The Lancet AUGUST 25, 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, et al.

Bottom Line

The MATRIX trial demonstrated that radial access significantly reduces net adverse clinical events compared to femoral access in patients with acute coronary syndromes, while bivalirudin provided no significant benefit over unfractionated heparin regarding major ischemic or net adverse events.

Key Findings

1. Radial access was associated with a lower rate of net adverse clinical events (NACE) compared to femoral access at 1 year (15.2% vs. 17.2%; rate ratio 0.87, 95% CI 0.78-0.97, P=0.0128).
2. There was no statistically significant difference in the primary endpoint of major adverse cardiovascular events (MACE) between radial and femoral access at 1 year (14.2% vs. 15.7%; rate ratio 0.89, 95% CI 0.80-1.00, P=0.0526).
3. Bivalirudin did not significantly reduce 30-day MACE or NACE compared with unfractionated heparin (MACE: 10.3% vs 10.9%, P=0.44; NACE: 11.2% vs 12.4%, P=0.12).
4. Patients treated with bivalirudin showed a higher incidence of definite stent thrombosis compared to those receiving heparin (1.0% vs 0.6%, RR 1.72; 95% CI 1.02-2.91).
5. The use of post-PCI bivalirudin infusion did not improve outcomes compared to no post-PCI infusion.

Study Design

Design
RCT
Open-Label
Sample
8,404
Patients
Duration
1 yr
Median
Setting
Multicentre, Europe
Population Patients with acute coronary syndromes (STEMI and NSTEMI) scheduled for invasive management.
Intervention Radial artery access and/or bivalirudin monotherapy.
Comparator Femoral artery access and/or unfractionated heparin with optional glycoprotein IIb/IIIa inhibitors.
Outcome 30-day MACE (death, myocardial infarction, or stroke) and 30-day NACE (MACE or non-CABG-related major bleeding).

Study Limitations

The trial was open-label, which may introduce observer bias, although clinical endpoints were adjudicated by a blinded committee.
The primary composite outcome for radial vs femoral access narrowly missed formal statistical significance at the prespecified alpha level at 30 days.
The study was not specifically powered to detect differences in mortality, despite trends favoring bivalirudin in secondary analyses.
The results regarding radial access are highly dependent on operator expertise and may not be fully generalizable to low-volume centers.

Clinical Significance

The MATRIX trial supports the transition toward radial access as the standard of care for patients with acute coronary syndrome undergoing invasive management due to its clear benefits in reducing bleeding and net adverse clinical events. Conversely, the results for bivalirudin suggest it does not offer a clear superiority over unfractionated heparin in preventing major ischemic events, reinforcing the need for individualized antithrombotic therapy.

Historical Context

Prior to MATRIX, trials like RIVAL had suggested benefits for radial access in high-risk patients, but evidence remained debated. MATRIX was designed as a large-scale, 2x2 factorial study to definitively compare both access sites and antithrombotic strategies (bivalirudin vs. heparin) across the full spectrum of ACS, influencing global practice guidelines and cementing the radial-first approach.

Guided Discussion

High-yield insights from every perspective

Med Student
Medical Student

Anatomically and physiologically, why does choosing the radial artery over the femoral artery as an access point for cardiac catheterization lead to a significant reduction in major bleeding complications?

Key Response

The radial artery is superficial and lies directly over the distal radius bone, making it easily compressible to achieve hemostasis. In contrast, the femoral artery is deeper and lacks a hard underlying structure for effective compression, increasing the risk of occult retroperitoneal hemorrhage or large hematomas which can lead to hemodynamic instability.

Resident
Resident

In the context of the MATRIX trial results, if a patient with ACS is undergoing PCI via radial access, does the evidence support the routine use of bivalirudin over unfractionated heparin (UFH) to reduce net adverse clinical events (NACE)?

Key Response

No. The MATRIX trial found that bivalirudin did not significantly reduce NACE or MACE compared to UFH. The previously observed benefits of bivalirudin in earlier trials were largely driven by a reduction in bleeding, which is already significantly minimized when using radial access. Therefore, UFH remains a standard, cost-effective choice in radial-first centers.

Fellow
Fellow

The MATRIX trial observed a reduction in all-cause mortality in the radial access group. Critically analyze whether this mortality benefit is solely attributable to reduced bleeding or if other factors like 'radial expertise' and crossover rates play a confounding role.

