三种药物支架应用于冠脉长血管病变、小血管病变和多支血管病变的安全性和有效性研究
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摘要
目的
将3种冠脉内药物支架应用于治疗冠心病患者的冠脉长节段、小血管和多支病变,分析3种支架的疗效和安全性,为PCI术中合理选择冠脉支架提供科学依据。
方法
连续选取2010年10月～2011年10月收住昆明医学院附一院,因心绞痛或心肌梗死接受冠脉造影证实靶血管狭窄≥70%的268例冠心病患者(男性185例,女性83例,年龄最大75岁,最小29岁,平均62.19±10.51岁)。按病变特征分为小血管病变、长血管病变和多支血管病变3组。常规方法实施PCI,随机选用美国雅培公司XIENCETM V EECSS系列依维莫司涂层支架(X支架)、北京医疗器械股份有限公司乐普PARTNERTM雷帕霉素洗脱支架(P支架)、大连垠艺生物材料研发公司垠艺(?)微盲孔载药紫杉醇支架(Y支架)。记录患者身高、体重、肝功、肾功、血脂、心肌酶、C-反应蛋白、凝血、心电图、心脏彩超等基线资料,病变类型、支架类型、支架释放压力等指标。术后至少随访6月,观察靶血管.竹重建(TVR)、再发心肌梗死、心源性死亡、脑卒中等事件,并记录以上事件的复合终点(MACE)。数据采用SPSS17.0软件包处理,P<0.05判为差异有显著性。
结果
1.268例患者者中,79例(30.0%)小血管病变含男性54例,女性25例,年龄最大74岁,最小40岁,平均60.20±10.65岁；长血管病变91例(34.0%)含男性60例,女性31例,年龄最大73岁,最小38岁,平均61.80±10.18岁；多支血管病变98例(36.0%)含男性71例,女性27例,年龄最大75岁,最小29岁,平均58.64±11.61岁；3组间基线特征未见统计学差异。PCI手术均成功(100%),PCI术后目测法靶血管部位均狭窄≤20%或术后复查冠造达TIMI血流3级。3种-药物涂层支架的植入技术相同,球囊扩张压力无统计学差异(P=0.856)。
2.268例患者植入的399枚支架中,X支架136枚(34.0%),P支架140枚(35.0%),Y支架123枚(31.0%),支架使用频度差异无显著性(p=0.408)。小血管病变植入的79枚支架中X支架26枚(33.0%),P支架25枚(32.0%),Y支架28枚(35.0%),p=0.876；长血管病变植入的131枚支架中X支架38枚(29.0%),P支架51枚(39.0%),Y支架42枚(32.0%),p=0.220；多支血管病变植入的189枚支架中X支架72枚(38.0%),P,支架64枚(34.0%),Y支架53枚(28.0%),p=0.113。
3.完成PCI术后随访的261例(97%)患者,不良事件24例(9.3%)的排序从高到低依次为靶血管再重建8例(3.1%),脑卒中7例(2.7%),再发心肌梗死6例(2.3%),心源性死亡3例(1.2%)(p<0.05)。靶血管再重建X、P、Y支架分别为0例(%)、4例(1.53%)、4例(1.53%),p=0.038。脑卒中X、P、Y支架分别为0例(0%)、3例(0.15%)、4例(1.53%),p=0.054。再发心肌梗死X、P、Y支架分别为0例(0%)、2例(0.77%)、4例(1.53%),p=0.062。心源性死亡X、P、Y支架分别为0例(%)、2例(0.77%)、1例(0.38%),p=0.249。
4.小血管病变组随访：靶血管再重建(TVR)中X支架0例(0%),P支架1例(4%),Y支架1例(4%),p=0.438。再发心肌梗死中X支架0例(0%),P支架0例(0%),Y支架1例(4%),p=0.329。心源性死亡中X支架0例(0%),P支架1例(4%),Y支架1例(4%),p=0.438。脑卒中中X支架0例(0%),P支架1例(4%),Y支架0例(()%),p=0.329。复合终点事件中X支架0例(0%),P支架3例(12%),Y支架3例(12%),X支架事件率较低,但差异无统计学意义(p=0.077)。
5.长血管病变组随访：靶血管再重建(TVR)中X支架0例(0%),P支架1例(3.3%),Y支架2例(6.7%),p=0.242。再发心肌梗死中X支架0例(0%),P支架1例(3.3%),Y支架1例(3.3%),P=0.439。心源性死亡中X支架0例(0%),P支架1例(3.3%),Y支架()例(0%),p=0.330。脑卒中中X支架0例(0%),P,支架0例(0%),Y支架1例(13.3%),p=0.330。复合终点中X支架0例(0%),P支架3例(10%),Y支架4例(13.3%),X支架事件率较低(p=0.047)。
