Clinical trial, year of publication Study design Intervention Number of patients Duration of the follow-up Mean plaque volume (TAV), baseline Mean plaque burden (PAV), baseline Mean absolute change in plaque volume (TAV), follow-up* Mean relative change in plaque volume (TAV), follow-up* Mean change in plaque burden (PAV), follow-up*
Drug treatment
REVERSAL, 2004 [1] RCT double-blind 80 mg of atorvastatin
(vs40 mg of pravastatin)
253 (vs 249) 18 months 184.4 mm3 38.4% -0.9 mm3 [median]
-0.4 mm3 [mean]
-0.4%
(vs +2.7%)
+0.2% [median]
+0.6% [mean]
CAMELOT, 2004 [2] RCT placebo-controlled Amlopidine 10 mg (vsenalapril 20 mg and placebo) 663 (vs 673 and 655) 24 months NA 39.9% NA NA +0.5% (vs +0.8% and +1.3%)
A-Plus, 2004 [3] RCT double-blind placebo-controlled Avisimibe 750 mg 117 24 months 202.3 mm3 45.3% +1.9% (NS) +1.0% (NS) +1.0% (NS)
ESTABLISH, 2004 [4] RCT Atorvastatin 20 mg daily 24 6 months 69.6 mm3 29.9% -8.3 mm3 -13.1% -3.8%
ASTEROID, 2006 [5] Prospective open-label blinded end-points Rosuvastatin 40 mg daily 349 24 months 212.2 mm3 39.6% -12.5 mm3 [median]
-14.7 mm3[mean]
-2.9% -0.79% [median]
-0.98% [mean]
ACTIVATE, 2006 [6] RCT placebo-controlled Pactimibe 100 mg daily (ACAT inhibitor) 554 18 months 198.1 mm3 39.8% -1.3 mm3 (vs -5.6 mm3 in placebo) -0.7% +0.69%
PERISCOPE, 2008 [6] RCT double-blind Pioglitazone 15 to 45 mg (vs glimepiride 1 to 4 mg) 543 18 months NA 40.6% NA NA -0.16% (vs +0.73%)
ILLUSTRATE, 2008 [6] RCT Torcetrapib/ atorvastatin 910 24 months NA 37.0% NA NA +0.1% (NS)
STRADIVARIUS, 2008 [6] RCT placebo-controlled Rimonabant 839 20 months 191.7 mm3 37.5% -2.2 mm3 -1.04% +0.25%
JAPAN-ACS, 2009 [7] RCT open-label parallel Atorvastatin 20 mg daily (vspitavastatin 4 mg daily) 252 12 months 63.9 mm3 50.5% -10.6 mm3
(vs -8.2 mm3)
-18.1%
(vs -16.9%)
-6.3%
(vs -5.7%)
COSMOS, 2009 [8] Open-label observational Rosuvastatin 2.5 mg daily with titration up to 20 mg daily 214 15 months NA NA NA -5.1% NA
TOGETHAR, 2010 [9] Open-label observational Pitavastatin 2 mg daily 90 12 months NA NA NA NS NA
SATURN, 2011 [10] RCT double-blind Rosuvastatin 20 mg daily
(vs atorvastatin 40 mg)
520
(vs 519)
24 months 144.1 mm3 36.7% -6.39 mm3(vs-4.42 mm3) [median]
-8.4 mm3(vs-5.7 mm3) [mean]
-5.8%
(vs -3.9%)
-1.22% (vs -0.99%)
[median]
-1.3% (vs -1.1%) [mean]
ApoAI-Milano, 2003 [11] RCT double-blind placebo-controlled Combined ETC 15 mg/kg and 45 mg/kg (five weekly infusions) 36 5 weeks 268.4 mm3 38.96% -13.3 mm3[median]
-14.1 mm3[mean]
-5.2% -1.06% [median]
-0.81% [mean]
IBIS-2, 2008 [12] RCT double-blind placebo-controlled Darapladib 160 mg daily orally (LpPLA2 inhibitor) 175 12 months 327 mm3 40.7% -5.0 mm3 -0.9% NS
PCSK 9 MAb phase II-III trial13 Running PCSK9 MAb NA NA NA NA NA NA NA
Coronary devices
ABSORB A, 2009 [14] Prospective open-label study Implantation of the bioresorbable scaffold Absorb BVS (Abbott Vascular, CA) 29 6-24 months 116.9 mm3 (6 months post-procedure) 62.3% -13.38 mm3 [median]
-18.24 mm3 [mean]
-15.6% (from 6 months) -6.9%
PLASMONICS, 2008 [15] Bench study, Yukatanswines on Western diet MICS implantation onto coronary artery of the bioengineered patch bearing gold nanoparticles with further intravascular transcatheter PPTT by near-infrared laser 101 12 months 179.6 mm3 60.9% -79.4 mm3 -44.2% -29.8%
NANOM-FIM, 2012 [16] Prospective observational study The same as above in PLASMONICS study 60 12 months 178.4 mm3 68.5% -60.3 mm3 -33.8% -30.7%
NANOM-PCI, 2013 (preliminary) [16] Prospective observational study Intravascular transcathetermicro-infusion of gold nanoparticles to the target lesion with further PPTT by transcatheter near-infrared laser 32 12 months 182.0 mm3 68.3% -84.1 mm3 -46.2% -32.1%
TAV–total atheroma volume (mm3), PAV–per cent atheroma volume (%). TAV and PAV calculated by analysis of IVUS (intravascular ultrasound).
MICS–minimally invasive cardiac surgery, PPTT–plasmonicphotothermal therapy, BVS–bioresorbable vascular scaffold, RCT–randomized controlled trial, PCSK9–proproteinconvertasesubtilisinkexin
9, ACAT – the enzyme acyl-CoA : cholesterol acyltransferase, LpPLA2 –lipoprotein-associated phospholipase A2.
NA – non-available, or not applicable; NS – non-significant changes of variables (p value>0.05).
*p value<0.05 for all comparisons.
Table 1: Glasgov atheroregression in thr trials with the drug treatment and implantation of coronary devices.