Ostial and midshaft lesions vs. bifurcation lesions in 1111 patients with unprotected left main coronary artery stenosis treated with drug-eluting stents: results of the survey from the Italian Society of Invasive Cardiology.

AIMS: In this study, we compared the cumulative risk of major adverse cardiac events (MACE) of patients with distal unprotected left main coronary artery (ULMCA) stenosis with those of patients with ostial and midshaft lesions treated with drug-eluting stent (DES). METHODS AND RESULTS: The survey promoted by the Italian Society of Invasive Cardiology on ULMCA stenosis was an observational study involving 19 high-volume Italian centres. We enrolled 1111 patients with ULMCA stenosis treated with DES. Major adverse cardiac events were defined as death, myocardial infarction, and target lesion revascularization. Three hundred and thirty-four patients had ostial or midshaft lesions (group 1) and 777 bifurcations (group 2). The adjusted hazards ratio of the risk of 2 year MACE of patients in group 2 vs. patients in group 1 was 1.50 (P = 0.024). However, we observed that there was a significant difference between patients with bifurcations treated with two stents and those in group 1 (P = 0.001), but not between patients with bifurcations treated with one stent and those in group 1 (P = 0.38). CONCLUSION: Patients with bifurcations have a worse outcome than patients with ostial and midshaft lesions. However, the technique used to treat bifurcations has a significant impact on clinical outcomes.

Long-term clinical benefit of drug-eluting stents over bare-metal stents in diabetic patients with de novo left main coronary artery disease: results from a real-world multicenter registry.

BACKGROUND: Few data are available on diabetic patients undergoing percutaneous coronary intervention (PCI) in the context of unprotected left main coronary artery (ULMCA) disease. The main goal of this study was to present the long-term relative benefits of using drug-eluting stent (DES) instead of bare-metal stent (BMS) for diabetic patients submitted to percutaneous ULMCA treatment in a large real world multicenter registry. METHODS: The GISE-SICI registry is a retrospective, observational multicenter registry promoted by the Italian Society of Invasive Cardiology in which 19 high-volume participating centers enrolled 1,453 consecutive patients who underwent PCI on ULMCA between January 2002 and December 2006. From the registry, a total of 398 consecutive patients with diabetes mellitus who underwent DES (n = 321) or BMS (n = 77) implantation were analyzed, with extensive multivariable adjustments. RESULTS: At 3-years, use of DES in diabetic patients resulted in no significant differences with respect to death (HR 0.56, 95% CIs 0.24-1.28), myocardial infarction (HR 0.82, 95% CIs 0.21-3.26), and the composite end-point of death or myocardial infarction (HR 0.56, 95% CIs 0.27-1.20). Conversely, DES were associated with significant reduction of target lesion revascularization (TLR, HR 0.33; 95% CIs 0.14-0.80, P = 0.001) rates. CONCLUSIONS: Patients presenting with ULMCA disease in the context of diabetes mellitus who are treated with stent-supported PCI have a significant reduction in the rate of TLR with no increased risk of death or myocardial infarction.

Appraising the impact of left ventricular ejection fraction on outcomes of percutaneous drug-eluting stenting for unprotected left main disease: insights from a multicenter registry of 975 patients.

BACKGROUND: Despite the well-known prognostic impact of systolic dysfunction in unselected patients undergoing percutaneous coronary intervention (PCI), limited data are available on its current predictive role after PCI for unprotected left main disease (ULM). We thus appraised the prognostic role of left ventricular ejection fraction (LVEF) in patients undergoing PCI for ULM with drug-eluting stents (DES). METHODS: Consecutive eligible subjects were retrospectively enrolled in a national registry. Patients were divided into three groups: LVEF < 30%, LVEF 30-45%, and LVEF > 45%. Relevant baseline and outcome data were compared with bivariate and multivariable tests. RESULTS: A total of 975 subjects was included (LVEF < 30%: 46, LVEF 30-45%: 208, LVEF > 45%: 721). Patients with LVEF < 30% had several other unfavorable clinical features, including older age and higher EuroSCORE. Adverse event rates were different already at 7 days (p = 0.012 for all-cause death and p = 0.015 for major adverse cardiac events [MACE]), with even more significant trends up to 30 days and at long-term (p < 0.001 for death, and p < 0.001 for MACE). After a median of 18 months, risk of death totaled 39 versus 13 versus 8% (p < 0.001) and risk of MACE 44 versus 24 versus 22% (p = 0.003). Multivariable analyses showed however that reduced LVEF was not an independent predictor of adverse events at any time-point. CONCLUSIONS: Whereas reduced LVEF is apparently a significant predictor of adverse events after PCI with DES for ULM, its prognostic impact is mostly due to clustering with other adverse features.

Impact of acute coronary syndromes on two-year clinical outcomes in patients with unprotected left main coronary artery stenosis treated with drug-eluting stents.

