Abstract
Introduction:
The optimal choice of either percutaneous or cutdown access for endovascular abdominal aortic repair (EVAR) remains uncertain due to insufficient evidence, particularly regarding patient-centered outcomes (PCOs). This study aimed at comparing both clinician-reported outcomes (ClinROs) and PCOs of percutaneous versus cutdown access in patients after EVAR.
Methods:
The study was a single-blind, single-center, non-inferiority, randomized controlled trial. After eligibility screening, patients diagnosed with abdominal aortic diseases were randomly assigned to either the intervention group receiving percutaneous EVAR or the control group receiving cutdown EVAR. Primary ClinRO was access-related complications, and primary PCO was time return to normal life/work.
Results:
Overall, 120 patients (containing 240 accesses) were allocated to either intervention group (n = 62) or control group (n = 58). Percutaneous EVAR (10/124, 8.1%) was non-inferior and not superior to cutdown EVAR (17/116, 14.7%) regarding access-related complications (P = 0.110; OR: 0.521, 95% CI: 0.225–1.157). As for PCOs, the recovery time back to normal life or work was superior in percutaneous EVAR compared to cutdown EVAR (16 vs. 28 days, P = 0.025; median difference: 7 days, 95% CI: 0–13 days). Moreover, percutaneous access did better in other PCOs, including a reduction in the duration of access-related pain (4 vs. 8 days, P = 0.001), decreased use of analgesics for access-related pain (0/61, 0% vs. 6/55, 10.9%; P = 0.026), and improved quality of life scores at 2 weeks following EVAR (0.876 vs. 0.782; P = 0.022). Prespecified subgroup analyses demonstrated percutaneous access significantly reduced the incidence of access-related complications compared to cutdown access in patients with thick subcutaneous tissue (1/42, 2.4% vs. 7/32, 21.9%; P = 0.026).
Conclusion:
In patients without massive common femoral artery calcification, percutaneous access may accelerate postoperative recovery and enhance patient experience and quality of life following EVAR, but did not provide obvious advantages regarding access-related complications.
Keywords: cutdown, endovascular abdominal aortic repair, percutaneous, randomized controlled trial
Introduction
The treatment of abdominal aorto-iliac artery aneurysms has significantly advanced over past three decades with the development of minimally invasive technologies, heralding the era of endovascular intervention. According to the 2024 clinical practice guidelines form the European Society for Vascular Surgery, endovascular abdominal aortic repair (EVAR) is recommended as the preferred treatment modality for most infrarenal abdominal aortic aneurysms (AAAs) with suitable anatomy[1]. This recommendation is classified as IIa and supported by level B evidence.
During EVAR procedure, stent grafts are typically delivered through common femoral artery (CFA), which can be achieved by two mainstream access, i.e. percutaneous or cutdown. Despite being considered a minor surgical procedure, cutdown access for EVAR is associated with a significant incidence of access site complications, with rates ranging from 14% to 22%[2]. In contrast, percutaneous access for EVAR is less invasive and more convenient, with lower risk of access site infections, seromas and lymphorrhagia[3-5]. However, some researches indicated that percutaneous access may lead to an increased risk of pseudoaneurysms, arterial occlusion and dissection[6-8]. The above controversy was mainly based on cohort studies conducted at disparate time periods. Only four randomized controlled trials (RCTs) have compared the two methods, finding no significant differences in most access-related complications[9-12]. Even so, all primary outcomes of these trials were judged to have a high likelihood of bias and imprecision due to limitations in the study design and implementation[13].
Patient experience and quality of life is becoming critical in selecting surgical approach, particularly for minimally invasive procedures. Patient-centered outcomes (PCOs) are expected to offer valuable insights into choosing access methods for EVAR. Unfortunately, no RCTs have compared PCOs between percutaneous and cutdown EVAR as mentioned in the trial sequential meta-analysis[13].
The percutaneous access was previously considered to carry a significant risk of technical failure and postoperative complications in specific populations with calcified femoral artery, scar tissue in the groin or obesity[7,14-16]. These conditions were regarded as relative contraindications. With the increasing prevalence of percutaneous EVAR, however, completely percutaneous puncture and hemostatic techniques have emerged for off-label use.
Overall, the available data did not provide clear evidence to support the advantages of one access method over another. Therefore, we performed a single-center, parallel, non-inferiority, randomized controlled trial to compare both clinician-reported outcomes (ClinROs) and PCOs between percutaneouS versus cutdoWn accEss in patients undergoing Endovascular abdominal aorTic repair (SWEET trial).
Methods
Trial design
The SWEET trial was a single-blind, single-center, parallel, non-inferiority, randomized controlled trial consisting of two independent cohorts: Cohort EVAR and Cohort Thoracic Endovascular Aortic Repair (TEVAR). Each cohort included an intervention group and a control group in a 1:1 ratio. This study reported the results from Cohort EVAR according to the extension of the Consolidated Standards of Reporting Trials (CONSORT) statement in this study[17]. And the checklist could be seen in Supplemental Digital Content (Table S1, http://links.lww.com/JS9/D767).
