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

  • bivalirudin versus heparin and Glycoprotein IIb iiia inhibition among patients with renal impairment undergoing percutaneous coronary intervention a subanalysis of the replace 2 trial
    American Journal of Cardiology, 2005
    Co-Authors: Derek P Chew, David J Cohen, Michael A Lincoff, Timothy D Henry, Hitinder S Gurm, Kathy Wolski, Frederick Feit, Eric J Topol
    Abstract:

    Among patients who undergo percutaneous coronary intervention, renal impairment is associated with an excessive risk of bleeding and ischemic events. Bivalirudin provides comparable suppression of ischemic events with a decrease in bleeding events compared with heparin and Glycoprotein IIb/IIIa inhibition. We examined the relation between adverse events, renal impairment, and antithrombotic therapy within a randomized comparison. The Second Randomized Evaluation in PCI Linking Bivalirudin to Reduced Clinical Events per-protocol study population was assessed. Renal function was defined as calculated creatinine clearance <60 ml/min. Events within the overall study population and within each study arm were assessed. Thirty-day events by renal function were compared by chi-square test and logistic regression. Late mortality was compared by log-rank test. Interaction analyses were performed. Among 5,710 patients, renal impairment was associated with increased ischemic events (hazard ratio 1.45, 95% confidence interval 1.13 to 1.88, p = 0.004), bleeding complications (hazard ratio 1.72, 95% confidence interval 1.06 to 2.80, p = 0.028), and excessive 12-month mortality (hazard ratio 3.85, 95% confidence interval 2.67 to 5.54, p <0.001). Bivalirudin provided suppression of ischemic events that was comparable to heparin and Glycoprotein IIb/IIIa inhibition regardless of renal impairment. Fewer bleeding events with bivalirudin were also evident irrespective of renal dysfunction. No interaction between treatment assignment, bleeding or ischemic complications, and renal impairment was observed. The safety and efficacy of bivalirudin compared with heparin and planned Glycoprotein IIb/IIIa inhibition in this high-risk group are comparable and consistent with the results of the overall trial.

  • comparison of two platelet Glycoprotein IIb iiia inhibitors tirofiban and abciximab for the prevention of ischemic events with percutaneous coronary revascularization
    The New England Journal of Medicine, 2001
    Co-Authors: Eric J Topol, Franzjosef Neumann, Eric A Cohen, David J Cohen, David J. Moliterno, Howard C Herrmann, Eric R Powers, Cindy L Grines, Michel E Bertrand, Gregg W Stone
    Abstract:

    Background In the setting of percutaneous coronary revascularization, agents in the class known as platelet Glycoprotein IIb/IIIa inhibitors have significantly reduced the incidence of death or nonfatal myocardial infarction at 30 days. We assessed whether there are differences in safety or efficacy between two such inhibitors, tirofiban and abciximab. Methods Using a double-blind, double-dummy design at 149 hospitals in 18 countries, we randomly assigned patients to receive either tirofiban or abciximab before undergoing percutaneous coronary revascularization with the intent to perform stenting. The primary end point was a composite of death, nonfatal myocardial infarction, or urgent target-vessel revascularization at 30 days. The trial was designed and statistically powered to demonstrate the noninferiority of tirofiban as compared with abciximab. Results The primary end point occurred more frequently among the 2398 patients in the tirofiban group than among the 2411 patients in the abciximab group (7....

  • increased mortality with oral platelet Glycoprotein IIb iiia antagonists a meta analysis of phase iii multicenter randomized trials
    Circulation, 2001
    Co-Authors: Derek P Chew, Shelly K Sapp, Deepak L Bhatt, Eric J Topol
    Abstract:

    Background—Numerous clinical trials have established the benefits of intravenous Glycoprotein IIb/IIIa inhibition in the management of coronary artery disease. In contrast, the recent large-scale, placebo-controlled, randomized trials of the oral Glycoprotein IIb/IIIa antagonists have failed to provide commensurate reductions in late composite ischemic end points despite potent inhibition of platelet aggregation. Methods and Results—The ORs for death, myocardial infarction, urgent revascularization, and major bleeding from the 4 large-scale, placebo-controlled, randomized trials with oral Glycoprotein IIb/IIIa inhibitors were calculated and combined. Stratification by low-dose or high-dose therapy and the use of concurrent aspirin was also undertaken. In 33 326 patients followed for >30 days, a consistent and statistically significant increase in mortality was observed with oral Glycoprotein IIb/IIIa therapy (OR, 1.37; 95% CI, 1.13 to 1.66; P=0.001). This effect was evident regardless of aspirin coadminis...

  • current role of platelet Glycoprotein IIb iiia inhibitors in acute coronary syndromes
    JAMA, 2000
    Co-Authors: Deepak L Bhatt, Eric J Topol
    Abstract:

