up. The reduction of cardiac death (CD) or nonfatal myocardial infarction (MI) represented the primary aim; secondary aim was the prevention of heart failure (HF). RESULTS: From September 2007 to May 2012, 520 patients (62 years; 104 female) were enrolled. Silent CAD was found in 20 of 262 patients (7.6%), revascularization was performed in 12 (4.6%). After a mean follow-up of 3.6 years 12 events (4.6%) occurred in the study group and 14 (5.4%) in the follow-up (HR=0.849, 95% CI: 0.393-1.827, P=0.678). The occurrence of first HF episode did not differ between groups: 2 (0.8%) in screened and 7 (2.7%) in follow-up (HR=0.273, 95% CI: 0.057-1.314, P=0.083). Subgroup analysis revealed a significantly lower HF episodes among patients with intermediate cardiovascular risk (Log rank P=0.022). Additionally, when CD and MI were analysed within subgroups, a significant lower number of CDs was observed among older than 60 years (P=0.044). CONCLUSION: Screening and revascularization of silent CAD in diabetics, failed to demonstrate a significant reduction in cardiac events and HF episodes. However, our data indicate that further research is warranted in patients older than 60 years and those with an intermediate cardiovascular risk. CLINICALTRIALS.GOV: NCT00547872.
Authors: Matthew J Budoff; Paolo Raggi; George A Beller; Daniel S Berman; Regina S Druz; Shaista Malik; Vera H Rigolin; Wm Guy Weigold; Prem Soman Journal: JACC Cardiovasc Imaging Date: 2016-02