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1.
目的 比较可降解涂层与永久性涂层药物洗脱支架治疗冠心病合并糖尿病患者的远期疗效及安全性.方法 回顾性分析2008年1月至2012年12月我院确诊为冠心病合并糖尿病并行经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)的患者364例,男性261例,女性103例,145例植入可降解涂层药物洗脱支架,219例植入永久性涂层药物洗脱支架;对比术后两组患者主要不良心血管事件(main adverse cardiac events,MACE)的发生情况.结果 两组患者在临床一般基线资料、冠脉病变特征等方面均无统计学差异(P>0.05).可降解涂层组与永久性涂层组相比,两组在心源性死亡(1.4% vs 1.9%)、非致死性心肌梗死(0.7% vs 0.9%)、支架内血栓(2.1% vs2.3%)、靶血管血运重建(2.8% vs 2.8%)方面差异均无统计学意义(P>0.05).结论 永久性涂层药物洗脱支架和可降解涂层药物洗脱支架治疗冠心病合并糖尿病患者均有效,且两者安全性无明显差异. 相似文献
2.
目的比较可降解涂层药物洗脱支架与永久涂层药物洗脱支架在冠状动脉粥样硬化性心脏病(简称冠心病)合并糖尿病患者中的应用疗效。方法回顾性分析240例择期行经皮冠状动脉介入术(PCI)置入药物洗脱支架治疗冠。0病合并糖尿病患者。其中112例患者置入可降解涂层药物洗脱支架(观察组),128例患者置入永久涂层药物洗脱支架(对照组),术后进行随访,观察患者的疗效及临床主要不良心脏事件的发生情况。结果平均随访时间(360±65)d。观察组与对照组在总死亡、靶病变重建、靶血管重建、支架内血栓形成及主要不良心脏事件等方面比较差异均无统计学意义(P〉0.05)。结论可降解涂层药物洗脱支架用于冠心病合并糖尿病患者PCI后近期疗效与永久涂层药物洗脱支架相当,其远期效果有待进一步研究。 相似文献
3.
目的对生物可降解聚合物涂层药物支架与非可降解药物洗脱支架应用于我国冠心病人群的安全有效性进行meta分析。方法通过计算机搜索国内外电子数据库,并结合文献追溯方式,收集已公开发表与生物可降解聚合物涂层药物支架(biodegradable polymer drug eluting stent,BPS)与永久聚合物涂层支架(permanent polymerdrug eluting stent,PPS)相关的临床对照研究资料,对随访末期主要不良心血管事件(major adverse cardiac events,MACE)、支架内血栓事件(stent thrombosis,ST)及支架内晚期管腔丢失(late lumen loss,LLL)情况进行meta分析,探讨BPS在我国冠心病人群中晚期应用的安全性及有效性。结果共纳入国内公开发表的研究共7篇文献,共有2 533名患者分别植入BPS及PPS。BPS与PPS两组之间,1年随访末期MACE发生差异无统计学意义(OR=0.94,95%CI:0.68~1.32,Z=0.34,P=0.74〉0.05),1年支架内血栓事件发生差异无统计学意义(OR=1.73,95%CI:0.59~5.04,Z=1.00,P=0.32〉0.05),随访末期血管造影支架内LLL发生无统计学差异(WMD=-0.02,95%CI:-0.24~0.19,Z=0.22,P=0.83〉0.05)。结论根据目前研究结果,BPS应用于中国人群其安全性并不劣于PPS,而以支架内LLL作为评价标准,BPS早期也并未表现出预期降低管腔丢失的优势。BPS的理论优越性尚需要随访时间更长、规模更大的临床研究来证实。 相似文献
4.
