Guidelines recommend trans-radial access (TRA) for all percutaneous coronary intervention (PCI). However, no randomized trials have shown a lower mortality when compared to the femoral approach in chronic coronary disease and femoral access may be preferred in certain situations. Consecutive eligible patients in a multi-center registry between 2014– 2020 were included. Clinical characteristics and outcomes were compared between those who underwent radial versus femoral access. The main outcomes were major bleeding and 5-year mortality. Of the 6,158 patients included, 3,784 (61.4%) had TRA and 2,374 (38.6%) femoral access. TRA predominated from 2016. The femoral group had higher rates of diabetes mellitus, renal dysfunction and prior stroke. Trans-femoral procedures were more complex with higher rates of ACC/AHA type B2/C lesions, chronic total occlusions, left main PCI, use of adjuvants including rotational atherectomy, and lower procedural success rates. Major bleeding was higher in the femoral group (radial 0.4% vs femoral 0.8%, p = 0.039), however femoral access did not predict major bleeding (OR 1.68, 95% CI 0.74 to 3.82). There was no difference in 5-year mortality (radial 20.3% vs femoral 21%, p = 0.65). In conclusion, TRA predominates in contemporary PCI for CCD. The femoral group had higher procedural complexity and risk with a higher incidence of peri‑procedural major bleeding. Nonetheless, femoral access did not predict major bleeding and there was no difference in 5-year mortality as compared to TRA. In the absence of a contemporary randomized trial, the femoral approach appears reasonable if clinically preferred in patients with chronic coronary disease undergoing PCI.
Highlights
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No randomized studies have shown trans-radial access (TRA) lowers mortality as compared to the femoral approach in patients with chronic coronary disease (CCD) undergoing PCI.
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Contemporary techniques in PCI including access have evolved which may improve outcomes.
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In this study, although femoral access had a higher rate of major bleeding overall, the femoral approach was not an independent predictor of major bleeding and there was no difference compared to TRA after 2018 which may reflect improved safety of contemporary techniques.
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There was no difference in 5-year mortality despite the femoral group having a higher risk profile and case complexity.
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Contemporary femoral access appears safe and in the absence of a randomized controlled trial in patients with CCD, this study suggests femoral access is reasonable if clinically preferred.
Graphical abstract
Transradial access (TRA) is now preferred for invasive coronary angiography (ICA) and percutaneous coronary intervention (PCI). The shift away from the femoral approach is driven by guidelines based on randomized controlled trials showing mortality is lower with TRA. ,, Importantly however, this mortality benefit has only been consistently proven in patients with ST elevation myocardial infarction and has not been demonstrated in the context of chronic coronary disease (CCD). , There are considerable differences in these distinct clinical entities and therefore extrapolation of data from acute coronary syndrome (ACS) to the stable setting should be discouraged. Available data comparing radial to femoral access in CCD is mostly limited to sub analyses of larger trials, usually with small patient numbers or short follow up duration, and few if any randomized studies would now be considered contemporary.
Although vascular and bleeding complications are higher with femoral access historically, techniques have evolved that improve success rates and may reduce such complications. , Further, there remain situations where the femoral approach is preferred, such as for large bore access or when radial arteries are not available. There is therefore a need for studies evaluating contemporary techniques and appraising current real-world practice to establish whether the use of femoral access has detrimental consequences in CCD. We sought to investigate the use of radial versus femoral access in a large prospective PCI registry to determine trends and the clinical impact of the chosen access strategy.
Methods
This was an observational analysis from the prospective Melbourne Interventional Group Registry (MIG). Consecutive patients who underwent PCI for CCD prospectively enrolled between 2014 and 2020 were included. Patients were grouped for analysis according to whether the procedure was performed via the femoral or radial approach. Patients with any access other than radial or femoral, those with a prior history of coronary artery bypass grafting (CABG), and patients with acute coronary syndrome were excluded. There was no patient or public involvement in the conduction of this research project. The Austin Health Human Research Ethics Committee has approved this study (HREC/101761/Austin-2023).
