Background

Cardiovascular disease (CVD) is the major cause of mortality worldwide. Coronary artery disease (CAD) contributes to half of mortalities caused by CVD. The mainstay of management of CAD is medical therapy and revascularisation. Revascularisation can be achieved via coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). Peripheral arteries, such as the femoral or radial artery, provide the access to the coronary arteries to perform diagnostic or therapeutic (or both) procedures.

Objectives

To assess the benefits and harms of the transradial compared to the transfemoral approach in people with CAD undergoing diagnostic coronary angiography (CA) or PCI (or both).

Search methods

We searched the following databases for randomised controlled trials on 10 October 2017: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and Web of Science Core Collection. We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform in August 2017. There were no language restrictions. Reference lists were also checked and we contacted authors of included studies for further information.

Selection criteria

We included randomised controlled trials that compared transradial and transfemoral approaches in adults (18 years of age or older) undergoing diagnostic CA or PCI (or both) for CAD.

Data collection and analysis

We used the standard methodological procedures expected by Cochrane. At least two authors independently screened trials, extracted data, and assessed the risk of bias in the included studies. We contacted trial authors for missing information. We used risk ratio (RR) for dichotomous outcomes and mean difference (MD) or standardised mean difference (SMD) for continuous data, with their 95% confidence intervals (CIs). All analyses were checked by another author.

Main results

We identified 31 studies (44 reports) including 27,071 participants and two ongoing studies. The risk of bias in the studies was low or unclear for several domains. Compared to the transfemoral approach, the transradial approach reduced short‐term net adverse clinical events (NACE) (i.e. assessed during hospitalisation and up to 30 days of follow‐up) (RR 0.76, 95% CI 0.61 to 0.94; 17,133 participants; 4 studies; moderate quality evidence), cardiac death (RR 0.69, 95% CI 0.54 to 0.88; 11,170 participants; 11 studies; moderate quality evidence). However, short‐term myocardial infarction was similar between both groups (RR 0.91, 95% CI 0.81 to 1.02; 19,430 participants; 11 studies; high quality evidence). The transradial approach had a lower procedural success rate (RR 0.97, 95% CI 0.96 to 0.98; 25,920 participants; 28 studies; moderate quality evidence), but was associated with a lower risk of all‐cause mortality (RR 0.77, 95% CI 0.62 to 0.95; 18,955 participants; 10 studies; high quality evidence), bleeding (RR 0.54, 95% CI 0.40 to 0.74; 23,043 participants; 20 studies; low quality evidence), and access site complications (RR 0.36, 95% CI 0.22 to 0.59; 16,112 participants; 24 studies; low quality evidence).

Authors’ conclusions

Transradial approach for diagnostic CA or PCI (or both) in CAD may reduce short‐term NACE, cardiac death, all‐cause mortality, bleeding, and access site complications. There is insufficient evidence regarding the long‐term clinical outcomes (i.e. beyond 30 days of follow‐up).

Background: Studies in patients with acute coronary syndrome (ACS) undergoing invasive management showed conflicting conclusions regarding the effect of access site on outcomes.

Purpose: To summarize evidence from recent, high-quality trials that compared clinical outcomes occurring with radial versus femoral access in invasively managed adults with ACS.

Data sources: English-language publications in MEDLINE, EMBASE, and Cochrane databases between January 1990 and August 2015.

Study selection: Randomized trials of radial versus femoral access in invasively managed patients with ACS.

Data extraction: Two investigators independently extracted the study data and rated the risk of bias.

Data synthesis: Of 17 identified randomized trials, 4 were high-quality multicenter trials that involved a total of 17 133 patients. Pooled data from the 4 trials showed that radial access reduced death (relative risk [RR], 0.73 [95% CI, 0.59 to 0.90]; P = 0.003), major adverse cardiovascular events (RR, 0.86 [CI, 0.75 to 0.98]; P = 0.025), and major bleeding (RR, 0.57 [CI, 0.37 to 0.88]; P = 0.011). Radial procedures lasted slightly longer (standardized mean difference, 0.11 minutes) and had higher risk for access-site crossover (6.3% vs. 1.7%) than did femoral procedures.

Limitation: Heterogeneity in outcomes definitions and potential treatment modifiers across studies, including operator experience in radial procedures and concurrent anticoagulant regimens.

Conclusion: Compared with femoral access, radial access reduces mortality, major adverse cardiovascular events, and major bleeding in patients with ACS undergoing invasive management.

OBJECTIVES The aim of this study was to provide a quantitative appraisal of the effects on clinical outcomes of radial access for coronary interventions in patients with coronary artery disease (CAD).

