Abciximab Group Research Articles

Efficacy and safety of abciximab versus tirofiban in addition to ticagrelor in STEMI patients undergoing primary percutaneous intervention

Platelet glycoprotein IIb/IIIa inhibitors (GPIs) have been part of the adjuvant treatment of acute coronary syndrome for years. However, real-life data regarding the efficacy and safety of GPIs under the current indications are lacking in the setting of potent platelet inhibition. The objectives were to assess the efficacy and safety of abciximab versus tirofiban in patients with ST-elevation acute myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) and pretreated with ticagrelor, and to identify independent predictor factors of efficacy, bleeding and platelet drop. Three hundred sixty-two patients were divided by GPI administered. Clinical, laboratory, angiographic and outcome characteristics were compared. The primary objective was a composite efficacy endpoint (death from any cause, nonfatal myocardial infarction and nonfatal stroke) at 30 days. The secondary objectives were its individual components, safety (bleeding) and the impact on platelet count during hospital stay. The composite efficacy endpoint was similar in the abciximab and tirofiban groups (6.1% vs 7.3%; p = .632). There were also no differences in cardiovascular death (2.5% vs 2.4%; p = .958), nonfatal myocardial infarction (3% vs 4.3%; p = .521) and nonfatal stroke (0.5% vs 1.8%; p = .332). Tirofiban administration was associated with a higher incidence of bleeding (11.6% vs 22%; p = .008) with no differences in BARC ≥ 3b bleeding (3.6 vs 2.5%; p = .760). In STEMI patients undergoing PPCI with ticagrelor, abciximab and tirofiban had similar rates in the composite efficacy endpoint at 30 days. The 30-day bleeding rate was significantly higher in the tirofiban group. Tirofiban administration was an independent predictor of both bleeding and platelet count drop.

Antiplatelet Therapy During Emergent Extracranial Internal Carotid Artery Stenting: Comparison of Three Intravenous Antiplatelet Perioperative Strategies

IntroductionGuidelines for antiplatelet therapy administration, during emergent stenting for extra-cranial internal carotid artery (EC-ICA) occlusion in the setting of acute ischemic stroke (AIS) are lacking. Different antiplatelet regimen are used in association to endovascular therapy (EVT) for the treatment of EC-ICA lesions. We aimed to compare the clinical and radiological effects of three intravenous antiplatelet agents used during emergent EC-ICA stenting. Material and MethodsClinical data were collected from January 2015 to December 2019 in a monocentric prospective registry of AIS patients treated by EVT. All patients who underwent emergent EC-ICA stenting were sorted regarding the intravenous antiplatelet agent used during the procedure. ResultsAmong 218 patients treated by EVT for an EC-ICA occlusion of the anterior circulation during the study period, 70 underwent an emergent stenting of the EC-ICA. 60 were included in the present study, 9 received intravenous (IV) Cangrelor, 8 IV abciximab and 43 Aspirin. The rate of favorable neurological outcome, defined as modified Rankin Scale (mRS) ≤ 2 at three months were better in the Cangrelor and Aspirin groups (66,7% and 58,1%, respectively) than in the Abciximab group (37,5%), as well as, the rate of any intracranial ICH (22,2% and 37,2% vs 62,5%). The rate of acute stent reocclusion was similar between groups. ConclusionWhen used as a rescue treatment during emergent stenting of EC-ICA, Cangrelor and Aspirin present a better safety profile than Abciximab, with less intracranial hemorrhages and a higher rate of good clinical outcome. Additional studies are needed to confirm these findings.

Thrombus Aspiration Plus Intracoronary Abciximab vs Intracoronary Abciximab Alone in Patients with STEMI Undergoing Primary PCI

