Abstract
Objective:
We previously demonstrated that everolimus drug-eluting stents (eDES) have reasonable short-term patency for the treatment of infrainguinal bypass stenoses. The aim of this study was to compare mid-term outcomes of eDES, plain balloon angioplasty (PTA), percutaneous cutting balloon (PCB), and drug-coated balloon (DCB) interventions for failing infrainguinal bypasses.
Methods:
We conducted a retrospective review of patients with infrainguinal bypass stenoses treated by endovascular intervention (08/2010–08/2021). The primary outcome was primary patency (PP). Secondary outcomes were primary-assisted patency (PAP), secondary patency (SP), limb salvage (LS), and mortality. Outcomes were compared by treatment using Kaplan-Meier curves with log-rank tests and Cox proportional hazards models adjusting for baseline differences between groups.
Results:
72 consecutive patients with 152 discrete infrainguinal bypass graft stenoses were identified. Mean age was 65.1±10.6 years, 55.6% were male, and 48.6% were Black. 81.9% of patients were originally treated for chronic limb-threatening ischemia, and 57.2% of distal anastomoses were to tibial or pedal targets. Of 152 lesions, 44.1% (n=67) were treated with PTA, 17.8% (n=27) with PCB, 20.4% (n=31) with DCB, and 17.8% (n=27) with eDES. Median follow-up was 28.5 months (IQR 11.5–51.9). There was no difference in bypass configuration, conduit choice, or stenosis location (proximal anastomosis, mid-bypass, distal anastomosis) between groups. At 24-months post-intervention, PP was significantly better for eDES (72.9%, 95% CI 49.8–85.6%), followed by PCB (55.9%, 95% CI 34.2–72.9), PTA (34.4%, 95% CI 21.7–47.4), and DCB (33.6%, 95% CI 14.5–53.9%) (P=0.03). PAP, LS, and mortality did not significantly differ between modalities (P>0.05). After risk adjustment, eDES was associated with the lowest risk of PP loss (HR vs. PTA 0.15, 95% CI 0.05–0.47).
Conclusion:
eDES are associated with superior 24-month patency rates compared to other endovascular technologies, and should be considered a primary therapy modality for the treatment of infrainguinal bypass graft stenoses.
Keywords: bypass revision, failing bypass graft, drug-eluting stent, drug-coated balloon, cutting balloon, balloon angioplasty
Introduction
Open surgical revision was the historical gold standard treatment for failing infrainguinal bypass grafts. With the advent of increasing endovascular interventions, however, a number of endovascular options have been described. Plain balloon angioplasty (PTA) was first described for the treatment of infrainguinal bypass graft stenoses with a series of case reports and feasibility studies, with the first comparative study published in 19991. Subsequent reports of percutaneous cutting balloons (PCB) showed good mid-term efficacy for the treatment of failing bypass grafts2, with similar primary patency rates compared to open surgery at 2 years3.
Drug-eluting technologies have further expanded the options for treatment of bypass graft stenoses. There have been a number of small studies comparing paclitaxel drug-coated balloons (DCB) to PTA for bypass graft stenoses published by groups in Europe with mixed results4–7. There is also an eleven-patient case series describing the use of paclitaxel drug-eluting stents for failing infrainguinal bypass grafts that reported a one-year patency of 90%, but with no comparison group and a very small sample size8. In 2019, we reported outcomes of everolimus drug-eluting stents (eDES) in 15 patients with infrainguinal bypass graft stenoses9. The patency results we reported were encouraging for eDES compared to PTA and PCB, but the study was underpowered to perform a risk-adjusted analysis and had a limited experience with DCB for this application at the time.
The aim of the current study was to report primary patency outcomes for eDES compared to PTA, PCB, and DCB in a larger cohort with longer follow-up, this time using risk adjustment.
Methods
Study Cohort
All patients at this single center who underwent endovascular therapy for an infrainguinal bypass stenosis with PTA, PCB, DCB, or eDES from August 1, 2010, to August 1, 2021, were included. Only intrinsic bypass stenoses (not inflow or outflow stenoses) were included. Patients with occluded bypasses undergoing attempted bypass salvage were excluded, as were one patient who received a paclitaxel drug-eluting stent and one patient who underwent distal anastomotic laser atherectomy. Patients were identified by surgeon case logs, and the electronic medical records were reviewed for baseline patient characteristics and demographics, bypass configuration and conduit type, management strategy, and outcomes. Institutional Board Review approval was obtained, and the study was deemed exempt from patient consent given the retrospective nature of the study design.
