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Table 1 Features of participating trials

From: Systematic study of the effects of lowering low-density lipoprotein-cholesterol on regression of coronary atherosclerotic plaques using intravascular ultrasound

Authors and trial name

Trial type and location

Objective

Year

N T/C

Study population

LDL-C at follow up

LDL-C reducing percentage

Treatments

Follow up

Main Results or Conclusion

Okazaki S [14];ESTABLISH

RCT: prospective, open-label, randomized, single center study. Japan

Effects of statins on changes in plaque by IVUS

2004

24/24

ACS

70/119

-44/-0.004

Ato 20 vs Diet

6

Plaque volume was sigificantly reduced in the Ato group compared with the control group.

Nissen SE [13]; REVERSAL

RCT: Double-blind, randomized active control multicenter trial; USA

Effects of statins (intensive or moderate) on changes in plaque by IVUS

2004

253/249

CAD

79/110

-46/-25

Ato 80 vs Pra40

18

Ato reduced progression of coronary plaque compared with Pra. Compared with baseline values, Ato had no change in atheroma burden, whereas patients treated with Pra showed progression of coronary plaque.

Tardif JC [21]; A-PLUS

RCT: international, multicenter, double-blind, placebo-controlled, randomized trial. Canada, USA

Effects of different dosage of avasimibe on changes in plaque by IVUS

2004

108/98/ 117/109

CAD

100/102/ 101/91

7.8/9.1/ 10.9/1.7

Ava50, 250, and 750 vs Placebo on the basis of LDL-C<125

18

Avasimibe did not favorably alter coronary atherosclerosis as assessed by IVUS.

Jensen LO [39]

Open non placebo controlled serial investigation; blinded end-points. Denmark

To investigate the effect of lipid lowering by simvastatin on coronary atherosclerotic plaque volumes and lumen.

2004

40

CAD

85

-46.3

Sim 40

15

Lipid-lowering therapy with Sim is associated with a significant plaque regression in coronary arteries.

Yokoyama M [15]

RCT: randomized, single center. Japan

Effects of statins on changes in plaque by IVUS

2005

29/30

Stable angina

87/124

-35/-0.075

Ato 10 vs Diet

6

Treatment with Ato may reduce volumes of coronary plaques.

Kawasaki M [16]

RCT: randomization, open-label, single-center study. Japan

Effects of statins on changes in plaque by IVUS

2005

17/18/17

Stable angina

95/102/149

-39/-32/-0.02

Ato 20, Pra 20 vs Diet

6

Treatment with Ato and Pra may not significantly reduce volumes of coronary plaques.

Tani S [33]

RCT: a prospective, single-center, randomized, open trial. Japan

Investigated the effects of pravastatin on the serum levels of MDA-LDL and coronary atherosclerosis.

2005

52/23

Stable angina

104/120

-20/-2.4

Pra 10-20 vs con

6

Plaque volume was sigificantly reduced in the Pra group compared with the control group.

Nissen SE [22]; ACTIVATE

RCT: randomized, multicenter. USA

Effects of pactimibe on changes in plaque by IVUS

2006

206/202

CAD

91/86

-9.6/-14.9

Pac100 vs Placebo

18

Pac is not an effective strategy for limiting atherosclerosis and may promote atherogenesis.

Nissen SE [37]; ASTEROID

Prospective, open-label blinded end-points. USA, Germany, France, Canada

Effects of Statins with different levels of LDL-C on changes in plaque by IVUS

2006

349

CAD

61

-53.2

Ros 40

24

Therapy using Ros can result in significant regression of atherosclerosis.

Yamada T [26]; REACH

RCT: open-labeled, randomized, multicenter study. Japan

Evaluate the effect of marked reduction of LDL-C in patients with CHD on progression of atherosclerosis.

2007

26/32

Stable angina

83/115

-43/0

Ato 5 vs Con

12

Ato treatment prevented the further progression of atherosclerosis by maintaining LDL-C below 100 mg/dl in patients with CHD.

Nissen SE [23]; ILLUSTRATE

RCT: prospective, randomized, multicenter, double-blind clinical trial. North America or Europe

Effects of CETP inhibitor on changes in plaque by IVUS

2007

446/464

CAD

87/70

6.6/-13.3

Ato10-80 vs Ato+Tor 60 on the basis of LDL-C≤100 by Ato

24

The Tor was associated with a substantial increase in HDL-C and decrease in LDL–C, and there was no significant decrease in the progression of coronary atherosclerosis.

