Background Polymer coating on coronary stents induces vascular inflammatory response, reduces re-endothelialization, and affects long-term outcome after percutaneous coronary intervention （PCI）. The SERY-1 registry ...Background Polymer coating on coronary stents induces vascular inflammatory response, reduces re-endothelialization, and affects long-term outcome after percutaneous coronary intervention （PCI）. The SERY-1 registry aimed to determine whether a novel polymer-free paclitaxel-eluting microporous Yinyi stent could improve 1-year outcome after index procedure in real-world clinical practice. Methods Clinical and angiographic data and follow-up outcome were collected in 1045 patients who underwent PCI with implantation of 〉1 Yinyi stents between June 2008 and August 2009 at 27 medical centers. The primary endpoint was the cumulative rate of composite major adverse cardiac events （MACE） and the secondary endpoint was the incidence of stent thrombosis at 1 year. Results Overall, 1376 lesions were treated successfully with 1713 Yinyi stents, and 1019 （98.7%） patients received dual antiplatelet therapy for at least 12 months. During 1-year follow-up, 8 patients （0.78%） had cardiac death, 6 （0.58%） suffered non-fatal myocardial infarction, and 46 （4.46%） underwent repeat PCI due to recurrence of angina, resulting in 1-year MACE-free survival of 94.09%. Stent thrombosis occurred in 10 （0.97%） patients, and the rate of Academic Research Consortium （ARC） definite or probable stent thrombosis was 0.78%. Conclusions Polymer-free paclitaxel-eluting microporous Yinyi stent is effective and safe for interventional treatment of coronary artery disease in real-world clinical practice, without recourse to carrier polymer. Potential long-term clinical advantages of this stent deserve further investigation.展开更多
Acute total or subtotal occlusion of left main coronary artery (LMCA) is a catastrophic and mostly fatal event. Patients may present with cardiogenic shock and die whenever this event occurs. Survival is strongly depe...Acute total or subtotal occlusion of left main coronary artery (LMCA) is a catastrophic and mostly fatal event. Patients may present with cardiogenic shock and die whenever this event occurs. Survival is strongly dependent on the presence of collateral blood flow to the left coronary artery or a dominant right coronary artery, and emergency intervention for preserving the left ventricular function. Here, we present a case of a 14-year-old boy with subtotal occlusion of the LMCA accompanying acute myocardial infarction probably caused by congenital syphilis according to his positive serum syphilis antibody. His survival was closely associated with a dominant right coronary artery and timely thrombolytic therapy. Finally, he was treated with angioplasty and paclitaxel-eluting stent implantation. He was followed up after stenting and was doing quite well at the time when we wrote this paper.展开更多
Background Recent 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） ...Background Recent 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 popuation 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.Methods From 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 （Ml）, thrombosis, target lesion revascularization （TLR）, target vessel revascularization （TVR）, and major adverse cardiac events （MACE, the composite of death, Ml, and TVR）. We used Cox＇s proportional-hazards models to assess relative risks of all the outcome measures before and after propensity match. Results Unadjusted clinical outcomes indicated that the patients treated with Firebird SES were associated with lower risk of TLR （HR0.38, 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.Conclusion Compared with Taxus PES, the use of domestic Firebird SES may decrease the risk of TLR, TVR and MACE in daily practice.展开更多
