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^ CLINICAL

INVESTIGATION ——————————————————————————

^

Midterm Outcomes of Subintimal Angioplasty Supported by Primary Proximal Stenting for Chronic Total Occlusion of the Superficial Femoral Artery Sung-Jin Hong, MD; Young-Guk Ko, MD; Jung-Sun Kim, MD, PhD; Myeong-Ki Hong, MD, PhD; Yangsoo Jang, MD, PhD; and Donghoon Choi, MD, PhD Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea ^

^

Purpose: To investigate the midterm outcomes of subintimal angioplasty in occluded superficial femoral arteries (SFA) and evaluate the clinical and procedural factors affecting these results. Methods: Between April 2004 and April 2012, 150 patients (122 men; mean age 69610 years) with chronic total occlusions in the SFA underwent subintimal angioplasty with primary stenting in 172 limbs. The average lesion length was 22.668.5 cm. Stents were routinely implanted at the proximal entry into the subintimal channel. The primary endpoint was binary restenosis. Results: Technical success was achieved in 161 (94%) limbs; there were no procedurerelated deaths or complications requiring surgery, but distal embolization and arterial perforation occurred in 2 and 4 limbs, respectively. The cumulative freedom from binary restenosis rates at 1 and 3 years were 77% and 59%, respectively, in the entire study group. The 96 patients without critical limb ischemia (CLI) had significantly higher patency rates at 1 and 3 years (84% and 66%, respectively) than the 54 patients with CLI (66% and 43%, respectively; p¼0.011). Based on multivariate analysis, a larger number of stents, lower post-procedure ankle-brachial index, and lower body mass index were each independent predictors of binary restenosis. Conclusion: Subintimal angioplasty with routine stenting at the proximal stump is safe and effective for the treatment of chronic total SFA occlusions. J Endovasc Ther. 2013;20:782–791 Key words: subintimal angioplasty, peripheral occlusive disease, superficial femoral artery, chronic total occlusion, critical limb ischemia, stent, primary stenting, intimal flap, restenosis, target lesion revascularization ^ ^

Intentional subintimal angioplasty (SA) has been increasingly utilized over the past two decades and is now an acceptable alternative technique for revascularization of chronic

total occlusion (CTO), especially in the superficial femoral artery (SFA).1–3 However, the results of primary patency after SA in SFA occlusive lesions vary widely, and most

The Healthcare Technology R&D Project, Ministry for Health, Welfare & Family Affairs, Republic of Korea (No. A085012, A000385, A110879, and A120478); the Korea Health 21 R&D Project, Ministry of Health & Welfare, Republic of Korea (No. A085136); and the Cardiovascular Research Center, Seoul, Korea. Drs. Sung-Jin Hong and Young-Guk Ko equally contributed to the preparation of this manuscript and have shared first authorship. The authors declare no association with any individual, company, or organization having a vested interest in the subject matter/products mentioned in this article. Corresponding author: Donghoon Choi, MD, PhD, Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, 250 Seongsanno, Seodaemun-gu, Seoul 120–752, Korea. E-mail: [email protected] Q 2013 by the INTERNATIONAL SOCIETY

OF

ENDOVASCULAR SPECIALISTS

Available at www.jevt.org

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studies report only relatively short-term outcomes.4 Furthermore, there are limited data on the outcomes of SA combined with stenting; previous reports have investigated various stenting methods, such as primary vs. provisional stenting or full coverage vs. spot stenting.5–10 We previously reported favorable 1-year outcomes of stent-supported SA for CTO of the SFA.11,12 Our stenting strategy after SA involved the routine implantation of stents at the proximal stump of the SFA CTO in order to keep the entry into the subintimal channel open. We avoided covering the distal SFA or popliteal artery with stents because of increased stent fracture risk at this site. The purpose of the present study was to investigate midterm outcomes after SA supported with primary proximal stenting in SFA CTOs and determine the clinical and procedural factors affecting these results.