Nissen SE [36]; PERISCOPE

RCT: prospective, randomized, multicenter, double-blind clinical trial. USA

To compare the effects of pioglitazone, and glimepiride on the progression of coronary atherosclerosis in patients with type 2 diabete and CAD

2008

181/179

CAD, DM

96.1/95.6

1.8/2.2

Gli1-4 mg vs Pio 15-45 mg on bases of statins therapy

18

In patients with type 2 diabetes and CAD, treatment with Pio resulted in a significantly lower rate of progression of coronary atherosclerosis compared with Gli.

Nissen SE [35]; STRADIVARIUS

RCT: Randomized, double-blinded, placebo-controlled, 2-group, parallel-group trial. North America, Europe, and Australia

The effect of rimonabant on regression of coronary disease in patients with the metabolic syndrome and CAD

2008

335/341

CAD,Obesity

87.6/86.3

-4.7/-3.6

Rim 20 mg vs Placebo on bases of statins therapy

18

Rim can reduce progression of coronary plaque, and increase HDL-C levels, decrease triglyceride levels.

Hiro T [12]; JAPAN-ACS

RCT: prospective, randomized, open-label, parallel group, multicenter. Japan

Effects of statins on changes in plaque by IVUS

2009

127/125

ACS

84/81

-36/-36

Ato 20 vs Pit 4

10

The administration of Pit or Ato in patients with ACS equivalently resulted in significant regression of coronary plaque volume.

Takayama T; COSMOS [40]

Prospective, open-label blinded end-points multicenter trial. Japan

Evaluate the effect of rosuvastatin on plaque volume in patients with stable CAD, including those receiving prior lipid-lowering therapy

2009

126

Stable angina

83

-38.6

Ros <20

14

Ros exerted significant regression of coronary plaque volume in Japanese patients with stable CAD.

Rodés-Cabau; ERASE [34]

RCT: multicenter randomized placebo-controlled. Canada

Evaluate the early effects of newly initiated statin therapy on coronary atherosclerosis as evaluated by IVUS.

2009

38/36

ACS

77/63

8.5/-37

Before ACS vs After ACS

<2

Newly initiated statin therapy is associated with rapid regression of coronary atherosclerosis.

Nasu K [41]

Prospective and multicenter study with nonrandomized and non-blinded design, but blinded end. Japan

Evaluate the effect of treatment with statins on the progression of coronary atherosclerotic plaques of a nonculprit vessel by serial IVUS.

2009

40/39

Stable angina

98.1/121

-32.3/-1.1

Flu 60 vs Con

12

One-year lipid-lowering therapy by Flu showed significant regression of plaque volume.

Hong MK [27]

RCT: randomized control trial. Korea.

Evaluated the effects of statin treatments for each component of coronary plaques.

2009

50/50

Stable angina

78/64

-34.5/-44.8

Sim 20 vs Ros 10

12

Statin treatments might be associated with significant changes in necrotic core and fibrofatty plaque volume.

Nicholls SJ; SATURN [28]

RCT: a prospective, randomized, multicenter, double-blind clinical trial. USA

Compare the effect of these two intensive statin regimens on the progression of coronary atherosclerosis.

2011

519/520

CHD

70.2/62.6

-41.5/-47.8

Ato 80 vs Ros 40

24

Maximal doses of Ros and Ato resulted in significant regression of coronary atherosclerosis.

Lee CW [29]; ARTMAP

RCT: a prospective, single-center, open-label, randomized comparison trial. Korea.

Compared the effects of atorvastatin 20 mg/day versus rosuvastatin 10 mg/day on mild coronary atherosclerotic plaques.

2012

143/128

Stable angina

56/53

-47/-49

Ato 20 vs Ros 10

6

Usual doses of Ato and Ros induced significant regression of coronary atherosclerosis in statin-naive patients.

  1. Abbreviations: RCT, randomized controlled trials; T, treatment group; C, control group IVUS, Intravascular ultrasound; CAD, Coronary artery disease; ACS, Acute coronary syndrome; CHD, Coronary heart disease; Ato, Atorvastatin; Ros, Rosuvastatin; Pra, Pravastatin; Pit, Pitavastatin; Sim, Simvastatin; Flu, Fluvastatin; Con, Control; Pac, Pactimibe; Tor, Torcetrapib, Ava 50, 250, 750, Avasimibe 50, 250, 750 mg; T/C, Treat/Control; Gli, Glimepiride; Pio, Pioglitazone; Rim, Rimonabant.