ISAR-REACT 4: Abciximab-heparin combo, bivalirudin similarly reduced risk for death

AHA Scientific Sessions 2011

ORLANDO, Fla. — Two commonly used anti-clotting regimens, abciximab plus heparin and bivalirudin, were similarly effective in preventing death, subsequent MI or need for further revascularization in patients with non-ST-segment elevation MI undergoing percutaneous coronary intervention.

Among patients assigned to abciximab (ReoPro, Centocor and Eli Lilly) plus unfractionated heparin (n=861), 10.9% experienced the primary composite endpoint of death, large recurrent MI, urgent target vessel revascularization or major bleeding in 30 days vs. 11% of patients assigned to bivalirudin (n=860; RR=0.99; 95% CI, 0.74-1.32). The secondary endpoint of efficacy in death, any recurrent MI or urgent TVR was also similar with dual therapy (12.8%) compared with bivalirudin (13.4%; RR=0.96; 95% CI, 0.74-1.25).

Furthermore, patients taking the abciximab-heparin combination were more likely to experience major bleeding than those taking bivalirudin (4.6% vs. 2.6%; RR=1.84; 95% CI, 1.1-3.07).”.

“These findings … show that bivalirudin might be the preferred drug in patients undergoing PCI for an acute MI, with or without ST-segment elevation,” Adnan Kastrati, MD, professor of interventional cardiology at Technische Universitat, Munich, Germany, said at a press conference.

The double blind ISAR-REACT 4 study included 1,721 patients with acute non-ST-segment elevation MI.

“Understanding which treatment works better is important because non-ST-segment elevation MI patients are in danger of further cardiovascular problems,” Kastrati said in a press release. “The results of PCI in these patients are strongly dependent on the efficacy and safety of the anti-clotting drugs used during the procedure.” – by Casey Murphy

For more information:

• Kastrati A. LBCT.01. Presented at: American Heart Association Scientific Sessions 2011; Nov. 12-16, 2011; Orlando, Fla.
• Kastrati A. N Eng J Med. 2011;doi:10.1056/NEJMoa1109596.

Disclosure: Dr. Kastrati reports receiving speaker fees and honoraria from Abbott, AstraZeneca, Bristol-Myers Squibb, Cordia, Daiichi Sankyo/Lilly and Medtronic.

Deepak L. Bhatt

Coupled with data from the HORIZONS-AMI trial, which showed a significantly lower mortality with bivalirudin than with heparin plus glycoprotein IIb/IIIa inhibitors, the data from ISAR-REACT 4 support the use of bivalirudin during PCI across the full spectrum of acute coronary syndromes and, at least in my opinion, will probably serve the final chapter in this story of what the preferred anticoagulant is to a PCI.

Deepak L. Bhatt, MD, MPH, FACC, FAHA
Cardiology Today Editorial Board member

Disclosure: Dr. Bhatt reports receiving research grants from Amarin, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Medtronic, Sanofi-Aventis, and The Medicines Company.

You’ll probably see in the US decreased use of abciximab and people will become more comfortable with bivalirudin, but the truth is trials that look at medications produce effects in practice slowly. Trials that look at devices produce changes quickly. I think you’ll see that. I don’t think this will mean no use of abciximab. I think this will have an effect of a routine use of abciximab simply because the patient has an elevated biomarker. Most likely you’ll see abciximab still used but in a little bit more of a niche in people who are high at risk for thrombosis and probably relatively low risk for bleeding. There are now data on bleeding scores that you can assign to people relatively easily and calculate their gross risk of bleeding during and after PCI, so I think this also puts a plug in for use of that kind of index. There is also a trial of intracoronary abciximab that's being organized. Small studies have pointed to a benefit of this administration route, so depending on its outcome, we may yet see some changes in the way abciximab is used.

Neil S. Kleiman, MD, FACC, FSCAI
Director, Cardiac Catheterization Laboratory,
Methodist DeBakey Heart and Vascular Center, Houston
Professor of medicine
Weill Cornell Medical College

Disclosure: Dr. Kleiman is a consultant for Eli Lilly.

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