老年患者置入新型药物洗脱支架术后6个月与12个月双联抗血小板治疗的有效性和安全性比较

目的比较老年患者置入新型药物洗脱支架(BP-SES)术后,应用6个月与12个月双联抗血小板治疗(DAPT)的疗效和安全性。方法纳入I-LOVE-IT 2研究中置入BP-SES老年患者(≥65岁)627例,其中接受6个月DAPT治疗319例(6个月DAPT组),12个月DAPT治疗308例(12个月DAPT组)。本研究的主要终点为12个月的靶病变失败(TLF,包含心源性死亡、靶血管心肌梗死和临床驱动的靶病变再次血运重建的复合终点),次要终点为12个月净不良临床事件(NACE,包含全因死亡、心肌梗死、缺血性卒中或全部出血的复合终点)以及12个月支架内血栓形成发生率。结果两组患者年龄、性别、体重指数、糖尿病、高血压病等方面比较,差异均无统计学意义(均P0.05)。基线SYNTAX评分、靶病变个数、靶血管位置等基线造影特征方面比较,差异均无统计学意义(均P0.05)。随访12个月Kaplan-Meier累积事件,6个月DAPT组主要终点TLF发生率(7.2%比7.1%,P=0.980),次要终点NACE发生率(14.1%比13.0%,P=0.726),支架内血栓形成发生率(2.8%比1.0%,P=0.101)与12个月DAPT组比较,差异均无统计学意义。明确或极可能的支架内血栓形成共5例,其中6个月和12个月DAPT组分别有3例和2例(0.9%比0.6%,P=0.682),差异无统计学意义。界标分析结果显示,在6至12个月随访期间,6个月DAPT组TLF(2.3%比1.7%,P=0.593),NACE事件发生率(4.2%比2.9%,P=0.392),出血发生率(1.0%比1.0%,P=0.961)与12个月DAPT组比较,差异无统计学意义。结论在接受新一代药物洗脱支架置入的老年患者中,术后接受6个月DAPT治疗者,有效性和安全性与接受12个月DAPT的患者差异无统计学意义。     

美国心脏病学会编制的2013年度心血管临床研究TOP 10(四)

<正>NO.7 OPTIMIZE试验OPTIMIZE试验纳入3 119例接受二代佐他莫司洗脱支架(ZES)的稳定型冠心病或低风险急性冠状动脉综合征(ACS)患者,随机分配到3个月DAPT组(n=1 563)或12个月DAPT(n=1 556)。DAPT为每日100²00 mg阿司匹林和75 mg氯吡格雷。结果显示佐他莫司支架置入后3个月DAPT不劣于标准12个月治疗。重要的是,DAPT时间的缩短并不增加支架内血栓形成的风险。OPTIMIZE试验显示二     

佐他莫司洗脱支架与依维莫司洗脱支架5年临床疗效比较

目的比较佐他莫司和依维莫司两类药物洗脱支架的长期临床安全性和有效性。方法纳入2011年1月至2012年12月于武汉亚洲心脏病医院接受经皮冠状动脉介入治疗的患者480例,根据置入支架类型,分为佐他莫司洗脱支架组(ZES组,244例)和依维莫司洗脱支架组(EES组,236例)。随访5年的临床疗效。初级终点是主要不良心血管事件,包括全因死亡、非致死性心肌梗死、靶血管再次血运重建。次级终点为支架内再狭窄及支架内闭塞。结果 5年随访结果显示,两组患者全因死亡率和非致死性急性心肌梗死发生率比较,差异均无统计学意义(均P0.05)。EES组患者靶血管再次血运重建(5.1%比10.2%,P=0.040)、支架内再狭窄(5.9%比11.5%,P=0.036)和支架内闭塞(2.1%比6.1%,P=0.038)发生率均显著低于ZES组,差异均有统计学意义。结论 EES的5年临床安全性和有效性优于ZES。     

