BACKGROUNDAvailable drug-eluting stents (DES) have achieved great success in reducing restenosis rates. Recently, investigators have demonstrated that the durable polymer carrier plays a significant role in DES-related hypersensitive reaction and delays vessel healing. TIVOLI stent is a novel sirolimus-eluting coronary stent with biodegradable coating containing sirolimus and polylactic-co-glycolic acid (PLGA) polymer. The present study sought to evaluate the effectiveness and safety of the TIVOLI biodegradable-polymer-based sirolimus-eluting stent in treating patients with coronary artery disease.

METHODSA prospective, multicenter clinical trial comparing TIVOLI biodegradable coated sirolimus-eluting stent with ENDEAVOR zotarolimus-eluting stent was conducted in 324 patients (TIVOLI group: 168 patients; ENDEAVOR group: 156 patients) at 12 centers in China to demonstrate the non-inferiority of in-stent late loss with TIVOLI stent compared to ENDEAVOR stent in subjects with a maximum of two de novo native coronary artery lesions (lesion length ≤ 40 mm, reference vessel diameter 2.25-4.00 mm). The primary end point was angiographic in-stent late loss at 8-month. The secondary end points were clinical outcomes at 2 years, including major adverse cardiac events (cardiac death, myocardial infarction, or target-lesion revascularization) and stent thrombosis.

RESULTSAngiographic late lumen loss at 8 months in the TIVOLI group was superior to the ENDEAVOR group (in-stent (0.25 ± 0.33) mm vs. (0.57 ± 0.55) mm, diff (95%CI) -0.23 (-0.32, -0.14), P < 0.0001; in-segment (0.25 ± 0.33) mm vs. (0.42 ± 0.55) mm, diff (95%CI) -0.13 (-0.23, -0.02), P = 0.0083). The rate of in-stent binary restenosis at 8 months was reduced from 8.6% in the ENDEAVOR group to 2.9% in the TIVOLI group (P = 0.0229). Compared to ENDEAVOR stent, TIVOLI stent resulted in a significant reduction in target-lesion revascularization (4.2% vs. 9.6%, P = 0.0495) at 2 years. The two-year major adverse cardiac events (MACE) rate was lower for the TIVOLI group, but not significantly different (6.6% vs. 10.9%, P = 0.1630).

CONCLUSIONSTIVOLI was superior to ENDEAVOR stent with respect to late lumen loss at 8 months, and it yielded both lower rates of angiographic binary restenosis at 8 months and target lesion revascularization (TLR) at 2 years. The MACE rate at 2 years was comparable in both groups.

Aged ; Angioplasty, Balloon, Coronary ; methods ; Coronary Angiography ; Coronary Artery Disease ; drug therapy ; therapy ; Drug-Eluting Stents ; Female ; Humans ; Immunosuppressive Agents ; therapeutic use ; Male ; Middle Aged ; Polymers ; chemistry ; Sirolimus ; analogs & derivatives ; therapeutic use ; Treatment Outcome

BACKGROUNDRecent data have shown that sirolimus-eluting stents (SES) reduced not only the incidences of restenosis but also of target vessel revascularization (TVR). CYPHER and FIREBIRD stents are both widely used SES in China. However, comparative data concerning differences in long-term safety and efficacy regarding CYPHER and FIREBIRD stents in the Chinese population are still not available.

METHODSFrom April 2004 to October 2006, 3979 consecutive patients who underwent successful SES (FIREBIRD 2274; CYPHER 1705) implantation were prospectively enrolled into this study. All enrolled patients were divided into two groups based on stent type. Follow-up data, including death, myocardial infarction (MI), thrombosis, target lesion revascularization (TLR), TVR, and major adverse cardiac events (MACE, the composite of death, MI, and TVR) were obtained at 24 months. Cox's proportional-hazards models were used to assess relative risks of all the outcome measures between the two groups before and after propensity match.

