Search

Objectives: The purpose of this study was to determine whether cilostazol reduces intimal hyperplasia in patients undergoing long zotarolimus-eluting stent implantation (stent length: ≥30 mm) for native long coronary lesions (length: ≥25 mm). Background: Restenosis after drug-eluting stent implantation remains a significant clinical problem in long coronary lesions. Methods: Patients (n = 499) were assigned randomly to triple (aspirin, clopidogrel, and cilostazol, triple group: n = 250) or dual antiplatelet therapy (aspirin and clopidogrel and placebo, dual group: n = 249) for 8 months after long zotarolimus-eluting stent implantation. The primary end point was in-stent late loss at the 8-month angiography according to the intention-to-treat principle. Results: The 2 groups had similar baseline characteristics. The in-stent (0.56 ± 0.55 mm vs. 0.68 ± 0.59 mm, p = 0.045) and in-segment (0.32 ± 0.54 mm vs. 0.47 ± 0.54 mm, p = 0.006) late loss were significantly lower in the triple versus dual group, as were 8-month in-stent restenosis (10.8% vs. 19.1%, p = 0.016), in-segment restenosis (12.2% vs. 20.0%, p = 0.028), and 12-month ischemic-driven target lesion revascularization (5.2% vs. 10.0%, p = 0.042) rates. At 12 months, major adverse cardiac events including death, myocardial infarction, and ischemic-driven target lesion revascularization tended to be lower in the triple group than the dual group (7.2% vs. 12.0%, p = 0.07). Percent intimal hyperplasia volume by volumetric intravascular ultrasound analysis was reduced from 27.1 ± 13.2% for the dual group to 22.1 ± 9.9% for the triple group (p = 0.017). Conclusions: Patients receiving triple antiplatelet therapy after long zotarolimus-eluting stent implantation had decreased extent of late luminal loss, percent intimal hyperplasia volume, and angiographic restenosis, resulting in a reduced risk of 12-month target lesion revascularization compared with patients receiving dual antiplatelet therapy. (Triple Versus Dual Antiplatelet Therapy after ABT578-Eluting Stent; NCT00589927) [Copyright &y& Elsevier]

Objectives: The aim of this study was to compare the effectiveness of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM). Background: Drug-eluting stent implantation significantly improved the angiographic and clinical outcomes compared with bare-metal stent implantation in diabetic patients. However, comparison of SES with PES in diabetic patients has not been sufficiently evaluated. Methods: This prospective, multicenter, randomized study compared SES (n = 200) and PES implantation (n = 200) for diabetic patients (n = 400). The primary end point was in-segment restenosis at 6 months according to intention-to-treat principle. Results: The 2 groups had similar baseline clinical and angiographic characteristics. Six-month in-stent (3.4% vs. 18.2%, p < 0.001) and in-segment restenosis (4.0% vs. 20.8%, p < 0.001) and 9-month target lesion revascularization (2.0% vs. 7.5%, p = 0.017) were significantly lower in the SES versus the PES group. The incidence of death (0% in SES vs. 0.5% in PES, p = 0.999) or myocardial infarction (0.5% in SES vs. 0.5% in PES, p = 0.999) at 9-month follow-up was not statistically different between the 2 groups. Major adverse cardiac events including death, myocardial infarction, and target lesion revascularization at 9 months (2.0% vs. 8.0%, p = 0.010) were lower in the SES versus the PES group. Conclusions: Sirolimus-eluting stent implantation is superior in reducing angiographic restenosis and improving 9-month clinical outcomes in patients with DM and coronary artery disease compared with PES implantation. [Copyright &y& Elsevier]

Objectives: We sought to evaluate the impact of cilostazol on neointimal hyperplasia after drug-eluting stent (DES) implantation in patients with diabetes mellitus (DM). Background: Although cilostazol has reduced the extent of neointimal hyperplasia and restenosis in patients after bare-metal stent implantation, it is not known whether this effect occurs after DES implantation in diabetic patients. Methods: This randomized, multicenter, prospective study compared triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol, triple group, n = 200) and dual antiplatelet therapy (aspirin and clopidogrel, standard group, n = 200) for 6 months in patients with DM receiving DES. The primary end point was in-stent late loss at 6 months. Results: The 2 groups had similar baseline clinical and angiographic characteristics. The in-stent (0.25 ± 0.53 mm vs. 0.38 ± 0.54 mm, p = 0.025) and in-segment (0.42 ± 0.50 mm vs. 0.53 ± 0.49 mm, p = 0.031) late loss were significantly lower in the triple versus standard group, as were 6-month in-segment restenosis (8.0% vs. 15.6%, p = 0.033) and 9-month target lesion revascularization (TLR) (2.5% vs. 7.0%, p = 0.034). At 9 months, major adverse cardiac events, including death, myocardial infarction, and TLR, tended to be lower in the triple than in the standard group (3.0% vs. 7.0%, p = 0.066). Multivariate analysis showed that sirolimus-eluting stents and the use of cilostazol were strong predictors of reduced restenosis or TLR. Conclusions: Triple antiplatelet therapy after DES implantation decreased angiographic restenosis and extent of late loss, resulting in a reduced risk of 9-month TLR compared with dual antiplatelet therapy in diabetic patients. [Copyright &y& Elsevier]

Objectives: We evaluated safety and efficacy of triple antiplatelet therapy with aspirin, clopidogrel, or ticlopidine and cilostazol after coronary stenting. Background: Triple antiplatelet therapy might have beneficial effect to prevent thrombotic complications in patients undergoing coronary stenting. Methods: Patients undergoing successful coronary stenting were divided into dual antiplatelet therapy (aspirin plus clopidogrel or ticlopidine, group I, n = 1,597) and triple antiplatelet therapy (aspirin plus clopidogrel or ticlopidine plus cilostazol, group II, n = 1,415) groups. The primary end point included death, myocardial infarction, target lesion revascularization, or stent thrombosis within 30 days. The secondary end point was side effects of study drugs, including major bleeding, vascular complication, hepatic dysfunction, and hematological complications. Results: Multi-vessel stenting and the use of long stents were more prevalent in group II than in group I. The primary end point was 0.8% in group I and 0.3% in group II (p = 0.085). Stent thrombosis within 30 days was significantly lower in group II (n = 1, 0.1%) than in group I (n = 9, 0.5%; p = 0.024). The independent predictors of stent thrombosis were primary stenting (odds ratio [OR] 7.9, 95% confidence interval [CI] 2.0 to 30.8, p = 0.003) and triple therapy (OR 0.12, 95% CI 0.015 to 0.98, p = 0.048). The overall adverse drug effects, including major bleeding, neutropenia, and thrombocytopenia, were no different between two groups (1.8% vs. 2.6%, p = 0.104). Conclusions: Compared with the dual antiplatelet regimen, triple antiplatelet therapy seemed to be more effective in preventing thrombotic complications after stenting without an increased risk of side effects. Triple antiplatelet therapy might be safely applied in patients or lesions with a high risk of stent thrombosis. [Copyright &y& Elsevier]

