The impact of unfractionated heparin or bivalirudin on patients with stable coronary artery disease undergoing percutaneous coronary intervention

Objectives

To compare bleeding and clinical events of patients with stable angina or silent ischemia undergoing percutaneous coronary intervention (PCI) treated with unfractionated heparin (UFH) or bivalirudin.

Background

Few direct comparisons between UFH monotherapy versus bivalirudin exist for patients with stable ischemic heart disease undergoing PCI.

Methods

A prospective, investigator‐initiated, single‐center, single‐blinded, randomized trial of UFH versus bivalirudin was conducted. The primary endpoint was all bleeding (major and minor) from index‐hospitalization to 30 days post discharge. Secondary endpoints included major adverse cerebral and cardiovascular events (MACCE) and net adverse clinical events (NACE).

Results

Two‐hundred‐sixty patients were randomized for treatment with either UFH (n = 123) (47%) or bivalirudin (n = 137) (53%) There were no significant differences in baseline clinical and angiographic characteristics between the two groups. Primary endpoint was similar in both groups (10.9% with bivalirudin vs 7.3% with UFH [P = 0.31]). Major bleeding rates were 5.8% and 2.4%, respectively (P = 0.17). There was a higher MACCE (3.5% vs 0%, P = 0.03) and NACE (8.8% vs 2.4%, P = 0.03) rate with bivalirudin compared to UFH, respectively. Bivalirudin had increased odds of NACE (OR = 3.65, 95% CI: 1.00‐13.3.6). Death and stent thrombosis rates were low and similar in both groups. Radial access was associated with fewer bleeding events compared to femoral access but not statistically significant (P = 0.29).

Conclusions

Among patients with stable angina or silent ischemia, there was no difference between UFH and bivalirudin in bleeding rates up to 30‐days post‐PCI. MACCE and NACE were higher among the bivalirudin group. Radial access was associated with a numerically lower rate of bleeding compared with femoral access.     

冠心病介入抗栓治疗相关最新进展概要

近年经皮冠状动脉介入治疗（PCI）相关抗栓领域取得了许多关键性的进展。以TWILIGHT等研究为代表的降阶治疗探索是目前PCI术后抗血小板策略研究的主流方向之一,而在合并心房颤动PCI患者中,联合新型口服抗凝药物的双联或短程三联抗栓方案的有效和安全性已获多项新研究的印证。比伐芦定新的研究结果将更新直接PCI抗凝的循证证...     

冠状动脉介入术后患者抑郁障碍及其与预后的关系

目的探讨经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)术后冠心病患者抑郁障碍的患病率及其和临床预后的关系。方法采用24项汉密尔顿抑郁量表(Hamilton depression rating scale,HAMD)对400例PCI患者术前及术后2周分别进行抑郁障碍评分,根据术后2周的抑郁障碍评分分为抑郁组(HAMD≥21分)和非抑郁组(HAMD21分),并于出院后对两组患者进行12个月的临床随访。随访终点为12个月内的主要不良心血管事件(major adverse cardiovascular event,MACE),包括全因死亡、非致死性心肌梗死和靶病变重建(target lesion revascularization,TLR)。结果术前符合HAMD抑郁诊断标准的患者为102例(25.5%),术后2周符合诊断标准的患者为154例(38.5%),PCI术后患者的抑郁患病率较术前明显增高(P0.001)。术后抑郁患者出院后12个月内有31例(20.1%)发生了MACE,明显高于无抑郁的患者(19例,7.7%),P0.001。Logistic多因素回归分析显示抑郁状态是PCI术后患者12个月MACE的独立危险因素(OR2.34,95%CI1.26～4.03,P=0.024)。结论PCI术后有较高比例的患者存在不同程度的抑郁状态。术后抑郁状态是PCI术后患者发生MACE的独立危险因素。     

Hyperuricemia and severity of coronary artery disease in patients undergoing selective percutaneous coronary intervention

