高危急性冠状动脉综合征介入治疗早期和即刻应用替罗非班改善冠状动脉血流和心肌灌注的临床疗效比较

目的:了解高危非ST段抬高型急性冠状动脉综合征(NSTE-ACS)冠状动脉介入治疗(PCI)时,术前早期和术前即刻应用替罗非班改善冠状动脉血流和心肌灌注的疗效.方法:将2006-07-2007-07入院、备行PCI的160例高危NSTE-ACS患者随机分配到PCI前早期应用组(A组,冠状动脉造影前4～6 h应用替罗非班)和PCI前即刻应用组(B组,导丝通过冠状动脉病变后应用替罗非班).观察2组在常规使用阿司匹林和氯吡格雷基础上,PCI术前和术后即刻靶血管TIMI血流分级和TIMI心肌灌注分级(TMPG),以及血小板聚集率.记录使用替罗非班治疗期间的出血并发症和血小板减少症的发生率.结果:A组冠状动脉造影前的血小板聚集率显著低于B组(8.5%∶42.0%,P<0.05).A组PCI前即刻靶血管TIMI血流2～3级(81%)、TMPG灌注2～3级(62%)的比率以及PCI后TMPG灌注2～3级比率(89%),均显著高于B组(62%、33%、64%),均P<0.05.A、B组PCI后靶血管TIMI血流3级比率差异无统计学意义(99%∶98%,P>0.05),使用替罗非班治疗期间,A、B组重度出血、中度出血及血小板减少症发生率分别为2.5%∶1.25%、1.25%∶1.25%及1.25%∶1.25%,2组比较差异均无统计学意义(P>0.05).结论:在阿司匹林、氯吡格雷抗血小板治疗的基础上,高危NSTE-ACS患者PCI前早期应用替罗非班比PCI前即刻应用,能及早抑制血小板聚集功能,显著改善术前靶血管血流和术前、后心肌灌注.     

高危急性冠状动脉综合征介入治疗早期或即刻应用替罗非班对主要不良心血管事件的影响

目的 观察高危非ST段抬高急性冠状动脉综合征(NSTE-ACS)经皮冠状动脉介入治疗(PCI)术前早期应用和术前即刻应用替罗非班对血小板功能和180 d主要不良心血管事件(MACE)的影响,探讨替罗非班的最佳应用时机.方法 2006年7月至2007年7月,160例备行PCI的高危NSTE-ACS患者随机分配到PCI前早期应用组(冠状动脉造影前4～6 h应用替罗非班)和PCI前即刻应用组(导丝通过冠状动脉病变后应用替罗非班).观察两组入院后、冠状动脉造影前和PCI后的血小板聚集率,随访术后24 h、3 d、7 d、30 d和180 d MACE.记录使用替罗非班治疗期间的出血并发症和血小板减少症的发生率.结果 应用替罗非班后,两组血小板聚集率均显著降低(P＜0.05).PCI前早期应用组冠状动脉造影前的血小板聚集率显著低于PCI前即刻应用组(8%比42%,P＜0.05).两组PCI后24 h和3 d内均未发生MACE,7 d MACE发生率均为1.3%.PCI前早期应用组术后30 d(3.8%比6.3%,P＞0.05)和180 d(13.0%比16.7%,P＞0.05)MACE发生率均低于PCI术前即刻应用组.两组180 d无MACE发生的生存率分别为87.0%和83.7%(P＞0.05).增龄(OR=1.164,P＜0.001)、高血压(OR=4.165,P=0.037)和2型糖尿病(OR=13.628,P＜0.001)是发生MACE的独立危险因素.替罗非班的应用时机对MACE发生率有一定程度的影响(OR=2.416,P=0.153).在使用替罗非班治疗期间,两组重度出血并发症发生率(2.5%比1.3%.P＞0.05)差异无统计学意义,中度出血并发症和轻度血小板减少症发生率均为1.25%.结论 在阿司匹林和氯吡格雷抗血小板治疗的基础上,高危NSTE-ACS患者PCI前早期应用替罗非班比PCI前即刻应用,能及早强化抗血小板治疗,有减少PCI后MACE发生率的趋势.增龄、高血压和2型糖尿病是高危NSTE-ACS患者PCI联合替罗非班治疗中发生MACE的独立危险因素.     