Background: Comparative outcomes of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for left main coronary artery (LMCA) disease were previously reported. However, data on very long-term (>10 years) outcomes are limited.Objectives: The authors compare 10-year outcomes after PCI and CABG for LMCA disease.Methods: In this observational study of the MAIN-COMPARE (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty versus Surgical Revascularization) registry, the authors evaluated 2,240 patients with unprotected LMCA disease who underwent PCI (n = 1,102) or underwent CABG (n = 1,138) between January 2000 and June 2006. Adverse outcomes (death; a composite outcome of death, Q-wave myocardial infarction, or stroke; and target-vessel revascularization) were compared with the use of propensity scores and inverse-probability-weighting adjustment. The follow-up was extended to at least 10 years of all patients (median 12.0 years).Results: In the overall cohort, there was no significant difference in adjusted risks of death and the composite outcome between the groups up to 10 years. The risk of target-vessel revascularization was significantly higher in the PCI group. In the cohort comparing drug-eluting stents and concurrent CABG, the 2 study groups did not differ significantly in the risks of death and the composite outcome at 5 years. However, after 5 years, drug-eluting stents were associated with higher risks of death (hazard ratio: 1.35; 95% confidence interval: 1.00 to 1.81) and the composite outcome (hazard ratio: 1.46; 95% confidence interval: 1.10 to 1.94) compared with CABG.Conclusions: In patients with significant LMCA disease, as compared with CABG, PCI showed similar rates of death and serious composite outcomes, but a higher rate of target-vessel revascularization at 10 years. However, CABG showed lower mortality and serious composite outcome rates compared with PCI with drug-eluting stents after 5 years. (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty versus Surgical Revascularization [MAIN-COMPARE]; NCT02791412). [ABSTRACT FROM AUTHOR]

Background: Limited data are available on the relative performances between different types of drug-eluting stents (DES) for obstructive left main coronary artery disease (LMCAD).Objectives: This study sought to compare effectiveness and safety profiles of various second-generation DES for LMCAD in real-world clinical practice.Methods: Among 4,470 patients in 3, multicenter, prospective registries (IRIS-DES [Interventional Cardiology Research Incorporation Society-Drug-Eluting Stents] registry, the IRIS-MAIN [Interventional Cardiology Research Incorporation Society-Left MAIN Revascularization] registry, and the PRECOMBAT [PREmier of Randomized COMparison of Bypass Surgery versus AngioplasTy Using Drug-Eluting Stent in Patients with Left Main Coronary Artery Disease] study) treated between July 2007 and July 2015, the authors identified 2,692 patients with significant LMCAD who received second-generation DES; 1,254 with cobalt-chromium everolimus-eluting stents (CoCr-EES), 232 with biodegradable polymer biolimus-eluting stents (BP-BES), 616 with platinum-chromium EES (PtCr-EES), and 590 with Resolute zotarolimus-eluting stent (Re-ZES). The primary outcome was target-vessel failure.Results: The observed 3-year rates of target-vessel failure were not significantly different for the different types of DES (16.7% for the CoCr-EES, 13.2% for the BP-BES, 18.7% for the PtCr-EES, and 14.7% for the Re-ZES; p = 0.15). In multiple treatment propensity score analysis, the adjusted hazard ratios (HRs) for target-vessel failure were similar in between-group comparisons of the different DES, except for the PtCr-EES versus the BP-BES (reference; HR: 1.60; 95% confidence interval: 1.01 to 2.54; p = 0.046). There were no significant differences in risk of composite of all-cause death, any myocardial infarction, or any revascularization and its individual components according to the different types of DES. Although the 3-year incidence of stent thrombosis was considerably low (≤1.0%) for all types of DES, between-group differences were observed, generally favoring the EES platforms.Conclusions: In this pooled analysis of 3 prospective registries involving unrestricted use of various second-generation DES for LMCAD, we found no significant between-group differences in 3-year risk of target-vessel failure, except for a higher risk of primary outcome with PtCr-EES compared to BP-BES. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133). [ABSTRACT FROM AUTHOR]

Left main coronary artery (LMCA) disease is the highest-risk lesion subset of ischemic heart disease, and has traditionally been an indication for coronary artery bypass grafting (CABG). Recent evidence suggests comparable clinical outcomes between percutaneous coronary intervention (PCI) and CABG for LMCA disease, with similar rates of mortality and serious composite outcomes, a higher rate of stroke with CABG, and a higher rate of repeat revascularization with PCI. These results have been translated to the current guideline recommendation that PCI is a reasonable alternative to CABG in patients with low to intermediate anatomic complexity. However, how the characteristics, treatment, and clinical outcomes of patients with unprotected LMCA disease have evolved over time has not yet been fully evaluated. We therefore described secular trends in the characteristics and long-term outcomes of unprotected LMCA disease using "real-world" clinical experience from the IRIS-MAIN (Interventional Research Incorporation Society-Left MAIN Revascularization) registry together with a broad review of this topic. [ABSTRACT FROM AUTHOR]

Background: In diabetic patients with multivessel coronary artery disease (CAD), the survival difference between coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) favors CABG. However, there are few data on the mortality difference between the 2 strategies in nondiabetic patients.Objectives: This study performed a patient-level meta-analysis to compare the effect of CABG versus PCI with drug-eluting stents on long-term mortality in 1,275 nondiabetic patients with multivessel CAD.Methods: Individual patient data from the SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) and the BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) trials were pooled. The primary outcome was death from any cause.Results: The median follow-up time was 61 months (interquartile range: 50 months to 62 months). The risk of death from any cause was significantly lower in the CABG group than in the PCI group (hazard ratio [HR]: 0.65; 95% confidence interval [CI]: 0.43 to 0.98; p = 0.039). A similar finding was observed for the risk of death from cardiac causes. The superiority of CABG over PCI was consistent across the major clinical subgroups. Likewise, the rate of myocardial infarction was remarkably lower after CABG than after PCI (HR: 0.40; 95% CI: 0.24 to 0.65; p < 0.001). However, the rate of stroke was not different between the 2 groups (HR: 1.13; 95% CI: 0.59 to 2.17; p = 0.714). The need for repeat revascularization was significantly lower in the CABG group than in the PCI group (HR: 0.55; 95% CI: 0.40 to 0.75; p < 0.001).Conclusions: CABG, as compared with PCI with drug-eluting stents, significantly reduced the long-term risk of mortality in nondiabetic patients with multivessel CAD. [ABSTRACT FROM AUTHOR]

