Complex femoropopliteal artery (FPA) lesions often require provisional stenting after suboptimal drug-coated balloon (DCB) angioplasty. This study compared midterm efficacy and safety of DCB alone versus DCB with provisional bare-metal stenting (BMS) in such lesions. In this retrospective cohort study, 326 propensity score-matched patients (163 per group) treated for FPA disease (2018 to 2022) were analyzed. Primary effectiveness endpoints were 24-month primary patency (PP) and freedom from clinically driven target lesion revascularization (FCD-TLR). Primary safety endpoints included amputation-free survival (AFS) and all-cause mortality. The stented group had longer lesions (21.2 vs 17.6 cm, p = 0.003), lower ankle-brachial index (0.32 vs 0.48, p <0.001), and more severe calcification (29.8% vs 20.6%, p = 0.009). At 24 months, PP (83.9% vs 83.5%, log-rank p = 0.873) and FCD-TLR (86.3% vs 85.9%, p = 0.853) were comparable. AFS (92.3% vs 94.1%, p = 0.508) and mortality (1.8% vs 2.4%, p = 0.715) also showed no significant differences. Secondary outcomes were similar. In conclusion, DCB with provisional BMS demonstrates comparable midterm efficacy and safety to DCB alone for complex FPA lesions, supporting provisional BMS use when suboptimal results occur.
Femoropopliteal artery (FPA) disease is a predominant subtype of peripheral artery disease. , The underlying pathogenesis involves atherosclerotic plaque deposition, resulting in hypoperfusion of distal limb tissues. Clinically, it manifests as progressive ischemic symptoms, with severe cases advancing to limb-threatening gangrene. , In recent years, drug-coated balloons (DCB) have been commonly used for FPA disease. Furthermore, clinical trials have demonstrated the clinical efficacy of DCB superior to percutaneous transluminal angioplasty in FPA disease. ,, However, in the real world, DCB for complex FPA lesions is often associated with suboptimal intraoperative results, which are often remedied with the use of provisional stents to deal with the suboptimal results. , Currently, provisional stenting mainly uses bare metal stents (BMS), , and there is a paucity of real-world clinical data on DCB combination with provisional BMS for the treatment of complex FPA disease. Therefore, the aim of this study was to systematically evaluate the potential impact of provisional stenting in real-life patients with complex FPA disease in terms of a variety of clinical efficacy and safety outcomes.
Materials and Methods
Study design and patient selection
This single-center retrospective cohort study collected the clinical data of 379 femoral-popliteal artery disease patients hospitalized in the Department of Vascular Surgery from January 2018 to October 2022, and 326 patients remained after propensity score matching (163 stented and 163 nonstented groups). Propensity score matching (PSM) was performed using a 1:1 nearest-neighbor matching algorithm without replacement, with a caliper width of 0.05. The PSM model incorporated the following baseline variables: age, sex, BMI, smoking status, hypertension, diabetes mellitus, hypercholesterolemia, coronary artery disease, preoperative antiplatelet agent use, preoperative anticoagulant use, preoperative antiplatelet and anticoagulant therapy, statin use, eGFR, creatinine, HDL, LDL, cholesterol, triglycerides, and D-dimer. To ensure that the results more accurately reflect real-world clinical practice, the covariates presented in Tables 2 and 3 were not included in the initial PSM model. The patient flow chart through 2 years is shown in Figure 1 . All patients were followed up for a total of 24 months, by telephone and outpatient at 3, 6, 12, and 24 months, with telephone follow-up including patients’ physical health status, medication intake, and occurrence of postoperative complications. Outpatient follow-up included CTA of both lower extremities and assessment of postoperative patency of femoropopliteal artery lesions and the necessity for reintervention based on the CTA outcomes. Follow-up CTA imaging was performed at 3, 6, 12, and 24 months as part of a standardized surveillance protocol, regardless of symptoms. The primary inclusion criteria were a diagnosis of femoropopliteal artery disease confirmed by CTA of both lower extremities and first treatment with DCB angioplasty alone or DCB combined with provisional BMS. The exclusion criteria included a combination of severe cardiovascular and cerebrovascular diseases or malignant tumors; mental disorders unable to cooperate; lower limbs that were already severely infected or gangrenous at the time of admission and needed to be amputated or there was already a case of limb loss; recent cerebral hemorrhage, gastrointestinal bleeding, which prevented the use of anticoagulant medication; clinical data that were missing or had not completed the 2-year follow-up. The Ethics Committee of Hospital approved this study in accordance with the Declaration of Helsinki (registration number: 2024-1015-01), and all patients signed the preoperative informed consent form.