Key Response

While reduced bleeding is the primary mediator of the mortality benefit, the trial also reflects high operator proficiency. A high crossover rate from radial to femoral (often due to radial artery spasm or tortuosity) can dilute the 'intention-to-treat' benefit. The mortality benefit suggests that preventing even non-fatal major bleeds avoids the subsequent inflammatory cascade and cessation of antiplatelet therapy that often follows hemorrhagic events in ACS.

Attending
Attending

Given the results of MATRIX, how should we approach the 'radial-to-femoral' transition in complex cases? Does the trial suggest that the benefits of radial access are robust enough to justify longer procedure times in the setting of acute STEMI?

Key Response

The trial supports a 'radial-first' approach as the default, but clinician judgment is required. In STEMI, 'time is muscle,' and while radial access reduces mortality through bleeding avoidance, excessive attempts at radial access that delay reperfusion can be detrimental. The MATRIX results should be taught as a mandate for radial proficiency, but with a low threshold for femoral transition if the radial approach significantly delays the primary goal of vessel patency.

Scholarly Review

Critical appraisal through the lens of expert reviewers and guideline development

PhD
PhD

Evaluate the 2x2 factorial design of the MATRIX trial. How does the potential interaction between the access site intervention and the anticoagulation intervention affect the statistical power to detect a difference in the bivalirudin arm?

Key Response

In a factorial design, if one intervention (radial access) drastically reduces the event rate (bleeding) that the second intervention (bivalirudin) is designed to target, the trial may become underpowered to show a treatment effect for the second intervention (a 'floor effect'). This interaction suggests that the utility of bivalirudin is conditional upon the baseline bleeding risk inherent to the access site.

Journal Editor
Journal Editor

As a reviewer, how would you address the open-label design of the access-site randomization in MATRIX, specifically regarding the potential for 'ascertainment bias' in the reporting of bleeding events?

Key Response

Open-label trials are vulnerable to bias where investigators may more diligently search for or report complications in the 'control' (femoral) arm. To mitigate this, a tough reviewer would look for blinded adjudication of endpoints by an independent committee (which MATRIX used) and evaluate if the bleeding definitions used (e.g., BARC) are objective enough to minimize subjective interpretation by unblinded site investigators.

Guideline Committee
Guideline Committee

Based on the 1-year MATRIX data, should the preference for radial access be elevated to a Class I, Level A recommendation in ACS guidelines, and how does this affect the current ESC/ACC recommendations for bivalirudin?

Key Response

The MATRIX trial provides definitive evidence supporting radial access as the superior strategy for reducing NACE and mortality in ACS, justifying a Class I recommendation (as seen in ESC 2017/2020). Conversely, it supports downgrading the routine use of bivalirudin to a Class IIa or IIb, suggesting it should be reserved for patients with high bleeding risk or heparin-induced thrombocytopenia, rather than being the default over UFH.

Clinical Landscape

Noteworthy Related Trials

2006

ACUITY Trial

n = 13,819 · NEJM

Tested

Bivalirudin alone or bivalirudin plus glycoprotein IIb/IIIa inhibitors

Population

Patients with moderate-to-high-risk acute coronary syndromes

Comparator

Heparin plus glycoprotein IIb/IIIa inhibitors

Endpoint

Composite of death, myocardial infarction, or unplanned revascularization

Key result: Bivalirudin alone was non-inferior to heparin plus a GP IIb/IIIa inhibitor with significantly lower rates of major bleeding.
2008

HORIZONS-AMI Trial

n = 3,602 · NEJM

Tested

Bivalirudin monotherapy

Population

Patients with ST-segment elevation myocardial infarction

Comparator

Heparin plus glycoprotein IIb/IIIa inhibitor

Endpoint

Major adverse cardiac events and major bleeding at 30 days

Key result: Bivalirudin monotherapy reduced major bleeding and 30-day mortality compared to heparin plus GP IIb/IIIa inhibitors.
2011

RIVAL Trial

n = 7,021 · Lancet

Tested

Radial artery access

Population

Patients with acute coronary syndrome

Comparator

Femoral artery access

Endpoint

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

Key result: There was no significant difference in the primary outcome between radial and femoral access in the overall population.

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