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发布于 2012-08-02 · 浏览 4061 · IP 上海上海
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All Comers trial.pdf翻译Discussion部分，在P1244-1246，包括相关表格。
Myocardial infarction adjudication.pdf不需要翻译
翻译质量较好者可以追加10个叮当。
pdf原文下载见
【-=需求=-】紧急翻译求助：英译中(40叮当，截止周四晚24点)
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参考资料：
Unrestricted randomized use of two new generation drug-eluting coronary stents: 2-year patient-related versus stent-related outcomes from the RESOLUTE All Comers trial 两种新一代药物洗脱冠脉支架简单随机对照研究——随访2年的患者相关与支架相关性的RESOLUTE全体受试者研究
Summary
Background In the RESOLUTE All Comers trial, the Resolute zotarolimus-eluting stent was non-inferior to the Xience V everolimus-eluting stent for the primary stent-related endpoint of target lesion failure (cardiac death, target vessel myocardial infarction, and ischaemia-driven target lesion revascularisation) at 1 year. However, data for long-term safety and efficacy from randomised studies of new generation drug-eluting coronary stents in patients treated in routine clinical practice are scarce. We report the prespecified 2-year clinical outcomes from the RESOLUTE All Comers trial.
背景：在RESOLUTE全体受试者研究中，佐他莫司洗脱支架(Resolute)与依维莫司洗脱支架（Xience V）在一年靶病变终点事件（心源性死亡、靶血管所致心肌梗死、缺血导致的靶病变血管血运重建）上表现相同，差异均在预设的非劣性范围之内。然而，新一代药物洗脱冠脉支架长期使用的安全性和有效性数据还比较匮乏。我们预先报告随访2年的RESOLUTE全体受试者研究结果。
Methods In 2008, patients with at least one coronary lesion 2·25–4·0 mm in diameter, with greater than 50% stenosis, were randomly assigned to a Resolute zotarolimus-eluting stent or a Xience V everolimus-eluting stent at 17 centres in Europe and Israel. Randomisation was by an interactive voice response system stratified by centre. Study investigators were not masked to treatment allocation; but those who did data management and analysis, and patients were masked. There were no restrictions as to the number of vessels or lesions treated, or the number of stents implanted. We assessed prespecified safety and efficacy outcomes at 2 years with specific focus on patient-related composite (all death, all myocardial infarction, all revascularisation) and stent-related composite outcomes. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00617084.
方法：2008年，在欧洲和以色列的17个医疗中心纳入至少有一处冠状动脉病变直径大于2.25-4.0毫米且狭窄率大于50％的患者，患者被随机分配到佐他莫司洗脱支架或依维莫司洗脱支架。按各中心的交互式语音应答系统将患者随机分配。分组情况对患者和数据分析人员设盲，但未对负责治疗的医生设盲。不限制置入支架的病变或血管数目。我们评估2年的安全性和有效性，侧重于患者相关的复合终点事件（全因死亡率，全因心肌梗死率，全因血运重建率），兼顾支架相关的复合终点事件。采用意向治疗分析。本研究在ClinicalTrials.gov上已注册，注册号为NCT00617084。
Findings 1140 patients were assigned to the zotarolimus-eluting stent and 1152 to the everolimus-eluting stent; 1121 and 1128 patients, respectively, completed 2-year follow-up. The patient-related outcome (231 [20·6%] zotarolimus vs 231 [20·5%] everolimus; diff erence 0·1%, 95%可信区间 –3·2 to 3·5; p=0·958) and stent-related outcome (126 [11·2%] vs 121 [10·7%]; difference 0·5%, –2·1 to 3·1; p=0·736) did not differ between groups, although rates of the stent-related outcome were substantially lower than were those for the patient-related outcome. Three patients in each group (0·3%) had very late (after 1 year) stent thrombosis.
结果：1,140名病患被分配到佐他莫司洗脱支架组，1152名病患被分配到依维莫司洗脱支架组。两组分别有1121例和1128例完成2年的随访。病人相关事件发生率比较（佐他莫司组231 (20.6％)，依维莫司组231 (20.5％)，相差0.1％，95%可信区间-3.2到3.5，P=0.958）；支架相关事件发生率比较（佐他莫司组126(11.2％)，依维莫司组121 (10.7％]，相差0.5％，95%可信区间-2.1至3.1，P=0.736）。虽然支架相关事件发生率比病人相关事件发生率明显减低，但两组之间没有差异。两组各有3例患者（0.3％）有极晚期支架内血栓形成（超过1年）。
Interpretation Similar safety and efficacy outcomes were sustained between two new generation drug-eluting stents at 2-year follow-up. The greater number of patient-related than stent-related events in patients with complex clinical and lesion characteristics emphasises that during long-term follow-up, the optimisation of secondary prevention is at least as important as the selection of which new generation drug-eluting stent to implant in a specific lesion.
