Table 1.
Randomized trials designed to compare effect of intensive glycemic control with that of standard therapy in patients presenting with ACS and associated SIH.
| Clinical trial (year) | Study population |
Number of patients (percentage of patients without known diabetes) |
Admission glycemia (mg/dL) |
Intervention glycemic target (mg/dL) |
Achieved glycemic target (intervention vs. control) (mg/dL) |
Primary endpoint | Result |
|---|---|---|---|---|---|---|---|
| DIGAMI (1995) |
AMI | 620 (13%) |
>198 mg/dL | 126–180 mg/dL in acute phase | 148 vs. 162 mg/dL at discharge* |
Mortality at 3 months | NS |
| DIGAMI 2 (2005) |
ACS | 1,253 (NA) |
>198 mg/dL | Group 1: 90–126 mg/dL(fasting), <180 mg/dL (non-fasting) Group 2: 126–180 mg/dL |
163.8 vs. 163.8 mg/dL during first 24 h (NS) |
All-cause mortality difference between group 1 and 2 | NS |
| A1c ~6.8 vs. 6.8% by the end of 2-year follow-up (NS) |
|||||||
| HI-5 (2006) |
AMI | 240 (52%) |
≥140 mg/dL | <140 mg/dL | 149.4 vs. 162 mg/dL during first 24 h (NS) |
Mortality at in-hospital stage, 3 and 6 months | NS |
| A1C 6.9 vs. 6.8% at 3 months (NS) |
|||||||
| A1C 7.4 vs. 7.0 at 6 months (NS) |
|||||||
| Marfella (2009) |
AMI (CABG) |
50 (58%) |
≥140 mg/dL | 80–140 mg/dL for intervention arm 180–200 mg/dL for control arm |
162.7 vs. 192.4 mg/dL* |
LVEF, oxidative stress, apoptosis | ↑LVEF* ↓oxidative stress and apoptosis* |
| Marfella (2012) |
AMI (CABG) |
50 (62%) | >140 mg/dL | 80–140 mg/dL for intervention arm | 160.9 vs. 193.9 mg/dL* |
Myocardial regeneration | ↑Myocardial regeneration* |
| 180–200 mg/dL for control arm | |||||||
| Marfella (2012) |
STEMI (pPCI) |
165 (53%) | ≥140 mg/dL | 80–140 mg/dL for intervention arm | 145 vs. 191 mg/dL* |
ISR | ↓ISR |
| 180–200 mg/dL for control arm | |||||||
| Marfella (2013) |
STEMI (pPCI) |
106 (62%) |
≥140 mg/dL | 80–140 mg/dL for intervention arm | 144 vs. 201 mg/dL** |
Myocardial salvage | ↑Myocardial salvage |
| 180–200 mg/dL for control arm | |||||||
| RECREATE (2012) |
STEMI | 287 (72%) |
≥144 mg/dL | 90–117 mg/dL | 117.5 vs. 142.9 mg/dL** |
Difference in mean glucose levels at 24 h | ↓Glycemia |
| BIOMArKS2 (2013) |
ACS (pPCI) |
280 (90%) |
140–288 mg/dL | 85–110 mg/dL | 112 vs. ≈130 mg/dL** |
hsTropT 72 h after admission | NS |
AMI, acute myocardial infarction; ACS, acute coronary syndrome; STEMI, ST-elevation myocardial infarction; NA, not available; NS, not significant.
*
p < 0.05;
**
p < 0.001; CABG, coronary artery bypass sugery; pPCI, primary percutaneous coronary intervention; LVEF, left ventricular ejection fraction; ISR, in-stent restenosis; hsTropT, high-sensitive troponin T-value.