Background: How statins alter the natural course of coronary atherosclerosis with compositional changes remains unclear.Objectives: This study aimed to determine the effect of statin therapy on modifying plaque composition.Methods: The STABLE (Statin and Atheroma Vulnerability Evaluation) prospective, single-center, double-blind, randomized study evaluated the effect of statins on functionally insignificant coronary stenoses. We randomly assigned 312 patients with a virtual histology (VH) intravascular ultrasound-defined fibroatheroma-containing index lesion to rosuvastatin 40 mg versus 10 mg (2:1 ratio). In 225 (72%) patients, grayscale- and VH-intravascular ultrasound were completed at baseline and 12 months. The primary endpoint was the change in VH-defined percent compositional volume within the target segment from baseline to follow-up in the per-protocol analysis set.Results: Percent necrotic core (NC) volume within the target segment significantly decreased from 21.3 ± 6.8% to 18.0 ± 7.5% during 1-year follow-up, whereas the percent fibrofatty volume increased (11.7 ± 5.8% vs. 14.8 ± 9.3%; all p < 0.001). Percent fibrous (59.4 ± 7.8% vs. 59.2 ± 8.6%) and dense calcium (7.6 ± 5.1% vs. 7.8 ± 5.6%) volumes were unchanged. Frequencies of VH (55% vs. 29%) decreased significantly. Normalized total (202.9 ± 72.3 mm(3) vs. 188.5 ± 67.8 mm(3); p = 0.001) and percent (51.4 ± 8.3% vs. 50.4 ± 8.8%; p = 0.018) atheroma volumes decreased. Independent predictors of percent NC volume change were body mass index (β = 0.37; 95% confidence interval [CI]: 0.05 to 0.70), high sensitivity C-reactive protein (β = -3.16; 95% CI: -5.64 to -0.69), and baseline percent NC volume (β = -0.44; 95% CI: -0.68 to -0.19; all p < 0.05). VH-defined percent compositional volume changes in the rosuvastatin 40- and 10-mg groups were similar.Conclusions: Rosuvastatin reduced NC and plaque volume and decreased thin-cap fibroatheroma rate. There were no significant differences between high- versus moderate-intensity rosuvastatin. (Statin and Atheroma Vulnerability Evaluation [STABLE]; NCT00997880). [ABSTRACT FROM AUTHOR]

Background In a previous randomized trial, we found that percutaneous coronary intervention (PCI) was not inferior to coronary artery bypass grafting (CABG) for the treatment of unprotected left main coronary artery stenosis at 1 year. Objectives This study sought to determine the 5-year outcomes of PCI compared with CABG for the treatment of unprotected left main coronary artery stenosis. Methods We randomly assigned 600 patients with unprotected left main coronary artery stenosis to undergo PCI with a sirolimus-eluting stent (n = 300) or CABG (n = 300). The primary endpoint was a major adverse cardiac or cerebrovascular event (MACCE: a composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target vessel revascularization) and compared on an intention-to-treat basis. Results At 5 years, MACCE occurred in 52 patients in the PCI group and 42 patients in the CABG group (cumulative event rates of 17.5% and 14.3%, respectively; hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 0.84 to 1.90; p = 0.26). The 2 groups did not differ significantly in terms of death from any cause, myocardial infarction, or stroke as well as their composite (8.4% and 9.6%; HR, 0.89; 95% CI, 0.52 to 1.52; p = 0.66). Ischemia-driven target vessel revascularization occurred more frequently in the PCI group than in the CABG group (11.4% and 5.5%, respectively; HR: 2.11; 95% CI: 1.16 to 3.84; p = 0.012). Conclusions During 5 years of follow-up, our study did not show significant difference regarding the rate of MACCE between patients who underwent PCI with a sirolimus-eluting stent and those who underwent CABG. However, considering the limited power of our study, our results should be interpreted with caution. (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT]; NCT00422968 ) [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to evaluate the impact of ischemia-guided (IG) revascularization. Background: The importance of IG revascularization has not been well-determined. Methods: The outcomes of IG revascularization, in which revascularization was performed in the matched coronary artery with the perfusion abnormality on myocardial perfusion image (MPI), were retrospectively compared with those of non-IG revascularization in a registry of 5,340 patients with multivessel coronary disease comprising 2,587 percutaneous coronary interventions (PCIs) with drug-eluting stents and 2,753 coronary artery bypass graft (CABG) surgeries after adjustment with inverse-probability-of-treatment weighting. Results: The MPI was performed in 42.3% of patients, and IG revascularization was performed in 17.3%, including 12.4% in PCI and 21.8% in CABG patients (p < 0.001). The incidence of major adverse cardiac and cerebrovascular events (MACCE) including death, myocardial infarction, stroke, or repeat revascularization was significantly lower in the IG than in the non-IG group (16.2% vs. 20.7%; adjusted hazard ratio [aHR]: 0.73; 95% confidence interval [CI]: 0.60 to 0.88; p = 0.001), primarily driven by the lower repeat revascularization rate (9.9% vs. 22.8%; aHR: 0.66; 95% CI: 0.49 to 0.90; p = 0.009). Subgroup analysis showed that IG reduced the risk of MACCE in PCI (17.4% vs. 22.8%; aHR: 0.59; 95% CI: 0.43 to 0.81; p = 0.001) but not in CABG (16.0% vs. 18.5%; aHR: 0.87; 95% CI: 0.67 to 1.14; p = 0.31) patients. Conclusions: Ischemia-guided revascularization with MPI, particularly in PCI-treated patients, seems to decrease the risk of repeat revascularization and MACCE for patients with multivessel disease. [Copyright &y& Elsevier]