Background: Thrombus embolization during the Percutaneous Coronary Intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) is common and results in suboptimal myocardial perfusion and increased infarct size. Two strategies proposed to reduce distal embolization and improve outcomes after primary PCI is bolus intracoronary Abciximab and manual aspiration thrombectomy. There are several factors which influence the decision of primary PCI in a patient with AMI in developing countries. Cost of therapy and affordability is probably the most important factor. The additional cost for thrombus aspiration needs to be considered against the additional advantages in terms of better clinical outcome. 
 Objectives: To compare the use of a combination of intracoronary Abciximab with manual thrombus aspiration to intracoronary Abciximab alone, in patients with STEMI undergoing primary PCI.
 Patients and Methods: This is a prospective observational study of patients with STEMI who underwent primary PCI between June 2018 to May 2019. A pre-approved study protocol was designed to determine the eligibility of STEMI patients to be included in the study. Patients with The patients have analysed in two groups: 84 patients received a combination of intracoronary Abciximab with manual thrombus aspiration & 80 patients received intracoronary Abciximab alone. 
 The primary endpoint was the assessment of myocardial perfusion parameters namely Myocardial Blush Grade (MBG) in the culprit vessel & ST-segment resolution of >70% on ECG at 90 min after PCI. Secondary endpoints were the improvement in LV ejection fraction, cardiovascular mortality & recurrent MI at one-month post-procedure.
 Results: Result of the 84 patients who received combination of intracoronary Abciximab with manual thrombus aspiration, the primary endpoints namely the myocardial blush grade (MBG) of 2/3 was achieved in 72 patients (90.74%) & ST-segment resolution of >70% at 90 min was seen in 66 patients (78.57%) (p<0.001). Of the 80 patients who received only intracoronary Abciximab without thrombus aspiration, MBG 2/3 was achieved in 38 patients (47.5%) & ST-segment resolution of >70% at 90 min was seen in 28 patients (35%). At one month of follow up the secondary endpoints namely the LVEF in the combination group improved from 43.42±3.73 to 47.88±4.16% (p=0.12)and in the Abciximab group improved from 44.78±3.34 to 46.20±3.63%. Recurrent MI was seen in one patient in the combination group (p<0.001) & two patients in the ic Abciximab group. There was no cardiovascular mortality noted in the present study (p<0.001).
 Conclusion: Intracoronary Abciximab + manual thrombus aspiration reduces thrombus burden with better results in microvascular perfusion assessed by ST-segment resolution of >70% at 90 min & higher Myocardial Blush Grade compared to intracoronary Abciximab alone in patients with STEMI undergoing primary PCI.

Intracoronary tenecteplase versus abciximab as adjunctive treatment during primary percutaneous coronary intervention in patients with anterior myocardial infarction

We sought to compare the effects of intracoronary administration of a fibrinolytic drug (tenecteplase) to those of a glycoprotein IIb/IIIa inhibitor (abciximab) in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). In this pilot trial, 76 patients (59 male) with anterior STEMI were randomised to intracoronary infusion of reduced-dose tenecteplase or abciximab during PPCI. Angiography was repeated at 48 hours to assess corrected TIMI frame count (cTFC) and TIMI myocardial perfusion grade (TMPG). The primary endpoint was infarct size as assessed by cardiac MRI. The abciximab group showed lower cTFC (median 14.1 [IQR 9.4-17.1]) than the tenecteplase group (18.2 [10.0-28.2]) (p=0.02), and the proportion of patients with TMPG grade 2/3 was higher in the abciximab group (90.3% vs. 67.7%; p=0.03). Major cardiac and cerebrovascular event rates did not differ; however, notably, 2/38 patients in the tenecteplase group experienced subacute stent thrombosis. At four months, there were no significant differences in infarct size between the tenecteplase and abciximab groups (17.0 g [9.6-27.5] vs. 21.1 g [11.3-35.0], p=0.33). Intracoronary administration of tenecteplase did not reduce infarct size compared to abciximab in STEMI patients undergoing PPCI. Tenecteplase exhibited poorer myocardial reperfusion and might be associated with increased subacute stent thrombosis.

Procedural and clinical outcomes after use of the glycoprotein IIb/IIIa inhibitor abciximab for saphenous vein graft interventions.

Percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) poses a high-risk for distal coronary thromboembolic events. Glycoprotein IIb/IIIa inhibitors are frequently used in hope of reducing the impact of this, although the safety and efficacy of these drugs to improve outcomes in this setting are understudied. Patients were included if they had prior coronary artery bypass surgery and subsequently underwent PCI of ≥1 SVG graft at a Dutch academic center between 1997 and 2008. These patients were matched 1:1 based on peri-procedural use of abciximab using a propensity-score matching algorithm based on 17 variables. Conditional logistic regression and Cox regression stratified on matched pairs were performed to evaluate the association between abciximab use and MACCE (the composite measure of mortality, myocardial infarction, stroke and repeat revascularization) at 30days and up to 1year. The composite of 30-day MACCE occurred in 18 patients (15.3%) in the abciximab group and 16 patients (13.6%) in the propensity matched control group (OR: 1.13, 95% CI: 0.57-2.21, p=0.73). At 1-year follow-up, MACCE rates were also similar (32.5% vs. 33.9%, HR: 0.97, 95% CI: 0.59-1.59). Major bleeding (BARC types 3a-c) was higher in the abciximab group (11.9% vs. 4.2%, OR: 2.80, 95% CI: 1.01-7.77). Ischemic outcomes did not differ among patients with acute coronary syndromes. The use of intravenous abciximab was not associated with improved clinical outcomes up to 1-year among patients undergoing SVG PCI, but was related to more bleeding.

Safety and Effectiveness of Adjunctive Intra-Arterial Abciximab in the Management of Acute Limb Ischemia

Contemporary endovascular management of acute limb ischemia (ALI) generally consists of tissue plasminogen activator (tPA) based catheter-directed thrombolysis (CDT) with or without pharmacomechanical thrombectomy (PMT). Although abciximab (Reopro), a GPIIb/IIIa receptor antagonist, is widely used in coronary revascularization, its safety and effectiveness in the treatment of ALI are unknown. Here, we review our contemporary experience with the endovascular management of ALI and assess the safety and effectiveness of abciximab. A total of 49 consecutive patients with Rutherford class II (RII) ALI undergoing CDT for ALI from 2011 to 2014 was identified. Demographics, procedural details, and outcomes were assessed and are reported. A total of 44 patients with RII ALI underwent tPA-based CDT in 49 discrete interventions. In 11 patients adjunctive abciximab infusion was also used. The majority (82%) of patients treated with tPA ± PMT required overnight infusion and at least one subsequent procedure. Single-stage (on-table) thrombolysis was achieved in 91% of cases with adjunctive abciximab use versus 18% with tPA alone (P < 0.001). There was significantly less need for intensive care unit (ICU) monitoring, and there were no bleeding complications associated with adjunctive abciximab use. Overall length of stay and total operating room (OR) time favored the abciximab group but did not reach statistical significance. Overall primary patency, secondary patency, and amputation-free survival were 46 ± 9.9%, 79 ± 6.6%, and 78 ± 9.2% at 1 year. Early results suggest adjunctive abciximab may safely facilitate on-table thrombolysis for RII ALI. This approach appears to be associated with reduced resource utilization including fewer procedures, shorter OR time, and less ICU admissions. One-year outcomes compare favorably to a similar cohort of ALI patients treated with tPA-based therapy alone.

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...

Mechanism of action of antiplatelet drugs on decompression sickness in rats: a protective effect of anti-GPIIbIIIa therapy.

Literature highlights the involvement of disseminated thrombosis in the pathophysiology of decompression sickness (DCS). We examined the effect of several antithrombotic treatments targeting various pathways on DCS outcome: acetyl salicylate, prasugrel, abciximab, and enoxaparin. Rats were randomly assigned to six groups. Groups 1 and 2 were a control nondiving group (C; n = 10) and a control diving group (CD; n = 30). Animals in Groups 3 to 6 were treated before hyperbaric exposure (HBE) with either prasugrel (n = 10), acetyl salicylate (n = 10), enoxaparin (n = 10), or abciximab (n = 10). Blood samples were taken for platelet factor 4 (PF4), thiobarbituric acid reactive substances (TBARS), and von Willebrand factor analysis. Onset of DCS symptoms and death were recorded during a 60-min observation period after HBE. Although we observed fewer outcomes of DCS in all treated groups compared with the CD, statistical significance was reached in abciximab only (20% vs. 73%, respectively, P = 0.007). We also observed significantly higher levels of plasmatic PF4 in abciximab (8.14 ± 1.40 ng/ml; P = 0.004) and enoxaparin groups (8.01 ± 0.80 ng/ml; P = 0.021) compared with the C group (6.45 ± 1.90 ng/ml) but not CD group (8.14 ± 1.40 ng/ml). Plasmatic levels of TBARS were significantly higher in the CD group than the C group (49.04 ± 11.20 μM vs. 34.44 ± 5.70 μM, P = 0.002). This effect was prevented by all treatments. Our results suggest that abciximab pretreatment, a powerful glycoprotein IIb/IIIa receptor antagonist, has a strong protective effect on decompression risk by significantly improving DCS outcome. Besides its powerful inhibitory action on platelet aggregation, we suggest that abciximab could also act through its effects on vascular function, oxidative stress, and/or inflammation.

