Study | Objective | Endpoints | Design | Follow-up | Patients & Lesion | Method | Results | Conclusion & Limitation | |||||||||||||||||||||||||||||||||||||||||
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Park 2001 (32) | Effect of debulking & IVUS guidance on elective stenting of unprotected left main coronary artery (LMCA) stenosis Nov 1995 – April 2000 |
Procedural success: <30% residual diameter stenosis by QCA & no procedural or in hospital complications Angiographic MLD, restenosis rates MACE = cardiac death, non-fatal MI & TLR |
Non-randomized observation al study Patients IVUS 77 No IVUS 50 Use of IVUS @ discretion of the operator |
Angiographic follow-up @ 6 months Clinical following -up up to 2 years |
Patients: Consecutive patients Inclusion criteria -Symptomatic LMCA disease or documented MI -Angiographic evidence of ≥50% diameter stenosis of LMCA Exclusion criteria -Contraindication to antiplatelet or anticoagulation therapy -LVEF<40% |
IVUS Group Preintervention (56) and postintervention (77) IVUS IVUS criteria for optimal stenting Complete stent tovessel wall apposition; lumen CSA≥90% of distal reference lumen CSA; full lesion coverage QCA: analyzed by 2 independent angiographers using on-line QCA system. Angiographic stenosis defined as diameter stenosis>50% @follow-up Directional atherectomy performed before stenting in 40 lesions. All pts received aspirin + coumadinor aspirin + ticlopidine At least 48 hours before stenting |
For entire cohort: MACE free survival 86.9% @ 1year & 2 years. Survival rate 98.1% @ 1 year &97% @ 2 year |
Stenting of unprotected LMCA stenosis might be associated with favourable long-term outcome in selected patients. Guidance with IVUS may optimize the immediate results & debulking before stenting seems to be effective in reducing the restenosis rate. Large-scale RCT needed. |
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Agostoni 2005 (33) | Assess short & midterm clinical impact of IVUS guidance in elective percutaneo ustreatment of unprotected left main coronary artery disease with drug-eluting stents |
Major adverse cardiac events defined as cardiac or non-cardiac death, non-fatal MI, & target vessel revascularization | Non-randomized cohort | Clinical Median 433 days(range 178–780 days) | Elective patients with symptomatic coronary artery disease & >50% occlusion of left main coronary artery. IVUS n = 24 No IVUS n = 34 |
Vessels measured Q baseline & after procedure with quantitative coronary angiography Unprotected left main coronary artery stented with drug-eluting stent (s) under guidance of coronary angiography or additional IVUS at the discretion of the operator. External elastic membrane areas & lumen cross-sectional area measured with computerized planimetry. Criteria for optimal stent placement: Complete stent-to-stent wall apposition, adequate stent expansion (>80% reference cross-sectional area), full lesion coverage. |
Incidence of MACE IVUS 8% No IVUS 20% (P = .18) Univariate analysis: Distal left main involvement & reference vessel diameter were the only significant predictors of MACE. Multivariate analysis: Distal left main disease was theonly significant predictor of MACE (Hazard ratio 7.7, 95% CI 1–62.6, P =.05). |
IVUS was not associated with additional clinical benefit with respect to angiographic-assisted stent deployment Major Limitation: Small sample Non-randomized No angiographic follow-up |