METHODS Study Design and Subjects A retrospective review was conducted of electronic and hospital records to identify all patients with claudication or critical limb ischemia (CLI) treated with balloon angioplasty and stent implantation between April 2004 and April 2012 at Severance Cardiovascular Hospital, Yonsei University Health System. The institutional review board at approved this study and waived requirements for informed consent for this retrospective analysis. The search identified 469 patients meeting the initial search parameters. This population was further culled to select only patients undergoing intentional SA and primary proximal stump stenting in SFA occlusions. This sampling produced 150 patients (122 men; mean age 69610 years) who underwent SA/ stenting for CTOs in the SFA of 172 limbs. All patients had a baseline physical evaluation, ankle-brachial index (ABI) measurement, and at least one imaging study including computed tomographic angiography (CTA), magnetic resonance angiography, or duplex ultrasound. Ninety-six patients (110 limbs) had moderate to severe claudication

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(Rutherford categories 2–3), and 54 patients (62 limbs) had CLI (Rutherford categories 4–6, Table 1). The mean length of the target lesions was 22.668.5 cm (range 546), and all lesions were totally occluded. Most lesions were TASC II (TransAtlantic Inter-Societal Consensus II) classification type C (19%) or type D (70%).

Angioplasty Procedure All procedures were performed under local anesthesia supplemented with intravenous sedation and analgesia when required. Systemic heparin (5000 units) was administered to achieve an activated clotting time .250 seconds. Either ipsilateral or contralateral femoral puncture was performed, depending on the distance to the target lesion. A 7-F introducer sheath (Terumo, Tokyo, Japan) was used for the ipsilateral approach, while a 6- to 8-F contralateral sheath (Balkin; Cook Inc., Bloomington, IN, USA) was employed for the crossover approach. A 0.035-inch hydrophilic guidewire (Radifocus; Terumo) and a supporting 5-F multipurpose catheter (Torkon NB; Cook Inc.) were used to cross the totally occluded lesion. The creation of a subintimal channel at the proximal stump of the occlusion was intentionally performed with a straight 0.035-inch hydrophilic guidewire that was then advanced distally using a loop formed at the tip. The loop of wire and catheter were advanced through the subintimal plane until the occlusion was passed and the wire re-entered the true lumen. The Outback LTD reentry catheter (Cordis, Bridgewater, NJ, USA) was used when the guidewire failed to enter into the true lumen. After the subintimal passage of the guidewire through the CTO, the target artery was dilated with a 5- or 6-mm-diameter balloon. A 6- to 8-mm-diameter self-expanding nitinol stent [S.M.A.R.T. (Cordis); Zilver (Cook); Complete SE (Medtronic, Santa Rosa, CA, USA); or Absolute Pro (Abbott Vascular, Redwood City, CA, USA)] was always deployed into the subintimally created channel at the proximal entry site, with about 1 to 2 cm of the stent protruding proximally into the normal artery. Deployed stents were dilated for better apposition, and the pressure gradient over

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^

^ TABLE 1 Baseline Demographics, Risk Factors, and Lesion Characteristics of 150 Patients Undergoing Treatment for SFA CTO in 172 Limbs Variables Demographics Age, y Men Body mass index, kg/m2 Risk factors Hypertension Diabetes mellitus Coronary artery disease History of smoking Dyslipidemia Chronic kidney disease Rutherford category 2 3 4 5 6 Lesion characteristics Mean lesion length, cm Level of SFA lesion Proximal Mid Distal Lesion type (TASC II) B C D Right/left side Runoff vessels 0 or 1 2 3 Ankle-brachial index Pre-procedure Post-procedure Number of stents 1 2 3 Stent diameter, mm 6 7 8 Stented length, cm

Total (n¼150) 69610 122 (81%) 22.663.3 105 70 95 72 46 25

(70%) (47%) (63%) (48%) (31%) (17%)

No CLI (n¼96)

CLI (n¼54)

69610 81 (84%) 22.762.8

70611 41 (76%) 21.363.2

65 40 65 53 33 12

(68%) (42%) (68%) (55%) (34%) (13%)

40 30 40 19 13 14

p 0.425 0.202 0.025

(74%) (56%) (74%) (35%) (24%) (26%)

0.414 0.102 0.414 0.018 0.189 0.037

14 (8%) 96 (56%) 24 (14%) 36 (21%) 2 (1%) (n¼172) 22.668.5

14 (13%) 96 (88%) 0 0 0 (n¼110) 21.768.6

0 0 24 (33%) 36 (50%) 2 (3%) (n¼62) 24.068.3

,0.001

128/172 (74%) 35/172 (20%) 9/172 (5%)

77/110 (70%) 25/110 (23%) 8/110 (7%)

51/62 (82%) 10/62 (16%) 1/62 (2%)

0.130

19/172 (11%) 32/172 (19%) 121/172 (70%) 77/95

16/110 (15%) 22/110 (20%) 72/110 (66%) 48/62

3/62 (5%) 10/62 (16%) 49/62 (79%) 29/33

0.093

59/172 (34%) 46/172 (27%) 67/172 (39%)

