Facilitated percutaneous coronary intervention versus primary percutaneous coronary intervention: design and rationale of the Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) trial

Background

Percutaneous coronary intervention (PCI) has emerged as the strategy of choice in reestablishing effective flow in occluded infarct-related arteries in patients with acute myocardial infarction (MI) if it can be administered in a timely fashion. Patients who enter the catheterization laboratory with Thrombolysis In Myocardial Infarction (TIMI) grade 3 blood flow in the infarct-related vessel have better clinical outcomes than patients presenting with impaired flow. We hypothesize that a strategy of early pharmacologic reperfusion therapy with abciximab alone or in conjunction with reduced-dose reteplase, followed by PCI will improve the outcome of patients eligible for primary PCI.

Study design

The Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) study is a 3000-patient, prospective, multicenter, randomized, double-blind, placebo-controlled trial. The study is designed to compare the efficacy and safety of early administration of reduced-dose reteplase and abciximab combination therapy or abciximab alone followed by PCI with abciximab alone administered just before PCI for acute MI. Patients will be randomized to one of these 2 facilitated PCI treatments or primary PCI in a 1:1:1 fashion. The primary efficacy end point of FINESSE is the composite of all-cause mortality or post-MI complications within 90 days of randomization. The primary safety outcome assessment will be Thrombolysis In Myocardial Infarction (TIMI) major bleeding.

Conclusions

The FINESSE study will answer important questions regarding the efficacy and safety of “upstream” medical therapy followed by planned intervention for patients with ST-elevation MI, potentially expanding the population eligible for a primary PCI approach. This study will also provide insight as to which facilitated regimen (reteplase/abciximab combination therapy or abciximab monotherapy) provides the best balance of efficacy and safety.     

Abciximab and early adjunctive percutaneous coronary intervention are associated with improved ST-segment resolution after thrombolysis: Observations from the TIMI 14 Trial

BACKGROUND: Percutaneous coronary intervention (PCI) improves clinical outcomes in selected patients with failed thrombolysis but has not been proven to benefit patients who achieve a patent infarct-related artery. Even after successful epicardial reperfusion, myocardial perfusion may be inadequate. We sought to evaluate whether a strategy that uses a reperfusion regimen containing abciximab and a reduced-dose thrombolytic agent (combination therapy), followed by early adjunctive PCI, would result in improved myocardial perfusion, as assessed by ST-segment resolution. METHODS: ST resolution from 90 to 180 minutes after therapy was calculated for all 410 patients from the TIMI 14 trial who had evaluable electrocardiograms at both time points and who were treated with alteplase or reteplase. Patients were grouped according to whether they were treated with combination therapy or full-dose thrombolytic agent alone and whether they underwent PCI between the 90- and 180-minute electrocardiographic measurements. RESULTS: Among 105 patients who underwent adjunctive PCI between 90 and 180 minutes, mean ST resolution from 90 to 180 minutes was significantly greater in those who had received combination therapy versus those who had received full-dose thrombolytic alone (54% vs 8%; P =.002). Among 241 patients with TIMI grade 3 flow in the infarct-related artery at 90 minutes, adjunctive PCI significantly improved mean ST resolution in patients who had been treated with combination therapy (57% [PCI] vs 24% [no PCI]; P =.006), but PCI did not have this effect in patients who had received thrombolytic therapy alone (1% [PCI] vs 10% [no PCI]; P =.70). In a multivariate model controlling for factors that would be expected to independently influence 90- to 180-minute ST resolution, abciximab treatment remained significantly associated with greater ST resolution (P =.008). CONCLUSIONS: A strategy that uses a combination reperfusion regimen that includes abciximab, followed by early adjunctive PCI, is associated with greater ST-segment resolution, which may reflect enhanced tissue level and microvascular perfusion. Future studies should evaluate prospectively the clinical efficacy of this strategy.     

Early administration of abciximab bolus in the emergency department improves angiographic outcome after primary PCI as assessed by TIMI frame count: results of the early ReoPro administration in myocardial infarction (ERAMI) trial.