BACKGROUND Randomized trials investigating radial versus femoral access for percutaneous coronary interventions have provided conflicting evidence. No comprehensive quantitative appraisal of the risks and benefits of each approach is available across the whole spectrum of patients with stable or unstable CAD.

METHODS The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched for randomized trials comparing radial versus femoral access for coronary interventions. Data were pooled by meta-analysis using a fixed-effects or a random-effects model, as appropriate. Pre-specified subgroup analyses according to clinical presentation, in terms of stable CAD, non–ST-segment elevation acute coronary syndromes, or ST-segment elevation myocardial infarction were performed.

RESULTS Twenty-four studies enrolling 22,843 participants were included. Compared with femoral access, radial access was associated with a significantly lower risk for all-cause mortality (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.59 to 0.87; p 1⁄4 0.001, number needed to treat to benefit [NNTB] 1⁄4 160), major adverse cardiovascular events
(OR: 0.84; 95% CI: 0.75 to 0.94; p 1⁄4 0.002; NNTB 1⁄4 99), major bleeding (OR: 0.53; 95% CI: 0.42 to 0.65; p < 0.001; NNTB 1⁄4 103), and major vascular complications (OR: 0.23; 95% CI: 0.16 to 0.35; p < 0.001; NNTB 1⁄4 117). The rates of myocardial infarction or stroke were similar in the 2 groups. Effects of radial access were consistent across the whole spectrum of patients with CAD for all appraised endpoints.

CONCLUSIONS Compared with femoral access, radial access reduces mortality and MACE and improves safety, with reductions in major bleeding and vascular complications across the whole spectrum of patients with CAD.

Background

Transfemoral approach (TFA) remains the most common vascular access for percutaneous coronary intervention (PCI) in many countries. However, in the last years several randomized trials compared transradial approach (TRA) with TFA in patients with acute coronary syndrome (ACS), but only few studies were powered to estimate rare events. The aim of the current study was to clarify whether TRA is superior to TFA approach in patients with ACS undergoing percutaneous coronary intervention. A meta-analysis, meta-regression and trial sequential analysis of safety and efficacy of TRA in ACS setting was performed.

Methods and Results

Medline, the Cochrane Library, Scopus, scientific session abstracts and relevant websites were searched. Data concerning the study design, patient characteristics, risk of bias, and outcomes were extracted. The primary endpoint was death. Secondary endpoints were: major bleeding and vascular complications. Outcomes were assessed within 30 days. Eleven randomized trials involving 9,202 patients were included. Compared with TFA, TRA significantly reduced the risk of death (odds ratio [OR] 0.70; 95% confidence interval [CI], 0.53–0.94; p = 0.016), but this finding was not confirmed in trial sequential analysis, indicating that sufficient evidence had not been yet reached. Furthermore, TRA compared with TFA reduced the risk of major bleeding (OR 0.60; 95% CI, 0.41–0.88; p = 0.008) and vascular complications (OR 0.35; 95% CI, 0.28–0.46; p<0.001); these findings were supported by trial sequential analyses.

Conclusions

In patients with ACS undergoing PCI, a lower risk of death was observed with TRA. Nevertheless, the association between mortality and TRA in ACS setting should be interpreted with caution because it is based on insufficient evidence. However, because of the clinical relevance associated with major bleeding and vascular complications reduction, TRA should be recommended as first-choice vascular access in patients with ACS undergoing cardiac catheterization.

(# of subjects/ studies, cohort definition etc)

(2018)

-Studies included men and women–

-2 trials included people undergoing coronary angiography, 13 trials involved people undergoing PCI. The remaining studies involved people undergoing coronary angiography.

-5 triasl included people undergoing elcective procedures, 15 studies enrolled people undergoing urgent procedures, the remaining 11 studies included people undergoing elective or urgent procedures.

-26 studies randomized participants to either transradial or transfemoral approach.

– 2. Cardiac death.

– 3. Myocardial infarction (MI).

– 4. Success of the procedure, defined as completion of procedure without cross-over to another access site, or as defined by trialists (not prespecified).

Secondary outcomes

-1. All-cause mortality.

-2. Bleeding (combined major and minor).

-3. Stroke (ischemic or hemorrhagic), as defined by trialists.

-4. Access site complications (e.g. hematoma, arteriovenous fistula, vasospasm, pseudoaneurysm, and perforation).

– 5. Total radiation dose. — 6. Length of hospital stay.

-7. Participant satisfaction, including early or reduced (or both) pain on ambulation, early hospital discharge, or as defined by trialists.

