Summary
Background
Data regarding radiation exposure related to radial versus femoral arterial access in patients undergoing percutaneous coronary intervention (PCI) remain controversial. This study aims to evaluate patients enrolled in the FERARI study regarding radiation exposure, fluoroscopy time and contrast agent use.
Methods
The Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) study evaluated prospectively 400 patients between February 2014 and May 2015 undergoing PCI either using the radial or femoral access. In these 400 patients, baseline characteristics, procedural data such as procedural duration, fluoroscopy time, dose–area product (DAP) as well as the amount of contrast agent used were documented and analyzed.
Results
Median fluoroscopy time was not significantly different in patients undergoing radial versus femoral access (12.2 vs. 9.8 min, p = 0.507). Furthermore, median DAP (54.5 vs. 52.0 Gycm2, p = 0.826), procedural duration (46.0 vs. 45.0 min, p = 0.363) and contrast agent use (185.5 vs. 199.5 ml, p = 0.742) were also similar in radial and femoral PCI.
Conclusion
There was no difference regarding median fluoroscopy time, procedural duration, radiation dose or contrast agent use between radial versus femoral arterial access in PCI.
Highlights
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Data comparing radiation exposure in radial versus femoral PCI remain controversial.
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400 enrolled in the FERARI study were prospectively evaluated.
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There was no difference regarding radiation exposure in radial versus femoral access.
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Furthermore, there was no significant difference regarding contrast agent use
1
Introduction
Besides the outstanding success and benefit of treating relevant coronary artery disease and acute myocardial infarction by percutaneous coronary intervention (PCI), important risk factors associated with PCI exist. Radiation exposure represents an underestimated hazard in daily routine for both the patient and the interventional cardiologist. While the number and complexity of PCI is increasing, life-long radiation exposure for the individual interventional cardiologist will most likely also rise . Previous studies have shown a higher risk for cancer, as well as a higher risk for possible local skin damage of a chronically exposed body part . During the last decades, various studies evaluated predictors that are correlated with an increased exposure to radiation during PCI. Clinical determinants such as high body mass index (BMI), patient sex, lesion complexity and lesion location seem to enhance the acquired radiation dosage during PCI . Recently, a paradigm change has taken place concerning the access site. While the femoral artery has been used as the standard access site for the past decades, the radial access is evolving into the “gold standard” if technically feasible. Radial access is associated with fewer rates of bleeding and major adverse cardiac events (MACE) combined with increased patient comfort . Whether the amount of radiation exposure relates to the access site has been discussed controversially. It is still not fully understood, whether the extend of procedural time or radiation exposure might solely be dependent on the operators experience, but also on patient characteristics and anatomic anomalies of the radial artery leading to prolonged time necessary for catheter advancement .
The Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) study is a prospective, non-randomized observational study including patients undergoing PCI either using a radial or femoral arterial access with specific vasculare closure/compression devices . Therefore, this sub-analysis of the FERARI study aims to evaluate comparatively procedural time, radiation exposure, fluoroscopy time, radiation dose as dose–area product (DAP) and the amount of contrast agent used between radial and femoral PCI.
2
Methods
2.1
Study population
The FERARI study is single-center, prospective, non-randomized observational study including 400 consecutive patients undergoing PCI from February 2014 to May 2015. The aim of the study is to evaluate the safety of a femoral closure device compared to a radial compression device. The methodology and design of the FERARI study have recently been published and described in detail . Briefly, either using a radial compression device (TR Band™, Terumo, Japan) or a femoral closure device (Angio-Seal™, St. Jude Medical, USA) it was aimed to compare an all-comer collective representative of daily PCI routine practice in terms of access site complications 30 days after PCI. Patients undergoing elective procedures as well as emergency procedures for STEMI and NSTEMI were both included. According to an estimation of the power using the data of the first 100 patients, a sample size of 200 patients in each group was necessary to power the study sufficiently for the primary endpoint. Therefore, 200 consecutive patients were recruited in both groups. Secondary endpoints furthermore included MACE defined as death (cardiovascular and non cardiovascular), myocardial infarction, stroke, acute kidney injury (AKI), stent thrombosis, target lesion revascularization (TLR) or target vessel revascularization (TVR) or any bleeding occurring within 12 months after initial PCI.
In this sub-analysis of the FERARI study, the radial and the femoral accesses were compared in regard to radiation exposure, procedure duration and contrast agent use. Consequently, the following parameters were documented.
2.2
Calculation of radiation exposure and procedure duration
Radiation measurements and procedural data were documented in each patient. Right radial arterial access was preferably used if feasible in the majority of patients. The left radial artery was used only in rare cases when right radial access was not feasible or in patients with prior CABG. The arterial puncture at the corresponding access site marked the beginning of the procedure. The end of each PCI procedure was defined as placing the specific vascular closure or compression device. Time of fluoroscopy was documented in minutes, and the dose–area product (DAP) was documented in Gy/cm 2 according to the recordings of the angiographic system (Philips Integris H, Philips, the Netherlands).