Technical Details and Management
Bypass graft stenoses were managed using an endovascular-first strategy with specific interventions determined based on physician discretion. In general, we perform an angiogram for a failing bypass graft in the setting of severe bypass graft stenoses (defined as peak systolic velocity [PSV] >300 cm/s, bypass graft velocity <45 cm/s, or PSV ratio >3.5). All DCBs were paclitaxel DCBs. All implanted eDES were everolimus-eluting coronary stents, which is off-label for the treatment of lower extremity bypass graft stenoses.
Following intervention, all patients are placed on dual antiplatelet therapy. Patients on pre-existing systemic anticoagulation are placed on clopidogrel and anticoagulation. Surveillance duplex is typically performed every 3 months following intervention for the first year, and then every 6 months thereafter.
Outcomes
The primary outcome was primary patency of the treated lesion. Secondary outcomes included primary-assisted patency (PAP), secondary patency, limb salvage and mortality. Patency outcomes were determined at clinical follow-up with surveillance duplex ultrasound evaluation of the bypass as noted above. All outcomes are reporting according with the Rutherford reporting standards10.
Statistical Analysis
Descriptive analysis used mean and standard deviation for normal continuous data, and frequency with percent for categorical variables. Patient variables are provided on a per-patient basis because individual patients may have multiple bypasses and/or multiple stenoses per bypass during the study period.
Bypass configurations, conduit choice, and stenosis location (proximal-, mid-, distal-bypass) were analyzed on a per-lesion basis across treatment type (PTA, PCB, DCB, eDES) using chi-squared tests. Follow up was assessed overall and by approach. A life table analysis evaluated the cohort at 6 months intervals for PP, PAP, SP and LS to allow for evaluation of standard error to determine appropriate follow-up analysis. Outcomes were truncated at 24 months of follow-up to ensure standard error <0.10 for all groups. Kaplan-Meier curves and log-rank tests were used to evaluate primary and secondary outcomes. Cox proportional hazards models were then used to assess the association of bypass intervention with loss of primary patency. All covariates with P<0.05 on univariate analysis, as well as number of prior interventions, were included in the multivariable model, with clustering by patient because some patients had more than one intervention.
We performed a sensitivity analysis including only the three approach types (PTA, PCB, eDES) from our prior study in order to allow for longer follow-up. Outcomes were truncated at 35 months to maintain standard error <0.10 in these three groups. Similar to the main analysis, Kaplan-Meier curves with log-rank tests and Cox proportional hazards models were used to assess the association of bypass graft intervention with primary patency.
A P-value less than 0.05 was considered significant for all analyses. Statistical analysis and figure creation were performed with STATA 17.0 (StataCorp LLC, College Station, TX).
Results
Patient Cohort
Seventy-two patients with 152 discrete bypass graft stenoses were included. Overall, mean age was 65.1±10.6 years, 55.6% (n=40) were male, and 48.6% (n=35) were Black. The majority of patients had hypertension (90.3%, n=65), hyperlipidemia (72.2%, n=52), and diabetes (62.5%, n=45); and 84.7% of patients had at least 2 comorbidities (Table 1). The predominant indication for bypass was chronic limb-threatening ischemia (82.0%, n=59), including tissue loss in 51.4% (n=37) and rest pain in 30.6% (n=22).
Table 1.
Baseline characteristics of patients undergoing endovascular bypass graft intervention
| Characteristic | Overall (N=72) |
|---|---|
| Age, years (mean±SD) | 65.1±10.6 |
| Sex | |
| Male | 40 (55.6) |
| Female | 32 (44.4) |
| Race | |
| White | 34 (47.2) |
| Black | 35 (48.6) |
| Other | 3 (4.2) |
| Body mass index, kg/m2 (mean±SD) | 28.2±7.0 |
| Comorbidities | |
| Diabetes | 45 (62.5) |
| Coronary artery disease | 33 (45.8) |
| Congestive heart failure | 25 (34.7) |
| Hypertension | 65 (90.3) |
| Hyperlipidemia | 52 (72.2) |
| Chronic kidney disease/hemodialysis | 27 (37.5) |
| ≥2 comorbidities | 61 (84.7) |
| Smoking | |
| Current | 17 (23.6) |
| Former | 35 (48.6) |
| Never | 20 (27.8) |
| ASA class | |
| 2 | 16 (22.2) |
| 3 | 56 (77.8) |
| Baseline medications | |
| Aspirin | 59 (81.9) |
| Clopidogrel | 44 (61.1) |
| Systemic anticoagulation | 31 (43.1) |
| Statin | 63 (87.5) |
| Indication for bypass | |
| Tissue loss | 37 (51.4) |
| Rest pain | 22 (30.6) |
| Claudication | 11 (15.3) |
| Acute limb ischemia | 2 (2.8) |
Bypass Characteristics and Interventions
The majority of bypasses originated from the common femoral artery (78.3%, n=119), and more than half of the bypasses (57.2%, n=87) were to a tibial or pedal target (Table 2). The most common conduit was great saphenous vein (78.9%, n=120), followed by arm vein (12.5%, n=19) and prosthetic with a vein cuff (9.9% n=15). Treated bypass graft stenoses were located at the proximal anastomosis in 69 cases (45.4%), distal anastomosis in 53 cases (34.9%), and mid-bypass in 32 cases (21.1%).