6.多支血管病变组随访：靶血管再重建(TVR)中X支架0例(0%),P支架2例(6.3%),Y支架1例(3.1%),p=0.242。再发心肌梗死中X支架0例(0%),P支架1例(3.1%),Y支架2例(6.3%),p=0.242。3种支架均无心源性死亡发生(0%)。脑卒中中X支架0例(0%),P支架2例(6.3%),Y支架3例(9.4%),p=0.110。复合终点中X支架0例(0%),P支架5例(15.6%),Y支架6例(18.8%),X支架事件率较低(p=0.008)。
结论
1.PCI术后6月随访,分别植入XIENCETM V系列、乐普系列、垠艺系列药物涂层支架治疗冠心病均获得满意疗效,且新出现的乐普系列、垠艺系列两类国产支架与美国雅培公司支架比较疗效的差异无显著性。
2.3种支架应用于冠脉小血管病变的不良事件发生率无显著性差异,提示2种新的国产药物支架应用于冠脉小血管病变安全。
3.乐普系列、垠艺系列药物支架应用于冠脉长病变和多支病变,虽各种事件的单独发生率与雅培支架无统计学差异,但MACE事件率高于雅培支架,提示这2种国产药物支架似需进一步改进。
4.PCI手术中植入3种药物涂层支架所需的操作技术相同,释放支架所需球囊扩张压力的差异无显著性,提示应用2种国产药物支架不会增加PCI手术难度。
5.鉴于乐普支架和垠艺支架用于冠心病患者PCI手术高效、不良事件发生率低、植入操作无特殊要求、价格低于进口支架等优势,符合中国国情,虽与进口药物支架存在差距,似仍可在中国冠心病需PCI治疗的人群中推广应用。
Objective
To compare the safety and efficiency of three different drug eluting stents: everolimus-eluting stents (XIENCETM V EECSS),rampamycin-eluting stents(Lepu PARTNER TM)and Paclitaxel-eluting stents (Yin Yi(?) micro blind hole-drug coronary stents) in coronary long lesion, small vesscle and multi-vesscle disease using target vessel revascularization, reinfarction, cardiac death and stroke rate at6month after percutaneous coronary intervention (PCI).
Method
From October2010to October2011,268patients with stenosis≥70%in any of main coronary artery determined by angiography were divided into long lesion, small vessel and multi-vesscle disease group. Patients in each group were randomized to receiving any of the three stents:XIENCETM V EECSS(evrolimus leluting stents, Abbott Corporation, USA), Yin Yi(?)(Paclitaxel micro blind hole-drug coronary stents. YinYI Biomaterial Corporation Dalian Liaoning China) or Lepu PARTNERTM drug-eluting stents(Beijing Medical Equipment Corporation). Baseline characteristics and details in PCI procedure were recorded for each patient. Follow-up was performed at6months after PCI, target vesscle revascularization (TVR). reinfarction, cardiac death, stroke and major adverse cardiac events (MACE) rate were compared with each group among three different stents.Statistic analyses were performed using SPSS17.0, two-tailed p<0.05was defined as significant.