OBJECTIVES: We assessed the safety and efficacy of early administration of abciximab prior to percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI) patients. BACKGROUND: Research suggests that platelet glycoprotein IIb/IIIa receptor inhibitors, e.g. abciximab, may improve myocardial perfusion. In particular, early administration in the emergency department, prior to PCI, may result in more effective reperfusion. METHODS: Eighty AMI patients with planned PCI were randomized in a double-blind fashion to receive a 0.25 mg/kg abciximab bolus either "early" in the emergency department or "late" in the catheterization laboratory after angiographic assessment. In total, 74 patients underwent PCI after diagnostic angiography, all of which then received an abciximab infusion of 0.125 microg/kg/min for 12 hr. RESULTS: Prior to PCI, no significant differences were observed between the two groups regarding the angiographic endpoints or ST-segment resolution. After PCI, thrombolysis in MI (TIMI) frame count (TFC) was significantly improved in patients treated early rather than in those treated late (23 +/- 10 vs. 41 +/- 35; P = 0.02). Consistent trends, also favoring early treatment, were observed for TIMI flow grade 3 (TFG 3), corrected TFC (CTFC), and TIMI myocardial perfusion grade 3 (TMPG 3). Nine deaths (4 early, 5 late) and six significant bleeds (4 early, 2 late) were observed at 30 days after randomization. CONCLUSIONS: Early administration of abciximab is both feasible and safe in patients planned for primary PCI, increasing coronary flow and myocardial reperfusion after PCI, as demonstrated by significantly decreased TFC scores and trends toward improvements in TFG, CTFC, and TMPG.     

Pharmacoinvasive therapy for ST elevation myocardial infarction in China: a pilot study

Most patients with acute ST-elevation myocardial infarction (STEMI) cannot receive timely primary percutaneous coronary intervention (PCI) because of lack of facilities or delays in patient transfer or catheterization team mobilization. In these patients, early routine post-thrombolysis PCI might be a reasonable, useful strategy. This study investigated feasibility and safety of early PCI after successful half-dose alteplase reperfusion in a Chinese population. Patients with STEMI received half-dose alteplase if expected time delay to PCI was ≥90?min. Patients who reached clinical criteria of successful thrombolysis reperfusion were recommended to undergo diagnostic angiography within 3-24?h after thrombolysis. Patients with residual stenosis ≥70% in the infarct-related artery underwent PCI, regardless of flow or patency status. Epicardial arterial flow was assessed using thrombolysis in myocardial infarction (TIMI) flow grade and TIMI frame count (CTFC). Myocardial perfusion was assessed using myocardial blush grade (MBG) and TIMI myocardial perfusion frame count (TMPFC). Forty-nine patients were enrolled and underwent diagnostic angiography 3-11.3?h (median 6.5?h) after thrombolysis. Forty-six patients underwent PCI. No procedure-related complications occurred, except two patients who had no reflow after PCI. Twenty-two (47.8%) patients had TIMI grade 3 flow before PCI and 33 (71.7%) after PCI. CTFC was significantly improved after PCI (48.5?±?32.1 vs. 37.9?±?25.6, P?=?0.01). MBG and TMPFC exhibited a similar improving trend after PCI, and the best myocardial perfusion tended to be achieved 3-12?h after lysis. During the 30-day follow-up, there were two deaths. The composite end point of death, cardiogenic shock, heart failure, reinfarction, and recurrent ischemia occurred in four patients. TIMI minor bleeding occurred in four patients. No TIMI major bleeding and stroke occurred. Early routine PCI after half-dose alteplase thrombolysis in Chinese population appears feasible. A larger clinical trial should be designed to further elucidate its efficacy and safety. Early PCI after thrombolysis in STEMI: The EARLY-PCI pilot feasibility study, ChiCTR-TNC-11001363.     

Effectiveness of early coronary angioplasty and abciximab for failed thrombolysis (reteplase or alteplase) during acute myocardial infarction (results from the GUSTO-III trial). Global Use of Strategies To Open occluded coronary arteries.

