留言板

尊敬的读者、作者、审稿人, 关于本刊的投稿、审稿、编辑和出版的任何问题, 您可以本页添加留言。我们将尽快给您答复。谢谢您的支持!

姓名
邮箱
手机号码
标题
留言内容
验证码
x 关闭 永久关闭

应中央军委要求，2022年9月起，《药学实践杂志》将更名为《药学实践与服务》，双月刊，正文96页；2023年1月起，拟出版月刊，正文64页，数据库收录情况与原《药学实践杂志》相同。欢迎作者踊跃投稿！

植入药物洗脱支架后短期与长期双联抗血小板疗效比较的Meta分析

费舒扬,  赵力,  孙琳,  张蓉,  李晶,  葛长江

downloadPDF
文章导航 > 药学实践与服务  > 2020 >  38(1): 81-87
费舒扬, 赵力, 孙琳, 张蓉, 李晶, 葛长江. 植入药物洗脱支架后短期与长期双联抗血小板疗效比较的Meta分析[J]. 药学实践与服务, 2020, 38(1): 81-87. doi: 10.3969/j.issn.1006-0111.201907135
引用本文: 费舒扬, 赵力, 孙琳, 张蓉, 李晶, 葛长江. 植入药物洗脱支架后短期与长期双联抗血小板疗效比较的Meta分析[J]. 药学实践与服务, 2020, 38(1): 81-87. doi: 10.3969/j.issn.1006-0111.201907135
shu
FEI Shuyang, ZHAO Li, SUN Lin, ZHANG Rong, LI Jing, GE Changjiang. Comparison of short-term and long-term dual antiplatelet therapy after implantation of drug-eluting stents—Meta analysis[J]. Journal of Pharmaceutical Practice and Service, 2020, 38(1): 81-87. doi: 10.3969/j.issn.1006-0111.201907135
Citation: FEI Shuyang, ZHAO Li, SUN Lin, ZHANG Rong, LI Jing, GE Changjiang. Comparison of short-term and long-term dual antiplatelet therapy after implantation of drug-eluting stents—Meta analysis[J]. Journal of Pharmaceutical Practice and Service, 2020, 38(1): 81-87. doi: 10.3969/j.issn.1006-0111.201907135
shu

植入药物洗脱支架后短期与长期双联抗血小板疗效比较的Meta分析

doi: 10.3969/j.issn.1006-0111.201907135
  • 1.

    首都医科大学附属北京安贞医院, 北京 100048

  • 2.

    解放军总医院第六医学中心, 北京 100048

Comparison of short-term and long-term dual antiplatelet therapy after implantation of drug-eluting stents—Meta analysis

  • 1.

    Anzhen Hospital, Capital Medical University, Beijing 100048, China

  • 2.

