Risk reduction of cardiac events by screening of unknown asymptomatic coronary artery disease in subjects with type 2 diabetes mellitus at high cardiovascular risk: an open-label randomized pilot study.
BACKGROUND
Evaluated the efficacy of reducing the risk of cardiac events by a preclinical diagnosis of CAD in subjects with type 2 diabetes mellitus with 2 or more cardiovascular risk factors.


METHODS
One hundred forty-one subjects with type 2 diabetes mellitus without known cardiac disease and asymptomatic, aged >45 to <76 years, were randomized into the screening arm for CAD (71 patients) or to the control arm (70 patients). The screening consisted in performing an exercise electrocardiogram test and dipyridamole stress echocardiography; if 1 test was abnormal, coronary angiography is done. Screening was positive in 15 subjects (21.4%). At coronary angiography, which was performed in 14 of 15 patients, stenoses > or =50% of vessel diameter were present in 9 patients, of these 4 underwent coronary artery bypass grafting and 4 underwent percutaneous transluminal coronary angioplasty. Stenoses <50% of vessel diameter were present in 5 patients.


RESULTS
Mean follow-up was 53.5 months (range, 42-54 months). During this period, 1 major (myocardial infarction) and 3 minor events (angina) occurred in the screening arm. Eleven major and 4 minor events occurred in the control arm. In the screened arm, the proportion of all events was significantly less (P = .018) (RR .226, 95% CI 0.707-0.719, P = .012); the proportion of major to minor events was significantly less (P = .006) (RR .07, 95% CI 0.0087-0.565, P = .013).


CONCLUSIONS
The preclinical diagnosis of CAD is effective in reducing the risk of cardiac events, especially major events, in subjects with type 2 diabetes mellitus at high cardiovascular risk.
Faglia
Ezio
E
Internal Medicine Unit, Diabetology Center, Policlinico Multimedica, Sesto San Giovanni, Milan, Italy. ezio.faglia@multimedica.it
Manuela
Mantero
M
Antonella
Quarantiello
Q
Michela
Gino
G
Vincenzo
Curci
C
Maurizio
Caminiti
C
Roberto
Mattioli
M
Alberto
Morabito
M
D000368:Aged; D000704:Analysis of Variance; D017023:Coronary Angiography; D003327:Coronary Disease / Q000175:diagnosis* / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D025401:Echocardiography, Stress; D005080:Exercise Test; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D010865:Pilot Projects; D012307:Risk Factors