The trial received approval from the Ethics Committee on Biomedical Research at our hospital and was registered on the Clinical Trial Registry website in November 2021. This study protocol has been previously published in a peer-reviewed journal[18]. The study was conducted in compliance with the Declaration of Helsinki and adhered to Good Clinical Practices[19]. Written informed consent was obtained from all patients, and data analysis was performed anonymously.
Participants
Patients were eligible if they were scheduled for EVAR due to abdominal aorto-iliac artery aneurysm or dissection and provided signed informed consent. Exclusion criteria included: a) emergent cases involving ruptured or impending rupture abdominal aortic diseases, and b) patients with more than 70% circumferentially calcified CFA. Compared to previous similar RCTs, we expanded the participant selection criteria to enhance the generalizability of our findings in real-world settings[9-12].
Interventions
In the percutaneous EVAR group, access was obtained by puncturing the CFA and deploying two ProGlide devices (Abbott Vascular, Santa Clara, Calif) using the Preclose techniques as described in the published study protocol[18]. Following successful stent-graft implantation and sheath removal, hemostasis was achieved by securely tightening pre-tied knots and sutures using a knot pusher. In the cutdown EVAR group, access was obtained by puncturing the CFA under direct vision after a 5-cm longitudinal incision in the inguinal region. Once endovascular repair was completed, the CFA access was repaired using a running prolene suture to perform hemostasis. Subsequently, the subcutaneous tissue and skin were sutured layer by layer. Both groups were administered prophylactic intravenous antibiotics and heparin during EVAR, followed by postoperative antiplatelet therapy.
Outcomes
Both ClinROs and PCOs were reported in our trial. The primary ClinRO focused on access-related complications including access site infection, postoperative bleeding/hematoma, access-related arterial injury, femoral artery occlusion, pseudoaneurysm, lymphorrhagia/seroma, etc., which were assessed during hospitalization, at 2 weeks, and 1 month after surgery. The primary PCO was time (in days) required for return to normal life/work, assessed through a telephone interview at 2 weeks postoperatively and verified during follow-up appointments at 1 month and three months in outpatient clinics. This endpoint was chosen based on a preliminary survey indicating it was of greatest concern to patients.
The secondary ClinROs included technique success, duration of surgery (in minutes), length of hospital stat (in days), 30-day overall complications and 30-day mortality. These endpoints were assessed simultaneously with the primary ClinRO. The secondary PCOs involved patient experience and quality of life. Patients’ medical experience was reflected by duration, level and analgesic use of access-related pain, which were evaluated from hospitalization to follow-up period. Patients’ quality of life scored with the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) were assessed at 2 weeks and 1 month after surgery[20,21]. The EQ-5D-5L evaluates overall health status by five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each dimension being rated on a scale from 1 (indicating the best level) to 5 (representing the worst level)[22]. The value set specific to China was utilized in the calculation of index scores for the EQ-5D-5L data, resulting in a range from −0.391 to 1.000[23]. Access-related pain level was assessed using NRS scores during hospitalization.
Sample size
Due to the lack of prior studies reporting on PCOs, sample size determination was based on the incidence of access-related complications. Previous research indicated an incidence rate of 7.64% for access-related complications in percutaneous EVAR compared to 11.81% in cutdown EVAR[13]. Considering a non-inferiority margin of 0.10 (bilateral α 5%, power 80%), 54 patients were required for each group. To allow for a dropout rate of 10% (i.e. withdrawal and loss to follow-up), the minimum sample size for each group was estimated to be 60 patients.
Randomization
Eligible participants were randomly assigned to the intervention group percutaneous EVAR or the control group cutdown EVAR in a 1:1 ratio. An independent biostatistician generated randomization sequence with a balanced distribution of numbers by using SPSS 26.0 software and informed the surgeon about the assigned access procedure prior to operation. To mitigate performance bias, each surgeon was required to have completed a minimum of 10 ProGlide procedures and possessed experience in at least 20 surgical cutdowns for CFA exposure. Due to the significant difference in access procedures, neither trial participants nor surgeons could be blinded to the intervention assignment, but data analysts were kept unaware of the study’s details.
Statistical methods
The main analysis population of this study consisted of modified intention-to-treat (ITT) population, while per-protocol (PP) population was utilized for sensitive analysis. In the ITT and PP analysis sets, the non-inferiority of percutaneous EVAR compared with cutdown EVAR was assessed with a margin of 10% for primary ClinRO and 3 days for primary PCO. Once non-inferiority was established for primary ClinRO and PCO respectively, ITT was further tested for superiority with a margin of 0. Prespecified subgroup analyses were conducted in the following populations: heavily calcified femoral artery (more than 50% circumferential calcification) versus none or lightly calcified femoral artery, sever tortuous iliac artery (visually doubled or more on a single slice of axial CTA) versus non-tortuous iliac artery, overweight (BMI >24) versus normal weight, smoking versus none, elderly (older than 70 years) versus younger population.