Objectives: The purpose of this study is to compare the efficacy of the treatment strategies for in-stent restenosis (ISR) of drug-eluting stents (DES) according to the morphologic pattern of restenosis. Background: Optimal treatment strategies for ISR within DES have not been adequately addressed yet. Methods: Patients with ISR of DES were randomized according to the lesion length to compare outcomes of sirolimus-eluting stent (SES) versus cutting balloon angioplasty for focal type (≤10 mm) and SES versus everolimus-eluting stent (EES) for diffuse type (>10 mm). The primary endpoint was in-segment late loss at 9 months. Overall 162 patients, 96 with focal ISR and 66 with diffuse ISR, were enrolled. Results: In focal lesions, in-segment late loss was significantly higher in the cutting balloon group (n = 48) than in the SES group (n = 48; 0.25 mm, interquartile range [IQR]: −0.01 to 0.68 mm vs. 0.06 mm, IQR: −0.08 to 0.17 mm; p = 0.04). Consequently, in-segment restenosis rate tended to be higher in the cutting balloon group than in the SES group (20.7% vs. 3.1%, p = 0.06) with comparable incidences of the composite of death, myocardial infarction, or target vessel revascularization at 12 months of clinical follow up (6.3% vs. 6.3%, p > 0.99). In 66 cases of diffuse ISR, in-segment late loss (0.11 mm, IQR: −0.02 to 0.30 mm; vs. 0.00 mm, IQR: −0.08 to 0.25 mm; p = 0.64), in-segment restenosis rate (5.0% vs. 14.3%, p = 0.32), and the composite incidence of death, myocardial infarction, or target lesion revascularization (9.6% vs. 8.8%, p > 0.99) did not differ between SES group (n = 32) and EES group (n = 34). Conclusions: For lesions of focal DES restenosis, repeat implantation of SES is more effective in reducing late luminal loss and subsequent restenosis rate than cutting balloon angioplasty. For diffuse DES restenosis, implantation of SES or EES is comparably effective in terms of angiographic and clinical outcomes. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to investigate clinical utility of on-site platelet function test and C-reactive protein (CRP) in patients undergoing percutaneous coronary intervention (PCI). Background: Data on long-term prognostic value of high on-treatment platelet reactivity (HTPR) on clopidogrel after PCI are limited. As a distinct biological pathway, CRP has been suggested to be associated with post-PCI atherothrombotic events. Methods: We evaluated 2,849 patients who received drug-eluting stents (DES) and had post-PCI VerifyNow P2Y12 assays (Accumetrics, San Diego, California) performed. Among them, baseline CRP measurement was available in 2,546 patients. The primary endpoint was a composite of all-cause death, nonfatal myocardial infarction, stent thrombosis, and stroke. Results: During follow-up (median, 2.2 years), the occurrence of the primary endpoint did not significantly differ among patients with and without HTPR (2.8% vs. 2.4% at 2 years; hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 0.88 to 2.01; p = 0.18). By contrast, patients with elevated CRP levels were at significantly higher risk for the primary endpoint, as compared with those with nonelevated CRP levels (5.6% vs. 1.7% at 2 years; HR: 2.81, 95% CI:, 1.83 to 4.31; p < 0.001). The VerifyNow test had no incremental usefulness to classify long-term risk. However, the incorporation of CRP into a model with conventional clinical and procedural risk factors significantly improved the C-statistic for the prediction of the primary endpoint (0.729 to 0.759; p = 0.03). Conclusions: We failed to identify that HTPR measured by VerifyNow P2Y12 assay was significantly associated with long-term atherothrombotic risks in patients receiving DES. However, elevated CRP levels were significantly associated with worse outcomes and had incremental predictive values over conventional risk factors. [Copyright &y& Elsevier]

Objectives: The aim of this study was to compare treatment effects of drug-eluting stents (DES) or coronary artery bypass grafting (CABG) for left main coronary artery (LMCA) disease according to the complexity of atherosclerotic disease burden. Background: Limited information is available on the relationships between the extent of coronary atherosclerosis and very long-term outcomes of surgical or percutaneous LMCA revascularization. Methods: A total of 1,146 patients with unprotected LMCA disease who received DES (n = 645) or underwent CABG (n = 501) were evaluated. The extent of atherosclerotic disease burden was measured using the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score; a low-risk score was defined as ≤22, an intermediate-risk score as 23 to 32, and a high-risk score as ≥33. Results: After multivariate adjustment with the inverse-probability-of-treatment weighting method, the 5-year risks for death (6.1% for DES vs. 16.2% for CABG; hazard ratio [HR]: 0.52; 95% confidence interval [CI]: 0.21 to 1.28; p = 0.15) and the composite of death, Q-wave myocardial infarction, or stroke (6.4% vs. 16.2%; HR: 0.54; 95% CI: 0.22 to 1.34; p = 0.18) favored DES in patients with low-risk SYNTAX scores; in contrast, the 5-year risks for death (26.9% vs. 17.8%; HR: 1.46; 95% CI: 0.92 to 2.30; p = 0.11) and the composite outcome (27.6% vs. 19.5%; HR: 1.36; 95% CI: 0.87 to 2.12; p = 0.18) favored CABG in patients with high-risk SYNTAX scores (interaction p = 0.047 for death, interaction p = 0.08 for composite outcome). Patients undergoing CABG consistently had lower rates of target vessel revascularization. Conclusions: According to the complexity of concomitant coronary disease, there were differential treatment effects on long-term mortality in patients with unprotected LMCA disease who received DES or underwent CABG. [ABSTRACT FROM AUTHOR]

Objectives: We aimed to define the relationship between cerebral atherosclerosis and stroke after coronary artery bypass grafting (CABG). Background: Although cerebral atherosclerosis may play a crucial role in the advent of post-CABG stroke, only extracranial carotid artery disease has been extensively studied, and the effects of atherosclerosis on the mechanisms underlying post-CABG stroke remain unclear. Methods: Pre-operative magnetic resonance angiography was performed on 1,367 consecutive CABG patients to assess intracranial and extracranial cerebral atherosclerosis. Disease severity was evaluated by atherosclerosis score, as determined by the number of steno-occlusions of cerebral arteries and the degree thereof. Post-CABG strokes (within 14 days) were classified as atherosclerotic (strokes attributable to pre-defined atherosclerosis) or other (strokes caused by other mechanisms). Associations between post-CABG stroke and each type of atherosclerotic disease (extracranial carotid artery disease, intracranial, extracranial, or extracranial and/or intracranial cerebral atherosclerosis), differentiated according to the involved arteries, were analyzed. Results: Stroke occurred in 33 patients, and the atherosclerosis score was independently associated with stroke development (odds ratio: 1.35; 95% confidence interval: 1.16 to 1.56). Atherosclerotic stroke was defined in 15 (45%), and constituted >40% of both immediate (within 24 h) and delayed strokes. Intracranial, extracranial, and extracranial and/or intracranial cerebral atherosclerosis were significantly associated with stroke. Conclusions: Cerebral atherosclerosis was closely related to the occurrence of post-CABG stroke, being both an independent risk factor for and the cause of a significant proportion of strokes. Pre-operative evaluation of intracranial and extracranial cerebral arteries, apart from the extracranial carotid artery, may be useful to predict the likelihood of post-CABG stroke. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to evaluate the incidence, predictors, and long-term outcomes of patients with in-stent restenosis (ISR) after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for unprotected left main coronary artery (LMCA) disease. Background: Few data on the clinical course and management of patients experiencing restenosis after DES treatment for unprotected LMCA disease have appeared. Methods: Between February 2003 and November 2007, 509 consecutive patients with unprotected LMCA disease underwent DES implantation, with 402 (80.1%) undergoing routine surveillance or clinically driven angiographic follow-up. A major adverse cardiac event was defined as the composite of death, myocardial infarction (MI), or target-lesion revascularization. Results: The overall incidence of angiographic ISR in LMCA lesions was 17.6% (71 of 402 patients, 57 with focal-type and 14 with diffuse-type ISR. Forty patients (56.3%) underwent repeated PCI, 10 (14.1%) underwent bypass surgery, and 21 (29.6%) were treated medically. During long-term follow-up (a median of 31.7 months), there were no deaths, 1 (2.2%) MI, and 6 (9.5%) repeated target-lesion revascularization cases. The incidence of major adverse cardiac event was 14.4% in the medical group, 13.6% in the repeated PCI group, and 10.0% in the bypass surgery group (p = 0.91). Multivariate analysis showed that the occurrence of DES-ISR did not affect the risk of death or MI. Conclusions: The incidence of ISR was 17.7% after DES stenting for LMCA. The long-term clinical prognosis of patients with DES-ISR associated with LMCA stenting might be benign, given that these patients were optimally treated with the clinical judgment of the treating physician. [ABSTRACT FROM AUTHOR]