23/110 (21%) 30/110 (27%) 57/110 (52%)

35/62 (57%) 17/62 (27%) 10/62 (16%)

,0.001

0.4760.16 0.8160.20

0.5060.16 0.8460.17

0.4060.15 0.7360.23

,0.001 0.004

132/172 (77%) 35/172 (21%) 5 (2%)

88/110 (80%) 20/110 (18%) 2/110 (2%)

44/62 (71%) 15/62 (24%) 3/62 (5%)

0.306

30 (19%) 76 (47%) 20 (35%) 12.867.3

16 (16%) 52 (51%) 35 (34%) 12.066.4

14 (24%) 24 (41%) 20 (35%) 14.268.4

0.345

0.089

0.691

0.091

^

^ Continuous data are presented as the means 6 standard deviation; categorical data are given as the counts (percentage). CLI: critical limb ischemia, SFA: superficial femoral artery, TASC: TransAtlantic Inter-Society Consensus.

the treated lesion was measured. If there was a significant residual stenosis (.30%), a flowlimiting dissection, or a pressure gradient .20 mmHg in the unstented segment, additional stents were implanted, with overlapping of

contiguous stents. After successful recanalization, all patients received a combination of aspirin (100 mg/d) and clopidogrel (75 mg/d) with or without additional cilostazol (200 mg/d) for at least 1 year.

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Figure 1 ^ (A,B) An 85-year-old woman with severe claudication (Rutherford 3) for 6 months underwent subintimal angioplasty supported by primary proximal stenting for a 20-cm SFA CTO. The final angiogram (C) showed successful recanalization of the SFA. The stent and subintimal tract of the SFA were patent by CTA at 1.5 (D) and 2.5 (E) years of follow-up (FU).

Follow-up All patients underwent noninvasive hemodynamic evaluations before discharge, including measurement of ABI, segmental pressures, and pulse volume recordings. Patients were seen 1 month after the procedure and then at 3-month intervals for a physical examination. Noninvasive hemodynamic evaluations were repeated at 1-year intervals or if symptom status deteriorated. At least one imaging study, such as CTA, duplex ultrasound, or intra-arterial angiography, was performed in the event of either a .0.15 decrement in the ABI on follow-up pulse volume recordings or worsening symptoms reflected by one Rutherford category change.

Study Endpoints and Definitions Each outcome was defined in accordance with the report from the DEFINE Group for peripheral endovascular revascularization trials. 13 Technical success was defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with ,30% residual diameter reduction of the treated lesion on

completion angiography. A major complication was defined as any event that was fatal or that required surgical management or rehospitalization within 30 days of the procedure. The primary endpoint was binary restenosis (50% narrowing at the target lesion site) as assessed by intra-arterial angiography, CTA, or duplex ultrasound. Peak velocity .180 cm/s or a lesion/adjacent segment velocity ratio .2.4 by duplex was considered to indicate a significant (50%) restenosis. Secondary endpoints included target lesion revascularization (TLR) and major adverse events (MAE), defined as a composite of all death and major amputation, planned and unplanned.

Statistical Analysis Data relating to mortality and MAE were analyzed on an intention-to-treat basis, while restenosis and TLR outcomes were based on patients having a technically successful procedure. Continuous data are presented as mean 6 standard deviation or median (interquartile range, IQR) and categorical data as counts (percentage). Baseline clinical and lesion characteristics were compared between the patients with CLI vs. without CLI

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using a Student t test for continuous data or Fisher exact test for categorical data. Primary and secondary endpoints were estimated using Kaplan-Meier survival analysis and compared by log-rank test; outcomes are reported as the cumulative rates of freedom from binary restenosis, TLR, and MAE. Multivariate analysis was performed using Cox proportional hazards regression, entering clinically important variables (e.g., age, sex) and variables achieving p,0.1 on univariate analysis into the model to determine independent predictors for the primary endpoint (binary restenosis). The area under the receiver operating characteristic (ROC) analysis was used to identify the optimal value of postprocedure ABI that was significant on multivariate analysis for predicting binary restenosis. Findings were considered significant at p,0.05. All statistical analyses were performed with SPSS software (version 18.0; IBM Corporation, Somers, NY, USA).

deployed (Table 1). Nearly half of the 161 limbs (78, 48%) required stenting at the bifurcation of the common femoral artery (CFA). Of these, 47 limbs had stents covering the deep femoral artery (DFA), 19 limbs were stented at just the bifurcation without covering the DFA (placement of the proximal edge of the stent at the carina), and the other 12 limbs were stented distal to the bifurcation without covering the DFA. After successful procedures, the ABI was increased from 0.4760.16 at baseline to 0.8160.20 (p,0.001). There were no procedure-related deaths or complications requiring surgery. However, 2 flow-limiting distal embolizations were treated successfully with aspiration or catheterbased administration of thrombolytic agents. Four arterial perforations occurred; 3 were managed conservatively and the other was successfully treated with a covered stent.