We evaluated the effects of abciximab treatment during early angioplasty after clinically failed thrombolysis for acute myocardial infarction. In the Global Use of Strategies To Open occluded coronary arteries (GUSTO-III) trial of reteplase versus alteplase for acute infarction (n = 15,059), 392 patients underwent angioplasty a median of 3.5 hours after thrombolysis and had complete procedural data. We compared 30-day mortality and in-hospital outcomes between patients who received abciximab (n = 83) and those who did not (n = 309), and (among patients given abciximab) between those randomized to alteplase versus reteplase. Patients given abciximab had anterior infarction less often, but were more often in Killip classes III or IV. The 30-day mortality rate tended to be lower with abciximab (3.6% vs 9.7%, p = 0.076), more so after adjustment for baseline differences (p = 0.042). The composite of death, stroke, or reinfarction did not differ significantly with abciximab treatment (12% vs 14%, p = 0.7), but it occurred less often among abciximab-treated patients who had been randomized to reteplase (n = 55) versus alteplase (n = 28) (7% vs 21%, p = 0.08). Severe bleeding was increased among abciximab-treated patients (3.6% vs 1.0%, p = 0.08), despite less heparin use. No intracranial hemorrhages occurred with abciximab. The use of abciximab for early angioplasty after clinically failed thrombolysis resulted in trends toward lower 30-day mortality and increased bleeding.     

Prospective evaluation of early abciximab and primary percutaneous intervention for patients with ST elevation myocardial infarction complicated by cardiogenic shock: results of the REO-SHOCK trial

OBJECTIVE: Patients with acute myocardial infarction complicated by cardiogenic shock have a high mortality despite the use of early reperfusion therapies with thrombolysis or percutaneous coronary intervention (PCI). Therefore, there is still need to evaluate therapy strategies in these patients. DESIGN: The REO-SHOCK trial was a prospective, non-randomized study, aimed at evaluation of a routine strategy of early abciximab and PCI in a high-risk group of acute ST elevation myocardial infarction (STEMI) patients with cardiogenic shock. RESULTS: Patients (n = 40) planned for coronary angioplasty or stenting received abciximab (0.25 mg/kg bolus followed by 0.125 mg/kg/minute over 12 hours), heparin and aspirin. The intervention was successful in 92.5% of the patients and achieved Thrombolysis In Myocardial Infarction (TIMI) grade 3 patency in 32 patients (80%). The primary endpoint, total mortality after 30 days, was observed in 42.5% (17/40), and was significantly different between patients aged > 75 years and patients aged 75 years (91% versus 24%, respectively; p < 0.001). Major bleeding occurred in 2 patients (5%), but stroke occurred in none. CONCLUSION: A strategy of abciximab with primary PCI in high-risk patients with cardiogenic shock is safe, associated with a high procedural success rate and seems to improve outcomes in patients < 75 years old.     

Glycoprotein IIb/IIIa inhibitors in acute ST segment elevation myocardial infarction

Limitations in the standard treatment of acute myocardial infarction have focused attention on inhibition of platelet activity by its final common pathway of activation, the glycoprotein IIb/IIIa receptor. Animal studies have suggested that a glycoprotein IIb/IIIa inhibitor could accelerate thrombolysis and prevent reocclusion after successful thrombolysis. Studies evaluating the use of a glycoprotein IIb/IIIa inhibitor alone without thrombolysis or percutaneous transluminal coronary revascularization do not suggest that isolated use of glycoprotein IIb/IIIa inhibitors restores TIMI 3 flow in a sufficient proportion of patients. Clinical studies evaluating the combination of thrombolytic therapy and glycoprotein IIb/IIIa inhibitors appear most promising, with evidence of improved angiographic outcomes. Reducing the dose of thrombolytic agents may result in reduction in bleeding risk. Current and future trials will investigate reduced-dose reteplase with abciximab and eptifibatide with reduced-dose alteplase. Available evidence suggests that glycoprotein IIb/IIIa inhibition may facilitate thrombolysis, thus adding a new element to future reperfusion regimens.     

The level I cardiovascular center: is it time?