The MIG registry is a multicenter PCI registry of 6 academic teaching hospitals in the state of Victoria, Australia and has been previously described in detail. The registry collates demographic, clinical, procedural and in-hospital outcome data that are prospectively recorded on case-report forms using standardized definitions for all fields. In-hospital complications were recorded at the time of discharge or death. Follow up at 30-days is via telephone interview, with events verified by reviewing participants medical records. To obtain all-cause long-term mortality, periodic linkage of the MIG registry to the Australian National Death Index (NDI) is performed. The NDI has been active since 1980 and records all deaths in Australia. Successful matching of patients via this linkage was achieved in 99.4% of patients in the MIG registry. The registry is coordinated by the Centre of Cardiovascular Research and Education in Therapeutics; an independent research body within the School of Public Health and Preventive Medicine at Monash University (Melbourne, Australia). Periodic audits of randomly selected data fields have demonstrated an accuracy rate of 98%. The ethics committee at each participating hospital has approved the MIG registry, including the use of “opt-out” consent.
Study definitions and outcomes
The main outcomes of this study were major bleeding and 5-year mortality. Secondary outcomes included 1-year mortality, procedural success, in-hospital major bleeding, myocardial infarction (MI), and death, as well as 30-day mortality, MI, stroke, target vessel revascularization (TVR) and MACE. MI was defined as a ≥ 20% rise in cardiac biomarkers and at least one of; a significant ST-segment change, development of new Q waves in ≥2 contiguous electrocardiographic leads, ischemic symptoms, angiographic evidence of flow limiting complications or imaging evidence of new loss of myocardium. Stroke was defined as sudden onset of persistent loss of neurological function caused by an ischemic or hemorrhagic event during or after PCI. In-hospital major bleeding was defined as bleeding requiring a transfusion and/or associated with a prolonged hospital stay and/or a drop-in hemoglobin >3 g/dL. New renal impairment was defined as an increase in serum creatinine to either > 0.20 mmol/L (2.27 mg/dL) or 2x the baseline serum creatinine level, or a new need for dialysis. Procedural success was defined by a residual stenosis of <20% after stenting, or 50% after balloon angioplasty only.
Statistical analysis
Continuous variables are expressed as mean ± standard deviation or median [interquartile range (IQR)], and categorical data are expressed as numbers/percentages. Differences in continuous data between the 2 groups were assessed using the independent t-test for normally distributed data and the Wilcoxon rank-sum test for nonparametric data. Categorical variables were compared using Pearson’s chi-squared test. Multivariable logistic regression was conducted to investigate adjusted in-hospital major bleeding rate between the 2 groups. The demographic and clinical variables considered included age, gender, hypertension, smoking status, dyslipidemia, family history of CAD, previous MI, heart failure, peripheral vascular disease, cerebrovascular disease, chronic lung disease, renal failure and left ventricular ejection fraction. Procedural characteristics including access site, drug-eluting stent use, lesion length, lesion location (ostial, bifurcation) and glycoprotein IIb/IIIa use were also assessed. Univariate variables yielding p <0.10 were included in the final multivariate model. No assumptions were made about missing data. All statistical analyses were performed using Stata 17.0, StataCorp LP, College Station, TX, USA. p-values <0.05 were considered statistically significant.
Results
Of the 6,158 eligible patients who underwent PCI for CCD between 2014 and 2020, 3,784 (61.4%) had TRA whilst 2,374 (38.6%) underwent the procedure via the femoral approach. Although initially femoral access was more common, TRA overtook the femoral approach in 2016 and by 2020 accounted for more than 3 quarters of cases ( Figure 1 ). There was no difference in mean age, however there were more patients aged 80 years and older in the femoral group. The radial group had a lower proportion of females, a higher mean BMI, and a lower rate of diabetes mellitus, smoking, renal dysfunction, and prior stroke. The radial group also had a lower rate of heart failure, prior PCI, and atrial fibrillation, whilst there were no differences noted in the rate of long-term oral anticoagulation use ( Table 1 ).
Temporal trends in radial versus femoral access. There has been a considerable increase in trans-radial access over the study period, having overtaken the femoral approach by 2016. The adoption of trans-radial access has continually increased.
