药物洗脱支架在高龄患者的应用：早期和中期结果,独家资讯,医心网

2008-05-06 17:48:28 by: doctor2

DES Effective in Very Elderly, Adverse Outcomes Age-Driven 高龄患者应用DES有效，但年龄催生不良事件   刊登在2008年4月份《美国心脏杂志》的一项新研究表明，与年轻患者相比，高龄患者（≥80岁）应用DES治疗手术操作成功率高，血运重建率相似，但是不良事件率明显高于置入DES的年轻患者。   美国Mayo Clinic （罗彻斯特, 明尼苏达州）的Pieter Vlaar教授研究组强调，与年轻患者相比，高龄患者手术操作成功率高（97%），但不良事件发生率更高。   在2003-2005年间，这项单中心、回顾性研究连续观察了2,453例在美国Mayo Clinic 置入DES的患者，当按年龄对患者进行分组后，研究人员分析了12个月结果（表1）。另外，高龄患者院内MACE率更高（OR 3.18; 95%CI 1.46-6.96, P=0.004）。高龄患者通常合并多种疾病，发病更紧急，冠脉病变更广泛，与年轻患者群相比，女性高龄患者居多。 <A href="http://www.ccheart.com.cn/supersite/batch.download.php?aid=499" target=_blank><IMG src="http://www.ccheart.com.cn/supersite/attachments/2008/05/18884_200805081340241.jpg" border=0></A>   年龄本身即是最大的危险因素   通过对明尼苏达州患者群的研究发现，尽管在接受DES的PCI术后，80岁以上的患者更可能发生不良事件，包括死亡，但是置入DES后的八旬患者预期寿命与相同年龄或性别的普通高龄老人很相似。   作者写道：“类似的存活时间表明，接受DES的PCI治疗是值得接受的，尤其是患者为了提高生活质量和改善症状，而不是延长寿命。”   在TCTMD电话采访中，Jeffrey Moses 教授说该研究代表了“一个非常独特的数据组，产生了良好的结果。”他认为这项研究提供了许多关于高龄患者的宝贵数据，这样的患者通常是不会被入选到随机试验中去的。“你可以看到，更高年龄的患者却没有发生过多的死亡事件，这项声明相当有意义：患者可从置入DES中受益，伴随低TLR率，高（操作）成功率和略微增高的支架血栓——而且通常是因操作引起的亚急性血栓。”Moses教授说。   高龄仍旧面临难关 Moses教授说，高龄患者将继续面临一些突出问题：   •更可能并发多种疾病，如肾病 •更弥漫的动脉粥样硬化 •更严重的动脉钙化 •因弥漫性疾病而易发中风   他解释道：“高龄患者是极有挑战性的亚组患者，更重要的是，当症状明显时，他们通常会来求助介入医生，因为选择PCI会使他们提高生活质量。”   然而，关于80岁以上的患者行PCI的数据很少，这是因为他们通常没有被选入研究。Moses教授认为他们（高龄患者）应该被入选到更多的随机试验中，但目前，这是不可能的，因为这些患者会影响统计结果。“这些重要试验的问题在于，厂商不希望因年龄因素增加的死亡率影响器械试验的效果。”他说，“这就是为什么高龄患者通常被排除：在一个样本量很小的研究组中，当存在细微的不均衡结果时，出现一个沉重的不良事件就可以将结论推向另一边。”   来源：<A href="http://www.tctmd.com">www.tctmd.com</A>   （医心网编辑刘瑞琦编译付世娜审校）   DES Effective in Very Elderly, Adverse Outcomes Age-Driven By Kiersten Feil A new study in the April issue of the American Heart Journal suggests that drug-eluting stents (DES) in octogenarians are associated with high procedural success rates and comparable revascularization rates to younger patients. However, adverse events are significantly higher among this subset of DES patients than their younger counterparts. Researchers led by Pieter Vlaar, MD, of the Mayo Clinic (Rochester, MN), stressed that the high procedural success rate (97%) occurred despite the higher risk profile of the very elderly compared with younger patients. The single-center, retrospective study examined 2,453 consecutive patients who underwent DES implantation at the Mayo Clinic between 2003 and 2005. After patients were classified according to age groups (≤79 and ≥80 years of age), researchers analyzed outcomes at 12 months (table 1). In addition, very old age was associated with higher in-hospital MACE rates (OR 3.18; 95% CI 1.46-6.96, P=0.004). Octogenarians had more comorbid