RESULTS

All 150 patients were followed for a median of 18 months (IQR 6–44). During that time, 17 patients died from ischemic heart disease (n¼4), heart failure (n¼1), pneumonia or urinary tract infection (n¼8), malignancy (n¼3), and trauma (n¼1). Despite a successful SA, 2 CLI patients had planned major amputations (above-knee and below-knee, respectively). Three patients with successfully treated CLI limbs had minor amputations (one planned). Therefore, MAE-free survival rates at 1 and 3 years were 94% and 89%, respectively (Fig. 2A): 95% and 92% in patients with claudication and 87% and 82% in the patients with CLI (p¼0.149).

Immediate Procedure Outcomes The technical success rate was 94% (161/172 limbs). An Outback reentry catheter was used in 6 limbs and was successful in all cases. The failures occurred in 7 limbs (7/110, 6%) in the patients without CLI and 4 limbs (4/62, 6%) in the patients with CLI. Failure was due to inability to enter or progress within the subintimal channel (4 limbs) or to reenter the true lumen in 7 heavily calcified vessels. Three of these failed patients underwent surgical bypass procedures, 7 had no further intervention, and 1 had another SA procedure that was successful at 6 months after the first procedure. All technically successful cases were treated with implantation of at least one stent at the proximal stump to keep the entry into the subintimal channel open (Fig. 1). Forty limbs (25%) were stented additionally beyond the proximal stump for suboptimal angioplasty with residual stenosis .30% or flow-limiting dissections. Of these 40 limbs, 13 also required stents at the distal reentry site. Overall, 35 limbs required 2 stents (overlapping in 17 limbs), and 5 limbs had 3 overlapping stents

Follow-up

Restenosis and TLR Analysis Among the 161 limbs with technical success (103 limbs without CLI, 58 limbs with CLI), 141 patients were followed for a median period of 15 months (IQR 5–40). During this time, 57 (35%) limbs exhibited binary restenosis of the target lesions (34 limbs without CLI and 23 with CLI). The majority of these were occlusions (47 limbs: 28 without CLI and 19 with CLI). Forty-eight of the 57 recurrences were instent restenoses (30%).

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Figure 2 ^ Kaplan-Meier estimates of freedom from (A) major adverse events (MAE), (B) binary restenosis, (C) reocclusion, and (D) target lesion revascularization (TLR); the standard errors exceeded 10% at 4.8, 3.8, 3.2, and 3.4 years, respectively.

The overall cumulative rates for freedom from binary restenosis at 1 and 3 years were 77% and 59% (Fig. 2B). According to symptom status, the patients without CLI had significantly higher rates (84% and 66%) than CLI patients (66% and 43%; p¼0.011). Also, the cumulative rates for freedom from reocclusion (Fig. 2C) at 1 and 3 years were 84% and 67% (patients without CLI 87% and 74% vs. 77% and 49% for CLI patients).

Of 57 limbs with binary restenosis, 12 limbs were treated medically due to either patient refusal of surgery or poor medical status, 10 limbs underwent surgery, and 35 limbs underwent repeat percutaneous revascularization (45 interventions, 30%). Among the 35 repeat procedures, 33 (94%) were successful; 2 cases failed because the wire could not pass the CTO. Also, among the 35 limbs with repeated percutaneous revascularization,

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^

^ TABLE 2 Univariate and Multivariate Analysis of Binary Restenosis Univariate Age Female gender Body mass index Diabetes Hypertension Chronic kidney disease Smoking Critical limb ischemia Post-procedure ABI Lesion length Runoff vessels 1 Number of stents 2 Stent diameter