Table 1
Baseline characteristics
|
Overall
( n = 6,158) |
Radial
( n = 3,784) |
Femoral
( n = 2,374) |
p-value | |
|---|---|---|---|---|
| Age, mean years | 65.6 ± 11.2 | 65.4 ± 10.8 | 65.9 ± 11.8 | 0.10 |
| ≥ 80 years old | 693 (11.3) | 378 (10.0) | 315 (13.3) | <0.001 |
| Female | 1,413 (22.9) | 783 (20.7) | 630 (26.5) | <0.001 |
| BMI, kg/m 2 | 29.2 ± 5.6 | 29.4 ± 5.8 | 28.9 ± 5.3 | <0.001 |
| Hypertension | 4,380 (71.1) | 2,652 (70.1) | 1,728 (72.8) | 0.023 |
| Diabetes Mellitus | 1,815 (29.5) | 1,047 (27.7) | 768 (32.4) | <0.001 |
| Hypercholesterolemia | 4,200 (68.2) | 2,541 (67.2) | 1,659 (69.9) | 0.025 |
| Current smokers | 1,048 (17.0) | 656 (17.3) | 392 (16.5) | <0.001 |
| Ex-smokers | 2,718 (44.1) | 1,650 (43.6) | 1,068 (45.0) | |
| COPD | 531 (8.6) | 338 (8.9) | 193 (8.1) | 0.27 |
| OSA | 431 (7.0) | 273 (7.2) | 158 (6.7) | 0.40 |
| Previous stroke | 320 (5.2) | 169 (4.5) | 151 (6.4) | 0.001 |
| PVD | 285 (4.6) | 145 (3.8) | 140 (5.9) | <0.001 |
| Family history of IHD | 1,710 (27.8) | 1,023 (27.0) | 687 (28.9) | 0.010 |
| eGFR | ||||
| ≥ 60+ mL/min/1.73 m 2 | 4,484 (75.4) | 2,863 (78.1) | 1,621 (71.2) | <0.001 |
| 30-59 mL/min/1.73 m 2 | 1,259 (21.2) | 734 (20.0) | 525 (23.0) | |
| < 30 mL/min/1.73 m 2 | 201 (3.4) | 69 (1.9) | 132 (5.8) | |
| Dialysis | 84 (1.4) | 20 (0.5) | 64 (2.7) | <0.001 |
| Creatinine | 97.3 ± 66.8 | 92.2 ± 44.5 | 105.6 ± 91.4 | <0.001 |
| Atrial fibrillation | 294 (4.8) | 174 (4.6) | 120 (5.1) | 0.018 |
| Previous MI | 1,986 (32.3) | 1123 (29.7) | 863 (36.4) | <0.001 |
| Congestive heart failure | 283 (4.6) | 153 (4.0) | 130 (5.5) | 0.009 |
| Previous PCI | 2,647 (43.0) | 1,566 (41.4) | 1,081 (45.5) | 0.001 |
| NYHA I | 3,769 (74.4) | 2,323 (77.3) | 1,446 (70.3) | <0.001 |
| NYHA II | 983 (19.4) | 511 (17.0) | 472 (22.9) | |
| NYHA III | 206 (4.1) | 109 (3.6) | 97 (4.7) | |
| NYHA IV | 106 (2.1) | 64 (2.1) | 42 (2.0) | |
| On anticoagulation | 499 (8.1) | 311 (8.2) | 188 (7.9) | 0.67 |
| Baseline LVEF | ||||
| >50 | 4,546 (85.5) | 2,878 (86.4) | 1,668 (83.9) | 0.084 |
| 45-50 | 459 (8.6) | 269 (8.1) | 190 (9.6) | |
| 35-44 | 24 (0.5) | 15 (0.5) | 9 (0.5) | |
| <35 | 291 (5.5) | 169 (5.1) | 122 (6.1) |
Data expressed as number (%), mean ± standard deviation, or median [IQR]. Where data are incomplete, the denominator is specified.
BMI = body mass index; COPD = chronic obstructive pulmonary disease; eGFR = estimated glomerular filtration rate; IHD = ischemic heart disease; LVEF = left ventricular ejection fraction; MI = myocardial infarction; NYHA = New York Heart Association; OSA = obstructive sleep apnea; PCI = percutaneous coronary intervention; PVD = peripheral vascular disease.