RESULTSUnadjusted clinical outcomes demonstrated higher TVR (hazard ratio (HR) 1.78, 95%CI 1.26 - 2.50) and MACE (HR 1.40, 95%CI 1.08 - 1.82) for patients treated with FIREBIRD SES. After propensity match, the results showed a non-significant trend towards superiority of the CYPHER stent in all the analyzed parameters, however, no significant differences were found for all events at 24 months between FIREBIRD and CYPHER groups, and all thrombosis rates by Academic Research Consortium (ARC) definition were comparable between the two groups.

CONCLUSIONSIn this large, real-world population, the use of domestic FIREBIRD SES in China was associated with nearly the same safety and efficacy versus the imported CYPHER SES. FIREBIRD SES can be taken as an alternative for CYPHER SES in daily practice.

Aged ; Angioplasty, Balloon, Coronary ; methods ; China ; Coronary Restenosis ; therapy ; Drug-Eluting Stents ; adverse effects ; Female ; Humans ; Male ; Middle Aged ; Myocardial Infarction ; therapy ; Proportional Hazards Models ; Sirolimus ; Treatment Outcome

BACKGROUNDRecent studies have shown that drug eluting stent (DES) implantation improved clinical outcome concerning efficacy compared with bare-metal stent (BMS) implantation, and sirolimus-eluting stent (SES) seemed superior to paclitaxel-eluting stent (PES) in improving the outcomes. Firebird SES is the most widely used SES in China. Long-term comparison of safety and efficacy between Firebird SES and Taxus PES in Chinese population is still not available. The aim of this research was to compare the safety and efficacy at 24 months after the successful implantation of Firebird SES and TAXUS PES in Chinese population.

METHODSFrom April 2004 to October 2006, 3110 consecutive patients who underwent successful DES (Firebird SES 2274; Taxus PES 836) implantation were prospectively enrolled into this study. All enrolled patients were divided into two groups based on stent type. By outpatient clinic visit and telephone interview, we obtained 24-month clinical outcome including death, myocardial infarction (MI), thrombosis, target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE, the composite of death, MI, and TVR). We used Cox's proportional-hazards models to assess relative risks of all the outcome measures before and after propensity match.

RESULTSUnadjusted clinical outcomes indicated that the patients treated with Firebird SES were associated with lower risk of TLR (HR 0.38, 95%CI 0.26 - 0.54), TVR (HR 0.51, 95%CI 0.38 - 0.68) and MACE (HR 0.53, 95%CI 0.41 - 0.68). The results after propensity match were consistent with that before matching, lower risk of TLR (HR 0.33, 95%CI 0.19 - 0.58), TVR (HR 0.41, 95%CI 0.26 - 0.64), MACE (HR 0.48, 95%CI 0.33 - 0.68) in Firebird group.

CONCLUSIONCompared with Taxus PES, the use of domestic Firebird SES may decrease the risk of TLR, TVR and MACE in daily practice.

Aged ; Angioplasty, Balloon, Coronary ; adverse effects ; Anti-Bacterial Agents ; therapeutic use ; Antineoplastic Agents, Phytogenic ; therapeutic use ; Drug-Eluting Stents ; adverse effects ; Female ; Humans ; Male ; Middle Aged ; Paclitaxel ; therapeutic use ; Sirolimus ; therapeutic use ; Treatment Outcome

OBJECTIVETo explore clinical outcomes of patients undergoing emergent coronary artery bypass grafting (CABG) following failed percutaneous coronary intervention (PCI) in the stent era.

METHODSEleven patients who underwent emergent CABG following failed PCI from January, 2002 to December 2010 were enrolled. The in-hospital follow-up included cardiac deaths, Q-wave myocardial infarction, kidney failure, and cerebrovascular events. The clinical end-point of out-hospital follow-up was the major adverse cardiac events including death, myocardial infarction, and target lesion revascularization.