替罗非班在急性冠脉综合征患者介入治疗中的早期及即刻应用比较

目的比较高危急性冠脉综合症患者介入治疗早期和即刻使用替罗非班的疗效及安全性。方法选取行经皮冠状动脉介入(percutaneous coronary interventions,PCI)治疗的高危急性冠脉综合征患者201例,按电脑随机数字法随机分为早期使用替罗非班组(冠脉造影术前4～6h给药)和即刻应用替罗非班组(冠状动脉导丝通过病变时给药)。我们通过量化分析血清心肌肌钙蛋白I浓度和肌酸激酶同工酶浓度,同时评价抑制血小板聚集功能及心肌梗死溶栓实验(thrombolysis in myocardial infarction,TIMI)分级。随访PCI治疗后24h、90d、180d的主要心血管事件,同时记录出血并发症及替罗非班组给药期间出现的血小板减少。结果早期应用组与即刻应用组相比,PCI治疗后48h的心肌肌钙蛋白I浓度峰值明显降低[0.33(0.06～1.11)ng/mL vs.0.60(0.08～1.50)ng/mL,P0.05],肌钙蛋白I升高速度明显减慢(65%vs.85%,P0.05)。而两组患者PCI治疗后48h的肌酸激酶同工酶浓度峰值及升高速度比较,差异无统计学意义[16(14～35)ng/L vs.17(12～39)ng/L,P0.05;37%vs.42%,P0.05]。两组心电图改变及抑制血小板聚集功能比较,差异无统计学意义(P0.05)。早期应用组和即刻应用组的90d和180d主要心血管事件发生率比较,差异无统计学意义[1%vs.7%,P=0.33;6%vs.13%,P=0.09)。两组患者出血并发症及血小板减少症的发生率比较,差异无统计学意义(10%vs.8%,P0.05)。结论高危的非ST段抬高急性冠脉综合征患者早期应用替罗非班可减轻心肌损害而不会增加并发症。     

A comparison of total hospital costs for percutaneous coronary intervention patients receiving abciximab versus tirofiban.

The purpose of this study was to examine the total hospital costs associated with the receipt of abciximab versus tirofiban for percutaneous coronary intervention (PCI) patients. Hospital billing data for patients with a primary procedure of PCI was examined for the period of July 1998 to June 1999 from HCIA-Sach's Clinical Pathways Database. Data were analyzed for all patient discharges whose records indicated use of abciximab or tirofiban with a PCI. Results are reported for 3,967 patients. Multivariate analysis was used to control for a wide range of factors (GP IIb/IIIa selection, patient demographics, stent use, insurance type, health conditions, admission information, and hospital characteristics) that may influence the cost of hospitalization. A two-stage sample selection model was used to estimate total costs. The first stage of the analysis utilizes a probit regression to determine the factors associated with the likelihood of receiving abciximab versus tirofiban. The second stage of the analysis examines the factors associated with total hospital costs, while controlling for unobserved factors that may be correlated with the patient's likelihood of receiving abciximab. The mean unadjusted cost per hospitalization, including drug costs, was $10,762 (abciximab $10,813 and tirofiban $10,567). After controlling for high-risk indications and selection bias with the two-stage sample selection model, results indicate there was no significant difference in costs associated with the receipt of abciximab versus tirofiban. However, the results also indicate that the two-stage sample selection model may not be needed (lambda was not statistically significant) hence, the cost equation was reestimated using ordinary least-squares methodology (OLS). In the OLS analysis, receipt of abciximab versus tirofiban was associated with a significant reduction in costs ($470 reduction; P = 0.05). This study uses real-world data to examine the total hospital costs for PCI patients who receive abciximab versus tirofiban. Results of the two-stage sample selection model indicate there is no difference in total hospital costs (including drug costs) between abciximab- and tirofiban-treated patients. If the results of the OLS model are considered, a slight decrease in total hospital costs is observed in abciximab recipients. Cost-containment strategies that focus on component costs may not lead to intended overall cost savings.     