conditions, more urgent presentation, more extensive coronary artery disease, and were more likely to be women than younger patients. Age Itself is Biggest Risk Factor Despite the finding that patients age 80 and older are more likely to suffer adverse events, including death, following PCI with DES, the expected survival of octogenarians who received DES was similar to the age-matched and sex-matched life expectancy of the general Minnesota population. The authors write, “This similar survival expectancy suggests that the survival after PCI with DES is acceptable, especially because PCI in the elderly is performed for quality of life and symptom improvement, and not for prolongation of life.” In a telephone interview with TCTMD, Jeffrey Moses, MD, of Columbia University Medical Center (New York, NY), said the study represents a “pretty unique data set with a particularly good outcome.” He added that this study provides much needed data on a sizeable cohort of the very elderly, a population not typically included in randomized trials. “What you see here is that there is really no excess mortality with these patients beyond their age. That’s a pretty profound statement. You have efficacy here with very low TLR rates, very high success rates, and a slightly higher stent thrombosis rate in the over 80 group, but it is subacute thrombosis, which is generally procedural,” Dr. Moses said. Very Elderly Still Face Unique Hurdles Dr. Moses said the very elderly will continue to face certain outstanding issues: • Greater likelihood of comorbidities such as renal disease • More diffuse atherosclerosis • More calcification of the arteries • More stroke due to diffuse disease “It’s a very challenging subset and more importantly, they generally come to the interventionalist when they are highly symptomatic, since PCI is generally a quality of life option for them,” he explained. Additionally, data are scarce on PCI outcomes in the over-80 demographic because they tend not to be enrolled in trials. Dr. Moses said he believed they ought to be represented in more randomized studies, though that remains unlikely because of the statistical effect these patients can have. “The problem in pivotal trials like these is that manufacturers don’t want the driver of mortality, which is age related, to overwhelm the effects of the device being tested,” he said “That’s why [the very elderly] are generally excluded. A heavy representation of an adverse event in a very small group can really swing things one way or another if there’s a slight imbalance.”   source：<A href="http://www.tctmd.com">www.tctmd.com</A>

