{"id":13531,"date":"2011-11-13T10:25:40","date_gmt":"2011-11-13T15:25:40","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=interventional&p=13531"},"modified":"2011-11-13T10:25:40","modified_gmt":"2011-11-13T15:25:40","slug":"isar-react-4-bivalirudin-works-great-less-bleeding","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/11\/13\/isar-react-4-bivalirudin-works-great-less-bleeding\/","title":{"rendered":"ISAR-REACT 4: Bivalirudin Works Great, Less Bleeding"},"content":{"rendered":"

In the previously published REPLACE-2<\/a> and ACUITY <\/a>trials, a trend was noted towards an increased incidence of ischemic complications with bivalirudin compared with glycoprotein IIb\/IIIa treatment in high-risk patients undergoing PCI. The Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 4 (ISAR-REACT 4<\/a>) trial was designed to show whether abciximab plus unfractionated heparin was superior to bivalirudin with respect to mortality, recurrent MI, urgent target-vessel revascularization, or major bleeding within 30 days.<\/p>\n

The study enrolled 1721 NSTEMI patients undergoing PCI within 24 hrs of hospital admission. There was no significant difference between the two treatment arms with respect to the primary composite endpoint. Moreover, there was a higher rate of bleeding in abciximab and unfractionated heparin recipients<\/em>. <\/strong><\/p>\n

 <\/p>\n\n\n\n\n\n\n\n\n\n
\n

30 Day Endpoints<\/strong><\/p>\n<\/td>\n

\n

Abciximab + heparin
\n(n=861)<\/strong><\/p>\n<\/td>\n

\n

Bivalirudin (n=860)<\/strong><\/p>\n<\/td>\n

\n

P value<\/strong><\/p>\n<\/td>\n<\/tr>\n

Primary Endpoint<\/strong><\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n
\u00a0\u00a0 Death, large recurrent MI, urgent TVR* or major bleeding<\/td>\n\n

10.9%<\/p>\n<\/td>\n

\n

11.0%<\/p>\n<\/td>\n

\n

0.94<\/p>\n<\/td>\n<\/tr>\n

<\/td>\n<\/tr>\n
Secondary Endpoints<\/strong><\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n
\u00a0\u00a0 Death, any MI or urgent TVR*<\/td>\n\n

12.8%<\/p>\n<\/td>\n

\n

13.4%<\/p>\n<\/td>\n

\n

0.76<\/p>\n<\/td>\n<\/tr>\n

\u00a0\u00a0 Major bleeding<\/td>\n\n

4.6%<\/p>\n<\/td>\n

\n

2.6%<\/p>\n<\/td>\n

\n

0.002<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

*TVR=target vessel revascularization<\/em><\/p>\n

In no prespecified groups, was there a suggestion of a benefit with abciximab. <\/strong>In this study, major bleeding was defined as the presence of intracranial, intraocular, or retroperitoneal hemorrhage; a decrease in the hemoglobin level of more than 40 g\/L plus either overt bleeding or the need for transfusion of 2 or more units of packed red cells or whole blood. <\/strong><\/p>\n

Since all patients in ISAR REACT 4 received a 600 mg loading dose of clopidogrel and most (99%) underwent PCI via the femoral approach with infrequent use of vascular closure devices (used in only 21% of patients), it isn\u2019t known whether these results are applicable to patients who receive newer adenosine receptor antagaonists or have\u00a0PCI performed through the radial artery.<\/p>\n

Although the study was funded by Nycomed Pharma — the former distributor of bivalirudin in Europe \u2013 the company reportedly had no role in the design of the study; the collection, analysis, or interpretation of the data; the writing of the manuscript; or the decision to submit the manuscript for publication.<\/p>\n

This study and previous ones are consistent in showing that bivalirudin alone provides anti-ischemic protection similar to that offered by abciximab and heparin with fewer bleeding complications in patients undergoing PCI for acute NSTEMI .<\/p>\n

So, is there any reason to use a\u00a0glycoprotein IIb\/IIIa rather than bivalirudin in the patient undergoing PCI? <\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

In the previously published REPLACE-2 and ACUITY trials, a trend was noted towards an increased incidence of ischemic complications with bivalirudin compared with glycoprotein IIb\/IIIa treatment in high-risk patients undergoing PCI. The Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 4 (ISAR-REACT 4) trial was designed to show whether abciximab plus unfractionated […]<\/p>\n","protected":false},"author":214,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[1041,256],"class_list":["post-13531","post","type-post","status-publish","format-standard","hentry","category-general","tag-bivalirudin","tag-nstemi"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/13531","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/214"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=13531"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/13531\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=13531"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=13531"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=13531"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}