Impact of upstream high bolus dose tirofiban on left ventricular systolic function in patients with acute anterior myocardial infarction treated by primary coronary intervention

BackgroundGlycoprotein IIb/IIIa inhibitor therapy during primary percutaneous coronary intervention (PCI) decreases the incidence of major adverse cardiac events.AimTo study the impact of high bolus dose tirofiban on left ventricular ejection fraction in patients with acute anterior ST segment elevation MI treated with primary PCI.Patients and methodsForty patients presenting to Ain Shams University, and specialized hospitals with the diagnosis of acute anterior STEMI were treated with primary PCI. Twenty patients were given conventional intravenous bolus dose tirofiban (10 μg/kg) upstream prior to primary angioplasty and twenty patients were given intravenous high bolus dose tirofiban (25 μg/kg) upstream prior to PCI. In-hospital follow up was done including echocardiography, and serial cardiac enzymes in addition to clinical follow up for MACE and bleeding complications.ResultsSuccessful primary angioplasty was attained in all patients. The LV systolic function was significantly better in the high bolus dose group in comparison to the conventional bolus dose groups (48% vs 41%, P < 0.01). The incidence of recurrent ischemia was statistically non-significant between the two groups (5% vs 25%, P > 0.05). Both regimens were safe and the bleeding complications were minimal and did not differ between the study groups.ConclusionIn patients presenting with acute anterior STEMI and treated with primary PCI, the high bolus dose tirofiban given intravenously upstream prior to PCI seems to be a safe and effective regimen to achieve a better left ventricular ejection fraction in comparison to the conventional bolus dose regimen, without increasing the risk of bleeding.     

A randomized two‐by‐two comparison of high‐dose bolus tirofiban versus abciximab and unfractionated heparin versus bivalirudin during percutaneous coronary revascularization and stent placement: The tirofiban evaluation of novel dosing versus abciximab with clopidogrel and inhibition of thrombin (TENACITY) study trial

Background : In the absence of high‐dose thienopyridines, placebo‐controlled trials have demonstrated a reduction in ischemic events with intravenous glycoprotein IIb/IIIa antagonists during percutaneous coronary intervention (PCI). One head‐to‐head trial comparing abciximab and tirofiban among PCI patients found tirofiban to be inferior, and laboratory evidence confirmed that the bolus dose of tirofiban tested in that trial to be less effective than abciximab. Whether a higher bolus dose of tirofiban would be as efficacious as abciximab during PCI is uncertain. Methods and Results : Patients undergoing PCI were randomized equally to abciximab or to tirofiban, given as high‐dose bolus (25 μg/kg) plus 12‐hr infusion (0.15 μg/kg/min). All patients received aspirin and clopidogrel and were additionally randomized to unfractionated heparin or bivalirudin. Approximately 8,000 patients were to be studied, but after 383 were enrolled, the study sponsor discontinued the trial for financial reasons. The primary endpoint of 30‐day death, myocardial infarction, or urgent target vessel revascularization occurred in 8.8% of patients randomized to abciximab and 6.9% of those randomized to tirofiban. The respective rates of major bleeding were 1.5 and 1.6%. Additionally, the primary endpoint occurred in 8.1% of patients randomized to unfractionated heparin and 7.6% of those randomized to bivalirudin. The respective rates of major bleeding were 2.5% and 0.5%. Conclusion : With limited assessment, this direct comparison of high‐dose bolus tirofiban versus abciximab produced encouraging results and suggests that further study of this tirofiban dose regimen is warranted. The limited assessments comparing heparin and bivalirudin are consistent with prior observations. © 2010 Wiley‐Liss, Inc.     

Prognostic value of cardiac troponin I re-elevation following percutaneous coronary intervention in high-risk patients with acute coronary syndromes.