Table 2.
Bypass graft characteristics overall and stratified by intervention
| Total N=152 (%) | PTA N=67 (%) | PCB N= 27 (%) | eDES N=27 (%) | DCB N=31 (%) | P-value | |
|---|---|---|---|---|---|---|
| Bypass Configuration | 0.09 | |||||
| Femoral-popliteal | 63 (41.4) | 29 (43.3) | 9 (33.3) | 12 (44.4) | 13 (41.9) | |
| Femoral-tibial | 56 (36.8) | 24 (35.8) | 8 (29.6) | 8 (29.6) | 16 (51.6) | |
| Popliteal-popliteal | 2 (1.32) | 0 | 1 (3.70) | 1 (3.70) | 0 | |
| Popliteal-tibial | 24 (15.8) | 11 (16.4) | 7 (25.9) | 4 (14.8) | 2 (6.45) | |
| Popliteal-pedal | 4 (2.63) | 3 (4.48) | 1 (3.70) | 0 | 0 | |
| Tibial-tibial | 2 (1.32) | 0 | 0 | 2 (7.41) | 0 | |
| Tibial-pedal | 1 (0.66) | 0 | 1 (3.70) | 0 | 0 | |
| Bypass Conduit | 0.17 | |||||
| Reversed GSV | 66 (43.4) | 34 (50.7) | 11 (40.7) | 9 (33.3) | 12 (38.7) | |
| Translocated GSV | 32 (21.1) | 13 (19.4) | 6 (22.2) | 6 (22.2) | 7 (22.6) | |
| In situ GSV | 4 (2.63) | 0 | 2 (7.41) | 2 (7.41) | 0 | |
| Spliced GSV | 18 (11.8) | 7 (10.4) | 4 (14.8) | 3 (11.1) | 4 (12.9) | |
| Spliced GSV/arm vein | 10 (6.58) | 1 (1.49) | 3 (11.1) | 2 (7.41) | 2 (6.45) | |
| Reversed arm vein | 9 (5.92) | 7 (10.4) | 0 | 2 (7.41) | 0 | |
| Prosthetic with vein cuff | 15 (9.87) | 5 (7.46) | 1 (3.70) | 3 (11.1) | 6 (19.4) | |
| Location of revision | 0.13 | |||||
| Proximal anastomosis | 69 (45.4) | 27 (40.3) | 9 (33.3) | 11 (40.7) | 21 (67.7) | |
| Mid-bypass | 32 (21.1) | 14 (20.9) | 7 (25.9) | 7 (25.9) | 4 (12.9) | |
| Distal anastomosis | 53 (34.9) | 26 (38.8) | 11 (40.7) | 9 (33.3) | 6 (19.4) |
PTA, plain balloon angioplasty; PCB, percutaneous cutting balloon; eDES, everolimus drug-eluting stent; DCB, drug-coated balloon; GSV, great saphenous vein
The most commonly used bypass intervention was PTA (44.1%, n=29), followed by DCB (20.4%, n=31), then PCB and eDES (both, 17.\8%, n=27). There were no significant differences in bypass configuration, conduit type, or location of the treated lesion between the treatment groups (all, P>0.05; Table 2).
