[The clinical efficacy and safety of fondaparinux combined with tirofiban hydrochloride in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention].

OBJECTIVE: To explore the efficacy and safety of fondaparinux combined with tirofiban in patients with high risk unstable angina (UA) undergoing complex percutaneous coronary intervention (PCI) . METHODS: A total of 389 patients were enrolled and randomized into two groups receiving either fondaparinux with tirofiban or enoxaparin with tirofiban. Bleeding, thrombosis and main adverse cardiovascular events (MACE) were compared between the two groups during hospitalization, at week 2 and week 4 after discharge. RESULTS: No severe bleeding was observed during hospitalization in the both groups, while lower rate of mild and minor bleeding was shown in the fondaparinux group (0 vs 1.5% and 18.2% vs 34.5%, P = 0.04 and P < 0.001 respectively). No difference was found between the two groups in the rate of MACE during hospitalization, at week 2 and week 4 weeks after discharge. The rates of death, recurrent myocardial infarction, refractory myocardial ischemia and target vessel revascularization were 0.5% vs 1.0%, 0.5% vs 1.0%, 1.6% vs 1.0% and 2.1% vs 1.5% during hospitalization; 0 vs 0, 1.0% vs 0.5%, 1.0% vs 1.5%, 0.5% vs 1.0% at week 2 after discharge; 0.5% vs 0.5%, 0.5% vs 0.5%, 2.6% vs 2.0%, 0 vs 0.5% at week 4 after discharge (all P values>0.05). CONCLUSION: The combination therapy of fondaparinux and tirofiban is of good safety and efficacy in high risk UA patients undergoing complex PCI.

[Efficacy and safety of tirofiban use after successful percutaneous coronary intervention for patients with moderate to high risk non-ST segment elevation acute coronary syndromes].

OBJECTIVE: To evaluate the efficacy and safety of tirofiban use immediately after successful percutaneous coronary intervention (PCI) in patients with moderate to high risk non-ST segment elevation acute coronary syndromes (NSTE-ACS). METHODS: NSTE-ACS patients undergoing successful PCI (n = 246) were randomized by the envelope method to tirofiban group (n = 122, 10 µg/kg bolus within 3 min followed by 0.10-0.15 µg×kg(-1)×min(-1) for 36 h i.v.) or control group (n = 124, saline i.v. for 36 h). The primary efficacy composite end point was death, myocardial infarction, target vascular revascularization or ischemic stroke at 30 days. The second end point was the occurrence of composite end point at 7 days or 6 months. Key safety end points were bleeding and thrombocytopenia 3 days after PCI. RESULTS: Baseline characteristics were well-balanced between the two groups (P > 0.05). The primary end point occurred in 0.9% (1/117) patients in the tirofiban group and 3.3% (4/123) patients of those in the control group (P = 0.40). There was no significant difference in the composite end point at 7 days [0.8% (1/122) vs. 3.2% (4/124), P = 0.38] between the groups, however, there was a trend towards lower composite efficacy end points at 6 months in tirofiban group compared to control group [0.9% (1/117) vs. 5.9% (7/118), P = 0.07]. The probability of survival free of composite end point was significantly higher in the tirofiban group than that in the control group (99.2% vs. 94.2%, log-rank test, P = 0.03). There was no GUSTO severe or moderate bleeding or severe thrombocytopenia within 3 days post-PCI. There was no significant difference in mild bleeding [13.1% (16/122) vs. 7.3% (9/124), P = 0.13] or mild thrombocytopenia [0.8% (1/122) vs. 0.8% (1/124), P = 1.00] between the groups. CONCLUSION: Tirofiban use after successful PCI can improve 6-month event-free survival without increasing the risk of bleeding for patients with moderate to high risk NSTE-ACS.

[Association between smoking status at follow-up and clinical outcomes in patients undergoing successful percutaneous coronary intervention].

OBJECTIVE: To assess the association between smoking status at follow-up and clinical outcomes in patients undergoing successful percutaneous coronary intervention (PCI). METHODS: The smoking status at follow-up was investigated in 592 patients undergoing successful PCI between Jan. 2003 and Nov. 2006. The patients were divided into three groups on the basis of their smoking status at follow-up: non-smokers (n = 272), quitters (n = 215) and current smokers (n = 105). Major adverse cardiac events were recorded. RESULTS: The average follow-up time was 19.0 months. At follow-up, current smokers were significantly younger (P < 0.01), more likely to be male (P < 0.01) than non-smokers and had more favorable clinical and angiographic characteristics: lower prevalence of hypertension (P < 0.05) and diabetes (P < 0.05), fewer diseased vessels (P < 0.05) and fewer implanted coronary stents (P < 0.01), larger target vessel diameter (P < 0.01). However, the incidence of non-fatal myocardial infarction (MI) in quitters (1.40%) was significantly higher than in nonsmokers (0.37%, P < 0.05), the incidence of nonfatal MI in current smokers (4.76%) was significantly higher than quitters (1.40%, P < 0.05) and nonsmokers (0.37%, P < 0.01). After adjustments for age, gender, hypertension, diabetes, dyslipidaemia, target vessel diameter, the number of diseased vessels, the kind and number of implanted stents, and the follow-up time, multi-variables logistic regression analysis showed that current smoking was a independent predictive factor for non-fatal MI (beta = 1.28, wald chi2 = 6.91, P < 0.01). CONCLUSIONS: Smokers, especially current smokers, were at increased risk for non-fatal MI post successful PCI. Therefore, all patients underwent PCI should be encouraged to stop smoking.

