Left Main Stenting in Comparison With Surgical Revascularization: 10-Year Outcomes of the (Left Main Coronary Artery Stenting) LE MANS Trial.

OBJECTIVES: This study has reported 10-year clinical follow-up of patients enrolled in the prospective, randomized LE MANS (Left Main Stenting) trial. BACKGROUND: The very long-term outcome after left main stenting in comparison with surgical revascularization remains unknown. METHODS: In this prospective, multicenter trial, we randomly assigned 105 patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease according to SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score to percutaneous coronary intervention (PCI) with stenting (n = 52) or coronary artery bypass grafting (CABG) (n = 53). Drug-eluting stents were implanted in 35%, whereas arterial grafts to the left anterior descending artery were utilized in 81%. Currently, the mean long-term follow-up was collected at 9.8 ± 1.0 years. Follow up for all-cause mortality is complete, whereas the incidence of major adverse cardiovascular and cerebral events (MACCE) was reported from 90% of patients. Ambulatory follow-up was completed in 46 (43.9%) patients. RESULTS: At 10 years, there was a trend toward higher ejection fraction in stenting when compared with surgery (54.9 ± 8.3% vs. 49.8 ± 10.3%; p = 0.07). The mortality (21.6% vs. 30.2%; p = 0.41) and MACCE (51.1% vs. 64.4%; p = 0.28) were statistically not different between groups; however, numerically the difference was in favor of stenting. Similarly, there was no difference in the occurrence of myocardial infarction (8.7 vs. 10.4%; p = 0.62), stroke (4.3 vs. 6.3%; p = 0.68), and repeated revascularization rates (26.1% vs. 31.3%; p = 0.64). The probability of very long-term survival up to 14 years was comparable between PCI and CABG (74.2% vs. 67.5%; p = 0.34; hazard ratio: 1.45, 95% confidence interval: 0.67 to 3.13); however, there was a trend toward higher MACCE-free survival in the PCI group (34.7% vs. 22.1%; p = 0.06; hazard ratio: 1.71, 95% confidence interval: 0.97 to 2.99). CONCLUSIONS: In patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease, stenting offers numerically, but statistically nonsignificant, favorable long-term outcome up to 10 years in terms of safety and efficacy outcome measures, therefore, constitutes an alternative therapy for CABG.

[Accelerated artherosclerosis in systemic lupus erythematosus patients and the role of some adipocytokines in this process].

The most severe forms of systemic lupus erythematosus (SLE) affect the kidneys, peripheral and central nervous system as well as heart and vessels. The underlying causes of heart and circulatory system disease are atherosclerosis, vasculitis and thromboembolic disorders; all these processes are interrelated. Premature atherosclerosis, the etiology of which remains incompletely accounted for, is of particular interest. Recently, some adipocytokines / adipokines have been indicated in the development of atherosclerosis, inflammatory and immune processes. It has been postulated that adipokines might regulate the immune response and hence also the atherogenic process.

Early and long-term outcomes after surgical and percutaneous myocardial revascularization in patients with non-ST-elevation acute coronary syndromes and unprotected left main disease.

UNLABELLED: Surgical myocardial revascularization (CABG) in patients with unprotected left main coronary artery disease (ULMCA) is a Class I recommendation in the AHA/ACC guidelines, however it is associated with increased perioperative risk in non-ST elevation acute coronary syndromes (NSTE-ACS). The aim of this study was to compare early and late results after percutaneous coronary intervention (PCI) and CABG in this cohort of patients. METHODS: A multicenter prospective registry included 138 patients with patent but severely narrowed (> 50%) ULMCA disease and NSTE-ACS diagnosed between January 2005 and April 2007. After emergent coronary angiography, 63 patients underwent PCI, whiles 75 were assigned for CABG. RESULTS: Groups were comparable with regard to sex, age and prevalence of diabetes mellitus (DM). They had similar left ventricular ejection fraction, SYNTAX Score and incidence of distal LM stenosis. However, PCI patients were at higher surgical risk (Euroscore 8.7 +/- 3.7 vs. 7.4 +/- 3.0; p = 0.02) and myocardial infarction incidence (28% vs. 14%; p = 0.07). The 30-day mortality was 1.5% after PCI vs. 12% after CABG (p = 0.043) and major adverse cardiovascular and cerebrovascular events (MACCE) were 3.2% vs. 14.7%, respectively (p = 0.04). After 12 months, there were 4 deaths in the PCI group and 12 deaths in the CABG group (6.3% vs. 16%; p = 0.14). There was no difference in MACCE (9.5% vs. 9.3% p = ns). Kaplan-Meier analysis revealed a trend toward better survival after PCI (p = 0.07). Revascularization with CABG and a Euroscore > 5 were the independent risk factors influencing early survival, while a Euroscore > 6 was the independent predictor of late mortality. CONCLUSIONS: PCI is a reasonable alternative to CABG in patients with NSTE-ACS and ULMCA stenosis.

