Abciximab Bolus Research Articles

A comparison of intracoronary treatment strategies for thrombus burden removal during primary percutaneous coronary intervention: a COCTAIL II substudy.

Manual thrombus aspiration and local drug delivery of abciximab have been proposed as a strategy to reduce thrombus burden during percutaneous coronary intervention in patients with ST elevation myocardial infarction; however, the effectiveness of these approaches, is uncertain. In this COCTAIL II substudy, we compared the effect of these strategies on prestenting and poststenting thrombus burden assessed by optical coherence tomography. COCTAIL II trial enrolled patients with ST elevation myocardial infarction randomized to intralesion (IL, by the ClearWay catheter) versus intracoronary (IC, by the guide catheter) abciximab bolus with or without aspiration thrombectomy (AT). The following parameters were used to quantify atherothrombotic burden: thrombus volume (TVol), maximum thrombus area (TA), and thrombus burden (TB). Primary endpoint was the comparison of prestenting TVol after the use of local drug delivery (group IL+IL abciximab plus AT) versus nonlocal drug delivery (group IC abciximab plus AT+IC). The final population consisted of 59 patients undergoing both prestenting and poststenting optical coherence tomography assessment. The amount of thrombus was not significantly different in the groups with local drug delivery of abciximab versus nonlocal drug delivery in both prestenting (TVol: 18.87±26.70 vs. 19.02±18.45; TB: 26.73±12.8 vs. 25.18±13.25; and maximum TA: 59.25±18.84 vs. 53.34±19.30) and poststenting (TVol: 8.46±9.15 vs. 8.05±6.81; TB: 6.68±3.54 vs. 6.24±3.66; and maximum TA: 15.47±7.61 vs. 16.52±11.55) evaluations. A good correlation between thrombus measurements after thrombus removal techniques and intrastent thrombus was observed. Either local drug delivery of abciximab or manual thrombus aspiration showed comparable results in terms of prestenting and poststenting thrombus burden removal.

Pooled Analysis Comparing the Efficacy of Intracoronary Versus Intravenous Abciximab in Smokers Versus Nonsmokers Undergoing Primary Percutaneous Coronary Revascularization for Acute ST-Elevation Myocardial Infarction

Cigarette smokers with ST-segment elevation myocardial infarction (STEMI) may present different response to potent antithrombotic therapy compared to nonsmokers. We assessed the impact of smoking status and intracoronary abciximab in patients with STEMI undergoing primary percutaneous coronary intervention (PCI). We pooled data from 5 randomized trials comparing intracoronary versus intravenous abciximab bolus in patients undergoing primary PCI. The primary end point was the composite of death or reinfarction at a mean follow-up of 292 ± 138days. Of 3,158 participants, 1,369 (43.3%) were smokers, and they had a lower risk of the primary end point in crude, but not in adjusted analyses (hazard ratio [HR] 0.87, 95% confidence interval [CI] 0.63 to 1.21, p= 0.405). Intracoronary versus intravenous abciximab was associated with a significant reduction in the risk of primary end point among smokers (3.6% vs 8.0%; HR 0.43, 95% CI 0.26 to 0.72, p=0.001), but not in nonsmokers (10.2% vs 9.9%; HR 0.99, 95% CI 0.72 to 1.36, p=0.96), with a significant interaction (p= 0.009). Furthermore, intracoronary abciximab decreased the risk of reinfarction in smokers (HR 0.30, 95% CI 0.15 to 0.62, p= 0.001), with no difference in nonsmokers (HR 1.20, 95% CI 0.71 to 2.01, p= 0.50). Stent thrombosis was lowered by intracoronary abciximab in smokers (HR 0.28, 95% CI 0.06 to 0.66, p= 0.009), but was ineffective in nonsmokers (HR 1.04, 95% CI 0.54 to 2.00, p=0.903). Interaction testing showed heterogeneity in treatment effect for reinfarction (p= 0.002) and stent thrombosis (p= 0.018) according to smoking status. In conclusion, among patients with STEMI undergoing primary PCI, smoking status did not affect the adjusted risk of clinical events. Intracoronary abciximab bolus improved clinical outcomes by reducing the risk of death or reinfarction.

Impact of oral P2Y12 inhibitors on residual thrombus burden and reperfusion indexes in patients with ST-segment elevation myocardial infarction.