There is no uniform approach to treating the 1.5 million US citizens who have an acute myocardial infarction (AMI) each year. This contrasts with the trauma system developed to efficiently triage and treat the critically injured accident victim. Only two thirds of patients with ST-segment elevation AMI in the United States are treated with thrombolytic therapy or primary angioplasty (percutaneous coronary intervention [PCI]) which can reduce the 30-day mortality rate from approximately 15% to 6%-10%. The Early Retavase-Thrombolysis in Myocardial Infarction (ER-TIMI) 19 trial demonstrated that AMI patients who received prehospital thrombolytic therapy and were brought to the nearest receiving hospital experienced a 32-minute reduction in the time to treatment and time to ST-elevation resolution compared with those treated at their time of hospital arrival. This expedited therapy was associated with a low in hospital mortality rate (4.7%). The potential benefit of facilitated PCI with partial-dose thrombolysis and abciximab administration was demonstrated by the Strategies for Patency Enhancement in the Emergency Department (SPEED) investigators who found that double bolus recombinant plasminogen activator (reteplase) (5 + 5 megaunits) and abciximab with the addition of early PCI, resulted in a final infarct-related artery TIMI 3 flow rate of 86% compared with 77% with combination therapy alone. The Primary Angioplasty in Acute Myocardial Infarction (PAMI) investigators have shown that patients admitted with infarct-related artery TIMI 3 flow at the time of primary PCI had less than a 1% 6-month mortality. Treating AMI patients with prehospital, partial dose thrombolysis followed by immediate transport to a Level I cardiovascular center (bypassing the closest hospital if necessary) for facilitated infarct-related artery PCI has the potential to reduce the mortality in ST-elevation AMI patients from 6%-10% to less than 4% which could translate into saving approximately 500 lives per day in the United States. It is time to validate this strategy with a randomized clinical trial, the Prehospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization trial (PATCAR).     

Early abciximab administration in acute myocardial infarction treated with primary coronary intervention

BACKGROUND: Glycoprotein IIb/IIIa inhibitors improve myocardial reperfusion and clinical outcomes of patients with acute myocardial infarction (AMI) undergoing primary percutaneous coronary intervention (PCI), but optimal timing of administration remains unclear. In this prospective randomized trial, we evaluated the impact of early abciximab administration on angiographic findings, myocardial salvage and left ventricular function. METHODS AND RESULTS: Fifty-five consecutive patients with first AMI, undergoing primary PCI, were randomized to abciximab administration either in the emergency room (early group: 27 patients) or in the catheterization laboratory after coronary angiography (late group: 28 patients). The primary outcome measures were initial Thrombolysis In Myocardial Infraction (TIMI) grade flow, corrected TIMI frame count and myocardial blush grade as well as salvage index and left ventricular function recovery as assessed by serial scintigraphic scans performed at admission, and 7 days and 1 month after PCI. Angiographic analysis showed a significant difference in initial TIMI grade 3 flow, corrected TIMI frame count and myocardial blush grade favouring early group. Moreover, salvage index and left ventricular function recovery were significantly greater in the early group (P=0.007; and P=0.043, respectively). CONCLUSIONS: In patients with AMI, treated with primary PCI, early abciximab administration improves myocardial salvage and left ventricular function recovery probably by starting early recanalization of the infarct-related artery.     

提前应用替罗非班对急性ST段抬高心肌梗死患者急诊介入治疗疗效的影响

目的通过随机对比分析,探讨急性ST段抬高心肌梗死(STEMI)患者急诊经皮冠状动脉介入治疗(PCI)时,提前应用血小板糖蛋白(GP)Ⅱb/Ⅲa受体拮抗剂替罗非班是否安全,以及能否进一步改善急诊PCI疗效。方法2005年4月至2006年4月,160例拟诊急性STEMI的患者接受急诊PCI时联合应用替罗非班,最终158例患者纳入研究,其中男性117例,女性41例,平均年龄58.8±25.2岁(36～78岁)。将患者随机分为两组,第一组共80例,在急诊冠状动脉造影结束后开始应用为常规使用组,第二组78例,在获取知情同意后在急诊室即开始应用者为早期使用组。比较两组间的基础临床状况、术前梗死相关血管前向血流情况,术后血流情况以及出血事件与近期心血管事件。结果两组基础临床情况差异无统计学意义,早期使用组提前39.8min应用替罗非班。早期组术前IRA前向血流达到TIMI2～3级的比率高于常规组(分别为39.7%和23.8%,P=0.040),其中达到TIMI3级的比率亦显著高于常规组(分别为23.1%和10.0%,P=0.032)。两组术后TIMI3级获得率,校正的TIMI计帧数和Blush3级获得率差异无统计学意义。两组近期主要心血管事件发生率、出血事件与血小板减少症发生率差异无统计学意义。结论急性STEMI患者急诊PCI前提前应用替罗非班是安全的,虽然术后造影结果和临床预后并没有明显改善,但是提前应用替罗非班可以提高PCI前的梗死相关血管前向血流。需要设计更大的样本量,更早的应用时机和合适的较大剂量提前应用替罗非班进一步深入研究。     

Combination reperfusion therapy with abciximab and reduced dose reteplase: results from TIMI 14. The Thrombolysis in Myocardial Infarction (TIMI) 14 Investigators.