Flow chart for the inclusion, exclusion and analysis of patients in this study. FPA = femoropopliteal artery; EVT = endovascular therapy; DCB = drug-coated balloon; BMS = bare-metal stenting, PSM = propensity score matching.
Data collection and definitions
Patients demographics, hypertension, diabetes, hypercholesterolemia, coronary artery disease, smoking, medication use (preoperative antiplatelet, postoperative statin, postoperative antiplatelet and anticoagulant), ankle-brachial index (ABI), Rutherford classification, TASC classification, Below-the-knee (BTK) runoff number, target lesion length, degree of calcification and chronic total occlusion (CTO) were collected from the electronic medical record. Meanwhile, in order to compare the 2 groups in further detail, metrics such as procedure time, puncture method, length, diameter, and number of DCBs, number and length of stents, length of stay (LOS), Postoperative length of stay (pLOS), total cost, material cost, and technical success and Procedural success rate were collected in this study. Rutherford classification was used to assess the severity of lower extremity ischemia. The Transatlantic Society for the Management of Peripheral Arterial Disease Consensus (TASC II) was used to categorize arterial occlusive lesions in the lower extremities. In addition, other blood biochemical characteristics, such as eGFR, creatinine, HDL, LDL, cholesterol, TG, and D-dimer were also recorded to reflect the patient’s hepatic and renal function and baseline status.
Standardized assessment of calcification severity in femoropopliteal artery (FPA) disease patients was performed using preoperative bilateral lower limb CT angiography (CTA) images on the NEUPACS 5.5 system (Neusoft Medical Systems, International Version). A dedicated scoring system evaluated the extent and distribution of calcification within the diseased FPA segment based on 3 parameters: morphology, circumferential involvement, and longitudinal involvement. Calcification morphology was scored from 0 to 3 points, ranging from no calcification to calcification with a maximum thickness of ≥2 mm on axial imaging. For each segment, circumferential involvement and longitudinal involvement scores (each ranging from 0 to 4 points) were assigned based on the maximum involved circumference and length, respectively. A total score of ≥10 points defined severe calcification.
Procedures
After 2% lidocaine local infiltration anesthesia, the ipsilateral or contralateral femoral artery was selected to be punctured according to the lesion characteristics, and systemic heparinization (75 U/kg) treatment was performed after sheath placement, and either a antegrade or a retrograde puncture was selected according to the actual situation during the operation, and a 0.035-inch or 0.018-inch guidewire and a supportive catheter were passed through the lesion area, and the appropriate balloon (Abbott, USA) was selected for predilatation firstly, and then an Orchid DCB (Acotec, China) close to the lesion vessel diameter was selected for further dilatation of the lesion segment. The dilatation pressure was 6 to 8 atm (standard atmospheric pressure), and the time was not less than 120 s. If the length of the lesion required >1 balloon, the overlap area of the balloon was at least 5 mm, and the patient’s postoperative contrast if seen persistent stenosis (residual stenosis ≥30%) or flow-limiting dissection (flow-limiting dissection Grade C or D), provisional bare metal stenting was performed. Specific indications for bailout stenting and the corresponding number of patients within the stent group in Table S1 . After the procedure, all patients take 100 mg of aspirin and 75 mg of clopidogrel daily for at least 12 weeks. At 3, 6, 12, and 24 months, they were evaluated in an outpatient clinic to learn more about the patient’s vascularization of the involved segment and to discuss any necessary medication adjustments or reinterventions.
Clinical effectiveness and safety outcomes
The primary clinical effectiveness endpoints were the 2-year primary patency and the cumulative incidence of freedom from clinically driven target lesion revascularization (FCD-TLR); secondary effectiveness endpoints included assisted primary patency (aPP) and freedom from open bypass; the primary safety endpoints were defined as amputation-free survival (AFS) and all-cause mortality at 2 years. Other safety endpoints included major amputation rate, minor amputation rate, and major adverse cardiovascular events (MACEs). Primary patency was defined as absence of restenosis (≤50% diameter stenosis) at the target lesion, confirmed by CT angiography (CTA). In addition, 2 second-year vascular surgery fellows were blinded to individual clinical information, and they effectively evaluated postoperative patient CTAs during follow-up. If there were any discrepancies, consensus was reached through discussion; FCD-TLR was defined as the rate of no further target lesion revascularization associated with worsening ischemic symptoms in the lower extremity; minor amputation was defined as amputation at the level of the ankle and below; major amputation was defined as amputation above the plane of the ankle; and MACEs included transient ischemic attack (TIA)/stroke, myocardial infarction (MI), and death occurring within 30 days. The Society for Vascular Surgery’s guidelines constitute the foundation for these outcome definitions.
