Drug-coated balloon with bailout stenting versus drug-eluting stent plus drug-coated balloon in TransAtlantic Inter-Society Consensus C and D femoropopliteal lesions: a propensity score-matched analysis

Introduction

Peripheral artery disease (PAD) affects over 200 million people worldwide, representing a significant global health burden (1,2). PAD is characterized by atherosclerotic occlusion of the lower extremity arteries, which leads to claudication, critical limb ischemia, and an increased risk of cardiovascular events (3). Epidemiological data show a rising prevalence, particularly among aging populations and individuals with diabetes or a history of smoking (1,4).

Drug-coated balloons (DCBs) have emerged as effective interventions, demonstrating favorable outcomes compared to balloon angioplasty (5-7). However, the lesions treated in clinical trials are typically shorter and simpler, whereas real-world lesions tend to be longer and more complex, often involving calcification or occlusions—commonly referred to as TransAtlantic Inter-Society Consensus (TASC) C and D lesions. These lesions present unique challenges to treatment (8-10). For such complex cases, an integrated approach using DCBs with bailout bare metal stenting, in combination with adjunctive therapies like atherectomy (referred to as the DCB bailout strategy), is commonly employed (11). The DCB bailout strategy still fails to maintain favorable long-term results in complex lesions (12).

With the introduction of drug-eluting stents (DES) into the peripheral intervention landscape, the combination of DCB and DES—defined as the double-drug strategy in the present study—has gained attention for its potential to reduce restenosis and maintain vessel patency in complex lesions (13). Although this approach shows promise, direct comparisons of patency outcomes between the double-drug strategy and the DCB bailout strategy are lacking in real-world clinical practice.

This study aimed to address this gap by using propensity score-matched analysis to compare the outcomes of the double-drug strategy and the DCB bailout strategy in TASC C and D femoropopliteal lesions, providing valuable insights into their relative effectiveness and safety for treating these complex lesions. We present this article in accordance with the STROBE reporting checklist (available at https://qims.amegroups.com/article/view/10.21037/qims-2025-367/rc).

Methods

Patients

This retrospective, single-center cohort study analyzed real-world data from patients with PAD involving femoropopliteal lesions who underwent DCB intervention at Peking University First Hospital between October 2016 and July 2024. The study adhered to the Declaration of Helsinki and its subsequent amendments and received approval from the Ethics Committee of Peking University First Hospital (No. 2022-363). Due to the retrospective nature of the research and complete anonymization of patient data, the requirement for written informed consent was waived. All procedures complied with applicable regulatory and ethical standards. Eligible patients met the following criteria: (I) aged 18 years or older; (II) diagnosed with PAD after clinical evaluation; and (III) the angiography shows lesions consistent with TASC C and D classification of femoropopliteal artery disease (14) (Appendix 1). Patients with acute limb ischemia, previous bypass surgery, or incomplete follow-up data were excluded. Being a pilot study, the sample size was determined by the available cohort population rather than formal power calculations.

In accordance with institutional standardized protocols, baseline patient characteristics including age, gender, cardiovascular risk factors, and Rutherford classification were systematically documented in a local database. Patients underwent a preoperative physical examination and vascular duplex ultrasound.