We sought to assess the impact of different oral P2Y12 receptor inhibitors on residual thrombus and reperfusion indexes in ST-segment elevation myocardial infarction patients enrolled in the COCTAIL II trial, which included 128 primary percutaneous coronary interventions randomized to intracoronary vs. intralesion abciximab bolus with or without thrombectomy. Patients were divided into three groups: clopidogrel (n = 44), prasugrel (n = 45) and ticagrelor (n = 39). Residual intra-stent thrombus was quantified by optical coherence tomography using both the number of cross-sections with thrombus area more than 10% and thrombus volume. Reperfusion indexes included thrombolysis in myocardial infarction (TIMI) flow, corrected TIMI frame count, myocardial blush grade (MBG) and complete ST-segment resolution (≥70%). In the prasugrel group, optical coherence tomography depicted a lower percentage of cross-sections with residual thrombus area more than 10% [4.0 (1.0-8.5)], as compared with clopidogrel [8.0 (1.0-15.0), P = 0.011] and ticagrelor [7.0 (3.0-13.5), P = 0.026].A higher thrombus volume was found in the clopidogrel group 4.0 mm(2.7-6.2) as compared with the prasugrel group [2.8 mm(1.8-4.4), P = 0.023], whereas the other between-group comparisons yield no significant differences. The frequency of MBG 3 was higher in the prasugrel group (73.3%) as compared with clopidogrel (45.5%) and ticagrelor [(56.4%), P = 0.027]. Final TIMI flow, TIMI frame count and ST resolution were not significantly different across the three groups (P = 0.423, 0.179 and 0.848, respectively). At multivariate analysis, pretreatment with prasugrel was independently associated with MBG 3 (odds ratio = 3.93; 95% confidence interval = 1.01-15.39). Prasugrel loading dose was associated with a lower percentage of cross-sections with residual thrombus area more than 10% as compared with both clopidogrel and ticagrelor, although intrastent thrombus volume was not significantly different between prasugrel and ticagrelor.The frequency of MBG 3 was the only reperfusion index that was significantly more prevalent in prasugrel treated group as compared with clopidogrel and ticagrelor groups.

1-Year Outcomes With Intracoronary Abciximab in Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention

BackgroundDiabetic patients are at increased risk for future cardiovascular events after ST-segment elevation myocardial infarction (STEMI). Administration of an intracoronary abciximab bolus during primary percutaneous coronary intervention (PCI) may be beneficial in this high-risk subgroup. ObjectivesThis study sought to report the 1-year clinical outcomes and cardiac magnetic resonance (CMR) findings in STEMI patients with and without diabetes randomized to intracoronary or intravenous abciximab bolus at the time of primary PCI. MethodsPatient-level data from 3 randomized trials were pooled. The primary endpoint was the composite of death or reinfarction. Comprehensive CMR imaging was performed in 1 study. ResultsOf 2,470 patients, 473 (19%) had diabetes and 1,997 (81%) did not. At 1 year, the primary endpoint was significantly reduced in diabetic patients randomized to intracoronary abciximab compared with those randomized to intravenous bolus (9.2% vs. 17.6%; hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.28 to 0.83; p = 0.009). The intracoronary abciximab bolus did not reduce the primary endpoint in patients without diabetes (7.4% vs. 7.5%; HR: 0.95; 95% CI: 0.68 to 1.33; p = 0.77), resulting in a significant interaction (p = 0.034). Among diabetic patients, intracoronary versus intravenous abciximab bolus was associated with a significantly reduced risk of death (5.8% vs. 11.2%; HR: 0.51; 95% CI: 0.26 to 0.98; p = 0.043) and definite/probable stent thrombosis (1.3% vs. 4.8%; HR: 0.27; 95% CI: 0.08 to 0.98; p = 0.046). At CMR (n = 792), the myocardial salvage index was significantly increased only in diabetic patients randomized to intracoronary compared with intravenous abciximab (54.4; interquartile range: 35.1 to 78.2 vs. 39.0, interquartile range: 24.7 to 61.7; p = 0.011; p for interaction vs. no diabetes = 0.016). ConclusionsIn diabetic patients with STEMI, the administration of intracoronary abciximab improved the effectiveness of primary PCI compared with the intravenous bolus.

