Table. Selected Mechanical and Drug Intervention Intravascular Ultrasound Studies
Abbreviations: IVUS=intravascular ultrasound; Angio=angiography; CSA= ; MILD=minimum lumen diameter; MSA= ; MACE=major adverse cardiac event; CI=confidence interval; TLR= ; LDL-C=low density lipoprotein-C; CAD=coronary artery disease; ACS=acute coronary syndrome; HDL-C=high density lipoprotein-C; CETP=cholesterol ester transfer protein; SBP=systolic blood pressure.
Study / Study Design / Results / Take Home PointsA)IVUS Versus Angiography Guided Percutaneous Coronary Intervention Trials
Colombo et al., 1995 (45) / Single-center registry,
359 patients underwent Palmaz-Schatz coronary stent insertion with IVUS guidance. / 70% of stents needed post-dilatation after IVUS examination (CSA<60% of reference). With IVUS guidance, decreased to 4%. Repeated angioplasty 13.1%. ST 1.4% on antiplatelet therapy at six months. / With IVUS guidance, the MLD increased from 2.7±0.5 to 3.1±0.5 mm (P<.0001). Study showed that high pressure stent implantation without post-procedure Coumadin is safe.
Albeiro et al.,
1997 (49) / Case-controlled study (2 sites) 346 patients. IVUS-guided (Milan) vs. angiography- guided (Hamburg) stent implantation. / In the early phase, the dichotomous restenosis rate was lower in the IVUS group than in the Angio group (9.2% vs. 22.3%; P=0.04). In the late phase, no difference in restenosis between groups (P=1). / Total repeat revascularization was the same 7% (IVUS) vs. 11.7% (Angio) (p=0.17). Better acute results can be achieved with IVUS guidance.
Fitzgerald et al., 2000 (48)
CRUISE / Case-controlled (multicenter) study. 525 patients, IVUS vs. angiography-guided stent implantation. / IVUS-guided group had a larger MLD (2.9±0.4 vs. 2.7±0.5 mm, p<.001) and a larger MSA (7.78±1.72 vs. 7.06±2.13 mm2, P<0.001). / 9-month TLR: 8.5% (IVUS) vs. 15.5% (Angio), p<0.05. Clinical outcomes improved by IVUS at 9-month follow-up.
Mudra et al.,
2001 (50) OPTICUS / Randomized, controlled trial, 550 patients. IVUS-guided vs. angiography-guided stent implantation. / 6-month MLD: 1.95+/-0.72 mm vs. 1.91+/-0.68 mm, p=0.52). Restenosis: 24.5% vs. 22.8%, p=0.68). 12 month MACE: 1.07; 95% CI 0.75-1.52, p=0.71. / Despite a greater acute gain in the IVUS group (2.07 mm2 vs. 1.93 mm2, p<0.001), clinical outcomes were similar in IVUS and Angio groups.
Oemrawsingh et al., 2003 (51) TULIP / Randomized, controlled trial, 144 patients with lesions >20mm. IVUS-guided vs. angiography-guided stent implantation. / 6-month restenosis: 23% IVUS vs. 45% Angio, p=0.008. 12-month TLR: 10% vs. 23%, p=0.018). / Better clinical outcomes with IVUS in this long lesion patient group.
B)IVUS Studies Monitoring the Impact of Pharmacological Interventions on Atherosclerotic Progression
Nissen et al.,
2004 (18) REVERSAL / Randomized, controlled trial, 502 patients. Angiographically established CAD, and LDL-C between 125 to 210 mg/dL. Atorvastatin 80mg vs. prava- statin 40mg for 18 months. / LDL-C level: 79 mg/dL with atorva- statin vs. 110 mg/dL with pravastatin. Atorvastatin group showed -0.4% decrease in PAV from baseline (p=0.98); pravastatin group progressed 2.7% from baseline (p=0.001). / Demonstrated that intensive LDL-C lowering strategy halted progression of coronary atherosclerosis.
Nissen et al.,
2004 (24) NORMALISE / Randomized, controlled trial. Compared the effects of amlodipine or enalapril vs. placebo in 274 patients with CAD and diastolic BP <100 mmHg over 24 months. / Compared with baseline, placebo group showed progression (p<.001), a trend toward progression in the enalapril group (p=.08), and no progression in amlodipine group (p=0.31). / A direct relationship was observed between the degree of BP lowering and impact on plaque progression. The results suggested that optimal BP in patients with CAD is lower than current guideline recommendations.
Okazaki et al., 2004 (21) ESTABLISH / Randomized, controlled trial, 70 ACS patients underwent emergency PCI. Atorvastatin 20 mg vs. usual care. 6-month
follow-up. / LDL-C level significantly decreased in the atorvastatin vs. the control group (41.7% vs. 0.7%, p<.0001). Plaque volume significantly decreased in the atorvastatin group vs. control (-13.1±2.8% vs. 8.7±4.9%, p<.0001). / Demonstrated that early aggressive lipid lowering by atorvastatin for 6 months significantly reduced the plaque volume in ACS patients.
Nissen et al.,
2006 (19) ASTERIOD / Randomized, controlled trial, 349 patients with angiographic CAD were treated with rosuvastatin
40 mg daily for 24 months. / LDL-C level: 60.8 mg/dL and 14.7% increase in HDL-C. Resulting reduction in the LDL-C/HDL-C ratio by 58%. Significant decrease in PAV (-0.79%) from baseline (p<.001). / Significant reductions in all measures of atheroma burden. Demonstrated that very high-intensity statin therapy, when accompanied by significant HDL-C increase, can regress atherosclerosis.
Tardif et al.,
2007 (23) ERASE / Randomized, controlled trial, 145 patients ACS patients. Treated with reconstituted HDL-C or placebo infusion for
6 weeks. / Change in plaque volume was the same in HDL and placebo groups (−5.3 mm3 vs.-2.3 mm3, p=0.39). Plaque characterization index was significantly different. −0.0097 for HDL and 0.0128 for the placebo
group (p=0.01). / These findings highlighted the potential importance of emerging therapies that promote HDL-C.
Nissen et al.,
2007 (25) ILLUSTRATE / Randomized, controlled trial, 910 CAD patients treated either with placebo or the CETP inhibitor torcetrapib 24 months follow-up. / Torcetrapib therapy increased HDL levels (61%) and decreased LDL. Torcetrapib was also associated with an increase in SBP of 4.6 mmHg. The PAV increase was similar between groups (p=.72) / The CETP inhibitor torcetrapib was associated with a substantial increase in HDL and decrease in LDL. However, it was also associated with an increase in BP. No significant decrease in
progression of atherosclerosis.