Endovascular procedures

Procedures were performed under local anesthesia, supplemented with intravenous sedation when necessary. Lesion length was measured using a radiopaque ruler positioned parallel to the target artery. All interventional strategies, including dual-drug therapy or DCB bailout, were determined by experienced vascular specialists. Orchid DCBs (Acotec Scientific, Beijing, China) and Eluvia DES (Boston Scientific, Marlborough, MA, USA) were used for treatment. During the vessel preparation phase, all lesions underwent at least one plain balloon angioplasty, with additional debulking performed using either the Turbohawk/HawkPlus (Medtronic, Dublin, Ireland) or Rotarex S [Becton, Dickinson and Co. (BD)/Straub, Franklin Lakes, NJ, USA] systems, as indicated. Successful preparation was defined as achieving residual stenosis ≤30% without evidence of flow-limiting dissection. In the double-drug group, successfully prepared segments subsequently received DCB treatment, whereas DES were used in preparation-failed segments. The DCB bailout group followed a similar preparation protocol, where all lesions underwent DCB treatment following vessel preparation. In this group, bare metal stents were deployed as bailout therapy when meeting identical procedural criteria post-DCB application. The bare metal stents used in the study were exclusively INNOVA (Boston Scientific). DCB or DES need to cover all the lesion length and overlap for at least 5 mm to avoid geographic loss. The DCB diameter was selected at 0.5–1 mm larger than the plain balloon, with DES consistently sized at 6 mm. Lesion characteristics—encompassing reference vessel diameter, stenosis degree, calcification, and inflow/outflow obstructions—were visually assessed. Patients often received treatment for inflow and outflow lesions concurrently during the same procedure. For tibial artery interventions, post-procedural angiography mandated at least one patent vessel; when all three tibial arteries showed stenosis or occlusion, the target artery was chosen based on minimal lesion severity and preserved outflow below the ankle. Standard tibial lesion crossing employed a 0.014-inch guidewire through either intraluminal or subintimal pathways, succeeded by balloon angioplasty.

Pharmacological protocol

All patients received preoperative dual antiplatelet therapy consisting of aspirin (100 mg daily) and clopidogrel (75 mg daily) for ≥7 days, or alternatively, a loading dose (aspirin 300 mg and clopidogrel 300 mg) administered 6 hours pre-procedure. Intraoperatively, heparin (100 IU/kg) was given after long sheath placement for anticoagulation. The postoperative protocol mandated continuation of dual antiplatelet therapy (aspirin 100 mg + clopidogrel 75 mg daily) for 6 months, followed by monotherapy. Physicians individualized regimens for cardiac comorbidities. Statin therapy was initiated when low-density lipoprotein (LDL) cholesterol exceeded 1.8 mmol/L (70 mg/dL) or non-high-density lipoprotein (non-HDL) cholesterol surpassed 2.6 mmol/L (100 mg/dL).

Follow-up

Patients were scheduled for follow-up at 1, 3, 6, and 12 months post-procedure, with annual evaluations thereafter in the outpatient clinic. Each visit included symptom assessment, physical examination, vascular ultrasound, and ankle-brachial index (ABI) measurement. Computed tomography angiography (CTA) was performed under any of the following circumstances: (I) a >20% decrease in ABI from baseline; (II) vascular ultrasound findings suggestive of significant restenosis (>50% diameter reduction); (III) recurrence of severe ischemic symptoms; or (IV) as part of the scheduled 12-month follow-up protocol. For patients who missed scheduled follow-up visits, clinical status was confirmed through quarterly telephone interviews.

Endpoints and definitions

The primary endpoint was 24-month primary patency, defined as the duration from initial intervention to first occurrence of >50% restenosis in the treated vessel. Secondary outcomes comprised 24-month rates of freedom from clinically-driven target lesion revascularization (CD-TLR), all-cause mortality, major adverse limb events (MALE), and symptomatic improvement. CD-TLR was characterized as either percutaneous or surgical reintervention on the target limb, performed for recurrent or persistent ischemic symptoms with angiographic confirmation of patency loss. MALE were defined as limb loss or revascularization. Symptom improvement was defined as either a one-level decline in Rutherford category or a ≥50% reduction in wound area for patients with ulcerations at the end of follow-up.

Moderate-to-severe calcification was defined as Peripheral Artery Calcium Scoring System (PACSS) grade 3 or 4 (15), indicating bilateral vascular wall involvement. Technical success required <30% residual stenosis in the target vessel on final angiographic assessment.