Background Since permanent polymer is implicated in adverse events associated with delayed vessel healing after drug eluting stents （DES） implantation, great efforts have been made to develop more biocompatible DES ...Background Since permanent polymer is implicated in adverse events associated with delayed vessel healing after drug eluting stents （DES） implantation, great efforts have been made to develop more biocompatible DES with biodegradable polymer or without polymer. The present study aimed to evaluate the safety and efficacy of polymer free paclitaxel-eluting stents （PF-PES） in comparison with permanent polymer sirolimus-eluting stents （PP-SES） in patients with acute ST-segment elevation myocardial infarction （STEMI）. Methods Patients with STEMI were randomly assigned to receive PP-SES （n=55）, and PF-PES （n=50）. The 6-month angiographic and 1-year clinical outcomes were compared between the two groups. Target lesion failure （TLF） was defined as the composite of cardiac death, recurrent nonfatal myocardial infarction （Re-MI）, or target lesion revascularization （TLR）. Results Follow-up angiography at six months was performed in 72.7% of the PP-SES group and 70.0% of the PF-PES group （P=0.757）. The two groups had comparable angiographic outcomes including minimal luminal diameter, diameter stenosis, late loss and binary restenosis. All patients were clinically followed up to one year. The two groups had similar clinical outcomes with relatively low rates of target lesion failure （10.9% PP-SES vs. 12.0% PF-PES, P=0.861） and definite or probable stent thrombosis （1.8% PP-SES vs. 2.0% PF-PES, P=1.000） at one year. Conclusions The present study suggests that the safety and efficacy of PF-PES in the setting of STEMI are comparable to PP-SES. Further randomized trials with laraer study DODUlations are needed to net definite conclusions.展开更多
Background In-stent restenosis caused by airway granulation poses a challenge due to the high incidence of recurrence after treatment.Weekly applications of anti-proliferative drugs have potential value in delaying th...Background In-stent restenosis caused by airway granulation poses a challenge due to the high incidence of recurrence after treatment.Weekly applications of anti-proliferative drugs have potential value in delaying the recurrence of airway obstruction.However,it is not practical to subject patients to repeated bronchoscopy and topical drug applications.We fabricated novel pacilitaxel-eluting tracheal stents with sustained and slow pacilitaxel release,which could inhibit the formation of granulation tissue.And we assessed the quality and drug release behaviors of drug-eluting stents （DESs） in vitro.Methods Stents were dipped vertically into a coating solution prepared by dissolving 0.5 g （2％ w/v） of poly lactic acid-coglycolic acid （PLGA） and 0.025 g （0.1％ w/v） of pacilitaxel in 25 ml of dichloromethane.DES morphology was examined by scanning electron microscopy （SEM）.Pacilitaxel release kinetics from these DESs was investigated in vitro by shaking in PBS buffer followed by high performance liquid chromatography （HPLC）.Results Using an orthogonal experimental design,we fabricated numerous pacilitaxel/PLGA eluting tracheal stents to assess optimum coating proportions.The optimum coating proportion was 0.1％ （w/v） pacilitaxel and 2％ （w/v） PLGA,which resulted in total pacilitaxel loading of （16.380 6±0.002 1） mg/stent.By SEM the coating was very smooth and uniform.Pacilitaxel released from DES was at （0.376 3±0.003 8） mg/d,which is a therapeutic level.There was a prolonged,sustained release of pacilitaxel of ＞40 days.Conclusions Paclitaxel-loaded PLGA coating tracheal stents were successfully developed and evaluated.Quality assessments demonstrated favorable surface morphology as well as sustained and effective drug release behavior,which provides an experimental reference for clinical practitioners.展开更多
A meta-analysis was performed to address the efficacy and safety of paclitaxel-eluting stent(PES) in ST-segment elevation myocardial infarction(STEMI) patients.A systematic literature search was conducted to identify ...A meta-analysis was performed to address the efficacy and safety of paclitaxel-eluting stent(PES) in ST-segment elevation myocardial infarction(STEMI) patients.A systematic literature search was conducted to identify all randomized clinical trials in mortality,recurrent myocardial infarction(rMI),repeat revascularization(RR),and stent thrombosis(ST).A total of 4190 STEMI patients were enrolled in six randomized trials comparing PES with bare-metal stent(BMS).The pooled repeat revascularization rate was 5.7% in PES group,significantly lower than 10.0% in BMS group with an odds ratio(OR) of 0.56,95% confidence interval(CI) [0.44,0.72](P<0.00001).No significant difference was found between PES and BMS groups in mortality at one year after the indexing procedure(3.9% vs.5.1%,OR 0.88,95% CI [0.63,1.21],P=0.42).Similarly,rMI rate did not differ significantly between the two groups(3.4% vs.4.1%,OR 0.80,95% CI [0.56,1.13],P=0.21).PES was also associated with the comparable pooled rate of definite stent thrombosis with BMS(2.3% vs.2.4%,OR 0.81,95% CI [0.52,1.26],P=0.35).The results show that PES improved clinical outcomes in STEMI patients with a decreased need for repeat revascularization and no concerns for safety.展开更多