Intracranial bleeding mimicking an extensive acute myocardial infarction with reversible apical ballooning and systolic left ventricular dysfunction. A case report

A novel syndrome with transient asynergy of the apical segments of the left ventricle, also known as tako-tsubo cardiomyopathy, has been recently described and presents characteristics and effects similar to acute myocardial infarction. We report the case of a 69-year-old woman presenting with chest pain typical of myocardial ischemia, electrocardiographic abnormalities typical of antero-lateral transmural myocardial infarction, and unstable clinical and hemodynamic condition. Trans-thoracic echocardiography showed a left ventricular dysfunction with a markedly decreased ejection fraction. The patient received heparin and abciximab bolus but coronary angiography demonstrated the absence of coronary stenoses, thrombi, and coronary spasm. Due to impaired neurological conditions the patient underwent brain tomography that showed subarachnoid haemorrhage secondary to a right vertebral artery aneurysm rupture. The possible occurrence of a reversible cardiomyopathy mimicking an acute coronary syndrome in presence of intracranial bleeding should be always considered.

Randomized evaluation of intralesion versus intracoronary abciximab and aspiration thrombectomy in patients with ST-elevation myocardial infarction: The COCTAIL II trial

Thrombus burden and distal embolization are predictive of no-reflow during primary percutaneous coronary intervention (PCI) in patients with acute ST-elevation myocardial infarction (STEMI). We sought to compare the efficacy of pharmacological and catheter-based strategies for thrombus in patients with STEMI and high atherothrombotic burden. Between January 2012 and December 2013, 128 STEMI patients undergoing primary PCI at 5 centers were randomly assigned in a 2 × 2 factorial design to intracoronary (IC) abciximab bolus (via the guide catheter) versus intralesion (IL) abciximab bolus, each with versus without aspiration thrombectomy (AT). Study end points were residual intrastent atherothrombotic burden, defined as the number of cross-sections with residual tissue area >10% as assessed by optical coherence tomography, and indices of angiographic and myocardial reperfusion. Residual intrastent atherothrombotic burden did not significantly differ with IL versus IC abciximab (median [interquartile range] 6.0 [1-15] vs 6.0 [2-11], P = .806) and with AT versus no aspiration (6.0 [1-13] vs 6.0 [2-12], P = .775). Intralesion abciximab administration was associated with improved angiographic myocardial reperfusion in terms of thrombolysis in myocardial infarction (TIMI) flow (3 [3-3] vs 3 [2-3], P = .040), corrected TIMI frame count (12 ± 5 vs 17 ± 16, P = .021), and myocardial blush grade (3 [2-3] vs 3 [2-3], P = .035). In particular, IL abciximab was associated with higher occurrence of final TIMI 3 flow (90% vs 73.8%, P = .032) and myocardial blush grade 3 (71.6% vs 52.4%, P = .039). Conversely, AT had no significant effect on indices of angiographic or myocardial reperfusion. In patients with STEMI and high thrombotic burden, neither IL versus IC abciximab nor AT versus no aspiration reduced postprocedure intrastent atherothrombotic burden in patients with STEMI undergoing primary PCI. However, IL abciximab improved indices of angiographic and myocardial reperfusion compared to IC abciximab, benefits not apparent with AT.

Intraprocedural abciximab bolus versus pretreatment oral dual antiplatelet medication for endovascular stenting of unruptured intracranial aneurysms

BackgroundStandard pretreatment with dual antiplatelet medication (DAPM) was compared with a standalone intraprocedural abciximab bolus for the prevention of thromboembolic and hemorrhagic events during endovascular stenting of unruptured intracranial aneurysms.Materials...

Intracoronary abciximab in diabetic patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention

BackgroundAlthough intracoronary abciximab failed to improve prognosis compared with intravenous route in unselected ST-segment elevation myocardial infarction (STEMI) patients, little is known about the role of intracoronary abciximab in diabetic patients. ObjectivesTo evaluate the efficacy of intracoronary abciximab administration in diabetic patients with STEMI undergoing primary percutaneous coronary intervention (PCI). MethodsReperfusional and clinical outcomes of intracoronary abciximab compared with intravenous bolus abciximab according to diabetic status were evaluated in a pooled analysis of five randomized trials including 3158 STEMI patients. The primary clinical endpoint of the study was the composite of death or reinfarction at 30-day follow-up. ResultsAmong 584 diabetic patients (18.5%), the composite of death or reinfarction was significantly reduced with intracoronary abciximab compared to intravenous abciximab (4.7% vs. 8.8%; rate ratio [RR], 0.50; 95% confidence intervals [CI], 0.26–0.99; p=0.04), driven by numerically lower deaths (3.7% vs. 6.4%; RR, 0.56; 95% CI, 0.26–1.20; p=0.13). Moreover, a significant reduction in definite or probable stent thrombosis was observed in patients receiving intracoronary abciximab (1% vs. 3.5%; RR, 0.27; 95% CI, 0.07–0.99; p=0.04). Although formal tests for interaction were not significant, no clinical benefit was apparent in the cohort of STEMI patients without diabetes (n=2574). ConclusionsIn diabetic patients with STEMI undergoing primary PCI, intracoronary abciximab may improve clinical outcomes as compared with standard intravenous use. These findings require confirmation in a dedicated randomized trial.

