Contemporary Outcomes After Endovascular Treatment for Aorto-Iliac Artery Disease

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1 Circulation Journal Official Journal of the Japanese Circulation Society ORIGINAL ARTICLE Peripheral Vascular Disease Contemporary Outcomes After Endovascular Treatment for Aorto-Iliac Artery Disease Yoshimitsu Soga, MD; Osamu Iida, MD; Daizo Kawasaki, MD; Yasutaka Yamauchi, MD; Kenji Suzuki, MD; Keisuke Hirano, MD; Ryoji Koshida, MD; Daisuke Kamoi, MD; Junichi Tazaki, MD; Michiaki Higashitani, MD; Yoshiaki Shintani, MD; Terutoshi Yamaoka, MD; Shinya Okazaki, MD; Nobuhiro Suematsu, MD; Taketsugu Tsuchiya, MD; Yusuke Miyashita, MD; Norihiko Shinozaki, MD; Hiroki Takahashi, MD; on behalf of REAL-AI investigators Background: The patency and complications in aorto-iliac (AI) stenting remain poorly understood. The aim of this paper was to investigate the safety and efficacy after AI stenting. Methods and Results: This study was performed as a large-scale multicenter, retrospective registry. A total of 2,147 consecutive patients with AI disease were enrolled. The safety endpoints were procedure success, complications and 30-day mortality. The efficacy endpoints were primary, assisted primary and secondary patency, overall survival, freedom from major adverse cardiovascular events (MACE; all-cause death, myocardial infarction and stroke), and major adverse cardiovascular and limb events (MACLE; any repeat revascularization for limb and leg amputation in addition to MACE). Procedure success, complication rate and 30-day mortality were 97.6%, 6.4% and 0.7%. Primary patency was 92.5%, 82.6% and 77.5% at 1, 3 and 5 years, assisted primary patency was 97.0%, 92.7% and 91.9% at 1, 3 and 5 years and secondary patency was 99.0%, 98.7% and 98.5% at 1, 3 and 5 years. The overall survival rate was 95.0%, 87.6%, and 79.3% at 1, 3 and 5 years. The cause of death was cardiovascular in 44.1%. Freedom from MACE (MACLE) was 93.3% (89.9%), 84.4% (76.7%), and 74.9% (66.8%) at 1, 3 and 5 years. Female gender, diabetes, renal failure, absence of aspirin, reference vessel diameter <8.0 mm and outflow lesion were found to be independent predictors of primary patency. Conclusions: The safety and efficacy after AI stenting are feasible compared to surgical reconstruction. (Circ J 2012; 76: ) Key Words: Aorto-iliac disease; Endovascular therapy; Patency; Stents The incidence of peripheral artery disease (PAD) of the lower extremities is high worldwide and the number of patients with this disease is increasing. 1 There is also likely to be an increase in the success of endovascular therapy (EVT) for PAD because of recent improvements in diagnostic performance and therapeutic devices, 2 4 and the number of endovascular procedures performed has been increasing yearly. 5,6 Favorable results of EVT in the field of the iliac artery have been reported 7 9 and EVT is indicated for lesions of a single region according to the Inter-Society Consensus for the Man- Received April 15, 2012; revised manuscript received June 5, 2012; accepted July 9, 2012; released online August 2, 2012 Time for primary review: 22 days Department of Cardiology, Kokura Memorial Hospital, Kitakyushu (Y. Soga); Cardiovascular Center, Kansai Rosai Hospital, Amagasaki (O.I.); Cardiovascular Division, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya (D. Kawasaki); Department of Cardiology, Kikuna Memorial Hospital, Yokohama (Y.Y.); Department of Cardiology, Saiseikai Yokohama-city Eastern Hospital, Yokohama (K.H.); Department of Cardiology, Sendai Kosei Hospital, Sendai (K.S.); Department of Cardiology, Tokeidai Memorial Hospital, Sapporo (R.K.); Department of Cardiology, Nagoya Kyoritsu Hospital, Nagoya (D. Kamoi); Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto (J.T.); Department of Cardiology, Tokyo Women s Medical University, Tokyo (M.H.); Department of Cardiology, Juntendo University Nerima Hospital, Tokyo (S.O.); Department of Cardiology, Shin- Koga Hospital, Kurume (Y. Shintani); Department of Surgery, Matsuyama Red Cross Hospital, Matsuyama (T.Y.); Department of Cardiology, Fukuoka Red Cross Hospital, Fukuoka (N. Suematsu); Division of Cardiovascular Trans-catheter Therapeutics, Kanazawa Medical University Hospital, Kanazawa (T.T.); Department of Advanced PAD Therapeutics, Shinshu University, Matsumoto (Y.M.); Department of Cardiology, Tokai University Hospital, Isehara (N. Shinozaki); and Department of Cardiology, Pulmonology and Nephrology, Yamagata University School of Medicine, Yamagata (H.T.), Japan Mailing address: Yoshimitsu Soga, MD, Department of Cardiology, Kokura Memorial Hospital, Asano, Kokurakita-ku, Kitakyushu , Japan. sogacchy@yahoo.co.jp ISSN doi: /circj.CJ All rights are reserved to the Japanese Circulation Society. For permissions, please cj@j-circ.or.jp