Statistical analysis
Baseline demographics and hospitalization characteristics were assessed on a patient basis, lesion characteristics were assessed on a lesion basis, and procedural characteristics were assessed on a procedure basis. Using propensity score matching to balance all baseline characteristics between the 2 groups. Normally distributed continuous variables were expressed as mean ± SD and compared using the independent samples t-test; skewed continuous variables were expressed as median and quartiles (interquartile spacing) and compared using the Mann-Whitney U test. Categorical data were presented in percentages and frequencies, and comparisons between groups were made using the Pearson chi-square test or Fisher’s exact test. Kaplan-Meyer (K-M) analysis was used to estimate primary clinical effectiveness and safety outcomes and secondary outcomes, and a log-rank test was used to determine the significance of differences. Multivariable Cox regression models were used to analyze the risk factors associated with primary patency and amputation-free survival in patients with femoropopliteal artery disease. IBM SPSS Statistics version 27.0 was used for statistical analysis. K-M curves were generated using GraphPad Prism version 9.5.1.
Results
Baseline and lesion characteristics
The flow chart for the patients is shown in Figure 1 . Between January 2018 and October 2022, 469 patients who underwent DCB alone or DCB combined with provisional BMS for femoral-popliteal artery disease participated in this study. After critical exclusion, 379 patients were finally included, 208 in the stented group and 171 in the nonstented group. After propensity score matching, the final number of patients in each of the 2 groups was 163. The patients’ baseline characteristics before propensity score matching were shown in Table 1 . There was a difference between the 2 groups between the history of postoperative antiplant combined with anticoagulant use (p = 0.048). The patients’ baseline characteristics after propensity score matching were shown in Table 2 . Baseline characteristics were generally similar between groups. Lesion characteristics of patients are reported in Table 3 . Overall, lesions in the stented group were generally more complicated than those in the nonstented group. When compared to the nonstented group, the stented group exhibited longer lesion lengths (21.2 cm vs 17.6 cm; p = 0.003), lower ABI (0.32 vs 0.48; p <0.001) and more severe calcification (29.8% vs 20.6%; p = 0.009). This indicated that for complex FPA lesions, DCB angioplasty alone may not be sufficient to achieve better intraoperative outcomes.
Table 1
Baseline characteristics of patients before PSM
| Patient characteristics | Stented group ( n = 208) | Nonstented group ( n = 171) | p-value |
|---|---|---|---|
| Age(years) | 74.0 ± 9.6 | 74.9 ± 9.9 | 0.342 |
| Sex(male) | 133(63.9%) | 119(69.6%) | 0.246 |
| BMI(kg/m 2) | 22.1 ± 3.0 | 22.5 ± 3.0 | 0.237 |
| Smoking | 63(30.3%) | 56(32.7%) | 0.608 |
| Hypertension | 158(76.0%) | 125(73.1%) | 0.524 |
| Diabetes mellitus | 118(56.7%) | 108(63.2%) | 0.204 |
| Hypercholesterolemia | 29(13.9%) | 20(11.7%) | 0.517 |
| Coronary artery disease | 36(17.3%) | 37(21.6%) | 0.287 |
| Antiplatelet | 0.172 | ||
| SAPT | 97(46.6%) | 81(47.4%) | |
| DAPT | 7(3.4%) | 1(0.6%) | |
| Anticoagulant | 70(33.7%) | 51(29.8%) | 0.426 |
| Antiplatelet and Anticoagulant | 31(14.9%) | 39(22.8%) | 0.048 |
| Statin | 198(95.2%) | 164(95.9%) | 0.738 |
| eGFR(mL/min/1.73 m²) | 88.6 ± 34.7 | 88.9 ± 34.3 | 0.942 |
| Creatinine(μmoI/L) | 73.5(58.0,101.6) | 76.0(60.0,94.0) | 0.744 |
| HDL(mmol/L) | 1.1 ± 0.3 | 1.1 ± 0.3 | 0.636 |
| LDL(mmol/L) | 2.3 ± 1.0 | 2.4 ± 0.8 | 0.593 |
| Cholesterol(mmol/L) | 4.0 ± 1.1 | 4.0 ± 1.1 | 0.653 |
| TG(mmol/L) | 1.2(0.9,1.6) | 1.1(0.9,1.5) | 0.693 |
| D-dimer(mg/L) | 0.6(0.4,1.2) | 0.6(0.4,1.1) | 0.725 |
BMI = body mass index; DAPT = Dual-antiplatelet therapy; eGFR = estimated Glomerular Filtration Rate; HDL = high-density lipoprotein; LDL = low-density lipoprotein; SAPT = Single-antiplatelet therapy; TG = triglycerides. Data are presented as number (%), median (interquartile range), or mean ± standard deviation.