1.04, 1.49, 0.91, 0.97, 0.98, 1.62, 1.10, 1.97, 0.05, 1.00, 2.36, 2.50, 0.79,

1.01 0.79 0.84 0.58 0.57 0.82 0.66 1.16 0.01 1.00 1.39 1.39 0.53

to to to to to to to to to to to to to

1.08 2.82 0.99 1.64 1.70 3.18 1.87 3.36 0.20 1.01 3.99 4.50 1.17

(0.018) (0.221) (0.022) (0.921) (0.946) (0.166) (0.699) (0.013) (,0.001) (0.156) (0.001) (0.002) (0.240)

Multivariate 1.01, 0.97 to 1.04 (0.764) 1.76, 0.77 to 4.03 (0.177) 0.90, 0.81 to 1.00 (0.041)

1.30, 0.66 to 2.57 (0.449) 0.15, 0.03 to 0.75 (0.020) 1.92, 0.94 to 3.92 (0.072) 2.44, 1.19 to 5.03 (0.015)

^

^ Data are given as the hazard ratio, 95% confidence interval (p). ABI: ankle-brachial index.

stent fracture was observed in 7 limbs. Thus, the overall rates of TLR (Fig. 2D) at 1 and 3 years were 84% and 72% (87% and 71% for patients without CLI vs. 81% and 53%, respectively, for patients with CLI).

Predictors for Binary Restenosis As determined by univariate analysis (Table 2), predictors for binary restenosis were age (HR 1.04, 95% CI 1.01 to 1.08, p¼0.018), lower BMI (HR 0.91, 95% CI 0.84 to 0.99, p¼0.022), presence of CLI (HR 1.97, 95% CI 1.16 to 3.36, p¼0.013), lower post-procedure ABI (HR 0.05, 95% CI 0.01 to 0.20, p,0.001), fewer runoff vessels (HR 2.36, 95% CI 1.39 to 3.99, p¼0.001), and a higher number of stents (HR 2.50, 95% CI 1.39 to 4.50, p¼0.002). Multivariate analysis determined lower BMI, lower post-procedure ABI, and a higher number of stents to be independent predictors of binary restenosis (Table 2). A post-procedure ABI cutoff of 0.8 was identified as the optimal value for predicting binary restenosis using ROC analysis (area under the curve 0.679, 95% CI 0.58 to 0.78; sensitivity 69%, specificity 62%; p¼0.001, Fig. 3). Kaplan-Meier analysis based on this threshold showed that patients who had ABI ,0.8 after the procedure had a significantly higher rate of binary restenosis (p¼0.001).

DISCUSSION The present study demonstrates that intentional SA with routine stent implantation at the proximal stump is effective for the treatment of chronic total SFA occlusions with a high rate of technical success and satisfactory freedom from binary restenosis both in the patients with severe claudication and CLI. Further, additional stenting beyond the proximal stump, with longer total stented length, was related to binary restenosis; lower BMI and post-procedure ABI were other independent predictors for binary restenosis. Subintimal angioplasty is an acceptable technique for the revascularization of long, totally occluded lesions, especially in the SFA,1,2 with similar technical success rates reported across the majority of published studies.4 However, little work is published investigating how various stenting strategies in combination with SA may improve patency (Table 4).5–10,12 Treiman et al.5 reported that routine stenting of the entire length of the lesion after SA resulted in primary patency as low as 18% after 3 years, even though the primary patency rates were as high as 85% and 64% at 1 and 2 years. Another study by Boufi et al.6 demonstrated that combining SA with a stent-graft along the entire subintimal tract did not improve patency when compared to not receiving a stent. The primary patency

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Figure 3 ^ Kaplan-Meier estimates of freedom from binary restenosis (right) based on a post-procedure ankle-brachial index (ABI) threshold of 0.8 derived from an ROC analysis (left, see text). Patients who had ABI ,0.8 after the procedure had significantly higher binary restenosis than those who had ABI 0.8. The standard error of the Kaplan-Meier curves did not exceed 10% within 5 years.

rates of bailout stenting at 1 and 2 years ranged from 55% to 97% and 42% and 94%, respectively.7–10,14 In the present study, the 1 and 3 years rates for freedom from restenosis (77% and 59%, respectively) were comparable to previous studies.5–10,14 Furthermore, our outcomes were superior compared with the data from Antusevas et al.9 As we reported, we routinely implanted a stent at the proximal stump to keep the entry into the subintimal channel open, and we tried not to cover long lesions with multiple stents because we wanted to avoid stent fractures or difficulties during future bypass surgery.11,12 We believe this strategy of stenting might help improve outcomes of SA. However, it is noteworthy that implanting .2 stents was associated with binary restenosis, which suggests that implanting more stents beyond the proximal stump might increase the likelihood of reocclusion. Similar to our findings, Siablis et al.10 recently reported that stenting showed good initial outcome, with a primary patency of 80% at 1 year, but full-lesion stenting was independently associated with 6-fold greater binary restenosis. In contrast, selective implantation of stents either in the subintimal entry or true lumen re-entry sites was linked to a decreased rate of restenosis.10 Further