Aims Abciximab has previously been shown to enhance thrombolysis and improve myocardial perfusion when combined with reduced doses of alteplase. The purpose of the reteplase phase of TIMI 14 was to evaluate the effects of abciximab when used in combination with a reduced dose of reteplase for ST-elevation myocardial infarction. Methods and Results Patients (n=299) with ST-elevation myocardial infarction were treated with aspirin and randomized to a control arm with standard dose reteplase (10+10 U given 30 min apart) or abciximab (bolus of 0.25 mg. kg(-1)and 12-h infusion of 0.125 microg. kg(-1). min(-1)) in combination with reduced doses of reteplase (5+5 U or 10+5 U). Control patients received standard weight-adjusted heparin (bolus of 70 U. kg(-1); infusion of 15 U. kg(-1). h(-1)), while each of the combination arms with abciximab and reduced dose reteplase received either low dose heparin (bolus of 60 U. kg(-1); infusion of 7 U. kg(-1). h(-1)) or very low dose heparin (bolus of 30 U. kg(-1); infusion of 4 U. kg(-1). h(-1)). The rate of TIMI 3 flow at 90 min was 70% for patients treated with 10+10 U of reteplase alone (n=87), 73% for those treated with 5+5 U of reteplase with abciximab (n=88), and 77% for those treated with 10+5 U of reteplase with abciximab (n=75). Complete (>/=70%) ST resolution at 90 min was seen in 56% of patients receiving a reduced dose of reteplase in combination with abciximab compared with 48% of patients receiving reteplase alone.Conclusions Reduced doses of reteplase when administered in combination with abciximab were associated with higher TIMI 3 flow rates than reported previously for reduced doses of reteplase without abciximab and were at least as high as for full dose reteplase alone Copyright 2000 The European Society of Cardiology.     

Early coronary intervention following pharmacologic therapy for acute myocardial infarction (the combined TIMI 10B-TIMI 14 experience).

Earlier studies have suggested that immediate percutaneous coronary intervention (PCI) following thrombolytic therapy for acute myocardial infarction (AMI) is associated with an increase in adverse events and that routine PCI in this setting has offered no advantage over a conservative strategy. To reassess this issue in a more recent era, we evaluated 1,938 patients from the Thrombolysis in Myocardial Infarction (TIMI) 10B and 14 trials of AMI. Patients in TIMI 10B were randomized to receive tissue plasminogen activator or TNK tissue plasminogen activator, whereas patients in TIMI 14B trial were randomized to receive thrombolytic therapy with or without abciximab. All patients underwent angiography 90 minutes after receiving pharmacologic therapy. Patients who underwent PCI were classified as having undergone a rescue procedure (TIMI 0 or 1 flow at 90 minutes), an adjunctive procedure (TIMI 2 or 3 flow at 90 minutes), or a delayed procedure (performed >150 minutes after symptom onset, median of 2.75 days). Among patients with TIMI 0 or 1 flow, there was a trend for lower 30-day mortality among patients who underwent rescue PCI than among those who did not (6% vs 17%, p = 0.01, adjusted p = 0.28). Patients who underwent adjunctive PCI had similar 30-day mortality and/or reinfarction as those who underwent delayed PCI. In a multivariate model both had lower 30-day mortality and/or reinfarction than patients with "successful thrombolysis" (i.e., TIMI 3 flow at 90 minutes) who did not undergo revascularization (p = 0.02). Thus, early PCI following AMI is associated with excellent outcomes. Randomized trials of an early invasive strategy following thrombolysis are warranted.     

Routine pretreatment with abciximab versus standard periprocedural therapy in mechanically ventilated cardiogenic shock patients undergoing primary percutaneous coronary intervention: Subanalysis of the PRAGUE-7 study

BACKGROUND:

The clinical outcome of patients with myocardial infarction (MI) complicated by cardiogenic shock (CS) who require mechanical ventilation (MV) is poor.