Objectives: We performed the long-term (5-year) follow-up of a large cohort of patients who underwent drug-eluting stent (DES) or coronary artery bypass graft (CABG) surgery for multivessel revascularization. Background: Limited information is available on very long-term outcomes after multivessel DES treatment relative to CABG. Methods: We evaluated 3,042 patients with multivessel disease who received DES (n = 1,547) or underwent CABG (n = 1,495) between January 2003 and December 2005, and for whom complete follow-up data were available for a median 5.6 years (interquartile range: 4.6 to 6.3 years). We compared adverse outcomes (death; a composite outcome of death, myocardial infarction, or stroke; and repeat revascularization). Results: After adjustment for differences in baseline risk factors, 5-year risk of death (hazard ratio [HR]: 1.00; 95% confidence interval [CI]: 0.76 to 1.32, p = 0.99) and the combined risk of death, myocardial infarction, or stroke (HR: 0.97; 95% CI: 0.76 to 1.24, p = 0.81) were similar between the DES group and the CABG group. However, the rates of revascularization were significantly higher in the DES group (HR: 2.93; 95% CI: 2.20 to 3.90, p < 0.001). Similar results were obtained in comparisons of DES with CABG for high-risk clinical and anatomic subgroups with diabetes mellitus, abnormal ventricular function, age 65 years or more, and 3-vessel and left main disease. However, mortality benefit with DES implantation relative to CABG was noted in patients with 2-vessel disease (HR: 0.57; 95% CI: 0.36 to 0.92, p = 0.02). Conclusions: For patients with multivessel disease, DES treatment, compared with CABG, showed similar rates of mortality and of the composite safety outcomes, but higher rates of revascularization up to 5 years. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to evaluate the long-term safety and effectiveness of percutaneous coronary intervention (PCI), as compared with coronary artery bypass grafting (CABG), for unprotected left main coronary artery (LMCA) disease. Background: Data on the long-term (beyond 5-year) comparative results of treatment of unprotected LMCA disease with stent implantation or CABG are limited. Methods: We performed a 10-year clinical follow-up of 350 patients with unprotected LMCA disease who underwent PCI with bare-metal stents (BMS) (n = 100) or CABG (n = 250) from January 1995 to April 1999, and 5-year clinical follow-up of 395 patients with unprotected LMCA disease who underwent PCI with drug-eluting stents (DES) (n = 176) or CABG (n = 219) from January 2003 to May 2004. The primary safety end points were all-cause mortality and the composite of death, Q-wave myocardial infarction (MI), or stroke, and the primary efficacy end point was target vessel revascularization (TVR). Results: In the 10-year follow-up cohort of BMS and concurrent CABG, the adjusted risks of death (hazard ratio [HR]: 0.81; 95% confidence interval [CI]: 0.44 to 1.50; p = 0.50) and the composite of death, Q-wave MI, or stroke (HR: 0.92; 95% CI: 0.55 to 1.53; p = 0.74) were similar between the 2 groups. The rate of TVR was significantly higher in the group that received BMS (HR: 10.34; 95% CI: 4.61 to 23.18; p < 0.001). In the 5-year follow-up cohort of DES and concurrent CABG, there was no significant difference in the adjusted risk of death (HR: 0.83; 95% CI: 0.34 to 2.07; p = 0.70) or the risk of the composite outcome (HR: 0.91; 95% CI: 0.45 to 1.83; p = 0.79). The rates of TVR were also higher in the DES group than the CABG group (HR: 6.22; 95% CI: 2.26 to 17.14; p < 0.001). Conclusions: For the treatment of unprotected LMCA disease, PCI with stent implantation showed similar long-term mortality and rates of death, Q-wave MI, or stroke. However, stenting, even with DES, was associated with higher rates of repeat revascularization than was CABG. [Copyright &y& Elsevier]

Objectives: The aim of this study was to evaluate the relative efficacy and safety of zotarolimus-eluting stents (ZES) in comparison with the established and widely used sirolimus- (SES) and paclitaxel-eluting stents (PES) in routine clinical practice. Background: Whether ZES might provide similar clinical and angiographic outcomes in a broad spectrum of patients compared with SES or PES is undetermined. Methods: We performed a single-blind, multicenter, prospectively randomized trial to compare ZES with SES and PES in 2,645 patients undergoing percutaneous coronary intervention. The primary end point was a composite of major adverse cardiac events (MACE) (death, myocardial infarction, and ischemia-driven target vessel revascularization) at 12 months. A noninferiority comparison (ZES vs. SES) and a superiority comparison (ZES vs. PES) were performed for the primary end point. Results: Baseline clinical and angiographic characteristics were similar in the 3 groups. At 12 months, the ZES group showed noninferior rates of MACE compared with the SES group (10.2% vs. 8.3%, p for noninferiority = 0.01, p for superiority = 0.17) and significantly fewer MACE than the PES group (10.2% vs. 14.1%, p for superiority = 0.01). The incidence of death or myocardial infarction was similar among the groups (ZES vs. SES vs. PES, 5.8% vs. 6.9% vs. 7.6%, respectively, p = 0.31). The incidence of stent thrombosis was significantly lower in the SES group (ZES vs. SES vs. PES, 0.7% vs. 0% vs. 0.8%, respectively, p = 0.02). Conclusions: In this large-scale, practical randomized trial, the use of ZES resulted in similar rates of MACE compared with SES and in fewer MACE compared with PES at 12 months. (Comparison of the Efficacy and the Safety of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent and PacliTaxel-Eluting Stent for Coronary Lesions; NCT00418067) [ABSTRACT FROM AUTHOR]

Objectives: We performed the long-term follow-up of a large cohort of patients in a multicenter study receiving left main coronary artery (LMCA) revascularization. Background: Limited information is available on long-term outcomes for patients with unprotected LMCA disease who underwent coronary stent procedure or coronary artery bypass grafting (CABG). Methods: We evaluated 2,240 patients with unprotected LMCA disease who received coronary stents (n = 1,102; 318 with bare-metal stents and 784 with drug-eluting stents) or underwent CABG (n = 1,138) between 2000 and 2006 and for whom complete follow-up data were available for at least 3 to 9 years (median 5.2 years). The 5-year adverse outcomes (death; a composite outcome of death, Q-wave myocardial infarction [MI], or stroke; and target vessel revascularization [TVR]) were compared with the use of the inverse probability of treatment weighted method and propensity-score matching. Results: After adjustment for differences in baseline risk factors with the inverse probability of treatment weighting, the 5-year risk of death (hazard ratio [HR]: 1.13; 95% confidence interval [CI]: 0.88 to 1.44, p = 0.35) and the combined risk of death, Q-wave MI, or stroke (HR: 1.07; 95% CI: 0.84 to 1.37, p = 0.59) were not significantly different for patients undergoing stenting versus CABG. The risk of TVR was significantly higher in the stenting group than in the CABG group (HR: 5.11; 95% CI: 3.52 to 7.42, p < 0.001). Similar results were obtained in comparisons of bare-metal stent with concurrent CABG and of drug-eluting stent with concurrent CABG. In further analysis with propensity-score matching, overall findings were consistent. Conclusions: During 5-year follow-up, stenting showed similar rates of mortality and of the composite of death, Q-wave MI, or stroke but higher rates of TVR as compared with CABG for patients with unprotected LMCA disease. [Copyright &y& Elsevier]