Early and long-term results of unprotected left main coronary artery stenting: the LE MANS (Left Main Coronary Artery Stenting) registry.

OBJECTIVES: The aim of the study was to evaluate early and late outcomes after percutaneous coronary intervention (PCI) of unprotected left main coronary artery disease (ULMCA) and to compare bare-metal stent (BMS) and drug-eluting stent (DES) subgroups. BACKGROUND: PCI is an increasingly utilized method of revascularization in patients with ULMCA. METHODS: This multicenter prospective registry included 252 patients after ULMCA stenting enrolled between March 1997 and February 2008. Non-ST-segment elevation acute coronary syndrome was diagnosed in 58% of patients; ST-segment elevation myocardial infarction cases were excluded. Drug-eluting stents were implanted in 36.2% of patients. RESULTS: Major adverse cardiovascular and cerebral events (MACCE) occurred in 12 (4.8%) patients during the 30-day period, which included 4 (1.5%) deaths. After 12 months there were 17 (12.1%) angiographically confirmed cases of restenosis. During long-term follow-up (1 to 11 years, mean 3.8 years) there were 64 (25.4%) MACCE and 35 (13.9%) deaths. The 5- and 10-year survival rates were 78.1% and 68.9%, respectively. Despite differences in demographical and clinical data in favor of BMS patients, unmatched analysis showed a significantly lower MACCE rate in DES patients (25.9% vs. 14.9%, p = 0.039). This difference was strengthened after propensity score matching. The DES lowered both mortality and MACCE for distal ULMCA lesions when compared with BMS. Ejection fraction <50% was the only independent risk factor influencing long-term survival. CONCLUSIONS: Stenting of ULMCA is feasible and offers good long-term outcome. Implantation of DES for ULMCA decreased the risk of long-term MACCE, and particularly improved survival in patients with distal ULMCA disease.

Acute and late outcomes of unprotected left main stenting in comparison with surgical revascularization.

OBJECTIVES: The purpose of this study was to compare the early and late results of percutaneous and surgical revascularization of left main coronary artery stenosis. BACKGROUND: Unprotected left main coronary artery (ULMCA) stenting is being investigated as an alternative to bypass surgery. METHODS: We randomly assigned 105 patients with ULMCA stenosis to percutaneous coronary intervention (PCI; 52 patients) or coronary artery bypass grafting (CABG; 53 patients). The primary end point was the change in left ventricular ejection fraction (LVEF) 12 months after the intervention. Secondary end points included 30-day major adverse events (MAE), major adverse cardiac and cerebrovascular events (MACCE), length of hospitalization, target vessel failure (TVF), angina severity and exercise tolerance after 1 year, and total and MACCE-free survival. RESULTS: A significant increase in LVEF at the 12-month follow-up was noted only in the PCI group (3.3 +/- 6.7% after PCI vs. 0.5 +/- 0.8% after CABG; p = 0.047). Patients performed equally well on stress tests, and angina status improved similarly in the 2 groups. PCI was associated with a lower 30-day risk of MAE (p < 0.006) and MACCE (p = 0.03) and shorter hospitalizations (p = 0.0007). Total and MACCE-free 1-year survival was comparable. Left main TVF was similar in the 2 groups. During the 28.0 +/- 9.9-month follow-up, there were 3 deaths in the PCI group and 7 deaths in the CABG group (p = 0.08). CONCLUSIONS: Patients with ULMCA disease treated with PCI had favorable early outcomes in comparison with the CABG group. At 1 year, LVEF had improved significantly only in the PCI group. After more than 2 years, MACCE-free survival was similar in both groups with a trend toward improved survival after PCI.