置入国产雷帕霉素药物洗脱支架冠心病患者双联抗血小板治疗效果的研究

目的:对置入国产雷帕霉素支架(Firebird)的冠心病患者,12个月双联抗血小板(DAPT)后继续延长DAPT时间能否获益进行分析。方法:回顾性分析2007年1月至2009年12月,于北京安贞医院心内科置入Firebird支架的患者,按照DAPT的时间,分为12个月停用DAPT组和12个月DAPT组,通过门诊或电话随访,评价术后患者死亡、心肌梗死、脑卒中联合终点发生率,靶血管再次血运重建发生率。结果:共入选患者1 073例,随访平均(29.4±6.2)个月,按照排除标准筛选后共955例患者纳入分析,12个月停用DAPT患者410例,12个月DAPT组患者545例。12个月停用DAPT和12个月DAPT组死亡/心肌梗死/脑卒中发生率分别为5.2和1.6,P=0.016,多因素校正后,12个月停用DAPT组仍较12个月DAPT组显著增加死亡/心肌梗死/脑卒中风险(HR=3.56,95%CI:1.18~10.8,P=0.025)。结论:对于置入Firebird的患者,与12个月时停用DAPT仅使用阿司匹林比较,12个月后继续使用DAPT显著降低不良事件风险。     

聚合物涂层可降解钴铬合金西罗莫司(雷帕霉素)洗脱支架(EXCEL2)治疗冠心病合并糖尿病患者的有效性与安全性:CREDIT研究亚组分析

目的通过对CREDITⅡ、Ⅲ研究中的糖尿病亚组资料进行分析,探讨第二代聚合物涂层可降解钴铬合金西罗莫司(雷帕霉素)洗脱支架(EXCEL2)在糖尿病患者中的有效性和安全性。方法入选了CREDITⅡ、Ⅲ研究中置入EXCEL2支架的所有患者。主要终点为24个月的靶病变失败,以心源性死亡、靶血管心肌梗死和临床驱动的靶病变血运重建为复合终点。次要终点为患者相关复合终点,包括全因死亡、心肌梗死和血运重建。结果入选828例患者24个月随访率99.5%,糖尿病组与非糖尿病组比较,主要终点事件发生率(P0.05)及次要终点发生率[全因死亡(2.5%比1.4%,P=0.290)、心肌梗死(7.5%比5.0%,P=0.215)、任何血运重建(5.0%比3.9%,P=0.533)以及支架内血栓形成(0.6%比0.5%,P=0.577)],差异均无统计学意义。结论 EXCEL2支架可降低糖尿病患者术后支架内再狭窄、靶病变血运重建率及支架内血栓形成风险,且不劣于非糖尿病患者。     

Firebird2~(TM)和Excel药物洗脱支架治疗冠心病的近期疗效比较

目的:比较Excel药物洗脱支架和Firebird 2TM药物洗脱支架在冠心病患者中应用的近期疗效。方法:将2009年12月至2010年9月,在安贞医院连续住院的264例原位冠状动脉病变的患者,纳入本项前瞻性随机对照研究。其中137例仅置入Firebird 2TM药物洗脱支架,127例仅置入Excel药物洗脱支架。规律随访患者,比较2组患者支架术后的心脏不良事件发生率。随访的具体内容包括主要终点事件(全因死亡、靶血管血运重建、非致死性心肌梗死、血栓事件)和次要终点事件(不稳定心绞痛、缺血性脑卒中及心功能衰竭)。分析支架多聚物涂层对心脏不良事件的影响。结果:2组患者年龄、性别、吸烟史、高血压、脂质异常、糖尿病、既往介入治疗、既往心肌梗死、既往冠状动脉旁路手术及本次入院诊断急性心肌梗死所占比例方面差异均无统计学意义。Firebird 2TM药物洗脱支架组患者平均支架个数较Excel药物洗脱支架组个数分别为(1.93±1.13)个和(1.57±0.94)个。临床随访1.84～10.78个月,平均(5.36±1.91)个月,2组患者均未发生心源性死亡、靶病变血管导致的心肌梗死、靶病变缺血导致的血运重建及支架血栓事件。Firebird 2TM药物洗脱支架组患者不稳定心绞痛1例,心力衰竭(心衰)1例,Excel药物洗脱支架组,不稳定心绞痛3例,心衰1例,Kaplan-Meier生存曲线显示2组患者全部终点事件没有差别。结论:Firebird 2TM药物洗脱支架和Excel药物洗脱支架,在冠心病患者中应用的近期安全性方面疗效相似。     