Abstract W MP30: Multi-Center Experience With Low Dose Intravenous Abciximab in Large Vessel Posterior Circulation Stroke

BACKGROUND: Although a phase 3 trial using cardiac dose of the GP IIb/IIIa inhibitor abciximab was halted, we previously reported that a 30% lower total intravenous (IV) abciximab dose achieved optimal platelet inhibition (92%) and showed benefit in patients ineligible for tPA when compared using a rigorous matching process to historical controls (Mandava et al, TSR 2010). Given lack of proven alternatives, we were interested in abciximab specifically in the posterior circulation. METHODS: 0.2 mg/kg IV bolus followed by 0.05 ug/kg/hr infusion over 12 hrs of abciximab was administered with suspected large vessel posterior circulation occlusion after informed consent and presentation of alternatives. Patients were ineligible for tPA mostly from time window (24 hrs, later changed to 12 hrs) or elevated INR &lt; 2.5. A weight based heparin protocol was used in most patients to achieve PTT 46-70. Ninety day follow up was obtained. To assess benefit, patients’ baseline characteristics were compared to the NINDS control arms subjects restricted to large vessel and cardioembolic subtypes. Matching was performed for 5 hour baseline NINDS NIHSS, age, glucose, and posterior stroke. An excess of posterior strokes in the abciximab group permitted 2:1 matching with outlier elimination. McNemars test compared 90 day mRS 0-1/0-2, mortality, and hemorrhage RESULTS: 26 subjects were treated in 3 university centers. Post-match baseline variables were slightly more severe in the abciximab group and they were treated later (Table). 90-day functional outcomes were higher in the abciximab group (mRS 0-1:54.5% vs 23.1%, mRS 0-2: 63.6% vs 30.8%; p&lt;0.008). Non-significant higher mortality was seen in the NINDS group while symptomatic hemorrhage rate was non-significantly higher after abciximab. CONCLUSION: Low dose IV abciximab in extended time window for large vessel posterior stroke shows promise. Given lack of proven alternatives, these results need to be verified prospectively.

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).

Comparison of bivalirudin with heparin versus abciximab with heparin for primary percutaneous coronary intervention in “Real World” practice

We aimed to carry out a "real world" comparison of bivalirudin plus unfractionated heparin (UFH) versus abciximab plus UFH in patients undergoing primary percutaneous coronary intervention (PPCI) for ST elevation myocardial infarction (STEMI). We included patients who had abciximab or bivalirudin during their PPCI in our unit between Sept 2009 and Nov 2011. The study included 516 and 484 patients in the bivalirudin and abciximab group respectively. There were more women in the bivalirudin group (29% vs 20%, p 0.001), while cardiogenic shock (6.4% vs 10.1%, p 0.04) and thrombectomy device use (76.6% vs 82%, p 0.04) were lower in the bivalirudin group. The primary composite end point of 30-day mortality, 30-day definite stent thrombosis or non-CABG major bleeding was similar between the bivalirudin and abciximab groups (7.8% vs 9.5%, OR 0.8, 95% CI 0.5 to 1.2, p 0.4). There was also no difference in in-hospital mortality (4.1% vs 4.3%, p 0.9), 30-day mortality (5.2% vs 6.4%, p 0.5), 1-year mortality (9.1% vs 9.9%, p 0.7), 30-day stent thrombosis (1% vs 0.4%, p 0.5) and non-CABG bleeding (2.7 vs 3.7%, p 0.4) between the bivalirudin and abciximab group respectively. On Cox proportional hazard analysis after adjusting for all the co-variates, the use of bivalirudin was not a predictor of 30-day mortality (HR 1.13, 95% CI 0.7-1.9, p 0.7). In this "real-world" observational study, there was no significant difference in the clinical outcome of PPCI for patients who had abciximab or bivalirudin after initial pre-treatment with UFH.