    ContextThe central role of platelet-rich thrombus in the pathogenesis of acute coronary syndromes (ACSs) is well-known. Glycoprotein IIb/IIIa (Gp IIb/IIIa) receptor antagonists are potent inhibitors of platelet function that may be expected to affect favorably the natural history of ACSs.ObjectiveTo define the optimal role of Gp IIb/IIIa inhibitors in treatment strategies for ACSs.Data SourcesA MEDLINE search was performed to identify all English-language articles regarding use of Gp IIb/IIIa inhibitors in ACSs published between 1966 and June 2000. In addition, relevant abstracts from the annual meetings of the American Heart Association, American College of Cardiology, and the European Society of Cardiology were reviewed.Study SelectionOnly studies of 500 or more patients were included. Of 15 studies identified, 10 randomized, placebo-controlled, double-blind trials of Gp IIb/IIIa inhibitors in ACSs were selected for review.Data ExtractionData quality was determined by publication in the peer-reviewed literature or presentation at an official cardiology society–sponsored meeting, as well as by verification with the primary author.Data SynthesisThree members of this class of drugs are available for intravenous use. Abciximab, eptifibatide, and tirofiban hydrochloride, each have data demonstrating their value in improving the outcomes of patients presenting with ACSs. Current evidence supports use of these drugs in both conservative and invasive treatment strategies. Glycoprotein IIb/IIIa–blocking therapy is safe, and with proper precautions, bleeding risks can be minimized. Biological differences exist among these agents, but as of yet, no head-to-head comparisons have been made of their clinical efficacy. Unlike intravenous Gp IIb/IIIa inhibitors, available data regarding any role of oral Gp IIb/IIIa inhibitors are not favorable.ConclusionCurrent data indicate that intravenous Gp IIb/IIIa inhibitor therapy merits a prominent role in the initial management of patients with ACSs.

  • platelet Glycoprotein IIb iiia blockade and outcome of cardiogenic shock complicating acute coronary syndromes without persistent st segment elevation
    Journal of the American College of Cardiology, 2000
    Co-Authors: David Hasdai, Maarten L. Simoons, Judith S Hochman, Robert A. Harrington, Eric J Topol, Alexander Battler, James W Box, Jaap W Deckers, David R Holmes
    Abstract:

    Abstract OBJECTIVES The study examined whether antiplatelet treatment with eptifibatide affected the frequency and outcome of shock among patients in the Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) trial who had acute coronary syndromes but not persistent ST-segment elevation. BACKGROUND Preliminary reports suggest a salutary effect of antiplatelet agents when shock complicates acute myocardial infarction. METHODS We analyzed the impact of antiplatelet treatment with eptifibatide on the frequency and outcome of cardiogenic shock developing after enrollment. PURSUIT was a double-blind, randomized trial that examined the efficacy of eptifibatide (180 μg/kg bolus + continuous infusion of 2.0 μg/kg/min for ≤96 h) versus placebo among patients who had acute coronary syndromes but not persistent ST-segment elevation. RESULTS Shock developed in 2.5% of the 9,449 patients at a median (25th, 75th interquartiles) of 94.0 (38, 206) h. Death by 30 days occurred in 65.8% of shock patients. Patients who had acute myocardial infarction upon enrollment had a greater incidence of shock (2.9% vs. 2.1%, p = 0.01), developed shock earlier (40.2% CONCLUSIONS Patients with shock treated with eptifibatide had significantly reduced adjusted odds of death, suggesting a salutary effect of antiplatelet therapy on shock. This finding warrants verification in specifically designed studies.

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

  • long term efficacy of bivalirudin and provisional Glycoprotein IIb iiia blockade vs heparin and planned Glycoprotein IIb iiia blockade during percutaneous coronary revascularization replace 2 randomized trial
    JAMA, 2004
    Co-Authors: Michael A Lincoff, Neal S. Kleiman, David J Cohen, Dean J. Kereiakes, Frederick Feit, John A Bittl, Daniel J Jackman, Ian J Sarembock, Douglas Spriggs, Ramin Ebrahimi
    Abstract:

    ContextIn the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, bivalirudin with provisional Glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition was found to be noninferior to heparin plus planned Gp IIb/IIIa blockade in the prevention of acute ischemic end points and was associated with significantly less bleeding by 30 days after percutaneous coronary intervention (PCI).ObjectiveTo determine whether the efficacy of bivalirudin remains comparable with that of heparin plus Gp IIb/IIIa blockade over 6 months and 1 year.Design, Setting, and ParticipantsFollow-up study to 1 year of a randomized, double-blind trial conducted among 6010 patients undergoing urgent or elective PCI at 233 community or referral hospitals in 9 countries from October 2001 through August 2002.InterventionsPatients were randomly assigned to receive intravenously bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition, or to receive heparin (65 U/kg bolus), with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI.Main Outcome MeasuresIncidence of death, myocardial infarction, or repeat revascularization by 6 months and death by 12 months after enrollment.ResultsAt 6 months, death occurred in 1.4% of patients in the heparin plus Gp IIb/IIIa group and in 1.0% of patients in the bivalirudin group (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.43-1.14; P = .15). Myocardial infarction occurred in 7.4% and 8.2% of patients, respectively (HR, 1.12; 95% CI, 0.93-1.34; P = .24), and repeat revascularization was required in 11.4% and 12.1% of patients, respectively (HR, 1.06; 95% CI, 0.91-1.23; P = .45). By 1 year, death occurred in 2.46% of patients treated with heparin plus Gp IIb/IIIa blockade and in 1.89% of patients treated with bivalirudin (HR, 0.78; 95% CI, 0.55-1.11; P = .16). Nonsignificant trends toward lower 1-year mortality with bivalirudin were present in all patient subgroups analyzed and were of greatest magnitude among high-risk patients.ConclusionLong-term clinical outcome with bivalirudin and provisional Gp IIb/IIIa blockade is comparable with that of heparin plus planned Gp IIb/IIIa inhibition during contemporary PCI.