    Sixth Medical Center of General Hospital of PLA, Beijing 100048, China

  • 摘要: 目的 评价短期（3～6个月）与长期（12个月）双联抗血小板治疗对冠状动脉药物洗脱支架植入后的临床效果。 方法 研究病例包括稳定性心绞痛、急性冠脉综合征、无症状心肌缺血，均为原位血管病变。临床观察终点为：全因死亡、心源性死亡、心肌梗死、卒中、支架内血栓形成、靶病变再血管化治疗、严重出血、净不良临床事件（net adverse clinical event）。通过检索Pubmed、中国生物医学文献等中、英文数据库及手工检索，对符合条件的随机对照研究经质量评估、数据提取，进行Meta分析。 结果 共计纳入12项随机对照研究。Detsky评分均大于5分。共计25 949个病例，随访率97.9%。两组在全因死亡（OR=0.86，95%CI 0.71～1.05，P=0.14）、心源性死亡（OR=0.94，95% CI 0.70～1.25，P=0.67）、支架血栓形成（OR=1.36，95%CI 0.94～1.98，P=0.11）、卒中（OR=1.01，95%CI 0.71～1.42，P=0.98）、靶病变再血管化（OR=0.121，95%CI 0.94～1.55，P=0.14）及净不良临床事件（OR=0.98，95%CI 0.83～1.14，P=0.75）均无明显差别；短期组随访期间心肌梗死发生率高于长期组（OR=1.27，95%CI 1.02～1.59，P=0.04），长期组严重出血的比例明显增加（OR=0.69，95%CI 0.50～0.95，P=0.02）。亚洲人群研究结果：长期治疗组全因死亡高于短期组（OR=0.72，95%CI 0.53～0.97，P=0.03），两组严重出血无明显差别。 结论 依据限定的临床观察终点，短期双联抗血小板疗效不劣于长期组；7项亚组人群研究，长期组全因死亡率高，不排除与样本量偏少产生的偏移及（或）人群的个体差异有关，结果还有待进一步验证。此结果可作为临床工作警示，依据患者出血风险及冠状动脉病变结果个体化调整双联抗血小板周期。
    Abstract: Objective To evaluate the clinical effects of short-term (3-6 months) and long-term (12 months) dual antiplatelet therapy (DAPT) after the implantation of coronary drug-eluting stents (DES). Methods The eligibilities of the patients included stable angina, acute coronary syndrome and silent ischemia. The lesions were in a native coronary vessel. The clinical observation endpoints were all-cause death, cardiogenic death, myocardial infarction, stroke, stent thrombosis, target lesion revascularization, severe bleeding, and true adverse clinical events. The clinical observation endpoints were all-cause death, cardiogenic death, myocardial infarction, stroke, stent thrombosis, target lesion revascularization, severe bleeding, and true adverse clinical events. By searching Pubmed, Chinese biomedical literature and other Chinese and English databases and manual search, qualified randomized controlled studies were evaluated and data were extracted for meta-analysis. Results A total of 12 randomized controlled studies were conducted. Detsky scores were all greater than 5 points. There were a total of 25949 patients in the study with a follow-up rate of 97.9%. There were no significantly different in all cause death (OR=0.86,95%CI 0.71-1.05,P=0.14), cardiac death (OR=0.94,95% CI 0.70-1.25,P=0.67), stent thrombosis (OR=1.36,95%CI 0.94-1.98,P=0.11), stroke (OR=1.01,95%CI 0.71-1.42,P=0.98), target lesion revascularization (OR=0.121,95%CI 0.94-1.55,P=0.14),and true adverse clinical events (OR=0.98,95%CI 0.83-1.14,P=0.75). The incident rate of myocardial infarction during the follow-up period was higher in the short-term group than in the long-term group (OR=1.27, 95% CI 1.02-1.59, P=0.04). The proportion of severe bleeding in the long-term group increased significantly (OR=0.69, 95% CI 0.50-0.95, P=0.02). Asian population studies showed that all-cause mortality was higher in the long-term treatment group than in the short-term group (OR=0.72, 95% CI 0.53-0.97, P=0.03), and there was no significant difference in severe bleeding between the two groups. Conclusion According to the defined clinical observation endpoints, the short-term dual antiplatelet effect is not inferior to the long-term group. Seven asian group studies have shown that the long-term group has high all-cause mortality. It can not rule out the deviation and/or population caused by the small sample size or individual variation. The results need to be further verified. This result can be used as a clinical warning to adjust the dual antiplatelet cycle based on the individualized risk of bleeding and coronary lesions.