佐他莫司药物洗脱支架和依维莫司药物洗脱支架二年临床疗效比较

目的:比较佐他莫司药物洗脱支架(ZES)和依维莫司药物洗脱支架(EES)的2年临床疗效。方法:纳入2013年在中国医学科学院阜外医院初次行经皮冠状动脉介入治疗(PCI)的患者2655例,根据支架类型分为两组:ZES组(n=1637)和EES组(n=1018)。2年随访的主要终点为主要不良心血管事件(MACE),包括死亡、非致死性心肌梗死和靶血管血运重建。结果:两组患者的人口学特征、危险因素和既往史、实验室检查结果以及药物应用方面均相似(P均>0.05)。在冠状动脉病变和介入治疗方面,与EES组相比,ZES组SYNTAX积分更高,左主干病变、B2/C型病变的比例更高,置入的支架直径更大、长度更长(P均<0.05)。2年随访结果显示,ZES组与EES组中MACE(5.4%vs 4.9%)以及各独立终点事件的发生率差异均无统计学意义(P均>0.05)。结论:以ZES和EES为代表的新一代药物洗脱支架临床应用安全、有效;2年随访结果显示,两种支架MACE发生率差异无统计学意义。     

糖尿病急性ST段抬高心肌梗死应用雷帕霉素药物洗脱支架1年随访分析

目的探讨雷帕霉素药物洗脱支架在糖尿病急性ST段抬高心肌梗死(STEMI)患者急诊经皮冠状动脉介入治疗(PCI)中应用的安全性和有效性。方法选择2002年11月至2005年10月间首都医科大学附属北京朝阳医院心脏中心收治的糖尿病急性STEMI患者106例,于发病12h内行急诊PCI治疗,置入雷帕霉素药物洗脱支架。记录术后1个月和12个月随访终点时的心血管事件发生率、支架内血栓发生率及支架内再狭窄发生率。结果105例患者急诊PCI治疗获得成功。106支梗塞相关血管(IRA)的110处罪犯病变处置入雷帕霉素药物洗脱支架134枚,未发生与介入治疗有关的并发症。1个月随访终点时死亡4例(3.77%),发生急性心肌梗死1例,心血管事件总发生率为4.72%;发生支架内血栓1例;血运重建1例。12个月随访终点时除1个月时死亡的4例外未再发生死亡病例,共发生心血管事件11例(10.38%),发生支架内血栓2例(1.89%),52例接受冠状动脉造影复查患者中发生支架内再狭窄6例(11.54%)。结论雷帕霉素药物洗脱支架在STEMI急诊PCI中应用有较高的安全性和有效性,并可以明显降低再狭窄率。     

佐他莫司和西罗莫司支架在老年冠心病患者介入治疗中的对比研究

目的 比较佐他莫司支架和西罗莫司支架治疗老年冠心病的临床效果. 方法回顾性分析2006年8月至2007年5月我院对635例老年冠心病患者连续支架植入治疗的临床资料.其中植入佐他莫司(佐他莫司组)支架334例,西罗莫司(西罗莫司组)支架301例.比较两组治疗成功率、主要心脏不良事件等临床情况,并进行对比分析. 结果两组基线临床特点佐他莫司组高脂血症和左主干病变少于西罗莫司组,佐他莫司组再狭窄病变、支架长度、支架最大释放压和后扩张比率均小于西罗莫司组.两组介入成功率均为100%.主要心脏不良事件发生率与佐他莫司组比较(分别为4.5%(15例)与4.3%(13例)],差异无统计学意义,其中心原性死亡、非致死性心肌梗死和靶血管重建率两组比较,差异无统计学意义.支架内血栓发生率佐他莫司组和西罗莫司组分别为0.3%(1例)和0.7%(2例),差异无统计学意义.早期、晚期支架内血栓发生率两组比较,差异无统计学意义.7个月随访,佐他莫司组和两罗莫司组支架内和血管段再狭窄率[分别为5.9%(4/68)和3.5%(3/36),7.4%(5/65)和4.7%(4/86)]比较,差异无统计学意义.但支架内和血管段的晚期丢失佐他莫司组均大于西罗莫司组,分别为(0.48±0.12)mm与(0.24±0.09)mm和(0.44±0.13)mm与(0.26±0.09)mm,均P< 0.01. 结论7个月随访结果证实,佐他莫司和西罗莫司支架对于老年冠心病患者具有相似的疗效.     