Background Drug eluting stents (DESs) made with biodegradable polymer have been developed in an attempt to improve clinical outcomes.However,the impact of biodegradable polymers on clinical events and stent thrombosis (ST) remains controversial.Methods We searched Medline,the Cochrane Library and other internet sources,without language or date restrictions for articles comparing clinical outcomes between biodegradable polymer DES and durable polymer DES.Safety endpoints were ST (definite,definite/probable),mortality,and myocardial infarction (MI).Efficacy endpoints were major adverse cardiac event (MACE) and target lesion revascularization (TLR).Results We identified 15 randomized controlled trials (n=17 068) with a weighted mean follow-up of 20.6 months.There was no statistical difference in the incidence of definite/probable ST between durable polymer-and biodegradable polymerDES; relative risk (RR) 0.83; 95% confidence interval (CI) 0.62-1.11; P=0.22.Biodegradable polymer DES had similar rates of definite ST (RR 0.94,95% CI 0.66-1.33,P=0.72),mortality (RR 0.94,95% C/0.82-1.09,P=0.43),MI (RR 1.08,95% CI 0.92-1.26.P=0.35),MACE (RR 0.99,95% CI 0.91-1.09,P=0.85),and TLR (RR,0.94,95% CI 0.83-1.06,P=0.30) compared with durable polymer DES.Based on the stratified analysis of the included trials,the treatment effect on definite ST was different at different follow-up times:≤1 year favoring durable polymer DES and 〉1 year favoring biodegradable polymer DES.Conclusions Biodegradable polymer DES has similar safety and efficacy for treating patients with coronary artery disease compared with durable polymer DES.Further data with longer term follow-up are warranted to confirm the potential benefits of biodegradable polymer DES. 相似文献
5.
在如今的老龄化社会中,冠心病已成为人类健康的一大杀手,血管支架作为心血管介入治疗的最主要的器械,其效能决定了介入手术的成败。冠状动脉冠脉支架的发展先后经历了裸金属支架、药物洗脱支架和生物可降解支架3个时代。该文通过归纳目前使用的生物可降解支架的临床试验,来阐述可降解冠脉支架大体的发展历程,指出目前疗效及所面临的难题,并对支架发展的未来作一展望。 相似文献
6.
Background Late stent thrombosis (LST) is still concerned by interventions cardiologists in daily clinical practice. This study aimed to compare the incidence of LST after implantation of different drug-eluting stents (DES) in coronary heart disease (CHD) patients in the real world.Methods From December 2001 to February 2009, a total of 11 875 consecutive CHD patients undergone DES implantation were enrolled in this single-center registery study. Patients with acute ST-segment elevation myocardial infarction, mixed DES implantation, restenosis lesions, and patients who could not take dual antiplatlet medication and those who were contraindicated for coronary interventional treatment were excluded. All patients were treated with completed dual antiplatelet medications for at least 9 months after DES deployment. The follow-up was completed by outpatient visits, letter correspondence, phone calls and coronary angiography. Definite LST was diagnosed auording to the Academic Research Consortium (ARC) definition.Results Cypher or Cypher Select stents were implanted in 4104 cases, Taxus or Taxus Liberty stents in 2271 cases and Firebird stents (Chinese rapamycin-eluting stents) in 5500 cases. One-year follow-up was completed in 9693 patients, including 3346 cases with Cypher or Cypher Select stents, 1529 cases with Taxus or Taxus Liberty stents and 4818 cases with Firebird stents. Two- and three-year follow-up results were obtained in 7133 and 4353 patients, respectively, including 2410 and 1760 cases with Cypher or Cypher Select stents, 1285 and 900 cases with Taxus or Taxus Liberty stents as well as 3438 and 1693 cases with Firebird stents. One-year follow-up results showed that the incidence of LST was 1.08% in patients with Cypher or Cypher Select stents, 1.24% in those with Taxus or Taxus Liberty stents and 0.71% in those with Firebird stents; there was no significant difference between those with Cypher or Cypher Select and Firebird stents, but there was significant difference between those with Taxus or Taxus Liberty and Firebird stents (P=0.044). The incidence of LST at the 2- and 3-year follow-up was 1.33% and 1.70% in those with Cypher or Cypher Select stents, 1.40% and 1.70% in those with Taxus or Taxus Liberty stents, and 0.83% and 0.95% in those with Firebird stents, respectively. There were no significant differences among the three groups.Conclusions This study indicates that first-generation DES are acceptable to treat complex coronary lesions, and there is no significant difference of LST for three different DES. 相似文献
7.