One-year outcomes with abciximab and unfractionated heparin versus bivalirudin during percutaneous coronary interventions in patients with non-ST-segment elevation myocardial infarction: updated results from the ISAR-REACT 4 trial

Thirty-day results of the double-blind, randomised Intracoronary Stenting and Antithrombotic Regimen -Rapid Early Action for Coronary Treatment (ISAR-REACT) 4 trial showed no difference in ischaemic complications and a reduction in bleeding by bivalirudin versus abciximab and heparin in 1,721 patients with non-ST-segment elevation myocardial infarction (NSTEMI) undergoing percutaneous coronary intervention (PCI). A longer follow-up may be required to assess the whole potential benefit of a periprocedural antithrombotic therapy. The primary outcome for this analysis was the composite of death, myocardial infarction or target vessel revascularisation one year after randomisation. Secondary outcome was the composite of death or myocardial infarction. At one year, the primary outcome occurred in 21.3% of patients assigned to abciximab and heparin versus 21.5% assigned to bivalirudin (hazard ratio [HR] 0.99; 95% confidence interval [CI]: 0.80-1.21; p=0.94). The combined incidence of death or myocardial infarction was 15.7% in the abciximab and heparin group versus 16.0% in the bivalirudin group (HR 0.99; 95% CI: 0.78-1.26; p=0.94). The mortality rates were 4.0% and 4.7%, respectively (HR 0.85; 95% CI: 0.54-1.34; p=0.48). At one year, no significant differences in the primary outcome were observed with abciximab and heparin versus bivalirudin in any of the subgroups analysed. In patients with NSTEMI undergoing PCI, abciximab with heparin and bivalirudin provide comparable outcomes at one year, although bivalirudin reduced the rate of bleeding at 30 days. URL www.clinicaltrials.gov; Unique identifier NCT00373451.

Intra-Arterial Infusion of a Glycoprotein IIb/IIIa Antagonist for the Treatment of Thromboembolism During Coil Embolization of Intracranial Aneurysm: A Comparison of Abciximab and Tirofiban

Abciximab and tirofiban are commonly used for the treatment of thromboembolisms that form during coiling of intracranial aneurysms; however, it is not known which of these inhibitors is safer and more effective. We report the safety and the recanalization rates for intra-arterial abciximab and intra-arterial tirofiban infusion for the treatment of thromboembolisms that form during coiling. Between March 2004 and April 2011, 346 intracranial aneurysms were treated with coiling. Thromboembolisms developed in 22 of these patients and were treated by use of intra-arterial tirofiban (n = 11) or abciximab (n = 11) infusion. In the abciximab group, the thromboembolisms were completely (n = 1) or partially (n = 7) resolved in 8 cases (72.7%) at the time of the final control angiography. Complete (n = 9) or partial (n = 2) resolution was achieved in all cases at the time of follow-up angiography (<3 days after the procedure). In the tirofiban group, thromboembolisms were completely (n = 4) or partially (n = 6) resolved in 10 cases (90.9%) at the time of the final control angiography. Complete (n = 9) or partial (n = 2) resolution was observed in all cases at the time of the follow-up angiography. There were no statistically significant differences between the 2 groups with respect to thrombus resolution (final angiography, P = .311; follow-up angiography, P = .707). No hemorrhagic complications developed in either group. These results suggest that tirofiban is more effective than abciximab for the immediate resolution of thromboembolisms, with no statistical significance. Both intra-arterial tirofiban and abciximab exhibited similar safety and recanalization rates.

Intracoronary Compared With Intravenous Bolus Abciximab Application During Primary Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction

The aim of the AIDA STEMI (Abciximab i.v. Versus i.c. in ST-elevation Myocardial Infarction) cardiac magnetic resonance (CMR) substudy was to investigate potential benefits of intracoronary versus intravenous abciximab bolus administration on infarct size and reperfusion injury in ST-segment elevation myocardial infarction. The AIDA STEMI trial randomized 2,065 patients to intracoronary or intravenous abciximab and found similar rates of major adverse cardiac events at 90 days with significantly less congestive heart failure in the intracoronary abciximab group. CMR can directly visualize myocardial damage and reperfusion injury, thereby providing mechanistic and pathophysiological insights. We enrolled 795 patients in the AIDA STEMI CMR substudy. CMR was completed within 1 week after ST-segment elevation myocardial infarction. Central core laboratory-masked analyses for quantified ventricular function, volumes, infarct size, microvascular obstruction, hemorrhage, and myocardial salvage were performed. The area at risk (p = 0.97) and final infarct size (16% [interquartile range: 9% to 25%] versus 17% [interquartile range: 8% to 25%], p = 0.52) did not differ significantly between the intracoronary and the intravenous abciximab groups. Consequently, the myocardial salvage index was similar (52 [interquartile range: 35 to 69] versus 50 [interquartile range: 29 to 69], p = 0.25). There were also no differences in microvascular obstruction (p = 0.19), intramyocardial hemorrhage (p = 0.19), or ejection fraction (p = 0.95) between both treatment groups. Patients in whom major adverse cardiac events occurred had significantly larger infarcts, less myocardial salvage, and more pronounced ventricular dysfunction. This largest multicenter CMR study in ST-segment elevation myocardial infarction patients to date demonstrates no benefit of intracoronary versus intravenous abciximab administration on myocardial damage and/or reperfusion injury. Infarct size determined by CMR was significantly associated with major adverse cardiac events.

Sex-related effectiveness of bivalirudin versus abciximab and heparin in non–ST-segment elevation myocardial infarction

Female sex independently predicts bleeding risk after percutaneous coronary intervention (PCI). Bivalirudin is safer than abciximab plus heparin in patients with non-ST-segment elevation myocardial infarction (NSTEMI). Thus, a greater benefit of bivalirudin in women would be expected. We performed a sex-based analysis of the patients with NSTEMI (n = 1,721, 399 women) enrolled in the ISAR-REACT 4 trial and randomized to receive bivalirudin or abciximab plus heparin. Main outcome was a 30-day composite of death, large recurrent myocardial infarction, urgent target vessel revascularization, or major bleeding. Secondary outcome was 1-year composite of death, myocardial infarction, or target vessel revascularization. No difference in the main outcome was observed in groups with bivalirudin or abciximab plus heparin: 12.6% versus 15.5% (hazard ratio [HR] 0.81, 95% CI 0.48-1.37) among women and 10.6% versus 9.5% (HR 1.12, 95% CI 0.77-1.64) among men. Major bleeding occurred in 4.5% in the bivalirudin group versus 7.5% in the abciximab plus heparin group (HR 0.60, 95% CI 0.26-1.39) among women and 2.0% versus 3.8% (HR 0.52, 0.27-1.02) among men. At 1 year, the secondary outcome was observed in 24.1% in the bivalirudin group versus 28.7% in the abciximab plus heparin group among women, HR of 0.80 (95% CI 0.55-1.17), and in 20.6% and 19.0%, respectively, HR of 1.10 (95% CI 0.86-1.40) among men. Despite a higher peri-PCI bleeding risk in women, bivalirudin is as effective as and safer than abciximab plus heparin in women and men with NSTEMI undergoing PCI.

Lack of Peri-Procedural Myocardial Necrosis Reduction from Abciximab in Patients on Dual Antiplatelet Therapy Revascularized with Rotational Atherectomy

Rotational atherectomy allows plaque remodeling in severely calcified lesions and, prior to the adoption of clopidogrel as standard therapy, small trials showed that abciximab reduces transient hypoperfusion associated with the procedure. However, no studies have evaluated it among patients receiving dual antiplatelet therapy. This study aimed to evaluate whether abciximab reduces procedure-related myocardial injury in a non-selected population of patients receiving dual antiplatelet therapy. The study comprised a retrospective review of a nonselected cohort of 139 consecutive procedures of rotational atherectomy performed in patients pre-treated with dual antiplatelet therapy. Abciximab was administered in 48 (34.5%) patients, whereas 91 (65.5%) did not receive it. The only difference between groups was a higher rate of diabetes mellitus in the abciximab group (89% vs. 51%, p=0.001). The rate of procedural complications was 10.5% for patients with abciximab vs. 6.2% for patients without (p=0.537). After 24 hours, the peak of biomarkers of myocardial damage (CKmb and TnT) did not differ, and the rate of procedure-related myocardial injury was 23.9% with abciximab and 20.7% without (p=0.664). In a restricted analysis to diabetic patients (n=84), the rate of myocardial injury was 27.5% with abciximab vs. 18.6% without, (p=0.435). After adjusting by clinical and procedural parameters in a logistic regression model, abciximab use did not confer any significant reduction on procedure-related myocardial injury. In conclusion, in a non-selected cohort of patients receiving dual antiplatelet therapy, the administration of abciximab in the setting of rotational atherectomy did not reduce the incidence of procedure related myocardial injury.