Troponin I is a predictive marker of short- and intermediate-term adverse cardiac events in patients with acute coronary syndromes (ACS). These high-risk patients may benefit from early percutaneous coronary intervention. However, whether additional myocardial injury, defined as postprocedural troponin I elevation, may be associated with adverse short- and intermediate-term outcomes has not been fully explored. Accordingly, we studied 132 consecutive patients with non-ST-elevation ACS (62% with non-Q-wave myocardial infarction) and elevated troponin I levels at admission (>0.15 ng/ml) who underwent percutaneous coronary intervention > or =48 hours after admission. Troponin I levels were routinely measured at 6 and 18 to 24 hours after intervention and patients were stratified according to the presence or absence of troponin I re-elevation, defined as postprocedural troponin I levels >1 times the admission levels. In-hospital and cumulative 6-month clinical outcomes were compared between groups. Patients with troponin I re-elevation (n = 51) were older (68 +/- 13 vs 64 +/- 12 years, p = 0.05) and had experienced prior myocardial infarction more frequently (92.5 vs 82.1, p = 0.09), but otherwise had similar baseline clinical characteristics. Patients with troponin I re-elevation had significantly higher in-hospital mortality (9.8% vs 0%, p = 0.016) and a higher 6-month cumulative death rate (24% vs 3.7%, p = 0.001). There was a trend for an increased 6-month myocardial infarction rate in patients with troponin I re-elevation (13.7% vs 3.7%, p = 0.11) and target vessel revascularization was similar between groups (16.7% vs 17.4%, p = 0.92). By multivariate analysis, troponin I re-elevation (odds ratio [OR] 6.2, p = 0.011) and diabetes mellitus (OR 5.7, p = 0.014) were the strongest independent predictors for increased 6-month cumulative mortality, whereas creatine kinase MB-fraction re-elevation had no prognostic value. We conclude that troponin I re-elevation after percutaneous coronary intervention in high-risk patients with ACS is associated with a substantial increase in mortality and reduced event-free survival at 6-month follow-up.     

Randomised comparison of femoral versus radial approach for percutaneous coronary intervention using abciximab in acute myocardial infarction: results of the FARMI trial

Objective

To compare bleeding complications and results of percutaneous coronary intervention (PCI) between patients treated by radial and femoral approaches for acute myocardial infarction (AMI,) and using abciximab and 5 French guiding‐catheters.

Patients

114 consecutive patients with AMI were prospectively randomised. Exclusion criteria were a history of coronary artery bypass graft, cardiogenic shock, atrioventricular block, and contraindication to abciximab or a negative Allen test. Local haemostasis was achieved by manual compression.

Results

Baseline characteristics were similar between the two groups. Peripheral arterial complication rates and delays to patient ambulation were significantly lower in the radial group than in the femoral group, whereas in‐hospital stay was similar between the two groups. A cross over was more often necessary in the radial group than in the femoral group. Coronary angiography duration and fluoroscopy time were significantly longer in the radial group than in the femoral group, whereas PCI duration was similar in both groups.

Conclusions

The FARMI trial showed that the radial route lowered peripheral arterial complication rates and allowed earlier ambulation, despite no significant benefit on the duration of hospitalisation.     

Mortality at 1 year for the direct comparison of tirofiban and abciximab during percutaneous coronary revascularization: do tirofiban and ReoPro give similar efficacy outcomes at trial 1-year follow-up.

AIMS: Compared with placebo, abciximab has been associated with mortality reduction at late follow-up. The TARGET trial was performed to test whether tirofiban and abciximab provide similar efficacy outcomes among patients undergoing non-emergent, stent-based percutaneous coronary intervention. We report here the 1-year mortality of the study population. METHODS AND RESULTS: In 18 countries at 149 hospitals, 4,809 patients undergoing elective or urgent stent implantation were randomly assigned a bolus and infusion of tirofiban or abciximab. Ischaemic events were assessed at 30 days and 6 months and mortality was assessed at 1 year. We previously reported that abciximab was superior to tirofiban considering the composite rate of death or myocardial infarction at 30 days among all patients and at 6 months among those with an acute coronary syndrome (ACS). At 1-year follow-up death occurred in 46 (1.9%) patients who received tirofiban and 42 (1.7%) patients who received abciximab (hazard ratio 1.10, 95% CI 0.72-1.67; P=0.660). Mortality rates for patients with ACS were 2.3% with tirofiban vs. 2.2% with abciximab (hazard ratio 1.03, 95% CI 0.64-1.67; P=0.897) and those without ACS were 1.4 vs. 1.0% (hazard ratio 1.32, 95% CI 0.56-3.13; P=0.530). CONCLUSION: At 1 year, tirofiban provided a similar level of survival benefit compared with abciximab.     