In this study we investigated the impact of acute coronary syndromes (ACSs) on clinical outcomes in patients with unprotected left main coronary artery (ULMCA) stenosis treated with drug-eluting stents (DESs). In this multicenter, retrospective, observational study we enrolled 1,101 patients with ULMCA stenosis treated with DESs. Six hundred eleven patients presented with ACS and 490 had stable coronary artery disease. ACS was defined as the presence of unstable angina or non-ST-segment elevation myocardial infarction (MI). During 2-year follow-up, the adjusted hazard ratio of cardiac mortality and MI of patients with ACS versus stable patients was 2.42 (95% confidence interval 1.37 to 4.28, p = 0.002). We observed a stepwise risk increase, namely patients with stable coronary disease had the lowest risk, patients with unstable angina an intermediate risk, and patients with non-ST-segment elevation MI the highest risk. The increased risk of cardiac mortality and MI of patients with ACS was concentrated in the first year after DES implantation. In conclusion, patients with ULMCA stenosis and ACS treated with DESs have an increased risk of cardiac mortality and MI during the first year after the intervention compared to stable patients.

Sex-related differences in patients undergoing percutaneous unprotected left main stenting.

AIMS: Percutaneous coronary intervention (PCI) is increasingly being used for unprotected left main (ULM) disease. Limited data are available on sex-related differences in this setting. We investigated gender-associated differences in patients undergoing stent-based PCI for ULM. METHODS AND RESULTS: We analysed baseline, procedural and long-term data of patients with ULM undergoing stent-based PCI at participating centres. The primary end-point was the long-term rate of major cardiovascular events rate (MACE, i.e., the composite of death, myocardial infarction, or target lesion revascularisation). The study population included 1,452 cases, with 27.8% females and 72.2% males. Women were older, more frequently diabetic, hypertensive or presenting with an acute coronary syndrome, and thus with a higher EuroSCORE, but were less commonly treated with drug-eluting stents (DES), in comparison to men (all p<0.01). After a median follow-up of 18 months, women showed an unadjusted higher risk of death (p=0.040), cardiac death (p=0.033), and the death/myocardial infarction (p=0.012). However, after multivariable adjustment, gender was no longer an independent predictor of death (hazard ratio=1.119 [0.804-1.558]), cardiac death (hazard ratio=1.045 [0.697-1.567]), or death/myocardial infarction (hazard ratio=0.531 [0.192-1.465]), given the predominant role of age, diabetes and EuroSCORE as independent predictors and confounders of the gender-based comparison. CONCLUSIONS: Women undergoing PCI for ULM present more often with an acute coronary syndrome, are treated less frequently with DES, and have more adverse events, but these gender biases are not confirmed after adjusting for confounders. Thus, stent-based PCI for ULM offers similarly favourable clinical results in women as well as in men.

Comparison of drug-eluting stents and bare-metal stents for the treatment of unprotected left main coronary artery disease in acute coronary syndromes.

The aim of this study was to compare long term clinical outcome after left main stenting in a large real world population of patients treated with drug-eluting stents (DES) or bare-metal stents (BMS) in the setting of acute coronary syndromes. The advent of DES decreased the risk of unprotected left main coronary artery restenosis as compared with BMS, but safety concerns still exist, especially when high-risk patients presenting with acute coronary syndromes are considered. The Gruppo Italiano Studi Emodinamici-Societa' Italiana di Cardiologia Invasiva (GISE-SICI) registry is a retrospective, observational multicenter registry promoted by the Italian Society of Invasive Cardiology in which 19 high-volume participating centers enrolled 1,453 consecutive patients who underwent percutaneous coronary intervention on unprotected left main coronary artery between January 2002 and December 2006. From the registry, a total of 849 consecutive patients presenting with unstable angina or non-ST-segment elevation myocardial infarction who underwent DES (n=611) or BMS (n=238) implantation were analyzed with extensive multivariable and propensity-score adjustments. At 3-year follow-up, the adjusted hazard ratio for the risk of mortality after DES implantation relative to BMS implantation was 0.90 (95% confidence intervals [CI] 0.59 to 1.38, p=0.617), and the adjusted hazard ratio for the risk of cardiac mortality was 0.75 (95% CI 0.45 to 1.27, p=0.287). DES were associated with significant reduction of myocardial infarction (hazard ratio 0.37, 95% CI 0.17 to 0.81, p=0.009) and target lesion revascularization rates (hazard ratio 0.38, 95% CI 0.21 to 0.69, p=0.001). Younger age, low ejection fraction, an increase in the cardiac biomarkers, absence of diabetes, and bifurcations showed a significant interaction with assigned treatment regarding myocardial infarction. The treatment effects on target lesion revascularization were consistent across multiple subgroups, with the possible exception of patients with nonbifurcational lesions. In conclusion, in a large population of patients with acute coronary syndromes and unprotected left main coronary artery disease DES were more effective than BMS in reducing myocardial infarction and target lesion revascularization. There was no evidence of a significant reduction in mortality with DES versus BMS.