The baseline data were presented as the mean ± standard deviation for continuous variables with a normal or approximately normal distribution, as the median (interquartile range) for continuous variables exhibiting a skewed distribution, and as the number (percentage) for categorical variables. The categorical primary and secondary outcomes between percutaneous and cutdown groups were compared using logistic regression, with adjustments made for age, gender, body mass index (BMI) and CFA calcification in multivariable analysis. To mitigate the impact of sparse data bias, we employed penalized likelihood for logistic regression to estimate odds ratio (OR) and calculate confidence interval (CI) using the R package logistf[24]. Mann-Whitney U test was applied to compare the skew continuous or ordinal outcomes between the two groups, while Hodges-Lehmann method was utilized to estimate median differences and CIs. All regressions were implemented using generalized linear models (GLM). A P value < 0.05 was considered statistically significant. All data analysis were performed using SPSS (version 26, IBM Corp, Armonk, NY) and R (version 4.3.3).
Results
The process of subject screening, randomization, intervention assignment, and post-treatment follow-up is illustrated in Figure 1. From November 2021 to November 2023, a total of 133 patients were recruited for the study. Six individuals refused to participate, while four patients with ruptured or impending rupture abdominal aortic diseases and three patients with more than 70% circumferentially calcified CFA were excluded. Ultimately, 120 patients ((containing 240 accesses) were allocated to either percutaneous EVAR group (n = 62) or cutdown EVAR group (n = 58). In the percutaneous EVAR group, unilateral access of two patients (3.2%) was converted to cutdown procedures due to unsuccessful hemostasis despite using more than three ProGlide devices. After the conversion, there were 60 patients in each group of percutaneous EVAR and cutdown EVAR, respectively. All enrolled patients underwent a follow-up period of three months or until death occurred, and no patients were lost to follow-up during this period.
Figure 1.
Participant flow diagram of the SWEET trial. EVAR, endovascular abdominal aortic repair.
Baseline data
The indications for EVAR in the entire study included 51.7% for AAA, 8.3% for isolated CIAA, 35.8% for aorta-iliac artery aneurysm, and 4.2% for abdominal aortic dissection or pseudoaneurysm (Supplemental Digital Content, Table S2, http://links.lww.com/JS9/D767). The majority of the patients were male (84.2%), with a mean age of 72.15 ± 8.48 years and a mean BMI of 23.09 ± 2.83 kg/m2. The percutaneous and cutdown group exhibited comparable baseline demographics, comorbidities, and particularly similar anatomical characteristics of access arteries. Specifically, the subcutaneous tissue thickness, diameter, and calcification proportion of bilateral CFAs showed no significant differences. Similarly, there were no significant variations observed in the minimum or maximum diameter and tortuosity of bilateral iliac arteries (Table 1).
Table 1.
Baseline characteristics of the study population
| Percutaneous EVAR (n = 62) | Cutdown EVAR (n = 58) | P value | |
|---|---|---|---|
| Demographics | |||
| Age (years), mean ± SD | 72.21 ± 6.83 | 72.09 ± 10.02 | 0.938 |
| Male, n (%) | 52 (83.9) | 49 (84.5) | 0.927 |
| BMI (kg/m2), mean ± SD | 23.51 ± 2.47 | 22.64 ± 3.14 | 0.090 |
| Comorbidities/medical history | |||
| Symptom, n (%) | 17 (27.4) | 20 (34.5) | 0.402 |
| Smoker, n (%) | 33 (53.2) | 34 (58.6) | 0.552 |
| Hypertension, n (%) | 42 (67.7) | 41 (70.7) | 0.727 |
| Diabetes mellitus, n (%) | 9 (14.5) | 12 (20.7) | 0.374 |
| COPD, n (%) | 24 (38.7) | 17 (29.3) | 0.278 |
| Coronary heart disease, n (%) | 22 (35.5) | 21 (36.2) | 0.934 |
| Coronary intervention, n (%) | 11 (17.7) | 16 (27.6) | 0.197 |
| Classification of NYHY | 0.905 | ||
| 1, n (%) | 40 (64.5) | 37 (63.8) | |
| 2, n (%) | 17 (27.4) | 15 (25.9) | |
| 3, n (%) | 5 (8.1) | 6 (10.3) | |
| Arrhythmia, n (%) | 10 (16.1) | 4 (6.9) | 0.115 |
| Stroke/TIA, n (%) | 5 (8.1) | 7 (12.1) | 0.465 |
| Renal insufficiency, n (%) | 9 (14.5) | 9 (15.5) | 0.878 |
| Tumor, n (%) | 5 (8.1) | 9 (15.5) | 0.204 |
| Anatomy of access arteries | |||
| Subcutaneous tissue thickness of left CFA (mm), mean ± SD | 22.03 ± 8.62 | 19.37 ± 9.36 | 0.108 |
| Subcutaneous tissue thickness of right CFA (mm), mean ± SD | 21.74 ± 9.37 | 19.40 ± 9.78 | 0.183 |
| Diameter of left CFA (mm), mean ± SD | 10.14 ± 1.67 | 9.88 ± 2.10 | 0.448 |
| Diameter of right CFA (mm), mean ± SD | 10.30 ± 1.72 | 10.23 ± 2.51 | 0.462 |
| Calcification proportion of left CFA, median (range) | 0.10 (0.00–0.20) | 0.10 (0.00–0.25) | 0.838 |
| Calcification proportion of right CFA, median (range) | 0.00 (0.00–0.20) | 0.05 (0.00–0.30) | 0.128 |
| Minimum diameter of left iliac artery (mm), mean ± SD | 8.40 ± 0.98 | 8.12 ± 1.58 | 0.256 |
| Minimum diameter of right iliac artery (mm), mean ± SD | 8.32 ± 1.06 | 8.00 ± 1.40 | 0.113 |
| Maximum diameter of left iliac artery (mm), median (range) | 16.00 (13.00–25.10) | 14.75 (12.00–20.00) | 0.323 |
| Maximum diameter of right iliac artery (mm), median (range) | 18.30 (13.50–26.30) | 15.70 (14.10–22.60) | 0.351 |
| Tortuosity index of left iliac artery, median (range) | 1.21 (1.13–1.32) | 1.22 (1.13–1.36) | 0.733 |
| Tortuosity index of right iliac artery, median (range) | 1.21 (1.15–1.33) | 1.26 (1.13–1.35) | 0.605 |
| Severe tortuosity of left iliac artery, n (%) | 15 (24.2) | 15 (25.9) | 0.833 |
| Severe tortuosity of left iliac artery, n (%) | 17 (27.4) | 19 (32.8) | 0.524 |
SD, standard deviation; BMI, body mass index; COPD, chronic obstructive pulmonary disease; NYHY, New York Heart Association; TIA, transient ischemic attacks; CFA, common femoral artery.