Results
Among268patients recruited,79(54male with mean age60.20±10.65),91(60male with mean age61.80±10.18) and98(71male with mean age58.64±11.61) patients were divided small vessel, long lesion and multi-vesscle group respectively according to angiographic characteristics. Within each group, there were no significant differences among patients in different stents subgroup in terms of baseline characteristics. Procedure succeccd rate was100%. After PCI, the target vessel stenosis≤20%or after review of Coronary angiography were TIMI flow3with Using the visual method.
They were implanted stents for399in268patients, usage of X, P and Y stents were34%,35%and31%, p=0.408; The mean stents used in each patients were comparable among3groups:In small disease group, usage of X, P and Y stents were33%,32%and35%, p=0.876; In long lesion group, usage of X, P and Y stents were29%,39%and32%, p=0.220; In multi-vesscle disease group, usage of X, P and Y stents were38%,34%and28%, p=0.113.
After PCI, the three drug eluting stents were compared in261patients. The total of events rates in the9.3%.High to low in the order of TVR3.1%, stroke2.7%, reinfarction2.3%, or cardiac death1.2%.They were significant differences(p<0.05). Amo-ng TVR(0vs.1.53vs.1.53%) XIENCETM V, Lepu PARTNER and YinYi(?) stents r-espectively,
p=0.038), stroke(0vs.0.15vs.1.53%, p=0.054), reinfarction(0vs.0.77vs.1.53%, p=0.062), or cardiac death(0vs.0.77vs.0.38%, p=0.249).
In small vesscle diasease group, there were no significant differences in TVR(0vs.4vs.4%in XIENCETM V, Lepu PARTNER and YinYi(?) stents respectively, p=0.438) reinfarction(0vs.0vs.4%, p=0.329), cardiac death(0vs.4vs.4%, p=0.438) or stroke(0vs.4vs.0%, p=0.329) within different stents. However, MACE was lower in the patients implanted XIENCETM V stents(0vs.12vs.12%in XIENCETM V, Lepu PARTNER and Yin Yi (?)stents respectively, p=0.077).
In long lesion group, there were no significant differences in TVR(0vs.3.3vs.6.7%in XIENCETM V, Lepu PARTNER and Yin Yi (?)stents respectively, p=0.242), reiniarction(0vs.3.3vs.3.3%, p=0.439), cardiac death(0vs.3.3vs.0%, p=0.330) or strokc(0vs.0vs.3.3%. p=0.330) within different stents. However, MACE was lower in the patients implanted XIENCETM V stents(0vs.12vs.12%in XIENCETM V, Lepu PARTNER and Yin Yi(?) stents respectively, p=0.047).
In multi-vesscle diasease group, there were no significant differences in TVR(0vs.6.3vs.3.1%in XIENCETM V, Lepu PARTNER and Yin Yi(?) stents respectively, p=0.242) reinfarction(0vs.3.1vs.6.3%, p=0.242), cardiac death(0vs.0vs.0%, p=0) or stroke(0vs.6.3vs.9.4%, p=0.110) within different stents. However, MACE was lower in the patients implanted XIENCETM V stents(0vs.15.6vs.18.8%in XIENCETM V, Lepu PARTNER and Yin Yi(?) stents respectively, p=0.008).
Conclusion
1. At6months after PCI, the rates of TVR, reinfarction, cardiac death and stroke were comparable among XIENCETM V EECSS, Lepu PARTNERTM and Yin Yi(?) micro blind hole-drug coronary stents in patients with long lesion, small vesscle disease or multi-vesscle disease. They were content with curative effect and were no difference.
2. The events rates were comparable among yinyi, XIENCETM V EECSS and lepu stents, but were no significant difference, which indicated the safety of these two stents made in china with the small vesscle disease.
3. The solo event rate was no significant difference among yinyi, XIENCETM V EECSS and lepu stents with long lesion and multi-vesscle disease. The two stents made in china were higher than Xience stents in the MACE, which indicated the two stents made in china were become better further.
4. Three stents were implanted in the PCI and the procedure is alike. There were no difference of inflation pressre the three stents, which indicated the difficulty in procedure were comparable.
5.They were high performance, the rate of adverse event was lower, procedure is simple and price in cheap with the two stents made in china. They were applicated to spread patients in coronary heart disease in the china.