Comparison of effectiveness of coronary artery bypass grafting versus percutaneous coronary intervention in patients with ischemic cardiomyopathy.

The REvascularization in Ischemic HEart Failure Trial (REHEAT) is a nonrandomized, case-controlled, prospective study assessing the hypothesis that surgical and percutaneous revascularizations in patients with ischemic cardiomyopathy are associated with comparable improvement in left ventricular ejection fraction (LVEF) and functional status 12 months after myocardial revascularization. The study population consisted of 141 patients with LVEFs of <40% and angiographically confirmed coronary artery disease. The primary end point was improvement in LVEF 12 months after intervention. Secondary end points were in-hospital major adverse events, length of hospitalization, exercise tolerance of treadmill stress testing after 12 months, 1-year survival, 1-year event-free survival, angina, and heart failure severity after 12 months. The case-controlled study included 55 patients who underwent percutaneous coronary intervention (PCI) and 54 who underwent coronary artery bypass grafting (CABG). The incidence of 30-day major adverse events was higher in the CABG group (40.7% vs 9%, p = 0.0003), whereas duration of hospital stay was shorter in the PCI group (6.8 +/- 3.6 vs 9.2 +/- 2.1 days, p = 0.00001). Increase in LVEF was comparable after PCI and CABG (6.0 +/- 7.2% vs 4.4 +/- 9.0% p = 0.12). Long-term functional status based on treadmill stress testing was better after PCI (Student's t test, p = 0.0003) but, according to Canadian Cardiovascular Society and New York Heart Association classifications, was similar in the 2 treatment arms (Wilcoxon test, p <0.01). Long-term survival was significantly better for patients after PCI (Wilcoxon test, p <0.01); however, major adverse event-free survival was better after CABG (Cox-Mantel test, p = 0.0013). In conclusion, PCI and CABG are associated with comparable improvements in LVEF in patients with ischemic cardiomyopathy. PCI offers a better 1-year survival rate than CABG, but the incidence of repeat revascularization is lower with CABG.

Local paclitaxel delivery as a treatment of persistent, recurrent in-stent restenosis -- safety assessment.

INTRODUCTION: In-stent restenosis still remains a serious clinical problem. Local intramural drug delivery (LDD -- Local Drug Delivery) seems to be an interesting alternative to drug-eluting stents (DES). AIM: The aim of the study was to assess the safety and effectiveness of local intramural paclitaxel administration in the treatment of recurrent in-stent restenosis (ISR). METHODS: Five patients were enrolled in the study (3 men, mean age 50+/-7 years) with at least a second episode of ISR within the same stent. Percutaneous coronary angioplasty was performed on a total of 11 vessel segments. Remedy delivery catheters (Boston Scientific) were used for balloon angioplasty. Inflation pressure was calibrated to obtain a balloon/vessel lumen ratio of 1.1:1. Then the pressure was lowered to 3 atmospheres and 100 microg of paclitaxel diluted in 2 ml of 0.9% NaCl was given over 60 seconds under the pressure of 2-3 atmospheres. This dose was used for each 10 mm of lesions. Control coronary angiography was performed six months after the procedure. RESULTS: In all patients effective target vessel revascularisation was achieved. No adverse events were observed in the periprocedural period or during the 6-month follow-up period. Control angiography revealed ISR in three segments (27.2%) and in-stent late lumen loss of 0.21+/-0.93 mm. CONCLUSIONS: Local intramural paclitaxel delivery is a safe and effective method of ISR treatment. The optimal paclitaxel dose should be established in further studies.

