CLINICAL STUDY: INTERVENTIONAL CARDIOLOGY
Long-term mortality benefit with abciximab in patients undergoing percutaneous coronary intervention
Keaven M. Anderson, PhD*,
Robert M. Califf, MD, FACC ,
Gregg W. Stone, MD, FACC**,
Franz-Josef Neumann, MD, FACC||,
Gilles Montalescot, MD¶,
Dave P. Miller, MS ,
James J. Ferguson, III, MD, FACC ,
James T. Willerson, MD, FACC,
Harlan F. Weisman, MD, FACC* and
Eric J. Topol, MD, FACC
* Centocor, Malvern, Pennsylvania, USA
Duke University, Durham, North Carolina, USA
Texas Heart Institute, Houston, Texas, USA
Lewin-TAG, Inc., San Francisco, California, USA
|| Deutsches Herzzentrum, Munich, Germany
¶ Centre Hospitalier Universitaire Pitié-Salpêtrière, Paris, France
** Lenox Hill Hospital, New York, New York, USA
Cleveland Clinic Foundation, Cleveland, Ohio, USA
Manuscript received February 22, 2000;
revised manuscript received February 13, 2001,
accepted March 1, 2001.
Reprint requests and correspondence: Dr. Keaven Anderson, Centocor, Inc., 200 Great Valley Parkway, Malvern, Pennsylvania 19355-1307
andersonk{at}centocor.com
OBJECTIVES
The goal of this study was to test: 1) if platelet glycoprotein IIb/IIIa (GP IIb/IIIa) blockade with abciximab bolus plus 12-h infusion reduces mortality after percutaneous coronary intervention (PCI); 2) if prevention of early myocardial infarction (MI) after PCI is a mechanism for reducing mortality; and 3) for risk factors for mortality after PCI.
BACKGROUND
Studies of PCI suggest that MI after intervention is predictive of mortality. Abciximab, a platelet GP IIb/IIIa receptor inhibitor, has consistently reduced the incidence of MI among PCI patients in several trials. The presumed mechanism is prevention of platelet thrombus associated with vessel wall injury and downstream embolization into the microcirculation.
METHODS
In eight trials, 5,154 patients were randomized to a regimen comprising conventional therapy plus a bolus of abciximab within 1 h before PCI followed by a 12-h infusion; 4,136 controls were randomized to conventional therapy alone. Patient follow-up from six months to three years was available. Survival differences are examined using proportional hazards regression and survival curves.
RESULTS
A hazard ratio of 0.71 (95% confidence interval 0.57 to 0.89; p = 0.003) suggests a mortality benefit with abciximab. The absolute reduction in mortality was estimated to be 0.5% through 30 days, 0.7% through six months, 0.9% through one year and 1.8% through three years. Early MI explained 18% of the observed mortality benefit at one year. Multivariate regression suggests that patients with advanced cardiovascular disease may derive the greatest mortality benefit from abciximab.
CONCLUSIONS
The evidence from 9,290 randomized PCI patients shows a mortality benefit provided by abciximab bolus plus 12-h infusion.
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Abbreviations and Acronyms
| | ADMIRAL | = Abciximab before Direct angioplasty and stenting in Myocardial Infarction Regarding Acute and Long-term follow-up | | CABG | = coronary artery bypass grafting | | CADILLAC | = Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications | | CAPTURE | = C7E3 AntiPlatelet Therapy in Unstable REfractory angina trial | | CHF | = congestive heart failure | | CI | = confidence interval | | EPIC | = Evaluation of 7E3 in Preventing Ischemic Complications trial | | EPILOG | = Evaluation in PTCA to Improve Long-term Outcome with abciximab GP IIa/IIIb blockade trial | | EPISTENT | = Evaluation of Platelet Inhibition in STENTing trial | | ERASER | = Evaluation of ReoPro And Stenting to Eliminate Restenosis | | GP IIb/IIIa | = glycoprotein IIb/IIIa | | HR | = hazard ratio | | ISAR-2 | = Intracoronary Stenting and Antithrombotic Regimen-2 trial | | MI | = myocardial infarction | | PCI | = percutaneous coronary intervention | | PTCA | = percutaneous transluminal coronary angioplasty | | PVD | = peripheral vascular disease | | RAPPORT | = ReoPro and Primary PTCA Organization and Randomized Trial |
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