Search

Objective: To evaluate the long-term efficacy of a second generation biodegradable polymer sirolimus-eluting stent (EXCEL2) in treating patients with de novo coronary artery diseases. Methods: CREDIT Ⅱ trial was a prospective, multicenter, randomized, controlled study, conducted at 15 Chinese cardiac centres from November 2013 to December 2014. In this analysis, eligible patients for coronary stenting ( n= 419) were randomized to receive either the EXCEL2 stent ( n= 208) or the EXCEL stent ( n= 211). The primary endpoint was target lesion failure (TLF) at 3 years after PCI defined as a composite endpoints of cardiac death, target vessel myocardial infarction (TVMI), or clinically indicated target lesion revascularization (CI-TLR). Secondary endpoints included patient-oriented composite endpoint (PoCE) including all-cause death, all MI, or any revascularization at 3 years and independent components, and stent thrombosis according to Academic Research Consortium's (ARC) definition. Results: Among 419 enrolled patients, 413 (98.6%) patients completed 3-year clinical follow-up. Compared with the EXCEL group, 3-year TLF (5.4%(11/204) vs. 11.5% (24/209), P= 0.025) and PoCE (9.8% (20/204) vs. 20.1% (42/209), P= 0.003) were significantly lower in the EXCEL2 group. The cumulative event rate of CI-TLR (2.0% (4/204) vs. 5.7% (12/209), P= 0.042) and any revascularization (4.9% (10/204) vs. 14.4% (30/209), P= 0.001) were statistically lower in the EXCEL2 group than in the EXCEL group. There were no significant difference between two groups in terms of all-cause death and all MI. Rates of stent thrombosis were low without significant difference between the two groups (EXCEL2 vs. EXCEL, 1.0% (2/204) vs. 2.9% (6/209), P= 0.285). Conclusion: 3-year clinical follow-up results demonstrate that EXCEL2 stents are effective and safe in treating CAD patients with de novo coronary lesions.

Objective: This study sought to evaluate the safety and efficacy of FIREHAWK, a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES) in patients with moderate-complex coronary lesions (including patients with small vessel disease, long lesion and multi vessel disease), and to validate the ability of the SYNTAX score (SS) to predict clinical outcomes in patients treated with FIREHAWK stent. Methods: TARGETⅡ was a prospective, multicenter, single-arm clinical trial, a total of 730 patients who underwent percutaneous coronary intervention (PCI) of de novo lesions in native coronary arteries in 24 medical centers in China from August 2011 to February 2012 were enrolled in this study. All patients were exclusively treated with the FIREHAWK stent. Clinical data including patients with diabetes, small vessel disease, long lesion and multi vessel disease were analyzed. The primary composite endpoint was the target lesion failure (TLF) of cardiac death, target vessel-related myocardial infarction (TV-MI), or target lesion revascularization (TLR). The secondary composite endpoint was patient-oriented endpoint (PoCE), a composite of all death, all myocardial in farction (MI), or any repeat revascularization; definite/probable stent thrombosis (ST) (including acute, late, and very late thrombosis) . SS was calculated in lesions with stenosis more than 50% with coronary artery diameter greater than 1.5 mm. Patients were grouped by tertiles of SS (≤7, >7 to ≤12, >12). Follow-up was performed up to 5 years. Results: A total of 730 patients were enrolled in the TARGET Ⅱ trial. The average SS was 10.9±6.9. 683 (93.6%) patients completed 5-year clinical follow-up. The 5-year incidence of TLF was 8.5%(58/683). The incidence of TLF components was as follows: cardiac death 2.0%(14/683), TV-MI 4.4%(30/683), TLR 3.4%(23/683). The incidence of PoCE was 16.4%(112/683). The incidence of definite/probable stent thrombosis was 0.7%(5/683).Multivariable Cox regression analysis showed that the diabetes subgroup ( HR =1.123, 95% CI 0.623-2.026, P= 0.699), the small vessel disease subgroup ( HR =0.909, 95% CI 0.526-1.570, P= 0.732), the long lesion subgroup ( HR =1.561, 95% CI 0.922-2.640, P= 0.097), and the multi vessel disease subgroup ( HR =1.062, 95% CI 0.611-1.846, P= 0.830) did not increase the HR of TLF compared with the counterpart subgroups. Multivariable Cox regression analysis showed that the hazard of TLF was not increased in the middle and high SS groups as compared with the low SS group ( HR =1.203,95% CI 0.607-2.385, P= 0.597; HR =1.548,95% CI 0.829-2.892, P= 0.171). Conclusions: The 5 years follow-up results of TARGET Ⅱ trial shows that the biodegradable polymer of FIREHAWK stents have long-lasting safety and efficacy for patients with moderate-complex coronary lesions. SS is not the predicting factor for the occurrence of TLF in FIREHAWK treated patients with moderate-complex coronary lesions. Trial Registration Clinical Trials.gov, NCT0141264.

