Abciximab

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Eric J Topol - One of the best experts on this subject based on the ideXlab platform.

  • mortality at 1 year for the direct comparison of tirofiban and Abciximab during percutaneous coronary revascularization do tirofiban and reopro give similar efficacy outcomes at trial 1 year follow up
    European Heart Journal, 2005
    Co-Authors: Debabrata Mukherjee, Franzjosef Neumann, Eric J Topol, Michel E Bertrand, Steen Dalby Kristensen, Howard C Herrmann, Steven J Yakubov, Jeanpierre Bassand, Rick R Mcclure, Gregg W Stone
    Abstract:

    Aims Compared with placebo, Abciximab has been associated with mortality reduction at late follow-up. The TARGET trial was performed to test whether tirofiban and Abciximab provide similar efficacy outcomes among patients undergoing non-emergent, stent-based percutaneous coronary intervention. We report here the 1-year mortality of the study population. Methods and results In 18 countries at 149 hospitals, 4809 patients undergoing elective or urgent stent implantation were randomly assigned a bolus and infusion of tirofiban or Abciximab. Ischaemic events were assessed at 30 days and 6 months and mortality was assessed at 1 year. We previously reported that Abciximab was superior to tirofiban considering the composite rate of death or myocardial infarction at 30 days among all patients and at 6 months among those with an acute coronary syndrome (ACS). At 1-year follow-up death occurred in 46 (1.9%) patients who received tirofiban and 42 (1.7%) patients who received Abciximab (hazard ratio 1.10, 95% CI 0.72–1.67; P =0.660). Mortality rates for patients with ACS were 2.3% with tirofiban vs. 2.2% with Abciximab (hazard ratio 1.03, 95% CI 0.64–1.67; P =0.897) and those without ACS were 1.4 vs. 1.0% (hazard ratio 1.32, 95% CI 0.56–3.13; P =0.530). Conclusion At 1 year, tirofiban provided a similar level of survival benefit compared with Abciximab.

  • Abciximab as adjunctive therapy to reperfusion in acute st segment elevation myocardial infarction a meta analysis of randomized trials
    JAMA, 2005
    Co-Authors: Giuseppe De Luca, Elliott M Antman, Harry Suryapranata, David Antoniucci, Frans Van De Werf, Franzjosef Neumann, James E Tcheng, Gregg W Stone, Eric J Topol
    Abstract:

    ContextThe benefits of Abciximab in patients with ST-segment elevation myocardial infarction (STEMI) are still a matter of debate.ObjectiveTo combine data from all randomized trials conducted with Abciximab in STEMI.Data SourcesFormal searches of electronic databases (MEDLINE, PubMed) from from January 1990 to December 2004.Study SelectionWe examined all completed, published, randomized trials of Abciximab in STEMI. The following key words were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, facilitated angioplasty, stenting, fibrinolysis, IIb-IIIa inhibitors, and Abciximab.Data ExtractionInformation on study design, type and dosage of drugs, inclusion and exclusion criteria, number of patients, and clinical outcome was extracted by 2 investigators. Disagreements were resolved by consensus.Data SynthesisEleven trials were analyzed, involving 27115 patients (12 602 [46.5%] in the Abciximab group, 14 513 [53.5%] in the control group). When compared with the control group, Abciximab was associated with a significant reduction in short-term (30 days) mortality (2.4% vs 3.4%, P = .047) and long-term (6-12 months) mortality (4.4% vs 6.2%, P = .01) in patients undergoing primary angioplasty but not in those treated with fibrinolysis or in all trials combined. Abciximab was associated with a significant reduction in 30-day reinfarction, both in all trials combined (2.1% vs 3.3%, P<.001), in primary angioplasty (1.0% vs 1.9%, P = .03), and in fibrinolysis trials (2.3% vs 3.6%, P<.001). Abciximab did not result in an increased risk of intracranial bleeding (0.61% vs 0.62%, P = .62) but was associated with an increased risk of major bleeding complications when combined with fibrinolysis (5.2% vs 3.1%, P<.001) but not with primary angioplasty (4.7% vs 4.1%, P = .36).ConclusionsThis meta-analysis shows that, when compared with the control group, adjunctive Abciximab for STEMI is associated with a significant reduction in 30-day and long-term mortality in patients treated with primary angioplasty but not in those receiving fibrinolysis. The 30-day reinfarction rate is significantly reduced in patients treated with either fibrinolysis or primary angioplasty. A higher risk of major bleeding complications is observed with Abciximab in association with fibrinolysis.

  • long term results after the glycoprotein iib iiia inhibitor Abciximab in unstable angina one year survival in the gusto iv acs global use of strategies to open occluded coronary arteries iv acute coronary syndrome trial
    Circulation, 2003
    Co-Authors: Jan Paul Ottervanger, Lars Wallentin, Stefan James, Eric J Topol, P W Armstrong, Elliott Barnathan, E Boersma, J S Cooper, E M Ohman, Maarten L. Simoons
    Abstract:

    BACKGROUND: This study was designed to investigate long-term effects of the glycoprotein IIb/IIIa inhibitor Abciximab in patients with acute coronary syndrome without ST elevation who were not scheduled for coronary intervention. METHODS AND RESULTS: A total of 7800 patients were included with an acute coronary syndrome without ST elevation, documented by either elevated cardiac troponin or transient or persistent ST-segment depression. They were randomized to Abciximab bolus and 24-hour infusion, Abciximab bolus and 48-hour infusion, or matching placebo. The overall 1-year mortality rate was 8.3% (649 patients). One-year mortality was 7.8% in the placebo group and 8.2% in the 24-hour and 9.0% in the 48-hour Abciximab infusion group. Compared with placebo, the hazard ratio for the 24-hour infusion of Abciximab was 1.1 (95% CI 0.86 to 1.29), and for the 48-hour infusion, it was 1.2 (95% CI 0.95 to 1.41). The lack of benefit of Abciximab was observed in every subgroup studied. Patients with negative troponin or elevated C-reactive protein had a higher mortality rate after treatment with Abciximab for 48 hours than with placebo: 8.5% versus 5.8% in those with negative troponin (P=0.02), 16.3% versus 12.1% in those with elevated C-reactive protein (P=0.04). CONCLUSIONS: Compared with placebo, Abciximab did not provide any survival benefit at 1 year in patients admitted with an acute coronary syndrome with ST depression and/or elevated troponin who were not scheduled to undergo early coronary revascularization. In subgroups of patients, in particular those with low cardiac troponin or elevated C-reactive protein, Abciximab was associated with excess mortality.

  • bivalirudin with planned or provisional Abciximab versus low dose heparin and Abciximab during percutaneous coronary revascularization results of the comparison of Abciximab complications with hirulog for ischemic events trial cachet
    American Heart Journal, 2002
    Co-Authors: Michael A Lincoff, Neal S Kleiman, Kandace Kottkemarchant, Elizabeth S Maierson, Kelly Maresh, Kathy Wolski, Eric J Topol
    Abstract:

    Abstract Background The direct thrombin inhibitor bivalirudin has previously been associated with better efficacy and lower hemorrhage risk than heparin during balloon angioplasty. This agent has not yet been tested with stenting or in combination with platelet glycoprotein IIb/IIIa antagonists. Methods and Results In a pilot trial, 268 patients who underwent coronary intervention were randomized in 3 sequential phases to treatment with bivalirudin (with or without Abciximab) or the control regimen of low-dose weight-adjusted heparin with Abciximab. Patients in the bivalirudin arms received bivalirudin (1.0 mg/kg bolus, infusion of 2.5 mg/kg/h for 4 hours) plus Abciximab in phase A, bivalirudin (0.5 mg/kg bolus, infusion of 1.75 mg/kg/h for the procedure duration) plus provisional ("rescue") Abciximab in phase B, or bivalirudin (0.75 mg/kg bolus, infusion of 1.75 mg/kg/h for the procedure duration) plus provisional Abciximab in phase C. Abciximab was necessitated on a provisional basis in 24% of the patients in the bivalirudin arms of phases B and C. A composite clinical endpoint of death, myocardial infarction, repeat revascularization, or major bleeding by 7 days occurred in 3.3%, 5.9%, 0, and 10.6% of the patients in the bivalirudin phase A, bivalirudin phase B, bivalirudin phase C, and heparin plus planned Abciximab arms, respectively ( P =.018 for the pooled bivalirudin groups versus the heparin group). Conclusion Bivalirudin with planned or provisional Abciximab may be at least as safe and effective as low-dose heparin plus Abciximab during percutaneous coronary intervention. (Am Heart J 2002;143:847-53.)

  • long term mortality benefit with the combination of stents and Abciximab for cardiogenic shock complicating acute myocardial infarction
    American Journal of Cardiology, 2002
    Co-Authors: Albert W Chan, Eric J Topol, David J. Moliterno, Deepak L. Bhatt, Derek P Chew, Stephen G Ellis
    Abstract:

    Cardiogenic shock secondary to ischemic heart disease is associated with a high mortality rate, and recent trials have established the benefit of an early invasive approach. However, the role of adjunctive Abciximab and stenting for cardiogenic shock has not been established. We prospectively examined collected data from 96 consecutive patients who underwent emergent percutaneous coronary intervention for cardiogenic shock over the past 7 years. Patients were classified as receiving stent plus Abciximab, stent alone, percutaneous transluminal coronary angiopplasty (PTCA) plus Abciximab, or PTCA alone. Baseline characteristics of the 4 groups were similar. During 2.5 years of follow-up, the mortality rates for stent plus Abciximab, stent only, PTCA plus Abciximab, and PTCA alone were 33%, 43%, 61%, and 68%, respectively (log-rank p = 0.028). Achievement of postprocedural Thrombolysis In Myocardial Infarction 3 flow was higher with stent plus Abciximab than with the other interventions (85% vs 65%, p = 0.048). By multivariate analysis, absence of stent use (hazard ratio 2.58, 95% confidence interval 1.36 to 4.90, p = 0.004) and left ventricular ejection function stent and Abciximab resulted in higher procedural Thrombolysis In Myocardial Infarction 3 flow rates and a long-term mortality benefit in patients with cardiogenic shock complicating acute myocardial infarction.

Neal S Kleiman - One of the best experts on this subject based on the ideXlab platform.