目的 比较生物可吸收支架与药物洗脱支架治疗心血管疾病的安全性和有效性。 方法 计算机检索中国生物医学文献服务系统(SinoMed)、万方、中国知网(CNKI)、维普(VIP)、PubMed、Medline、Embase数据库,检索年限为1980年1月至2018年10月,筛选出符合纳入标准的临床试验研究文献,采用R 3.5.1软件计算评价指标比值比( OR)及95%置信区间( CI),评估生物可吸收支架与药物洗脱支架治疗心血管疾病的安全性和有效性。 结果 最终纳入22项研究,包含33 570名研究对象。在合并的心脏冠状动脉疾病的临床试验随访结果中,生物可吸收支架相对于药物洗脱支架,主要的安全性指标、有效性指标差异均无统计学意义( P均>0.05),其中心源性死亡率合并 OR(95% CI)为1.01(0.88,1.16)、总体死亡率合并 OR(95% CI)为0.97(0.88,1.08)、心肌梗死发生率合并 OR(95% CI)为0.98(0.87,1.10)、靶病变血运重建率合并 OR(95% CI)为0.99(0.89,1.09)、靶血管血运重建率合并 OR(95% CI)为1.03(0.95,1.13)。针对生物可吸收支架的应用目的对各时期支架内血栓发生率的合并分析中,临床确诊或疑似支架内血栓发生率合并 OR(95% CI)为0.80(0.65,0.99),差异有统计学意义( P=0.042);早期支架内血栓发生率合并 OR(95% CI)为0.97(0.69,1.37),差异无统计学意义( P=0.906);晚期支架内血栓发生率合并 OR(95% CI)为0.61(0.43,0.86),差异有统计学意义( P=0.004)。 结论 在冠心病的治疗中,不能认为生物可吸收支架与药物洗脱支架存在安全性或有效性的差异,但生物可吸收支架可降低支架内血栓尤其是晚期血栓的发生风险。 相似文献
8.
目的:比较涂层可降解药物洗脱支架(Excel)与涂层不可降解药物洗脱支架(Partner)在冠状动脉疾病治疗中的近期疗效及安全性。方法:将1315例接受药物洗脱支架治疗的冠心病患者纳入此回顾性对照研究,其中Excel组498例,Partner组817例.观察术后1年内两组患者主要不良心脏事件(MACE)及支架内血栓事件发生情况。结果:两组患者在基线资料、冠脉病变特征等方面均无统计学差异(P〉0.05);两组患者平均置入支架直径[(2.97±0.39)mm vs(3.03±0.46)mm]及置入支架长度[(25.37±7.39)mm vs(24.57±7.11)mm]比较,差异均有统计学意义(P〈0.05)。尽管Excel组患者平均置入支架直径较小且支架长度偏长,但随访结果显示两组患者1年内主要不良心脏事件及支架内血栓事件发生情况差异均无统计学意义(2.41%vs2.69%,P〉0.05;0.60%vs0.86%,P〉0.05)。结论:涂层可降解与不可降解药物洗脱支架在冠状动脉疾病治疗中的近期疗效及安全性相似。 相似文献
9.
