By Bruce Sylvester
CHICAGO -- April 2, 2008 -- Treatment with tirofiban resulted in noninferior ST-segment resolution compared with abciximab among patients undergoing angioplasty for ST-elevation myocardial infarction (STEMI).
Investigators reported this finding on March 30 here at the Annual Scientific Sessions of the Society for Cardiovascular Angiography and Interventions (SCAI 2008), held in partnership with the American College of Cardiology Innovation in Intervention: i2 Summit.
In a press briefing, lead investigator Marco Valgimigli, MD, PhD, Staff Cardiologist, University of Ferrara, Ferrara, Italy, presented the findings of the Multicentre Evaluation of Single High-Dose Bolus Tirofiban Versus Abciximab With Sirolimus-Eluting Stent or Bare Metal Stent in Acute Myocardial Infarction Study (MULTISTRATEGY).
"The results of this important trial show that in STEMI patients undergoing primary angioplasty, treatment with tirofiban results in similar clinical outcomes as well as improved safety, in terms of lower thrombocytopaenia, when compared to abciximab treatment."
Briefing panel member, E. Magnus Ohman, MD, Professor of Medicine, Director, Program for Advanced Coronary Disease at Duke University School of Medicine in Durham, North Carolina, added, "this study is an important addition to our knowledge of optimal therapy in primary [percutaneous coronary intervention]."
Abciximab infusion and uncoated stent implantation are currently used as complementary treatment strategies to reduce major adverse cardiac events in patients undergoing angioplasty for STEMI, according to Dr. Valgimigli and colleagues.
The researchers used a 2-by-2 factorial design, randomising 745 STEMI patients at treatment centres in Italy, Spain, and Argentina to undergo primary angioplasty with infusion of abciximab (n=373) or tirofiban (n=372), with implantation of an uncoated (n=372) or sirolimus-eluting stent (n=373).
Primary endpoints included (1) tirofiban's noninferiority to abciximab for cumulative ST-segment resolution, expressed as the proportion of subjects who achieved at least a 50% recovery within 90 minutes after intervention; and (2) whether the sirolimus-eluting stent is superior to uncoated-stent in terms of the composite of death from any cause, reinfarction, and clinically driven target vessel revascularisation in the first 8 months.
Among 722 patients with interpretable electrocardiograms, at least 50% recovery from ST-elevation was observed in 85.3% of tirofiban subjects and 83.6% of abciximab patients (noninferiority P = .008).
They also reported that the cumulative incidence of major adverse coronary events at 30 days or 8 months and bleeding rates did not differ between tirofiban and abciximab groups, but thrombocytopaenia was more common among abciximab subjects (4.0 vs 0.8%, P = .004).
At 8 months, the researchers found that the primary clinical endpoint was achieved by 14.5% of patients in the uncoated stent group as compared with 7.8% in the sirolimus-stent group (P = .0039), attributable largely to a 69% relative risk reduction in target vessel revascularisation (from 10.2% to 3.2%; P = .0004).
The findings of the phase 3, open-label, multinational study were published online in the Journal of the American Medical Association and will appear in the April 16 issue [Valgimigli M et al. Published online ahead of print March 30. doi:10.1001/jama.299.15.joc80026].
Funding for the study was provided by Merck & Co., Inc. In January of 2008, Iroko Pharmaceuticals acquired all non-US rights to Aggrastat from Merck.
[Presentation title: Comparison of Angioplasty With Infusion of Tirofiban or Abciximab and With Implantation of Sirolimus-Eluting or Uncoated Stents for the Treatment of Acute Myocardial Infarction. Abstract 2404-11]
E-Mail this DGDispatch to a colleague
