Efficacy and safety of abciximab on acute myocardial infarction treated with percutaneous coronary interventions: A meta-analysis of randomized, controlled trials

doi:10.1016/j.ahj.2004.05.047

American Heart Journal

Volume 148, Issue 6, December 2004, Pages 937-943

https://doi.org/10.1016/j.ahj.2004.05.047 Get rights and content

Abstract

Objective

To evaluate the efficacy and safety of abciximab following acute myocardial infarction (AMI) treated with percutaneous coronary interventions.

Methods

A meta–analysis of randomized controlled trials of platelet glycoprotein IIb/IIIa inhibitor abciximab as adjunctive therapy to percutaneous coronary interventions for AMI was performed. Main outcomes measured were: (1) mortality, (2) reinfarction, (3) target vessel revascularization (TVR), (4) major cardiac events (MACE) that were a composite endpoint of death, reinfarction, and TVR, and (5) major bleeding.

Results

Six trials randomized 3755 patients who were followed for a mean of 5.5 months. Compared with the control, abciximab significantly reduced mortality (OR 0.70, 95% CI 0.50–0.97), TVR (0.79, 95% CI 0.65–0.96) and MACE (0.76, 95% CI 0.65–0.90). Reduction on TVR and MACE was confirmed in stent patients, but not in balloon angioplasty patients. Abciximab was associated with an increased risk of major bleeding (OR 1.39, 95% CI 1.03–1.87), but bleeding was observed only with a 100U/kg heparin bolus followed by a maintenance infusion (OR 1.89, 95% CI 1.10–3.28) and not with a bolus of 70U/kg (OR 1.22, 95% CI 0.85–1.73).

Conclusions

Abciximab, as adjunctive therapy to percutaneous coronary interventions, reduces mortality, TVR and MACE following AMI. The reduction of clinical outcomes occurs with stent implantation but not with balloon angioplasty. A 70U/kg heparin bolus must be used to avoid major bleeding.

Section snippets

Trials

Using the terms abciximab and acute myocardial infarction, we carried out an extensive search for reports of randomized, controlled trials of abciximab as adjuvant therapy to percutaneous coronary interventions in AMI through MEDLINE and Cochrane controlled trials register (1996–July 2003), plus the scientific sessions abstracts of the American Heart Association, the American College of Cardiology, the European Society of Cardiology, and the Transcatheter Therapeutics Meetings (1998–2003). The

Literature review

We identified 6 trials that compared the abciximab use in percutaneous coronary interventions: ReoPro in Acute myocardial infarction and Primary PTCA Organization and Randomized Trial (RAPPORT),¹³ Intracoronary Stenting and Antithrombotic Regimen trial-2 (ISAR-2),¹⁴ Abciximab before Direct angioplasty and stenting in Myocardial Infarction Regarding Acute and Long-Term follow-up (ADMIRAL),¹⁵ Petronio et al,¹⁶ Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications

Discussion

The main result of this meta–analysis is the demonstration that, compared with controls, abciximab significantly reduces mortality, TVR and MACE following AMI treated with percutaneous coronary interventions. Two previous systematic reviews investigated this topic and both demonstrated a significant reduction in TVR and MACE.9, 10 However, the observation of a significant reduction of 30% in the “hard” endpoint mortality with abciximab was not reported before. Until now, only cohort studies

Conclusion

Randomized trials of the effect of abciximab as adjunctive therapy to percutaneous coronary interventions in AMI evidenced a significant reduction in the “hard” endpoint mortality, as well as a reduction in MACE and TVR. In general, these benefits were also demonstrated for cases treated by stenting but not for balloon angioplasty patients. An increased risk of major bleeding was observed with abciximab. However, the current schedule for this drug infusion, which includes a heparin bolus of 70

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Cited by (49)