RESULTSThe patients were (61 ± 5) years old. Coronary angiography showed 5 patients had triple vessel lesions. There were 9 target lesions on left anterior descending artery. There were 3 (27.3%) severe calcified, 4 (36.4%) chronic total occlusion, and 4 (36.4%) diffused long lesions. Reasons for emergent CABG were dissection (n = 5, 45.5%), perforation (n = 3, 27.3%), failure to sufficient predilation (n = 1, 9.1%), acute closure (n = 1, 9.1%) and stent loss (n = 1, 9.1%). The average duration of follow-up was (47 ± 33) months. During in-hospital follow-up, there were 1 (9.1%) cardiac death and 2 (18.2%) Q wave myocardial infarction. During follow-up after hospital discharge, 1 patient (9.1%) died of kidney failure, and there was no rehospitalization due to cardiac events.

CONCLUSIONSEmergent CABG after failed PCI often happened in patients with complex coronary lesions. The long term outcome of patients requiring emergent CABG after failed PCI was favorable in this cohort.

Aged ; Coronary Artery Bypass ; Coronary Artery Disease ; diagnosis ; surgery ; Emergency Treatment ; Female ; Humans ; Male ; Middle Aged ; Percutaneous Coronary Intervention ; Prognosis ; Retrospective Studies ; Treatment Outcome

Objective:To explore the risk factors for in-hospital mortality in patients with non-ST segment elevation myocardial infarction (NSTEMI) in China.Methods:The information of 5816 NSTEMI patients from 2013-01 to 2014-09 by China Acute Myocardial Infarction (CAMI) registry were extracted.Our research included in 2 groups:In-hospital death group,n=352 and In-hospital survival group,n=5464.The baseline condition,laboratory examination,treatment and the in-hospital outcomes were collected;the independent risk factors for in-hospital mortality were studied by multivariable Logistic regression analysis.Results:6.05％ (352/5816) patients died during hospitalization.The baseline conditions were different between 2 groups.Multivariable Logistic regression analysis indicated that age,BMI,systolic blood pressure,Killip classification,heart arrest,ST-segment depression in ECG,new onset of Complete left bundle branch block,serum creatinine,white blood cells,Count nonsmoker,previous history of MI and PCI were the independent risk factors for in-hospital mortality in NSTEMI patients.Conclusion:The above 12 variables were the independent risk factors for in-hospital mortality in NSTEMI patients which should be helpful for identifying the high risk patients at the early stage in clinical practice.

Objectives:To explore the clinical and coronary disease characteristics and prognosis of Chinese patients with ST segment elevation myocardial infarction and without typical chest pain. Methods:By extracting data from China Acute Myocardial Infarction Registry, we included 12 145 STEMI patients who underwent coronary angiography between 01 January 2013 to 30 September 2014. Variables of interest were extracted and compared between AMI patients without vs with typical chest pain. Multivariable logistic regression analysis was used to identify independent predictors of in-hospital mortality. Results:There were approximately 24% (2922/12145) STEMI patients without typical chest pain. Compared with typical chest pain patients, patients without typical chest pain had higher prevalence of diabetes (20.0% vs 17.8%), longer time of disease onset to hospital, lower rate of IRA disease of left anterior descending artery (44.6% vs 51.2%). These patients were less likely to receive primary percutaneous coronary intervention (64.9% vs 73.9%) and had higher in-hospital mortality (3.3% vs 2.2%, P＜0.05). Multivarite Logistic regression analysis indicated atypical chest pain was an independent risk factor for in-hospital death (OR:1.364, 95% confidence interval:1.018-1.827). Conclusions:Approximately a quarter STEMI patients presented without typical chest pain in this patient cohort and they had longer disease onset to hospital time, were less likely to receive PCI, and associated with higher in-hospital mortality risk. Efforts should be made to identify these patients in order to apply the optimal treatments to them.

OBJECTIVETo compare the clinical and angiographic outcome in patients with total occlusion lesion treated with drug-eluting stent (DES) or bare-metal stent (BMS).

