Elsevier

The Lancet

Volume 385, Issue 9986, 20–26 June 2015, Pages 2465-2476
The Lancet

Articles
Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial

https://doi.org/10.1016/S0140-6736(15)60292-6Get rights and content

Summary

Background

It is unclear whether radial compared with femoral access improves outcomes in unselected patients with acute coronary syndromes undergoing invasive management.

Methods

We did a randomised, multicentre, superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention. Patients were randomly allocated (1:1) to radial or femoral access with a web-based system. The randomisation sequence was computer generated, blocked, and stratified by use of ticagrelor or prasugrel, type of acute coronary syndrome (ST-segment elevation myocardial infarction, troponin positive or negative, non-ST-segment elevation acute coronary syndrome), and anticipated use of immediate percutaneous coronary intervention. Outcome assessors were masked to treatment allocation. The 30-day coprimary outcomes were major adverse cardiovascular events, defined as death, myocardial infarction, or stroke, and net adverse clinical events, defined as major adverse cardiovascular events or Bleeding Academic Research Consortium (BARC) major bleeding unrelated to coronary artery bypass graft surgery. The analysis was by intention to treat. The two-sided α was prespecified at 0·025. The trial is registered at ClinicalTrials.gov, number NCT01433627.

Findings

We randomly assigned 8404 patients with acute coronary syndrome, with or without ST-segment elevation, to radial (4197) or femoral (4207) access for coronary angiography and percutaneous coronary intervention. 369 (8·8%) patients with radial access had major adverse cardiovascular events, compared with 429 (10·3%) patients with femoral access (rate ratio [RR] 0·85, 95% CI 0·74–0·99; p=0·0307), non-significant at α of 0·025. 410 (9·8%) patients with radial access had net adverse clinical events compared with 486 (11·7%) patients with femoral access (0·83, 95% CI 0·73–0·96; p=0·0092). The difference was driven by BARC major bleeding unrelated to coronary artery bypass graft surgery (1·6% vs 2·3%, RR 0·67, 95% CI 0·49–0·92; p=0·013) and all-cause mortality (1·6% vs 2·2%, RR 0·72, 95% CI 0·53–0·99; p=0·045).

Interpretation

In patients with acute coronary syndrome undergoing invasive management, radial as compared with femoral access reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality.

Funding

The Medicines Company and Terumo.

Introduction

Over the past two decades early invasive management and the use of combined antithrombotic therapies have lowered the risk of recurrent myocardial infarction in patients with acute coronary syndromes, but have also been associated with a significant increase in bleeding.1, 2 Bleeding is associated with worse short-term and long-term clinical outcomes, and this relation is thought to be causal.3, 4 Therefore, reducing the frequency of bleeding events while maintaining effectiveness is an important goal in the management of patients with acute coronary syndrome, and has the potential to reduce mortality, morbidity, and costs.5

A common site of bleeding in invasively managed patients is at the femoral artery puncture site used for heart catheterisation.6 Compared with the femoral artery, the radial artery is more superficial and has a smaller calibre. Radial access is therefore technically more demanding, but makes access site haemostasis more predictable.7 Previous studies have come to differing conclusions about the role of radial access in reducing adverse outcomes in patients with acute coronary syndrome undergoing catheterisation or percutaneous coronary intervention.8, 9 Whether avoiding access site bleeding and vascular complications by the use of routine transradial intervention improves outcomes in largely unselected patients with acute coronary syndrome undergoing invasive management remains unclear.8

Therefore, we did a large, multicentre, randomised trial in patients with acute coronary syndrome who were about to undergo coronary angiography and possible percutaneous coronary intervention, if indicated, to assess whether radial access is superior to femoral access.

Section snippets

Study design and participants

Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX Access) was a randomised multicentre superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention, if indicated.10, 11 This trial is part of the MATRIX programme (registered at ClinicalTrials.gov

Results

Between Oct 11, 2011, and Nov 7, 2014, 8404 patients were randomly allocated to receive radial (4197 patients) or femoral access (4207 patients). Of these patients, 3951 (94·1%) received radial access and 4098 (97·4%) received femoral access. Access was attempted but failed in 243 (5·8%) radial patients and 96 (2·3%) femoral patients, and access was not attempted in three (0·1%) radial and 13 (0·3%) femoral patients. Complete follow-up to 30 days was available in 4183 radial and 4191 femoral

Discussion

Among patients with an acute coronary syndrome, with or without ST-segment elevation who underwent invasive management, the use of radial access for coronary angiography followed by percutaneous coronary intervention, if indicated, significantly reduced the rate of net adverse clinical events, defined as the composite of major adverse cardiovascular events or major bleeding, with a number needed to treat of 56. The 15% relative risk reduction for major adverse cardiovascular events did not meet

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