  • bivalirudin with planned or provisional Abciximab versus low dose heparin and Abciximab during percutaneous coronary revascularization results of the comparison of Abciximab complications with hirulog for ischemic events trial cachet
    American Heart Journal, 2002
    Co-Authors: Michael A Lincoff, Neal S Kleiman, Kandace Kottkemarchant, Elizabeth S Maierson, Kelly Maresh, Kathy Wolski, Eric J Topol
    Abstract:

    Abstract Background The direct thrombin inhibitor bivalirudin has previously been associated with better efficacy and lower hemorrhage risk than heparin during balloon angioplasty. This agent has not yet been tested with stenting or in combination with platelet glycoprotein IIb/IIIa antagonists. Methods and Results In a pilot trial, 268 patients who underwent coronary intervention were randomized in 3 sequential phases to treatment with bivalirudin (with or without Abciximab) or the control regimen of low-dose weight-adjusted heparin with Abciximab. Patients in the bivalirudin arms received bivalirudin (1.0 mg/kg bolus, infusion of 2.5 mg/kg/h for 4 hours) plus Abciximab in phase A, bivalirudin (0.5 mg/kg bolus, infusion of 1.75 mg/kg/h for the procedure duration) plus provisional ("rescue") Abciximab in phase B, or bivalirudin (0.75 mg/kg bolus, infusion of 1.75 mg/kg/h for the procedure duration) plus provisional Abciximab in phase C. Abciximab was necessitated on a provisional basis in 24% of the patients in the bivalirudin arms of phases B and C. A composite clinical endpoint of death, myocardial infarction, repeat revascularization, or major bleeding by 7 days occurred in 3.3%, 5.9%, 0, and 10.6% of the patients in the bivalirudin phase A, bivalirudin phase B, bivalirudin phase C, and heparin plus planned Abciximab arms, respectively ( P =.018 for the pooled bivalirudin groups versus the heparin group). Conclusion Bivalirudin with planned or provisional Abciximab may be at least as safe and effective as low-dose heparin plus Abciximab during percutaneous coronary intervention. (Am Heart J 2002;143:847-53.)

  • clinical benefit of glycoprotein iib iiia blockade with Abciximab is independent of gender pooled analysis from epic epilog and epistent trials
    Journal of the American College of Cardiology, 2000
    Co-Authors: Leslie Cho, Robert M. Califf, Eric J Topol, James E Tcheng, Neal S Kleiman, Craig Balog, Joanne Micale Foody, Joan E Booth, Catherine F Cabot, Michael A Lincoff
    Abstract:

    OBJECTIVES We sought to determine the efficacy and safety of platelet glycoprotein IIb/IIIa receptor (GP IIb/IIIa) blockade with Abciximab in women undergoing percutaneous coronary intervention. BACKGROUND Although gender differences in response to platelet glycoprotein IIb/IIIa receptor blockade have been described, there have been no large clinical studies to assess these differences. METHODS Outcomes were determined using meta-analysis technique. RESULTS In the pooled analysis, the primary end point of death, myocardial infarction (MI) or urgent revascularization within 30 days was reduced from 11.3% to 5.8% (p < 0.001) in men and from 12.7% to 6.5% (p < 0.001) in women treated with Abciximab. At six months, death, MI or urgent revascularization was reduced from 14.1% to 8.3% (p < 0.001) in men and 16.0% to 9.9% (p < 0.001) in women receiving Abciximab. At one year, mortality was reduced from 2.7% to 1.9% (p = 0.06) in men and 4.0% to 2.5% (p = 0.03) in women treated with Abciximab. Major bleeding events occurred in 2.9% versus 3.0% (p = 0.96) of women and 2.7% versus 1.3% (p = 0.003) of men treated with placebo versus Abciximab, respectively. Minor bleeding events occurred in 4.7% versus 6.7% (p = 0.01) of women and 2.3% versus 2.2% (p = 0.94) of men treated with placebo versus Abciximab, respectively. CONCLUSIONS This pooled analysis demonstrated no gender difference in protection from major adverse outcomes with GP IIb/IIIa inhibition with Abciximab. Although women had higher rates of both major and minor bleeding events with Abciximab compared with men, major bleeding in women was similar with and without Abciximab. There was a small increased risk of minor bleeding with Abciximab in women.

  • Abciximab, ticlopidine, and concomitant Abciximab-ticlopidine therapy: ex vivo platelet aggregation inhibition profiles in patients undergoing percutaneous coronary interventions.
    American heart journal, 2000
    Co-Authors: Neal S Kleiman, Kelly Maresh, Nikki Grazeiadei, Rebecca J. Taylor, Bart Frederick, Ellen T. Lance, Mark B. Effron, Robert E. Jordan, Mary Ann Mascelli
    Abstract:

    Abstract Background We examined the ex vivo platelet aggregation profiles of patients who underwent percutaneous coronary intervention and received either Abciximab, ticlopidine, or both agents. Study Design and Methods The trial was a prospective, nonrandomized, single-center, open-label study of 42 patients undergoing percutaneous coronary intervention who received the following regimens: group 1, Abciximab (0.25 mg/kg bolus and 12-hour, 0.125 μg/kg per minute infusion); group 2, ticlopidine (250 mg twice daily for 14 consecutive days, initiated 12 to 18 hours before intervention); group 3, Abciximab plus ticlopidine initiated 12 to 18 hours before procedure; and group 4, Abciximab plus ticlopidine initiated 72 to 96 hours before procedure. Platelet aggregation measurements to adenosine diphosphate (ADP) and a thrombin receptor activating peptide (TRAP, 8 μmol/L) were obtained before ticlopidine treatment, after initiation of ticlopidine, and immediately before Abciximab treatment and intervention, then at several time periods after onset of Abciximab treatment. Platelet surface Abciximab levels were monitored by flow cytometry. Results Neither ticlopidine regimen resulted in appreciable platelet inhibition before intervention and before administration of Abciximab. In the ticlopidine-only arm, suppression of platelet aggregation to the weakest stimuli (5 μmol/L ADP; 23% ± 7.5%) was detected within 24 hours after intervention, with maximal inhibition to both 5 and 20 μmol/L ADP observed 7 days after intervention (48% ± 7.9% and 18% ± 8.7%, respectively). In contrast, ticlopidine marginally suppressed TRAP-mediated platelet activation at times when maximal effects on ADP-mediated platelet aggregation were evident. Neither ticlopidine regimen appreciably enhanced platelet inhibition during or shortly after cessation of Abciximab treatment. For all 3 Abciximab treatment arms, profound inhibition of ADP-induced (>80%) and TRAP-induced (>65%) platelet aggregation was observed 2 hours after treatment. In the Abciximab-only arm, platelet aggregation responses gradually recovered, with the rate of response directly proportional to the strength of stimuli. However, in the ticlopidine plus Abciximab arms, recovery of platelet aggregation at later times (7 and 14 days) reached a plateau and reflected the extent of inhibition observed in ticlopidine-treated patients. No difference in the clearance of surface-bound Abciximab from circulating platelets was observed between the Abciximab and Abciximab plus ticlopidine arms. Conclusions Concomitant Abciximab plus ticlopidine treatment yields a platelet inhibition profile that is a composite of the effects of the 2 agents. In the early stages of treatment, inhibition of ex vivo platelet aggregation was mediated primarily by Abciximab; effects were more moderate and were predominately mediated by ticlopidine. (Am Heart J 2000;140:492-501.)

  • outcomes at 1 year and economic implications of platelet glycoprotein iib iiia blockade in patients undergoing coronary stenting results from a multicentre randomised trial
    The Lancet, 1999
    Co-Authors: Eric J Topol, Michael A Lincoff, Neal S Kleiman, Joan E Booth, Eric A Cohen, Daniel B Mark, Jeffrey R Burton, David Talley, Shelly Sapp, Catherine F Cabot
    Abstract:

    Summary Background We assessed in a randomised trial the long-term outcomes for potent adjunctive antiplatelet therapy given at the time of coronary stenting. Methods In 63 hospitals in the USA and Canada, 2399 patients were randomly assigned stenting with Abciximab, stenting with placebo, or balloon angioplasty with Abciximab. Standard adjunctive therapy with aspirin, tictopidine, and heparin was used. The major outcomes of death and myocardial infarction were assessed at 1-year follow-up by intention to treat We also investigated the 1-year costeffectiveness of combined stenting and Abciximab therapy. Findings At 1-year follow-up, eight (1·0%) of 794 patients in the stent plus Abciximab group had died, compared with 19 (2·4%) of 809 in the stent plus placebo group (hazard ratio 0·43 [95% CI 0·19–0·97], p=0·037). The combined endpoint of death or large myocardial infarction occurred in 42 (5·3%) and 89 (11·0%), respectively (0·46 [0·32–0·67], p Interpretation Coronary stenting with Abciximab, compared with stenting alone or balloon angioplasty with Abciximab, is associated with improved survival and is an economically attractive therapy by conventional standards.

  • effectiveness of early coronary angioplasty and Abciximab for failed thrombolysis reteplase or alteplase during acute myocardial infarction results from the gusto iii trial
    American Journal of Cardiology, 1999
    Co-Authors: Julie M Miller, Eric J Topol, Neal S Kleiman, Christoph Bode, Richard W Smalling, Magnus E Ohman, Amadeo Betriu, Jonathan S Schildcrout, Eugenia Bastos, Robert M. Califf
    Abstract:

    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.

Giuseppe De Luca - One of the best experts on this subject based on the ideXlab platform.

  • clinical efficacy and safety of intracoronary vs intravenous Abciximab administration in stemi patients undergoing primary percutaneous coronary intervention a meta analysis of randomized trials
    Platelets, 2012
    Co-Authors: Eliano Pio Navarese, Marek Kozinski, Karolina Obonska, Massimo Margheri, Paul A Gurbel, Jacek Kubica, Giuseppe De Luca
    Abstract:

    Adjunctive therapy with Abciximab has been proven to reduce mortality and reinfarction in patients with ST-elevation myocardial infarction (STEMI) referred to invasive management. Standard Abciximab regimen consists of an intravenous (IV) bolus followed by a 12-h IV infusion. Experimental studies and small clinical trials suggest the superiority of intracoronary (IC) injection of Abciximab over the IV route. We aimed to perform a meta-analysis of randomized controlled trials to assess the clinical efficacy and safety of IC vs. IV Abciximab administration in STEMI patients undergoing primary percutaneous coronary intervention (PPCI). The primary endpoint was mortality, while recurrent myocardial infarction and target vessel revascularization (TVR) were selected as secondary endpoints. The safety endpoint was the risk of major bleeding complications. A total of six randomized trials were finally included in the meta-analysis, enrolling a total of 1246 patients. Compared to IV route, IC Abciximab was associa...