2.3
Measurement of contrast agent use
In our institution, Imeron 350 is used as a contrast agent (Bracco Imaging, Germany). The amount of used contrast agent per procedure was recorded in ml.
2.4
Percutaneous coronary intervention
PCI was performed using either the radial or the femoral approach per the operator’s discretion. The interventional cardiologists involved in the study had an experience of at least 150 radial procedures per year each. Coronary angiography was performed according to standard practice with the use of devices and the recording of views per the operator’s discretion. Treatment of relevant lesions was also performed at the operator’s discretion using standard balloons and stents. Radiation shielding using lead shields employed under the catheterization table as well as ceiling-mounted lead shields was used in every procedure. Procedural success was defined as satisfactory acquisition of angiographic views and treatment of relevant lesions per stent implantation or balloon dilatation.
2.5
Statistical analysis
Categorical variables are presented as frequencies with group-related percentages. These were compared by chi-square-test or Fisher’s exact test. Continuous variables are presented as mean and standard deviation (SD) or standard error of mean (SEM) or median with interquartile ranges (IQR). These were compared according to the treatment groups (either femoral or radial) by the Student’s t-test or Mann–Whitney-U-test. Statistical analyses were performed by SPSS (version 22.0; SPSS, Chicago, IL, USA) or GraphPad Prism (GraphPad Software Inc., La Jolla, USA).
2
Methods
2.1
Study population
The FERARI study is single-center, prospective, non-randomized observational study including 400 consecutive patients undergoing PCI from February 2014 to May 2015. The aim of the study is to evaluate the safety of a femoral closure device compared to a radial compression device. The methodology and design of the FERARI study have recently been published and described in detail . Briefly, either using a radial compression device (TR Band™, Terumo, Japan) or a femoral closure device (Angio-Seal™, St. Jude Medical, USA) it was aimed to compare an all-comer collective representative of daily PCI routine practice in terms of access site complications 30 days after PCI. Patients undergoing elective procedures as well as emergency procedures for STEMI and NSTEMI were both included. According to an estimation of the power using the data of the first 100 patients, a sample size of 200 patients in each group was necessary to power the study sufficiently for the primary endpoint. Therefore, 200 consecutive patients were recruited in both groups. Secondary endpoints furthermore included MACE defined as death (cardiovascular and non cardiovascular), myocardial infarction, stroke, acute kidney injury (AKI), stent thrombosis, target lesion revascularization (TLR) or target vessel revascularization (TVR) or any bleeding occurring within 12 months after initial PCI.
In this sub-analysis of the FERARI study, the radial and the femoral accesses were compared in regard to radiation exposure, procedure duration and contrast agent use. Consequently, the following parameters were documented.
2.2
Calculation of radiation exposure and procedure duration
Radiation measurements and procedural data were documented in each patient. Right radial arterial access was preferably used if feasible in the majority of patients. The left radial artery was used only in rare cases when right radial access was not feasible or in patients with prior CABG. The arterial puncture at the corresponding access site marked the beginning of the procedure. The end of each PCI procedure was defined as placing the specific vascular closure or compression device. Time of fluoroscopy was documented in minutes, and the dose–area product (DAP) was documented in Gy/cm 2 according to the recordings of the angiographic system (Philips Integris H, Philips, the Netherlands).
2.3
Measurement of contrast agent use
In our institution, Imeron 350 is used as a contrast agent (Bracco Imaging, Germany). The amount of used contrast agent per procedure was recorded in ml.
2.4
Percutaneous coronary intervention
PCI was performed using either the radial or the femoral approach per the operator’s discretion. The interventional cardiologists involved in the study had an experience of at least 150 radial procedures per year each. Coronary angiography was performed according to standard practice with the use of devices and the recording of views per the operator’s discretion. Treatment of relevant lesions was also performed at the operator’s discretion using standard balloons and stents. Radiation shielding using lead shields employed under the catheterization table as well as ceiling-mounted lead shields was used in every procedure. Procedural success was defined as satisfactory acquisition of angiographic views and treatment of relevant lesions per stent implantation or balloon dilatation.
2.5
Statistical analysis
Categorical variables are presented as frequencies with group-related percentages. These were compared by chi-square-test or Fisher’s exact test. Continuous variables are presented as mean and standard deviation (SD) or standard error of mean (SEM) or median with interquartile ranges (IQR). These were compared according to the treatment groups (either femoral or radial) by the Student’s t-test or Mann–Whitney-U-test. Statistical analyses were performed by SPSS (version 22.0; SPSS, Chicago, IL, USA) or GraphPad Prism (GraphPad Software Inc., La Jolla, USA).
