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 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
Background First generation drug-eluting stents （DES） were associated with a high incidence of late stent thrombosis （ST）,mainly due to delayed healing and re-endothelization by the durable polymer coating.This st...Background First generation drug-eluting stents （DES） were associated with a high incidence of late stent thrombosis （ST）,mainly due to delayed healing and re-endothelization by the durable polymer coating.This study sought to assess the safety and efficacy of the Nano polymer-free sirolimus-eluting stent （SES） in the treatment of patients with de novo coronary artery lesions.Methods The Nano trial is the first randomized trial designed to compare the safety and efficacy of the Nano polymer-free SES and Partner durable-polymer SES （Lepu Medical Technology,Beijing,China） in the treatment of patients with de novo native coronary lesions.The primary endpoint was in-stent late lumen loss （LLL） at 9-month follow-up.The secondary endpoint was major adverse cardiac events （MACE）,a composite of cardiac death,myocardial infarction or target lesion revascularization.Results A total of 291 patients （Nano group：n=143,Partner group：n=148） were enrolled in this trial from 19 Chinese centers.The Nano polymer-free SES was non-inferior to the Partner durable-polymer DES at the primary endpoint of 9 months （P 〈0.001）.The 9-month in-segment LLL of the polymer-free Nano SES was comparable to the Partner SES （0.34±0.42） mm vs.（0.30±0.48） mm,P=0.21）.The incidence of MACE in the Nano group were 7.6% compared to the Partner group of 5.9% （P=0.75） at 2 years follow-up.The frequency of cardiac death and stent thrombosis was low for both Nano and Partner SES （0.8% vs.0.7%,0.8% vs.1.5%,both P=1.00）.Conclusions In this multicenter randomized Nano trial,the Nano polymer-free SES showed similar safety and efficacy compared with the Partner SES in the treatment of patients with de novo coronary artery lesions.Trials in patients with complex lesions and longer term follow-up are necessary to confirm the clinical performance of this novel Nano polymer-free SES.展开更多
Background Durable polymer drug eluting stent （DES） is confronted with many issues, especially the inci- dence of late stent thrombosis （ST） which is mainly due to delayed healing and re-endothelization by the dur...Background Durable polymer drug eluting stent （DES） is confronted with many issues, especially the inci- dence of late stent thrombosis （ST） which is mainly due to delayed healing and re-endothelization by the durable polymer coating. Newer polymer-free DES might have a reduction in late stent thrombosis. Therefore, the aim of this study was to evaluate the efficacy and safety of two different drug eluting stents in patients with acute coro- nary syndromes （ACS） by one year follow-up. Methods This study assessed the results of the Nano polymer- free SES （Lepu Medical Technology, Beijing, China） and Endeavor durable-polymer ZES （Medtronic, Minneapo- lis, MN, USA） in ACS patients by clinical follow-up and coronary angiography analysis. The primary endpoint was the onset of any major adverse cardiac events （MACE） such as cardiac death, myocardial infarction （MI） and target vessel revascularization （TVR）. The secondary endpoints were target lesion revascularization （TLR） and stent thrombosis （ST） at the end of one year follow-up. Results Between April 2014 and June 2015, a total of 513 consecutive patients were enrolled in this trial. There were 259 patients enrolled in Nano group and 253 pa- tients in Endeavor group. Mean age was 62.8 ＋10.3 years old （range： 28 to 87 years of age）, and 65.3% of pa- tients were male. Compared Nano-SES to Endeavor-ZES, the incidence of MACE was 5.4% vs. 7.1%. The hazard ratio （HR） was 1.32 with 95% confidence interval （CI） as 0.64-2.72 （P = 0.45）. Secondary end points showed TLR （1.9% vs. 3.2%; HR, 1.42; 95% CI, 0.45-4.55; P = 0.55） and ST （0.4% vs. 0.8%; HR, 2.03; 95% CI, 0.18- 5.37; P = 0.99）, in the one-year period of follow-up. Conclusion Within one-year, the Nano polymer-free SES has similar safety and efficacy compared with the Endeavor durable-polymer ZES in the treatment of patients with ACS.展开更多
Durable polymers used for first-generation drug-eluting stents potentially contribute to persistent inflammation and late stent thrombosis. BICARE （Lepu Medical Technology Co., Ltd, Beijing, China） is a novel polyme...Durable polymers used for first-generation drug-eluting stents potentially contribute to persistent inflammation and late stent thrombosis. BICARE （Lepu Medical Technology Co., Ltd, Beijing, China） is a novel polymer-free stent system with nanotechnology and elutes rapamycin （1.6 μg/mm2） and probucol （0.8 μg/mm2）. The millpores on the surface of the stents were produced by nanotechnology. Studies on in-vitro release profile and the preliminary feasibility and safety of the BICARE stent were conducted. The results of release profile study demonstrated the ability of dual-drug polymer-free loading stents to release rapamycin and probucol in a controlled and sustained manner. The preliminary feasibility and safety of BICARE dual-drug polymer-free stent are demonstrated firstly in human study. Optical coherence tomography （OCT） findings indicated excellent stent strut coverage at 4-month. Further pivotal randomized trial will confirm if this early results could translate into longer term safety and efficacy benefits.展开更多