Similar anti-inflammatory effects of intracoronary and intravenous Abciximab during primary percutaneous coronary intervention

Intracoronary Abciximab administration during primary percutaneous coronary intervention (pPCI) could offer theoretical advantages over the intravenous route. Besides antiplatelet effects, Abciximab can modulate inflammation via cross-reactivity with GPIIb/IIIa, avb3, and aMb2 receptors. The aim of our study was to assess whether the Abciximab administration route could influence its anti-inflammatory effects. Eighty-nine consecutive ST elevation myocardial infarction patient candidates for pPCI were randomized to intracoronary (Group A-47 patients) or intravenous (Group B-42 patients) Abciximab bolus administration. The primary endpoint was the extent of inflammation, measured by C-reactive protein (CRP), vascular cell adhesion molecule 1 (VCAM-1) and inter-cellular adhesion molecule 1 (ICAM-1) levels. This study is registered with ClinicalTrials.gov, NCT01757457. Data are expressed in medians (interquartiles). In both groups, troponin levels were similar [baseline: 0.12 (0.03-0.94) vs. 0.27 (0.07-1.24) ng/ml, P = 0.73; postprocedural: 22.00 (14.75-69.43) vs. 31.96 (8.23-7.20) ng/ml, P = 0.83]. Both groups also showed similar baseline [0.31 (0.14-0.69) vs. 0.22 (0.09-0.59) mg/ml, P = 0.80] and postprocedural CRP levels [2.28 (1.37-4.23) vs. 2.16 (1.15-3.22) mg/dl, P = 0.69], similar baseline [272.5 (224.7-340.8) vs. 262.2 (221.2-306.4) ng/ml, P = 0.33] and postprocedural soluble ICAM-1 levels [281.5 (244.6-337.4) vs. 287.2 (226.9-359.2) ng/ml P = 0.71], and similar baseline [771.6 (620.9-971.0) vs. 748.6 (592.2-838.8) ng/ml, P = 0.30] and postprocedural soluble VCAM-1 levels [785.2 (671.6-947.1) vs. 745.9 (641.1-841.9) ng/ml, P = 0.17]. In-hospital and 6-month event rates were similar in the two groups. Our study suggests that Abciximab has similar anti-inflammatory effects irrespective of the administration route. It is unlikely that the potential clinical benefits of intracoronary Abciximab can be related to modulation of integrin receptors.

Effects of Baseline Coronary Occlusion and Diabetes Mellitus in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Several studies have highlighted the prognostic role of preprocedural Thrombolysis In Myocardial Infarction (TIMI) flow in the infarct-related artery (IRA) in patients with ST-segment elevation myocardial infarction (STEMI). However, the impact of preprocedural IRA occlusion in patients with diabetes with STEMI has been insufficiently studied. The aim of this study was to evaluate the effects of baseline IRA occlusion and diabetic status in patients with STEMI who underwent primary percutaneous coronary intervention by using data from a pooled analysis of randomized trials comparing intracoronary with intravenous abciximab bolus administration. A total of 3,046 patients with STEMI who underwent primary percutaneous coronary intervention were included. Diabetes was present in 578 patients (19%). The primary outcome was mortality after a median follow-up period of 375 days. Secondary end points were reinfarction and stent thrombosis. In patients without diabetes, IRA occlusion versus no occlusion was not associated with increased rates of mortality (4.3% vs 2.7%, p = 0.051) and reinfarction (3.3% vs 2.5%, p = 0.33). Patients with diabetes with IRA occlusion compared with those without occlusion showed higher rates of mortality (10.6% vs 4.6%, p = 0.01) and reinfarction (5.6% vs 2.1%, p = 0.03). Baseline IRA occlusion increased the rate of stent thrombosis in the nondiabetic (2.1% vs 1.0%, p = 0.04) and diabetic (3.2% vs 0.8%, p = 0.05) cohorts. Interaction analysis demonstrated that the risk for death and reinfarction was significantly increased when diabetes and IRA occlusion occurred concomitantly. In conclusion, patients with STEMI with diabetes and baseline IRA occlusion had disproportionately higher rates of death and reinfarction. Preprocedural IRA occlusion increased the risk for stent thrombosis, irrespective of diabetic status.