OBJECTIVE:

To analyze the impact of abciximab pretreatment in this high-risk population of MI patients.

METHODS:

The present study was a retrospective subanalysis of the multicentre randomized Routine Upfront Abciximab Versus Standard Peri-Procedural Therapy in Patients Undergoing Percutaneous Coronary Intervention for Cardiogenic Shock (PRAGUE-7) study, which included 80 MI patients in CS undergoing primary percutaneous coronary intervention (PCI). Patients were randomly assigned into group A (routine pretreatment with an abciximab bolus followed by a 1 h abciximab infusion) and group B (standard therapy). The subanalysis included 37 patients requiring MV. Seventeen patients were in group A and 20 were in group B. The primary end point (death/stroke/reinfarction/new severe renal failure) at 30 days, procedural success (thrombosis in myocardial infarction [TIMI] flow) and frequency of bleeding were assessed. The χ² and Student’s t tests were used for statistical analysis; P<0.05 was considered to be statistically significant.

RESULTS:

The primary end point occurred in nine (53%) patients in group A and 12 (60%) patients in group B (P=0.66). TIMI flow after primary PCI was higher in group A (2.75 versus 2.31; P<0.05). Major bleeding occurred in 12% of patients in group A versus 10% of patients in group B (P=0.86). Minor or minimal bleeding was more common in group A (29%) compared with group B (5%; P<0.05).

CONCLUSION:

The results of the present study suggest that routine pretreatment with abciximab before primary PCI in mechanically ventilated patients with MI complicated by cardiogenic shock was associated with better angiographic results but also with a higher incidence of bleeding.     

Effect of glycoprotein IIb/IIIa inhibition without thrombolytic therapy on reperfusion in acute myocardial infarction: results of ReoMI pilot study.

The efficacy of abciximab and moderate dose heparin in attaining reperfusion in acute MI was tested in a multicenter pilot study. Patients with acute MI of less than 6-hr onset triaged to primary PTCA received intravenous abciximab bolus and infusion and heparin (70 u/kg) in the emergency room. Mean time to angiography from administration of abciximab was 34 +/- 23 min. TIMI flow rates were: grade 0-62%, grade I-20%, grade II-9%, and grade III-9%. Primary PTCA was performed with 100% success rate. Access site bleeding occurred in 10% of patients with no incidence of intracranial bleeding. TIMI II/III flow rates were 50% in a patient subset where angiography was delayed by 45 min. While not an alternative to thrombolytics in AMI, abciximab administration in the emergency room in patients triaged to PTCA may be beneficial in situation where door to needle time is delayed as TIMI II/III flows may be attained in some patients. Cathet. Cardiovasc. Intervent. 48:430-434, 1999.     

Significance of thrombolysis in myocardial infarction (TIMI) grade 2 flow early after thrombolysis followed by immediate percutaneous coronary intervention in patients with acute myocardial infarction.

Although pre-interventional thrombolysis has recently been shown to restore early patency and preserve left ventricular function in patients with acute myocardial infarction, the significance of Thrombolysis in Myocardial Infarction (TIMI) grade flow early after thrombolysis remains unclear. Patients were classified into 3 groups according to TIMI grade flow 45 min after thrombolysis; 38 patients with TIMI grade 0 or 1 flow (group T0) and 46 with TIMI grade 2 flow (group T2) additionally received immediate percutaneous coronary intervention (PCI) and 50 patients with TIMI grade 3 flow (group T3) were treated conservatively after thrombolysis. Although the door-to-balloon times did not differ in groups T0 and T2, group T2 had lower peak creatine kinase, a higher rate of complete (>/=70%) ST resolution and better regional wall motion at discharge as compared with group T0, similar to group T3 (group T2, group T3 vs group T0; 2,857+/-1,756, 2,314+/-1,948 vs 3,779 +/-2,214 mU/ml; 57, 72 vs 34%; -1.5+/-1.6, -1.2+/-1.6 vs -2.2+/-1.6; all p<0.01, respectively). These results suggest TIMI grade 2 flow at 45 min after thrombolysis followed by immediate PCI, as well as TIMI grade 3 flow, is associated with greater myocardial salvage than TIMI grade 0 or 1 flow.     