Procedural characteristics
Procedural characteristics are shown in Table 2 . Most patients underwent their procedure via a 6 French sheath. Sheaths > 6F were far more common from the femoral approach (radial 1% vs femoral 15.7%, p <0.001). More than 95% of patients underwent PCI to a de novo lesion. Procedural complexity was higher in the femoral group with higher rates of ACC/AHA Type B2/C lesions (radial 52.4% vs femoral 60.0%, p <0.001), in-stent-restenosis (radial 3.8% vs femoral 5.0%, p = 0.024), chronic total occlusions (radial 5.3% vs femoral 13.3%, p <0.001), left main interventions (radial 1.4% vs femoral 2.5%, p = 0.003), and use of rotational atherectomy (radial 1.2% vs femoral 4.5%, p <0.001). The radial group were more likely to have a drug eluting stent (radial 87.4% vs femoral 81.3%, p <0.001) and less likely to have plain old balloon angioplasty (radial 5.6% vs femoral 8.7%, p <0.001). Procedural success was more common in the radial group (radial 95.2% vs femoral 92.5%, p <0.001). Almost a quarter (24.1%) of patients in the femoral group had an arteriotomy closure device used.
Table 2
Presenting and procedural characteristics
| Overall ( n = 6,158) |
Radial
( n = 3,784) |
Femoral
( n = 2,374) |
p-value | |
|---|---|---|---|---|
| De novo lesion | 5,893 (95.7) | 3,644 (96.3) | 2,249 (94.7) | 0.003 |
| In stent re-stenosis | 261 (4.2) | 143 (3.8) | 118 (5.0) | 0.024 |
| Chronic total occlusion | 517 (8.4) | 202 (5.3) | 315 (13.3) | <0.001 |
| Bifurcation | 968 (15.7) | 577 (15.2) | 391 (16.5) | 0.20 |
| Target vessel | ||||
| LMCA | 113 (1.8) | 54 (1.4) | 59 (2.5) | 0.003 |
| LAD | 2,745 (44.6) | 1,726 (45.6) | 1,019 (42.9) | 0.039 |
| LCx | 789 (12.8) | 492 (13.0) | 297 (12.5) | 0.57 |
| RCA | 1,659 (26.9) | 940 (24.8) | 719 (30.3) | <0.001 |
| Disease extent | ||||
| Single vessel | 2,872 (46.6) | 1,804 (47.7) | 1,068 (45.0) | 0.097 |
| 2 vessel | 2,306 (37.4) | 1,398 (36.9) | 908 (38.2) | |
| 3 vessel | 980 (15.9) | 582 (15.4) | 398 (16.8) | |
| Sheath size | ||||
| ≤ 5 | 98 (1.6) | 80 (2.1) | 18 (0.8) | <0.001 |
| 6 | 5,651 (91.8) | 3,666 (96.9) | 1,985 (83.6) | |
| 7 | 374 (6.1) | 38 (1.0) | 336 (14.2) | |
| ≥ 8 | 35 (0.6) | 0 (0.0) | 35 (1.5) | |
| ACC/AHA Type B2/C | 3,407 (55.3) | 1,983 (52.4) | 1,424 (60.0) | <0.001 |
| Intravascular ultrasound | 89 (1.4) | 29 (0.8) | 60 (2.5) | <0.001 |
| Cutting balloon | 187 (3.0) | 87 (2.3) | 100 (4.2) | <0.001 |
| Glycoprotein IIb/IIIa | 227 (3.7) | 128 (3.4) | 99 (4.2) | 0.11 |
| Rotational atherectomy | 153 (2.5) | 46 (1.2) | 107 (4.5) | <0.001 |
| Pressure wire use | 246 (4.0) | 157 (4.1) | 89 (3.7) | 0.44 |
| Bare Metal Stent | 446 (7.2) | 232 (6.1) | 214 (9.0) | <0.001 |
| Drug Eluting Stent | 5,237 (85.0) | 3,307 (87.4) | 1,930 (81.3) | <0.001 |
| BMS and DES | 14 (0.2) | 7 (0.2) | 7 (0.3) | 0.38 |
| Balloon angioplasty only | 418 (6.8) | 211 (5.6) | 207 (8.7) | <0.001 |
| Perforation | 12 (0.2) | 8 (0.2) | 4 (0.2) | 0.71 |
| No re-flow | ||||
| No | 6,072 (98.6) | 3,733 (98.7) | 2,339 (98.5) | 0.92 |
| Transient | 52 (0.8) | 31 (0.8) | 21 (0.9) | |
| Persistent | 34 (0.6) | 20 (0.5) | 14 (0.6) | |
| Coronary dissection | 203 (3.3) | 96 (2.5) | 107 (4.5) | <0.001 |
| Unsuccessful procedure | 361 (5.9) | 182 (4.8) | 179 (7.5) | <0.001 |
| Closure Device | 571 (9.3) | 0 (0) | 571 (24.1) | <0.001 |
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