Statistical analysis

To minimize baseline differences between the treatment groups, propensity scores were calculated using a logistic regression model. Covariates included age, gender, hypertension, dyslipidemia, diabetes, stroke, coronary heart disease, renal insufficiency, lesion length, Rutherford classification, PACSS, lesion type [de novo vs. in-stent restenosis (ISR)], and occlusion. Optimal matching with a 1 (double-drug group): 3 (DCB bailout group) ratio was employed, ensuring that each patient in the double-drug strategy group was matched to three patients in the DCB group. A caliper width of 0.2 was applied to limit the absolute difference in propensity scores between matched pairs. A standardized mean difference (SMD) threshold of <0.2 for covariate balance assessment was predefined. Statistical analysis was performed using R 4.4.2 (The R Foundation for Statistical Computing, Vienna, Austria) and SPSS 22.0 (IBM Corp., Armonk, NY, USA). Continuous data are shown as mean ± standard deviation (SD), and categorical data were shown as numbers with percentages. Normally distributed continuous variables were compared using a 2-sided Student’s t-test, and nonnormally distributed continuous variables were compared using the Wilcoxon signed-rank test. Means of baseline and immediate postoperative or follow-up data were compared using paired t-tests. Comparisons of categorical variables were performed using a Chi-squared test or Fisher’s exact test. Sensitivity analyses were performed using the worst-case scenario analysis and multiple imputation analysis. Primary patency and freedom from CD-TLR were assessed using Kaplan-Meier survival analysis, with between-group comparisons performed via log-rank testing.

Independent predictors of restenosis were identified using Cox proportional hazards regression. Candidate variables were first screened through univariable analysis, with those demonstrating marginal association (P<0.1) progressing to the multivariable model. Results are reported as hazard ratios (HRs) with corresponding 95% confidence intervals (CIs). Complete-case analysis was performed, excluding observations with missing data. A two-sided P value <0.05 was considered statistically significant.

Results

Patient and lesion characteristics

A total of 352 patients with 372 limbs with TASC C and D femoropopliteal artery disease were included. Among the cohort, 32 limbs (from 32 patients) received the double-drug strategy therapy, whereas the remaining patients were treated with the DCB bailout approach (see Tables S1,S2 for full baseline and procedural characteristics of the DCB bailout group). After propensity score matching (PSM), 32 limbs in the double-drug strategy group and 96 limbs in the DCB bailout strategy group of matched patients were included in the analysis, and the patient and lesion characteristics between the two groups were comparable (Table 1). The mean age of the entire cohort was 71.25±9.51 years, and the majority of patients were male (65.63%). Smoking history was reported in 28.12% of both groups. There were no significant differences between the two groups in terms of baseline demographics, including the prevalence of hypertension, diabetes, dyslipidemia, stroke, coronary heart disease, renal insufficiency, and smoking history (all P>0.05). The distribution of Rutherford classifications was also comparable between the two groups (P=0.066).

Lesion and procedural characteristics are provided in Table 2. In terms of lesion location, femoral-only lesions accounted for 42.97% of cases, whereas femoropopliteal lesions were observed in 57.03%. The proportion of femoropopliteal lesions did not significantly differ between the DCB bailout (56.25%) and double-drug (59.38%) groups (P=0.768). Calcification severity evaluated by PACSS was similar between two groups (P=0.889). Lesion type analysis showed that 85.16% of cases were de novo lesions and ISR was present in 14.84% of cases, similar in both groups (P>0.99). Chronic total occlusions (CTOs) were highly prevalent in both groups (92.19%), with no significant differences (P>0.99). Below-the-knee (BTK) interventions were performed in 45.31% of the cohort, with 43.75% in the DCB bailout strategy group and 50.00% in the double-drug strategy group (P=0.542). The mean lesion length was 215.55±103.72 mm in the entire cohort, with comparable values in the DCB bailout strategy (212.19±110.16 mm) and double-drug strategy (225.62±82.15 mm) groups (P=0.528).