Safety and Efficacy of Glycoprotein IIb/IIIa Inhibitors in Patients With Acute Myocardial Infarction in the Presence of Intracoronary Thrombus: An Analysis From the Grand Drug-eluting Stent Registry
2020, Clinical Therapeutics
Citation Excerpt :
Glycoprotein IIb/IIIa inhibitors (GPIs) are potent antiplatelet agents used during percutaneous coronary intervention in the treatment of patients with acute coronary syndrome. Previous meta-analyses have found conflicting results for the use of GPIs; some studies reported that GPI use could reduce the rate of death and ischemic events in patients with acute myocardial infarction (AMI),1,2 whereas other studies failed to prove the beneficial effect of GPIs.3,4 Although current guidelines recommend that GPIs should be considered for bailout therapy in the event of angiographic evidence of a thrombotic complication,5 the clinical safety and efficacy of this agent have not been tested in a randomized trial and are still in dispute.
To evaluate the safety and efficacy of glycoprotein IIb/IIIa inhibitors (GPIs) in patients with acute myocardial infarction (AMI) in the presence of intracoronary thrombus undergoing percutaneous coronary interventions.
This study, performed from January 1, 2004, to November 31, 2014, at 55 centers in Korea, was based on the Grand Drug-Eluting Stent registry, which is a Korean, nationwide, multicenter, pooled registry of drug-eluting stents. The registry enrolled all-comers without any exclusion criteria except patient withdrawal of consent. A total of 1329 patients with AMI who had an overt intracoronary thrombus at the initial coronary angiography were analyzed. The efficacy end point was a 1-year major adverse cardiovascular event, defined as a composite of all death, myocardial infarction, target lesion revascularization, and stent thrombosis. The primary safety end point was any 30-day bleeding event.
GPIs were associated with a significantly higher rate of any bleeding events at 30 days (0.9% vs 2.9% in the non-GPI and GPI groups, respectively; P = 0.015), whereas GPI use was the only significant independent predictor of 30-day bleeding events by multivariable Cox proportional hazards regression analysis (hazard ratio = 4.76; 95% CI, 1.66–13.64; P = 0.004). Regarding the efficacy end points, no significant differences were noted according to GPI use (7.0% vs 9.0%, P = 0.287), and GPI use has no significant effect on 1-year major adverse cardiovascular events (hazard ratio = 1.33; 95% CI, 0.82–2.15; P = 0.253).
Early upstream use of GPIs should not be considered even in the presence of an intracoronary thrombotic occlusion. ClinicalTrials.gov identifier: NCT03507205.
The 'MAP strategy' (Maximum aspiration of atherothrombus and adjunctive glycoprotein IIb/IIIa inhibitor utilization combined with prolonged inflation of balloon/stent) for preventing no-reflow in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention: A retrospective analysis of seventy-one cases
2015, Indian Heart Journal
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TIMI grade 3 flow in 89% cases is comparable to the incidence of TIMI grade 3 flow in 86% cases in the TAPAS3 trial. Previous findings of positive associations5–9 with glycoprotein IIb/IIIa inhibitors are congruent with our results in that up to 9 months after the PCI, no death, reinfarction, or target vessel revascularization was reported. Furthermore, none of the subjects in the present study encountered any major bleeding episode.
‘No-reflow’ phenomenon is a common occurrence in percutaneous coronary intervention (PCI). A three-component ‘MAP strategy’ was designed to prevent no-reflow by addressing both intralesional and intraluminal thrombus in patients with ST-segment elevation myocardial infarction (STEMI). In this analysis, we observed Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 or 2 in all patients, with no incidence of no-reflow. Myocardial blush grade (MBG) 3 or 2 was observed in most (87.32%) patients. Left ventricular ejection fraction (LVEF) was improved, without any incidence of death up to 9-month follow-up. All patients safely tolerated the strategy-driven prolonged, 35-s inflation of the balloon/stent.
Current role of glycoprotein IIb/IIIa receptor inhibitors in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention after pretreatment with loading dose thienopyridines
2013, International Journal of Cardiology
Citation Excerpt :
GPIs have been studied in many primary PCI trials. Several previous meta-analyses of these trials found that the adjunctive use of GPIs for primary PCI was associated with a significant reduction in short-term (in-hospital or 30-day) and long-term (up to 3 years) mortality as well as reinfarction in patients with STEMI [3–5]. However, this benefit appears to mainly be confined to patients who were not pretreated with thienopyridines before mechanical reperfusion.
Intracoronary abciximab in STEMI using local drug delivery catheter - Single center experience
2013, Indian Heart Journal
Citation Excerpt :
High local concentrations of the drug would lead to fewer GP IIb/IIIa receptors being available for cross-linking with fibrinogen in the coronary microcirculation and also lead to an optimization of both IIb/IIIa and non-IIb/IIIa dependent properties. Moreover, during PCI, the intracoronary administration of abciximab can be easily performed due to the use of selective coronary catheters.12 Super selective drug delivery catheters give the highest local concentration of the drug avoiding draining off the drug into non-culprit vessels.
Despite restoration of epicardial flow during primary PCI in STEMI, microvascular obstruction may persist as a result of both atheromatous and thrombotic embolization and vasospasm. Compared with the systemic administration of IV pharmaco-therapies, highly localized administration of intracoronary pharmacotherapy may be associated with a several-hundred-fold increase in the local concentration of an agent in the epicardial artery and microcirculation. Despite restoration of epicardial flow during primary PCI in STEMI, microvascular obstruction may persist as a result of both atheromatous and thrombotic embolization and vasospasm. We are presenting our experience with use of intracoronary abciximab using local drug delivery catheter in STEMI patients.
We retrospectively evaluated 15 patients presented to us with STEMI undergoing primary PCI between March 2011 and September 2012 who had super selective intracoronary abciximab using local drug delivery catheter. With standard antiplatelet therapy, both Pre and Post TIMI flow, TMP grading were assessed.
Mean age was 55 years. The TIMI flow increased by 3 grades in thirteen patients, TMP grading increased by 2 grades in five patients and by 3 grades in nine patients. Thus TIMI flow and TMP grading improved after super selective intracoronary abciximab.
Super selective intracoronary abciximab using local drug delivery catheter during primary PCI in STEMI patients significantly improves TMP grading without increased risk of bleeding. This benefit is achieved even in patients without thrombus aspiration. We need to assess the long-term outcomes in the form of reduction in infarct size using this strategy in large group of patients.
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2013, Platelets
αIIbβ3 (GPIIb-IIIa) Antagonists
2012, Platelets, Third Edition

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Curriculum in cardiologyEfficacy and safety of abciximab on acute myocardial infarction treated with percutaneous coronary interventions: A meta-analysis of randomized, controlled trials

Abstract

Objective

Methods

Results

Conclusions

Section snippets

Trials

Literature review

Discussion

Conclusion

Am J Cardiol

J Am Coll Cardiol

Am J Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

Am J Cardiol

J Am Coll Cardiol

Am Heart J

J Am Coll Cardiol

Am J Cardiol

Am J Cardiol

Am J Cardiol

Curriculum in cardiology
Efficacy and safety of abciximab on acute myocardial infarction treated with percutaneous coronary interventions: A meta-analysis of randomized, controlled trials