Abciximab in the management of acute myocardial infarction with ST-segment elevation: evidence-based treatment, current clinical use, and future perspectives.

Introduction of antiplatelet agents has contributed substantially to improve the outcome of patients with acute coronary syndromes. Meta-analysis of the studies on abciximab administration during primary percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction (STEMI) has clearly confirmed the mortality benefit associated with intravenous bolus and infusion of abciximab compared to placebo. Recently, introduction of new oral P2Y12 inhibitors (prasugrel, ticagrelor), with a faster and more pronounced antiplatelet effect, have decreased the use of abciximab even in patients with STEMI. However, recent studies have shown a delayed onset of antiplatelet effect of new oral antiplatelet drugs in the setting of STEMI, especially in patients with hemodynamic compromise. Thus, the use of abciximab as an intravenous agent should be strongly considered when oral P2Y12 inhibitors might fail or cannot be given before primary PCI for STEMI. An additional benefit of abciximab administration was reported when abciximab was given early, before primary PCI, compared to typical periprocedural use. To the contrary, no clear clinical benefit was confirmed for intracoronary administration of abciximab compared with intravenous administration. Future studies should focus on the role of abciximab given on top of new oral P2Y12 inhibitor (prasugrel, ticagrelor) or used as an alternative to an intravenous P2Y12 inhibitor (cangrelor). Undoubtedly, the results of these studies will change everyday practice of STEMI treatment.

Impact of Delay to Reperfusion on Reperfusion Success, Infarct Size, and Clinical Outcomes in Patients With ST-Segment Elevation Myocardial Infarction: The INFUSE-AMI Trial (INFUSE-Anterior Myocardial Infarction)

Our aim was to study the impact of delay from symptom onset to first coronary device oninfarct size and clinical outcomes at 30 days and 1 year in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention. Longer delay from symptom onset to reperfusion has been linked to increased mortality and worse clinical outcome. The mechanisms underpinning this association are not entirely clear. The INFUSE-AMI trial (INFUSE-Anterior Myocardial Infarction) randomized patients with anterior STEMI undergoing primary percutaneous coronary intervention with bivalirudin anticoagulation within 5 h of symptom onset to intralesion (IL) bolus abciximab versus no abciximab and to thrombus aspiration versus no aspiration. The primary endpoint was contrast magnetic resonance infarct size (IS) (percentage of left ventricular mass) at 30 days. Time to reperfusion was classified as <3 versus ≥3 h. There were 280 patients (62%) with <3-h delay and 170 patients (38%) with ≥3-h delay. Patients with longer delay were significantly older, more often women, and diabetic. Earlier reperfusion was not associated with higher rates of final Thrombolysis In Myocardial Infarction flow grade 3 or myocardial blush grade 2/3, but was an independent predictor of smaller IS (p= 0.02 by multivariable linear regression). Mortality at 1 year was reduced in patients with shorter delay to reperfusion (4.0% vs. 9.2%, p= 0.02). In patients with large anterior myocardial infarction undergoing relatively early reperfusion, longer delays to reperfusion were associated with larger IS and 1-year mortality, but notwith reduced reperfusion success. (The INFUSE - Anterior Myocardial Infarction [AMI] Study; NCT00976521).