2 2698 SOGA Y et al. Figure 1. Study flowchart. agement of Peripheral Arterial Disease (TASCII). 10 Endovascular therapy may also be effective for more complicated lesions, but lesions such as obstruction in an extended region consisting of the entire iliac artery, diffuse lesions, aorto-iliac (AI) bifurcation lesions, and infrarenal AI occlusive disease remain as major limitations of EVT, and the safety and efficacy of the procedure for such lesions have not been examined in detail. In addition, the patency and prognosis in patients with AI occlusive disease treated with EVT have not been evaluated, which is a concern because the prognosis of PAD patients is poor. 9,10 Herein we report the results of a study on the safety and efficacy of stent placement for infrarenal AI lesions. Methods Subjects The REtrospective multicenter AnaLysis of Aorto-iliac stenting (REAL-AI) registry is a multicenter registry in Japan enrolling consecutive patients undergoing stent placement for de novo lesion. Between January 2005 and December 2009, 11,583 patients were identified as having undergone endovascular procedures. A total of 2,809 patients underwent EVT for infrarenal AI disease and these patients comprise the study population. Of these patients, 713 were excluded because of asymptomatic or unknown symptom before EVT (53 patients), treatment with angioplasty alone (161 patients), restenotic lesions (125 patients), history of lower extremities bypass surgery or EVT (169 patients), acute onset limb ischemia (34 patients) or inadequate data (120 patients). Therefore, 2,147 patients who underwent EVT for de novo AI disease were identified retrospectively and analyzed with regard to the safety endpoints. Of them, 2,096 patients (2,601 lesions) who underwent successful stenting were analyzed for efficacy endpoints (Figure 1). All identified patients were analyzed for each endpoint without intentional seclusion. Demographic, angiographic and procedural data were collected from each hospital chart or database by independent researchers according to prespecified definitions. Follow-up data were obtained from hospital charts or by contacting patients, family members or referring physicians. The mean follow-up interval for the 1,858 survivors was 31.2±15.0 months. The research protocol was approved by the hospital ethics committees or relevant review boards in all 18 participating centers and the study was performed in accordance with the Declaration of Helsinki. Written informed consent was obtained from every patient. This study is registered with the University Hospital Medi-