将3种冠脉内药物支架应用于治疗冠心病患者的冠脉长节段、小血管和多支病变,分析3种支架的疗效和安全性,为PCI术中合理选择冠脉支架提供科学依据。
方法
连续选取2010年10月～2011年10月收住昆明医学院附一院,因心绞痛或心肌梗死接受冠脉造影证实靶血管狭窄≥70%的268例冠心病患者(男性185例,女性83例,年龄最大75岁,最小29岁,平均62.19±10.51岁)。按病变特征分为小血管病变、长血管病变和多支血管病变3组。常规方法实施PCI,随机选用美国雅培公司XIENCETM V EECSS系列依维莫司涂层支架(X支架)、北京医疗器械股份有限公司乐普PARTNERTM雷帕霉素洗脱支架(P支架)、大连垠艺生物材料研发公司垠艺(?)微盲孔载药紫杉醇支架(Y支架)。记录患者身高、体重、肝功、肾功、血脂、心肌酶、C-反应蛋白、凝血、心电图、心脏彩超等基线资料,病变类型、支架类型、支架释放压力等指标。术后至少随访6月,观察靶血管.竹重建(TVR)、再发心肌梗死、心源性死亡、脑卒中等事件,并记录以上事件的复合终点(MACE)。数据采用SPSS17.0软件包处理,P<0.05判为差异有显著性。
结果
1.268例患者者中,79例(30.0%)小血管病变含男性54例,女性25例,年龄最大74岁,最小40岁,平均60.20±10.65岁；长血管病变91例(34.0%)含男性60例,女性31例,年龄最大73岁,最小38岁,平均61.80±10.18岁；多支血管病变98例(36.0%)含男性71例,女性27例,年龄最大75岁,最小29岁,平均58.64±11.61岁；3组间基线特征未见统计学差异。PCI手术均成功(100%),PCI术后目测法靶血管部位均狭窄≤20%或术后复查冠造达TIMI血流3级。3种-药物涂层支架的植入技术相同,球囊扩张压力无统计学差异(P=0.856)。
2.268例患者植入的399枚支架中,X支架136枚(34.0%),P支架140枚(35.0%),Y支架123枚(31.0%),支架使用频度差异无显著性(p=0.408)。小血管病变植入的79枚支架中X支架26枚(33.0%),P支架25枚(32.0%),Y支架28枚(35.0%),p=0.876；长血管病变植入的131枚支架中X支架38枚(29.0%),P支架51枚(39.0%),Y支架42枚(32.0%),p=0.220；多支血管病变植入的189枚支架中X支架72枚(38.0%),P,支架64枚(34.0%),Y支架53枚(28.0%),p=0.113。
3.完成PCI术后随访的261例(97%)患者,不良事件24例(9.3%)的排序从高到低依次为靶血管再重建8例(3.1%),脑卒中7例(2.7%),再发心肌梗死6例(2.3%),心源性死亡3例(1.2%)(p<0.05)。靶血管再重建X、P、Y支架分别为0例(%)、4例(1.53%)、4例(1.53%),p=0.038。脑卒中X、P、Y支架分别为0例(0%)、3例(0.15%)、4例(1.53%),p=0.054。再发心肌梗死X、P、Y支架分别为0例(0%)、2例(0.77%)、4例(1.53%),p=0.062。心源性死亡X、P、Y支架分别为0例(%)、2例(0.77%)、1例(0.38%),p=0.249。
4.小血管病变组随访：靶血管再重建(TVR)中X支架0例(0%),P支架1例(4%),Y支架1例(4%),p=0.438。再发心肌梗死中X支架0例(0%),P支架0例(0%),Y支架1例(4%),p=0.329。心源性死亡中X支架0例(0%),P支架1例(4%),Y支架1例(4%),p=0.438。脑卒中中X支架0例(0%),P支架1例(4%),Y支架0例(()%),p=0.329。复合终点事件中X支架0例(0%),P支架3例(12%),Y支架3例(12%),X支架事件率较低,但差异无统计学意义(p=0.077)。
5.长血管病变组随访：靶血管再重建(TVR)中X支架0例(0%),P支架1例(3.3%),Y支架2例(6.7%),p=0.242。再发心肌梗死中X支架0例(0%),P支架1例(3.3%),Y支架1例(3.3%),P=0.439。心源性死亡中X支架0例(0%),P支架1例(3.3%),Y支架()例(0%),p=0.330。脑卒中中X支架0例(0%),P,支架0例(0%),Y支架1例(13.3%),p=0.330。复合终点中X支架0例(0%),P支架3例(10%),Y支架4例(13.3%),X支架事件率较低(p=0.047)。
6.多支血管病变组随访：靶血管再重建(TVR)中X支架0例(0%),P支架2例(6.3%),Y支架1例(3.1%),p=0.242。再发心肌梗死中X支架0例(0%),P支架1例(3.1%),Y支架2例(6.3%),p=0.242。3种支架均无心源性死亡发生(0%)。脑卒中中X支架0例(0%),P支架2例(6.3%),Y支架3例(9.4%),p=0.110。复合终点中X支架0例(0%),P支架5例(15.6%),Y支架6例(18.8%),X支架事件率较低(p=0.008)。
结论
1.PCI术后6月随访,分别植入XIENCETM V系列、乐普系列、垠艺系列药物涂层支架治疗冠心病均获得满意疗效,且新出现的乐普系列、垠艺系列两类国产支架与美国雅培公司支架比较疗效的差异无显著性。