药物洗脱支架置入后≤6个月与≥12个月双联抗血小板治疗的Meta分析

目的:系统评价药物洗脱支架(DES)置入后≤6个月与≥12个月双联抗血小板治疗(DAPT)的安全性和有效性。方法:收集2015-01之前公布随访数据的DES置入后≤6个月对比≥12个月DAPT的随机对照试验。计算机检索PubM ed、EMBASE、Cochrane Library、Scopus和中国生物医学文献数据库,同时手动检索国内外相关心血管会议记录,由两名研究员独立进行文献筛选、资料提取和质量评估,采用STATA12.0软件进行Meta分析。结果:最终纳入7个随机对照研究,共包含15 378例患者,术后接受DAPT治疗≤6个月为7 672例(≤6个月DAPT组),≥12个月为7 706例(≥12个月DAPT组)。Meta分析结果显示:与≥12个月DAPT组相比,≤6个月DAPT组可有效降低主要出血(比值比=0.58,95%可信区间:0.37~0.91,P=0.017),差异有统计学意义;而在全因死亡(比值比=0.90,95%可信区间:0.73~1.11,P=0.314)、心原性死亡(比值比=0.93,95%可信区间:0.70~1.24,P=0.617)、心肌梗死(比值比=1.13,95%可信区间:0.91~1.41,P=0.275)、支架内血栓(比值比=1.21,95%可信区间:0.79~1.85,P=0.382)、脑血管意外(比值比=1.00,95%可信区间:0.66~1.51,P=1.000)方面,两组差异均无统计学意义。结论:在接受DES治疗的冠心病患者中,≤6个月DAPT组与≥12个月DAPT组在预防缺血性心脑血管事件方面差异均无统计学意义,但≤6个月DAPT组能有效降低出血风险,更适用于新一代DES置入后,高出血风险、低血栓风险、服药依从性差和正常药物反应性的患者。然而≤6个月DAPT组对置入DES的特定中国人群临床结局的影响仍有待大规模临床随机对照研究去验证。     

Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE

BackgroundResolute Onyx polymer-based zotarolimus-eluting stents (ZES) were noninferior in safety and effectiveness to BioFreedom polymer-free biolimus A9-coated stents (DCS) in high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) at 1 year.ObjectivesThis study reports the final 2-year results of the randomized Onyx ONE trial.MethodsThe Onyx ONE (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients) trial randomly assigned HBR patients to treatment with ZES or DCS. Following 1-month DAPT, event-free patients received SAPT (either aspirin or a P2Y₁₂ inhibitor at physician discretion). The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year. Rates of primary and secondary endpoints were calculated after final follow-up at 2 years.ResultsA total of 1,003 patients were randomly allocated to ZES and 993 patients to DCS. Follow-up was complete in 980 (97.7%) ZES patients and 962 (96.9%) DCS patients at 2 years. The primary safety endpoint occurred in 208 (21.2%) patients in the ZES group and 199 (20.7%) patients in the DCS group (risk difference: 0.5%; 95% CI: ?3.1% to 4.2%; P = 0.78) at 2 years without significant differences in individual components of the composite endpoint. The secondary effectiveness endpoint occurred in 217 (22.1%) patients in the ZES group and 202 (21.0%) patients in the DCS group (risk difference: 1.1%; 95% CI: ?2.5% to 4.8%; P = 0.54).ConclusionsAmong patients at HBR treated with 1-month DAPT followed by SAPT, the Resolute Onyx polymer-based ZES had similar 2-year outcomes for the primary safety and secondary effectiveness endpoint compared with the BioFreedom polymer-free DCS. (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy [DAPT] for High-Bleeding Risk Patients [Onyx ONE]; NCT03344653)     