3 Outcomes After Aorto-Iliac Stenting 2699 Table 1. Patient Characteristics N 2,096 Age (years) 71.3±7.5 Male 1,708 (81.5) BMI (kg/m 2 ) 22.2±2.6 Hypertension 1,609 (80.9) Dislipidemia 936 (44.7) Diabetes 1,007 (48.0) Insulin 330 (15.7) Renal failure 528 (25.2) Hemodialysis 377 (18.0) Smoker 1,417 (67.6) Current 770 (36.7) Previous 647 (30.9) Previous stroke 492 (23.5) CAD 1,051 (50.1) Heart failure 249 (11.9) LV dysfunction 202 (9.6) Rutherford class I/II/III/IV/V/VI 160/621/954/181/144/36 CLI 361 (17.2) Pre-procedural ABI 0.61±0.18 Post-procedural ABI 0.87±0.16 Medication Aspirin 1,812 (86.5) Thienopyridines 999 (47.7) Cilostazol 907 (43.3) Statins 794 (37.9) ACEI/ARB 1,134 (54.1) β-blockade 491 (23.4) Ca-antagonist 901 (43.0) Warfarin 254 (12.1) Data given as n (%) or mean ± SD. LV dysfunction was defined as <40% of LV ejection fraction. ABI, ankle-brachial index; ACEI, angiotensin-converting enzyme inhibitors; ARB, angiotensin receptor blockers; BMI, body mass index; CAD, coronary artery disease; CLI, critical limb ischemia; LV, left ventricular. Table 2. Lesion Characteristics No. lesions 2,601 Lesion location Aorta 13 (0.5) Common iliac artery 1,112 (43.9) External iliac artery 946 (36.4) Common to external iliac artery 498 (19.1) Aorto-iliac occlusion 32 (1.2) Outflow lesion Common femoral 119 (4.6) Femoropopliteal 867 (33.3) Infrapopliteal 279 (10.7) Lesion length (mm) 52.9±31.2 Reference vessel diameter (mm) 8.1±0.9 Pre-diameter stenosis (%) 78.9±16.6 Post-diameter stenosis (%) 20.7±7.58 Total stent length (mm) 68.1±33.9 Mean stent diameter (mm) 8.5±1.1 No. stents (per lesion) 1.2±0.4 Total no. stents 3,245 Use of stent Self-expandable stent 2,282 (70.3) Luminexx 452 SMART 1,683 Self X 67 Wall RP 80 Balloon-expandable stent 963 (29.3) Palmaz 348 Express LD 615 Chronic total occlusion 615 (23.6) Calcified lesion 1,348 (51.8) Aorto-iliac bifurcation lesion 246 (9.5) TASCII classification A/B/C/D 1,201/694/311/395 TASCII C/D (%) 706 (27.1) Data given as n (%) or mean ± SD. Calcified lesion defined as obvious densities noted within the apparent vascular wall in the angiogram. TASCII, Trans-Atrantic Inter-Society Consensus. cal Information Network-Clinical Trials Registry (UMIN-CTR), as accepted by the International Committee of Medical Journal Editors (No. UMIN ). Endpoints The safety endpoints were procedure success, complication rate and 30-day mortality. The efficacy endpoints were primary patency, assisted primary patency, secondary patency, overall survival, freedom from major adverse cardiovascular events (MACE; all-cause death, myocardial infarction [MI] and stroke) and freedom from major adverse cardiovascular and limb events (MACLE; any repeat revascularization for limb and major amputation [defined as above-the-ankle amputation] in addition to MACE). Definitions Procedure success was defined as <30% of residual stenosis without suboptimal result. Complications included death, stroke, acute MI, intestinal bleeding, access site complication, blood transfusion, distal embolization, worsening renal function, surgical repair, perforation or rupture, aortic dissection, stent thrombosis, systemic embolism or blue toe, or any other reason for prolonged hospital stay. Primary patency was defined as treated vessel without restenosis and repeat revascularization that remained patent. Assisted primary patency was defined as patent treated vessel that underwent repeat revascularization to improve patency. Secondary patency was defined as treated vessel that subsequently become totally occluded and was reopened by repeat revascularization. Restenosis was defined as >2.4 of peak systolic velocity ratio on duplex, >50% stenosis on angiography or computed tomography, or 0.2 decrease of resting ankle-brachial index (ABI). MI was defined as significant elevation of serum biomarkers (troponin T >0.1 ng/ml or creatinine kinase level twice that of normal) or new Q waves on the electrocardiogram. Coronary artery disease (CAD) was defined as stable angina with documented CAD, history of percutaneous coronary intervention, history of coronary artery bypass graft surgery, or previous MI. Stroke was defined as cerebral stroke that persisted for at least 24 h and indicated the occurrence of a neurological deficit. Heart failure (HF) was defined

4 2700 SOGA Y et al. Figure 2. Primary, assisted primary and secondary patency after aorto-iliac stenting. as previous diagnosis of HF, history of hospitalization for HF, or current treatment for HF. Diabetes was defined as HbA1c >6.5%, casual plasma glucose >200 mg/dl or treatment with oral hypoglycemic agents or insulin injection. Hypertension was defined as systolic blood pressure 140 mmhg and/or diastolic blood pressure 90 mmhg or ongoing therapy for hypertension. Renal failure was regarded as present when serum creatinine was >1.5 mg/dl. Elderly age was defined as >75 years. Outflow vessel was assessed on angiography before or after procedure. Outflow lesion was regarded as present when >50% stenosis in common femoral or femoropopliteal artery, or infrapopliteal poor run-off (defined as one or no infrapopliteal vessel run-off) were observed. Statistical Analysis Continuous variables are expressed as mean ± SD. Vessel patency rates and event-free survival curves were estimated using the Kaplan-Meier method and compared using the log-rank test. To determine the baseline risk factors for primary patency and mortality, we conducted log-rank tests for the following 30 clinically prespecified potential variables: elderly age (>75 years); gender; body mass index (BMI) <25; hypertension; dislipidemia; diabetes; renal failure; current smoker status; stroke; CAD; HF; critical limb ischemia (CLI); pre-procedural ABI; outflow lesion; lesion length; reference vessel diameter (RVD); use of self-expandable stent; total stent length; number of stents; total occlusion; calcified lesion; AI bifurcation lesion; TASCII C/D; and use of medications such as statins, aspirin, thienopyridines, cilostazol, angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB), β-blockade, calcium antagonist, and warfarin. All continuous variables were dichotomized for the median except age and BMI. Those variables with P<0.05 on univariate analysis and the proportional assumptions were generally fair were included in multivariate analysis. P<0.05 was considered statistically significant. Results Safety Procedure success was achieved in 97.6% of patients (2,096/ 2,147). Prespecified complications occurred in 6.4% of patients (137/2,147), (death, n=7; stroke, n=4; acute MI, n=2; intestinal bleeding, n=4; access site complications, n=40 [29 hematoma prolonged hospital stay, 6 pseudoaneurysm, 1 abscess, 4 others]; blood transfusion, n=33; distal embolization, n=24; worsening renal function, n=17; surgical repair, n=13; perforation or rupture, n=10; aortic dissection, n=3; stent thrombosis, n=5; systemic embolism or blue toe, n=7; other, n=6; in some cases there was more than 1 complication). No amputation was observed after distal emboli in this analysis. In the 7 patients who died after surgery due to a poor general status or comorbidities, EVT was performed because systemic anesthesia was difficult. Five of these 7 patients had CLI and the deaths of these 5 patients were due to sepsis in 2 cases, systemic embolism in 2 cases, and cerebral infarction in 1 case. The other 2 claudi-