Primary clinRO
The access-related complications were reported by the number of CFA access instead of the number of patients. In the ITT analysis set, a total of ten accesses (10/124, 8.1%) reported overall access-related complications in the percutaneous group compared to seventeen (17/116, 14.7%) in the cutdown group, indicating no statistically significant difference between the two groups (OR: 0.521, 95% CI: 0.225–1.157; P = 0.110). This finding remained unchanged after conducting multivariate adjustment for characteristics of access artery (OR: 0.620, 95%CI: 0.259–1.440; P = 0.267) (Table 2). The results from non-inferiority and superiority test demonstrated that percutaneous EVAR was non-inferior to cutdown EVAR and did not show superiority over it (incidence differences: −0.066, 95% CI: −0.147–0.015) (Fig. 2a).
Table 2.
Primary ClinRO based on the number of CFA access
| Primary ClinRO (ITT analysis) | Percutaneous Access (n = 124) | Cutdown Access (n = 116) | Univariate analysis | Multivariate analysis | |||
|---|---|---|---|---|---|---|---|
| OR (95% CI) | P | OR (95% CI) | P | ||||
| Access-related complications | 10 (8.1) | 17 (14.7) | 0.521 (0.225–1.157) | 0.110 | 0.620 (0.259–1.440) | 0.267 | |
| Access site infection | 1 (0.8) | 2 (1.7) | 0.556 (0.050–4.244) | 0.566 | 0.386 (0.035–2.915) | 0.347 | |
| Postoperative bleeding/hematoma | 6 (4.8) | 11 (9.5) | 0.503 (0.175–1.332) | 0.168 | 0.634 (0.210–1.823) | 0.397 | |
| Access-related arterial injury | 2 (1.6) | 1 (0.9) | 1.571 (0.206–17.359) | 0.660 | 2.054 (0.255–22.725) | 0.492 | |
| Femoral artery occlusion | 0 | 1 (0.9) | 0.309 (0.002–5.856) | 0.440 | 0.480 (0.003–33.269) | 0.713 | |
| Pseudoaneurysm | 4 (3.2) | 0 | 8.701 (0.913–1158) | 0.062 | 14.156 (1.293–3657) | 0.026 | |
| Lymphorrhagia/seroma | 0 | 4 (3.4) | 0.100 (0.001–0.957) | 0.045 | 0.085 (0.001–0.812) | 0.029 | |
| Access-related nerve injury | 0 | 1 (0.9) | 0.309 (0.002–5.856) | 0.440 | 0.273 (0.002–4.723) | 0.382 | |
| Primary ClinRO (PP analysis) | Percutaneous Access (n = 127) | Cutdown Access (n = 113) | Univariate analysis | Multivariate analysis | |||
| OR (95% CI) | P | OR (95% CI) | P | ||||
| Access-related complications | 10 (7.9) | 17 (15.0) | 0.528 (0.226–1.184) | 0.121 | 0.617 (0.257–1.439) | 0.263 | |
| Access site infection | 0 | 3 (2.7) | 0.124 (0.001–1.297) | 0.087 | 0.090 (0.001–0.924) | 0.042 | |
| Postoperative bleeding/hematoma | 7 (5.5) | 10 (8.8) | 0.685 (0.245–1.846) | 0.452 | 0.851 (0.291–2.472) | 0.764 | |
| Access-related arterial injury | 0 | 3 (2.7) | 0.124 (0.001–1.297) | 0.087 | 0.145 (0.001–1.676) | 0.134 | |
| Femoral artery occlusion | 1 (0.8) | 0 | 2.692 (0.142–394) | 0.518 | 3.146 (0.123–540) | 0.492 | |
| Pseudoaneurysm | 4 (3.1) | 0 | 8.271 (0.868–1101) | 0.070 | 11.694 (1.188–2292) | 0.033 | |
| Lymphorrhagia/seroma | 0 | 4 (3.5) | 0.095 (0.001–0.909) | 0.040 | 0.081 (0.001–0.782) | 0.027 | |
| Access-related nerve injury | 0 | 1 (0.9) | 0.294 (0.002–5.570) | 0.420 | 0.260 (0.002–4.521) | 0.363 | |
ClinRO, clinician-reported outcome; ITT, intention-to-treat; OR, odds ratio; CI, confidence interval; PP, per-protocol.