METHODSA total of 155 (138 males) consecutive patients with total occlusion lesion underwent successful revascularization with DES (n = 74) or BMS (n = 81) in our hospital were included in this study. All patients received aspirin 300 mg and clopidogrel 75 mg once daily for at least 3 months after the procedure. Clinical and angiographic follow-up were completed in all patients at 6 months post stenting.

RESULTSDemographic data between the two groups were similar except there was more diabetic patients in DES group (33.8% vs. 18.5%, P < 0.05). A total of 232 stents for 159 target lesions (77 treated with DES, 82 treated with BMS) were implanted. There were 85.4% C ACC/AHA type lesions and 17.0% lesions were treated with overlapping stents. Six months post stenting, the incidence of restenosis (15.6% vs. 41.5%, P < 0.001), the cumulative rate of major adverse cardiac events (MACE) (1.4% vs. 11.1%, P = 0.032) and TLR (5.8% vs. 19.9%, P = 0.001) were significantly lower in DES group than that of BMS group. The incidence of local restenosis in DES group is higher in DES group than that in BMS group (58.3%, 17.6%, P < 0.001). Two DES treated patients developed late in-stent thrombosis.

CONCLUSIONFor patients with total occlusion lesion, the clinical and angiographic outcome 6 months post DES stenting is clearly superior to that of BMS stenting.

Aged ; Coronary Angiography ; Coronary Disease ; complications ; diagnostic imaging ; therapy ; Diabetes Mellitus, Type 2 ; complications ; diagnostic imaging ; Female ; Follow-Up Studies ; Humans ; Hypertension ; complications ; Male ; Middle Aged ; Prognosis ; Stents

BACKGROUNDCoronary artery disease (CAD) is generally considered as a disease of middle-aged men. It is widely accepted that the risk for CAD of premenopausal women is low because of hormone protection. Based on our clinical experience, more and more premenopausal women suffer from angina and myocardial infarction without adequate concern. Even now, there are still limited detailed data to describe the characteristics, mechanism and prognosis of premenopausal CAD patients. This article aimed to analyze the clinical and angiographic characteristics of premenopausal women with CAD.

METHODSA total of 565 premenopausal women and 721 postmenopausal women (56 - 60 years old) who underwent coronary angiography for the first time from April 2004 to December 2007 were enrolled. The clinical data and coronary angiographic characteristics (presence, localization, length and severity) were compared between the premenopausal and postmenopausal CAD groups.

RESULTSPremenopausal CAD patients presented less frequently with hypertension, diabetes mellitus and dyslipidemia compared with postmenopausal CAD patients (55.0% vs 66.0%, 15.0% vs 31.5%, 23.9% vs 37.4%, respectively; all P < 0.05). Although we found more frequent involvement of single vessel in premenopausal CAD (43.2% vs 26.9%, P = 0), and triple vessels in postmenopausal (56 - 60 years old) CAD patients (33.8% vs 20.4%, P = 0), much more severe lesions (> or = 90%) at left main (2.9% vs 1.1%, P = 0.048) and proximal left anterior descending artery (LAD) (28.2% vs 16.6%, P = 0) in the premenopausal CAD group were found.

CONCLUSIONPremenopausal women with chest discomfort are always found to have obvious atherosclerosis, more inclined to be located at the left main and proximal LAD, which is a strong predictor of an adverse clinical outcome.

Coronary Angiography ; Coronary Artery Disease ; diagnostic imaging ; pathology ; Diabetes Mellitus ; pathology ; Dyslipidemias ; pathology ; Female ; Humans ; Hypertension ; pathology ; Middle Aged ; Postmenopause ; Premenopause

BACKGROUNDIn response to the increasing concern with the safety of the drug-eluting stent (DES), the present study aimed to evaluate the long-term safety and efficacy of DES used for a Chinese patient population.