Unadjusted Outcomes
The overall median follow-up time for all bypass graft interventions was 28.5 months (IQR 11.5–51.9), ranging from 15.0 (IQR 9.0–30.3) months for the DCB group to 48.3 (IQR 11.7–85.6) months for the PCB group. The estimated 24-month primary patency was highest for the eDES group (72.0%, 95% CI 49.8–85.6%), followed by PCB (55.9%, 95% CI 34.2–72.9%), PTA (34.4%, 95% CI 21.7–47.4%), and DCB (33.6%, 95% CI 14.5–53.9%) groups (P=0.03; Figure 1). A similar pattern was observed for PAP and secondary patency, although these did not quite reach statistical significance (P=0.065 and 0.051, respectively; Table 3). Limb salvage at 24 months ranged from 86.1% to 100%, and did not significantly differ between groups (P>0.05). Mortality occurred in 19.4% (n=14) patients overall, and did not significantly differ between groups (P>0.05).
Figure 1.
Kaplan-Meier curves* showing primary patency for interventions with plain balloon angioplasty (PTA), percutaneous cutting balloon (PCB), drug-coated balloon (DCB), and everolimus drug-eluting stent (eDES) for the treatment of infrainguinal bypass graft stenoses truncated at 24 months of follow-up *All SE < 0.10
Table 3.
Estimated 24-month outcomes (%, 95% CI) for bypass graft interventions
| 24-month Outcome | PTA N=67 | PCB N= 27 | DCB N=31 | eDES N=27 | P-value |
|---|---|---|---|---|---|
| Primary patency | 34.4 (21.7–47.4) | 55.9 (34.2–72.9) | 33.6 (14.5–53.9) | 72.0 (49.8–85.6) | 0.03 |
| Primary-assisted patency | 68.7 (54.0–97.6) | 84.2 (63.2–93.8) | 49.8 (26.3–68.9) | 86.4 (63.4–95.4) | 0.07 |
| Secondary patency | 73.5 (58.9–83.5) | 84.2 (63.2–93.8) | 48.7 (25.5–68.4) | 87.5 (66.1–95.8) | 0.051 |
PTA, plain balloon angioplasty; PCB, percutaneous cutting balloon; eDES, everolimus drug-eluting stent; DCB, drug-coated balloon
Cox Proportional Hazards Model
Based on univariate analysis, eDES was associated with a lower loss of primary patency compared to PTA (HR 0.33, 95% CI 0.15–0.74). Other patient factors associated with primary patency included patient age (HR 0.98, 95% CI 0.95–0.99) and chronic kidney disease/hemodialysis (HR 0.40, 95% CI 0.22–0.70). After adjusting for these risk factors as well as number of prior interventions, eDES remained significantly associated with lower loss of primary patency (HR 0.15, 95% CI 0.05–0.47). PCB (HR 0.30, 95% CI 0.10–0.87) and DCB (HR 0.32, 95% CI 0.14–0.71) were also significantly associated with lower loss of primary patency compared to PTA after risk adjustment (Table 4).
Table 4.
Cox proportional hazards models (HR, 95% CI) assessing covariates associated with loss of primary patency
| Univariate (HR, 95% CI) | Multivariable (HR, 95% CI) | |
|---|---|---|
| Age, per year | 0.98 (0.95–0.99) | 0.96 (0.93–0.99) |
| Sex | ||
| Female | Ref | -- |
| Male | 0.95 (0.60–1.53) | -- |
| Race | ||
| White | Ref | -- |
| Black | 0.88 (0.55–1.41) | -- |
| Other | 0.67 (0.21–2.18) | -- |
| Body mass index, per kg/m2 | 1.01 (0.98–1.04) | -- |
| Diabetes | 0.95 (0.58–1.56) | -- |
| Coronary artery disease | 0.64 (0.40–1.03) | -- |
| Congestive heart failure | 0.92 (0.56–1.52) | -- |
| Hypertension | 0.56 (0.24–1.29) | -- |
| Hyperlipidemia | 0.87 (0.47–1.59) | -- |
| Chronic kidney disease/Hemodialysis | 0.40 (0.22–0.70) | 0.35 (0.17–0.72) |
| ≥2 comorbidities | 0.65 (0.33–1.28) | -- |
| Smoking | ||
| Never | Ref | -- |
| Former | 1.08 (0.61–1.92) | -- |
| Current | 0.98 (0.49–1.94) | -- |
| ASA Class | ||
| 2 | Ref | -- |
| 3 | 0.70 (0.40–1.20) | -- |
| Number of prior revisions, per revision | 0.86 (0.62–1.21) | 1.13 (0.58–2.21) |
| Inflow | ||
| Femoral | Ref | -- |
| Popliteal | 0.99 (0.60–1.65) | -- |
| Outflow | ||
| Popliteal | Ref | -- |
| Tibial/pedal | 0.85 (0.53–1.36) | -- |
| Conduit type | ||
| Vein | Ref | -- |
| Prosthetic | 1.94 (0.99–3.79) | -- |
| Type of revision | ||
| PTA | Ref | Ref |
| PCB | 0.57 (0.29–1.11) | 0.30 (0.10–0.87) |
| DCB | 0.66 (0.36–1.20) | 0.32 (0.14–0.71) |
| eDES | 0.33 (0.15–0.74) | 0.15 (0.05–0.47) |
PTA, plain balloon angioplasty; PCB, percutaneous cutting balloon; DCB, drug-coated balloon; eDES, everolimus drug-eluting stent