Figure 2.
(A) The differences of incidence of access-related complications between percutaneous and cutdown group. The upper limits of 95%CI for both ITT and PP lied between the non-inferior margin of 0.1 (vertical dashed line) and superiority margin of 0 (vertical solid line). (B) The differences of time back to normal life/work between percutaneous and cutdown group. The dashed line was non-inferiority margin of 3 and vertical solid line was superiority margin of 0.
Specifically speaking, postoperative bleeding/hematoma was the most frequently observed complication, occurring in six accesses (4.8%) in the percutaneous group and eleven accesses (9.5%) in the cutdown group (OR: 0.503, 95% CI: 0.175–1.332; P = 0.168). One access site infection (0.8%) was recorded in the percutaneous group compared with two (1.7%) in the cutdown group (OR:0.556, 95%CI: 0.050–4.244; P = 0.566). Regarding access-related arterial injuries, two events (1.6%) and one event (0.9%) event were respectively recorded in the percutaneous and cutdown group (OR: 1.571, 95%CI: 0.206–17.359; P = 0.660). All three cases underwent open repair of the femoral artery following EVAR. One femoral artery occlusion (0.9%) occurred after cutdown access and received endarterectomy. Four pseudoaneurysms (3.2%) were only reported following percutaneous access procedures, while all four lymphorrhagia/seromas (3.4%) and one access-related nerve injury (0.9%) were solely observed after cutdown access procedures, all of which were managed conservatively due to mild symptoms. In terms of individual complications, percutaneous access significantly reduced the risk of lymphorrhagia/seromas (OR: 0.100, 95%CI: 0.001–0.957; P = 0.04), while it did not show any advantages in other complications and even significantly increased the risk of pseudoaneurysms after adjusting for characteristics of access artery (OR: 14.156, 95%CI: 1.293–3657; P = 0.026) (Table 2).
PP analysis showed similar results regarding the incidence of overall access-related complications between percutaneous group (10/127, 7.9%) and cutdown group (17/133, 15.0%) (OR: 0.528, 95%CI: 0.226–1.184; P = 0.121) (Table 2). The outcomes of non-inferiority and superiority test were also consistent with the ITT analysis (Fig. 2b). Unlike the ITT analysis set, cutdown access procedures resulted all three cases of access site infection (2.7%) and significantly increased the risk compared to percutaneous access procedures after multivariate adjustment in the PP analysis (OR:0.090, 95%CI: 0.001–0.924; P = 0.042). The univariate and multivariate analysis results of other individual complications kept similar trends with the ITT analysis (Table 2).
Primary PCO
The time back to normal life or work were reported based on the number of patients who completed three months of postoperative follow-up. In the ITT analysis set, patients who underwent percutaneous EVAR had an apparently shorter recovery time back to normal life/work compared to those who underwent cutdown EVAR (16 vs. 28 days, P = 0.025; median difference: 7 days, 95% CI: 0–13 days). The result of PP analysis was consistent with those of the ITT analysis (Table 3). The percutaneous EVAR demonstrated not only non-inferiority but also superiority over cutdown EVAR regarding the time back to normal life or work, as shown in both the ITT and PP analysis sets (Fig. 2b).
Table 3.
Primary and secondary PCOs based on survival patients
| PCOs (ITT analysis) | Percutaneous EVAR (n = 61) | Cutdown EVAR (n = 55) | P | Median Differences or ORs (95% CI) |
|---|---|---|---|---|
| Primary PCO | ||||
| Time back to normal life/work, days | 16 (14–32) | 28 (19–37.5) | 0.025 | 7 (0–13) |
| Secondary PCOs | ||||
| Duration of access-related pain, days | 4 (3–7) | 8 (5–15.5) | 0.001 | 4 (1–5) |
| Analgesics used to relieve access-related pain postoperatively, n (%) | 0 | 6 (10.9) | 0.026 | NA |
| 1 | 0 | 4 (7.3) | ||
| 2 | 0 | 1 (1.8) | ||
| 3 | 0 | 1 (1.8) | ||
| Access-related pain level, n (%) | 0.220 | 0.559 (0.207–1.507) | ||
