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Design and rationale for the Minimizing Adverse haemorrhagic events by TRansradial access site and systemic
1Thoraxcenter, Ba 587, Erasmus MC, Rotterdam, The Netherlands.
Insights
Transradial intervention (TRI) and bivalirudin infusion may reduce bleeding and ischemic complications in acute coronary syndrome (ACS) patients. The MATRIX program investigates their independent roles in contemporary invasive management.
Area of Science:
- Cardiology
- Interventional Cardiology
- Acute Coronary Syndromes
Background:
- Transradial intervention (TRI) and bivalirudin infusion are associated with reduced bleeding in acute coronary syndromes (ACS).
- The independent impact of TRI and bivalirudin on ischemic or combined ischemic-bleeding complications in ACS patients remains unclear.
- Contemporary invasive management strategies for ACS require clarification of these treatment effects.
Purpose of the Study:
- To assess if TRI reduces ischemic or composite endpoints compared to transfemoral coronary intervention in ACS patients.
- To evaluate if bivalirudin infusion reduces ischemic or composite endpoints compared to unfractionated heparin plus glycoprotein IIb/IIIa inhibitors in ACS patients.
- To determine the optimal duration of bivalirudin infusion after percutaneous coronary intervention in ACS patients.
Main Methods:
- The MATRIX study is a large-scale, multicenter trial with 3 randomized comparisons and blind event adjudication.
- It includes 8,200 patients for the access site comparison and 6,800 for the antithrombin regimen comparison.
- Primary endpoints are assessed at 30 days with clinical follow-up up to 1 year.
Main Results:
- Results are pending further analysis and publication.
- The study is powered to detect significant differences in primary endpoints.
- Key findings will elucidate the role of TRI and bivalirudin in ACS management.
Conclusions:
- The MATRIX program aims to definitively establish the role of TRI in ACS patients.
- It seeks to confirm the benefits of bivalirudin infusion in the contemporary management of ACS.
- The study will provide crucial insights into optimizing invasive strategies for ACS.
Background:
Transradial intervention (TRI) and bivalirudin infusion compared with transfemoral coronary intervention or unfractionated heparin plus glycoprotein IIb/IIIa inhibitors decrease bleeding complications in patients with acute coronary syndromes (ACS). Although bleeding is thought to be associated with worse outcomes, it remains unclear whether TRI and bivalirudin both independently lower ischemic or combined ischemic and bleeding complications in ACS patients undergoing contemporary invasive management.
Hypotheses:
The primary objectives of the MATRIX program are to assess whether TRI or bivalirudin as compared, respectively, with transfemoral coronary intervention (MATRIX access site) or unfractionated heparin plus provisional glycoprotein IIb/IIIa inhibitors, (MATRIX antithrombin) decrease the 30-day incidence of an ischemic (ie, death, myocardial infarction or stroke) or an ischemic and bleeding composite end point across the whole spectrum of ACS patients, including clarifying the optimal duration of bivalirudin infusion after percutaneous coronary intervention (MATRIX treatment duration).
Study Design:
The MATRIX (NCT01433627) study, which incorporates 3 randomized comparisons in a nonfactorial manner and primary end points at 30 days and clinical follow-up ≤ 1 year, is a large-scale, multicenter study with blind event adjudication conducted at approximately 100 European sites. With 8,200 patients in the randomized comparison of access sites and 6,800 individuals participating in the randomized comparison of antithrombin regimens, this study will have ≥ 85% power for the primary end points.
Summary:
The MATRIX program aims at conclusively ascertaining the role of TRI and bivalirudin infusion in the whole spectrum of ACS patients undergoing contemporary invasive management.