Objective: To evaluate the safety and efficacy of the drug coated balloon (DCB) with paclitaxel in patients with symptomatic peripheral artery disease (PAD)., Methods: The clinical data of 18 patients, who were diagnosed as PAD and treated with DCB from October 2013 to June 2014 in Department of Vascular Surgery, People's Liberation Army General Hospital, were retrospectively analyzed.Thirteen male and 5 female patients were in the series, the mean age of the patients was (65±7) years, and the Rutherford's categories were level 3 to 5. Patients were followed up at 3- and 6-month postoperative. The main efficacy end point were late lumen loss(LLL), rate of restenosis and clinically driven target lesion revascularization (TLR). Meanwhile, the clinical events were recorded., Results: Mean lesion length, the percentage of total occlusions and the percentage of in-stent restenosis were (138±91) mm, 9/18 and 2/18, respectively. Rate of technical success was 18/18. At 6-month postoperative, LLL, rate of restenosis and TLR were (0.1±0.9) mm, 2/14 and 0, respectively. There was no deaths or no amputations., Conclusion: DCB with paclitaxel is safe in patients with PAD, and associated with reductions in LLL, restenosis and clinically driven TLR 6-month postoperative.

Objective: To prepare Danshen phenolic acid fast release micro-pellets and study its preparation craft., Methods: The factors which could impact yield, extrude shaping, dissolution of Danshen phenolic acid micro-pellets such as wetting agent, drug loading dose, adjuvant, lactose dose, disintegrant, CMS-Na dose and wetting agent dose was investigated. The optimum preparation craft of Danshen phenolic acid fast release micro-pellets was screened out by orhogonal design., Results: Formula of Danshen phenolic acid fast release micro-pellets was calculated as volume dose 50 g. The formula was as follows: principal agent 22.5 g, lactose 5 g, CMS-Na 2 g, MCC 20.5 g, 27 mL 30% ethanol as wetting agent. Extrusion-spheronization was applied. The optimum conditions were screened out as follows: extrusion frequency (25 Hz), spheronization machine frequency (50 Hz), spheronization time (4 min)., Conclusion: The process was scientific and rational. The preparation is stable settles basis for multi-drug delivery system of Tongmai micro-pellets.

Objective: To evaluate the effectiveness of mild hypothermia on low cardiac output in patients after cardiac surgery., Methods: Twelve patients manifesting low cardiac output after cardiac surgery despite of the use of massive doses of catecholamine and intra-aortic balloon pump (IABP) underwent mild hypothermia during May 2009 to February 2011. Changes in hemodynamic parameters of the patients were measured, including cardiac index (CI),mixed venous oxygen saturation [SvO(2)] and urine volume., Results: In the process of mild hypothermia treatment, bladder temperature of patients was lowered to 33-35 centigrade in order to reduce the body oxygen demand. The CI [ml·s(-1)·m(-2)]of patients after mild hypothermia treatment was increased obviously (38.34 ± 5.00 vs. 30.01 ± 5.00), the same as SvO(2) (0.64 ± 0.07 vs. 0.54 ± 0.08) and urine output [ml·kg(-1)·h(-1): 3.0 ± 2.1 vs. 1.5 ± 1.1, all P < 0.05]. However, there was no significant change in heart rate, mean arterial pressure and blood oxygen pressure., Conclusion: Mild hypothermia is an effective and simple procedure to improve the cardiac function in patients after cardiac surgery complicated with low cardiac output.

