The Lancet September 08, 2018

Radial versus femoral access and bivalirudin versus unfractionated heparin in invasively managed patients with acute coronary syndrome (MATRIX): final 1-year results of a multicentre, randomised controlled trial

Marco Valgimigli, Enrico Frigoli, Sergio Leonardi, Pascal Vranckx, et al. (MATRIX Investigators)

Bottom Line

In patients with acute coronary syndrome, transradial access significantly reduced net adverse clinical events compared to transfemoral access at 1 year, while bivalirudin did not significantly improve composite ischemic or net clinical outcomes compared to unfractionated heparin.

Key Findings

1. In the access-site randomization (N=8,404), MACE at 1 year occurred in 14.2% of patients in the transradial group versus 15.7% in the transfemoral group (RR 0.89, 95% CI 0.80–1.00; p=0.0526).
2. Net Adverse Clinical Events (NACE) at 1 year were significantly lower in the transradial group (15.2%) compared to the transfemoral group (17.2%) (RR 0.87, 95% CI 0.78–0.97; p=0.0128), driven by fewer major bleeding complications.
3. In the antithrombin randomization (N=7,213), MACE at 1 year occurred in 15.8% of the bivalirudin group versus 16.8% of the unfractionated heparin group (RR 0.94, 95% CI 0.83–1.05; p=0.28).
4. NACE at 1 year was 17.0% with bivalirudin and 18.4% with heparin (RR 0.91, 95% CI 0.81–1.02; p=0.10), failing to show a statistically significant superiority for bivalirudin.
5. Among patients randomized to bivalirudin, post-PCI bivalirudin infusion did not significantly lower the rate of the 1-year primary composite endpoints compared to a no-infusion strategy (MACE 17.4% vs. 17.4%; RR 0.99, p=0.90).

Study Design

Design
Multicenter RCT (2x2 Factorial)
Open-Label
Sample
8,404
Patients
Duration
1 yr
Median
Setting
Multicenter, Europe
Population Patients with acute coronary syndrome (with or without ST-segment elevation) scheduled to undergo early invasive management.
Intervention Randomization 1: Transradial access. Randomization 2: Bivalirudin (bolus plus infusion), with a subsequent 1:1 nested randomization to post-PCI infusion vs. no infusion.
Comparator Randomization 1: Transfemoral access. Randomization 2: Unfractionated heparin (UFH) at 70-100 U/kg, with provisional glycoprotein IIb/IIIa inhibitors allowed.
Outcome Co-primary endpoints of MACE (composite of all-cause mortality, myocardial infarction, or stroke) and NACE (MACE plus BARC major bleeding not related to CABG) originally at 30 days and finalized at 1 year.

Study Limitations

The open-label design of the trial may have influenced physician decisions, particularly regarding the provisional use of glycoprotein IIb/IIIa inhibitors, which were used much more frequently in the heparin arm (25.9%) than in the bivalirudin arm (4.6%), potentially driving the higher bleeding rates in the heparin group.
Operators were required to be highly experienced in transradial access (performing at least 75 procedures in the previous year); thus, the results might not perfectly generalize to lower-volume radial operators or centers.
The complex 2x2 factorial design, combined with an additional nested randomization for bivalirudin infusion duration, created multiple subgroups which may have limited the trial's statistical power to definitively address secondary endpoints.

Clinical Significance

The MATRIX trial is a landmark study that cemented transradial access as the default Class I recommended approach for patients with acute coronary syndrome undergoing invasive management, due to its durable benefits in reducing bleeding and improving net clinical outcomes. Conversely, the trial shifted clinical momentum away from bivalirudin. Because bivalirudin failed to demonstrate a significant reduction in MACE or NACE compared to the much less expensive unfractionated heparin, guidelines deprioritized its routine use, reserving it primarily for patients at high risk of bleeding.

Historical Context

Historically, percutaneous coronary intervention (PCI) for ACS was performed via the transfemoral route using unfractionated heparin and glycoprotein IIb/IIIa inhibitors. This approach carried a high risk of access-site bleeding, which was independently associated with mortality. Earlier trials, such as RIVAL (which suggested a mortality benefit for transradial access in STEMI) and HORIZONS-AMI (which showed bleeding and mortality benefits for bivalirudin), highlighted alternative strategies. However, subsequent trials like HEAT-PPCI challenged bivalirudin's supremacy. The MATRIX trial was specifically designed as a large-scale, 2x2 factorial study to definitively settle these debates by concurrently testing bleeding-avoidance strategies (radial access and bivalirudin) in a broad ACS population.

Guided Discussion

High-yield insights from every perspective

Med Student
Medical Student

How does minimizing access site bleeding through transradial access biologically and clinically translate to a reduction in all-cause mortality in patients with acute coronary syndrome?