Stent Thrombosis in Drug-Eluting or Bare-Metal Stents in Patients Receiving Dual Antiplatelet Therapy

ObjectivesThis study sought to compare rates of stent thrombosis and major adverse cardiac and cerebrovascular events (MACCE) (composite of death, myocardial infarction, or stroke) after coronary stenting with drug-eluting stents (DES) versus bare-metal stents (BMS) in patients who participated in the DAPT (Dual Antiplatelet Therapy) study, an international multicenter randomized trial comparing 30 versus 12 months of dual antiplatelet therapy in subjects undergoing coronary stenting with either DES or BMS.BackgroundDespite antirestenotic efficacy of coronary DES compared with BMS, the relative risk of stent thrombosis and adverse cardiovascular events is unclear. Many clinicians perceive BMS to be associated with fewer adverse ischemic events and to require shorter-duration dual antiplatelet therapy than DES.MethodsProspective propensity-matched analysis of subjects enrolled into a randomized trial of dual antiplatelet therapy duration was performed. DES- and BMS-treated subjects were propensity-score matched in a many-to-one fashion. The study design was observational for all subjects 0 to 12 months following stenting. A subset of eligible subjects without major ischemic or bleeding events were randomized at 12 months to continued thienopyridine versus placebo; all subjects were followed through 33 months.ResultsAmong 10,026 propensity-matched subjects, DES-treated subjects (n = 8,308) had a lower rate of stent thrombosis through 33 months compared with BMS-treated subjects (n = 1,718, 1.7% vs. 2.6%; weighted risk difference −1.1%, p = 0.01) and a noninferior rate of MACCE (11.4% vs. 13.2%, respectively, weighted risk difference −1.8%, p = 0.053, noninferiority p < 0.001).ConclusionsDES-treated subjects have long-term rates of stent thrombosis that are lower than BMS-treated subjects. (The Dual Antiplatelet Therapy Study [DAPT study]; NCT00977938)     

Safety and Efficacy of Ultra Short-duration Dual Antiplatelet Therapy After Percutaneous Coronary Interventions: A Meta-analysis of Randomized Controlled Trials

Dual antiplatelet therapy (DAPT) is required after percutaneous coronary intervention (PCI) to reduce stent thrombosis, but DAPT increases bleeding risks. The optimal duration of DAPT that provides the maximum protective ischemic effect along with the minimum bleeding risk is unclear. This is the first meta-analysis comparing outcomes for 1-month versus longer DAPT strategies following PCI.We searched PubMed, Cochrane, and ClinicalTrials.gov databases (from inception to October 2021) for randomized controlled trials that compared 1-month duration vs > 1-month duration of DAPT following PCI. We used a random-effects model to calculate risk ratio (RR) with 95% confidence interval (CI). The co-primary outcomes for study selection were all-cause mortality, major bleeding, and stent thrombosis. Secondary outcomes included myocardial infarction (MI), cardiovascular mortality, ischemic stroke and target vessel revascularization. A total of five randomized controlled trials were included [n = 29,355; 1-month DAPT(n = 14,662) vs > 1-month DAPT (n = 14,693)]. There was no statistically significant difference between the two groups in terms of all-cause mortality (RR 0.89; 95% CI 0.78-1.03; P = 0.12) and stent thrombosis (RR 1.07; 95% CI 0.80-1.43; P = 0.65). Similarly, there were no significant differences in MI, cardiovascular mortality, ischemic stroke, and target vessel revascularization. The rate of major bleeding was significantly lower in the group treated with DAPT for 1-month (RR 0.74; 95% CI 0.56-0.99, P = 0.04).There is no difference in all-cause mortality, cardiovascular mortality, MI, stent thrombosis, ischemic stroke, and target vessel revascularization with 1-month of DAPT following PCI with contemporary drug eluting stents compared to longer DAPT duration.     