studies are needed to elucidate the reasons why more stents in the subintimal tract are associated with poor outcomes. In our study, 78 limbs were stented at the CFA bifurcation. Whether or not to cover the DFA is a common concern in stenting ostial SFA lesions. More than half of our CFA stents covered the DFA, but flow limitation was observed in only 5 limbs in which the DFA was covered and another 3 in which it was not. Also, when binary restenosis was compared according to the stenting strategies, there were no differences between the groups, although the numbers were too small to have statistical significance. Univariate analysis in our study confirmed that a higher number of patent runoff vessels is important for patency after SA, consistent with previous studies.3,15,16 This finding suggests the need to recanalize runoff vessels to improve patency. Further, we were able to show that a lower post-procedure ABI is linked with poor outcomes after SA, in agreement with previously published data.16 Surprisingly, other known risk factors, such as diabetes and small stent diameter, were not significant in our study,8,15–18 although a lower BMI was associated with binary restenosis. While two recent studies showed that increased BMI was inversely associated with

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^

^ TABLE 3 Binary Restenosis Rates From Published Studies of Stent-Assisted Subintimal Angioplasty Binary Restenosis, % Author 5

Treiman, 2006 Boufi, 20106 Lipsitz, 20037 Scott, 20078 Antusevas, 20089 Siablis, 201210 Ko, 200712

Lesion Location

Limbs

1 Year

2 Years

Stenting

FP FP Infrainguinal Infrainguinal FP FP FP

29 34 39 105 73 105 61

85 62 74 55 69 80 77

64 NR NR 43 66 42 NR

Primary: entire lesion Primary: entire lesion Bailout Bailout Bailout Bailout Primary: entry site

^

^ FP: femoropopliteal, NR: not reported.

mortality in patients with peripheral artery disease, most studies have not evaluated the effects of obesity or low weight on SA outcomes.19–21 The association between leaner body mass and a greater risk of binary restenosis, the obesity paradox, might be attributed to confounding factors, such as high frequencies of smoking, chronic obstructive lung disease, underweight status, and overall malnutrition, which are more common among lean individuals than heavier individuals.19 Our patients were generally lean, with a mean BMI of 22.6 kg/m2, and the combined proportion of overweight and obese patients was low at 18%. A larger study population leading to more statistical power is, therefore, required to confirm the obesity paradox regarding outcomes after SA.

Limitations First, this was a study of single-center registry data from a relatively small group of patients; it had the inherent limitations associated with a retrospective design and small patient cohort. Second, noninvasive testing in follow-up was less rigorously carried out than would be achieved in a prospective study. Third, we could not compare the routine placement of stents and provisional stenting or subintimal angioplasty alone. The present study showed only the outcomes after SA with routine stenting at the proximal stump; placement of additional stents was related to binary restenosis. A randomized study comparing routine stenting, selective stenting,

and no stenting is needed to define the role of these devices. Furthermore, a cost per quality-adjusted life-year analysis is needed to assess the use of additional stents on economic grounds.

Conclusion Intentional SA with routine stent implantation at the proximal stump is effective for the treatment of chronic total SFA occlusions, with a high technical success rate and few complications in patients with severe claudication or CLI. In addition, most procedures provided not only a high short-term freedom from binary restenosis but also satisfactory midterm outcomes. However, additional stenting beyond the proximal stump is related to higher binary restenosis rates; lower postprocedure ABI and lower BMI were independent predictors for binary restenosis. Acknowledgments: We gratefully acknowledge financial support for this study from the Healthcare Technology R&D Project, Ministry for Health, Welfare & Family Affairs, Republic of Korea; the Korea Health 21 R&D Project, Ministry of Health & Welfare, Republic of Korea; and the Cardiovascular Research Center, Seoul, Korea.

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STENT-SUPPORTED SUBINTIMAL ANGIOPLASTY Hong et al.

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Midterm outcomes of subintimal angioplasty supported by primary proximal stenting for chronic total occlusion of the superficial femoral artery.

To investigate the midterm outcomes of subintimal angioplasty in occluded superficial femoral arteries (SFA) and evaluate the clinical and procedural ...
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