2.3种支架应用于冠脉小血管病变的不良事件发生率无显著性差异,提示2种新的国产药物支架应用于冠脉小血管病变安全。
3.乐普系列、垠艺系列药物支架应用于冠脉长病变和多支病变,虽各种事件的单独发生率与雅培支架无统计学差异,但MACE事件率高于雅培支架,提示这2种国产药物支架似需进一步改进。
4.PCI手术中植入3种药物涂层支架所需的操作技术相同,释放支架所需球囊扩张压力的差异无显著性,提示应用2种国产药物支架不会增加PCI手术难度。
5.鉴于乐普支架和垠艺支架用于冠心病患者PCI手术高效、不良事件发生率低、植入操作无特殊要求、价格低于进口支架等优势,符合中国国情,虽与进口药物支架存在差距,似仍可在中国冠心病需PCI治疗的人群中推广应用。
Objective
To compare the safety and efficiency of three different drug eluting stents: everolimus-eluting stents (XIENCETM V EECSS),rampamycin-eluting stents(Lepu PARTNER TM)and Paclitaxel-eluting stents (Yin Yi(?) micro blind hole-drug coronary stents) in coronary long lesion, small vesscle and multi-vesscle disease using target vessel revascularization, reinfarction, cardiac death and stroke rate at6month after percutaneous coronary intervention (PCI).
Method
From October2010to October2011,268patients with stenosis≥70%in any of main coronary artery determined by angiography were divided into long lesion, small vessel and multi-vesscle disease group. Patients in each group were randomized to receiving any of the three stents:XIENCETM V EECSS(evrolimus leluting stents, Abbott Corporation, USA), Yin Yi(?)(Paclitaxel micro blind hole-drug coronary stents. YinYI Biomaterial Corporation Dalian Liaoning China) or Lepu PARTNERTM drug-eluting stents(Beijing Medical Equipment Corporation). Baseline characteristics and details in PCI procedure were recorded for each patient. Follow-up was performed at6months after PCI, target vesscle revascularization (TVR). reinfarction, cardiac death, stroke and major adverse cardiac events (MACE) rate were compared with each group among three different stents.Statistic analyses were performed using SPSS17.0, two-tailed p<0.05was defined as significant.
Results
Among268patients recruited,79(54male with mean age60.20±10.65),91(60male with mean age61.80±10.18) and98(71male with mean age58.64±11.61) patients were divided small vessel, long lesion and multi-vesscle group respectively according to angiographic characteristics. Within each group, there were no significant differences among patients in different stents subgroup in terms of baseline characteristics. Procedure succeccd rate was100%. After PCI, the target vessel stenosis≤20%or after review of Coronary angiography were TIMI flow3with Using the visual method.
