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 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 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
In this work, we developed a novel triboelectricity-assisted polymer-free method for the transfer of large-area chemical vapor deposited graphene films. With the assistance of electrostatic forces from friction-genera...In this work, we developed a novel triboelectricity-assisted polymer-free method for the transfer of large-area chemical vapor deposited graphene films. With the assistance of electrostatic forces from friction-generated charges, graphene sheets were successfully transferred from copper foils to flexible polymer substrates. Characterization results confirmed the presence of high quality graphene with less defects and contaminations, compared to graphene transferred by conventional poly(methyl rnethacrylate)-mediated processes. In addition, the graphene samples possessed outstanding electrical transport capabilities and mechanical stability, when studied as electron transfer matrixes in graphene/ZnO hybrid flexible photodetectors. Our results showed a broad application potential for this transfer method in future flexible electronics and optoelectronics.展开更多
Background Drug-eluting stents represent a major advance in interventional cardiology. However, the current drug- eluting stents have significant limitations. One of the major problems is very late stent thrombosis, w...Background Drug-eluting stents represent a major advance in interventional cardiology. However, the current drug- eluting stents have significant limitations. One of the major problems is very late stent thrombosis, which is likely caused by inflammation and a hypersensitivity reaction related to a polymer on the stent. A polymer-free sirolimus-eluting stent with a unique nano-porous surface has been developed. This study aimed to evaluate this novel polymer-free sirolimus- eluting stent for its efficacy and safety in a pig model. Methods Stents were directly coated with sirolimus (a drug concentration of 2.2 μg/mm2 on the stent surface). The polymer-free sirolimus-eluting stents (PFSES) were compared to standard polymer-coated sirolimus-eluting stents (PCSES) and bare-metal stents (BMS) in 18 pigs. Results At one month the degree of neointimal hyperplasia was similar between the two sirolimus-eluting stent groups and was significantly less compared to BMS ((1.93±0.51) mm2, (1.57±0.69) mm2 vs. (4.45±1.05) mm2, P 〈0.05)At three months, PFSES maintained the low level of neointima ((2.41±0.99) mm2 vs. (4.32±1.16) mm2, P 〈0.05), whereas PCSES had developed significant neointimal proliferation similar to BMS. The inflammation level was significantly higher in PCSES when compared with BMS three months post-implantation (2.50±0.55 vs. 0.83±0.75, P 〈0.05) whereas PFSES showed a low level of inflammation comparable to PCSES (1.33±0.52 vs. 2.50±0.55, P 〈0.05). Conclusion The PFSES is effective and safe. and appears to be suoerior to standard PCSEs.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
Background:Permanent polymer drug eluting stents (PP-DES) may induce inflammation of the vessel wall due to the existence of the polymer,which may delay intimal healing.Polymer-free DES (PF-DES) that eliminate the pol...Background:Permanent polymer drug eluting stents (PP-DES) may induce inflammation of the vessel wall due to the existence of the polymer,which may delay intimal healing.Polymer-free DES (PF-DES) that eliminate the polymeric carrier may potentially lead to safer DES.However,the safety and efficacy of PF-DES remains controversial.Methods:Randomized controlled trials comparing PF-DES with PP-DES were searched in online database including MEDLINE,Excerpta Medica Database (EMBASE) and Cochrane Library.Studies reporting late lumen loss (LLL),all-cause death,myocardial infarction (MI),target lesion revascularization (TLR) and late stent thrombosis (LST) were enrolled and quantitatively analyzed.Results:Ten studies enrolling 6575 patients were included in this meta-analysis.The PF-DES showed a benefit in reducing all-cause death (OR =0.77,95% CI:0.61 to 0.98,P =0.03) and long-term LLL (weighted mean difference (WMD)-0.16 mm,95% CI:-0.22 to -0.11 mm,P < 0.001),while no superiority was found in reducing short-term LLL (WMD 0.03 mm,95% CI:-0.07-0.13 mm,P =0.57),MI (OR =1.12,95% CI:0.19 to 23.18,P=0.39),TLR (OR =1.19,95% CI:0.42 to 3.38,P=0.83)and LST (OR =0.92,95%CI:0.05 to 5.71,P =0.74).Conclusion:PF-DES showed benefits in reducing long-term LLL and mortality compared with PP-DES,but no superiority was found in short-term LLL,MI,TLR and LST.These findings provide a sound basis for the wide application of PF-DES in the future.展开更多
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 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 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.