Sensitivity Analysis
The median follow-up time for the PTA, PCB, and eDES groups was 34.5 months (IQR 11.7–53.0 months). In a sensitivity analysis where post-intervention follow-up time was increased to 35 months (removing the DCB group), eDES was associated with significantly higher primary patency compared to both PCB and PTA (P=0.006; Figure 2). On univariate analysis, eDES was associated with a significantly lower loss of primary patency compared to PTA (HR 0.20, 95% CI 0.07–0.59). Other patient factors associated with primary patency included coronary artery disease (HR 0.36, 95% CI 0.16–0.80), and chronic kidney disease/hemodialysis (HR 0.30, 95% CI 0.14–0.66). After risk adjustment, eDES was associated with a persistently lower loss of primary patency (HR 0.19, 95% CI 0.07–0.52; Appendix Table A).
Figure 2.
Kaplan-Meier curves* showing primary patency for interventions with plain balloon angioplasty (PTA), percutaneous cutting balloon (PCB), and everolimus drug-eluting stent (eDES) for the treatment of infrainguinal bypass graft stenoses extended to 35 months of follow-up *All SE < 0.10
Discussion
The use of endovascular interventions to address infrainguinal bypass graft stenoses is becoming increasingly common. As new endovascular technologies arise, there are more options to utilize in an attempt to improve patency outcomes over traditional methods. In the current study, we aimed to assess the primary patency outcomes for a cohort of institutional patients treated with PTA, PCB, DCB, and eDES over the past 11 years. We found that, at 24 months of follow-up, absolute primary patency rates were best for bypass lesions treated with eDES, followed by PCB, PTA, and DCB. After risk adjustment, eDES had persistently better outcomes compared to the other modalities, but PCB and DCB had a lower risk of primary patency loss than PTA. In a sensitivity analysis limited to technologies with longer follow-up, eDES continued to show better patency outcomes compared to PCB and PTA. Overall, these data suggest that eDES are a safe and feasible tool for the treatment of infrainguinal bypass graft stenoses.
The 24-month primary patency of bypass graft interventions ranged from 33.6% to 72.0% depending on the technology used. These patency rates are aligned with previously published studies on this topic. Twelve month patency is most commonly reported among prior studies, and has ranged from 36% to 66% for PTA3, 5, 11, 48% to 70% for PCB, 58% to 87% for DCB2, 7, 9, and 88% to 90% for DES8, 9. In a study by Schneider et al., that reported 2-year outcomes for open surgery, PCB, and PTA, primary patency rates were 74%, 62%, and 34%, respectively3. There are no studies that we know of that compare all four endovascular treatment modalities out to 2 years of follow-up. There is also a paucity of data on the use of DES for the treatment of infrainguinal bypass graft stenoses. Our data suggest that eDES have real, practical applications for this pathology, and possibly better outcomes compared to alternative technologies.
Although PCB and DCB were not superior to PTA on univariate analysis, both technologies were associated with a lower loss of primary patency out to 24 months compared to PTA after risk adjustment. This finding likely reflects some of the treatment bias inherent in this retrospective study; patients with lower-risk lesions or less complicated physiologic states may be treated with PTA, whereas PCB and DCB are reserved for higher-risk lesions. The same observation holds true for eDES; the risk of primary patency loss was one-third that of PTA on univariable analysis, and decreased to one-sixth that of PTA after risk adjustment. Most previous work evaluating the use of endovascular technologies for treating bypass graft stenoses have not employed the use of multivariable models to evaluate their outcomes4, 6, 7. By accounting for baseline differences between groups, we show that the treatment differences for PTA compared to alternative therapies are even greater than originally reported.