替罗非班对急性心肌梗死患者急诊PCI治疗疗效的影响

目的探讨急性心肌梗死(AMI)患者急诊冠状动脉介入治疗(PCI)不同时间应用替罗非班PCI疗效的差别。方法选择急诊入院的60例AMI患者随机分为早期治疗组(n=30)与晚期治疗组(n=30),早期治疗组于急诊入院即刻静脉给予替罗非班;晚期治疗组于冠状动脉造影后静脉给替罗非班。比较两组患者PCI术前后的TIMI血流分级、TIMI心肌灌注分级(TIMI myocardial perfusion grade,TMPG)、血小板聚集率及出血情况。记录住院期间及随访3个月时的主要心血管事件(心源性死亡、非致死性心肌梗死及再发性心绞痛、主要心脏不良事件)的发生率。结果(1)术前TIMI前向血流达到3级的比例:早期治疗组明显高于晚期治疗组;术后两组差异无统计学意义。(2)术前和术后的TMPG 2-3级比例:早期治疗组均显著高于晚期治疗组。(3)术后血小板聚集率:两组患者均较术前明显下降,两组之间差异无统计学意义。结论AMI患者入院时尽早应用替罗非班对急诊PCI治疗是安全有效的,且能够更明显改善靶血管前向血流TIMI分级及心肌灌注TMPG分级。     

Randomized early versus late abciximab in acute myocardial infarction treated with primary coronary intervention (RELAx-AMI Trial).

OBJECTIVES: This prospective randomized trial evaluates the impact of early abciximab administration on angiographic and left ventricular function parameters. BACKGROUND: Glycoprotein IIb/IIIa inhibitors improve myocardial reperfusion in patients with acute myocardial infarction (AMI) undergoing primary percutaneous coronary intervention (PCI), but optimal timing of administration remains unclear. METHODS: Two-hundred ten consecutive patients with first AMI undergoing primary PCI were randomized to abciximab administration either in the emergency room (early group: 105 patients) or in the catheterization laboratory, after coronary angiography (late group: 105 patients). Primary end points were initial Thrombolysis In Myocardial Infarction (TIMI) flow grade, corrected TIMI frame count (cTFC), and myocardial blush grade (MBG), as well as left ventricular function recovery as assessed by serial echocardiographic evaluations. RESULTS: Angiographic pre-PCI analysis showed a significantly better initial TIMI flow grade 3 (24% vs. 10%; p = 0.01), cTFC (78 +/- 30 frames vs. 92 +/- 21 frames; p = 0.001), and MBG 2 or 3 (15% vs. 6%; p = 0.02) favoring the early group. Consistently, post-PCI tissue perfusion parameters were significantly improved in the early group, as assessed by 60-min ST-segment reduction > or =70% (50% vs. 35%; p = 0.03) and MBG 2 or 3 (79% vs. 58%; p = 0.001). Left ventricular function recovery at 1 month was significantly greater in the early group (mean gain ejection fraction 8 +/- 7% vs. 6 +/- 7%, p = 0.02; mean gain wall motion score index 0.4 +/- 0.3 vs. 0.3 +/- 0.3, p = 0.03). CONCLUSIONS: In patients with AMI treated with primary PCI, early abciximab administration improves pre-PCI angiographic findings, post-PCI tissue perfusion, and 1-month left ventricular function recovery, possibly by starting early recanalization of the infarct-related artery.     

Early administration of abciximab in patients with acute myocardial infarction improves angiographic and clinical outcome after primary angioplasty.

Adjunctive use of abciximab during percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) improves clinical outcome. This study addresses the outcome of patients with AMI treated with abciximab, initiated either before transport to a PCI center (early group) or immediately upon arrival at the catheterization laboratory (late group) for primary PCI. Of 446 consecutive patients with AMI, angiographic data and clinical complications were evaluated up to 6 months after primary PCI. Patients received abciximab before transport (early group; n = 138) or just before the intervention (late group; n = 308). Baseline data, including transport time (45 +/- 15 min; range, 15-60 min), were comparable in both groups. Early reperfusion was more prevalent in the early group (35% vs. late 19%; P < 0.001). Furthermore, a better final TIMI 3 flow was noted in the early group (91% vs. late 83%; P = 0.05). Although mortality reduction attributable to early abciximab treatment could not be demonstrated, major adverse cardiac events (MACE) occurred in 27% in the early group and 36% in the late group (P = 0.05). Revascularization rates were similar, but repeat acute coronary syndromes were less frequent in the early group (11% vs. late group 20%; P = 0.04). In multivariate analysis, cardiogenic shock, out-of-hospital cardiac arrest, and previously known coronary artery disease were independent predictors of higher MACE rate, whereas early reperfusion and final TIMI 3 flow reduced 6-month MACE rate. Abciximab pretreatment of patients with AMI for primary PCI results in better initial and final TIMI flow and tends to improve 6-month clinical outcome.     