目的评价垠艺TM紫杉醇微孔载药支架在非ST段抬高急性冠脉综合征介入治疗中的安全性和有效性。方法将97例非ST段抬高急性冠脉综合征患者随机分为实验组47例和对照组50例,分别置入垠艺TM紫杉醇药物涂层支架60枚和Partner支架72枚。随访术...目的评价垠艺TM紫杉醇微孔载药支架在非ST段抬高急性冠脉综合征介入治疗中的安全性和有效性。方法将97例非ST段抬高急性冠脉综合征患者随机分为实验组47例和对照组50例,分别置入垠艺TM紫杉醇药物涂层支架60枚和Partner支架72枚。随访术后6个月2组不良心脏事件(MACE)发生率,术后30 d MACE及术后6个月再狭窄率。结果 2组随访6个月,均无心源性死亡、非致死性心肌梗死。实验组8例、对照组3例冠脉造影复查时发现支架内再狭窄,予行支架内球囊扩张术治疗,手术成功。结论置入垠艺TM紫杉醇药物涂层支架术后6个月,冠脉再狭窄率和MACE发生率与置入Partner者相似,这一结论仍有待大规模、多中心的随机对照试验进一步证实。展开更多
Aim: In the present study, we analyzed 7-year clinical outcomes of patients included in the BIO degradable Polymer coated drug-eluting stent REgistry of Sahajanand Medical Technologies Pvt. Ltd. stents in Saudi Arabia...Aim: In the present study, we analyzed 7-year clinical outcomes of patients included in the BIO degradable Polymer coated drug-eluting stent REgistry of Sahajanand Medical Technologies Pvt. Ltd. stents in Saudi Arabia (BIOPRESS)-Infinnium? registry. Methods: This was multicentre, observational, non-randomized, post-marketing surveillance registry, which included 276 consecutive patients treated with Infinnium? paclitaxel-eluting stent between July-2004 and June-2006. All patients underwent single-vessel or multiple-vessel percutaneous coronary intervention with high atherosclerotic risk factors and the patients were followed up to 7 years. Baseline and post-procedure angiographic follow-up were pre-specified in 231 patients. Results: The registry included 276 consecutive patients (81.5% male) with a mean age of 56.0 ± 11.1 years. Among 276 patients, diabetes and hypertension were present in 142 (51.4%) and 172 (62.3%) of patients respectively. Of all patients studied, 186 (67.4%) had single-vessel disease, 75 (27.2%) had double-vessel disease, and 15 (5.4%) had triple-vessel disease. Total 476 Infinnium? stents were implanted with an average stent length of 21.8 ± 7.5 mm. The incidence of major adverse cardiac events (MACE) up to 1 year was 26 (9.4%). Clinical follow-up was completed in 235 patients at seven-year follow-up. The data of seven-year clinical outcomes were as follow: cumulative MACE rate of 18.1% with 7.6% of total mortality and 3.6% of restenosis. Conclusion: These 7-year results of BIOPRESS-Infinnium? registry clearly provide evidence for safety and long-term effectiveness of the Infinnium? paclitaxel-eluting stent with the biodegradable polymer in real-life patients.展开更多
文摘Background Polymer coating on coronary stents induces vascular inflammatory response, reduces re-endothelialization, and affects long-term outcome after percutaneous coronary intervention （PCI）. The SERY-1 registry aimed to determine whether a novel polymer-free paclitaxel-eluting microporous Yinyi stent could improve 1-year outcome after index procedure in real-world clinical practice. Methods Clinical and angiographic data and follow-up outcome were collected in 1045 patients who underwent PCI with implantation of 〉1 Yinyi stents between June 2008 and August 2009 at 27 medical centers. The primary endpoint was the cumulative rate of composite major adverse cardiac events （MACE） and the secondary endpoint was the incidence of stent thrombosis at 1 year. Results Overall, 1376 lesions were treated successfully with 1713 Yinyi stents, and 1019 （98.7%） patients received dual antiplatelet therapy for at least 12 months. During 1-year follow-up, 8 patients （0.78%） had cardiac death, 6 （0.58%） suffered non-fatal myocardial infarction, and 46 （4.46%） underwent repeat PCI due to recurrence of angina, resulting in 1-year MACE-free survival of 94.09%. Stent thrombosis occurred in 10 （0.97%） patients, and the rate of Academic Research Consortium （ARC） definite or probable stent thrombosis was 0.78%. Conclusions Polymer-free paclitaxel-eluting microporous Yinyi stent is effective and safe for interventional treatment of coronary artery disease in real-world clinical practice, without recourse to carrier polymer. Potential long-term clinical advantages of this stent deserve further investigation.