  • [1] BYRNE R A, SARAFOFF N, KASTRATI A, et al. Drug-eluting stents in percutaneous coronary intervention: a benefit-risk assessment[J]. Drug Saf,2009,32(9):749-770
    [2] VALGIMIGLI M, BUENO H, BYRNE R A, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS[J]. Eur J Cardiothorac Surg,2018,53(1):34-78
    [3] LEVINE G N, BATES E R, BITTL J A, et al. 2016 ACC/AHA guideline focused update on duration of dual antiplatelet therapy in patients with coronary artery disease: A report of the American college of cardiology/ American heart association task force on clinical practice guidelines[J]. J Am Coll Cardiol,2016,68(10):1082-1115
    [4] BONACA M P, BHATT D L, COHEN M, et al. Long-term use of ticagrelor in patients with prior myocardial infarction[J]. N Engl J Med,2015,372(19):1791-1800
    [5] YEH R W, SECEMSKY E A, KEREIAKES D J, et al. Development and validation of a prediction rule for benefit and harm of dual antiplatelet therapy beyond 1 year after percutaneous coronary intervention[J]. JAMA,2016,315(16):1735-1749
    [6] BABER U, MEHRAN R, GIUSTINO G, et al. Coronary thrombosis and major bleeding after PCI with drug-eluting stents: risk scores from Paris[J]. J Am Coll Cardiol,2016,67(19):2224-2234
    [7] GRANGER C B, GOLDBERG R J, DABBOUS O, et al. Predictors of hospital mortality in the global registry of acute coronary events[J]. Arch Intern Med,2003,163(19):2345-2353
    [8] MEHRAN R, POCOCK S J, NIKOLSKY E, et al. A risk score to predict bleeding in patients with acute coronary syndromes[J]. J Am Coll Cardiol,2010,55(23):2556-2566
    [9] DETSKY A S, NAYLOR C D, O'ROURKE K, et al. Incorporating variations in the quality of individual randomized trials into meta-analysis[J]. J Clin Epidemiol,1992,45(3):255-265
    [10] GWON H C, HAHN J Y, PARK K W, et al. Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the efficacy of xience/promus versus cypher to reduce late loss after stenting (EXCELLENT) randomized, multicenter study[J]. Circulation,2012,125(3):505-513
    [11] KIM B K, HONG M K, SHIN D H, et al. A new strategy for discontinuation of dual antiplatelet therapy: the RESET Trial (Real safety and efficacy of 3-month dual antiplatelet therapy following endeavor zotarolimus-eluting stent implantation)[J]. J Am Coll Cardiol,2012,60(15):1340-1348
    [12] FERES F, COSTA R A, ABIZAID A, et al. Three vs twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the OPTIMIZE randomized trial[J]. JAMA,2013,310(23):2510-2522
    [13] COLOMBO A, CHIEFFO A, FRASHERI A, et al. Second-generation drug-eluting stent implantation followed by 6-versus 12-month dual antiplatelet therapy: the SECURITY randomized clinical trial[J]. J Am Coll Cardiol,2014,64(20):2086-2097
