Intracoronary Versus Intravenous Administration of Abciximab in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention With Thrombus Aspiration The Comparison of Intracoronary Versus Intravenous Abciximab Administration During Emergency Reperfusion of ST-Segment Elevation Myocardial Infarction (CICERO) Trial

Department of Cardiology, Thorax Center, University Medical Center Groningen, University of Groningen, Hanzeplein 1, PO Box 30001 9700 RB Groningen, Netherlands.
Circulation (Impact Factor: 14.43). 12/2010; 122(25):2709-17. DOI: 10.1161/CIRCULATIONAHA.110.002741
Source: PubMed


administration of the glycoprotein IIb/IIIa inhibitor abciximab is an effective adjunctive treatment strategy during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. Although small-scale studies have suggested beneficial effects of intracoronary over intravenous administration of abciximab, this has not been investigated in a medium-scale randomized clinical trial.
a total of 534 ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention with thrombus aspiration within 12 hours of symptom onset were randomized to either an intracoronary or an intravenous bolus of abciximab (0.25 mg/kg). Patients were pretreated with aspirin, heparin, and clopidogrel. The primary end point was the incidence of restored myocardial reperfusion, defined as complete ST-segment resolution. Secondary end points included myocardial reperfusion as assessed by myocardial blush grade, enzymatic infarct size, and major adverse cardiac events at 30 days. The incidence of complete ST-segment resolution was similar in the intracoronary and intravenous groups (64% versus 62%; P=0.562). However, the incidence of myocardial blush grade 2/3 was higher in the intracoronary group than in the intravenous group (76% versus 67%; P=0.022). Furthermore, enzymatic infarct size was smaller in the intracoronary than in the intravenous group (P=0.008). The incidence of major adverse cardiac events was similar in both groups (5.5% versus 6.1%; P=0.786).
in ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention with thrombus aspiration, intracoronary administration of abciximab compared with intravenous administration does not improve myocardial reperfusion as assessed by ST-segment resolution. However, intracoronary administration is associated with improved myocardial reperfusion as assessed by myocardial blush grade and a smaller enzymatic infarct size.