应用双联抗血小板治疗评分指导冠状动脉慢性闭塞病变患者抗血小板药物治疗

目的探讨双联抗血小板治疗(DAPT)评分是否可用于指导冠状动脉慢性闭塞病变(CTO)患者经皮冠状动脉介入(PCI)术后的双联抗血小板药物治疗。方法选取2014年1月至2017年6月于白求恩国际和平医院心血管内科接受PCI治疗的CTO患者497例,应用DAPT评分工具评估,分别观察≥2分及<2分的患者采用标准双联抗血小板治疗(12个月)或延长治疗(12~58个月)的主要心脑血管事件(MACCE)发生率及出血情况。采用SPSS 22.0软件进行数据统计分析。结果共入组患者405例,随访时间34(28,44)个月。(1)在DAPT评分≥2分的患者中,延长双抗治疗组较标准双抗治疗组MACCE的发生率低,差异有统计学意义(5.5%和14.0%,P=0.040)。延长双抗治疗组心源性死亡、靶血管血运重建的发生率低于标准双抗治疗组,分别为(1.8%和8.6%,1.8%和8.6%),差异均有统计学意义(P<0.05)。Kaplan-Meier分析显示,延长双抗治疗组与标准双抗治疗组MACCE生存率比较,差异有统计学意义(P=0.046)。(2)在DAPT评分<2分的患者中,2组MACCE的比较,差异无统计学意义(P<0.05)。标准双抗治疗组的BARC 2,3,5型出血事件显著低于延长双抗治疗组(3.4%和12.8%,P=0.018)。Kaplan-Meier分析显示,标准双抗治疗组较延长双抗治疗组无出血事件生存率高(P=0.034)。结论DAPT评分可用于指导CTO患者PCI术后双抗治疗的时程,≥2分的CTO患者PCI术后给予延长的双联抗血小板治疗获益更多,<2分的患者给予标准时程的双联抗血小板治疗出血风险更低。     

Impact of prolonged dual antiplatelet therapy on patients after drug-eluting stents implantation

Background Impact of dual antiplatelet therapy beyond 12 months on patients implanted with DES remains unsolved.Methods From January 2010 to June 2011,1873 patients who have been taking DAPT and free from death,myocardial infarction,stroke,repeat coronary revascularization,stent thrombosis,and major or minor bleeding according to TIMI criteria for 12 months after implantation of DES were randomly assigned to continuous (prolonged DAPT group) or discontinuous (standard DAPT group) clopidogrel (75 mg/day).The primary outcome was major adverse cardiovascular events (MACEs) which compose of death,nonfatal myocardial infarction (MI),nonfatal stroke,target vessel revascularization (TVR) or stent thrombosis (ST) at 180 days.Results There was no significant difference in the incidence of 180-day MACEs between prolonged DAPT group and standard DAPT group (8.98 % versus 10.13 %,respectively,P=0.400).The frequency of major bleeding was 0.64 % in prolonged DAPT arm and 0.43% in standard DAPT arm (P=0.523),that of minor bleeding was 3.32 % versus 2.87 % (P=0.585),respectively.Conclusions Prolonged DAPT beyond 12 months neither improve prognosis nor increase risk of bleeding in patients implanted with DES.     

Ticagrelor Monotherapy Versus Ticagrelor With Aspirin in Patients With ST-Segment Elevation Myocardial Infarction