基金This work was supported by the National Basic Research Program of China (No. 2013CB932602), the Program of Introducing Talents of Discipline to Universities (No. B14003), National Natural Science Foundation of China (Nos. 51527802 and 51232001), Beijing Municipal Science & Technology Commission, the Fundamental Research Funds for Central Universities.
文摘In this work, we developed a novel triboelectricity-assisted polymer-free method for the transfer of large-area chemical vapor deposited graphene films. With the assistance of electrostatic forces from friction-generated charges, graphene sheets were successfully transferred from copper foils to flexible polymer substrates. Characterization results confirmed the presence of high quality graphene with less defects and contaminations, compared to graphene transferred by conventional poly(methyl rnethacrylate)-mediated processes. In addition, the graphene samples possessed outstanding electrical transport capabilities and mechanical stability, when studied as electron transfer matrixes in graphene/ZnO hybrid flexible photodetectors. Our results showed a broad application potential for this transfer method in future flexible electronics and optoelectronics.
文摘Background Drug-eluting stents represent a major advance in interventional cardiology. However, the current drug- eluting stents have significant limitations. One of the major problems is very late stent thrombosis, which is likely caused by inflammation and a hypersensitivity reaction related to a polymer on the stent. A polymer-free sirolimus-eluting stent with a unique nano-porous surface has been developed. This study aimed to evaluate this novel polymer-free sirolimus- eluting stent for its efficacy and safety in a pig model. Methods Stents were directly coated with sirolimus (a drug concentration of 2.2 μg/mm2 on the stent surface). The polymer-free sirolimus-eluting stents (PFSES) were compared to standard polymer-coated sirolimus-eluting stents (PCSES) and bare-metal stents (BMS) in 18 pigs. Results At one month the degree of neointimal hyperplasia was similar between the two sirolimus-eluting stent groups and was significantly less compared to BMS ((1.93±0.51) mm2, (1.57±0.69) mm2 vs. (4.45±1.05) mm2, P 〈0.05)At three months, PFSES maintained the low level of neointima ((2.41±0.99) mm2 vs. (4.32±1.16) mm2, P 〈0.05), whereas PCSES had developed significant neointimal proliferation similar to BMS. The inflammation level was significantly higher in PCSES when compared with BMS three months post-implantation (2.50±0.55 vs. 0.83±0.75, P 〈0.05) whereas PFSES showed a low level of inflammation comparable to PCSES (1.33±0.52 vs. 2.50±0.55, P 〈0.05). Conclusion The PFSES is effective and safe. and appears to be suoerior to standard PCSEs.
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.
文摘Background:Permanent polymer drug eluting stents (PP-DES) may induce inflammation of the vessel wall due to the existence of the polymer,which may delay intimal healing.Polymer-free DES (PF-DES) that eliminate the polymeric carrier may potentially lead to safer DES.However,the safety and efficacy of PF-DES remains controversial.Methods:Randomized controlled trials comparing PF-DES with PP-DES were searched in online database including MEDLINE,Excerpta Medica Database (EMBASE) and Cochrane Library.Studies reporting late lumen loss (LLL),all-cause death,myocardial infarction (MI),target lesion revascularization (TLR) and late stent thrombosis (LST) were enrolled and quantitatively analyzed.Results:Ten studies enrolling 6575 patients were included in this meta-analysis.The PF-DES showed a benefit in reducing all-cause death (OR =0.77,95% CI:0.61 to 0.98,P =0.03) and long-term LLL (weighted mean difference (WMD)-0.16 mm,95% CI:-0.22 to -0.11 mm,P < 0.001),while no superiority was found in reducing short-term LLL (WMD 0.03 mm,95% CI:-0.07-0.13 mm,P =0.57),MI (OR =1.12,95% CI:0.19 to 23.18,P=0.39),TLR (OR =1.19,95% CI:0.42 to 3.38,P=0.83)and LST (OR =0.92,95%CI:0.05 to 5.71,P =0.74).Conclusion:PF-DES showed benefits in reducing long-term LLL and mortality compared with PP-DES,but no superiority was found in short-term LLL,MI,TLR and LST.These findings provide a sound basis for the wide application of PF-DES in the future.