  • benefits from intracoronary as compared to intravenous Abciximab administration for stemi patients undergoing primary angioplasty a meta analysis of 8 randomized trials
    Atherosclerosis, 2012
    Co-Authors: Giuseppe De Luca, Monica Verdoia, Harry Suryapranata
    Abstract:

    BACKGROUND: Adjunctive Abciximab administration has been demonstrated to reduce mortality and reinfarction in patients with ST-elevation myocardial infarction (STEMI) referred to invasive management. Standard Abciximab regimen consists of an intravenous (IV) bolus followed by a 12-h IV infusion. Experimental studies and small clinical trials suggest the superiority of intracoronary (IC) injection of Abciximab over IV route. Therefore, the aim of the current study was to perform a meta-analysis of randomized trials (RCTs) to assess the clinical efficacy and safety of IC vs IV Abciximab administration in STEMI patients undergoing primary angioplasty. METHODS: We obtained results from all RCTs enrolling STEMI patients undergoing primary percutaneous coronary intervention (PCI). The primary endpoint was mortality, while recurrent myocardial infarction, postprocedural epicardial (TIMI 3) and myocardial (MBG 2-3) perfusion were identified as secondary endpoints. The safety endpoint was the risk of major bleeding complications. RESULTS: A total of 8 randomized trials were finally included in the meta-analysis, enrolling a total of 3259 patients. As compared to IV route, IC Abciximab was associated with a significant improvement in myocardial perfusion (OR [95% CI]=1.76 [1.28-2.42], p<0.001), without significant benefits in terms of mortality (OR [95% CI]=0.85 [0.59-1.23], p=0.39), reinfarction (OR [95% CI]=0.79 [0.46-1.33], p=0.37), or major bleeding complications (OR [95% CI]=1.19 [0.76-1.87], p=0.44). However, we observed a significant relationship between patient's risk profile and mortality benefits from IC Abciximab administration (p=0.011). CONCLUSIONS: The present updated meta-analysis showed that IC administration of Abciximab is associated with significant benefits in myocardial perfusion, but not in clinical outcome at short-term follow-up as compared to IV Abciximab administration, without any excess of major bleedings in STEMI patients undergoing primary PCI. However, a significant relationship was observed between patient's risk profile and mortality benefits from IC Abciximab administration. Therefore, waiting for long-term follow-up results and additional randomized trials, IC Abciximab administration cannot be routinely recommended, but may be considered in high-risk patients.

  • Abciximab as adjunctive therapy to reperfusion in acute st segment elevation myocardial infarction a meta analysis of randomized trials
    JAMA, 2005
    Co-Authors: Giuseppe De Luca, Elliott M Antman, Harry Suryapranata, David Antoniucci, Frans Van De Werf, Franzjosef Neumann, James E Tcheng, Gregg W Stone, Eric J Topol
    Abstract:

    ContextThe benefits of Abciximab in patients with ST-segment elevation myocardial infarction (STEMI) are still a matter of debate.ObjectiveTo combine data from all randomized trials conducted with Abciximab in STEMI.Data SourcesFormal searches of electronic databases (MEDLINE, PubMed) from from January 1990 to December 2004.Study SelectionWe examined all completed, published, randomized trials of Abciximab in STEMI. The following key words were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, facilitated angioplasty, stenting, fibrinolysis, IIb-IIIa inhibitors, and Abciximab.Data ExtractionInformation on study design, type and dosage of drugs, inclusion and exclusion criteria, number of patients, and clinical outcome was extracted by 2 investigators. Disagreements were resolved by consensus.Data SynthesisEleven trials were analyzed, involving 27115 patients (12 602 [46.5%] in the Abciximab group, 14 513 [53.5%] in the control group). When compared with the control group, Abciximab was associated with a significant reduction in short-term (30 days) mortality (2.4% vs 3.4%, P = .047) and long-term (6-12 months) mortality (4.4% vs 6.2%, P = .01) in patients undergoing primary angioplasty but not in those treated with fibrinolysis or in all trials combined. Abciximab was associated with a significant reduction in 30-day reinfarction, both in all trials combined (2.1% vs 3.3%, P<.001), in primary angioplasty (1.0% vs 1.9%, P = .03), and in fibrinolysis trials (2.3% vs 3.6%, P<.001). Abciximab did not result in an increased risk of intracranial bleeding (0.61% vs 0.62%, P = .62) but was associated with an increased risk of major bleeding complications when combined with fibrinolysis (5.2% vs 3.1%, P<.001) but not with primary angioplasty (4.7% vs 4.1%, P = .36).ConclusionsThis meta-analysis shows that, when compared with the control group, adjunctive Abciximab for STEMI is associated with a significant reduction in 30-day and long-term mortality in patients treated with primary angioplasty but not in those receiving fibrinolysis. The 30-day reinfarction rate is significantly reduced in patients treated with either fibrinolysis or primary angioplasty. A higher risk of major bleeding complications is observed with Abciximab in association with fibrinolysis.

Michael A Lincoff - One of the best experts on this subject based on the ideXlab platform.

  • bivalirudin with planned or provisional Abciximab versus low dose heparin and Abciximab during percutaneous coronary revascularization results of the comparison of Abciximab complications with hirulog for ischemic events trial cachet
    American Heart Journal, 2002
    Co-Authors: Michael A Lincoff, Neal S Kleiman, Kandace Kottkemarchant, Elizabeth S Maierson, Kelly Maresh, Kathy Wolski, Eric J Topol
    Abstract:

    Abstract Background The direct thrombin inhibitor bivalirudin has previously been associated with better efficacy and lower hemorrhage risk than heparin during balloon angioplasty. This agent has not yet been tested with stenting or in combination with platelet glycoprotein IIb/IIIa antagonists. Methods and Results In a pilot trial, 268 patients who underwent coronary intervention were randomized in 3 sequential phases to treatment with bivalirudin (with or without Abciximab) or the control regimen of low-dose weight-adjusted heparin with Abciximab. Patients in the bivalirudin arms received bivalirudin (1.0 mg/kg bolus, infusion of 2.5 mg/kg/h for 4 hours) plus Abciximab in phase A, bivalirudin (0.5 mg/kg bolus, infusion of 1.75 mg/kg/h for the procedure duration) plus provisional ("rescue") Abciximab in phase B, or bivalirudin (0.75 mg/kg bolus, infusion of 1.75 mg/kg/h for the procedure duration) plus provisional Abciximab in phase C. Abciximab was necessitated on a provisional basis in 24% of the patients in the bivalirudin arms of phases B and C. A composite clinical endpoint of death, myocardial infarction, repeat revascularization, or major bleeding by 7 days occurred in 3.3%, 5.9%, 0, and 10.6% of the patients in the bivalirudin phase A, bivalirudin phase B, bivalirudin phase C, and heparin plus planned Abciximab arms, respectively ( P =.018 for the pooled bivalirudin groups versus the heparin group). Conclusion Bivalirudin with planned or provisional Abciximab may be at least as safe and effective as low-dose heparin plus Abciximab during percutaneous coronary intervention. (Am Heart J 2002;143:847-53.)

  • Abciximab suppresses the rise in levels of circulating inflammatory markers after percutaneous coronary revascularization
    Circulation, 2001
    Co-Authors: Michael A Lincoff, Kamlesh Patel, Marian T Nakada, Dean J. Kereiakes, Bart Frederick, Mary Ann Mascelli, Lawrence I Deckelbaum, Elliot S Barnathan, Eric J Topol
    Abstract:

    Background—Previous investigators have shown that systemic markers of inflammation may be increased in patients with acute ischemic syndromes or after percutaneous coronary revascularization and that persistent elevation in these markers is predictive of excess risk of subsequent adverse cardiac events. By virtue of its cross-reactivity with the glycoprotein IIb/IIIa, avb3, and aMb2 receptors, Abciximab may reduce inflammatory processes. Methods and Results—Assays for the inflammatory markers C-reactive protein, interleukin-6, and tumor necrosis factor- a were performed on serum samples obtained from 160 patients in a placebo-controlled, randomized trial of Abciximab during angioplasty. Eighty patients each had received a placebo or Abciximab bolus plus a 12-hour infusion. Serum samples were drawn at baseline (before revascularization), 24 to 48 hours after study drug administration, and 4 weeks after study drug administration. Between baseline and 24 to 48 hours, the increase in C-reactive protein was 32% less in patients receiving Abciximab than placebo (P50.025); the rise in interleukin-6 levels was 76% less in the Abciximab group (P,0.001); and the rise in tumor necrosis factor-a levels was 100% less with Abciximab therapy (P50.112). By 4 weeks, most marker levels had returned to baseline, with no significant differences between placebo and Abciximab groups. Conclusions—Systemic markers of inflammation increase in the first 24 to 48 hours after angioplasty, but the magnitude of that rise is diminished by periprocedural Abciximab. Some of the long-term clinical benefit derived from this agent may be related to an anti-inflammatory effect. (Circulation. 2001;104:163-167.)

  • clinical benefit of glycoprotein iib iiia blockade with Abciximab is independent of gender pooled analysis from epic epilog and epistent trials
    Journal of the American College of Cardiology, 2000
    Co-Authors: Leslie Cho, Robert M. Califf, Eric J Topol, James E Tcheng, Neal S Kleiman, Craig Balog, Joanne Micale Foody, Joan E Booth, Catherine F Cabot, Michael A Lincoff
    Abstract:

    OBJECTIVES We sought to determine the efficacy and safety of platelet glycoprotein IIb/IIIa receptor (GP IIb/IIIa) blockade with Abciximab in women undergoing percutaneous coronary intervention. BACKGROUND Although gender differences in response to platelet glycoprotein IIb/IIIa receptor blockade have been described, there have been no large clinical studies to assess these differences. METHODS Outcomes were determined using meta-analysis technique. RESULTS In the pooled analysis, the primary end point of death, myocardial infarction (MI) or urgent revascularization within 30 days was reduced from 11.3% to 5.8% (p < 0.001) in men and from 12.7% to 6.5% (p < 0.001) in women treated with Abciximab. At six months, death, MI or urgent revascularization was reduced from 14.1% to 8.3% (p < 0.001) in men and 16.0% to 9.9% (p < 0.001) in women receiving Abciximab. At one year, mortality was reduced from 2.7% to 1.9% (p = 0.06) in men and 4.0% to 2.5% (p = 0.03) in women treated with Abciximab. Major bleeding events occurred in 2.9% versus 3.0% (p = 0.96) of women and 2.7% versus 1.3% (p = 0.003) of men treated with placebo versus Abciximab, respectively. Minor bleeding events occurred in 4.7% versus 6.7% (p = 0.01) of women and 2.3% versus 2.2% (p = 0.94) of men treated with placebo versus Abciximab, respectively. CONCLUSIONS This pooled analysis demonstrated no gender difference in protection from major adverse outcomes with GP IIb/IIIa inhibition with Abciximab. Although women had higher rates of both major and minor bleeding events with Abciximab compared with men, major bleeding in women was similar with and without Abciximab. There was a small increased risk of minor bleeding with Abciximab in women.