Background Drug-eluting stents(DES) with durable polymer have significantly reduced restenosis and target vessel revascularization compared with bare metal stents. Durable polymer has been linked with persistent inflammation of vessel wall and delayed endothelial healing that may increase the risk of late and very late stent thrombosis. This study sought to evaluate the efficacy and safety of HELLOS completed biodegradable polymer sirolimus-eluting stent (SES) in de novo coronary lesions.Methods Totally, 287 patients with one or two de novo coronary lesions (lesion length ≤38 mm and reference vessel diameter 2.5-4.0 mm) were enrolled in the HOPE study, a prospective, multicenter, randomized, non-inferiority trial. Patients were randomized to treatment either with HELIOS completed biodegradable polymer SES (n=142) or PARTNER durable polymer SES (n=145). The primary endpoint was angiographic in-stent late lumen loss (LLL) at 9-month follow-up. The secondary endpoint included stent thrombosis and major adverse cardiac events including cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR).Results The 9-month in-stent LLL in the HELIOS group was similar to the PARTNER group, (0.16±0.22) mm vs. (0.19±0.30) mm (P=0.28). The difference and 95% confidence interval were -0.03 (-0.09, 0.04), and the P value for non-inferiority 〈0.01. Major adverse cardiovascular event (MACE) occurred in 7.9% vs. 8.2%, MI in 2.4% vs. 3.0%, TLR in 5.5% vs. 3.0%, and stent thrombosis in 0 vs. 1.5%; and events were comparable between the HELIOS group and PARTNER aroup at three-year follow-up (all P 〉0.05). The three-year cardiac death was lower in the HELIOS group, butwith no significant difference, 0 vs. 3.0% (P=0.12). Conclusions In the HOPE trial, the novel completed biodegradable polymer SES HELIOS was non-inferior to the durable polymer SES PARTNER with respect to nine-month in-stent LLL in de novo coronary lesions. The incidence of other clin 相似文献
10.
Supported by growing evidence from randomized clinical trials and observational or registry studies,percutaneous coronary intervention (PCI) with implantation of drug-eluting stents (DES) has become the standard of care for coronary artery disease,because of reduced repeat intervention and improved clinical outcomes in comparison with bare metal stent.1-3Currently,majority of coronary artery disease patients with complicated lesion subsets or clinical conditions can be successfully treated with DES-based PCI with favorable results.4-6 In 2011,around 300000 PCI procedures have been performed in China,with the penetration rate of DES reaching beyond 90% in most of the centers. 相似文献
11.
目的 评估多药物支架植入术的近期疗效及安全性.方法 对我院从2004年6月到2005年12月共34例多个药物支架(≥3枚)植入术进行回顾性分析,对照组为单个支架植入组(n=64)和两支架植入组(n=53),随访术后6月冠状动脉内急性及亚急性血栓形成的发生率、再狭窄和心血管事件的发生率.结果 151例患者PCI治疗均成功.介入治疗1个月随访结果显示,多支架组、两支架组及单支架组均没有发生冠状动脉内血栓形成(P>0.05),介入治疗6个月随访结果显示,再狭窄及心血管事件发生率均无统计学差异(P>0.05).结论 多个药物支架植入治疗,并不增加近期血栓形成和心血管事件的发生率. 相似文献
12.
Background Some larger scale, randomized studies have demonstrated the superiority of drug-eluting stents (DES) over bare metal stents (BMS) for the treatment of acute myocardial infarction (AMI). This study aimed to investigate the impact of DES, in comparison with BMS, on the 2-year clinical outcomes in patients with ST-elevation myocardial infarction (STEMI).
Methods From January 2002 to December 2008, a total of 1301 consecutive STEMI patients treated with coronary stenting in Shenyang Northern Hospital were prospectively registered. Patients received BMS (n=868) or DES (n=435) implantation in the infarction related artery according to physician’s discretion. A propensity score analysis was performed and two well matched subgroups were selected (BMS, n=288; DES, n=288) to evaluate the 2-year clinical outcomes. The primary outcome was the occurrence of major adverse cardiac events (MACE), which was defined as a composite of all-cause death, myocardial infarction (MI), or target vessel revascularization (TVR).
Results Survival salvage analysis showed that 2-year cumulative hazards were not significantly different between the two groups with respect to TVR (2.8% vs. 3.1%, log-rank P=0.780), stent thrombosis (1.7% vs. 4.2%, log-rank P=0.079) and MACE (8% vs. 10.8%, log-rank P=0.236). Multivariate analysis showed that DES was an independent protective factor of MI (HR: 0.211, 95% CI: 0.049 to 0.908) and stent thrombosis (HR: 0.327, 95% CI: 0.107 to 0.994).