Procedural and follow-up outcomes

Kaplan-Meier analysis demonstrated that the 12-month primary patency rate was 86.0% (95% CI: 74.2–99.7%) in the double-drug strategy group and 84.6% (95% CI: 76.7–93.5%) in the DCB bailout strategy group. At 24 months, the estimated primary patency rates were 64.5% (95% CI: 35.9–100.0%) and 76.4% (95% CI: 70.0–87.4%), respectively. The log-rank test indicated no statistically significant difference in primary patency between the two treatment strategies (P=0.76), suggesting comparable mid-term patency in patients undergoing either approach (Figure 1).

Figure 1 Kaplan-Meier curve for primary patency in DCB bailout vs. double-drug groups. DCB, drug-coated balloon.

The freedom from CD-TLR rate at 12 months was 95.8% (95% CI: 88.2–100.0%) in the double-drug strategy group and 89.0% (95% CI: 82.0–96.5%) in the DCB bailout strategy group. At 24 months, the freedom from CD-TLR rates were 95.8% (95% CI: 88.2–100.0%) and 79.1% (95% CI: 69.8–89.6%), respectively. The log-rank test showed no statistically significant difference in freedom from CD-TLR between the two groups (P=0.20), indicating similar reintervention rates over time (Figure 2). Representative images in the double-drug group and DCB bailout group are shown in Figures 3,4, respectively.

Figure 2 Kaplan-Meier curve for freedom from target lesion revascularization in DCB bailout versus double-drug groups. DCB, drug-coated balloon; TLR, target lesion revascularization.

Figure 3 Representative case of double-drug strategy for TASC D lesion of the right femoropopliteal artery. (A) The preoperative DSA angiogram; (B) the plain balloon dilation; (C) the postoperative DSA angiogram; (D) the 12-month follow-up CTA images. CTA, computed tomography angiography; DSA, digital subtraction angiography; R, right; TASC, TransAtlantic Inter-Society Consensus.

Figure 4 Representative case of DCB-bailout strategy for TASC D lesion of the left femoropopliteal artery. (A) The preoperative DSA angiogram; (B) the DCB balloon dilation; (C,D) the postoperative DSA angiogram; (E) the 12-month follow-up CTA reconstructed images. CTA, computed tomography angiography; DCB, drug-coated balloon; DSA, digital subtraction angiography; L, left; TASC, TransAtlantic Inter-Society Consensus.

Complete-case analysis demonstrated significant symptom improvement rates in in the double-drug group [96.88% vs. 81.18%, odds ratio (OR) =0.14, P=0.042]. Sensitivity analyses confirmed the robustness of findings: the worst-case scenario analysis (assuming all lost-to-follow-up cases in were non-responders) accentuated the between-group disparity (OR =0.08, P=0.003), whereas multiple imputation analysis yielded concordant conclusions (OR =0.15, P=0.029). Mortality rates were 11.46% (n=11) in the DCB bailout group and 3.13% (n=1) in the double-drug group (P=0.225). MALE events rates were 4.16% (n=4) and 3.13% (n=1), respectively (P=0.715).

A multivariate Cox proportional hazards model was performed to identify independent predictors associated with loss of primary patency. The analysis included key clinical and procedural variables as covariates, and the results are summarized in Table 3. Among the analyzed risk factors, diabetes mellitus and dyslipidemia entered the multivariable model (P<0.1). Dyslipidemia (HR =3.03, P=0.024) was identified as an independent risk factor for loss of primary patency.

Discussion

This study demonstrates that both the double-drug strategy and the DCB bailout strategy are effective and safe for treating TASC C and D femoropopliteal PAD, with comparable clinical outcomes. Overall survival and limb salvage rates were similar between the two groups. At the 24-month follow-up, the double-drug strategy group showed no significant difference in primary patency and freedom from target lesion revascularization (TLR) compared to the DCB bailout strategy group. However, patients receiving double-drug therapy demonstrated a clinically relevant trend toward superior symptomatic improvement.