Key Response

Students must understand that bleeding in ACS is not merely a nuisance; it leads to hemodynamic compromise, sympathetic nervous system activation, cessation of critical life-saving antiplatelet therapies, and subsequent ischemic events or death. Radial access mechanically allows for easy compressibility, preventing the hidden and often fatal retroperitoneal bleeds associated with femoral access.

Resident
Resident

Given the MATRIX trial's findings regarding bivalirudin versus unfractionated heparin, how should this influence your choice of systemic anticoagulation for an ACS patient heading to the cath lab, particularly when radial access is already planned?

Key Response

Residents should recognize that if bleeding risk is already heavily mitigated by radial access, the theoretical bleeding benefit of the more expensive bivalirudin is diminished. Its lack of superiority in composite ischemic outcomes compared to UFH makes UFH the standard, cost-effective choice for routine ACS cases.

Fellow
Fellow

The MATRIX trial demonstrated a net adverse clinical event and mortality benefit for radial over femoral access, but how does the 'radial paradox' apply to hemodynamically unstable patients or those in cardiogenic shock, and how does operator learning curve impact these outcomes?

Key Response

Fellows need to grapple with complex PCI scenarios. The patients at highest bleeding risk (e.g., shock) benefit the most from radial access, yet radial access is technically harder to obtain in hypotensive, peripherally vasoconstricted states. Interpreting MATRIX requires acknowledging that the survival benefit is highly dependent on operator proficiency and radial volume.

Attending
Attending

Should transradial access be the absolute default for all invasive ACS management at our institution based on the MATRIX data, and if so, how do we systematically maintain femoral access proficiency among our trainees for complex cases requiring large-bore access?

Key Response

Attendings must balance adopting the superior technique (radial) for patient safety and mortality benefit while recognizing the necessity of femoral skills for large-bore access devices (e.g., Impella, TAVR, complex CTOs). The teaching point is managing the unintended consequence of procedural skill attrition.

Scholarly Review

Critical appraisal through the lens of expert reviewers and guideline development

PhD
PhD

The MATRIX trial utilized a 2x2 factorial design to simultaneously assess access site and anticoagulant choice. What are the statistical assumptions regarding the interaction between these two interventions, and how might a synergistic or sub-additive effect on bleeding outcomes complicate the interpretation of the marginal effects?

Key Response

Researchers must evaluate the assumption of independent effects in factorial designs. Since both radial access and bivalirudin primarily target bleeding reduction, sub-additive effects could occur (i.e., bivalirudin has no added benefit if radial access already prevents bleeding), potentially rendering the trial underpowered to detect a significant interaction term.

Journal Editor
Journal Editor

In reviewing the 1-year outcomes of the MATRIX trial, how does the open-label design for the access site allocation and the potentially asymmetric crossover rate between the radial and femoral groups threaten the internal validity of the mortality and MACE endpoints?

Key Response

Editors look for systematic bias. Open-label trials are subject to performance and detection bias. Furthermore, if crossover from radial to femoral was higher (due to radial spasm or anatomical failure) than femoral to radial, an intention-to-treat analysis might dilute the true effect of radial access, which a rigorous reviewer must flag.

Guideline Committee
Guideline Committee

Based on the definitive 1-year data from MATRIX showing a mortality benefit, should transradial access be universally designated as a Class I, Level of Evidence A recommendation for all ACS patients, and how does the lack of bivalirudin superiority reshape the algorithm for periprocedural anticoagulation in current ESC and ACC/AHA guidelines?

Key Response

Guideline committees evaluate whether data is robust enough to mandate a practice shift. MATRIX, alongside RIVAL, solidifies radial access as a Class I recommendation. Meanwhile, the lack of benefit for bivalirudin over UFH supports prioritizing UFH due to cost and similar efficacy, moving bivalirudin to an alternative status (Class IIa/IIb) in modern guidelines.

Clinical Landscape

Noteworthy Related Trials

2008

HORIZONS-AMI Trial

n = 3,602 · NEJM

Tested

Bivalirudin monotherapy

Population

Patients with STEMI undergoing primary PCI

Comparator

Unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor

Endpoint

Major bleeding and net adverse clinical events at 30 days

Key result: Bivalirudin significantly reduced the rates of major bleeding and 30-day net adverse clinical events compared to heparin plus GPI.
2011

RIVAL Trial

n = 7,021 · Lancet

Tested

Radial artery access

Population

Patients with acute coronary syndromes

Comparator

Femoral artery access

Endpoint

Composite of death, myocardial infarction, stroke, or non-CABG-related major bleeding at 30 days

Key result: There was no significant difference in the primary endpoint, but radial access significantly reduced major vascular complications.
2014

HEAT-PPCI Trial

n = 1,812 · Lancet

Tested

Unfractionated heparin

Population

Patients with STEMI undergoing primary PCI

Comparator

Bivalirudin

Endpoint

Major adverse cardiovascular events at 28 days

Key result: Heparin reduced ischemic events compared to bivalirudin without increasing bleeding complications.

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