文摘Acute total or subtotal occlusion of left main coronary artery (LMCA) is a catastrophic and mostly fatal event. Patients may present with cardiogenic shock and die whenever this event occurs. Survival is strongly dependent on the presence of collateral blood flow to the left coronary artery or a dominant right coronary artery, and emergency intervention for preserving the left ventricular function. Here, we present a case of a 14-year-old boy with subtotal occlusion of the LMCA accompanying acute myocardial infarction probably caused by congenital syphilis according to his positive serum syphilis antibody. His survival was closely associated with a dominant right coronary artery and timely thrombolytic therapy. Finally, he was treated with angioplasty and paclitaxel-eluting stent implantation. He was followed up after stenting and was doing quite well at the time when we wrote this paper.
文摘Background Recent 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 popuation 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.Methods From 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 （Ml）, thrombosis, target lesion revascularization （TLR）, target vessel revascularization （TVR）, and major adverse cardiac events （MACE, the composite of death, Ml, and TVR）. We used Cox＇s proportional-hazards models to assess relative risks of all the outcome measures before and after propensity match. Results Unadjusted clinical outcomes indicated that the patients treated with Firebird SES were associated with lower risk of TLR （HR0.38, 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.Conclusion Compared with Taxus PES, the use of domestic Firebird SES may decrease the risk of TLR, TVR and MACE in daily practice.
文摘Background Since permanent polymer is implicated in adverse events associated with delayed vessel healing after drug eluting stents （DES） implantation, great efforts have been made to develop more biocompatible DES with biodegradable polymer or without polymer. The present study aimed to evaluate the safety and efficacy of polymer free paclitaxel-eluting stents （PF-PES） in comparison with permanent polymer sirolimus-eluting stents （PP-SES） in patients with acute ST-segment elevation myocardial infarction （STEMI）. Methods Patients with STEMI were randomly assigned to receive PP-SES （n=55）, and PF-PES （n=50）. The 6-month angiographic and 1-year clinical outcomes were compared between the two groups. Target lesion failure （TLF） was defined as the composite of cardiac death, recurrent nonfatal myocardial infarction （Re-MI）, or target lesion revascularization （TLR）. Results Follow-up angiography at six months was performed in 72.7% of the PP-SES group and 70.0% of the PF-PES group （P=0.757）. The two groups had comparable angiographic outcomes including minimal luminal diameter, diameter stenosis, late loss and binary restenosis. All patients were clinically followed up to one year. The two groups had similar clinical outcomes with relatively low rates of target lesion failure （10.9% PP-SES vs. 12.0% PF-PES, P=0.861） and definite or probable stent thrombosis （1.8% PP-SES vs. 2.0% PF-PES, P=1.000） at one year. Conclusions The present study suggests that the safety and efficacy of PF-PES in the setting of STEMI are comparable to PP-SES. Further randomized trials with laraer study DODUlations are needed to net definite conclusions.
文摘Background In-stent restenosis caused by airway granulation poses a challenge due to the high incidence of recurrence after treatment.Weekly applications of anti-proliferative drugs have potential value in delaying the recurrence of airway obstruction.However,it is not practical to subject patients to repeated bronchoscopy and topical drug applications.We fabricated novel pacilitaxel-eluting tracheal stents with sustained and slow pacilitaxel release,which could inhibit the formation of granulation tissue.And we assessed the quality and drug release behaviors of drug-eluting stents （DESs） in vitro.Methods Stents were dipped vertically into a coating solution prepared by dissolving 0.5 g （2％ w/v） of poly lactic acid-coglycolic acid （PLGA） and 0.025 g （0.1％ w/v） of pacilitaxel in 25 ml of dichloromethane.DES morphology was examined by scanning electron microscopy （SEM）.Pacilitaxel release kinetics from these DESs was investigated in vitro by shaking in PBS buffer followed by high performance liquid chromatography （HPLC）.Results Using an orthogonal experimental design,we fabricated numerous pacilitaxel/PLGA eluting tracheal stents to assess optimum coating proportions.The optimum coating proportion was 0.1％ （w/v） pacilitaxel and 2％ （w/v） PLGA,which resulted in total pacilitaxel loading of （16.380 6±0.002 1） mg/stent.By SEM the coating was very smooth and uniform.Pacilitaxel released from DES was at （0.376 3±0.003 8） mg/d,which is a therapeutic level.There was a prolonged,sustained release of pacilitaxel of ＞40 days.Conclusions Paclitaxel-loaded PLGA coating tracheal stents were successfully developed and evaluated.Quality assessments demonstrated favorable surface morphology as well as sustained and effective drug release behavior,which provides an experimental reference for clinical practitioners.