The use of DCBs or DES for femoropopliteal artery lesions is well-established, with both having demonstrated superior results in clinical trials. Emerging evidence from large-scale registries and meta-analyses suggests that long-term patency rates and freedom from TLR are comparable between DCBs and DES (16-18). However, DCBs have limitations, such as elastic recoil, dissection, and impaired drug delivery. In real-world settings, particularly for complex lesions, bailout stents following DCB treatment are often required, and the DCB bailout strategy has been widely adopted for TASC C and D lesions (19). Although DES may offer durable vessel patency through continuous drug elution, they are associated with risks such as aneurysmal formation, ISR, and stent fracture (20,21).

DCB and bailout DES therapy appears safe and is associated with high primary patency, providing excellent 1- and 2-year primary patency rates of 93.3% and 92.9%, respectively (22). These results led vascular specialists to consider whether the combination of DCB and DES may generate superior results. In this study, the double-drug [also known as drug-within-drug (DWD)] strategy involved the deployment of systemic DES following suboptimal vessel preparation, whereas DCBs were used in the successfully prepared segments to minimize both stent and drug burdens (13). This approach achieved similar patency and freedom from TLR rates as full DES strategy, while reducing the extent of stent coverage (13). Our analysis revealed comparable rates of primary patency and freedom from TLR between double-drug strategy and conventional DCB bailout strategy groups. Although superior symptom improvement was observed with the double-drug strategy, the study’s limited sample size necessitates cautious interpretation and further validation in larger cohorts.

In multivariable analysis, dyslipidemia was identified as a major risk factor for restenosis, whereas other common cardiovascular risk factors did not show significant associations with loss of patency. These findings are consistent with the literature and emphasize the importance of metabolic control and aggressive secondary prevention strategies in dyslipidemia patients undergoing endovascular therapy for PAD (23).

The study has several limitations. First, its retrospective, single-center design and relatively small sample size limit the generalizability of the results and may have introduced bias. Second, the follow-up period was only 24 months. Furthermore, the double-drug therapy group exhibited progressive attrition during follow-up, resulting in limited sample sizes for long-term analysis beyond 12 months. Future studies with larger sample sizes and longer follow-up durations are needed to assess the long-term impact of these risk factors on patency and clinical outcomes. Third, the generalizability of findings may be impacted by exclusion of most DCB-bailout cases during PSM, yet this approach was essential to minimize confounding in this retrospective analysis.

Conclusions

In this propensity score-matched analysis, the double-drug strategy and the DCB bailout strategy demonstrated comparable 24-month patency and freedom from TLR in TASC C and D femoropopliteal PAD. The double-drug strategy showed potential symptom benefits, but these results need cautious interpretation and confirmation in broader patient populations.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://qims.amegroups.com/article/view/10.21037/qims-2025-367/rc

Data Sharing Statement: Available at https://qims.amegroups.com/article/view/10.21037/qims-2025-367/dss

Funding: This study was supported by Beijing Natural Science Foundation (No. 7242280 to M.Y.), the National Natural Science Foundation of China (No. 82200537 to B.Z.), and National Health Commission Capacity Building and Continuing Education Center Research Fund (No. GWJJ2022100305 to M.Y.). The article processing charge (APC) was funded by Peking University First Hospital.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://qims.amegroups.com/article/view/10.21037/qims-2025-367/coif). M.Y. reports funding from Beijing Natural Science Foundation (No. 7242280) and National health commission capacity building and continuing education center research fund (No. GWJJ2022100305). B.Z. reports funding from the National Natural Science Foundation of China (No. 82200537). The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study adhered to the Declaration of Helsinki and its subsequent amendments and received approval from the Ethics Committee of Peking University First Hospital (No. 2022-363). Due to the retrospective nature of the research and complete anonymization of patient data, the requirement for written informed consent was waived.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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