Background Hyperuricemia as an independent predictor for presence of coronary artery disease(CAD)has been studied insufficiently. In this study, we evaluated the predictive value of hyperuricemia for the severity of coronary artery disease. Methods A total of 683 patients undergoing elective percutaneous coronary intervention (PCI) were prospectively observed and were divided into two groups (hyperuricemic group, n = 216, and normouricemic group, n = 467). Hyperuricemia (HUA) was defined as an serum uric acid level 7 mg/dL in males and 6 mg/dL in females. Severe CAD was defined as triple-vessel disease or left main disease. Results One hundred and eighteen (55%) severe CAD occurred in the hyperuricemic group and 211(45%) in the normouricemic group (P = 0.02). The median uric acid levels of the severe CAD patients were significantly higher than secondary CAD (single vessel disease or two-vessel disease) patients (379 ± 111 vs 360 ± 105, P = 0.02). Multivariate logistic regression analysis, after adjusting for potential confounding factors, showed that HUA was an independent risk factor of coronary artery disease (odds radio = 1.63, 95% confidence interval, 1.02-2.61, P = 0.040). Moiety of in-hospital complications such as acute heart failure (17.6% vs. 6.2%, P 0.001), hypotension (3.8%, vs. 1.3%, P = 0.04), contrast induced nephropathy (CIN) (7.4% vs. 1.3%, P 0.001) after PCI, were significantly higher in hyperuricemic groups. Conclusions Hyperuricemia was an independent predictor for severe coronary artery disease (triple-vessel disease or left main disease).     

行经皮冠状动脉介入术老年人的冠状动脉病变特点

目的调查老年人行经皮冠状动脉介入术的冠心病患者冠状动脉病变特点。方法对比老年与中青年冠心病患者的临床特点、冠状动脉造影所见病变特点及经皮冠状动脉介入术疗效。结果老年组冠状动脉病变支数为(1.8±0.8)支;中青年组平均为(1.4±0.7)支。差异有统计学意义(P=0.024)。老年组单支病变18例,双支病变14例,3支病变10例;中青年组单支病变33例,双支病变9例,3支病变5例。老年组有心肌梗死史6例(14%),中青年组有心肌梗死史18例(38%),差异有统计学意义(P<0.02)。术后6个月电话随访生存率为99.2%。问卷随访(21±9)个月,其中出现心血管不良事件4例,老年组1例,中青年组3例;6例经皮冠状动脉介入术不满意者,术后症状未改善,其中老年组2例,中青年组4例(P>0.05)。结论老年冠心病患者冠状动脉病变程度较重,多支血管病变多见。应选择合适病例进行经皮冠状动脉介入术治疗。     

Prehospital statin therapy and one-year mortality in patients with stable coronary artery disease undergoing percutaneous coronary intervention

BackgroundStatins have multiple effects in patients with coronary artery disease. No studies have investigated whether chronic statin pretreatment before percutaneous coronary intervention (PCI) has an impact on long-term mortality in patients with stable angina.MethodsThe study included 8041 patients with stable angina. At the time of PCI, 5939 patients (73.8%) were receiving statins for ≥ 1 month before procedure and 2102 patients (26.2%) were not receiving statins. The primary outcome analysis was 1-year mortality.ResultsThere were 192 deaths during the follow-up: 119 deaths among patients receiving statins and 73 deaths among patients not receiving statins (Kaplan–Meier estimates of 1-year mortality 2.06% and 3.59%; unadjusted hazards ratio [HR] = 0.56, 95% confidence interval [CI] 0.42–0.75; P < 0.001). Landmark analysis showed that almost all mortality benefit occurred in the first 30-days after PCI: 10 deaths among patients receiving statins and 22 deaths among patients not receiving statins (Kaplan–Meier estimates of 30-day death, 0.17% and 1.06%, respectively; HR = 0.16, 95% CI 0.08–0.34, P < 0.001). No significant difference in mortality according to statin pretreatment between 30 days and 1 year was observed (109 deaths among patients receiving statins vs 51 deaths among patients not receiving statins; Kaplan–Meier estimates 1.89% and 2.53%; HR = 0.75, 95% CI 0.53–1.05, P = 0.095). After adjustment in the Cox proportional hazards model, statin pretreatment was associated with a 35% reduction in the adjusted risk for 1-year mortality (adjusted HR = 0.65, 95% CI 0.44–0.98, P = 0.039).ConclusionsPretreatment with statins before PCI was associated with a significant reduction of 1-year mortality in patients with stable angina.     

Prognostic significance of Troponin I in patients undergoing primary percutaneous coronary intervention

This observational study investigates the prognostic significance of troponin I in patients undergoing primary percutaneous intervention (pPCI). Sequential cardiac biomarker sampling of the enrolled patients (n = 167) was performed on admission and at 6,12,24 and 48 h. Clinical characteristics, major adverse cardiac and cerebrovascular events (MACCE) (death, reinfarction, stroke and new or worsening heart failure) and left ventricular ejection fraction (LVEF) were noted on admission and 30 day follow-up. A 24-h troponin I level >60 ng/ml predicted MACCE (OR 4.06, p = 0.023; adjusted OR 5.09, p = 0.034) and less than 10% improvement in LVEF on follow-up (OR 2.49, p = 0.007).Thus, in patients undergoing pPCI, 24-h cardiac Troponin I is a good non-invasive surrogate to predict MACCE and improvement in LVEF.     