解释：两个新一代药物洗脱支架随访2年，其安全性和有效性类似。长期随访发现，具有复杂临床及靶血管特征的患者，其患者相关事件率高于支架相关事件率，说明二级预防的优化重要性，不亚于在具体病变选择何种新一代药物洗脱支架。
Results
2292 patients were enrolled and randomly assigned to treatment with the zotarolimus-eluting stent (n=1140) or the everolimus-eluting stent (n=1152). 1121 (98·3%) of zotarolimus patients and 1128 (97·9%) of everolimus patients completed follow-up at 2 years (figure 1). Table 1 summarises the baseline demographics and the clinical and angiographic characteristics of all patients.
2292例患者被随机分配到佐他莫司洗脱支架组（1140）或依维莫司洗脱支架组（1152）。1121例（98·3％）佐他莫司洗脱支架组及1128例（97·9％）佐他莫司的患者完成了2年随访（图1）。表1总结了研究人群基线值统计和所有患者的临床和血管造影的特点。
At 2 years, a patient-related outcome occurred in 231 patients in each group (table 2); the number of stent-related outcomes events was substantially lower, but did not differ between groups (table 2). Kaplan-Meier analyses showed no differences between the two groups in the incidence of patient-related or stent-related endpoints (figure 2). Furthermore, we noted no differences between the two stent groups for any major clinical event (table 2).
随访2年，两组均有231例病人出现患者相关事件（表2）；支架相关事件发生率明显较低，但两组之间没有差别（表2）。 Kaplan-Meier生存分析显示，在有关病人或支架相关的终点事件的发生率两组之间无显着差异（图2）。此外，我们注意到两组之间的重大临床事件发生率没有差异（表2）。
1520 of 2292 (66.3%) patients were classified as complex (table 1). At 2 years, the zotarolimus and everolimus patient groups had similar outcomes irrespective of complexity. For the complex group, a patient-related outcome occurred in 162 of 752 (21·5%) patients in the zotarolimus group versus 166 of 738 (22·5%) in the everolimus group (difference –1·0%, 95%CI –5·2 to 3·3; p=0·662) and stent-related outcomes in 91 of 752 (12·1%) versus 93 of 738 (12·6%) patients (difference –0·5, –3·8 to 2·8; p=0·813). For the simple group (patients not meeting complex criteria), patient-related outcomes occurred in 69 of 369 (18·7%) patients in the zotarolimus group versus 65 of 390 (16·7%) in the everolimus group (difference 2·0%, –3·4 to 7·4%; p=0·505) and stent-related outcomes in 35 of 369 (9·5%) versus 28 of 390 (7·2%) patients (difference 2·3%, –1·6 to 6·2; p=0·293).
2292例入选者中，有1520（66.3％）例患者存在复杂病变（表1）。 随访2年，佐他莫司??和依维莫司的患者群临床事件结果类似，和病变复杂性无关。对于复杂病变人群，752例佐他莫司组患者有162（21·5％）例出现患者相关事件； 738例依维莫司组患者有166（22.5％）例出现患者相关事件（差异-1.0％，95％可信区间为-5.2至3.3，P = 0.662）。两组的支架相关事件发生率分别为91/752（12.1％）与93/738（12.6％）（差异-0.5，95％可信区间为- 3.8至2 8，P = 0.813）。对于不存在复杂病变的患者，369例佐他莫司组患者有69（18.7％）例出现患者相关事件；390例依维莫司组患者有65（16.7％）例出现患者相关事件（差异2.0％，95％可信区间为-3.4至7.4，P = 0.662）。两组的支架相关事件发生率分别为35/369（9.5％）与28/390（7.2％）（差异2.3%，95％可信区间为1.6至6.2，P = 0.293）。
At 1 year, 933 of 1110 (84·1%) patients in the zotarolimus group and 929 of 1108 (83·8%) in the everolimus group were taking dual antiplatelet therapy (p=0·908). After 2 years, 201 of 1080 (18·6%) zotarolimus patients and 195 of 1076 (18·1%) everolimus patients were still on dual antiplatelet therapy (p=0·781). Three patients in each group (0·3% for both) had an ARC definite or probable stent thrombosis event during the second year (ie, very late stent thrombosis), with no associated mortality (table 3, figure 3).