| No pain (NRS score 0) | 53 (86.9) | 44 (80.0) | ||
| Mild pain (NRS score 1–3) | 7 (11.5) | 5 (9.1) | ||
| Moderate pain (NRS score 4–6) | 1 (1.6) | 6 (10.9) | ||
| EQ–5D-5L scores at 2 weeks postoperatively | 0.876 (0.784–0.876) | 0.782 (0.589–0.876) | 0.022 | −0.066 (–0.130–0) |
| EQ-5D-5L scores at a month postoperatively | 0.942 (0.876–1.000) | 0.934 (0.826–1.000) | 0.076 | 0 (–0.058–0) |
| PCOs (PP analysis) | Percutaneous EVAR (n = 59) | Cutdown EVAR (n = 57) | P | Median Differences or ORs (95% CI) |
| Primary PCO | ||||
| Time back to normal life/work, days | 16 (13.5–31) | 30 (20–38) | 0.011 | 8 (2–13) |
| Secondary PCOs | ||||
| Duration of access-related pain, days | 4 (3–7) | 8 (5–16) | <0.001 | 4 (1–6) |
| Analgesics used to relieve access-related pain postoperatively, n (%) | 0 | 6 (10.5) | 0.032 | NA |
| 1 | 0 | 4 (7.0) | ||
| 2 | 0 | 1 (1.8) | ||
| 3 | 0 | 1 (1.8) | ||
| Access-related pain level, n (%) | 0.129 | 0.559 (0.207–1.507) | ||
| No pain (NRS score 0) | 52 (88.1) | 45 (78.9) | ||
| Mild pain (NRS score 1–3) | 7 (11.9) | 5 (8.8) | ||
| Moderate pain (NRS score 4–6) | 0 | 7 (12.3) | ||
| EQ-5D-5L scores at 2 weeks postoperatively | 0.876 (0.783–0.876) | 0.782 (0.604–0.876) | 0.027 | −0.058 (−0.124–0) |
| EQ-5D-5L scores at a month postoperatively | 0.942 (0.876–1.000) | 0.942 (0.826–1.000) | 0.115 | 0 (−0.058–0) |
PCOs, patient-centered outcomes; ITT, intention-to-treat; EVAR, endovascular abdominal aortic repair; OR, odds ratio; CI, confidence interval; NRS, numerical rating scale; EQ-5D-5L, five-level EuroQol five-dimensional; PP, per-protocol.
Secondary clinROs
Secondary ClinROs were analyzed by the number of patients. Two cases (3.2%) of percutaneous access technique failure were recorded and then converted to cutdown procedures for achieving hemostasis. One patient (1.7%) experienced continuous bleeding at the unilateral access site, and received blood transfusion and a second operation within one day following the cutdown EVAR. Although the success rate of access technique was similar between the two groups (96.8% vs. 98.3%, P = 1.000; OR: 0.526, 95%CI: 0.046–5.964), thirteen patients (21%) required extra vascular closure devices during percutaneous EVAR due to characteristics of access arteries or operating factors (Table 4).
Table 4.
Secondary ClinROs based on the number of patients
| Secondary ClinROs (ITT analysis) | Percutaneous EVAR (n = 62) | Cutdown EVAR (n = 58) | P | Median differences or ORs (95% CI) |
| Access technique success, n (%) | 60 (96.8) | 57 (98.3) | 1.000 | NA |
| Use of extra ProGlide device | 13 (21.0) | NA | ||
| 1 | 10 (16.1) | NA | ||
| 2 | 2 (3.2) | NA | ||
| 3 | 1 (1.6) | NA | ||
| Duration of surgery, minutes | 90 (64–120) | 157 (133–208) | <0.001 | 70 (53–88) |
| Length of hospital stay, days | 11 (8–13) | 12 (10–16) | 0.016 | 2 (0–3) |
| Length of postoperative hospital stay, days | 4 (3–6) | 5 (3–7) | 0.059 | 1 (0–1) |
| 30-day overall complications, n (%) | 8 (12.9) | 7 (12.1) | 0.890 | 1.079 (0.365–3.192) |
| 30-day mortality, n (%) | 1 (1.6) | 3 (5.2) | 0.564 | 0.301 (0.030–2.975) |
| Secondary ClinROs (PP analysis) | Percutaneous EVAR (n = 60) | Cutdown EVAR (n = 60) | P | Median differences or ORs (95% CI) |
| Access technique success, n (%) | 60 (100) | 59 (98.3) | 1.000 | NA |
| Use of extra ProGlide device | 11 (18.3) | NA | ||
| 1 | 9 (15.0) | NA | ||
| 2 | 2 (3.3) | NA | ||
| 3 | 0 | NA | ||
| Duration of surgery, minutes | 90 (64–120) | 157 (133–208) | <0.001 | 70.5 (54–88) |
| Length of hospital stay, days | 11 (8–13) | 12 (10–16) | 0.040 | 2 (0–3) |
| Length of postoperative hospital stay, days | 4 (3–6) | 5 (3–7) | 0.165 | 0 (0–1) |
| 30-day overall complications, n (%) | 7 (11.7) | 8 (13.3) | 0.783 | 0.858 (0.290–2.538) |
| 30-day mortality, n (%) | 1 (1.7) | 3 (5.0) | 0.611 | 0.322 (0.033–3.187) |
ClinROs, clinician-reported outcomes; ITT, intention-to-treat; EVAR, endovascular abdominal aortic repair; OR, odds ratio; CI, confidence interval; PP, per-protocol.