2008-05-06 17:48:28 by: doctor2

DES Effective in Very Elderly, Adverse Outcomes Age-Driven 高龄患者应用DES有效，但年龄催生不良事件   刊登在2008年4月份《美国心脏杂志》的一项新研究表明，与年轻患者相比，高龄患者（≥80岁）应用DES治疗手术操作成功率高，血运重建率相似，但是不良事件率明显高于置入DES的年轻患者。   美国Mayo Clinic （罗彻斯特, 明尼苏达州）的Pieter Vlaar教授研究组强调，与年轻患者相比，高龄患者手术操作成功率高（97%），但不良事件发生率更高。   在2003-2005年间，这项单中心、回顾性研究连续观察了2,453例在美国Mayo Clinic 置入DES的患者，当按年龄对患者进行分组后，研究人员分析了12个月结果（表1）。另外，高龄患者院内MACE率更高（OR 3.18; 95%CI 1.46-6.96, P=0.004）。高龄患者通常合并多种疾病，发病更紧急，冠脉病变更广泛，与年轻患者群相比，女性高龄患者居多。 <A href="http://www.ccheart.com.cn/supersite/batch.download.php?aid=499" target=_blank><IMG src="http://www.ccheart.com.cn/supersite/attachments/2008/05/18884_200805081340241.jpg" border=0></A>   年龄本身即是最大的危险因素   通过对明尼苏达州患者群的研究发现，尽管在接受DES的PCI术后，80岁以上的患者更可能发生不良事件，包括死亡，但是置入DES后的八旬患者预期寿命与相同年龄或性别的普通高龄老人很相似。   作者写道：“类似的存活时间表明，接受DES的PCI治疗是值得接受的，尤其是患者为了提高生活质量和改善症状，而不是延长寿命。”   在TCTMD电话采访中，Jeffrey Moses 教授说该研究代表了“一个非常独特的数据组，产生了良好的结果。”他认为这项研究提供了许多关于高龄患者的宝贵数据，这样的患者通常是不会被入选到随机试验中去的。“你可以看到，更高年龄的患者却没有发生过多的死亡事件，这项声明相当有意义：患者可从置入DES中受益，伴随低TLR率，高（操作）成功率和略微增高的支架血栓——而且通常是因操作引起的亚急性血栓。”Moses教授说。   高龄仍旧面临难关 Moses教授说，高龄患者将继续面临一些突出问题：   •更可能并发多种疾病，如肾病 •更弥漫的动脉粥样硬化 •更严重的动脉钙化 •因弥漫性疾病而易发中风   他解释道：“高龄患者是极有挑战性的亚组患者，更重要的是，当症状明显时，他们通常会来求助介入医生，因为选择PCI会使他们提高生活质量。”   然而，关于80岁以上的患者行PCI的数据很少，这是因为他们通常没有被选入研究。Moses教授认为他们（高龄患者）应该被入选到更多的随机试验中，但目前，这是不可能的，因为这些患者会影响统计结果。“这些重要试验的问题在于，厂商不希望因年龄因素增加的死亡率影响器械试验的效果。”他说，“这就是为什么高龄患者通常被排除：在一个样本量很小的研究组中，当存在细微的不均衡结果时，出现一个沉重的不良事件就可以将结论推向另一边。”   来源：<A href="http://www.tctmd.com">www.tctmd.com</A>   （医心网编辑刘瑞琦编译付世娜审校）   DES Effective in Very Elderly, Adverse Outcomes Age-Driven By Kiersten Feil A new study in the April issue of the American Heart Journal suggests that drug-eluting stents (DES) in octogenarians are associated with high procedural success rates and comparable revascularization rates to younger patients. However, adverse events are significantly higher among this subset of DES patients than their younger counterparts. Researchers led by Pieter Vlaar, MD, of the Mayo Clinic (Rochester, MN), stressed that the high procedural success rate (97%) occurred despite the higher risk profile of the very elderly compared with younger patients. The single-center, retrospective study examined 2,453 consecutive patients who underwent DES implantation at the Mayo Clinic between 2003 and 2005. After patients were classified according to age groups (≤79 and ≥80 years of age), researchers analyzed outcomes at 12 months (table 1). In addition, very old age was associated with higher in-hospital MACE rates (OR 3.18; 95% CI 1.46-6.96, P=0.004). Octogenarians had more comorbid conditions, more urgent presentation, more extensive coronary artery disease, and were more likely to be women than younger patients. Age Itself is Biggest Risk Factor Despite the finding that patients age 80 and older are more likely to suffer adverse events, including death, following PCI with DES, the expected survival of octogenarians who received DES was similar to the age-matched and sex-matched life expectancy of the general Minnesota population. The authors write, “This similar survival expectancy suggests that the survival after PCI with DES is acceptable, especially because PCI in the elderly is performed for quality of life and symptom improvement, and not for prolongation of life.” In a telephone interview with TCTMD, Jeffrey Moses, MD, of Columbia University Medical Center (New York, NY), said the study represents a “pretty unique data set with a particularly good outcome.” He added that this study provides much needed data on a sizeable cohort of the very elderly, a population not typically included in randomized trials. “What you see here is that there is really no excess mortality with these patients beyond their age. That’s a pretty profound statement. You have efficacy here with very low TLR rates, very high success rates, and a slightly higher stent thrombosis rate in the over 80 group, but it is subacute thrombosis, which is generally procedural,” Dr. Moses said. Very Elderly Still Face Unique Hurdles Dr. Moses said the very elderly will continue to face certain outstanding issues: • Greater likelihood of comorbidities such as renal disease • More diffuse atherosclerosis • More calcification of the arteries • More stroke due to diffuse disease “It’s a very challenging subset and more importantly, they generally come to the interventionalist when they are highly symptomatic, since PCI is generally a quality of life option for them,” he explained. Additionally, data are scarce on PCI outcomes in the over-80 demographic because they tend not to be enrolled in trials. Dr. Moses said he believed they ought to be represented in more randomized studies, though that remains unlikely because of the statistical effect these patients can have. “The problem in pivotal trials like these is that manufacturers don’t want the driver of mortality, which is age related, to overwhelm the effects of the device being tested,” he said “That’s why [the very elderly] are generally excluded. A heavy representation of an adverse event in a very small group can really swing things one way or another if there’s a slight imbalance.”   source：<A href="http://www.tctmd.com">www.tctmd.com</A>