Complications of intracoronary abciximab bolus-only versus standard protocol during percutaneous coronary intervention in acute coronary syndrome

BackgroundAbciximab reduces major adverse cardiac events in patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention (pPCI). Standard protocol is intravenous abciximab bolus during PCI plus abciximab infusion for 12–18 h post pPCI. Intracoronary (IC) abciximab bolus administration results in high local drug concentrations and hence it should have higher antiplatelet effect. In this study, we assess the short-term efficacy and safety of IC compared to IV bolus of abciximab in ACS patients during pPCI. MethodsWe compared the clinical outcomes between the IC (n = 56) and standard protocol (n = 170) group of patients. Primary endpoints included bleeding/vascular/ischemic complications and MACE. ResultsThe two groups were similar with respect to baseline characteristics. IC abciximab bolus only reduced bleeding complications, with no moderate bleed versus 7.2% in standard protocol group (p value 0.04). Ischemic/vascular complications had statistically insignificant difference between the two groups. ConclusionWe found no significant difference between IC abciximab bolus only and standard abciximab therapy in terms of ischemic/vascular complications and MACE. But there was higher risk of moderate bleed in standard therapy group. The IC bolus route of abciximab may be superior to the intravenous route. Prospective randomized trials are warranted to validate these findings.

Coronary Kinking in a Marathon Runner: A “Dangerous Liaison”?

We report the case of a 48-year-old male marathon runner, without any cardiovascular risk factor, referred to our hospital for an anterior ST-segment elevation myocardial infarction that occurred during endurance training. Coronary angiography showed thrombus in the mid segment of the left descending artery, localized just before a sharp angle of the vessel that produced a peculiar ‘‘kinking’’ of the coronary artery (Figure A), with preserved TIMI 3 flow. Successful manual thromboaspiration (Eliminate, TERUMO, Japan), together with abciximab bolus followed by 12-hour infusion, were performed with almost complete resolution of thrombus in the acute phase (Figure B). After 3 days, a new coronary angiography confirmed persistence of artery patency with complete resolution of thrombus (Figure C). This is an emblematic case allowing us to unravel a pathophysiological cause of acute coronary syndrome. Previous in vitro studies demonstrated that high-intensity exercise is able to induce platelet hyperreactivity and a hypercoagulable state mediated by the shear stress mechanism. In addition, systolic kinking of coronary artery, often associated with myocardial bridging, might cause ischemia through direct damage to the underlying endothelial cells. Furthermore, anatomic properties of myocardial bridging may predispose to myocardial infarction through the convergence of increased atherosclerosis at the entry site of the tunneled coronary segment. In our case, exercise-induced high heart rate, shortened diastolic perfusion time, increased contractility, compression of artery and increased flow velocity might have caused myocardial ischemia and locally impaired shear stress with subsequent acute thrombus formation. This case could represent a paradigm of ST-segment elevation myocardial infarction in which long-term antiplatelet therapy may be preferred over stent implantation. Figure.

Intracoronary versus intravenous bolus abciximab administration in patients undergoing primary percutaneous coronary intervention with acute ST-elevation myocardial infarction: a pooled analysis of individual patient data from five randomised controlled trials

In recent years, intracoronary bolus abciximab has emerged as an alternative to the standard intravenous route in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The aim of the current study was to perform an individual patient-level pooled analysis of randomised trials, comparing intracoronary versus intravenous abciximab bolus use in STEMI patients undergoing primary PCI. Individual data of 3,158 patients enrolled in five trials were analysed. Reperfusion endpoints were: post-procedural Thrombolysis in Myocardial Infarction (TIMI) 3 flow, myocardial blush grade (MBG) 2/3 and complete ST-segment resolution. The primary clinical endpoint of interest was the composite of death and reinfarction at 30 days. Compared with the intravenous route, intracoronary abciximab bolus administration did not improve TIMI 3 flow (odds ratio [OR] 1.19; 95% confidence interval [CI]: 0.90-1.59; p=0.23) and complete ST-segment resolution (OR 1.22, 95% CI: 0.92-1.63, p=0.17), but increased MBG 2/3 occurrence (OR 1.83, 95% CI: 1.05-3.18, p=0.03). At 30-day follow-up, intracoronary bolus abciximab did not reduce the risk of death and reinfarction (OR 0.78, 95% CI: 0.55-1.10, p=0.16), death (OR 0.77, 95% CI: 0.51-1.17, p=0.22), reinfarction (OR 0.79, 95% CI: 0.46-1.33, p=0.38) and stent thrombosis (OR 0.77, 95% CI: 0.43-1.35, p=0.36) as compared with intravenous administration. In STEMI patients undergoing primary PCI, intracoronary abciximab does not provide additional benefits as compared with standard intravenous treatment and, therefore, it should not be recommended as the default route of administration in this setting.