  • argatroban anticoagulation in conjunction with Glycoprotein IIb iiia inhibition in patients undergoing percutaneous coronary intervention an open label nonrandomized pilot study
    Journal of Thrombosis and Thrombolysis, 2004
    Co-Authors: Ikkyung Jang, Bruce E Lewis, William H Matthai, Neal S. Kleiman
    Abstract:

    Background: Argatroban, a direct thrombin inhibitor, blocks clot-bound thrombin more effectively than does heparin. This multicenter, prospective pilot study evaluated the efficacy and safety of argatroban in combination with Glycoprotein IIb/IIIa inhibition in patients undergoing percutaneous coronary intervention. Methods: Patients (N = 152) received argatroban as a 250- or 300-μg/kg bolus, followed by a 15-μg/kg/min infusion during percutaneous coronary intervention. An additional 150-μg/kg bolus was administered if activated clotting times 5–15 min after initiating argatroban were <275 s. Abciximab (N = 150) or double-bolus eptifibatide (N = 2) was administered simultaneously. Results: Median activated clotting times at the beginning and end of the procedure were approximately 300 s. The primary efficacy endpoint—a composite of death, myocardial infarction, or urgent revascularization at 30 days—occurred in 4 (2.6%) patients (no death, 4 myocardial infarctions, and 2 revascularizations). Two (1.3%) patients had major bleeding by the Thrombolysis in Myocardial Infarction criteria (1 retroperitoneal, 1 groin hematoma). Conclusions: Argatroban in combination with Glycoprotein IIb/IIIa inhibition appears to provide adequate anticoagulation and be well tolerated with an acceptable bleeding risk for patients undergoing percutaneous coronary intervention. Additional studies are warranted.

  • differential treatment benefit of platelet Glycoprotein IIb iiia inhibition with percutaneous coronary intervention versus medical therapy for acute coronary syndromes exploration of methods
    Circulation, 2004
    Co-Authors: Karen S Pieper, Neal S. Kleiman, Vic Hasselblad, Eric Boersma, Anastasios A Tsiatis, Marie Davidian, Wei Ching Chang, Jeffrey Griffin, Paul W Armstrong
    Abstract:

    Background-Although many believe that platelet Glycoprotein IIb/IIIa inhibitors should be used only in acute coronary syndrome patients undergoing percutaneous coronary intervention, supporting data from randomized clinical trials are tenuous. The assumption that these agents are useful only in conjunction with percutaneous coronary intervention is based primarily on inappropriate subgroup analyses performed across the Glycoprotein IIb/IIIa inhibitor trials. Methods and Results-We describe the problems with these analytical techniques and demonstrate that different approaches to the question can result in opposing answers. Conclusions-Clinical-practice decisions and practice guidelines should be based on overall trial results and not analyses of post-randomization subgroups.

  • bivalirudin and provisional Glycoprotein IIb iiia blockade compared with heparin and planned Glycoprotein IIb iiia blockade during percutaneous coronary intervention replace 2 randomized trial
    JAMA, 2003
    Co-Authors: Michael A Lincoff, Neal S. Kleiman, David J Cohen, Robert A. Harrington, Frederick Feit, John A Bittl, Daniel J Jackman, Ian J Sarembock, Douglas Spriggs, Ramin Ebrahimi
    Abstract:

    ContextThe direct thrombin inhibitor bivalirudin has been associated with better efficacy and less bleeding than heparin during coronary balloon angioplasty but has not been widely tested during contemporary percutaneous coronary intervention (PCI).ObjectiveTo determine the efficacy of bivalirudin, with Glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition on a provisional basis for complications during PCI, compared with heparin plus planned Gp IIb/IIIa blockade with regard to protection from periprocedural ischemic and hemorrhagic complications.Design, Setting, and ParticipantsThe Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)–2 trial, a randomized, double-blind, active-controlled trial conducted among 6010 patients undergoing urgent or elective PCI at 233 community or referral hospitals in 9 countries from October 2001 through August 2002.InterventionsPatients were randomly assigned to receive intravenous bivalirudin (0.75-mg/kg bolus plus 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition (n = 2999), or heparin (65-U/kg bolus) with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide) (n = 3011). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI.Main Outcome MeasuresThe primary composite end point was 30-day incidence of death, myocardial infarction, urgent repeat revascularization, or in-hospital major bleeding; the secondary composite end point was 30-day incidence of death, myocardial infarction, or urgent repeat revascularization.ResultsProvisional Gp IIb/IIIa blockade was administered to 7.2% of patients in the bivalirudin group. By 30 days, the primary composite end point had occurred among 9.2% of patients in the bivalirudin group vs 10.0% of patients in the heparin-plus-Gp IIb/IIIa group (odds ratio, 0.92; 95% confidence interval, 0.77-1.09; P = .32). The secondary composite end point occurred in 7.6% of patients in the bivalirudin vs 7.1% of patients in the heparin-plus-Gp IIb/IIIa groups (odds ratio, 1.09; 95% confidence interval 0.90-1.32; P = .40). Prespecified statistical criteria for noninferiority to heparin plus Gp IIb/IIIa were satisfied for both end points. In-hospital major bleeding rates were significantly reduced by bivalirudin (2.4% vs 4.1%; P<.001).ConclusionsBivalirudin with provisional Gp IIb/IIIa blockade is statistically not inferior to heparin plus planned Gp IIb/IIIa blockade during contemporary PCI with regard to suppression of acute ischemic end points and is associated with less bleeding.