Conclusion DES was associated with similar 2-year clinical outcomes to those of BMS for the treatment of STEMI in daily practice. 相似文献
13.
目的评估使用非顺应性球囊后扩张对经置入药物洗脱支架冠状动脉粥样硬化性心脏病(以下简称冠心病)患者的疗效。方法回顾性分析2011年1月至2011年5月共356例行药物洗脱支架植入且使用非顺应性球囊后扩张的患者,采用倾向性评分抽取同期356例行药物洗脱支架植入术而未后扩张的患者与之1∶1匹配。结果 2组在年龄、性别、临床表现、主要危险因素及冠状动脉病变特征方面比较,差异无统计学意义(P>0.05),具有可比性。平均随访时间18个月,后扩张组主要不良心血管事件(major adverse cardiac events,MACE)明显低于未后扩张组(10.1%vs 15.7%,P=0.020),主要是靶血管重建(6.2%vs10.7%,P=0.010)、支架内血栓(1.1%vs 3.7%,P=0.030)发生率比较,差异有统计学意义(P<0.05),而心肌梗死(3.9%vs4.6%,P=0.700)、死亡(1.1%vs 1.7%,P=0.760)比较,差异没有统计学意义。结论冠心病患者置入药物洗脱支架后使用非顺应性球囊后扩张安全,可改善患者的临床预后。 相似文献
14.
Background Sirolimus-eluting stents (SES) are reported to be associated with reduced late lumen loss (LLL),resulting in less frequent restenosis when compared to bare-metal stent.The current study aime... 相似文献
15.
Background Previous studies indicated that long coronary lesions are one of the key predictors of drug-eluting stent (DES) failure.The purpose of this study was to evaluate the efficacy and the safety ... 相似文献
16.
目的评价国产药物洗脱支架(Firebird)临床应用的安全性和有效性。方法对110例冠心病患者置入Firebird支架治疗,术后对患者进行随访,观察有无胸痛复发、心电图异常改变、重要心脏不良事件发生等。结果110例患者共置入Firebird支架146枚,手术即刻成功率100%。对患者至少随访3个月,平均8个月,无重要心脏不良事件发生,38例患者6个月后复查造影2例出现再狭窄,再狭窄率5.2%。结论Firebird支架置入即刻成功率高,能有效预防PCI术后再狭窄,治疗冠心病安全、有效。 相似文献
17.
Background Drug-eluting stents (DES) have been shown to significantly reduce clinical events and angiographic restenosis in the treatment of coronary artery disease (CAD). This study was conducted to assess the long-term efficacy and safety of the polymer-based sirolimus-eluting cobalt-chromium Firebird 2TM stents in the treatment of patients with CAD. Methods This first-in-man study using the Firebird 2TM stent is a prospective, historically-controlled multicenter clinical study, which enrolled 67 patients with CAD who were treated with the sirolimus-eluting cobalt-chromium stent (Firebird 2TM, Microport Shanghai, Firebird 2 group), compared to another 49 patients treated with a bare cobalt alloy stent (Driver, Medtronic, control group). Continued 2-year clinical follow-up was performed after getting the initial 6-month angiographic and 1-year clinical follow-up. The incidence of major adverse cardiac events (MACE) including cardiac death, reinfarction and target lesion revascularization (TLR) and stent thrombosis were compared between the two groups. Results All patients in the Firebird 2 group (100.0%) and 48 patients in the control group (98.0%) completed the 2-year clinical follow-up. At the 1-year follow-up the use of the Firebird 2 stent was highly effective, resulting in a significant 94% decrease of TLR (26.5% in the control group and 1.5% in the Firebird 2 group, P〈0.0001). A significant difference in TLR was maintained at 2-year follow-up, Firebird 2 group 1.5% and the control group 31.3% (P〈0.0001). Between 1- and 2-year post-stenting, no more TLR occurred in the Firebird 2 group compared with two cases in the control group (P〉0.05). There was a 1.5% incidence of MACE at 1- and 2-year follow-up in the Firebird 2 group, compared with 26.5% and 33.3% in the control group, respectively (all P〈0.0001). The cumulative 1- and 2-year MACE free survival rates were 98.5% in the Firebird 2 group vs 73.5% and 66.7% in the control group (log rank P〈0.000 相似文献
18.