Efficacy of Combination Treatment with Intracoronary Abciximab and Aspiration Thrombectomy on Myocardial Perfusion in Patients with ST-Segment Elevation Myocardial Infarction Undergoing Primary Coronary Stenting

PurposeWe aimed to investigate whether combination therapy using intracoronary (IC) abciximab and aspiration thrombectomy (AT) enhances myocardial perfusion compared to each treatment alone in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).Materials and MethodsWe enrolled 40 patients with STEMI, who presented within 6 h of symptom onset and had Thrombolysis in MI flow 0/1 or a large angiographic thrombus burden (grade 3/4). Patients were randomly divided into 3 groups: 10 patients who received a bolus of IC abciximab (0.25 mg/kg); 10 patients who received only AT; and 20 patients who received both treatments. The index of microcirculatory resistance (IMR) was measured with a pressure sensor/thermistor-tipped guidewire following successful PCI. Microvascular obstruction (MVO) was assessed using cardiac magnetic resonance imaging on day 5.ResultsIMR was lower in the combination group than in the IC abciximab group (23.5±7.4 U vs. 66.9±48.7 U, p=0.001) and tended to be lower than in the AT group, with barely missed significance (23.5±7.4 U vs. 37.2±26.1 U, p=0.07). MVO was observed less frequently in the combination group than in the IC abciximab group (18.8% vs. 88.9%, p=0.002) and tended to occur less frequently than in the AT group (18.8% vs. 66.7%, p=0.054). No difference of IMR and MVO was found between the IC abciximab and the AT group (66.9±48.7 U vs. 37.2±26.1 U, p=0.451 for IMR; 88.9% vs. 66.7%, p=0.525 for MVO, respectively).ConclusionCombination treatment using IC abciximab and AT may synergistically improve myocardial perfusion in patients with STEMI undergoing primary PCI (Trial Registration: clinicaltrials. gov Identifier: NCT01404507).

Relationship between ST-segment resolution and anterior infarct size after primary percutaneous coronary intervention: analysis from the INFUSE-AMI trial

ST-segment resolution (STR) after reperfusion therapy has been shown to correlate with prognosis in patients with ST-segment elevation myocardial infarction (STEMI). We investigated whether acute ECG measurements also correlate with ultimate infarct size. The INFUSE-AMI trial randomized 452 patients with anterior STEMI to intracoronary bolus abciximab vs. no abciximab, and to thrombus aspiration vs. no aspiration. Infarct size as percentage of total LV mass was calculated by cardiac magnetic resonance imaging (MRI) 30 days post intervention. Five ECG methods were analysed for their ability to predict MRI infarct mass: (1) summed STR across all infarct-related ECG leads (ΣSTR); (2) STR in the single lead with maximum baseline ST-segment elevation (maxSTR); (3) summed residual ST-segment elevation across all infarct-related leads at 60 min post intervention (ΣST residual); (4) maximum residual ST-segment elevation in the worst single lead at 60 min post intervention (maxST residual); (5) number of new significant Q-waves (Qwave) at 60 min. All ECG methods strongly correlated with 30-day MRI infarct mass (all p<0.003). Simpler ECG measurements such as maxSTresidual and Qwave were as predictive as more complex measurements. A subset analysis of 158 patients who had microvascular obstruction (MVO) determined by MRI 5 days post intervention also showed strong correlations of MVO with the ECG measures. ST-segment and Q-wave changes after primary PCI in anterior STEMI strongly correlated with 30-day infarct size by MRI. In particular, maxST residual and Qwave at 60 min are simple ECG parameters that offer rapid analysis for prognostication.

Intralesional Abciximab and Thrombus Aspiration in Patients With Large Anterior Myocardial Infarction