In the ITT analysis set, the duration of surgery was significantly shorter in the percutaneous group compared to the cutdown group (90 vs. 157 minutes, P < 0.001; median difference: 70 minutes, 95% CI: 53–88 minutes). The length of hospital stay was also apparently shorter for patients who underwent percutaneous EVAR (11 vs 12 days, P = 0.016; median difference: 2 days, 95% CI: 0–3 days). No significant differences were observed in length of postoperative hospital stay, 30-day overall complications and 30-day mortality between the two groups. The PP analysis set showed consistent trends (Table 4). Among the three deaths (5.2%) reported in the cutdown group, two patients died from severe pneumonia, while one patient experienced anaphylactic shock due to contrast material. In the percutaneous group, one patient (1.7%) died within 2 weeks after surgery due to septic shock.
Secondary PCOs
The assessment of pain-related outcomes after minimally invasive surgery could well reflect the patient’s treatment experience. Regarding shortening the duration of access-related pain, percutaneous EVAR did better than cutdown EVAR obviously (4 vs. 8 days, P = 0.001; median difference: 4 days, 95% CI: 1–5 days). Additionally, the use of analgesics for relieving access-related pain was significantly less frequent in the percutaneous group (0/61, 0%) than in the cutdown group (6/55, 10.9%) (P = 0.026). However, the percutaneous procedures did not apparently reduce the level of access-related pain compared to cutdown procedures during postoperative hospitalization period (OR: 0.559, 95%CI: 0.207–1.507; P = 0.220) (Table 3). Barthel index evaluated during hospitalization reflecting did not show any statistically significant differences, either (Supplemental Digital Content, Table S3, http://links.lww.com/JS9/D767)[25,26].
The EQ-5D-5L questionnaire was utilized to assess the patients’ quality of life after discharge. The median value index was higher in percutaneous group than that in cutdown group two weeks after surgery (0.876 vs. 0.782, P = 0.022); however, no statistically significant difference was observed one month after surgery (0.942 vs. 0.934, P = 0.076) (Table 3). Patients in the percutaneous group exhibited superior outcomes in self-care, usual activities and anxiety/depression dimensions of EQ-5D-5L compared to those in the cutdown group at 2 weeks postoperatively. These differences remained statistically significant until 1 month after surgery. However, there was no significant disparity between the two groups regarding mobility or pain/discomfort all along (Supplemental Digital Content, Table S4, http://links.lww.com/JS9/D767).
Subgroup analysis
The results of subgroup analysis are illustrated in Figure 3. Percutaneous access was associated with a significant reduction in the incidence of access-related complications compared to cutdown access in patients with subcutaneous tissue thickness to CFA ≥ 25 mm (2.4% vs. 21.9%, P = 0.026; OR: 0.088, 95% CI: 0.010–0.750). On the contrary, the incidence of access-related complications was higher in percutaneous group compared to the cutdown group in subgroups with severe tortuous iliac artery, although this difference did not reach statistically significant (9.4% vs 8.8%, P = 0.938; OR: 1.069, 95% CI: 0.200–5.727). The results of the other subgroups were consistent with those obtained from the overall analysis.
Figure 3.
Forest plots showing subgroup analysis of access-related complications and time back to normal life/work. CFA, common femoral artery.
The recovery time back to normal life/work was shorter following percutaneous EVAR across all subgroups, consistent with the overall population results. This trend was particularly pronounced among individuals with a normal BMI (16 vs. 30 days, P = 0.015; Median difference: 10 days, 95% CI: 2–16 days).
Discussion
This study, conducted as part of SWEET trial, compared both ClinROs and PCOs between percutaneous versus cutdown access in patients undergoing EVAR. Our findings suggested that despite no obvious advantages in access-related complications between the two groups, percutaneous access did better in PCOs. These benefits included a significant reduction in recovery time back to normal life/work, duration of access-related pain and the need for analgesic to manage access-related pain. Additionally, percutaneous access improved quality of life within 2 weeks postoperatively. Regarding other ClinROs, percutaneous EVAR shortened the duration of surgery and the length of hospital stay compared with cutdown EVAR. Considering specific population, percutaneous access was associated with a reduction of access complication among patients with subcutaneous tissue thickness > 25 mm.
Heavily calcified CFA, severely tortuous iliac artery and obesity were considered as predictors of percutaneous access failure[5,7,14-16]. In our study, two patients (3.2%) in percutaneous group were converted to cutdown procedures, both of whom had one or more of those risk factors. In terms of individual complications, percutaneous obviously reduced the risk of lymphorrhagia/seroma but increased the risk of pseudoaneurysm after multivariable adjustment. Despite the lack of significant overall differences in access-related complications between the two groups, further subgroup analysis suggested potential benefits of percutaneous access in patients with enough thick subcutaneous tissue to CFA. These findings underscore the importance of comprehensive evaluation of the access site in patients undergoing EVAR to identify suitable candidates for percutaneous access. Furthermore, our center’s experience has showed that the use of color Doppler ultrasound for percutaneous puncture could be helpful when facing challenging arterial access. Such methods are anticipated to reduce the incidence of intraoperative conversion to cutdown and postoperative complications, thereby optimizing the advantages of percutaneous EVAR.