    [14] GILARD M, BARRAGAN P, NORYANI A A L, et al. 6-versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial[J]. J Am Coll Cardiol,2015,65(8):777-786
    [15] SCHULZ-SCHUPKE S, BYRNE R A, TEN BERG J M, et al. Intracoronary stenting and antithrombotic regimen: safety and efficacy of 6 months dual antiplatelet therapy after drug-eluting stenting (ISAR-SAFE) trial investigators. ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting[J]. Eur Heart J,2015,36:1252-1263
    [16] HONG S J, SHIN D H, KIM J S, et al. 6-month versus 12-month dual-antiplatelet therapy following long everolimus-eluting stent implantation: the IVUS-XPL randomized clinical trial[J]. JACC Cardiovasc Interv,2016,9(14):1438-1446
    [17] HAN Y L, XU B, XU K, et al. Six versus 12 months of dual antiplatelet therapy after implantation of biodegradable polymer sirolimus-eluting stent: randomized substudy of the I-LOVE-IT 2 trial[J]. Circ Cardiovasc Interv,2016,9(2):e003145
    [18] NAKAMURA M, ⅡJIMA R, AKO J, et al. Dual antiplatelet therapy for 6 versus 18 months after biodegradable polymer drug-eluting stent implantation[J]. JACC Cardiovasc Interv,2017,10(12):1189-1198
    [19] LEE B K, KIM J S, LEE O H, et al. Safety of six-month dual antiplatelet therapy after second-generation drug-eluting stent implantation: OPTIMA-C Randomised Clinical Trial and OCT Substudy[J]. EuroIntervention,2018,13(16):1923-1930
    [20] HAHN J Y, SONG Y B, OH J H, et al. 6-month versus 12-month or longer dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (SMART-DATE): a randomised, open-label, non-inferiority trial[J]. Lancet,2018,391(10127):1274-1284
    [21] KEDHI E, FABRIS E, VAN DER ENT M, et al. Six months versus 12 months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI): randomised, multicentre, non-inferiority trial[J]. BMJ,2018:k3793
    [22] VALGIMIGLI M, CAMPO G, MONTI M, et al. Prolonging dual antiplatelet treatment after grading stent-induced intimal hyperplasia study (PRODIGY) investigators. Short-versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial[J]. Circulation,2012,125:2015-2026
    [23] MAURI L, KEREIAKES D J, YEH R W, et al. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents[J]. N Engl J Med,2014,371(23):2155-2166
    [24] COLLET J P, SILVAIN J, BARTHÉLÉMY O, et al. Dual-antiplatelet treatment beyond 1 year after drug-eluting stent implantation (ARCTIC-Interruption): a randomised trial[J]. Lancet,2014,384(9954):1577-1585
    [25] LEE C W, AHN J M, PARK D W, et al. Optimal duration of dual antiplatelet therapy after drug-eluting stent implantation: a randomized, controlled trial[J]. Circulation,2014,129(3):304-312
    [26] PARK S J, PARK D W, KIM Y H, et al. Duration of dual antiplatelet therapy after implantation of drug-eluting stents[J]. N Engl J Med,2010,362(15):1374-1382
    [27] GARRATT K N, WEAVER W D, JENKINS R G, et al. Prasugrel plus aspirin beyond 12 months is associated with improved outcomes after Taxus Liberté paclitaxel-eluting coronary stent placement[J]. Circulation,2015,131(1):62-73