Objectives: This study was designed to examine the impact of the extent of coronary disease on long-term outcomes after coronary stenting or coronary artery bypass graft (CABG) surgery for unprotected left main coronary artery (ULMCA) stenosis. Background: The differential outcome of ULMCA revascularization according to the coronary involvement remains uncertain. Methods: From the MAIN-COMPARE (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty versus Surgical Revascularization) registry, 2,240 patients with ULMCA stenosis who underwent either stenting or CABG were stratified by number of diseased vessels. Results: Following adjustment with EuroSCORE (European System for Cardiac Operative Risk Evaluation), diabetes mellitus, and bifurcation stenosis, stents and CABG had similar risks of death and major adverse cardiac events including death, Q-wave myocardial infarction, or stroke in all subgroups regardless of the number of diseased vessels over 4 years. In patients with 2-vessel (23.0% vs. 14.2%; hazard ratio [HR]: 1.739; 95% confidence interval [CI]: 1.171 to 2.582; p = 0.006) or 3-vessel (25.0% vs. 17.6%; HR: 1.493; 95% CI: 1.096 to 2.035; p = 0.011) disease, however, stenting was associated with a higher risk of major adverse cardiac and cerebrovascular events including major adverse cardiac events or target vessel revascularization than CABG. Interaction of vascular involvement with type of stent or CABG was not significant. Conclusions: Stenting appears to be a safe alternative to CABG in patients having ULMCA stenosis combined with additional vascular disease. The advantage of CABG over stenting lies principally in the reduction of repeat revascularization across subgroups stratified by the number of diseased vessels. [Copyright &y& Elsevier]

Objectives: This study compared intravascular ultrasound (IVUS) findings at drug-eluting stent (DES) and bare-metal stent (BMS) sites in patients with very late stent thrombosis (VLST). Background: VLST is being increasingly identified since the introduction of DES. VLST can also develop after BMS placement, but the underlying mechanisms remain unknown. Methods: A total of 30 consecutive VLST patients with acute myocardial infarction (DES, n = 23; BMS, n = 7) were enrolled. Patients underwent IVUS examination before coronary angioplasty. Results: The baseline characteristics were similar for the 2 groups, with the exception of reference vessel size, lesion length, stent length, minimal lumen diameter, and diameter stenosis after the procedure. Overall, VLST occurred at a mean 50.8 ± 36.2 months after the index procedure, and occurred earlier after DES than BMS (33.2 ± 12.5 months vs. 108.4 ± 26.5 months, p < 0.001). IVUS variables were generally similar for the 2 groups. However, plaque burden at the distal reference segment, stent, and neointimal area of the in-stent segment were smaller in the DES group. Stent malapposition was observed in 73.9% of DES patients, but in no BMS patients (p = 0.001). Disease progression with neointimal rupture within the stent was observed in 10 DES patients (43.5%) and 7 BMS patients (100%; p = 0.010). Conclusions: Stent malapposition was unique to DES-related VLST, whereas disease progression with neointimal rupture was more common in BMS patients. These findings suggest that different biological mechanisms underlie VLST development depending upon the stent type. [Copyright &y& Elsevier]

Objectives: The aim of this study was to evaluate long-term clinical outcomes after implantation of sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) among patients with unprotected left main coronary artery (LMCA) disease. Background: There have been few comparisons of long-term outcomes among currently available drug-eluting stents (DES) for the treatment of LMCA disease. Methods: A total of 858 consecutive patients with unprotected LMCA stenosis were treated with SES (n = 669) or PES (n = 189) between May 2003 and June 2006. Primary outcome was the composite of death, myocardial infarction (MI), or target vessel revascularization (TVR). Results: Baseline clinical and angiographic characteristics were similar in the 2 groups. During 3 years of follow-up, the adjusted risk of primary composite outcome was similar among the groups (SES vs. PES: 25.8% vs. 25.7%, hazard ratio [HR]: 0.95, 95% confidence interval [CI]: 0.64 to 1.41, p = 0.79). The 2 groups also showed a comparable adjusted rate of each component of outcome: death (9.1% vs. 11.0%, HR: 0.92, 95% CI: 0.47 to 1.80, p = 0.82), MI (8.1% vs. 8.0%, HR: 0.80, 95% CI: 0.43 to 1.48, p = 0.47), and TVR (12.1% vs. 10.6%, HR: 1.10, 95% CI: 0.53 to 2.29, p = 0.81). The 3-year rates of definite or probable stent thrombosis were 0.6% in the SES group and 1.6% in the PES group (adjusted p = 0.18). Conclusions: In consecutive patients with unprotected LMCA disease undergoing DES implantation, SES and PES showed similar long-term clinical outcomes in terms of death, MI, repeat revascularization, and stent thrombosis. [Copyright &y& Elsevier]

Objectives: The purpose of this study was to determine the impact of adjunctive cilostazol in patients with high post-treatment platelet reactivity (HPPR) undergoing coronary stenting. Background: Although addition of cilostazol to dual antiplatelet therapy enhances adenosine diphosphate (ADP)-induced platelet inhibition, it is unknown whether adjunctive cilostazol can reduce HPPR. Methods: Sixty patients with HPPR after a 300-mg loading dose of clopidogrel were enrolled. HPPR was defined as maximal platelet aggregation (Aggmax) >50% with 5 μmol/l ADP. Patients were randomly assigned to receive either adjunctive cilostazol (triple group; n = 30) or high maintenance dose (MD) clopidogrel (high-MD group; n = 30). Platelet function was assessed at baseline and after 30 days with conventional aggregometry and the VerifyNow assay. Results: Baseline platelet function measurements were similar in both groups. After 30 days, significantly fewer patients in the triple versus high-MD group had HPPR (3.3% vs. 26.7%, p = 0.012). Percent inhibitions of 5 μmol/l ADP-induced Aggmax and late platelet aggregation (Agglate) were significantly greater in the triple versus high-MD group (51.1 ± 22.5% vs. 28.0 ± 18.5%, p < 0.001, and 70.9 ± 27.3% vs. 45.3 ± 23.4%, p < 0.001, respectively). Percent inhibitions of 20 μmol/l ADP-induced Aggmax and Agglate were consistently greater in the triple versus high-MD group. Percent change of P2Y12 reaction units demonstrated a higher antiplatelet effect in the triple versus high-MD group (39.6 ± 24.1% vs. 23.1 ± 29.9%, p = 0.022). Conclusions: Adjunctive cilostazol reduces the rate of HPPR and intensifies platelet inhibition as compared with a high-MD clopidogrel of 150 mg/day. [Copyright &y& Elsevier]