  • outcomes at 1 year and economic implications of platelet glycoprotein iib iiia blockade in patients undergoing coronary stenting results from a multicentre randomised trial
    The Lancet, 1999
    Co-Authors: Eric J Topol, Michael A Lincoff, Neal S Kleiman, Joan E Booth, Eric A Cohen, Daniel B Mark, Jeffrey R Burton, David Talley, Shelly Sapp, Catherine F Cabot
    Abstract:

    Summary Background We assessed in a randomised trial the long-term outcomes for potent adjunctive antiplatelet therapy given at the time of coronary stenting. Methods In 63 hospitals in the USA and Canada, 2399 patients were randomly assigned stenting with Abciximab, stenting with placebo, or balloon angioplasty with Abciximab. Standard adjunctive therapy with aspirin, tictopidine, and heparin was used. The major outcomes of death and myocardial infarction were assessed at 1-year follow-up by intention to treat We also investigated the 1-year costeffectiveness of combined stenting and Abciximab therapy. Findings At 1-year follow-up, eight (1·0%) of 794 patients in the stent plus Abciximab group had died, compared with 19 (2·4%) of 809 in the stent plus placebo group (hazard ratio 0·43 [95% CI 0·19–0·97], p=0·037). The combined endpoint of death or large myocardial infarction occurred in 42 (5·3%) and 89 (11·0%), respectively (0·46 [0·32–0·67], p Interpretation Coronary stenting with Abciximab, compared with stenting alone or balloon angioplasty with Abciximab, is associated with improved survival and is an economically attractive therapy by conventional standards.

  • attainment and maintenance of platelet inhibition through standard dosing of Abciximab in diabetic and nondiabetic patients undergoing percutaneous coronary intervention
    Circulation, 1999
    Co-Authors: Steven R Steinhubl, Eric J Topol, Kandace Kottkemarchant, David J. Moliterno, Monique Rosenthal, Nikki K Godfrey, Barry S Coller, Michael A Lincoff
    Abstract:

    Background —Although the effectiveness of Abciximab (c7E3 Fab; ReoPro) in large populations of patients undergoing a percutaneous coronary intervention has been consistently proved in clinical trials, it is unknown whether all patients achieve and maintain target inhibition during treatment. Diabetic patients in particular are a subgroup of patients with known underlying platelet abnormalities whose long-term response to Abciximab has been shown to vary from that of nondiabetic patients. Methods and Results —Forty-nine diabetic and 51 nondiabetic patients who received adjunctive Abciximab therapy during percutaneous coronary interventions were evaluated prospectively. The degree of platelet function inhibition was determined immediately after the Abciximab bolus, 8 hours after the bolus (during the 12-hour Abciximab infusion), and the next morning (13 to 26 hours after the bolus) with the use of a rapid platelet function assay (Accumetrics). After the Abciximab bolus, platelet function was inhibited by 95±4% (mean±SD). By 8 hours, the average percent inhibition had decreased to 88±9%, with 13% of patients with Conclusions —Although the majority of patients achieve and maintain ≥80% platelet inhibition during the 12-hour infusion with standard-dose Abciximab, there is substantial variability among patients. Diabetic status does not appear to influence this variability.

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  • Safety and efficacy of Abciximab combined with dalteparin in treatment of acute coronary syndromes
    European Heart Journal, 2002
    Co-Authors: Stefan James, Steen Husted, M. Niemminen, Frederic Kontny, Maarten L. Simoons, Robert M. Califf, Matthias Pfisterer, Paul W Armstrong, Lars Wallentin
    Abstract:

    Aims The safety and efficacy of Abciximab in addition to low-molecular-weight-heparin as the primary medical treatment of acute coronary syndromes has not previously been investigated. Methods and Results The GUSTO IV–ACS trial included 7800 patients with chest pain and either ST-segment depression or a positive troponin test. They were randomized to Abciximab for 24h, 48h or placebo. In the dalteparin substudy, 974 patients received 5 days of s.c. dalteparin, instead of a 48h infusion of unfractionated heparin (UFH). Major and minor bleedings were more frequent for Abciximab (24 and 48h combined) than placebo both in the dalteparin (Abciximab 5·0% vs placebo 1·8% P

  • safety and efficacy of Abciximab combined with dalteparin in treatment of acute coronary syndromes
    European Heart Journal, 2002
    Co-Authors: Stefan James, Steen Husted, M. Niemminen, Frederic Kontny, Maarten L. Simoons, Robert M. Califf, Matthias Pfisterer, Paul W Armstrong, Lars Wallentin
    Abstract:

    Aims The safety and efficacy of Abciximab in addition to low-molecular-weight-heparin as the primary medical treatment of acute coronary syndromes has not previously been investigated. Methods and Results The GUSTO IV–ACS trial included 7800 patients with chest pain and either ST-segment depression or a positive troponin test. They were randomized to Abciximab for 24h, 48h or placebo. In the dalteparin substudy, 974 patients received 5 days of s.c. dalteparin, instead of a 48h infusion of unfractionated heparin (UFH). Major and minor bleedings were more frequent for Abciximab (24 and 48h combined) than placebo both in the dalteparin (Abciximab 5·0% vs placebo 1·8% P <0·05) and in the UFH cohort (3·8% vs 1·8% P <0·001). However, stroke rates were low, ≤0·6%. At 30 days there were no significant differences in the rate of death or MI, either in the dalteparin (Abciximab 9·6% vs placebo 11·3%: O.R. 0·85; 95% C.I. 0·58–1·25) or in the UFH cohort (8·5% vs 7·6%: O.R.; 1·12: 0·95–1·34). Conclusion Treatment with Abciximab, aspirin and s.c. dalteparin is associated with a low risk of major side effects and is as safe as the combination of Abciximab and UFH. Without early coronary intervention there is no indication for Abciximab treatment. Copyright 2002 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved .

  • Risk of stroke associated with Abciximab among patients undergoing percutaneous coronary intervention
    JAMA, 2001
    Co-Authors: K. Martijn Akkerhuis, Robert M. Califf, Eric J Topol, James E Tcheng, Keaven M Anderson, Craig Balog, Jaap W. Deckers, A. Michael Lincoff, Eric Boersma, Maarten L. Simoons
    Abstract:

    Context Abciximab, a potent inhibitor of the platelet glycoprotein IIb/IIIa receptor, reduces thrombotic complications in patients undergoing percutaneous coronary intervention (PCI). Because of its potent inhibition of platelet aggregation, the effect of Abciximab on risk of stroke is a concern. Objective To determine whether Abciximab use among patients undergoing PCI is associated with an increased risk of stroke. Design Combined analysis of data from 4 double-blind, placebo-controlled, randomized trials (EPIC, CAPTURE, EPILOG, and EPISTENT) conducted between November 1991 and October 1997 at a total of 257 academic and community hospitals in the United States and Europe. Patients A total of 8555 patients undergoing PCI with or without stent deployment for a variety of indications were randomly assigned to receive a bolus and infusion of Abciximab (n=5476) or matching placebo (n=3079). One treatment group in EPIC received a bolus of Abciximab only. Main Outcome Measure Risk of hemorrhagic and nonhemorrhagic stroke within 30 days of treatment among Abciximab and placebo groups. Results No significant difference in stroke rate was observed between patients assigned Abciximab (n =2 2 [0.40%]) and those assigned placebo (n =9 [0.29%]; P= .46). Excluding the EPIC Abciximab bolus-only group, there were 9 strokes (0.30%) among 3023 patients who received placebo and 15 (0.32%) in 4680 patients treated with Abciximab bolus plus infusion, a difference of 0.02% (95% confidence interval [CI], ˛0.23% to 0.28%). The rate of nonhemorrhagic stroke was 0.17% in patients treated with Abciximab and 0.20% in patients treated with placebo (difference, ˛0.03%; 95% CI, ˛0.23% to 0.17%), and the rates of hemorrhagic stroke were 0.15% and 0.10%, respectively (difference, 0.05%; 95% CI, ˛0.11% to 0.21%). Among patients treated with Abciximab, the rate of hemorrhagic stroke in patients receiving standard-dose heparin in EPIC, CAPTURE, and EPILOG was higher than in those receiving low-dose heparin in the EPILOG and EPISTENT trials (0.27% vs 0.04%; P=.057).

  • clinical benefit of glycoprotein iib iiia blockade with Abciximab is independent of gender pooled analysis from epic epilog and epistent trials
    Journal of the American College of Cardiology, 2000
    Co-Authors: Leslie Cho, Robert M. Califf, Eric J Topol, James E Tcheng, Neal S Kleiman, Craig Balog, Joanne Micale Foody, Joan E Booth, Catherine F Cabot, Michael A Lincoff
    Abstract:

    OBJECTIVES We sought to determine the efficacy and safety of platelet glycoprotein IIb/IIIa receptor (GP IIb/IIIa) blockade with Abciximab in women undergoing percutaneous coronary intervention. BACKGROUND Although gender differences in response to platelet glycoprotein IIb/IIIa receptor blockade have been described, there have been no large clinical studies to assess these differences. METHODS Outcomes were determined using meta-analysis technique. RESULTS In the pooled analysis, the primary end point of death, myocardial infarction (MI) or urgent revascularization within 30 days was reduced from 11.3% to 5.8% (p < 0.001) in men and from 12.7% to 6.5% (p < 0.001) in women treated with Abciximab. At six months, death, MI or urgent revascularization was reduced from 14.1% to 8.3% (p < 0.001) in men and 16.0% to 9.9% (p < 0.001) in women receiving Abciximab. At one year, mortality was reduced from 2.7% to 1.9% (p = 0.06) in men and 4.0% to 2.5% (p = 0.03) in women treated with Abciximab. Major bleeding events occurred in 2.9% versus 3.0% (p = 0.96) of women and 2.7% versus 1.3% (p = 0.003) of men treated with placebo versus Abciximab, respectively. Minor bleeding events occurred in 4.7% versus 6.7% (p = 0.01) of women and 2.3% versus 2.2% (p = 0.94) of men treated with placebo versus Abciximab, respectively. CONCLUSIONS This pooled analysis demonstrated no gender difference in protection from major adverse outcomes with GP IIb/IIIa inhibition with Abciximab. Although women had higher rates of both major and minor bleeding events with Abciximab compared with men, major bleeding in women was similar with and without Abciximab. There was a small increased risk of minor bleeding with Abciximab in women.

  • effectiveness of early coronary angioplasty and Abciximab for failed thrombolysis reteplase or alteplase during acute myocardial infarction results from the gusto iii trial
    American Journal of Cardiology, 1999
    Co-Authors: Julie M Miller, Eric J Topol, Neal S Kleiman, Christoph Bode, Richard W Smalling, Magnus E Ohman, Amadeo Betriu, Jonathan S Schildcrout, Eugenia Bastos, Robert M. Califf
    Abstract:

    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.

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