Stent implantation for the unprotected left main coronary artery. The long-term outcome of 62 patients.

INTRODUCTION: Stent implantation for the unprotected left main coronary artery (ULMCA) is regarded as controversial and coronary heart disease with LMCA stenosis still remains a basic indication for bypass surgery. Although there is no doubt that the risk of stent implantation for LMCA lesions is low, there are still limited data on long-term outcomes. There have been no reports so far answering the question whether ULMCA stenting ensures adequate coronary blood flow in the vessel. AIM: Assessment of the effect of LMCA flow restoration with stenting on the coronary flow reserve assessed by an exercise test, as well as on left ventricular function and angina in patients followed for 12 months after the procedure. METHODS: The study population included 62 patients (17 women and 45 men) aged 61.4+/-11.1 (35-84 years) who underwent coronary angioplasty with elective ULMCA stenting. In all patients, serial echocardiography (before and 1, 3, 6, and 12 months after the procedure) and the exercise test according to the Bruce protocol (1, 3, 6, 12 months after the procedure) were carried out. Routine coronary angiography was performed 3 to 6 months after the procedure. Fifty-nine patients (95.2%) survived a 12-month period. In 24 (38.7%) patients major adverse cardiac events (MACE) occurred. In-stent restenosis was observed in 13 patients; in 11 of them repeated PCI was performed and 2 of them underwent CABG. One patient after repeated PCI required CABG. RESULTS: Severity of angina, evaluated according to the CCS scale, decreased significantly in the 12-month follow-up period as compared with the preprocedural period (p <0.00001). The mean baseline left ventricular ejection fraction was 51.6+/-12.5%. It increased to 53.8+/-12.8% (p <0.02) at 6 months and remained at this level at 12 months. The mean exercise test time was 7.0+/-3.4 minutes in the first month after ULMCA stenting, and in the sixth and the twelfth month of follow-up it increased to 7.6+/-3.4 minutes (p <0.002) and 7.8+/-3.2 minutes (p <0.05), respectively. The metabolic equivalent task (MET) value did not change significantly during the observation period. CONCLUSIONS: Restoration of the physiological blood flow in the unprotected left main coronary artery with stent implantation is associated with a significant reduction of angina, significant improvement of the left ventricular systolic function and preservation of exercise capacity in long-term follow-up.

Early and late results of percutaneous revascularization in patients with ischemic cardiomyopathy and decreased left ventricular ejection fraction. (Revascularisation in Heart Failure Trial, REHEAT Registry).

AIMS: REvascularization in Ischaemic HEart Failure Trial (REHEAT) is a registry prospectively evaluating the outcomes of percutaneous myocardial revascularization in postinfarction patients with ischemic cardiomyopathy and various categories of surgical risk. METHODS AND RESULTS: One hundred seventy consecutive postinfarction patients with LVEF <40% and angiographically documented coronary stenoses eligible for PCI were enrolled to the study. The study end-points included: angiographic success of PCI, major adverse events at 30 days and 1 year after procedure, long-term survival, functional status (CCS and NYHA class) and LVEF 12 months after the intervention. Angiographic success rate was 98,8% and complete revascularization was achieved in 38.8% cases. No periprocedural deaths were registered. Thirtieth-days survival was 97% and was better in comparison to calculated survival for CABG patients; 1-year survival was 94.4% and was not inferior to predicted survival after CABG. In the general study population a significant improvement of LVEF (27,8+/-7,0 to 35,9+/-9,4%) was shown (absolute change mean 6.45+/-10%). In low/intermediate risk group the LVEF increase was lower (6.5+/-10,9) in comparison to high risk group (10,3+/-9,6%)(p=0,042). In both groups a significant and comparable reduction of angina and heart failure severity was shown in 1-year follow-up. CONCLUSION: PCI in postinfarction patients with markedly reduced LVEF is associated with a significant increase of LVEF and favorable clinical outcome (CCS and NYHA class). PCI is safe, feasible and can be an alternative approach to CABG both in low/intermediate and high surgical risk patients.