[Effects of intracoronary autologous bone marrow mononuclear cells transplantation in patients with dilated cardiomyopathy].

OBJECTIVE: To evaluate the safety and efficacy of intracoronary autologous bone marrow mononuclear cells (BM-MNCs) transplantation in patients with dilated cardiomyopathy (DCM). METHODS: On top of standard therapy, DCM patients received BM-MNCs transplantation (n = 71) or saline injection (n = 187). The baseline clinical characteristics of two groups were comparable. Data on echocardiography, Holter, six-minute-walk test, cardiac SPECT and annual hospital days were obtained in all patients at baseline, 1, 3, 6, 12 and 24 months after transplantation. RESULTS: Six-minute-walk distance was significantly longer at one month [(345 +/- 76) m vs. (286 +/- 104) m, P < 0.05] and thereafter (all P < 0.05) in BM-MNCs group compared with saline group. Left ventri ocular ejection fraction (LVEF) at one month in BM-MNCs group was significantly higher compared with saline group [(41.5 +/- 9.4)% vs. (37.3 +/- 6.6)%, P < 0.05] and with pre-transplantation value [(41.5 +/- 9.4)% vs. (32.4 +/- 8.5)%, P < 0.05] while LVEF was similar at 24 months after transplantation between the two groups [(43.6 +/- 6.3)% vs. (43.2 +/- 6.0)%, P > 0.05]. Three months after transplantation, the number of ischemic segments of BM-MNCs group was significantly reduced compared with that of saline group (2.0 +/- 1.0 vs. 3.1 +/- 1.4, P < 0.05) and with baseline (2.0 +/- 1.0 vs. 3.1 +/- 1.2, P < 0.05) while the number of necrotic segments were similar in both groups during the follow-up. There were no significant difference in survival between two groups during 2 years follow-up (95.4% vs. 94.9%, P > 0.05) but the annual hospitalization days of BM-MNCs group was significantly lower than that of saline group [(23.6 +/- 13.4) d vs. (33.0 +/- 14.0) d, P > 0.05]. CONCLUSIONS: Intracoronary transplantation of autologous BM-MNCs was safe and could increase LVEF and the six-minute-walk distance and reduce hospitalization days for patients with dilated cardiomyopathy.

Long-term effect of persistent smoking on the prognosis of Chinese male patients after percutaneous coronary intervention with drug-eluting stent implantation.

OBJECTIVES: This study aimed to survey the adherence to smoking cessation and assess the influence of persistent smoking on the prognosis in male patients after drug-eluting stent (DES) implantation. METHODS: The smoking status at the time of the index procedure and at follow-up was surveyed in 656 male patients undergoing successful percutaneous coronary intervention (PCI) with DES in our center. These patients were divided into three groups, based on their smoking status: nonsmokers (n=226), quitters (n=283), and persistent smokers (n=147). Major adverse cardiac and cerebrovascular events (MACCE) during the follow-up period were carefully recorded and their relationship with smoking status was investigated for 24-41 months. RESULTS: Among 656 patients who were followed up for 27.24±6.33 (7-40) months, 430 of them were smokers (65.5%) at the index procedure. A total of 147 patients (22.4%) who continued to smoke, accounted for 34.2% of smokers at the time of PCI. Persistent smokers and quitters were more likely to be young (p<0.001) than nonsmokers, persistent smokers had more dyslipidemia (p=0.005), and fewer took aspirin (p=0.016) and statins (p=0.045) than quitters and nonsmokers. Weight gain was greater for quitters (p<0.016) than for nonsmokers. The incidence of all-cause death (6.1% v.s. 1.8% and 1.1%, p=0.004) and MACCE (15.0% vs 7.1% and 5.3%, p=0.002) in persistent smokers were significantly higher than those in nonsmokers and quitters. Multiple regression analysis showed that persistent smoking was a significantly determinant factor for all-cause death [hazard ratio (HR)=2.432, 95% confidence interval (CI) 1.170-5.054; p<0.017] and MACCE (HR=1.519, 95% CI 1.049-2.200; p=0.027). CONCLUSIONS: This is the first follow-up report about the long-term effect of persistent smoking in Chinese male patients after DES implantation. Our findings strongly indicate that poor adherence to smoking cessation is a predictive factor for all-cause death and MACCE.