ObjectivesThe aim of this study was to assess whether the effects of ticagrelor monotherapy after 3-month dual-antiplatelet therapy (DAPT) are consistent among patients presenting with ST-segment elevation myocardial infarction (STEMI), non–ST-segment elevation myocardial infarction, and unstable angina treated with drug-eluting stents.BackgroundTicagrelor monotherapy after short-term DAPT has not been investigated in patients with STEMI.MethodsThis was a pre-specified, stratified, subgroup analysis of the STEMI cohort from the TICO (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome) trial, which constituted 36% of the total population. The primary outcome was a composite of major bleeding and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction, stent thrombosis, stroke, or target vessel revascularization). The secondary outcomes were major bleeding and MACCE.ResultsThe incidence of the primary outcome was 4.4% in patients with STEMI (n = 1,103), 6.0% in those with non–ST-segment elevation myocardial infarction (n = 1,027), and 4.1% in those with unstable angina (n = 926), without statistical significance (p = 0.09). Compared with ticagrelor-based 12-month DAPT, ticagrelor monotherapy after 3-month DAPT showed consistent effects on the primary outcome across clinical presentations (p for interaction [p_int] = 0.64). Furthermore, the effect of ticagrelor monotherapy on the reduction of major bleeding was consistent across clinical presentations (p_int = 0.36). The effect of ticagrelor monotherapy on MACCE was also consistent in patients with STEMI, without evidence of a higher risk for MACCE (p_int = 0.14).ConclusionsThis pre-specified subgroup analysis revealed no heterogeneity in the effects of ticagrelor monotherapy after 3-month DAPT, compared with 12-month DAPT, for the primary outcome, major bleeding, and MACCE across clinical presentations including STEMI, though larger studies are needed to demonstrate these findings with adequate power. (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome [TICO Study]; NCT02494895)     

P2Y12 Inhibitor or Aspirin Following Dual Antiplatelet Therapy After Percutaneous Coronary Intervention: A Network Meta-Analysis

BackgroundIt is still unknown which antiplatelet monotherapy should be continued after a period of dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI).ObjectivesThe aim of this study was to compare aspirin vs P2Y₁₂ inhibitor (P2Y₁₂-I) monotherapy after dual antiplatelet therapy (DAPT) discontinuation in patients undergoing percutaneous coronary intervention (PCI).MethodsRandomized studies enrolling patients undergoing PCI with second-generation drug-eluting stents and comparing aspirin or P2Y₁₂-I monotherapy after DAPT discontinuation vs prolonged DAPT or aspirin vs P2Y₁₂-I monotherapy after DAPT were included. Primary efficacy and safety endpoints were myocardial infarction (MI) and major bleeding (MB), respectively. Point estimates for dichotomous outcomes were pooled using frequentist and Bayesian frameworks. Sensitivity analyses and treatment hierarchy were performed.ResultsNineteen studies encompassing 73,126 patients were included. The transitivity assumption was met. Under the frequentist framework, patients receiving aspirin had a significantly higher risk for MI compared with P2Y₁₂-I monotherapy (risk ratio: 1.32; 95% CI: 1.08-1.62). Compared with DAPT, both monotherapies reduced MB, but only P2Y₁₂-I showed equivalent efficacy in preventing MI. No significant differences in MB, death, and other thrombotic outcomes were observed. However, point estimates for the risk for stent thrombosis and stroke favored P2Y₁₂-I monotherapy. Consistent results were found in a fixed-effects model and the Bayesian framework, with all models having adequate convergence. P2Y₁₂-I vs aspirin monotherapy had the highest probability of being ranked first for reduction of all assessed outcomes.ConclusionsP2Y₁₂-I monotherapy following DAPT discontinuation after PCI is associated with a significantly lower risk for MI and similar risk for MB, suggesting a potentially relevant net clinical benefit vs aspirin monotherapy. These findings strengthen the rationale for further studies directly comparing the 2 monotherapies after DAPT in PCI patients.     

Impact of proton pump inhibitors on clinical outcomes in patients after acute myocardial infarction: a propensity score analysis from China Acute