    [28] COSTA F, VRANCKX P, LEONARDI S, et al. Impact of clinical presentation on ischaemic and bleeding outcomes in patients receiving 6- or 24-month duration of dual-antiplatelet therapy after stent implantation: a pre-specified analysis from the PRODIGY (Prolonging dual-antiplatelet treatment after grading stent-induced intimal hyperplasia) trial[J]. Eur Heart J,2015,36(20):1242-1251
    [29] SABATÉ M, RÄBER L, HEG D, et al. Comparison of newer-generation drug-eluting with bare-metal stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of the EXAMINATION (clinical evaluation of the xience-V stent in acute myocardial infarction) and COMFORTABLE-AMI (comparison of biolimus eluted from an erodible stent coating with bare metal stents in acute ST-elevation myocardial infarction) trials[J]. JACC Cardiovasc Interv,2014,7(1):55-63
    [30] 中华医学会心血管病学. 2013年抗血小板治疗中国专家共识[J]. 中华心血病杂志, 2013, 40(3):183-194
  • [1] 陈晓芸, 赵旭, 曾位位.  艾普拉唑肠溶片用于治疗反流性食管炎的有效性及安全性Meta分析 . 药学实践与服务, 2023, 41(7): 443-448. doi: 10.12206/j.issn.2097-2024.202111080
    [2] 谢小云, 黄爱文, 李莉, 江彦, 蔡佳松.  药物基因多态性对替格瑞洛抗血小板聚集效果的影响 . 药学实践与服务, 2023, 41(10): 629-633, 642. doi: 10.12206/j.issn.2097-2024.202207087
    [3] 熊明彪, 曹辉, 杨德钱.  连花清瘟胶囊对比奥司他韦治疗流行性感冒疗效和安全性的Meta分析 . 药学实践与服务, 2021, 39(5): 454-459. doi: 10.12206/j.issn.1006-0111.202012021
    [4] 李星霞, 霍炎, 孙习鹏, 陈燕, 陆瑶华, 郭澄.  冠心病合并血小板减少的分析与处理策略 . 药学实践与服务, 2020, 38(1): 77-80. doi: 10.3969/j.issn.1006-0111.201906105
    [5] 林莉莉, 黄爱文, 林美钦, 方婕, 沈钦勇, 宋洪涛.  替吉奥单药或联合铂类治疗晚期非小细胞肺癌患者疗效与安全性的Meta评价 . 药学实践与服务, 2019, 37(6): 563-570. doi: 10.3969/j.issn.1006-0111.2019.06.018
    [6] 金飞虹, 陈婕, 杨文超.  银杏二萜内酯葡胺注射液治疗脑梗死的疗效及安全性的Meta分析 . 药学实践与服务, 2019, 37(1): 80-85. doi: 10.3969/j.issn.1006-0111.2019.01.019
    [7] 阮军, 尹恒, 寇国先, 刘茗心, 杨蕊西.  异甘草酸镁治疗抗结核药物所致肝损伤疗效的Meta分析 . 药学实践与服务, 2019, 37(4): 375-379. doi: 10.3969/j.issn.1006-0111.2019.04.018
    [8] 吴思凡, 谭长宇, 樊红彬, 印晓星, 鲁茜.  奥卡西平和卡马西平治疗脑卒中后继发性癫痫疗效与安全性的Meta分析 . 药学实践与服务, 2018, 36(4): 373-378. doi: 10.3969/j.issn.1006-0111.2018.04.020
    [9] 黄瑾, 曾颖, 唐帆, 袁芳.  中药及其活性成分与氯吡格雷抗血小板聚集的相互作用 . 药学实践与服务, 2016, 34(5): 389-392,398. doi: 10.3969/j.issn.1006-0111.2016.05.002
    [10] 蔡和平, 王卓.  拓扑替康标准方案与周疗方案治疗小细胞肺癌的荟萃分析 . 药学实践与服务, 2014, 32(1): 23-26,30. doi: 10.3969/j.issn.1006-0111.2014.01.006
    [11] 景莉, 范开华, 周倩.  经皮冠脉支架置入围手术期预防性使用抗菌药物的调查分析 . 药学实践与服务, 2012, 30(1): 61-63. doi: 10.3969/j.issn.1006-0111.2012.01.018
    [12] 何志高, 鲍思蔚, 翟晓波.  吉西他滨或长春瑞滨联合顺铂治疗晚期非小细胞肺癌的系统评价 . 药学实践与服务, 2012, 30(2): 131-136. doi: 10.3969/j.issn.1006-0111.2012.02.015
    [13] 黄秋明, 涂雪松, 晏琼, 史传林.  马来酸桂哌齐特治疗糖尿病周围神经病变的Meta分析 . 药学实践与服务, 2012, 30(2): 137-142. doi: 10.3969/j.issn.1006-0111.2012.02.016
    [14] 张琪, 夏爱军.  重组人血管内皮抑制素联合化疗治疗非小细胞肺癌疗效的Meta分析 . 药学实践与服务, 2010, 28(6): 451-455.
    [15] 张美和, 黄成华, 丁晓虎, 沈晓琴, 韩竹俊.  国产加替沙星与左氧氟沙星双盲随机对照治疗细菌感染的Meta分析 . 药学实践与服务, 2006, (6): 346-351.
    [16] 赵国玺, 傅鹰.  随机对照双盲试验中病例剔除情况的分析 . 药学实践与服务, 2005, (2): 93-95.
    [17] 薛冬.  药物经济学对3种心绞痛治疗方案的分析 . 药学实践与服务, 1996, (6): 334-336.
    [18] 赵仲坤, 赵宏轩.  抗心绞痛药物选择与临床正确应用 . 药学实践与服务, 1993, (2): 108-110.
    [19] 陈仕珠.  去郁敏治疗肠易激综合征 . 药学实践与服务, 1988, (3): 57-57.
    [20] CineaDB.  达那唑治疗骨髓增生异常综合征 . 药学实践与服务, 1987, (4): 20-20.
  • 加载中
WeChat 点击查看大图
计量
  • 文章访问数:  4134
  • HTML全文浏览量:  463
  • PDF下载量:  2837
  • 被引次数: 0
出版历程
  • 收稿日期:  2019-07-29
  • 修回日期:  2019-12-25