对接受介入治疗的急性冠状动脉综合征患者的慢性肾脏病调查

目的探讨中国急性冠脉征接受介入治疗患者中慢性肾脏病的患病率及危险因素。方法对于全国20个中心的1854例在2007年2月1日以前接受介入治疗的急性冠脉综合征患者进行病史采集、肾脏损伤指标及相关危险因素的检测。结果在1793例资料完整的患者中,白蛋白尿的患病率为10.6%,肾功能下降的患病率为10.0%,血尿或非感染性白细胞尿的患病率为7.1%。在急性冠脉综合征接受介入治疗的患者中慢性肾脏病的患病率为22.8%,知晓率为11.3%。多因素logistic回归提示,性别、既往慢性肾脏病病史、高血压、糖尿病、贫血、高尿酸血症、尿蛋白阳性以及年龄每增加10岁均是肾小球滤过率(eGFR)低于60ml.min-1.1.73m-2的危险因素。结论慢性肾脏病在急性冠脉综合征接受介入治疗的患者中患病率高,但临床中自我知晓率明显偏低,对所有因急性冠脉综合征而住院的患者尤其那些合并相关危险因素的患者应进行eGFR估算。     

血栓弹力图评价急性冠状动脉综合征患者介入术后血小板高反应性对不良预后影响分析

目的:探讨由血栓弹力图(TEG)测定二磷酸腺苷激活血小板形成最大血凝块强度(MAADP),评价急性冠状动脉综合征(ACS)经皮冠状动脉介入治疗术(PCI)后,与氯吡格雷治疗相关的血小板高反应性(HTPR)对预后的影响。方法:入选2011年1月至2012年9月,行PCI术的ACS患者360例。使用TEG检测其血小板的反应性,记录患者基线资料,并进行12个月随访,记录心脏不良事件的发生情况(全因性死亡、非致死性心肌梗死、再次血运重建及反复心绞痛导致再住院等)。结果:采用受试者工作特征(ROC)曲线分析TEG检测ACS患者HTPR的MA-ADP最佳界值47mm,并依此分组,HTPR组71例,NTPR组289例。与NTPR组相比,HTPR组女性(39.4%vs.23.9%,P0.05),非ST段抬高性心肌梗死(14.1%vs.5.5%,P0.05),糖尿病(45.1%vs.31.5%,P0.05),高敏C反应蛋白(3.2vs.1.4,P0.05),纤维蛋白原[(3.2±0.7)vs.(2.9±0.7),P0.05]较高。Logistic回归显示女性、纤维蛋白原升高是TEG测定的HTPR的独立危险因素(OR=2.011,95%CI:1.144~3.533;OR=1.624,95%CI:1.122~2.350,P0.05);COX回归分析MAADP47mm是缺血事件的危险因素(HR=4.863,95%CI:2.505~9.439,P0.05)。结论:TEG测定的MAADP评价HTPR可预测ACS患者PCI术后再发缺血事件。     

Influence of dual antiplatelet therapy on mean platelet volume in patients with coronary artery disease undergoing percutaneous coronary intervention

Mean platelet volume (MPV) is a well-established marker of platelet activation, and recent studies have shown that platelet activation is central to the processes in the pathophysiology of coronary artery disease (CAD). The study population consisted of 45 patients with stable CAD who underwent successful percutaneous coronary intervention (PCI) with drug-eluting stents. We selected 45 age- and sex-matched control subjects without cardiovascular diseases who did not require antiplatelet therapy. Hematological test was performed 3 times within 1 month before DAPT (baseline), at 2 weeks after PCI (post PCI) and at 9 months after PCI (follow-up). Compared to control subjects, MPV was significantly larger in patients with CAD (10.0 ± 0.6 vs 10.7 ± 0.8 fl, p < 0.01) although there was no significant difference in white blood cell count, hemoglobin, and platelet count between the 2 groups. In patients with CAD, DAPT did not affect platelet count (19.3 ± 4.8 × 10⁴–18.9 ± 4.6 × 10⁴/μl) or MPV (10.7 ± 0.8–10.5 ± 0.9 fl) during the follow-up period. MPV remained to be higher at follow-up in patients with CAD despite DAPT compared to control subjects (10.1 ± 0.7 vs 10.5 ± 0.9 fl, p < 0.05). Our data suggested that MPV might not be suitable for monitoring the effects of DAPT on platelet activity in patients with CAD undergoing PCI.     