They were implanted stents for399in268patients, usage of X, P and Y stents were34%,35%and31%, p=0.408; The mean stents used in each patients were comparable among3groups:In small disease group, usage of X, P and Y stents were33%,32%and35%, p=0.876; In long lesion group, usage of X, P and Y stents were29%,39%and32%, p=0.220; In multi-vesscle disease group, usage of X, P and Y stents were38%,34%and28%, p=0.113.
After PCI, the three drug eluting stents were compared in261patients. The total of events rates in the9.3%.High to low in the order of TVR3.1%, stroke2.7%, reinfarction2.3%, or cardiac death1.2%.They were significant differences(p<0.05). Amo-ng TVR(0vs.1.53vs.1.53%) XIENCETM V, Lepu PARTNER and YinYi(?) stents r-espectively,
p=0.038), stroke(0vs.0.15vs.1.53%, p=0.054), reinfarction(0vs.0.77vs.1.53%, p=0.062), or cardiac death(0vs.0.77vs.0.38%, p=0.249).
In small vesscle diasease group, there were no significant differences in TVR(0vs.4vs.4%in XIENCETM V, Lepu PARTNER and YinYi(?) stents respectively, p=0.438) reinfarction(0vs.0vs.4%, p=0.329), cardiac death(0vs.4vs.4%, p=0.438) or stroke(0vs.4vs.0%, p=0.329) within different stents. However, MACE was lower in the patients implanted XIENCETM V stents(0vs.12vs.12%in XIENCETM V, Lepu PARTNER and Yin Yi (?)stents respectively, p=0.077).
In long lesion group, there were no significant differences in TVR(0vs.3.3vs.6.7%in XIENCETM V, Lepu PARTNER and Yin Yi (?)stents respectively, p=0.242), reiniarction(0vs.3.3vs.3.3%, p=0.439), cardiac death(0vs.3.3vs.0%, p=0.330) or strokc(0vs.0vs.3.3%. p=0.330) within different stents. However, MACE was lower in the patients implanted XIENCETM V stents(0vs.12vs.12%in XIENCETM V, Lepu PARTNER and Yin Yi(?) stents respectively, p=0.047).
In multi-vesscle diasease group, there were no significant differences in TVR(0vs.6.3vs.3.1%in XIENCETM V, Lepu PARTNER and Yin Yi(?) stents respectively, p=0.242) reinfarction(0vs.3.1vs.6.3%, p=0.242), cardiac death(0vs.0vs.0%, p=0) or stroke(0vs.6.3vs.9.4%, p=0.110) within different stents. However, MACE was lower in the patients implanted XIENCETM V stents(0vs.15.6vs.18.8%in XIENCETM V, Lepu PARTNER and Yin Yi(?) stents respectively, p=0.008).
Conclusion
1. At6months after PCI, the rates of TVR, reinfarction, cardiac death and stroke were comparable among XIENCETM V EECSS, Lepu PARTNERTM and Yin Yi(?) micro blind hole-drug coronary stents in patients with long lesion, small vesscle disease or multi-vesscle disease. They were content with curative effect and were no difference.
2. The events rates were comparable among yinyi, XIENCETM V EECSS and lepu stents, but were no significant difference, which indicated the safety of these two stents made in china with the small vesscle disease.
3. The solo event rate was no significant difference among yinyi, XIENCETM V EECSS and lepu stents with long lesion and multi-vesscle disease. The two stents made in china were higher than Xience stents in the MACE, which indicated the two stents made in china were become better further.
4. Three stents were implanted in the PCI and the procedure is alike. There were no difference of inflation pressre the three stents, which indicated the difficulty in procedure were comparable.
5.They were high performance, the rate of adverse event was lower, procedure is simple and price in cheap with the two stents made in china. They were applicated to spread patients in coronary heart disease in the china.
引文
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