文摘A meta-analysis was performed to address the efficacy and safety of paclitaxel-eluting stent(PES) in ST-segment elevation myocardial infarction(STEMI) patients.A systematic literature search was conducted to identify all randomized clinical trials in mortality,recurrent myocardial infarction(rMI),repeat revascularization(RR),and stent thrombosis(ST).A total of 4190 STEMI patients were enrolled in six randomized trials comparing PES with bare-metal stent(BMS).The pooled repeat revascularization rate was 5.7% in PES group,significantly lower than 10.0% in BMS group with an odds ratio(OR) of 0.56,95% confidence interval(CI) [0.44,0.72](P<0.00001).No significant difference was found between PES and BMS groups in mortality at one year after the indexing procedure(3.9% vs.5.1%,OR 0.88,95% CI [0.63,1.21],P=0.42).Similarly,rMI rate did not differ significantly between the two groups(3.4% vs.4.1%,OR 0.80,95% CI [0.56,1.13],P=0.21).PES was also associated with the comparable pooled rate of definite stent thrombosis with BMS(2.3% vs.2.4%,OR 0.81,95% CI [0.52,1.26],P=0.35).The results show that PES improved clinical outcomes in STEMI patients with a decreased need for repeat revascularization and no concerns for safety.
文摘目的评价垠艺TM紫杉醇微孔载药支架在非ST段抬高急性冠脉综合征介入治疗中的安全性和有效性。方法将97例非ST段抬高急性冠脉综合征患者随机分为实验组47例和对照组50例,分别置入垠艺TM紫杉醇药物涂层支架60枚和Partner支架72枚。随访术后6个月2组不良心脏事件(MACE)发生率,术后30 d MACE及术后6个月再狭窄率。结果 2组随访6个月,均无心源性死亡、非致死性心肌梗死。实验组8例、对照组3例冠脉造影复查时发现支架内再狭窄,予行支架内球囊扩张术治疗,手术成功。结论置入垠艺TM紫杉醇药物涂层支架术后6个月,冠脉再狭窄率和MACE发生率与置入Partner者相似,这一结论仍有待大规模、多中心的随机对照试验进一步证实。
文摘Aim: In the present study, we analyzed 7-year clinical outcomes of patients included in the BIO degradable Polymer coated drug-eluting stent REgistry of Sahajanand Medical Technologies Pvt. Ltd. stents in Saudi Arabia (BIOPRESS)-Infinnium? registry. Methods: This was multicentre, observational, non-randomized, post-marketing surveillance registry, which included 276 consecutive patients treated with Infinnium? paclitaxel-eluting stent between July-2004 and June-2006. All patients underwent single-vessel or multiple-vessel percutaneous coronary intervention with high atherosclerotic risk factors and the patients were followed up to 7 years. Baseline and post-procedure angiographic follow-up were pre-specified in 231 patients. Results: The registry included 276 consecutive patients (81.5% male) with a mean age of 56.0 ± 11.1 years. Among 276 patients, diabetes and hypertension were present in 142 (51.4%) and 172 (62.3%) of patients respectively. Of all patients studied, 186 (67.4%) had single-vessel disease, 75 (27.2%) had double-vessel disease, and 15 (5.4%) had triple-vessel disease. Total 476 Infinnium? stents were implanted with an average stent length of 21.8 ± 7.5 mm. The incidence of major adverse cardiac events (MACE) up to 1 year was 26 (9.4%). Clinical follow-up was completed in 235 patients at seven-year follow-up. The data of seven-year clinical outcomes were as follow: cumulative MACE rate of 18.1% with 7.6% of total mortality and 3.6% of restenosis. Conclusion: These 7-year results of BIOPRESS-Infinnium? registry clearly provide evidence for safety and long-term effectiveness of the Infinnium? paclitaxel-eluting stent with the biodegradable polymer in real-life patients.