随访1年，1110例佐他莫司组患者有933例(84.1％)服用双联抗血小板聚集治疗；而1108例依维莫司组患者有929例（83.8％）服用双联抗血小板聚集治疗（P = 0.908）。随访2年，1080例佐他莫司组患者有201例(18.6％)服用双联抗血小板聚集治疗；而1076例依维莫司组患者有195例（18.1％）服用双联抗血小板聚集治疗（P = 0.781）。在第二年，各组患者均出现3例（0.3％）ARC定义的或可能的支架血栓事件（即极晚期支架血栓形成），没有相关的死亡率（表3，图3）。
All Comers trial.pdf翻译Discussion部分，在P1244-1246，包括相关表格。
Myocardial infarction adjudication.pdf不需要翻译
翻译质量较好者可以追加10个叮当。
pdf原文下载见
【-=需求=-】紧急翻译求助：英译中(40叮当，截止周四晚24点)
认领者请及时跟帖，以免重复认领。
参考资料：
Summary
Background In the RESOLUTE All Comers trial, the Resolute zotarolimus-eluting stent was non-inferior to the Xience V everolimus-eluting stent for the primary stent-related endpoint of target lesion failure (cardiac death, target vessel myocardial infarction, and ischaemia-driven target lesion revascularisation) at 1 year. However, data for long-term safety and efficacy from randomised studies of new generation drug-eluting coronary stents in patients treated in routine clinical practice are scarce. We report the prespecified 2-year clinical outcomes from the RESOLUTE All Comers trial.
背景：在RESOLUTE全体受试者研究中，佐他莫司洗脱支架(Resolute)与依维莫司洗脱支架（Xience V）在一年靶病变终点事件（心源性死亡、靶血管所致心肌梗死、缺血导致的靶病变血管血运重建）上表现相同，差异均在预设的非劣性范围之内。然而，新一代药物洗脱冠脉支架长期使用的安全性和有效性数据还比较匮乏。我们预先报告随访2年的RESOLUTE全体受试者研究结果。
Methods In 2008, patients with at least one coronary lesion 2·25–4·0 mm in diameter, with greater than 50% stenosis, were randomly assigned to a Resolute zotarolimus-eluting stent or a Xience V everolimus-eluting stent at 17 centres in Europe and Israel. Randomisation was by an interactive voice response system stratified by centre. Study investigators were not masked to treatment allocation; but those who did data management and analysis, and patients were masked. There were no restrictions as to the number of vessels or lesions treated, or the number of stents implanted. We assessed prespecified safety and efficacy outcomes at 2 years with specific focus on patient-related composite (all death, all myocardial infarction, all revascularisation) and stent-related composite outcomes. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00617084.
方法：2008年，在欧洲和以色列的17个医疗中心纳入至少有一处冠状动脉病变直径大于2.25-4.0毫米且狭窄率大于50％的患者，患者被随机分配到佐他莫司洗脱支架或依维莫司洗脱支架。按各中心的交互式语音应答系统将患者随机分配。分组情况对患者和数据分析人员设盲，但未对负责治疗的医生设盲。不限制置入支架的病变或血管数目。我们评估2年的安全性和有效性，侧重于患者相关的复合终点事件（全因死亡率，全因心肌梗死率，全因血运重建率），兼顾支架相关的复合终点事件。采用意向治疗分析。本研究在ClinicalTrials.gov上已注册，注册号为NCT00617084。
Findings 1140 patients were assigned to the zotarolimus-eluting stent and 1152 to the everolimus-eluting stent; 1121 and 1128 patients, respectively, completed 2-year follow-up. The patient-related outcome (231 [20·6%] zotarolimus vs 231 [20·5%] everolimus; diff erence 0·1%, 95%可信区间 –3·2 to 3·5; p=0·958) and stent-related outcome (126 [11·2%] vs 121 [10·7%]; difference 0·5%, –2·1 to 3·1; p=0·736) did not differ between groups, although rates of the stent-related outcome were substantially lower than were those for the patient-related outcome. Three patients in each group (0·3%) had very late (after 1 year) stent thrombosis.
结果：1,140名病患被分配到佐他莫司洗脱支架组，1152名病患被分配到依维莫司洗脱支架组。两组分别有1121例和1128例完成2年的随访。病人相关事件发生率比较（佐他莫司组231 (20.6％)，依维莫司组231 (20.5％)，相差0.1％，95%可信区间-3.2到3.5，P=0.958）；支架相关事件发生率比较（佐他莫司组126(11.2％)，依维莫司组121 (10.7％]，相差0.5％，95%可信区间-2.1至3.1，P=0.736）。虽然支架相关事件发生率比病人相关事件发生率明显减低，但两组之间没有差异。两组各有3例患者（0.3％）有极晚期支架内血栓形成（超过1年）。
Interpretation Similar safety and efficacy outcomes were sustained between two new generation drug-eluting stents at 2-year follow-up. The greater number of patient-related than stent-related events in patients with complex clinical and lesion characteristics emphasises that during long-term follow-up, the optimisation of secondary prevention is at least as important as the selection of which new generation drug-eluting stent to implant in a specific lesion.