Objectives: We sought to evaluate the impact of cilostazol on neointimal hyperplasia after drug-eluting stent (DES) implantation in patients with diabetes mellitus (DM). Background: Although cilostazol has reduced the extent of neointimal hyperplasia and restenosis in patients after bare-metal stent implantation, it is not known whether this effect occurs after DES implantation in diabetic patients. Methods: This randomized, multicenter, prospective study compared triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol, triple group, n = 200) and dual antiplatelet therapy (aspirin and clopidogrel, standard group, n = 200) for 6 months in patients with DM receiving DES. The primary end point was in-stent late loss at 6 months. Results: The 2 groups had similar baseline clinical and angiographic characteristics. The in-stent (0.25 +/- 0.53 mm vs. 0.38 +/- 0.54 mm, p = 0.025) and in-segment (0.42 +/- 0.50 mm vs. 0.53 +/- 0.49 mm, p = 0.031) late loss were significantly lower in the triple versus standard group, as were 6-month in-segment restenosis (8.0% vs. 15.6%, p = 0.033) and 9-month target lesion revascularization (TLR) (2.5% vs. 7.0%, p = 0.034). At 9 months, major adverse cardiac events, including death, myocardial infarction, and TLR, tended to be lower in the triple than in the standard group (3.0% vs. 7.0%, p = 0.066). Multivariate analysis showed that sirolimus-eluting stents and the use of cilostazol were strong predictors of reduced restenosis or TLR. Conclusions: Triple antiplatelet therapy after DES implantation decreased angiographic restenosis and extent of late loss, resulting in a reduced risk of 9-month TLR compared with dual antiplatelet therapy in diabetic patients. [ABSTRACT FROM AUTHOR]

Objectives: This study used serial angiographic and intravascular ultrasound (IVUS) analysis to evaluate the long-term efficacy of a nonpolymeric, paclitaxel-eluting stent coating on intimal hyperplasia (IH) 2 years after implantation. Background: Long-term efficacy of patients treated with nonpolymeric paclitaxel-eluting stents beyond 1 year has not been well determined. Methods: Patients were randomized to placebo or 1 of 2 doses of paclitaxel (low dose, 1.28 μg/mm2; high dose, 3.10 μg/mm2). Complete after-procedure, 6-month, and 2-year angiographic and IVUS data were available in 53 patients (17, 17, and 19 patients, respectively). Results: Baseline characteristics were similar among the 3 groups. Although 6-month minimal luminal diameter (MLD) was significantly smaller in placebo compared with paclitaxel-eluting stent patients (1.9 ± 0.6 mm in placebo, 2.5 ± 0.6 mm in low-dose, and 2.6 ± 0.5 mm in high-dose patients, p = 0.004), the MLDs at 2 years were similar (2.3 ± 0.6 mm, 2.3 ± 0.7 mm, and 2.0 ± 0.8 mm, respectively, p = 0.4). Despite a stepwise reduction in IH accumulation at 6 months (23 ± 18 mm3 in placebo, 14 ± 11 mm3 in low-dose, and 10 ± 12 mm3 in high-dose, p = 0.017), the increase of IH volume from 6 months to 2 years was significantly greater in the high-dose patients (13 ± 14 mm3 in high-dose vs. 4 ± 7 mm3 in low-dose patients, p = 0.074; and vs. 1 ± 13 mm3 in placebo, p = 0.019). Late target lesion revascularization (beyond 1 year) was performed in 2 high-dose patients. Conclusions: Despite the suppression of IH after non-polymeric paclitaxel-eluting stents compared with bare-metal stents at 6 months, a “late catch-up” IH growth was found in the high-dose patients at 2-year follow-up. [Copyright &y& Elsevier]

Objectives: This study was designed to evaluate the clinical and angiographic outcomes of sirolimus-eluting stent (SES) implantation for ostial left anterior descending (LAD) lesions compared with bare-metal stent (BMS) implantation. Background: The effectiveness of SES implantation for ostial LAD lesions is currently unknown. Methods: Sirolimus-eluting stents were implanted in 68 consecutive patients with ostial LAD stenoses. The control group was composed of 77 patients treated with BMS during the preceding two years. In the SES group, for complete lesion coverage, stent positioning was intentionally extended into the distal left main coronary artery (LMCA) in 23 patients (34%) with intermediate LMCA narrowing. Results: Compared with the BMS group, the SES group had more multivessel involvement, received fewer debulking atherectomies, underwent more direct stenting, had a greater number of stents, and had more segments stented. The procedural success rate was 100% in both groups. The six-month angiographic restenosis rate was significantly lower in the SES group than in the BMS group (5.1% vs. 32.3%, p &#60; 0.001). During the one-year follow-up period, neither death nor myocardial infarction occurred in either group, but target lesion revascularization was less frequent in the SES group than in the BMS group (0% vs. 17%, p &#60; 0.001). In the SES group, there were no restenoses in cases with LMCA coverage, compared with three restenoses (7.9%) in cases with precise stent positioning (p = NS). Conclusions: Sirolimus-eluting stent implantation in ostial LAD lesions achieved excellent results regarding restenosis and clinical outcomes compared with BMS implantation. This finding may be associated with reduced neointimal hyperplasia and complete lesion coverage. [Copyright &y& Elsevier]

Objectives: We evaluated the axial location of plaque ruptures in native coronary arteries. Background: It is clinically important to understand the potential sites of plaque rupture. Methods: We performed three-vessel intravascular ultrasound (IVUS) examination in 392 patients; 231 had acute coronary syndrome (ACS) and 161 had stable angina pectoris (SAP). The IVUS detected plaque ruptures in 206 patients: 158 ACS patients and 48 SAP patients. The distance between each coronary plaque rupture segment and the respective coronary ostium was measured with motorized IVUS transducer pullback in all three coronary arteries. Results: There were a total of 273 plaque ruptures in these 206 patients; 143 in the left anterior descending artery (LAD), 40 in the left circumflex artery (LCX), and 90 in the right coronary artery (RCA). There were 67 plaque ruptures in SAP patients and 206 in ACS patients; there were 197 culprit/target lesion plaque ruptures and 76 non-culprit/non-target lesion plaque ruptures. The LAD plaque ruptures were predominantly located between 10 and 40 mm from the LAD ostium (83%, 119 of 143). The LCX plaque ruptures were evenly distributed in the entire LCX tree. Most RCA plaque ruptures were located in segments between 10 and 40 mm (48%, 43 of 90) and in segments >70 mm from the ostium (32%, 29 of 90). Conclusions: Three-vessel IVUS imaging showed that plaque ruptures occurred mainly in proximal segments of the LAD (83% of LAD plaque rupture), the proximal and distal segments of the RCA (48% and 32% of RCA plaque ruptures, respectively), and the entire LCX. [Copyright &y& Elsevier]

