Two anti-clotting regimens similarly effective in patients undergoing angioplasty after heart attack / American Heart Association

Two anti-clotting regimens similarly effective in patients undergoing angioplasty after heart attack

American Heart Association Late-Breaking Clinical Trial Report - Abstract: 18569 - EMBARGOED until 8am ET
November 13, 2011

Study Highlights:
•Two anti-clotting treatments ― abciximab with heparin, or bivalirudin ― were similar in preventing death, subsequent heart attack or need for further revascularization in heart attack patients undergoing an artery-opening procedure.
•Compared with bivalirudin, the dual treatment significantly raised patients’ risk of suffering major bleeding.

ORLANDO, FLA., Nov. 13, 2011 — Two commonly used anti-clotting regimens were similarly effective in preventing death or subsequent heart problems in patients undergoing an artery-opening procedure for a non ST-elevation heart attack, according to late-breaking research presented at the American Heart Association’s Scientific Sessions 2011.

The study is simultaneously published in the New England Journal of Medicine.

In the Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT 4) Study, researchers found the combination of the antiplatelet drug abciximab and the blood-thinner heparin, was no more effective than another anti-clotting drug, bivalirudin.

Furthermore, patients on the abciximab-heparin combo were more likely to experience major bleeding than those taking bivalirudin.

The large, randomized clinical trial enrolled 1,721 patients who experienced a non-ST-segment elevation (non-STEMI) heart attack, where a partially blocked coronary artery reduces blood flow to the heart. The patients underwent percutaneous coronary intervention, or PCI, which includes balloon angioplasty and in most cases, placement of stents to open blocked arteries that supply blood to the heart.

Both treatment regimens, abciximab-heparin and bivalirudin, are widely used in non-STEMI patients but have not previously been compared directly in a large, randomized setting, said Adnan Kastrati, M.D., lead researcher and director of the ISAResearch Center at Deutsches Herzzentrum at the German Heart Center, in Munich.

In the double-blinded trial, about half the patients received each regimen. The study tested how many patients in each group within 30 days of treatment died, had another major heart attack, required another procedure to unblock the same artery or suffered major bleeding.

They found:
•95 patients (11 percent) taking bivalirudin had at least one of those outcomes compared to 94 (10.9 percent) of those taking abciximab and heparin.
•22 patients (2.6 percent) on bivalirudin experienced major bleeding compared to 40 patients (4.7 percent) taking abciximab and heparin.
The results indicate people receiving the abciximab plus heparin combo faced about an 80 percent greater relative risk of bleeding.

 “Understanding which treatment works better is important because non-STEMI heart attack patients are in danger of further cardiovascular problems,” Kastrati said. “The results of PCI in these patients are strongly dependent on the efficacy and safety of the anti-clotting drugs used during the procedure.”

The research was conducted in Germany in Munich, Bad Krozingen, Berlin and Tübingen, as well as in Florence, Italy and Danville, Penn. Researchers found no differences in outcome across borders, among different racial or ethnic groups, or between men and women.

Co-authors are Franz-Josef Neumann, M.D.; Stefanie Schulz, M.D.; Steffen Massberg, M.D.; Karl-Ludwig Laugwitz, M.D.; Miroslaw Ferenc, M.D.; David Antoniucci, M.D.; Peter B. Berger, M.D.; Julinda Mehilli, M.D.; and Albert Schömig, M.D.

Disclosures are here: http://newsroom.heart.org/pr/aha/document/Disclosures_for_LBCT.xlsx.
Nycomed Pharma and a grant from Deutsches Herzzentrum in Munich funded the study.

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Two anti-clotting regimens similarly effective in patients undergoing angioplasty after heart attack / American Heart Association