Our previous study evaluated primary patency outcomes out to 26 months of follow-up, but only included 15 lesions in the eDES group9. In our current sensitivity analysis, we reported outcomes out to 35 months, and included 27 lesions treated with eDES. Even with longer follow-up, the patency benefits we observed for eDES were persistent. There were no failures in the eDES group after 12 months of follow-up, suggesting good long-term patency of eDES after an initial period of risk. We currently keep all patients on dual antiplatelet therapy (or clopidogrel and anticoagulation if they were on pre-existing anticoagulation) indefinitely following any bypass graft intervention given the high-risk of failure in a bypass with a previous stenosis12. Given the stability in patency we are seeing long-term in eDES, it is unclear whether we may be able to relax this practice to better align with post-percutaneous coronary intervention guidelines moving forward.
It is notable that we have chosen to use everolimus DES (eDES) for our stenting interventions related to bypass graft stenoses. The prior study that reported 90% one-year patency in 11 patients treated with DES for bypass graft stenoses used exclusively paclitaxel DES (Zilver PTX, Cook Medical Inc., Bloomington IN)8. Everolimus- or sirolumus-eluting technology is preferred over paclitaxel-eluting technology in the treatment of coronary artery disease due to a higher risk of reintervention and stent thrombosis observed with paclitax-eleluting stents13–15. Paclitaxel is an antimicrotuble agent that inhibits smooth muscle cell proliferation and migration16. Everolimus and sirolimus are mTOR (mammalian target of rapamycin) inhibitors, which suppress cell proliferation and trigger autophagy17. Paclitaxel-eluting technologies (DCB and DES) are still predominantly used in the treatment of peripheral artery disease due to the better bioavailability observed with paclitaxel compared to the mTOR inhibitors18. We began using eDES as a salvage intervention for recalcitrant bypass graft stenoses, and because of the smaller diameter and shorter stent lengths available in coronary artery stents, we favored eDES over traditional femoropopliteal paclitaxel-eluting stents. After our prior publication showing good preliminary outcomes with eDES9, we have started using the technology more liberally for the treatment of infrainguinal bypass graft stenoses. The current analysis reinforces this decision, and we now use eDES more liberally as long as anatomic constraints allow. We avoid the use of eDES for bypass grafts that are tunneled subcutaneously, or for stenoses located at a join (e.g. knee, ankle) or pedal artery that may result in stent fracture. For lesions in these high-risk locations, PCB or DCB is preferred.
There are some limitations to our study. Our patient cohort consists of 72 patients with 152 bypass graft lesions. We clustered by patient in our multivariable analysis to account for this, and also included number of prior bypass revisions as a covariate in our multivariable models. However, there is likely some residual confounding by patient and by treatment bias that we were unable to account for. Our study size is relatively small, although larger than most other studies on this topic. We found significant differences in primary patency between groups that suggests adequate power for our primary outcome, but given the point estimates and confidence intervals for our secondary outcomes we were likely underpowered to detect significant differences in those analyses. Furthermore, there was crossover between groups such that patients who initially had PTA, PCB or DCB may have had an eDES to maintain PAP or SP. We tried to account for this in our multivariable model by adjusting for number of prior interventions but there may still be some residual confounding present. In addition, our secondary outcomes may not represent the initial therapy chosen and may simply represent the patency rates of the eDES. PCB based on prior concerns19, although more recent data suggest that paclitaxel-related mortality concerns are largely resolved20. We included a broad range of bypass graft configurations and conduits. Inflow and outflow vessel and conduit type were not significantly associated with primary patency in our analysis, but given the large number of variations we included we were likely underpowered to detect subtle differences between these groups. Finally, we did not collect information on procedures costs in this study. It is important to acknowledge that the cost of using eDES to treat failing bypass grafts is likely higher than that of other technologies, and deserves consideration.
Conclusion
We found that eDES are associated with excellent primary patency out to 35 months post-intervention. PCB and DCB were associated with improved primary patency compared to PTA out to 24 months of follow-up after risk adjustment. These data support the concept that eDES are a safe and effective management strategy for the treatment of infrainguinal bypass graft stenoses, and should be considered for as a primary treatment modality for infrainguinal bypass graft stenoses rather than limited to bypass stenosis salvage.
Supplementary Material
Source of Funding:
No specific funding was utilized for this work. Dr. Hicks is supported by a grant from the NIH/NIDDK (K23DK124515).
Footnotes
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Presented at the 2022 Annual Winter Meeting of the VESS, Jan. 2022, Aspen CO; Podium Presentation.
Disclosures: The authors have no relevant conflicts of interest to disclose.
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