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 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Background First generation drug-eluting stents （DES） were associated with a high incidence of late stent thrombosis （ST）,mainly due to delayed healing and re-endothelization by the durable polymer coating.This study sought to assess the safety and efficacy of the Nano polymer-free sirolimus-eluting stent （SES） in the treatment of patients with de novo coronary artery lesions.Methods The Nano trial is the first randomized trial designed to compare the safety and efficacy of the Nano polymer-free SES and Partner durable-polymer SES （Lepu Medical Technology,Beijing,China） in the treatment of patients with de novo native coronary lesions.The primary endpoint was in-stent late lumen loss （LLL） at 9-month follow-up.The secondary endpoint was major adverse cardiac events （MACE）,a composite of cardiac death,myocardial infarction or target lesion revascularization.Results A total of 291 patients （Nano group：n=143,Partner group：n=148） were enrolled in this trial from 19 Chinese centers.The Nano polymer-free SES was non-inferior to the Partner durable-polymer DES at the primary endpoint of 9 months （P 〈0.001）.The 9-month in-segment LLL of the polymer-free Nano SES was comparable to the Partner SES （0.34±0.42） mm vs.（0.30±0.48） mm,P=0.21）.The incidence of MACE in the Nano group were 7.6% compared to the Partner group of 5.9% （P=0.75） at 2 years follow-up.The frequency of cardiac death and stent thrombosis was low for both Nano and Partner SES （0.8% vs.0.7%,0.8% vs.1.5%,both P=1.00）.Conclusions In this multicenter randomized Nano trial,the Nano polymer-free SES showed similar safety and efficacy compared with the Partner SES in the treatment of patients with de novo coronary artery lesions.Trials in patients with complex lesions and longer term follow-up are necessary to confirm the clinical performance of this novel Nano polymer-free SES.
文摘Background Durable polymer drug eluting stent （DES） is confronted with many issues, especially the inci- dence of late stent thrombosis （ST） which is mainly due to delayed healing and re-endothelization by the durable polymer coating. Newer polymer-free DES might have a reduction in late stent thrombosis. Therefore, the aim of this study was to evaluate the efficacy and safety of two different drug eluting stents in patients with acute coro- nary syndromes （ACS） by one year follow-up. Methods This study assessed the results of the Nano polymer- free SES （Lepu Medical Technology, Beijing, China） and Endeavor durable-polymer ZES （Medtronic, Minneapo- lis, MN, USA） in ACS patients by clinical follow-up and coronary angiography analysis. The primary endpoint was the onset of any major adverse cardiac events （MACE） such as cardiac death, myocardial infarction （MI） and target vessel revascularization （TVR）. The secondary endpoints were target lesion revascularization （TLR） and stent thrombosis （ST） at the end of one year follow-up. Results Between April 2014 and June 2015, a total of 513 consecutive patients were enrolled in this trial. There were 259 patients enrolled in Nano group and 253 pa- tients in Endeavor group. Mean age was 62.8 ＋10.3 years old （range： 28 to 87 years of age）, and 65.3% of pa- tients were male. Compared Nano-SES to Endeavor-ZES, the incidence of MACE was 5.4% vs. 7.1%. The hazard ratio （HR） was 1.32 with 95% confidence interval （CI） as 0.64-2.72 （P = 0.45）. Secondary end points showed TLR （1.9% vs. 3.2%; HR, 1.42; 95% CI, 0.45-4.55; P = 0.55） and ST （0.4% vs. 0.8%; HR, 2.03; 95% CI, 0.18- 5.37; P = 0.99）, in the one-year period of follow-up. Conclusion Within one-year, the Nano polymer-free SES has similar safety and efficacy compared with the Endeavor durable-polymer ZES in the treatment of patients with ACS.
文摘Durable polymers used for first-generation drug-eluting stents potentially contribute to persistent inflammation and late stent thrombosis. BICARE （Lepu Medical Technology Co., Ltd, Beijing, China） is a novel polymer-free stent system with nanotechnology and elutes rapamycin （1.6 μg/mm2） and probucol （0.8 μg/mm2）. The millpores on the surface of the stents were produced by nanotechnology. Studies on in-vitro release profile and the preliminary feasibility and safety of the BICARE stent were conducted. The results of release profile study demonstrated the ability of dual-drug polymer-free loading stents to release rapamycin and probucol in a controlled and sustained manner. The preliminary feasibility and safety of BICARE dual-drug polymer-free stent are demonstrated firstly in human study. Optical coherence tomography （OCT） findings indicated excellent stent strut coverage at 4-month. Further pivotal randomized trial will confirm if this early results could translate into longer term safety and efficacy benefits.