Objective: To compare the effect of sirolimus-eluting stents to paclitaxel-eluting stents in complex and diffuse coronary lesions., Methods: 138 consecutive patients with complex and diffuse coronary lesions were enrolled from April 2004 to August 2005; they were implanted with more than 25 mm long sirolimus-eluting stents or paclitaxel-eluting stents. Unsuccessful cases were excluded. All patients received medical treatment according to guideline. Aspirin 300 mg and clopidogrel 75 mg once daily were continually administered for 6 months after the procedure. The patients were followed up after 6 months., Results: The study population consisted of 138 patients, including 124 men and 14 women. There were 129 (87.8%) C ACC/AHA type lesions. The average reference vessel diameter was (2.91 +/- 0.43) mm. The average lesion length was (36.36 +/- 12.27) mm. The average stent length per lesion was (40.25 +/- 12.79) mm. There was no difference of patient and lesion baseline characteristics between the groups of sirolimus-eluting and paclitaxel-eluting stents. At the end of follow up, in-stent restenosis rate (5.9% vs 17.7%, P = 0.023) and in-segment restenosis rate (9.4% vs 21.0%, P = 0.048) in the group of sirolimus-eluting stents were less than that in the group of paclitaxel-eluting stents. The difference was also seen in in-stent late luminal loss [(0.26 +/- 0.46) mm vs (0.60 +/- 0.66) mm, P = 0.001)] and in-segment late lumens loss [(0.16 +/- 0.52) mm vs (0.45 +/- 0.65) mm, P = 0.003)]. There was no difference between the sirolimus-eluting stents group and paclitaxel-eluting stents group in the incidence of target lesion revascularization (7.1% vs 12.9%, P = 0.223)., Conclusions: In patients with complex and diffuse coronary lesions, the use of the sirolimus-eluting stent was associated with a decrease in the extent of late luminal loss, as compared with use of paclitaxel-eluting stents, suggesting that sirolimus-eluting stent might be more suitable to be used in small vessel.

Objective: To evaluate the clinical effect and safety of Safflower Yellow injection (SYI) in treating coronary heart disease angina pectoris (CHD-AP) with Xin-blood stagnation syndrome (XBSS)., Methods: Adopted was the multi-centered, randomized, positive parallel controlled method, 448 patients with CHD-AP-XBSS were enrolled and divided into two groups, 336 in the tested group treated with SYI and 112 in the control group treated with Salvia injection by intravenous dripping once a day for 14 days, so as to observe the conditions of angina, electrocardiogram, and therapeutic effect on traditional Chinese medicine (TCM) symptoms as well as the safety of the treatment., Results: The significantly effective rate and total effective rate in the tested group were 60.06% (194/323) and 91.02% (294/323) respectively; Those in improvement of TCM symptoms were 40.18% (129/321) and 75.23% (243/323) respectively, which were better than those in the control group (P < 0.01)., Conclusion: SYI Injection is effective and safe in treating CHD-AP-XBSS.

Twenty ventricular septal defect patients who underwent cardiopulmonary bypass (CPB) were divided into 1,6-diphosphate group and controlled group (10 cases each). Blood samples were taken at pre- and post-cardiopulmonary bypass 30 min, 6 h, and 24 h to determine lactate dehydrogenase enzyme(LDH), creatine kinase enzyme(CK) and its isoenzyme(CK-MB) levels. We found that 1,6-diphosphate decreased the increasing levels of LDH, CK, and CK-MB after cardiopulmonary bypass. It is suggested that 1,6-diphosphate may attenuate myocardial ischemia/reperfusion injuries during cardiopulmonary bypass.

The patients with congestive heart failure which were treated by combination of digoxin with cyclovirobuxine D were described, with good result, of which prominating effect was 45.5%. Researchful result of 11 patients showed serum concentration of digoxin before and after combined treatment was not obviously different (P less than 0.05). Basis of pharmacokinetics was provided for using combined treatment of these drugs with long time and greater safeness.