3
Results
3.1
Baseline characteristics
In total 400 patients were included in the FERARI study with PCI performed in 200 patients via the femoral access and in 200 patients via the radial access. Baseline characteristics are listed in Table 1 . Mean age and BMI did not differ between the two groups (mean age 70.0 years (IQR 66.0–77.0) and mean BMI 28.0 (IQR 24.0–31.0), respectively), however the radial access group consisted of significantly more male patients (78.0% vs. 67.5%; p = 0.018).
| All ( n = 400) | Femoral access ( n = 200) | Radial access ( n = 200) | p Value ⁎ | |
|---|---|---|---|---|
| Male, n (%) | 291 (72.8) | 135 (67.5) | 156 (78.0) | 0.018 |
| Age, y (IQR) | 70 (66–77) | 71 (61–78) | 69 (59–76) | 0.093 |
| Height, cm (IQR) | 172 (166–178) | 171 (165–178) | 172 (167–178) | 0.061 |
| Weight, kg (IQR) | 81 (72–93) | 81 (71–92) | 81 (72–93) | 0.531 |
| BMI (IQR) | 28 (24–31) | 28 (24–31) | 27 (24–30) | 0.759 |
| Indication, n (%) | ||||
| Elective | 49 (12.3) | 28 (14.0) | 21 (10.5) | 0.286 |
| Stable AP | 88 (22.0) | 50 (25.0) | 38 (19.0) | 0.148 |
| Unstable AP | 71 (17.8) | 35 (17.5) | 36 (18.0) | 0.896 |
| NSTEMI | 94 (23.5) | 47 (23.5) | 47 (23.5) | 1.000 |
| STEMI | 25 (6.3) | 13 (6.5) | 12 (6.0) | 0.796 |
| Positive viability testing | 42 (10.5) | 11 (5.5) | 31 (15.5) | 0.001 |
| Invasive control | 49 (12.3) | 28 (14.0) | 21 (10.5) | 0.286 |
| Arrhythmia | 14 (3.5) | 5 (2.5) | 9 (4.5) | 0.416 |
| Syncope | 8 (2.0) | 5 (2.5) | 3 (1.5) | 0.724 |
| Heart failure | 9 (2.3) | 6 (3.0) | 3 (1.5) | 0.503 |
| Cardiovascular risk factors, n (%) | ||||
| Arterial hypertension | 292 (73.0) | 155 (77.5) | 137 (68.5) | 0.043 |
| Diabetes mellitus | 130 (32.5) | 68 (34.0) | 62 (31.0) | 0.528 |
| Smoking | ||||
| Active | 81 (20.3) | 36 (18.0) | 45 (22.5) | 0.263 |
| History of | 75 (18.8) | 38 (19.0) | 37 (18.5) | 0.898 |
| Dyslipidemia | 155 (38.8) | 85 (42.5) | 70 (35.0) | 0.144 |
| Cardiac family history | 87 (21.8) | 33 (16.5) | 54 (27.0) | 0.011 |
| Medical history, n (%) | ||||
| Coronary artery disease | 195 (48.8) | 101 (50.5) | 94 (47.0) | 0.546 |
| Previous CABG | 29 (7.2) | 22 (11.0) | 7 (3.5) | 0.006 |
| Peripheral arterial disease | 34 (8.5) | 15 (7.5) | 19 (9.5) | 0.473 |
| Stroke/TIA | 32 (8.0) | 14 (7.0) | 18 (9.0) | 0.461 |
| Heart valve surgery | 5 (1.3) | 4 (2.0) | 1 (0.5) | 0.372 |
| Atrial fibrillation | ||||
| Paroxysmal | 21 (5.3) | 10 (5.0) | 11 (5.5) | 0.823 |
| Persistent | 5 (1.3) | 2 (1.0) | 3 (1.5) | 1.000 |
| Permanent | 10 (2.5) | 5 (2.5) | 5 (2.5) | 1.000 |
| Unclassified | 15 (3.8) | 9 (4.5) | 6 (3.0) | 0.600 |
| Pacemaker | 12 (3.0) | 8 (4.0) | 4 (2.0) | 0.380 |
| Implantable defibrillator | 16 (4.0) | 7 (3.5) | 9 (4.5) | 0.800 |
| Impaired liver function | 4 (1.0) | 1 (0.5) | 3 (1.5) | 0.623 |
| Echocardiography and lab tests, median (IQR) | ||||
| LVEF, % | 43 (35–51) | 41 (30–50) | 47 (40–55) | 0.033 |
| Serum creatinine, mg/dl | 1.21 (0.86–1.22) | 1.28 (0.84–1.26) | 1.13 (0.88–1.19) | 0.573 |
| GFR, ml/min | 65 (56–75) | 63 (54–75) | 68 (67–75) | 0.041 |
| Hb, g/dl | 13.6 (12.6–14.9) | 13.3 (12.1–14.7) | 14.0 (12.9–15.3) | 0.001 |
| Thrombocytes, 10 9 /l | 221 (178–251) | 228 (178–261) | 214 (178–239) | 0.231 |
| INR | 1.09 (0.96–1.08) | 1.06 (0.96–1.06) | 1.12 (0.96–1.09) | 0.329 |
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