  • platelet Glycoprotein IIb iiia inhibition in acute coronary syndromes gradient of benefit related to the revascularization strategy
    European Heart Journal, 2002
    Co-Authors: Marco Roffi, David J. Moliterno, Derek P Chew, Debabrata Mukherjee, Deepak L Bhatt, Jennifer White, Christopher Heeschen, Christian W Hamm, Mark Robbins, Neal S. Kleiman
    Abstract:

    Aims To assess the efficacy of platelet Glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndromes primarily medically managed. Methods and Results We performed a meta-analysis of the randomized clinical trials of platelet Glycoprotein IIb/IIIa inhibitor therapy in the medical management of non-ST-elevation acute coronary syndromes. Among 29570 patients, IIb/IIIa integrin blockade was associated with a reduction in death or non-fatal myocardial infarction at 30 days, from 11·5% to 10·7% (odds ratio 0·91, P =0·02). Patients undergoing percutaneous coronary intervention during index hospitalization sustained a greater reduction in ischaemic events (odds ratio 0·82, P =0·01) than patients medically managed (odds ratio 0·95, P =0·27). Among patients undergoing intervention, the benefit was more pronounced if the procedure was performed during Glycoprotein IIb/IIIa inhibitor infusion (odds ratio 0·74; P =0·02), than if revascularization was performed after drug discontinuation (odds ratio 0·87, P =0·17). Conclusion This analysis, including the entire large-scale trial experience of intravenous Glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndromes primarily medically managed, demonstrates an overall significant, albeit moderate, reduction in 30-day death or myocardial infarction associated with therapy. Although not based on a prospectively defined hypothesis, the findings suggest a gradient of benefit conferred by these agents depending on the revascularization strategy used. Copyright 2002 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved .

Robert A. Harrington - One of the best experts on this subject based on the ideXlab platform.

  • the efficacy and safety of cangrelor with and without Glycoprotein IIb iiia inhibitors in patients undergoing percutaneous coronary intervention a pooled analysis of the champion trials
    Journal of the American College of Cardiology, 2016
    Co-Authors: Gregg W Stone, Michael C Gibson, Robert A. Harrington, Muthiah Vaduganathan, Ph. Gabriel Steg
    Abstract:

    Cangrelor, an intravenous, reversible P2Y12 antagonist, was recently approved for use in patients undergoing percutaneous coronary intervention (PCI) in the US. We evaluated the efficacy and safety of cangrelor compared with clopidogrel in the subgroup who received Glycoprotein IIb/IIIa inhibitors

  • association between angiographic complications and clinical outcomes among patients with acute coronary syndrome undergoing percutaneous coronary intervention an early acs early Glycoprotein IIb iiia inhibition in non st segment elevation acute coron
    Jacc-cardiovascular Interventions, 2012
    Co-Authors: Yuri B Pride, Robert A. Harrington, Kristin L Newby, Robert P Giugliano, Eugene Braunwald, Satishkumar Mohanavelu, Cafer Zorkun, Vijayalakshmi Kunadian, Robert M. Califf, Michael C Gibson
    Abstract:

    Objectives The goal of this analysis was to determine the association between intraprocedural complications and clinical outcomes among patients with high-risk non–ST-segment elevation acute coronary syndrome (NSTEACS) undergoing percutaneous coronary intervention (PCI). Background Among patients undergoing PCI for NSTEACS, the relationship between intraprocedural complications and clinical outcomes, independent of epicardial and myocardial perfusion, has not been well characterized. Methods The EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non–ST-Segment Elevation Acute Coronary Syndrome) trial enrolled 9,406 patients with high-risk NSTEACS undergoing an early invasive strategy. Of these, 1,452 underwent angiographic assessment in an independent core laboratory and did not have a myocardial infarction (MI) between enrollment and angiography. We assessed the relationship between abrupt closure, loss of side branch(es), distal embolization, and no-reflow phenomenon and 30-day clinical outcomes in these patients. Results Of the patients, 166 (11.4%) experienced an intraprocedural complication. Baseline clinical characteristics were similar between patients who did and did not have complications. The 30-day composite of death or MI was significantly higher among patients with an intraprocedural complication (28.3% vs. 7.8%, odds ratio [OR]: 4.68, 95% confidence interval [CI]: 3.2 to 7.0, p Conclusions Among high-risk NSTEACS patients undergoing an invasive strategy, the incidence of intraprocedural complications is high, and the occurrence of these complications is associated with worse clinical outcomes independent of epicardial and myocardial perfusion. (Early Glycoprotein IIb/IIIa Inhibition in Patients With Non–ST-segment Elevation Acute Coronary Syndrome [EARLY ACS]; NCT00089895 )

  • comparison of st segment resolution with combined fibrinolytic and Glycoprotein IIb iiia inhibitor therapy versus fibrinolytic alone data from four clinical trials
    American Journal of Cardiology, 2005
    Co-Authors: Abdallah G Rebeiz, Kristin L Newby, Per Johanson, Cynthia L Green, Suzanne W Crater, Anatoly Langer, Robert P Giugliano, Michael A Lincoff, Robert A. Harrington
    Abstract:

    We compared combination fibrinolytic plus Glycoprotein IIb/IIIa inhibitor therapy with stand-alone fibrinolysis with respect to speed and stability of reperfusion in patients who had acute ST-segment elevation myocardial infarction; data were obtained from 654 patients in 4 trials (Integrilin to Manage Platelet Aggregation to Combat Thrombosis in Acute Myocardial Infarction, Platelet Aggregation Receptor Antagonist Dose Investigation and Reperfusion Gain in Myocardial Infarction, Integrilin and Tenecteplase in Acute Myocardial Infarction, and the Fifth Global Use of Strategies to Open Occluded Coronary Arteries) that compared thrombolytics plus lamifiban, eptifibatide, or abciximab with standard thrombolysis. We found significantly faster and more stable ST-segment recovery with combination therapy starting at 60 minutes (56.7% vs 48.0% with >/=50% ST-segment resolution, p = 0.03) and sustained over 180 minutes after drug administration; this transient benefit may suggest a time frame when more optimal percutaneous coronary intervention can be performed.