冠状动脉介入治疗中阿昔单抗两种给药途径治疗效果比较的meta分析

目的:比较冠状动脉介入治疗（PCI）中冠状动脉内和静脉内使用阿昔单抗的治疗效果。方法: 计算机检索 PubMed、 EMbase、 Cochrane图书馆、 中国生物医学文献光盘数据等数据库,系统性搜索已发表的相关临床研究,并对纳入的研究进行质量评价,对相关结果进行meta分析。共纳入6个随机对照临床研究,共1 138例患者,其中试验组580例（冠状动脉内运用阿昔单抗组）,对照组558 例（静脉内运用阿昔单抗组）。纳入患者均为急性ST段抬高型心肌梗死。结果: 冠状动脉内运用阿昔单抗组仅在心肌梗死溶栓后Ⅲ级血流所占比例优于静脉内运用阿昔单抗组［RR=1.06,95%CI（1.01,1.12）,P=0.02］。而在病死率［RR=0.48,95%CI（0.23,1.02）,P=0.06］、靶血管血运重建［RR=0.55,95%CI（0.30,0.99）,P=0.05］,以及出血事件发生率［RR=0.88,95%CI（0.63,1.23）,P=0.44］,两组没有统计学意义上的差异。结论:与静脉内使用阿昔单抗组相比,冠状动脉内使用阿昔单抗改善了急性ST段抬高型心肌梗死患者的心肌灌注,但并未降低其病死率、靶血管血运重建及出血事件发生率。     

Review of immediate angioplasty after fibrinolytic therapy for acute myocardial infarction: insights from the RESCUE I, RESCUE II, and other contemporary clinical experiences

BACKGROUND: Prompt restoration of Thrombolysis In Myocardial Infarction (TIMI) grade 3 flow improves survival in patients with acute ST-segment elevation myocardial infarction (MI). Fibrinolytic therapy fails to restore TIMI 3 flow within 90 minutes in 40% to 50% of patients. Because the results of percutaneous coronary intervention (PCI) for MI seem to be improving, a reevaluation of the role of PCI after fibrinolytic therapy for MI appears to be warranted. METHODS AND RESULTS: Data from all 9 randomized controlled trials (including new data from 4 trials) of rescue percutaneous transluminal coronary angioplasty (PTCA) versus conservative therapy after fibrinolytic therapy (1456 patients), 4 contemporary registries of PCI in this setting (977 patients), and other germane studies are reviewed. PTCA after failed fibrinolysis (TIMI 0 to 1 flow) appears to reduce early severe heart failure (3. 8% vs 11.7%, P =.04) and improve survival over 1 year in patients with moderate to large MI (92% vs 87%, P =.001) and possibly reduces early repeat MI (4.3% vs 11.3%, P =.08). Assessment of the possible benefit of PTCA for TIMI 2 flow is hampered by the small number of patients randomly assigned. Repeat MI may be decreased and left ventricular functional recovery enhanced. PTCA early after successful fibrinolysis is nearly always technically successful and may reduce repeat MI and hospital length of stay. However, it must be recalled that randomized trials from the 1980s suggested increased mortality rates with PTCA after restoration of TIMI 2 to 3 flow with fibrinolysis. Data from contemporary randomized studies of stents and glycoprotein IIb/IIIa inhibitors suggest that PCI as performed today may yield better results than those reviewed. CONCLUSIONS: These data suggest a probable benefit of rescue PTCA in several distinct scenarios and that the pivotal mid-1980s studies suggesting no benefit or harm for PTCA after fibrinolytic therapy may no longer be relevant. The role of mechanical intervention in the treatment of patients treated in these settings should be reassessed.