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      Intracoronary Reopro during Percutaneous Coronary Intervention in Acute and Stable Patient can Influence Stent Thrombosis Formation (IRPASST) Study

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          Abstract

          Background:

          In patients with acute myocardial infarction or unstable angina undergoing coronary angioplasty, abciximab reduces major adverse cardiac events (MACE). Most clinical trials have studied mainly intravenous administration. Intracoronary (IC) bolus application of abciximab causes very high local drug concentrations and may be more effective in reducing acute and sub-acute stent thrombosis (ST). We studied whether IC bolus administration of abciximab is associated with a reduced ST and target vessels revascularization (TVR); therefore, less MACE rate compared with the standard intravenous IV bolus and infusion application.

          Materials and Methods:

          This was a single-center observational study conducted between June 2007 and 2009. We studied a total of 447 patients admitted with either acute coronary intervention (PCI) and stenting. Patients with bleeding disorder, recent major surgery and high blood pressure were excluded. Patients were divided into two groups: Group I ( n = 199) patient received IC bolus of abciximab (reopro) 0.25 μg/kg during the PCI in cath lab. Group II ( n = 248) received the standard dose of reopro-a bolus intravenous 0.25 μg/kg and maintenance dose of 0.125 μg/kg over 12 h.

          Results:

          There were no differences between the groups with regard to diabetes mellitus, group I (56%) vs. group II (58%), P = 0.613; ACS, group I (38%) vs. group II (44%), P = 0.175; Dietthylstilbestrol Drug eluted stent (DES) in group I (66.5%) vs. (57.6%) group II, P = 0.056; Bare Metal Stent (BMS) in group I (33%) vs. (40.7%) group II, P=0.093; target vessel revascularization (TRV) was seen in 9 patients (4%) in group I vs. 16 patients (6%) in group II. ST elevation was seen in 4 patients (2%) in group I vs. 7 patients (2.8%) in group II, all presented with STEMI.

          Conclusion:

          In this study, there was a trend toward less ST and TVR in patients who received IC reopro vs. intravenous route both in ACS and stable CAD. The percentage of DM was high in both groups (56%), especially in Saudi patients. In-stent restenosis (ISR) was less in group I than in group II, this was mainly associated with BMS usage. The percentage of BMS was more than 30% in both groups, either due to STEMI cases or large vessel size. Randomized controlled trials are warranted to further assess IC application of abciximab in reducing ST.

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          Most cited references21

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          American College of Cardiology key data elements and definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes. A report of the American College of Cardiology Task Force on Clinical Data Standards (Acute Coronary Syndromes Writing Committee).

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            Facilitated PCI in patients with ST-elevation myocardial infarction.

            We hypothesized that percutaneous coronary intervention (PCI) preceded by early treatment with abciximab plus half-dose reteplase (combination-facilitated PCI) or with abciximab alone (abciximab-facilitated PCI) would improve outcomes in patients with acute ST-segment elevation myocardial infarction, as compared with abciximab administered immediately before the procedure (primary PCI). In this international, double-blind, placebo-controlled study, we randomly assigned patients with ST-segment elevation myocardial infarction who presented 6 hours or less after the onset of symptoms to receive combination-facilitated PCI, abciximab-facilitated PCI, or primary PCI. All patients received unfractionated heparin or enoxaparin before PCI and a 12-hour infusion of abciximab after PCI. The primary end point was the composite of death from all causes, ventricular fibrillation occurring more than 48 hours after randomization, cardiogenic shock, and congestive heart failure during the first 90 days after randomization. A total of 2452 patients were randomly assigned to a treatment group. Significantly more patients had early ST-segment resolution with combination-facilitated PCI (43.9%) than with abciximab-facilitated PCI (33.1%) or primary PCI (31.0%; P=0.01 and P=0.003, respectively). The primary end point occurred in 9.8%, 10.5%, and 10.7% of the patients in the combination-facilitated PCI group, abciximab-facilitated PCI group, and primary-PCI group, respectively (P=0.55); 90-day mortality rates were 5.2%, 5.5%, and 4.5%, respectively (P=0.49). Neither facilitation of PCI with reteplase plus abciximab nor facilitation with abciximab alone significantly improved the clinical outcomes, as compared with abciximab given at the time of PCI, in patients with ST-segment elevation myocardial infarction. (ClinicalTrials.gov number, NCT00046228 [ClinicalTrials.gov].) Copyright 2008 Massachusetts Medical Society.
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              Abciximab as adjunctive therapy to reperfusion in acute ST-segment elevation myocardial infarction: a meta-analysis of randomized trials.

              The benefits of abciximab in patients with ST-segment elevation myocardial infarction (STEMI) are still a matter of debate. To combine data from all randomized trials conducted with abciximab in STEMI. Formal searches of electronic databases (MEDLINE, PubMed) from from January 1990 to December 2004. We 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. Information 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. Eleven 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). This 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.
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                Author and article information

                Journal
                Heart Views
                Heart Views
                HV
                Heart Views : The Official Journal of the Gulf Heart Association
                Medknow Publications & Media Pvt Ltd (India )
                1995-705X
                0976-5123
                Apr-Jun 2013
                : 14
                : 2
                : 62-67
                Affiliations
                [1]King Saud Bin Abdulaziz University for Health Sciences, KACC, National Guard, Riyadh, Kingdom of Saudi Arabia
                Author notes
                Address for correspondence: Dr. Mohammed Balghith, P. O. Box 22490, Riyadh, Saudi Arabia. E-mail: mbalghith@ 123456hotmail.com
                Article
                HV-14-62
                10.4103/1995-705X.115498
                3752878
                23983910
                cd5a81bf-76c0-4af8-8dc7-f11edd647733
                Copyright: © Heart Views

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Categories
                Original Article

                Cardiovascular Medicine
                abciximab,acute coronary artery disease,intracoronary,intravenous,stent thrombosis,tirofiban

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