  • bivalirudin and provisional Glycoprotein IIb iiia blockade compared with heparin and planned Glycoprotein IIb iiia blockade during percutaneous coronary intervention replace 2 randomized trial
    JAMA, 2003
    Co-Authors: Michael A Lincoff, Neal S. Kleiman, David J Cohen, Robert A. Harrington, Frederick Feit, John A Bittl, Daniel J Jackman, Ian J Sarembock, Douglas Spriggs, Ramin Ebrahimi
    Abstract:

    ContextThe direct thrombin inhibitor bivalirudin has been associated with better efficacy and less bleeding than heparin during coronary balloon angioplasty but has not been widely tested during contemporary percutaneous coronary intervention (PCI).ObjectiveTo determine the efficacy of bivalirudin, with Glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition on a provisional basis for complications during PCI, compared with heparin plus planned Gp IIb/IIIa blockade with regard to protection from periprocedural ischemic and hemorrhagic complications.Design, Setting, and ParticipantsThe Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)–2 trial, a randomized, double-blind, active-controlled trial conducted among 6010 patients undergoing urgent or elective PCI at 233 community or referral hospitals in 9 countries from October 2001 through August 2002.InterventionsPatients were randomly assigned to receive intravenous bivalirudin (0.75-mg/kg bolus plus 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition (n = 2999), or heparin (65-U/kg bolus) with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide) (n = 3011). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI.Main Outcome MeasuresThe primary composite end point was 30-day incidence of death, myocardial infarction, urgent repeat revascularization, or in-hospital major bleeding; the secondary composite end point was 30-day incidence of death, myocardial infarction, or urgent repeat revascularization.ResultsProvisional Gp IIb/IIIa blockade was administered to 7.2% of patients in the bivalirudin group. By 30 days, the primary composite end point had occurred among 9.2% of patients in the bivalirudin group vs 10.0% of patients in the heparin-plus-Gp IIb/IIIa group (odds ratio, 0.92; 95% confidence interval, 0.77-1.09; P = .32). The secondary composite end point occurred in 7.6% of patients in the bivalirudin vs 7.1% of patients in the heparin-plus-Gp IIb/IIIa groups (odds ratio, 1.09; 95% confidence interval 0.90-1.32; P = .40). Prespecified statistical criteria for noninferiority to heparin plus Gp IIb/IIIa were satisfied for both end points. In-hospital major bleeding rates were significantly reduced by bivalirudin (2.4% vs 4.1%; P<.001).ConclusionsBivalirudin with provisional Gp IIb/IIIa blockade is statistically not inferior to heparin plus planned Gp IIb/IIIa blockade during contemporary PCI with regard to suppression of acute ischemic end points and is associated with less bleeding.

  • platelet Glycoprotein IIb iiia inhibitors in acute coronary syndromes a meta analysis of all major randomised clinical trials
    The Lancet, 2002
    Co-Authors: Eric Boersma, David J. Moliterno, Robert A. Harrington, Harvey D White, Pierre Theroux, Frans Van De Werf, Anneke De Torbal, Paul W Armstrong, Lars Wallentin, Robert G Wilcox
    Abstract:

    Summary Background Platelet Glycoprotein IIb/IIIa inhibitors have been shown to reduce cardiac complications in patients undergoing percutaneous coronary intervention. The clinical efficacy of these drugs in acute coronary syndromes, however, is still unclear. We did a meta-analysis of all large randomised trials designed to study the clinical efficacy and safety of Glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndromes who were not routinely scheduled to undergo early coronary revascularisation. Methods Inclusion criteria were: randomisation of patients with acute coronary syndromes but without persistent ST elevation; comparison of a Glycoprotein IIb/IIIa inhibitor with placebo or control therapy; non-recommendation of early coronary revascularisation during study-drug infusion; and enrolment of at least 1000 patients. Data on individual patients were obtained from all participants in these trials.

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

  • comparison of st segment resolution with combined fibrinolytic and Glycoprotein IIb iiia inhibitor therapy versus fibrinolytic alone data from four clinical trials
    American Journal of Cardiology, 2005
    Co-Authors: Abdallah G Rebeiz, Kristin L Newby, Per Johanson, Cynthia L Green, Suzanne W Crater, Anatoly Langer, Robert P Giugliano, Michael A Lincoff, Robert A. Harrington
    Abstract:

    We compared combination fibrinolytic plus Glycoprotein IIb/IIIa inhibitor therapy with stand-alone fibrinolysis with respect to speed and stability of reperfusion in patients who had acute ST-segment elevation myocardial infarction; data were obtained from 654 patients in 4 trials (Integrilin to Manage Platelet Aggregation to Combat Thrombosis in Acute Myocardial Infarction, Platelet Aggregation Receptor Antagonist Dose Investigation and Reperfusion Gain in Myocardial Infarction, Integrilin and Tenecteplase in Acute Myocardial Infarction, and the Fifth Global Use of Strategies to Open Occluded Coronary Arteries) that compared thrombolytics plus lamifiban, eptifibatide, or abciximab with standard thrombolysis. We found significantly faster and more stable ST-segment recovery with combination therapy starting at 60 minutes (56.7% vs 48.0% with >/=50% ST-segment resolution, p = 0.03) and sustained over 180 minutes after drug administration; this transient benefit may suggest a time frame when more optimal percutaneous coronary intervention can be performed.