Table 2
Baseline characteristics of patients after PSM
| Patient characteristics | Stented group ( n = 163) | Nonstented group ( n = 163) | p-value |
|---|---|---|---|
| Age(years) | 74.6 ± 9.7 | 74.9 ± 10.1 | 0.779 |
| Sex(male) | 103(63.2%) | 111(68.1%) | 0.246 |
| BMI(kg/m 2) | 22.4 ± 3.0 | 22.5 ± 3.0 | 0.714 |
| Smoking | 44(27.0%) | 52(31.9%) | 0.331 |
| Hypertension | 120(73.6%) | 117(71.8%) | 0.709 |
| Diabetes mellitus | 98(60.1%) | 102(62.6%) | 0.649 |
| Hypercholesterolemia | 21(12.9%) | 18(11.0%) | 0.609 |
| Coronary artery disease | 29(17.8%) | 33(20.2%) | 0.572 |
| Antiplatelet | 0.229 | ||
| SAPT | 84(51.5%) | 76(46.6%) | |
| DAPT | 4(2.5%) | 1(0.6%) | |
| Anticoagulant | 50(30.7%) | 48(29.4%) | 0.809 |
| Antiplatelet and Anticoagulant | 31(19.0%) | 35(21.5%) | 0.581 |
| Statin | 156(95.7%) | 156(95.7%) | 1.000 |
| eGFR(mL/min/1.73m²) | 89.4 ± 34.0 | 89.3 ± 34.9 | 0.966 |
| Creatinine(μmoI/L) | 72.0(58.0,98.0) | 73.0(59.0,94.0) | 0.647 |
| HDL(mmol/L) | 1.1 ± 0.3 | 1.0 ± 0.3 | 0.450 |
| LDL(mmol/L) | 2.4 ± 1.0 | 2.4 ± 0.8 | 0.933 |
| Cholesterol(mmol/L) | 4.0 ± 1.1 | 4.0 ± 1.0 | 0.965 |
| TG(mmol/L) | 1.2(0.8,1.5) | 1.1(0.8,1.5) | 0.844 |
| D-dimer(mg/L) | 0.6(0.4,1.2) | 0.6(0.4,1.1) | 0.662 |
BMI = body mass index; DAPT = Dual-antiplatelet therapy; eGFR = estimated Glomerular Filtration Rate; HDL = high-density lipoprotein; LDL = low-density lipoprotein; SAPT = Single-antiplatelet therapy; TG = triglycerides. Data are presented as number (%), median (interquartile range), or mean ± standard deviation.
Table 3
Lesion characteristics of patients in our cohort
| Lesion characteristics | Stented group ( n = 163 patients) | Nonstented group ( n = 163 patients) | p-value |
|---|---|---|---|
| Lesion length(cm) | 21.2 ± 12.1 | 17.6 ± 10.5 | 0.003 |
| ABI | 0.3 ± 0.2 | 0.5 ± 0.2 | <0.001 |
| CTO | 64(38.1%) | 70(41.2%) | 0.563 |
| Calcification | 0.009 | ||
| mild | 65(38.7%) | 94(55.3%) | |
| moderate | 53(31.5%) | 42(24.1%) | |
| severe | 50(29.8%) | 35(20.6%) | |
| Rutherford classification | 0.204 | ||
| 3 | 45(26.8%) | 62(36.5%) | |
| 4 | 54(32.1%) | 52(30.6%) | |
| 5 | 40(23.8%) | 36(21.2%) | |
| 6 | 29(17.3%) | 20(11.8%) | |
| TASC classification | 0.236 | ||
| A | 38(22.6%) | 45(26.5%) | |
| B | 70(41.7%) | 57(33.5%) | |
| C | 29(17.3%) | 41(24.1%) | |
| D | 31(18.5%) | 27(15.9%) | |
| Runoff BTK vessels | 0.837 | ||
| 0/1 | 68(40.5%) | 72(42.4%) | |
| 2 | 62(36.9%) | 64(37.6%) | |
| 3 | 38(22.6%) | 34(20.0%) |
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