BackgroundProton pump inhibitors (PPIs) are recommended by the latest guidelines to reduce the risk of bleeding in acute myocardial infarction (AMI) patients treated with dual antiplatelet therapy (DAPT). However, previous pharmacodynamic and clinical studies have reported controversial results on the interaction between PPI and the P₂Y₁₂ inhibitor clopidogrel. We investigated the impact of PPIs use on in-hospital outcomes in AMI patients, aiming to provide a new insight on the value of PPIs.MethodsA total of 23, 380 consecutive AMI patients who received clopidogrel with or without PPIs in the China Acute Myocardial Infarction (CAMI) registry were analyzed. The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE) defined as a composite of in-hospital cardiac death, re-infarction and stroke. Propensity score matching (PSM) was used to control potential baseline confounders. Multivariate logistic regression analysis was performed to evaluate the effect of PPIs use on MACCE and gastrointestinal bleeding (GIB).ResultsAmong the whole AMI population, a large majority received DAPT and 67.5% were co-medicated with PPIs. PPIs use was associated with a decreased risk of MACCE (Before PSM OR: 0.857, 95% CI: 0.742-0.990, P = 0.0359; after PSM OR: 0.862, 95% CI: 0.768-0.949, P = 0.0245) after multivariate adjustment. Patients receiving PPIs also had a lower risk of cardiac death but a higher risk of complicating with stroke. When GIB occurred, an alleviating trend of GIB severity was observed in PPIs group.ConclusionsOur study is the first nation-wide large-scale study to show evidence on PPIs use in AMI patients treated with DAPT. We found that PPIs in combination with clopidogrel was associated with decreased risk for MACCE in AMI patients, and it might have a trend to mitigate GIB severity. Therefore, PPIs could become an available choice for AMI patients during hospitalization.     

24- and 6-month dual antiplatelet therapy after coronary stenting did not differ for clinical outcomes

QUESTION What is the relative efficacy of dual antiplatelet therapy (DAPT) given for 24 months compared with 6 months after coronary stent implantation? METHODS DESIGN Randomized controlled trial (RCT) (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study [PRODIGY]). ClinicalTrials.gov NCT00611286. ALLOCATION Unclear allocation concealment.* BLINDING Blinded* (event adjudication committee). FOLLOW-UP PERIOD 2 years. SETTING 3 referral centers in Italy. PATIENTS 1970 patients ≥?18 years of age (mean age 68 y, 77% men) who had chronic, stable coronary artery disease or an acute coronary syndrome; ≥?1 lesion with ≥?50% diameter stenosis in a vessel ≥?2.25 mm in diameter that was suitable for coronary stent implantation; and elective, urgent, or emergent coronary angioplasty with 1 of 4 randomly assigned types of stent (bare metal or everolimus-, paclitaxel-, or zotarolimus-eluting) 30 days before DAPT randomization. Exclusion criteria included planned surgery within 24 months unless DAPT could be continued, major surgery within 15 days, history of bleeding diathesis, active bleeding or stroke in the past 6 months, expected need for oral anticoagulation therapy, pregnancy, or life expectancy <?24 months. INTERVENTION DAPT using oral clopidogrel, loading dose of 300 or 600 mg and then 75 mg/d, plus aspirin, loading dose of 160 to 325 mg orally or IV 500 mg and then 80 to 160 mg/d orally for 24 months (n =?987); or for 6 months followed by aspirin alone (n =?983). OUTCOMES Primary composite endpoint (all-cause mortality, nonfatal myocardial infarction, or cerebrovascular accident). Other outcomes included components of the composite endpoint, stent thrombosis, and bleeding. 1700 patients were needed to detect a 40% relative reduction in the primary endpoint at 2 years from 8% in the 6-month group (80% power, 2-sided α =?0.05). PATIENT FOLLOW-UP 99.6% (intention-to-treat analysis). MAIN RESULTS The main results are in the Table. CONCLUSION 24-month dual antiplatelet therapy after stent implantation increased bleeding and did not improve a composite of mortality, myocardial infarction, and cerebrovascular accident more than 6-month therapy.24 mo vs 6 mo of dual antiplatelet therapy after coronary stent implantation?Outcomes24-mo treatment6-mo treatmentAt 2 yRRI (95% CI)NNH (CI)Primary composite?10.1%10.0%2% (-27 to 25)Not significantBleeding§7.4%3.5%53% (30 to 68)26 (20 to 45)RRR (CI)NNT (CI)Definite or probable stent thrombosis1.3%1.5%15% (-45 to 139)Not significant?Abbreviations defined in Glossary. RRI, RRR, NNH, and CI calculated from hazard ratios and event rates in article.?All-cause mortality (6.6% vs 6.6%, P =?0.98), myocardial infarction (4.0% vs 4.2%, P =?0.80), and cerebrovascular accident (2.1% vs 1.4%, P =?0.17).§Bleeding Academic Research Consortium classification type 5, 3, or 2.