Effect of MGuard net protective stent on the release of troponin I in patients with acute coronary syndromes. A randomized controlled trial

This study was designed to determine whether the treatment of patients with unstable angina pectoris or non-Q-wave myocardial infarction with a stent containing a protection net to prevent coronary microembolization affects the severity of biomarker release.The MGuard stent (InspireMD, Tel Aviv, Israel) was designed as a plaque/thrombus-trapping device, using a conventional bare metal stent covered with an ultrathin, flexible mesh net. We hypothesized that this stent would partly eliminate distal embolization and decrease subsequent troponin I (TnI) release.Forty-six acute coronary syndrome patients referred for percutaneous coronary intervention (PCI) were included and randomized in this study. Serum concentrations of TnI were measured prior to, as well as 24 and 48 hours after, the PCI procedure.Technical success was 95% and 100% in the MGuard group and non-MGuard group, respectively. A transient no-reflow phenomenon was observed in one interventional procedure in each group of patients (5% versus 4%; NS). Two patients (one in each group) died during the hospital stay. There was no statistically significant difference in median postprocedural TnI levels in either group.The results suggest that coronary stenting with a stent system containing a protection net to prevent coronary microembolization (eg the MGuard stent) in patients with acute coronary syndromes does not decrease procedural myocardial injury, as measured by TnI release. It seems likely that stenting with the MGuard stent is feasible, however, its safety should be verified in larger studies.     

Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: results from the OASIS-5 trial.

OBJECTIVES: This study reports a prospectively planned analysis of patients with acute coronary syndrome who underwent early percutaneous coronary intervention (PCI) in the OASIS-5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) trial. BACKGROUND: In the OASIS-5 trial, fondaparinux was similar to enoxaparin for short-term efficacy, but reduced major bleeding by one-half and 30-day mortality by 17%. METHODS: The OASIS-5 trial was a double-blind, randomized comparison of fondaparinux and enoxaparin in 20,078 patients with acute coronary syndrome. A total of 12,715 patients underwent heart catheterization during the initial hospitalization, and 6,238 patients underwent PCI. In the fondaparinux group, intravenous fondaparinux was given for PCI. In the enoxaparin group, no additional anticoagulant was given if PCI was <6 h from last subcutaneous dose, and additional intravenous unfractionated heparin (UFH) was given if PCI was >6 h. RESULTS: Fondaparinux compared with enoxaparin reduced major bleeding by more than one-half (2.4% vs. 5.1%, hazard ratio [HR] 0.46, p < 0.00001) at day 9, with similar rates of ischemic events, resulting in superior net clinical benefit (death, myocardial infarction, stroke, major bleeding: 8.2% vs. 10.4%, HR 0.78, p = 0.004). Fondaparinux reduced major bleeding 48 h after PCI irrespective of whether PCI was performed <6 h of the last enoxaparin dose (1.6% vs. 3.8%, HR 0.42, p < 0.0001) or >6 h when UFH was given (1.3% vs. 3.4%, HR 0.39, p < 0.0001). Catheter thrombus was more common in patients receiving fondaparinux (0.9%) than enoxaparin alone (0.4%), but was largely prevented by using UFH at the time of PCI, without any increase in bleeding. CONCLUSIONS: Upstream therapy with fondaparinux compared with upstream enoxaparin substantially reduces major bleeding while maintaining efficacy, resulting in superior net clinical benefit. The use of standard UFH in place of fondaparinux at the time of PCI seems to prevent angiographic complications, including catheter thrombus, without compromising the benefits of upstream fondaparinux.