Reversal of Atherosclerosis with Aggressive Lipid Lowering (REVERSAL)

1
Reversal of Atherosclerosis with Aggressive Lipid
Lowering (REVERSAL)

• 654 patients with symptomatic CAD with
  angiographic stenosis gt20 and LDL-C 125210
  mg/dL 502 with evaluable follow-up
• Randomization to pravastatin 40 mg/d or
  atrovastatin 80 mg/d for 18 months
• IVUS performed at baseline and 18 months
• Primary endpoint percent change in atheroma
  volume assessed with IVUS

Nissen SE et al. JAMA 20042911071-1080.
2
Baseline Characteristics REVERSAL
Pravastatin (n249) Atorvastatin (n253) p
Age, y 56.6 55.8 .37
Male 73 71 .69
White 87 90 .54
Current smoker 27 26 .97
Past or nonsmoker 74 74 .97
Hx HTN 70 68 .70
Prior statin use 32 25 .06
Hx DM 18 20 .65
LDL-C, mg/dL 150.2 25.9 150.2 27.9 .99
HDL-C, mg/dL 42.9 11.4 42.3 9.9 .51
TG, mg/dL 197.7 105.6 197.2 95.7 .96
CRP, mg/L 3.0 2.9 2.8 3.0 .46
Nissen SE et al. JAMA 20042911071-1080.
3
REVERSAL Primary and Secondary Endpoints
Change in Atheroma Volume Assessed by IVUS
p.01
4.4
p.02
p.001
2.7
plt.001
p.02
1.6
plt.001
Change from Baseline,
p.18
0.2
p.98
p.72
0.4
0.9
1 endpoint Percent change in atheroma volume
Total atheroma volume
Change in percent atheroma volume
Nissen SE et al. JAMA 20042911071-1080.
4
REVERSAL Lipid and CRP Changes
TC
LDL-C
HDL-C
TG
Apo B-100
CRP
5.6
2.9
5.2
6.8
Change from Baseline,
18.4
20.0
22.0
25.2
34.1
36.4
39.1
46.3
plt.001
plt.001
p.06
plt.001
plt.001
plt.001
Nissen SE et al. JAMA 20042911071-1080.
5
REVERSAL Final Lipids on Treatment
165.8
148.4
118.1
110.4
91.8
78.9
Mg/dL
44.6
43.1
LDL-C
Apo B-100
TG
HDL-C
Nissen SE et al. JAMA 20042911071-1080.
6
REVERSAL Effects on LDL-C

• LDL-C was reduced to a mean of 110 mg/dL with
  pravastatin 40 mg and 79 mg/dL with atorvastatin
  80 mg
• ATP III goal of LDL-C lt100 mg/dL was achieved by
  65 of pravastatin patients and 97 of
  atorvastatin patients

Nissen SE et al. JAMA 20042911071-1080.