– In people with STEMI, there was a reduction of short‐term NACE with the transradial approach (RR 0.67, 95% CI 0.51 to 0.87; 7676 participants; 4 studies; I² = 57%;), whereas in people with NSTE‐ACS, there was no difference in short‐term NACE between the two groups (RR 0.94, 95% CI 0.71 to 1.23; 9457 participants;

-Compared to

transfemoral approach, there was a reduction in cardiac death with the transradial approach

– Twenty-eight studies reported success of the procedure, which was mainly defined as the completion of procedure without crossover to another access site, or as defined by trialists

-There was no difference between the groups regarding MI (high quality evidence). Procedural success was less with the trans radial approach, due to a higher rate of cross-over to a different arterial access (moderate quality evidence)

-There is little bias in this study. The Cochrane Reviews minimizes bias in the process of conducting systematic reviews.

-The mean or median age of participants in the 4 trials ranged between 62 and 65 years, and men accounted for 72% to 79% of patients.

-All trials reported clinical outcomes at 30 days

–

–

– The main outcome of interest was all-cause death.

-Other outcomes included myocardial infarction, stroke, major adverse cardiovascular events (MACE), access site bleeding, and major bleeding.

-Procedural data (duration and crossover rates [that is, switch from radial to femoral in the radial group and from femoral to radial in the femoral group]) were also explored

– Radial access was associated with a 4-fold higher risk for access-site crossover

– There were no statistically significant differences between radial and femoral access in myocardial infarction and stroke

– The pooled analysis of 4 large, high-quality, contemporary randomized clinical trials shows statistically significant reductions in all-cause death, MACE, access site bleeding, and major bleeding with radial versus femoral access, with no notable effects on myocardial infarction or stroke.

– The authors could  not assess whether the definitions of myocardial infarction used in each individual trial satisfy the modern criteria for adjudication of “clinically relevant” events.

-They also could not use any standardized definition of major bleeding across the studies

-The 4 studies included has a low risk of bias.

(2016)

– Eligible   trials   had   to   satisfy   the   following pre-specified  criteria:

1)  randomized  design  that compared radial versus femoral access for coronary intervention;

and

2) inclusion of patients under going coronary angiography followed by PCI in at least 50%of cases.

-In contrast, studies were excluded if they assessed  the  comparison  of  radial  versus  femoral access in patients undergoing coronary diagnostic procedures  only  and/or  PCI,  following  coronary angiography, was performed in<50% cases

all-cause mortality and major bleeding.

-Secondary efficacy and safety outcomes were  myocardial  infarction,  stroke,  the composite of major adverse cardiovascular events(MACE), and major vascular complications. The definition of MACE consisted of the composite of death, stroke, and myocardial infarction in  most studies.  Major bleeding was defined  according  to the scales used in each study.

– Rates of myocardial infarction and stroke did not differ be-tween the 2 groups

– Rates of myocardial infarction and stroke did not differ be-tween the 2 groups

– Among patients with ACS, radial access, compared with femoral access, was associated with fewer NACE

– There was a high prevalence of high risk for bias for most domains across most studies, that is, all studies enrolling patients with stable coronary artery disease and several studies of patients with with ACS. A  low  risk  for  bias  was  observed  in  5  studies

– No evidence for publication bias was detected by the Harbord test for all endpoints, except for major bleeding

-There was significant hetrogenicity with respect to endpoint of NACE

-Although  this  meta-analysis  provides  evidence supporting  the  superiority  of  radial  approach, compared with the femoral approach, differences in absolute event rates between groups were small for several endpoints, leading to a number needed to treat to benefit or harm greater than 100.

Gennaro Galasso ,

Ernesto Capuano

Stefania De Luca,

Giovanni Esposito,

Bruno Trimarco,

Federico Piscione

(2014)

2) inclusion of patients with ACS  3) the use of TRA in the experimental arm.

–  Eleven trials were included in this meta-analysis, enrolling a total of 9,202 patients

study

-Secondary endpoints were: major bleeding and vascular complications

-A total of 200 patients died (2.15%)

– TRA significantly reduced major bleeding complications as compared with TFA (0.94% vs. 1.58%, respectively, OR 0.60; 95% CI, 0.41–0.88; p = 0.008)

– TRA was associated with a significant reduction in vascular complications

-all trials were performed by experinaced operators skil;ed in TRA, thus limiting the results of the transfemoral procedures

–  this meta-analysis provides clinical follow-up within 30 days and it is still underpowered to evaluate the risk of death as demonstrated by trial sequential analysis.

– Harbord and Peters tests were used for statistical bias. And studies were high risk of bias in blinding of outcomes