Effect of Abciximab on the Levels of Circulating Microparticles in Patients with Acute Myocardial Infarction Treated by Primary Angioplasty

Background and ObjectivesWe investigated the effect of the additional use of abciximab during percutaneous coronary intervention (PCI) on the level of procoagulant microparticles (MPs) in patients with ST-segment elevation myocardial infarction (STEMI) who had undergone primary PCI.Subjects and MethodsIn this study, we studied 86 patients with STEMI (72 men, age 58±13) who had undergone primary PCI. The decision to administer abciximab immediately prior to PCI was left to the discretion of the operator. Blood samples for analysis of MPs were obtained from the femoral artery before and after PCI. MPs with procoagulant potential were measured using a commercial kit. The cellular origins of MPs were determined by antigenic capture with specific antibodies.ResultsProcoagulant MPs captured onto annexin V were not changed significantly after PCI {13.4±13.2 nM vs. 13.2±16.1 nM phosphatidylserine equivalent (PS eq), p=0.479}. Abciximab was used in 30 of 86 patients (35%) immediately prior to PCI. In patients who had undergone PCI without abciximab, no significant change in the level of MPs was observed after PCI. However, in the abciximab group, the level of circulating MPs was significantly decreased after PCI (12.0±10.7 nM vs. 7.8±11.7 nM PS eq, p=0.018). Levels of endothelial- and platelet-derived MPs also showed a significant reduction after PCI in the abciximab group.ConclusionPrimary PCI with additional abciximab significantly reduced the level of procoagulant MPs regardless of their cellular origins in patients with STEMI.

Early administration of abciximab reduces mortality in female patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention (from the EUROTRANSFER Registry)

The present study assessed the impact of early administration of abciximab in female and male patients with ST-segment elevation myocardial infarction (STEMI) transferred for primary angioplasty (PPCI). Data were gathered for 1,650 consecutive patients with STEMI transferred for PPCI from hospital networks in seven countries in Europe from November 2005 to January 2007 (the EUROTRANSFER Registry population). Among 1,086 patients who received abciximab, there were 186 women and 541 men who received abciximab early (>30 min before PPCI), and 86 women and 273 men treated with late abciximab. Female patients were high-risk individuals, with advanced age and increased rate of ischemic events. Early abciximab administration was associated with enhanced patency of the infarct-related artery before PPCI, and improved epicardial flow after PPCI in both women and men. Early abciximab in women led to the decrease in ischemic events, including 30 day (adjusted OR 0.26, 95 % CI 0.10–0.69, p = 0.007) and 1 year (adjusted OR 0.37, 95 % CI 0.16–0.84, p = 0.017) mortality reduction. In contrast, the reduction in 30 day (adjusted OR 0.69, 95 % CI 0.35–1.39, p = 0.27) and 1 year (adjusted OR 0.68, 95 % CI 0.38–1.22, p = 0.19) mortality was not significant in men. The frequency of bleeding events was similar in the early abciximab group compared to the late abciximab group in both women and men. Early administration of abciximab improved patency of the infarct-related artery before and after PPCI, and led to improved survival in female patients with STEMI.

Comparison of Abciximab Versus Eptifibatide During Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction (from the HORIZONS-AMI Trial)