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    • "The mean age of the patients ranged from 57 to 68, the patient follow-up duration ranged from 1 to 12 months, and the number of patients included in each study ranged from 45 to 2065. The outcomes were major cardiovascular events available in 6 trials [5], [12], [19], [20], [22], [23], total mortality in 9 trials [5], [11], [12], [19]–[24], reinfarction in 7 trials [5], [11], [12], [19]–[22], TVR in 5 trials [5], [12], [19], [20], [22], cardiac death in 3 trials [11], [12], [23], congestive heart failure in 2 trials [11], [20], major bleeding in 4 trials [11], [19], [21], [22], and stroke in 2 trials [11], [23]. Although the included trials scarcely reported on the key indicators of trial quality, the quality of the trials was also assessed according to the pre-defined criteria using Jadad scores [14]. "
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    ABSTRACT: Background Abciximab is a widely used adjunctive therapy for acute coronary syndrome (ACS). However, the effect of intracoronary (IC) administration of abciximab on cardiovascular events remains unclear when compared with intravenous (IV) therapy. Methodology and Principal Findings We systematically searched the Medline, Embase, and Cochrane Central Register of Controlled Trials databases and reference lists of articles and proceedings of major meetings for obtaining relevant literature. All eligible trials included ACS patients who received either IC administration of abciximab or IV therapy. The primary outcome was major cardiovascular events, and secondary outcomes included total mortality, reinfarction, and any possible adverse events. Of 660 identified studies, we included 9 trials reporting data on 3916 ACS patients. Overall, IC administration of abciximab resulted in 45% reduction in relative risk for major cardiovascular events (RR; 95% confidence interval [CI], 24−60%), 41% reduction in RR for reinfarction (95% CI, 7−63%), and 44% reduction in RR for congestive heart failure relative to IV therapy (95% CI, 8−66%); however, compared to IV therapy, IC administration of abciximab had no effect on total mortality (RR, 0.69; 95% CI, 0.45−1.07). No other significant differences were identified between the effect of IC abciximab administration and IV therapy. Conclusions/Significance IC administration of abciximab can reduce the risk of major cardiovascular events, reinfarction, and congestive heart failure when compared with IV therapy.
    PLoS ONE 02/2013; 8(2):e58077. DOI:10.1371/journal.pone.0058077 · 3.23 Impact Factor
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    • "Meta-analysis by Friedland et al. [22] demonstrated favorable effect of intracoronary bolus on TIMI flow, target vessel revascularization, and short-term mortality after PCI with no increase of bleeding complications. With a rationale that more potent ADP receptor blockers, bivalirudin, thrombus aspiration, and primary stenting are available for most of the STEMI patients and that the continuous intravenous infusion might not be benefitial to further improve outcome but increase the risk of bleeding, Gu et al. [23] applied intracoronary bolus of abciximab only with no maintenance infusion and found better blush grade and reduced infact size in those with intracoronary application of abciximab. The intracoronary application of abciximab results in lower platelet reactivity in coronary sinus blood samples when compared with intravenous dosing [24]. "
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    ABSTRACT: Primary percutaneous coronary intervention is the best treatment of patients with ST elevation myocardial infarction (STEMI). When managing a STEMI patient, our approach must be rapid and aggresive in order to interrupt the pathological process of thrombus formation and stabilization. The therapy must be initiated prior to angiography (pretreatment), continued during the procedure (periprocedural), recovery phase (in-hospital), and follow-up. The treatment strategies resulting in thrombus dissolution/extraction have focused on optimization of both pharmacological and interventional therapies. At present, there is no optimal evidence-based approach to all patients with STEMI, and the treatment of these patients needs to be modified with respect to the risk profile, availability of medical resources, and our experience. In this review, we summarize current pharmacological and interventional strategies used in the setting of STEMI and discuss potential benefits of novel dosing regimens and combinations of drugs and techniques.
    Journal of Cardiovascular Translational Research 02/2013; 6(3). DOI:10.1007/s12265-013-9448-1 · 3.02 Impact Factor
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    • "More recently, intracoronary delivery of GPI into the infarct related artery has been proposed to achieve further clinical efficacy, with the hypothesis that a higher local concentration can be reached through direct intracoronary bolus injection as compared to standard intravenous administration [4]. Clinical trials comparing intracoronary (IC) with intravenous (IV) abciximab bolus have shown conflicting results, with some studies being underpowered to evaluate clinical hard endpoints [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15]. Recently, the AIDA STEMI trial randomized a large number of patients to either intracoronary or intravenous administration of abciximab bolus, but failed to demonstrate a significant difference in the combined clinical endpoint [5]. "
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    ABSTRACT: Background: Successful reperfusion of epicardial coronary arteries does not necessarily result in actual myocardial perfusion. Local intracoronary (IC) delivery of GP IIb/IIIa inhibitors (GPI) has been proposed to achieve further clinical efficacy when compared to standard intravenous (IV) administration. However clinical trials have shown conflicting results. The aim of the present study was to compare IC with IV abciximab administration on mortality and MACEs in patients with ACS undergoing PCI. Methods: We performed a meta-analysis of all available clinical trials comparing intracoronary versus intravenous abciximab administration. Results: At short-term analysis, incidence of MACEs was significantly lower in the IC group than in the IV group (OR=0.56; 95% CI 0.35-0.89; p=0.015). Interestingly, subgroup analysis showed that most benefit was coming from those studies with a main baseline LVEF<50% (OR=0.33 95% CI 0.18-0.59). Similarly, long-term incidence of MACEs was significantly lower in the IC group than in the IV group (OR=0.47; 95% CI 0.31-0.71; p<0.001), with most benefit coming from those studies enrolling patients with a main baseline EF<50% (OR=0.38 95% CI 0.23-0.63 p<0.001). In addition, long-term incidence of death was also lower in the IC group than in the IV group (OR=0.42; 95% CI 0.20-0.86; p=0.009). Conclusions: Our meta-analysis provides evidence of a net clinical benefit for intracoronary versus intravenous abciximab administration, with the highest benefit observed in high-risk ACS patients, such as those with reduced baseline LVEF.
    International journal of cardiology 12/2012; 168(2). DOI:10.1016/j.ijcard.2012.12.003 · 4.04 Impact Factor
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