Early Invasive Versus Conservative Strategy

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In diabetic patients with non-ST-segment elevation ACS, the positive impact of an early invasive strategy can be derived from subgroup analyses of large-scale randomized studies. The Fragmin and Fast Re-vascularisation during InStability in Coronary artery disease (FRISC II) study randomized 2457 patients to an invasive or conservative strategy and detected a significant survival benefit associated with the invasive strategy at 1 year.94 The reduction in 1-year death or MI associated with early coronary angiography followed by revascularization (if needed) was marked among diabetic patients (n = 299), in terms of relative and particularly of absolute risk reduction (39% and

OGTT FPG

Acute admission

OGTT

Elective consultation

□ = Impaired fasting glucose

□ = Impaired glucose tolerance

□ = Newly detected diabetes

Figure 2-8. Prevalence of abnormal glucose regulation in patients without known diabetes mellitus in the Euro Heart Survey assessed by oral glucose tolerance test (OGTT) or fasting plasma glucose (FPG). (From Bartnik M, Ryden L, Ferrari R, et al: The prevalence of abnormal glucose regulation in patients with coronary artery disease across Europe. Eur Heart J 2004;25:1880-1890.)

Table 2-8. In-Hospital Clinical Outcomes in Diabetic Patients with Non-ST-Elevation Acute Coronary Syndromes in the CRUSADE Registry

Adjusted Odds Ratio (95% CI)

Table 2-8. In-Hospital Clinical Outcomes in Diabetic Patients with Non-ST-Elevation Acute Coronary Syndromes in the CRUSADE Registry

Adjusted Odds Ratio (95% CI)

Clinical Outcome

Nondiabetic (N = 31,049)

NIDDM (N = 9,773)

IDDM (N = 5,588)

NIDDM*

IDDM+

Death (%)

4.4

5.4

6.8

1.14 (1.02-1.29)

1.29 (1.12-1.49)

Reinfarction(%)

3.2

3.5

3.8

1.07 (0.96-1.19)

1.07 (0.93-1.24)

Congestive heart

8.0

12.4

13.7

1.25 (1.16-1.34)

1.19 (1.09-1.31)

failure (%)

Shock (%)

2.5

3.2

3.5

1.22 (1.05-1.41)

1.18 (0.97-1.44)

Red blood cell

12.9

17.4

20.8

1.31 (1.23-1.40)

1.51 (1.40-1.63)

transfusion (%)

ACS, acute coronary syndromes; CI, confidence interval; IDDM, insulin-dependent diabetes mellitus; NIDDM, non-insulin-dependent diabetes mellitus. *Nondiabetic vs. type 2 diabetic patients. 'Nondiabetic vs. iDDM patients.

From Brogan GX, Peterson ED, Mulgund J, et al: Treatment disparities in the care of patients with and without diabetes presenting with non-ST-segment elevation acute coronary syndromes. Diabetes Care 2006;29:9-14.

ACS, acute coronary syndromes; CI, confidence interval; IDDM, insulin-dependent diabetes mellitus; NIDDM, non-insulin-dependent diabetes mellitus. *Nondiabetic vs. type 2 diabetic patients. 'Nondiabetic vs. iDDM patients.

From Brogan GX, Peterson ED, Mulgund J, et al: Treatment disparities in the care of patients with and without diabetes presenting with non-ST-segment elevation acute coronary syndromes. Diabetes Care 2006;29:9-14.

FRISC II: 1-year death or MI

Noninvasive, diabetes mellitus

FRISC II: 1-year death or MI

Noninvasive, diabetes mellitus

0 60 120 180 240 300 360

A Follow up (days)

0 60 120 180 240 300 360

A Follow up (days)

TACTICS: 6-month death, MI, rehospitalization for ACS

TACTICS: 6-month death, MI, rehospitalization for ACS

27.7%

□ Invasive

_

□ Conservative

20.1%

14.2%

16.4%

-

-

No diabetes

Figure 2-9. Outcomes according to diabetic status in the FRISC II (A) and TACTICS (B) trials of invasive versus conservative strategy in acute coronary syndromes (ACS). MI, myocardial infarction. (A, From Norhammar A, Malmberg K, Diderholm E, et al: Diabetes mellitus: The major risk factor in unstable coronary artery disease even after consideration of the extent of coronary artery disease and benefits of revascularization. J Am Coll Cardiol 2004;43:585-591; B, Data from Cannon CP, Weintraub WS, Demopoulos LA, et al: Comparison of early invasive and conservative strategies in patients with unstable coronary syndromes treated with the glycoprotein IIb/IIIa inhibitor tirofiban. N Engl J Med 2001;344:1879-1887.)

Diabetes

No diabetes

Figure 2-9. Outcomes according to diabetic status in the FRISC II (A) and TACTICS (B) trials of invasive versus conservative strategy in acute coronary syndromes (ACS). MI, myocardial infarction. (A, From Norhammar A, Malmberg K, Diderholm E, et al: Diabetes mellitus: The major risk factor in unstable coronary artery disease even after consideration of the extent of coronary artery disease and benefits of revascularization. J Am Coll Cardiol 2004;43:585-591; B, Data from Cannon CP, Weintraub WS, Demopoulos LA, et al: Comparison of early invasive and conservative strategies in patients with unstable coronary syndromes treated with the glycoprotein IIb/IIIa inhibitor tirofiban. N Engl J Med 2001;344:1879-1887.)

9.3%, respectively) (Fig. 2-9). Among nondiabetics, the effect was less pronounced (28% and 3.1%, respectively). Because of differences in sample size, the benefit observed barely missed statistical significance in diabetic patients but achieved it in nondia-betic individuals. In addition, diabetic patients undergoing early invasive therapy had a 38% reduction in the relative risk of 1-year death (7.7% versus 12.5%), again not reaching statistical significance owing to the small sample size.94

In the Treat Angina with Aggrastat and Determine Cost of Therapy with an Invasive or Conservative Strategy (TACTICS)-TIMI 18 trial, an early invasive strategy was associated with a significant 22% reduc tion in the relative risk of death, MI, or rehospitaliza-tion for ACS at 6 months, compared with an early conservative strategy.95 All patients were treated with aspirin, clopidogrel, and tirofiban. Diabetic patients derived a greater benefit than nondiabetics from an early invasive strategy, in terms of both absolute (7.6% versus 1.8%) and relative (27% versus 13%) event reduction at 6 months (see Fig. 2-9).

According to the 2002 Guidelines of the European Society of Cardiology (ESC), diabetes patients with ACS are to be classified automatically as high risk and therefore qualify for an early invasive strategy and for GP IIb/IIIa receptor inhibitors on top of standard treatment.96 Within the CRUSADE registry, however, diabetic patients had a statistically significant lesser chance to get early coronary angiography compared with nondiabetic individuals.89

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