2008-05-06 17:48:28 by: doctor2

DES Effective in Very Elderly, Adverse Outcomes Age-Driven 高龄患者应用DES有效，但年龄催生不良事件   刊登在2008年4月份《美国心脏杂志》的一项新研究表明，与年轻患者相比，高龄患者（≥80岁）应用DES治疗手术操作成功率高，血运重建率相似，但是不良事件率明显高于置入DES的年轻患者。   美国Mayo Clinic （罗彻斯特, 明尼苏达州）的Pieter Vlaar教授研究组强调，与年轻患者相比，高龄患者手术操作成功率高（97%），但不良事件发生率更高。   在2003-2005年间，这项单中心、回顾性研究连续观察了2,453例在美国Mayo Clinic 置入DES的患者，当按年龄对患者进行分组后，研究人员分析了12个月结果（表1）。另外，高龄患者院内MACE率更高（OR 3.18; 95%CI 1.46-6.96, P=0.004）。高龄患者通常合并多种疾病，发病更紧急，冠脉病变更广泛，与年轻患者群相比，女性高龄患者居多。 <A href="http://www.ccheart.com.cn/supersite/batch.download.php?aid=499" target=_blank><IMG src="http://www.ccheart.com.cn/supersite/attachments/2008/05/18884_200805081340241.jpg" border=0></A>   年龄本身即是最大的危险因素   通过对明尼苏达州患者群的研究发现，尽管在接受DES的PCI术后，80岁以上的患者更可能发生不良事件，包括死亡，但是置入DES后的八旬患者预期寿命与相同年龄或性别的普通高龄老人很相似。   作者写道：“类似的存活时间表明，接受DES的PCI治疗是值得接受的，尤其是患者为了提高生活质量和改善症状，而不是延长寿命。”   在TCTMD电话采访中，Jeffrey Moses 教授说该研究代表了“一个非常独特的数据组，产生了良好的结果。”他认为这项研究提供了许多关于高龄患者的宝贵数据，这样的患者通常是不会被入选到随机试验中去的。“你可以看到，更高年龄的患者却没有发生过多的死亡事件，这项声明相当有意义：患者可从置入DES中受益，伴随低TLR率，高（操作）成功率和略微增高的支架血栓——而且通常是因操作引起的亚急性血栓。”Moses教授说。   高龄仍旧面临难关 Moses教授说，高龄患者将继续面临一些突出问题：   •更可能并发多种疾病，如肾病 •更弥漫的动脉粥样硬化 •更严重的动脉钙化 •因弥漫性疾病而易发中风   他解释道：“高龄患者是极有挑战性的亚组患者，更重要的是，当症状明显时，他们通常会来求助介入医生，因为选择PCI会使他们提高生活质量。”   然而，关于80岁以上的患者行PCI的数据很少，这是因为他们通常没有被选入研究。Moses教授认为他们（高龄患者）应该被入选到更多的随机试验中，但目前，这是不可能的，因为这些患者会影响统计结果。“这些重要试验的问题在于，厂商不希望因年龄因素增加的死亡率影响器械试验的效果。”他说，“这就是为什么高龄患者通常被排除：在一个样本量很小的研究组中，当存在细微的不均衡结果时，出现一个沉重的不良事件就可以将结论推向另一边。”   来源：<A href="http://www.tctmd.com">www.tctmd.com</A>   （医心网编辑刘瑞琦编译付世娜审校）   DES Effective in Very Elderly, Adverse Outcomes Age-Driven By Kiersten Feil A new study in the April issue of the American Heart Journal suggests that drug-eluting stents (DES) in octogenarians are associated with high procedural success rates and comparable revascularization rates to younger patients. However, adverse events are significantly higher among this subset of DES patients than their younger counterparts. Researchers led by Pieter Vlaar, MD, of the Mayo Clinic (Rochester, MN), stressed that the high procedural success rate (97%) occurred despite the higher risk profile of the very elderly compared with younger patients. The single-center, retrospective study examined 2,453 consecutive patients who underwent DES implantation at the Mayo Clinic between 2003 and 2005. After patients were classified according to age groups (≤79 and ≥80 years of age), researchers analyzed outcomes at 12 months (table 1). In addition, very old age was associated with higher in-hospital MACE rates (OR 3.18; 95% CI 1.46-6.96, P=0.004). Octogenarians had more comorbid conditions, more urgent presentation, more extensive coronary artery