  • bivalirudin versus heparin and Glycoprotein IIb iiia inhibition among patients with renal impairment undergoing percutaneous coronary intervention a subanalysis of the replace 2 trial
    American Journal of Cardiology, 2005
    Co-Authors: Derek P Chew, David J Cohen, Michael A Lincoff, Timothy D Henry, Hitinder S Gurm, Kathy Wolski, Frederick Feit, Eric J Topol
    Abstract:

    Among patients who undergo percutaneous coronary intervention, renal impairment is associated with an excessive risk of bleeding and ischemic events. Bivalirudin provides comparable suppression of ischemic events with a decrease in bleeding events compared with heparin and Glycoprotein IIb/IIIa inhibition. We examined the relation between adverse events, renal impairment, and antithrombotic therapy within a randomized comparison. The Second Randomized Evaluation in PCI Linking Bivalirudin to Reduced Clinical Events per-protocol study population was assessed. Renal function was defined as calculated creatinine clearance <60 ml/min. Events within the overall study population and within each study arm were assessed. Thirty-day events by renal function were compared by chi-square test and logistic regression. Late mortality was compared by log-rank test. Interaction analyses were performed. Among 5,710 patients, renal impairment was associated with increased ischemic events (hazard ratio 1.45, 95% confidence interval 1.13 to 1.88, p = 0.004), bleeding complications (hazard ratio 1.72, 95% confidence interval 1.06 to 2.80, p = 0.028), and excessive 12-month mortality (hazard ratio 3.85, 95% confidence interval 2.67 to 5.54, p <0.001). Bivalirudin provided suppression of ischemic events that was comparable to heparin and Glycoprotein IIb/IIIa inhibition regardless of renal impairment. Fewer bleeding events with bivalirudin were also evident irrespective of renal dysfunction. No interaction between treatment assignment, bleeding or ischemic complications, and renal impairment was observed. The safety and efficacy of bivalirudin compared with heparin and planned Glycoprotein IIb/IIIa inhibition in this high-risk group are comparable and consistent with the results of the overall trial.

  • long term efficacy of bivalirudin and provisional Glycoprotein IIb iiia blockade vs heparin and planned Glycoprotein IIb iiia blockade during percutaneous coronary revascularization replace 2 randomized trial
    JAMA, 2004
    Co-Authors: Michael A Lincoff, Neal S. Kleiman, David J Cohen, Dean J. Kereiakes, Frederick Feit, John A Bittl, Daniel J Jackman, Ian J Sarembock, Douglas Spriggs, Ramin Ebrahimi
    Abstract:

    ContextIn the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, bivalirudin with provisional Glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition was found to be noninferior to heparin plus planned Gp IIb/IIIa blockade in the prevention of acute ischemic end points and was associated with significantly less bleeding by 30 days after percutaneous coronary intervention (PCI).ObjectiveTo determine whether the efficacy of bivalirudin remains comparable with that of heparin plus Gp IIb/IIIa blockade over 6 months and 1 year.Design, Setting, and ParticipantsFollow-up study to 1 year of a randomized, double-blind trial conducted among 6010 patients undergoing urgent or elective PCI at 233 community or referral hospitals in 9 countries from October 2001 through August 2002.InterventionsPatients were randomly assigned to receive intravenously bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition, or to receive heparin (65 U/kg bolus), with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI.Main Outcome MeasuresIncidence of death, myocardial infarction, or repeat revascularization by 6 months and death by 12 months after enrollment.ResultsAt 6 months, death occurred in 1.4% of patients in the heparin plus Gp IIb/IIIa group and in 1.0% of patients in the bivalirudin group (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.43-1.14; P = .15). Myocardial infarction occurred in 7.4% and 8.2% of patients, respectively (HR, 1.12; 95% CI, 0.93-1.34; P = .24), and repeat revascularization was required in 11.4% and 12.1% of patients, respectively (HR, 1.06; 95% CI, 0.91-1.23; P = .45). By 1 year, death occurred in 2.46% of patients treated with heparin plus Gp IIb/IIIa blockade and in 1.89% of patients treated with bivalirudin (HR, 0.78; 95% CI, 0.55-1.11; P = .16). Nonsignificant trends toward lower 1-year mortality with bivalirudin were present in all patient subgroups analyzed and were of greatest magnitude among high-risk patients.ConclusionLong-term clinical outcome with bivalirudin and provisional Gp IIb/IIIa blockade is comparable with that of heparin plus planned Gp IIb/IIIa inhibition during contemporary PCI.

  • bivalirudin and provisional Glycoprotein IIb iiia blockade compared with heparin and planned Glycoprotein IIb iiia blockade during percutaneous coronary intervention replace 2 randomized trial
    JAMA, 2003
    Co-Authors: Michael A Lincoff, Neal S. Kleiman, David J Cohen, Robert A. Harrington, Frederick Feit, John A Bittl, Daniel J Jackman, Ian J Sarembock, Douglas Spriggs, Ramin Ebrahimi
    Abstract:

    ContextThe direct thrombin inhibitor bivalirudin has been associated with better efficacy and less bleeding than heparin during coronary balloon angioplasty but has not been widely tested during contemporary percutaneous coronary intervention (PCI).ObjectiveTo determine the efficacy of bivalirudin, with Glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition on a provisional basis for complications during PCI, compared with heparin plus planned Gp IIb/IIIa blockade with regard to protection from periprocedural ischemic and hemorrhagic complications.Design, Setting, and ParticipantsThe Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)–2 trial, a randomized, double-blind, active-controlled trial conducted among 6010 patients undergoing urgent or elective PCI at 233 community or referral hospitals in 9 countries from October 2001 through August 2002.InterventionsPatients were randomly assigned to receive intravenous bivalirudin (0.75-mg/kg bolus plus 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition (n = 2999), or heparin (65-U/kg bolus) with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide) (n = 3011). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI.Main Outcome MeasuresThe primary composite end point was 30-day incidence of death, myocardial infarction, urgent repeat revascularization, or in-hospital major bleeding; the secondary composite end point was 30-day incidence of death, myocardial infarction, or urgent repeat revascularization.ResultsProvisional Gp IIb/IIIa blockade was administered to 7.2% of patients in the bivalirudin group. By 30 days, the primary composite end point had occurred among 9.2% of patients in the bivalirudin group vs 10.0% of patients in the heparin-plus-Gp IIb/IIIa group (odds ratio, 0.92; 95% confidence interval, 0.77-1.09; P = .32). The secondary composite end point occurred in 7.6% of patients in the bivalirudin vs 7.1% of patients in the heparin-plus-Gp IIb/IIIa groups (odds ratio, 1.09; 95% confidence interval 0.90-1.32; P = .40). Prespecified statistical criteria for noninferiority to heparin plus Gp IIb/IIIa were satisfied for both end points. In-hospital major bleeding rates were significantly reduced by bivalirudin (2.4% vs 4.1%; P<.001).ConclusionsBivalirudin with provisional Gp IIb/IIIa blockade is statistically not inferior to heparin plus planned Gp IIb/IIIa blockade during contemporary PCI with regard to suppression of acute ischemic end points and is associated with less bleeding.

  • management of patients with acute coronary syndromes in the united states by platelet Glycoprotein IIb iiia inhibition insights from the platelet Glycoprotein IIb iiia in unstable angina receptor suppression using integrilin therapy pursuit trial
    Circulation, 2000
    Co-Authors: Michael A Lincoff, Judith S Hochman, Neal S. Kleiman, Robert A. Harrington, Alan D Guerci, Magnus E Ohman, Carl J Pepine, Steven L Kopecky, Cynthia M Pacchiana
    Abstract:

    Background—A multinational, randomized, placebo-controlled trial (Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy, PURSUIT) demonstrated that the platelet Glycoprotein IIb/IIIa receptor antagonist eptifibatide reduced the incidence of death or myocardial infarction among patients with acute ischemic syndromes without ST-segment elevation. Because of expected differences in practice patterns, a prospectively planned analysis of outcomes as a function of regions of the world was performed. The current study provides a detailed assessment of eptifibatide among the subgroup of patients enrolled within the United States. Methods and Results—Patients presenting with chest pain within the previous 24 hours and ischemic ECG changes or creatine kinase–MB elevation were eligible for enrollment. Of the 10 948 patients randomized worldwide, 4035 were enrolled within the United States. Patients were allocated to placebo or eptifibatide infusion for up to 72 to 96 hours....

Michael C Gibson - One of the best experts on this subject based on the ideXlab platform.

  • Stent Parameters Predict Major Adverse Clinical Events and the Response to Platelet Glycoprotein IIb/IIIa Blockade Findings of the ESPRIT Trial
    2016
    Co-Authors: James E Tcheng, Md Ing, Haan Lim, Mbbs Shankar Srinivasan, Phd Joseph Jozic, Michael C Gibson
    Abstract:

    Background—Only limited data describe relationships between stent parameters (length and diameter), adverse events after percutaneous coronary intervention, and effects of platelet Glycoprotein IIb/IIIa blockade by stent parameters. Methods and Results—In this post hoc analysis of the 1983 patients receiving a stent in the Enhanced Suppression of the Platelet Glycoprotein IIb/IIIa Receptor with Integrilin Therapy randomized percutaneous coronary intervention trial of eptifibatide versus placebo, rates of the major adverse cardiac event (MACE) end point (death, myocardial infarction, urgent target-vessel revascularization, or thrombotic bailout) at 48 hours and 1 year were correlated with stent parameters and then analyzed by randomization to eptifibatide versus placebo. In the placebo group, MACE increased with number of stents implanted, total stent length (by quartiles of 15, 15 to 18, 18 to 30, and 30 mm), and total stented vessel area (by quartiles of area141, 141 to188, 188 to292, and292 mm2). By stent parameters, MACE at 48 hours was reduced in the eptifibatide group at stent lengths of 18 to30 mm (odds ratio [OR], 0.55; 95 % CI, 0.32 to 0.94; P0.030) and 30 mm (OR, 0.43; 95 % CI, 0.25 to 0.75; P0.003), stent diameters of 2.5 to 3.5 mm (OR, 0.56; 95 % CI, 0.39 to 0.82; P0.002), and with 2 stents implanted (OR, 0.39; 95 % CI, 0.22 to 0.69; P0.001). In the placebo group, near-linear relationships were observed between both increasing stent length and increasing stented vessel area and MACE at 48 hours and 1 year (all, P0.001); these gradients were flattened in the eptifibatide group (P0.005 for stent length)

  • the efficacy and safety of cangrelor with and without Glycoprotein IIb iiia inhibitors in patients undergoing percutaneous coronary intervention a pooled analysis of the champion trials
    Journal of the American College of Cardiology, 2016
    Co-Authors: Gregg W Stone, Michael C Gibson, Robert A. Harrington, Muthiah Vaduganathan, Ph. Gabriel Steg
    Abstract:

    Cangrelor, an intravenous, reversible P2Y12 antagonist, was recently approved for use in patients undergoing percutaneous coronary intervention (PCI) in the US. We evaluated the efficacy and safety of cangrelor compared with clopidogrel in the subgroup who received Glycoprotein IIb/IIIa inhibitors

  • association between angiographic complications and clinical outcomes among patients with acute coronary syndrome undergoing percutaneous coronary intervention an early acs early Glycoprotein IIb iiia inhibition in non st segment elevation acute coron
    Jacc-cardiovascular Interventions, 2012
    Co-Authors: Yuri B Pride, Robert A. Harrington, Kristin L Newby, Robert P Giugliano, Eugene Braunwald, Satishkumar Mohanavelu, Cafer Zorkun, Vijayalakshmi Kunadian, Robert M. Califf, Michael C Gibson
    Abstract:

    Objectives The goal of this analysis was to determine the association between intraprocedural complications and clinical outcomes among patients with high-risk non–ST-segment elevation acute coronary syndrome (NSTEACS) undergoing percutaneous coronary intervention (PCI). Background Among patients undergoing PCI for NSTEACS, the relationship between intraprocedural complications and clinical outcomes, independent of epicardial and myocardial perfusion, has not been well characterized. Methods The EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non–ST-Segment Elevation Acute Coronary Syndrome) trial enrolled 9,406 patients with high-risk NSTEACS undergoing an early invasive strategy. Of these, 1,452 underwent angiographic assessment in an independent core laboratory and did not have a myocardial infarction (MI) between enrollment and angiography. We assessed the relationship between abrupt closure, loss of side branch(es), distal embolization, and no-reflow phenomenon and 30-day clinical outcomes in these patients. Results Of the patients, 166 (11.4%) experienced an intraprocedural complication. Baseline clinical characteristics were similar between patients who did and did not have complications. The 30-day composite of death or MI was significantly higher among patients with an intraprocedural complication (28.3% vs. 7.8%, odds ratio [OR]: 4.68, 95% confidence interval [CI]: 3.2 to 7.0, p Conclusions Among high-risk NSTEACS patients undergoing an invasive strategy, the incidence of intraprocedural complications is high, and the occurrence of these complications is associated with worse clinical outcomes independent of epicardial and myocardial perfusion. (Early Glycoprotein IIb/IIIa Inhibition in Patients With Non–ST-segment Elevation Acute Coronary Syndrome [EARLY ACS]; NCT00089895 )

  • intracoronary eptifibatide bolus administration during percutaneous coronary revascularization for acute coronary syndromes with evaluation of platelet Glycoprotein IIb iiia receptor occupancy and platelet function the intracoronary eptifibatide ice
    Circulation, 2010
    Co-Authors: Albert J. Deibele, James E Tcheng, Lisa K. Jennings, Cathy Neva, Angela D. Earhart, Michael C Gibson
    Abstract:

    Background— Eptifibatide reduces major adverse cardiac events in patients with acute coronary syndromes undergoing percutaneous coronary intervention (PCI). Intracoronary bolus administration of eptifibatide may result in higher levels of platelet Glycoprotein IIb/IIIa receptor occupancy in the local coronary bed, disaggregate thrombus in the epicardial artery and microvasculature, and thereby improve coronary flow. Methods and Results— Patients undergoing PCI for an acute coronary syndrome were randomized to either intracoronary or intravenous bolus administration of eptifibatide. The primary end point was the local Glycoprotein IIb/IIIa receptor occupancy measured in the coronary sinus. There were no angiographic, electrophysiological, or other adverse findings attributable to intracoronary eptifibatide. Platelet Glycoprotein IIb/IIIa receptor occupancy was significantly greater with intracoronary versus intravenous administration: first bolus, 94±9% versus 51±15% (P<0.001); and second bolus, 99±2% vers...

  • diabetes mellitus is associated with distal embolization impaired myocardial perfusion and higher mortality in patients with st segment elevation myocardial infarction treated with primary angioplasty and Glycoprotein IIb iiia inhibitors
    Atherosclerosis, 2009
    Co-Authors: Giuseppe De Luca, Michael C Gibson, Francesco Bellandi, Marko Noc, Dariusz Dudek, Uwe Zeymer, H R Arntz, Donald E Cutlip, Mauro Maioli, Simona Zorman
    Abstract:

    Abstract Background It has been shown that, among patients with ST-segment elevation myocardial infarction (STEMI), diabetes is associated with a significantly higher mortality. The aim of the current study was to investigate the impact of diabetes on myocardial perfusion and mortality among STEMI patients treated with primary angioplasty and Glycoprotein IIb-IIIa inhibitors. Methods Our population is represented by a total of 1662 patients undergoing primary angioplasty for STEMI included in 11 randomized trials. Myocardial perfusion was evaluated by angiography ( n =1324) or postprocedural ECG ( n =1371). Distal embolization was defined as an abrupt "cutoff" in the main vessel or one of the coronary branches of the infarct-related artery, distal to the angioplasty site (data available in 1181 patients). Results Diabetes was observed in a total of 281 patients (16.9%). Diabetic patients were older, with a larger prevalence of female gender, hypertension, hypercholesterolemia, advanced killip class at presentation and multivessel disease. Diabetes was associated with impaired postprocedural TIMI 3 flow (82% vs 90%, p p p p p p =0.001). Conclusion This study showed that, among patients with STEMI undergoing primary angioplasty on the top of Glycoprotein IIb-IIIa inhibitors, diabetes mellitus is independently associated with impaired perfusion and distal embolization, that contribute to explain the higher mortality observed in these patients.