Whether intralesional abciximab administration and thrombus aspiration confer clinical benefits to patients undergoing primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction is controversial. A total of 452 patients with ST-segment-elevation myocardial infarction caused by proximal or mid left anterior descending artery occlusion undergoing primary percutaneous coronary intervention with bivalirudin anticoagulation were randomized in a 2×2 factorial design to bolus abciximab delivered locally at the infarct lesion site versus no abciximab and to manual thrombus aspiration versus no aspiration. Treatment with intralesional abciximab, thrombus aspiration, or both therapies compared with no active therapy before stent implantation resulted in lower 1-year rates of death (4.5% versus 10.4%; P=0.03), severe heart failure (4.2% versus 10.3%; P=0.02), and stent thrombosis (0.9% versus 3.8%; P=0.046). Between 30 days and 1 year of follow-up, treatment with intralesional abciximab compared with no abciximab was associated with a lower rate of death (1.4% versus 4.9%; P=0.04) and composite major adverse ischemic events (3.3% versus 7.8%; P=0.04), with nonsignificantly different overall 1-year rates of mortality, composite ischemic events, and heart failure-related events. Thrombus aspiration compared with no aspiration was associated with lower rates of new-onset severe heart failure between 30 days and 1 year (0.9% versus 4.5%; P=0.02) and of rehospitalization for heart failure from randomization to 1 year (0.9% versus 5.4%; P=0.0008), with nonsignificantly different rates of mortality. Intralesional abciximab and thrombus aspiration may have long-term benefits in patients with anterior ST-segment-elevation myocardial infarction presenting early after symptom onset and undergoing primary percutaneous coronary intervention with bivalirudin anticoagulation. http://www.clinicaltrials.gov. Unique identifier: NCT00976521.

Relationship Between Myocardial Reperfusion, Infarct Size, and Mortality: The INFUSE-AMI (Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction) Trial

This study sought to compare infarct size (IS) measured by magnetic resonance imaging in patients with successful (myocardial blush grade [MBG] 2/3) versus unsuccessful (MBG 0/1) microcirculatory reperfusion in the INFUSE-AMI (Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction) trial. Successful microcirculatory reperfusion, defined angiographically by MBG 2 or 3, is associated with improved outcomes in patients with ST-segment elevation myocardial infarction. The precise mechanism underlying this association is not well defined. The INFUSE-AMI trial randomized 452 patients with anterior ST-segment elevation myocardial infarction to intracoronary bolus abciximab delivered locally at the infarct lesion versus no abciximab, and to manual thrombus aspiration versus no aspiration. The primary endpoint was IS (percentage of left ventricular mass) at 30 days. MBG 2/3 was achieved in 367 patients (81.4%). IS was significantly lower in patients with MBG 2/3 than in those with MBG 0/1 (median: 16.7% [interquartile range (IQR): 7.0 to 22.7] vs. 19.5% [IQR: 11.1 to 29.2]; p = 0.002). Intracoronary abciximab further reduced IS in patients with MBG 2/3 (median: 14.4% [IQR: 5.4 to 20.9] vs. 17.4% [IQR: 10.5 to 23.8]; p = 0.01). MBG 2/3 was associated with ∼30% reduction in infarct mass (p = 0.002) and ∼90% reduction in microvascular obstruction on day 5. Ejection fraction was higher with MBG 2/3 at 30 days: median: 50.3% (IQR: 43.8 to 57.8) versus 46.9% (IQR: 37.5 to 54.0); p = 0.004. At 30 days, the rate of death was significantly lower (1.7% vs. 8.3%; p = 0.0008) in the MBG 2/3 group. MBG 2/3 occurs in 80% of ST-segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention and is associated with smaller infarct size, less microvascular obstruction, improved ejection fraction, and significantly lower 30-day mortality. (Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction [INFUSE-AMI]; NCT00976521).

Abciximab bolus with optional infusion in intervention for ST-elevation myocardial infarction

Objectives. The standard abciximab regimen is a bolus dose followed by a 12-h infusion. Whether the bolus dose alone is sufficient for ST-elevation myocardial infarction patients receiving a high loading dose of clopidogrel is unknown. Design. In an observational study, 693 consecutive patients were treated with abciximab during percutaneous coronary intervention for ST-elevation myocardial infarction. Totally 354 patients received standard strategy of abciximab bolus and infusion followed by 339 patients that recieved abciximab bolus only (271 patients) or bolus and infusion if suboptimal result (68 patients) in combination with a higher loading dose of clopidogrel (600 mg) – the modified strategy. Results. The two groups were similar regarding baseline characteristics and in hospital bleeding events. At 30 days, the composite of death, re-infarction or target vessel revascularization was 9.1% in the standard and 7.5% in the modified strategy (p = 0.45). The rate of stent thrombosis was lower in the modified strategy group with 0% and 2.3% in the standard group (p < 0.001) and the mean total medical cost was lower in the modified strategy group with €8032 and €8665 in the standard group (p < 0.001). Conclusions. In primary percutaneous coronary intervention with a loading dose of 600 mg clopidogrel, it seems safe and cost-saving to give abciximab bolus with optional infusion.