植入药物洗脱支架后短期与长期双联抗血小板疗效比较的Meta分析

doi: 10.3969/j.issn.1006-0111.201907135
  • 1. 首都医科大学附属北京安贞医院, 北京 100048
  • 2. 解放军总医院第六医学中心, 北京 100048
  • 收稿日期: 2019-07-29
  • 修回日期: 2019-12-25

摘要: 目的 评价短期（3～6个月）与长期（12个月）双联抗血小板治疗对冠状动脉药物洗脱支架植入后的临床效果。 方法 研究病例包括稳定性心绞痛、急性冠脉综合征、无症状心肌缺血，均为原位血管病变。临床观察终点为：全因死亡、心源性死亡、心肌梗死、卒中、支架内血栓形成、靶病变再血管化治疗、严重出血、净不良临床事件（net adverse clinical event）。通过检索Pubmed、中国生物医学文献等中、英文数据库及手工检索，对符合条件的随机对照研究经质量评估、数据提取，进行Meta分析。 结果 共计纳入12项随机对照研究。Detsky评分均大于5分。共计25 949个病例，随访率97.9%。两组在全因死亡（OR=0.86，95%CI 0.71～1.05，P=0.14）、心源性死亡（OR=0.94，95% CI 0.70～1.25，P=0.67）、支架血栓形成（OR=1.36，95%CI 0.94～1.98，P=0.11）、卒中（OR=1.01，95%CI 0.71～1.42，P=0.98）、靶病变再血管化（OR=0.121，95%CI 0.94～1.55，P=0.14）及净不良临床事件（OR=0.98，95%CI 0.83～1.14，P=0.75）均无明显差别；短期组随访期间心肌梗死发生率高于长期组（OR=1.27，95%CI 1.02～1.59，P=0.04），长期组严重出血的比例明显增加（OR=0.69，95%CI 0.50～0.95，P=0.02）。亚洲人群研究结果：长期治疗组全因死亡高于短期组（OR=0.72，95%CI 0.53～0.97，P=0.03），两组严重出血无明显差别。 结论 依据限定的临床观察终点，短期双联抗血小板疗效不劣于长期组；7项亚组人群研究，长期组全因死亡率高，不排除与样本量偏少产生的偏移及（或）人群的个体差异有关，结果还有待进一步验证。此结果可作为临床工作警示，依据患者出血风险及冠状动脉病变结果个体化调整双联抗血小板周期。

English Abstract

费舒扬, 赵力, 孙琳, 张蓉, 李晶, 葛长江. 植入药物洗脱支架后短期与长期双联抗血小板疗效比较的Meta分析[J]. 药学实践与服务, 2020, 38(1): 81-87. doi: 10.3969/j.issn.1006-0111.201907135
引用本文: 费舒扬, 赵力, 孙琳, 张蓉, 李晶, 葛长江. 植入药物洗脱支架后短期与长期双联抗血小板疗效比较的Meta分析[J]. 药学实践与服务, 2020, 38(1): 81-87. doi: 10.3969/j.issn.1006-0111.201907135
shu
FEI Shuyang, ZHAO Li, SUN Lin, ZHANG Rong, LI Jing, GE Changjiang. Comparison of short-term and long-term dual antiplatelet therapy after implantation of drug-eluting stents—Meta analysis[J]. Journal of Pharmaceutical Practice and Service, 2020, 38(1): 81-87. doi: 10.3969/j.issn.1006-0111.201907135
Citation: FEI Shuyang, ZHAO Li, SUN Lin, ZHANG Rong, LI Jing, GE Changjiang. Comparison of short-term and long-term dual antiplatelet therapy after implantation of drug-eluting stents—Meta analysis[J]. Journal of Pharmaceutical Practice and Service, 2020, 38(1): 81-87. doi: 10.3969/j.issn.1006-0111.201907135
shu

    全文HTML

参考文献 (30)

目录

    /

    返回文章
    返回

    版权所有：《药学实践与服务》编辑委员会

    主管、主办: 中国人民解放军海军军医大学地址: 上海市杨浦区国和路325号邮政编码: 200433

    电话: （021）81871324,81871397 E-mail: yxsjzzs@163.com

    网站备案号 沪ICP备05003363号-1

    本系统由 北京仁和汇智信息技术有限公司 开发    百度统计