disease, and were more likely to be women than younger patients. Age Itself is Biggest Risk Factor Despite the finding that patients age 80 and older are more likely to suffer adverse events, including death, following PCI with DES, the expected survival of octogenarians who received DES was similar to the age-matched and sex-matched life expectancy of the general Minnesota population. The authors write, “This similar survival expectancy suggests that the survival after PCI with DES is acceptable, especially because PCI in the elderly is performed for quality of life and symptom improvement, and not for prolongation of life.” In a telephone interview with TCTMD, Jeffrey Moses, MD, of Columbia University Medical Center (New York, NY), said the study represents a “pretty unique data set with a particularly good outcome.” He added that this study provides much needed data on a sizeable cohort of the very elderly, a population not typically included in randomized trials. “What you see here is that there is really no excess mortality with these patients beyond their age. That’s a pretty profound statement. You have efficacy here with very low TLR rates, very high success rates, and a slightly higher stent thrombosis rate in the over 80 group, but it is subacute thrombosis, which is generally procedural,” Dr. Moses said. Very Elderly Still Face Unique Hurdles Dr. Moses said the very elderly will continue to face certain outstanding issues: • Greater likelihood of comorbidities such as renal disease • More diffuse atherosclerosis • More calcification of the arteries • More stroke due to diffuse disease “It’s a very challenging subset and more importantly, they generally come to the interventionalist when they are highly symptomatic, since PCI is generally a quality of life option for them,” he explained. Additionally, data are scarce on PCI outcomes in the over-80 demographic because they tend not to be enrolled in trials. Dr. Moses said he believed they ought to be represented in more randomized studies, though that remains unlikely because of the statistical effect these patients can have. “The problem in pivotal trials like these is that manufacturers don’t want the driver of mortality, which is age related, to overwhelm the effects of the device being tested,” he said “That’s why [the very elderly] are generally excluded. A heavy representation of an adverse event in a very small group can really swing things one way or another if there’s a slight imbalance.”   source：<A href="http://www.tctmd.com">www.tctmd.com</A>

药物洗脱支架在高龄患者的应用：早期和中期结果

发布于:2008-05-06 17:45

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