解释：两个新一代药物洗脱支架随访2年，其安全性和有效性类似。长期随访发现，具有复杂临床及靶血管特征的患者，其患者相关事件率高于支架相关事件率，说明二级预防的优化重要性，不亚于在具体病变选择何种新一代药物洗脱支架。
Results
2292 patients were enrolled and randomly assigned to treatment with the zotarolimus-eluting stent (n=1140) or the everolimus-eluting stent (n=1152). 1121 (98·3%) of zotarolimus patients and 1128 (97·9%) of everolimus patients completed follow-up at 2 years (figure 1). Table 1 summarises the baseline demographics and the clinical and angiographic characteristics of all patients.
2292例患者被随机分配到佐他莫司洗脱支架组（1140）或依维莫司洗脱支架组（1152）。1121例（98·3％）佐他莫司洗脱支架组及1128例（97·9％）佐他莫司的患者完成了2年随访（图1）。表1总结了研究人群基线值统计和所有患者的临床和血管造影的特点。
At 2 years, a patient-related outcome occurred in 231 patients in each group (table 2); the number of stent-related outcomes events was substantially lower, but did not differ between groups (table 2). Kaplan-Meier analyses showed no differences between the two groups in the incidence of patient-related or stent-related endpoints (figure 2). Furthermore, we noted no differences between the two stent groups for any major clinical event (table 2).
随访2年，两组均有231例病人出现患者相关事件（表2）；支架相关事件发生率明显较低，但两组之间没有差别（表2）。 Kaplan-Meier生存分析显示，在有关病人或支架相关的终点事件的发生率两组之间无显着差异（图2）。此外，我们注意到两组之间的重大临床事件发生率没有差异（表2）。
1520 of 2292 (66.3%) patients were classified as complex (table 1). At 2 years, the zotarolimus and everolimus patient groups had similar outcomes irrespective of complexity. For the complex group, a patient-related outcome occurred in 162 of 752 (21·5%) patients in the zotarolimus group versus 166 of 738 (22·5%) in the everolimus group (difference –1·0%, 95%CI –5·2 to 3·3; p=0·662) and stent-related outcomes in 91 of 752 (12·1%) versus 93 of 738 (12·6%) patients (difference –0·5, –3·8 to 2·8; p=0·813). For the simple group (patients not meeting complex criteria), patient-related outcomes occurred in 69 of 369 (18·7%) patients in the zotarolimus group versus 65 of 390 (16·7%) in the everolimus group (difference 2·0%, –3·4 to 7·4%; p=0·505) and stent-related outcomes in 35 of 369 (9·5%) versus 28 of 390 (7·2%) patients (difference 2·3%, –1·6 to 6·2; p=0·293).
2292例入选者中，有1520（66.3％）例患者存在复杂病变（表1）。 随访2年，佐他莫司??和依维莫司的患者群临床事件结果类似，和病变复杂性无关。对于复杂病变人群，752例佐他莫司组患者有162（21·5％）例出现患者相关事件； 738例依维莫司组患者有166（22.5％）例出现患者相关事件（差异-1.0％，95％可信区间为-5.2至3.3，P = 0.662）。两组的支架相关事件发生率分别为91/752（12.1％）与93/738（12.6％）（差异-0.5，95％可信区间为- 3.8至2 8，P = 0.813）。对于不存在复杂病变的患者，369例佐他莫司组患者有69（18.7％）例出现患者相关事件；390例依维莫司组患者有65（16.7％）例出现患者相关事件（差异2.0％，95％可信区间为-3.4至7.4，P = 0.662）。两组的支架相关事件发生率分别为35/369（9.5％）与28/390（7.2％）（差异2.3%，95％可信区间为1.6至6.2，P = 0.293）。
At 1 year, 933 of 1110 (84·1%) patients in the zotarolimus group and 929 of 1108 (83·8%) in the everolimus group were taking dual antiplatelet therapy (p=0·908). After 2 years, 201 of 1080 (18·6%) zotarolimus patients and 195 of 1076 (18·1%) everolimus patients were still on dual antiplatelet therapy (p=0·781). Three patients in each group (0·3% for both) had an ARC definite or probable stent thrombosis event during the second year (ie, very late stent thrombosis), with no associated mortality (table 3, figure 3).
随访1年，1110例佐他莫司组患者有933例(84.1％)服用双联抗血小板聚集治疗；而1108例依维莫司组患者有929例（83.8％）服用双联抗血小板聚集治疗（P = 0.908）。随访2年，1080例佐他莫司组患者有201例(18.6％)服用双联抗血小板聚集治疗；而1076例依维莫司组患者有195例（18.1％）服用双联抗血小板聚集治疗（P = 0.781）。在第二年，各组患者均出现3例（0.3％）ARC定义的或可能的支架血栓事件（即极晚期支架血栓形成），没有相关的死亡率（表3，图3）。
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