Patient’s experience and quality of life constituted another major aspect of this study. Previous RCTs have either ignored these factors or focused solely on pain scores and quality-of-life questionaries deemed important by clinicians[9-12]. To address this gap, we conducted a preliminary survey prior to this study to investigate primary concerns of patients regarding their healthcare experience and quality of life. The time return to normal life/work was most frequently mentioned by patients, thus becoming the primary PCO of our study. Additionally, the patients indicated that the duration of pain was more concerning than its intensity. The use of the EQ-5D-5L value set, specifically developed for the Chinese population, enabled us to evaluate health status and quality of life of patients following EVAR without potential biases related to race, nationality, socioeconomic background or cultural differences[23]. Overall, percutaneous access demonstrated significant advantages over cutdown access in terms of achieving a rapid recovery to normal life and optimizing patient experience following EVAR.
From the perspective of optimizing health resource utilization, percutaneous EVAR demonstrated several significant advantages over cutdown EVAR. Notably, it can effectively shorten duration of surgery and hospital stays, consequently optimizing hospital occupation rate and improving the overall efficiency of healthcare resource. This is particularly meaningful for regions with limited medical resources such as Western China. The duration of percutaneous EVAR was reduced by 70 minutes compared to cutdown EVAR, despite the general consistency in EVAR types between the two groups. This difference is more pronounced than previous studies, and may be attributed to a decline in surgeon’s proficiency with the cutdown access technique in the context of the widespread adoption of percutaneous techniques.
To the best of our knowledge, this trial was the first RCT comparing PCOs between percutaneous and cutdown access in patients after EVAR, and it also pioneered prespecified subgroup analyses to assess the advantages of each access method within specific populations. Moreover, this study not only expanded the indications for EVAR but also relaxed the restrictions on access sites, thereby enhancing its applicability in clinical practice. In addition, patient-centered experience and quality of life were representative of the regional population through preliminary survey and EQ-5D-5L value set for Chinese population. Last but not least, our trial provided comprehensive anatomical characteristics of access arteries, which had impact on outcomes but were not sufficiently detailed in previous RCTs.
Our study also had some limitations. Firstly, the trial was conducted at a single center, which may limit the generalizability of the findings to other centers due to variations in characteristics of patients, surgical volume, operator proficiency, and care teams. Secondly, the difficulty of achieving blinding among patients due to the significant disparities in groin wounds resulting from the two accesses may have introduced bias into patient-centered experiences and outcome measures. Thirdly, the absence of standardized and objective criteria for evaluating patient experience and quality of life resulted in the possibility of reporting bias. And we took some measures to minimize the potential bias. On one hand, assessment tools with validated reliability and validity, such as NRS and EQ-5D-5L scores, have been employed to evaluate patient experience and quality of life. On the other hand, we introduced a relatively objective outcome, the number of analgesics used, to assist in assessing the level of access-related pain.
In conclusion, despite no significant advantages in access-related complications, percutaneous access greatly accelerated postoperative recovery and improved the medical experience and quality of life in patients without massive CFA calcification compared with cutdown access following EVAR. Considering specific population, percutaneous access was associated with lower risk of access complication in patients with thick subcutaneous tissue. On the part of individual access complications, percutaneous reduced the risk of lymphorrhagia/seroma but increased the likelihood of pseudoaneurysm.
Footnotes
Yuhang Zhou and Jiarong Wang have contributed equally to this work.
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
Supplemental Digital Content is available for this article. Direct URL citations are provided in the HTML and PDF versions of this article on the journal’s website, www.lww.com/international-journal-of-surgery.
Published online 04 February 2025
Contributor Information
Yuhang Zhou, Email: zyh.zhz@foxmail.com.
Jiarong Wang, Email: wangjiarong@wchscu.cn.
Jichun Zhao, Email: zhaojichun@wchscu.cn.
Ding Yuan, Email: yuanding@wchscu.cn.
Chengxin Weng, Email: chengxin-weng@wchscu.cn.
Bin Huang, Email: huangbin1@wchscu.cn.
Tiehao Wang, Email: tiehao.wang@wchscu.cn.
Ethical approval
The trial was approved by the Ethics Committee on Biomedical Research, West China Hospital of Sichuan University (approval number: 2021-1316).
Consent
The patients/participants provided their written informed consent to participate in this study.
Sources of funding
This trial was funded by the National Natural Science Foundation of China (82302152, 82300542), the Foundation of Science and Technology Department of Sichuan Province (2024YFFK0238), and the 1·3·5 Project for Disciplines of Excellence–Clinical Research Fund, West China Hospital, Sichuan University (2024HXFH040).
Author’s contribution
Y.Z. and J.W. contributed to the conception and design of the trial. J.W., J.Z., and D.Y. recruited and screened the participants. Y.Z., J.W., and C.W. participated in data collection and analysis. Y.Z. and J.W. drafted the manuscript. J.Z., D.Y., T.W., and B.H. provided supervision support. All authors contributed to the critical revisions and final approval of the manuscript.
Conflicts of interest disclosure
None.
Research registration unique identifying number (UIN)
The trial was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR2100053161).
Guarantor
Tiehao Wang.
Provenance and peer review
Not invited.
Data availability statement
The data can be obtained upon reasonable request. All data relevant to the study are included in the article or provided as supplemental information online.
Presentation
None.
Assistance with the study
We thank all patients, their families, as well as the diligent investigators, dedicated nurses, and exceptional research teams involved in this study.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The data can be obtained upon reasonable request. All data relevant to the study are included in the article or provided as supplemental information online.