There are limited safety and effectiveness data comparing glycoprotein IIb/IIIa inhibitors in the setting of primary percutaneous coronary intervention. In this substudy of the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, the clinical and bleeding outcomes of eptifibatide versus abciximab were evaluated in patients with ST-segment elevation myocardial infarction who underwent percutaneous coronary intervention. Three-year clinical outcomes of patients in the heparin plus glycoprotein IIb/IIIa inhibitor arm were compared according to treatment with abciximab (n = 907) versus eptifibatide (n = 803). Adjudicated end points included major adverse cardiovascular events (MACEs; mortality, reinfarction, ischemia-driven target vessel revascularization, or stroke), major bleeding, and net adverse clinical events (MACEs or major bleeding). Propensity score matching was used to identify 1,342 matched cases (671 each in the abciximab and eptifibatide groups). Multivariate analysis was performed in the entire cohort and the propensity-matched groups. At 3-year follow-up, eptifibatide and abciximab resulted in nonsignificantly different rates of MACEs (18.3% vs 19.6%, hazard ratio [HR] 0.93, 95% confidence interval [CI] 0.74 to 1.16, p = 0.51), major bleeding (10.7% vs 11.9%, HR 0.90, 95% CI 0.67 to 1.19, p = 0.44), and net adverse clinical events (24.5% vs 25.5%, HR 0.96, 95% CI 0.79 to 1.17, p = 0.69). Similarly, at 3 years by multivariate analysis, there was no statistically significant difference between abciximab and eptifibatide for net adverse clinical events (HR 0.89, 95% CI 0.73 to 1.09, p = 0.27), MACEs (HR 0.96, 95% CI 0.77 to 1.20, p = 0.73), and major bleeding (HR 1.05, 95% CI 0.78 to 1.41, p = 0.75). The propensity-matched groups also had similar outcomes. In conclusion, abciximab and eptifibatide have comparable bleeding risks and clinical efficacy in primary percutaneous coronary intervention.

Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction

Thrombus embolization during percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) is common and results in suboptimal myocardial perfusion and increased infarct size. Two strategies proposed to reduce distal embolization and improve outcomes after primary PCI are bolus intracoronary abciximab and manual aspiration thrombectomy. To determine whether bolus intracoronary abciximab, manual aspiration thrombectomy, or both reduce infarct size in high-risk patients with STEMI. Between November 28, 2009, and December 2, 2011, 452 patients presenting at 37 sites in 6 countries within 4 hours of STEMI due to proximal or mid left anterior descending artery occlusion undergoing primary PCI with bivalirudin anticoagulation were randomized in an open-label, 2 x 2 factorial design to bolus intracoronary abciximab delivered locally at the infarct lesion site vs no abciximab and to manual aspiration thrombectomy vs no thrombectomy. A 0.25-mg/kg bolus of abciximab was administered at the site of the infarct lesion via a local drug delivery catheter. Manual aspiration thrombectomy was performed with a 6 F aspiration catheter. Primary end point: infarct size (percentage of total left ventricular mass) at 30 days assessed by cardiac magnetic resonance imaging (cMRI) in the abciximab vs no abciximab groups (pooled across the aspiration randomization); major secondary end point: 30-day infarct size in the aspiration vs no aspiration groups (pooled across the abciximab randomization). Evaluable cMRI results at 30 days were present in 181 and 172 patients randomized to intracoronary abciximab vs no abciximab, respectively, and in 174 and 179 patients randomized to manual aspiration vs no aspiration, respectively. Patients randomized to intracoronary abciximab compared with no abciximab had a significant reduction in 30-day infarct size (median, 15.1%; interquartile range [IQR], 6.8%-22.7%; n = 181, vs 17.9% [IQR, 10.3%-25.4%]; n = 172; P = .03). Patients randomized to intracoronary abciximab also had a significant reduction in absolute infarct mass (median, 18.7 g [IQR, 7.4-31.3 g]; n = 184, vs 24.0 g [IQR, 12.1-34.2 g]; n = 175; P = .03) but not abnormal wall motion score (median, 7.0 [IQR, 2.0-10.0]; n = 188, vs 8.0 [IQR, 3.0-10.0]; n = 184; P = .08). Patients randomized to aspiration thrombectomy vs no aspiration had no significant difference in infarct size at 30 days (median, 17.0% [IQR, 9.0%-22.8%]; n = 174, vs 17.3% [IQR, 7.1%-25.5%]; n = 179; P = .51), absolute infarct mass (median, 20.3 g [IQR, 9.7-31.7 g]; n = 178, vs 21.0 g [IQR, 9.1-34.1 g]; n = 181; P = .36), or abnormal wall motion score (median, 7.5 [IQR, 2.0-10.0]; n = 186, vs 7.5 [IQR, 2.0-10.0]; n = 186; P = .89). In patients with large anterior STEMI presenting early after symptom onset and undergoing primary PCI with bivalirudin anticoagulation, infarct size at 30 days was significantly reduced by bolus intracoronary abciximab delivered to the infarct lesion site but not by manual aspiration thrombectomy. clinicaltrials.gov Identifier: NCT00976521.