The prognostic importance of nonsignificant left main coronary artery disease in patients undergoing percutaneous coronary intervention.

OBJECTIVES: The purpose of this research was to study the association between nonsignificant (<50%) left main coronary artery disease (LMCAD) and short- and long-term survival in patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: The prognostic importance of nonsignificant LMCAD is unknown; however, the co-existence of nonsignificant LMCAD may influence revascularization decisions. METHODS: We analyzed mortality and repeat catheterization rates of 11,855 patients in a prospective cardiac registry database who underwent single-vessel or multivessel PCI from January 1996 through December 2001. Of this cohort, 11.7% (n = 1,385) had nonsignificant (<50%) LMCAD. Outcomes were compared with those without LMCAD. A secondary analysis was performed on a larger cohort of 34,586 patients undergoing cardiac catheterization, irrespective of mode of revascularization therapy. RESULTS: Patients with nonsignificant LMCAD had more co-morbidities, and a significantly higher crude mortality rate at 1 year compared with those without LMCAD (4.4% vs. 3.4%; p = 0.05). The 7-year crude mortality hazard ratio (HR) of PCI patients with <50% LMCAD versus those with no LMCAD was 1.18 (95% confidence interval [CI] 0.94 to 1.46). After risk adjustment for differences in baseline clinical profile, however, the HR decreased to 0.98 (95% CI 0.79 to 1.23). Repeat catheterization rates at 1 year did not differ between groups. The secondary analysis in all patients with nonsignificant LMCAD showed an adjusted HR of 1.03 (95% CI 0.94 to 1.14). CONCLUSIONS: Patients undergoing single-vessel or multivessel PCI who have <50% LMCAD have a nonsignificantly increased 18% relative risk for mortality compared with those without detectable LMCAD that appears to be related to these patients' higher incidence of co-morbidities rather than the left main stenosis itself.     

Platelet reactivity in patients with chronic kidney disease undergoing percutaneous coronary intervention

This study aimed to evaluate the platelet reactivity in real-world patients with different chronic kidney disease (CKD) stages after percutaneous coronary intervention (PCI), and to examine whether high residual platelet reactivity (HRPR) is associated with higher incidence of adverse cardiovascular events in a 2-year follow up. A total of 10 724 consecutive patients receiving DAPT with aspirin and clopidogrel after PCI throughout 2013 were enrolled. We applied modified thromboelastography (mTEG) in 6745 patients. Kaplan–Meier analysis and Cox proportional regression analysis were applied to illustrate end points for patients. The prevalence of HRPR for adenosine diphosphate (ADP) was higher in patients with CKD3-5 than patients with CKD1-2 (47.0% vs. 37.3%, p = 0.002), but not for arachidonic acid (AA). No significant difference was observed for MACCE between patients with or without HRPR for ADP (HR 1.004, 95%CI: 0.864–1.167, p = 0.954). Patients with HRPR for ADP was associated with less bleeding events than patients without HRPR for ADP (HR 0.795, 95%CI: 0.643–0.982, p = 0.034). In this large cohort of real-world patients after PCI, the deterioration of renal function was linked to HRPR for ADP. HRPR was not associated with MACCE in patients with CKD in a 2-year follow up. Bleeding risks were significantly lower in PCI patients with versus without HRPR for ADP.     

直接经皮冠状动脉介入治疗同期干预非梗死相关动脉对ST段抬高型心肌梗死多支血管病变患者预后的影响

目的探讨ST段抬高型心肌梗死(STEMI)多支血管病变直接经皮冠状动脉介入治疗(PCI)成功开通梗死相关血管(IRA)后,同期干预非梗死相关血管(non-IRA)对患者预后的影响。方法选择178例2015年1月至2016年6月于第四军医大学西京医院心血管内科住院治疗的STEMI多支血管病变患者为研究对象,根据non-IRA的干预时机分为一次PCI组(42例)和分期PCI组(136例)。比较两组患者PCI资料和围术期并发症,随访1年,对比两组心功能改善情况和主要不良心血管事件(MACE)发生率。结果与分期PCI组比较,一次PCI组住院时间[(5.5±1.5)d比(9.5±1.5)d,t=3.97,P=0.02]和住院费用[(46 765±20 242)元比(54 884±22 885)元,t=3.88,P=0.04]显著下降;一次PCI组围术期并发症有增加趋势,但差异无统计学意义[6例(14.3%)比13例(9.6%),χ2=0.61,P=0.40];一次PCI组术后1年心功能改善情况优于分期PCI组(左心室射血分数:59.7%±3.4%比55.0%±4.1%,t=3.87,P=0.04),两组MACE发生率的差异无统计学意义[10例(23.8%)比24例(17.6%),χ2=0.79,P=0.38]。结论 STEMI多支血管病变直接PCI同期干预non-IRA显著减少住院时间、住院费用和造影剂用量,更好地改善患者心功能,且未增加围术期并发症和术后发生MACE的风险,在预期成功率较高的情况下可作为STEMI患者直接PCI的一种策略。     