Background Restenosis of bare-metal stents (BMS) and drug-eluting stents (DES) has been increasingly treated with sirolimus-eluting stents (SES), but the long-term outcomes are unknown.
Methods In our study, 388 consecutive patients (144 DES restenosis and 244 BMS restenosis) with 400 lesions (147 DES restenosis and 253 BMS restenosis) treated with SES were included. The rates of target lesion revascularization (TLR) and major adverse cardiac events (MACE) at 42 months were analyzed.
Results At the mean follow-up of 42 months, the rates of death (3.5% vs. 3.3%, P=1.000) and myocardial infarction (2.8% vs. 1.2%, P=0.431) in the DES group and BMS group were comparable. Compared with the BMS group, ischemia-driven TLR occurred with a higher frequency in the DES group (18.8% vs.10.7%, P=0.024). This translated into an increased rate of MACE in the DES group (22.2% vs. 14.0%, P=0.034). Stent thrombosis occurred with a similar frequency in both groups (2.8% vs. 1.6%, P=0.475). Multivariate analysis showed that DES restenosis ( OR=1.907, 95% CI 1.108 –3.285, P=0.020) and smoking ( OR=2.069; 95% CI 1.188–3.605; P=0.010) were independent predictors of MACE.
Conclusions Although SES implantation appears to be safe and effective, it was associated with higher TLR recurrence for DES than BMS restenosis. 相似文献
19.
目的通过复查冠脉造影观察国产药物洗脱支架择期治疗冠心病的临床疗效。方法择期接受Firebird支架(雷帕霉素洗脱支架)治疗的57例冠心病患者,78支病变血管的90处罪犯病变置入98枚Firebird支架,随访6~9个月并复查冠脉造影。结果支架内再狭窄率为3.51%。结论国产药物洗脱支架具有良好的临床疗效。 相似文献
20.
Background The durable presence of polymer coating on drug-eluting stent (DES) surface may be one of the principal reasons for stent thrombosis. The long-term coronary arterial response to biodegradable polymer-coated sirolimus-eluting stent (BSES) in vivo remained unclear.
Methods Forty-one patients were enrolled in this study and virtual histology intravascular ultrasound (VH-IVUS) was performed to assess the native artery vascular responses to BSES compared with durable polymer-coated SES (DSES) during long-term follow-up (median: 8 months). The incidence of necrotic core abutting to the lumen was evaluated at follow-up.
Results With similar in-stent late luminal loss (0.15 mm (0.06–0.30 mm) vs. 0.19 mm (0.03–0.30 mm), P=0.772), the overall incidence of necrotic core abutting to the lumen was significantly less in BSES group than in DSES group (44% vs. 63%, P <0.05) (proximal 18%, stented site 14% and distal 12% in BSES group, proximal 19%, stented site 28% and distal 16% in DSES group). The DSES-treated segments had a significant higher incidence of necrotic core abutting to the lumen through the stent struts (73% vs. 36%, P <0.01). In addition, more multiple necrotic core abutting to the lumen was observed in DSES group (overall: 63% vs. 36%, P <0.05). Furthermore, when the stented segments with necrotic core abutting to the lumen had been taken into account only, DSES-treated lesions tended to contain more multiple necrotic core abutting to the lumen through the stent struts than BSES-treated lesions (74% vs. 33%), although there was no statistically significant difference between them (P=0.06).
Conclusions By VH-IVUS analysis at follow-up, a greater frequency of stable lesion morphometry was shown in lesions treated with BSESs compared with lesions treated with DSESs. The major reason was BSES produced less toxicity to the arterial wall and facilitated neointimal healing as a result of polymer coating on DES surface biodegraded as time went by. 相似文献
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