Temporal pattern of ischemic events in relation to dual antiplatelet therapy in patients with unprotected left main coronary artery stenosis undergoing percutaneous coronary intervention.

OBJECTIVES: The aim of this study was to investigate whether there is a temporal pattern of ischemic events in relation to dual antiplatelet therapy in patients with unprotected left main coronary artery (ULMCA) stenosis treated with percutaneous coronary intervention (PCI). BACKGROUND: Identifying which periods during follow-up of patients with ULMCA stenosis treated with PCI are associated with higher risk of clinical events might help to improve therapeutic strategies. METHODS: We analyzed data from 15 centers involved in an observational study conducted by the Italian Society of Invasive Cardiology on patients with ULMCA stenosis treated with PCI. Eight hundred ninety-four patients were enrolled. RESULTS: At 30-day follow-up, the rate of cardiac mortality and myocardial infarction (MI) was 5.4%. In patients still taking dual antiplatelet therapy, the adjusted incidence rate ratio/10,000 patient-days of the combination of cardiac mortality and MI in the 31- to 180-day interval compared with the 181- to 360-day interval after PCI was 3.64 (p = 0.035). This risk was particularly high in patients with acute coronary syndromes. After stopping clopidogrel, the adjusted incidence rate ratio of cardiac mortality and MI in the 0- to 90-day interval compared with the 91- to 180-day interval was 4.20 (p = 0.009). CONCLUSIONS: In patients with ULMCA stenosis taking dual antiplatelet therapy there is an increased hazard of cardiac mortality and MI between 31 and 180 days compared with 181 to 360 days. Furthermore, there is an increased hazard of cardiac mortality and MI in the first 90 days after stopping clopidogrel.

Two-year clinical outcome with drug-eluting stents versus bare-metal stents in a real-world registry of unprotected left main coronary artery stenosis from the Italian Society of Invasive Cardiology.

Data are limited about the relative efficacy of drug-eluting stents (DESs) versus bare-metal stents (BMSs) for the treatment of unprotected left main coronary artery (ULMCA) stenosis. The survey promoted by the Italian Society of Invasive Cardiology on ULMCA stenosis was an observational study involving 19 high-volume Italian centers of patients with ULMCA stenosis treated using percutaneous coronary intervention (PCI). From January 2002 to December 2006, of 1,453 patients identified with ULMCA stenosis treated with PCI, 1,111 were treated with DESs and 342 were treated with BMSs. During a 2-year follow-up, risk-adjusted survival free from cardiac death was significantly higher in patients treated with DESs than in those treated with BMSs. The propensity-adjusted hazard ratio for risk of 2-year cardiac mortality after DES versus BMS implantation was 0.49 (95% confidence interval 0.32 to 0.77). The benefit of DESs in reducing cardiac mortality was obtained in the period from 3 to 6 months and maintained up to 2 years. In conclusion, for patients with ULMCA stenosis undergoing PCI, DES implantation was associated with higher adjusted rates of 2-year survival free from cardiac death. The benefit of DESs in reducing cardiac mortality was obtained in the period in which clinical manifestations of restenosis usually peak.

Impact of bifurcation technique on 2-year clinical outcomes in 773 patients with distal unprotected left main coronary artery stenosis treated with drug-eluting stents.

BACKGROUND: Distal unprotected left main coronary artery (ULMCA) stenosis represents a technical challenge for interventional cardiologists. In this study, we compared 2-year clinical outcomes of different stenting strategies in patients with distal ULMCA stenosis treated with drug-eluting stents. METHODS AND RESULTS: The survey promoted by the Italian Society of Invasive Cardiology on ULMCA stenosis was an observational study on patients with ULMCA stenosis treated with percutaneous coronary intervention. In this study, we selected patients with distal ULMCA stenosis treated with drug-eluting stents. Seven hundred seventy-three patients were eligible for this study: 456 were treated with 1 stent (group 1) and 317 with 2 stents (group 2). The primary end point of the study was the incidence of major adverse cardiac events (MACEs), defined as the occurrence of mortality, myocardial infarction, and target lesion revascularization. During a 2-year follow-up, risk-adjusted survival free from MACE was significantly higher in patients in group 1 than in patients in group 2. The propensity-adjusted hazard ratio for the risk of 2-year MACE in patients in group 1 versus group 2 was 0.53 (95% CI, 0.37 to 0.76). The propensity-adjusted hazard ratio for the risk of 2-year cardiac mortality and myocardial infarction in patients in group 1 versus group 2 was 0.38 (95% CI, 0.17 to 0.85). CONCLUSIONS: Compared with the 2-stent technique, the 1-stent technique is associated with a better 2-year MACE-free survival. The stenting strategy is a prognostic factor that should be taken into account when deciding the optimal revascularization treatment.