METHODSAll patients, who underwent an index elective percutaneous coronary intervention with an implantation of either DES or bare-metal stent (BMS) in a single institution from April 2004 to December 2006, were included in the analysis. A propensity-score matching technique was applied to adjust and to minimize the impact of confounding factors.

RESULTSOverall, there were 1465 patients (20.2%) who had undergone an implantation of only BMS, and 5769 patients (79.8%) of only DES. The propensity-score matching technique set up 1321 pairs of patients for analysis. There were no significant differences between the rates of stent thrombosis (definite and probable) of the two groups (1.06% vs 1.21%, P = 0.8580). Although rates of mortality and myocardial infarction (MI) during the 2-year follow-up period had not differed significantly, rates of death/MI (3.0% vs 4.5%, P = 0.0263), target-lesion revascularization (TLR, 3.2% vs 8.5, P = 0.0001), target-vessel revascularization (TVR, 5.8% vs 9.5%, P < 0.0001) and any revascularization (10.0% vs 13.3%, P = 0.0066) were significantly lower for the DES group than for the BMS group. Among the patients in whom devices were implanted for off-label indications, the propensity-score matched rates of stent thrombosis, mortality, MI, and death/MI were not significantly different, while rates of TLR, TVR and any revascularization were significantly lower for the DES group than for the BMS group.

CONCLUSIONSDuring the 2 years of follow-up post stenting, DES use is associated with lower rates of death/MI, TLR, TVR and any revascularization, compared with BMS, in propensity-score matched Chinese patient populations. In the setting of off-label usage, DES use is also associated with similar advantages.

Adult ; Aged ; Angioplasty, Balloon, Coronary ; mortality ; Databases, Factual ; Drug-Eluting Stents ; adverse effects ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Myocardial Infarction ; mortality ; Stents ; adverse effects

OBJECTIVECompare drug-eluting stent (DES) to bare-metal stent (BMS) in prognosis on treating diffuse coronary lesions and analysis risk factor of treating complex and diffuse lesions in PCI.

METHODS205 consecutive patients with complex and diffuse coronary lesions enrolled our hospital, who were treated with more than 25 mm long DES or BMS. We exclude unsuccessful operation and location. All patients received medical treatment by guideline, and aspirin 300 mg and clopidogrel 75 mg once daily were continued at 6 months after the procedure. The patients were followed up after 6 months.

RESULTSThe study population were consisted of 205 patients that there were 181 man, and 24 women, who got 382 stents for 227 target lesions in coronary. There were 93.8% C and 6.2% B2 ACC/AHA type lesion. There were 86.8% patients with binary or above vessel treated. The average reference vessel diameter was 2.88 +/- 0.43 mm. The average stent length of per lesion was 40.09 +/- 12.94 mm. There were 54.2% lesions treated with overlapping stent. There were not different between DES and BMS in patients baseline characteristics, but RVD of group DES less than of group BMS (2.80 +/- 0.37 mm, 3.10 +/- 0.48 mm, P = 0.005) in lesion baseline characteristics. After 6 months, restenosis rate in group DES was less than in group BMS (15.4%, 48.4%, P < 0.001). There were obvious superiority TVR of DES than of BMS (11.6%, 38.5%, P < 0.001). The rate of local restenosis in group of DES was higher than that in group of BMS (33.3%, 18.2%, P = 0.029). We analyzed the risk factors for diffuse lesion by a logistic regression model, the significant univariate clinical and angiographic predictors of restenosis were treating with overlapping stent (OR = 2.82, P = 0.017) and drug-eluting stent (OR = 5.71, P < 0.001).

CONCLUSIONSWe find that implantation of DES in patients with diffuse lesions in coronary is relatively more safe and associated with more good clinical outcomes, than of BMS.

Aged ; Angioplasty, Balloon, Coronary ; Coronary Angiography ; Coronary Artery Disease ; diagnostic imaging ; therapy ; Coronary Restenosis ; diagnostic imaging ; therapy ; Drug-Eluting Stents ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Prognosis ; Stents ; Treatment Outcome