Prognostic value of interleukin-1 receptor antagonist in patients undergoing percutaneous coronary intervention

Elevated plasma levels of inflammatory markers, such as C-reactive protein (CRP), have been associated with adverse outcome in selected patients with coronary artery disease (CAD) treated with coronary angioplasty or stenting. The aim of this study was to evaluate the predictive value of preprocedural interleukin-1 receptor antagonist (IL-1Ra) plasma levels for long-term major adverse cardiac events (MACE) in a series of unselected patients with symptomatic CAD treated with percutaneous coronary intervention (PCI). Seventy-three consecutive patients (62 men, aged 62 +/- 9 years) undergoing PCI were enrolled in a prospective follow-up study. IL-1Ra and CRP plasma levels were measured before the procedure; 36 patients (49%) had unstable angina pectoris on admission, 37 (51%) had chronic stable angina pectoris, and 30 (41%) had multivessel CAD, 15 of whom underwent multivessel PCI. Success was achieved in all 73 patients, with coronary stenting performed in 63 (86%). Follow-up clinical assessment included occurrence of MACE at 3, 6, 12, and 18 months. Logistic regression analysis, performed to determine independent predictors of MACE, identified IL-1Ra levels in the upper quartile as the only independent predictive factor of MACE at 18 months (19% in the fourth quartile vs 0% in the first quartile; p = 0.032). Patients with high preprocedural CRP levels (fourth quartile) had a nonsignificant increased risk of MACE (p = 0.09). Thus, preprocedural IL-1Ra plasma levels appear to be a valuable independent predictive factor of MACE in unselected patients undergoing PCI.     

Intensive statin therapy for Chinese patients with coronary artery disease undergoing percutaneous coronary intervention (ISCAP study)

Background: Myocardial necrosis is related to higher incidence of cardiovascular events and higher mortality rates during follow‐up. Statins have been demonstrated to lower the risk of periprocedural myocardial infarction. The aim of this study is to evaluate the safety and efficacy of intensive statin therapy and the long‐term outcome of patients in the Asian population. Study design: Approximately 1,100 patients with stable angina or non‐ST elevation acute coronary syndrome undergoing selective percutaneous coronary intervention (PCI) are enrolled in this study. Patients are randomized either to the experimental group (80 mg atorvastatin 80 mg/day × 2 days before and 40 mg/day × 30 days after PCI) or to the control group (usual care). Creatine kinase‐MB (CK‐MB), troponin I (cTnI), and serum creatine are measured at 24 hours after the procedure. The total follow‐up period is 6 months. The primary objective is to evaluate the efficacy of intensive atorvastatin treatment compared with usual care in reducing 30‐day primary cardiovascular endpoints in patients undergoing selective PCI. Secondary endpoints are changes in myocardial biomarkers (cTnI, CK‐MB) and hs‐CRP, CIN morbidity, 6‐month clinical outcomes, and safety. Conclusion: The result of the ISCAP study will provide important evidence on the efficacy and safety of periprocedural serial intensive statin treatment in Asian patients with coronary artery disease undergoing selective PCI. © 2011 Wiley Periodicals, Inc.     

冠状动脉搭桥与冠脉介入治疗的比较

冠状动脉旁路移植术（CABG）和经皮冠状动脉介入术（PCI）是目前治疗冠状动脉狭窄的两种主要治疗方法。CABG是半个世纪以来治疗冠心病经典手段之一,近年来由于对桥血管的选择和保护、全动脉再血管化等的重视,其近远期治疗效果明显提高。随着介入技术的发展,这项技术以其微创、安全、易于被患者所接受等特点,适应证不断扩大。本文就近年来CABG和PCI在治疗冠心病方面的发展和优势作一综述。