Objectives: This study was designed to compare the clinical and angiographic outcomes of sirolimus-eluting stent (SES) and bare metal stent (BMS) implantation for unprotected left main coronary artery (LMCA) stenosis. Background: The safety and effectiveness of SES implantation for unprotected LMCA stenosis have not been ascertained. Methods: Elective SES implantation for de novo unprotected LMCA stenosis was performed in 102 consecutive patients with preserved left ventricular function from March 2003 to March 2004. Data from this group were compared to those from 121 patients treated with BMS during the preceding two years. Results: Compared to the BMS group, the SES group received more direct stenting, had fewer debulking atherectomies, had a greater number of stents, had more segments stented, and underwent more bifurcation stenting. The procedural success rate was 100% for both groups. There were no incidents of death, stent thrombosis, Q-wave myocardial infarction (MI), or emergent bypass surgery during hospitalization in either group. Despite less acute gain (2.06 ± 0.56 mm vs. 2.73 ± 0.73 mm, p < 0.001) in the SES group, SES patients showed a lower late lumen loss (0.05 ± 0.57 mm vs. 1.27 ± 0.90 mm, p < 0.001) and a lower six-month angiographic restenosis rate (7.0% vs. 30.3%, p < 0.001) versus the BMS group. At 12 months, the rate of freedom from death, MI, and target lesion revascularization was 98.0 ± 1.4% in the SES group and 81.4 ± 3.7% in the BMS group (p = 0.0003). Conclusions: Sirolimus-eluting stent implantation for unprotected LMCA stenosis appears safe with regard to acute and midterm complications and is more effective in preventing restenosis compared to BMS implantation. [Copyright &y& Elsevier]

: ObjectivesWe evaluated the impact of reference vessel segment plaque burden on lesion remodeling.: BackgroundIntravascular ultrasound (IVUS) assessment of lesion remodeling compares lesions to reference segments. However, reference segments are rarely disease-free and, therefore, have also undergone remodeling changes.: MethodsPre-intervention IVUS was obtained in 274 patients with right coronary artery lesions selected because the right coronary artery has less tapering and fewer side branches than the left anterior descending or left circumflex artery. Standard IVUS definitions were used. Patients were divided according to reference vessel segment plaque burden: group A (minimal reference disease, n = 91), both proximal and distal reference plaque burden <20%; group B (n = 91), either proximal or distal reference plaque burden 20% to 40% but both ≤40%; and group C (n = 92), either proximal or distal reference plaque burden >40%.: ResultsThe remodeling index measured 0.98 ± 0.16 in group A (range, 0.68 to 1.47), 1.04 ± 0.18 in group B (range, 0.67 to 1.91), and 1.04 ± 0.15 in group C (range, 0.74 to 1.70), analysis of variance p = 0.0208 (p = 0.0234 group A vs. group B and p = 0.0012 group A vs. group C, but p = 0.8 group B vs. group C). Positive, intermediate, and negative remodeling were observed in 24 (26%), 24 (26%), and 43 lesions (48%) in group A; 36 (40%), 28 (30%), and 27 lesions (30%) in group B; and 34 (37%), 39 (42%), and 19 lesions (21%) in group C, respectively (p = 0.0022).: ConclusionsNegative remodeling occurs commonly in coronary lesions with minimal reference segment disease. Negative remodeling is not just an “artifact” introduced by comparing lesions to diseased reference segments. [Copyright &y& Elsevier]

Objectives: The aim of this study was to evaluate the feasibility and the ability of intravascular optical coherence tomography (OCT) to visualize the components of coronary plaques in living patients.Background: Disruption of a vulnerable coronary plaque with subsequent thrombosis is currently recognized as the primary mechanism for acute myocardial infarction. Although such plaques are considered to have a thin fibrous cap overlying a lipid pool, imaging modalities in current clinical practice do not have sufficient resolution to identify thin (< 65 microm) fibrous caps. Optical coherence tomography is a new imaging modality capable of obtaining cross-sectional images of coronary vessels at a resolution of approximately 10 microm.Methods: The OCT images and corresponding histology of 42 coronary plaques were compared to establish OCT criteria for different types of plaques. Atherosclerotic lesions with mild to moderate stenosis were identified on angiograms in 10 patients undergoing cardiac catheterization. Optical coherence tomography and intravascular ultrasound (IVUS) images of these sites were obtained in all patients without complication.Results: Comparison between OCT and histology demonstrated that lipid-rich plaques and fibrous plaques have distinct OCT characteristics. A total of 17 IVUS and OCT image pairs obtained from patients were compared. Axial resolution measured 13 +/- 3 microm with OCT and 98 +/- 19 microm with IVUS. All fibrous plaques, macrocalcifications and echolucent regions identified by IVUS were visualized in corresponding OCT images. Intimal hyperplasia and echolucent regions, which may correspond to lipid pools, were identified more frequently by OCT than by IVUS.Conclusions: Intracoronary OCT appears to be feasible and safe. Optical coherence tomography identified most architectural features detected by IVUS and may provide additional detailed structural information. [ABSTRACT FROM AUTHOR]

: ObjectivesThe aim of this study was to evaluate the feasibility and the ability of intravascular optical coherence tomography (OCT) to visualize the components of coronary plaques in living patients.: BackgroundDisruption of a vulnerable coronary plaque with subsequent thrombosis is currently recognized as the primary mechanism for acute myocardial infarction. Although such plaques are considered to have a thin fibrous cap overlying a lipid pool, imaging modalities in current clinical practice do not have sufficient resolution to identify thin (<65 μm) fibrous caps. Optical coherence tomography is a new imaging modality capable of obtaining cross-sectional images of coronary vessels at a resolution of approximately 10 μm.: MethodsThe OCT images and corresponding histology of 42 coronary plaques were compared to establish OCT criteria for different types of plaques. Atherosclerotic lesions with mild to moderate stenosis were identified on angiograms in 10 patients undergoing cardiac catheterization. Optical coherence tomography and intravascular ultrasound (IVUS) images of these sites were obtained in all patients without complication.: ResultsComparison between OCT and histology demonstrated that lipid-rich plaques and fibrous plaques have distinct OCT characteristics. A total of 17 IVUS and OCT image pairs obtained from patients were compared. Axial resolution measured 13 ± 3 μm with OCT and 98 ± 19 μm with IVUS. All fibrous plaques, macrocalcifications and echolucent regions identified by IVUS were visualized in corresponding OCT images. Intimal hyperplasia and echolucent regions, which may correspond to lipid pools, were identified more frequently by OCT than by IVUS.: ConclusionsIntracoronary OCT appears to be feasible and safe. Optical coherence tomography identified most architectural features detected by IVUS and may provide additional detailed structural information. [Copyright &y& Elsevier]