5 Outcomes After Aorto-Iliac Stenting 2701 Figure 3. (A) Primary patency for stenosis vs. occlusion (77.8% vs. 76.5% at 5 years, log-rank P=0.10); (B) primary patency for balloon-expandable vs. self-expandable stents (79.0% vs. 75.2% at 5 years, log-rank P=0.99); (C) primary patency for claudicant vs. critical limb ischemia (CLI) patients (77.6% vs. 78.2% at 5 years, log-rank P=0.14); (D) primary patency for TASCII category (TASCII A, B, C, D: 77.8%, 78.0%, 73.3%, 80.5% at 5 years, log-rank P=0.55). Table 3. Predictors of Primary Patency Univariate Multivariate HR 95%CI P-value HR 95%CI P-value Female gender Diabetes Renal failure Absence of aspirin < < RVD <8.0 mm Outflow lesion < < Outflow lesion was regarded as present when >50% stenosis in common femoral or femoropopliteal artery, or infrapopliteal poor run-off (defined as one or no infrapopliteal vessel runoff) was observed. CI, confidence interval; HR, hazard ratio; RVD, reference vessel diameter. cant patients died due to retroperitoneal hematoma and multiple organ failure caused by systemic embolism, respectively. With regard to postoperative death, in-hospital mortality was 0.3% (7/2,147; 0.1%, 2/1,766 claudicant; 1.3%, 5/381 CLI) and 30-day mortality was 0.7% (15/2,147; 0.2%, 4/1,766 claudicant; 2.9%, 11/381 CLI). Patient and Lesion Characteristics The age of the 2,096 patients who underwent successful procedure ranged from 37 to 98 years (mean, 71.3±7.5 years). The characteristics of the patients and lesions are given in Tables 1,2. The proportion of patients with intermittent claudication and CLI was 82.8% and 17.2%, respectively. The mean lesion length was 52.9±31.2 mm and total stent length was 68.1±33.9 mm. In the TASCII classification, 1,201 (46.2%), 694 (26.7%), 311 (12.0%), and 395 patients (15.2%) were in classes A, B, C and D, respectively. Efficacy The overall primary patency was 92.5%, 82.6% and 77.5% at

6 2702 SOGA Y et al. Figure 4. Freedom from all-cause mortality, major adverse cardiovascular events (MACE) and major adverse cardiovascular and limb events (MACLE) after aorto-iliac stenting. MACE include death, myocardial infarction and stroke. MACLE include any repeat revascularization and major amputation (defined as above-the-ankle amputation) in addition to MACE. Table 4. Predictors of Mortality Univariate Multivariate HR 95%CI P-value HR 95%CI P-value CLI < < Renal failure < < Heart failure < Outflow lesion < Pre-procedural ABI < < Elderly (>75 years) < BMI < Use of warfarin CAD Female Use of ACEI/ARB Use of statin Abbreviations as in Tables 1,3. 1, 3 and 5 years, assisted primary patency was 97.0%, 92.7% and 91.9% at 1, 3 and 5 years and the secondary patency was 99.0%, 98.7% and 98.5% at 1, 3 and 5 years (Figure 2). There was no significant difference of primary patency rate at 5 years between stenosis and occlusion (stenosis vs. occlusion, 77.8% vs. 76.5% at 5 years, P=0.10; log-rank test; Figure 3A). Also, there was no significant difference between the 2 types of implanted stent (balloon-expandable vs. self-expandable, 79.0% vs. 75.2% at 5 years, P=0.99; log-rank test; Figure 3B) and between claudicant and CLI patients (claudicant vs. CLI, 77.6%

7 Outcomes After Aorto-Iliac Stenting 2703 vs. 78.2% at 5 years, P=0.14; log-rank test, Figure 3C). The TASCII lesion classification had no clinical utility. Primary patency did not differ between TASCII category (TASCII A, B, C, D, 77.8%, 78.0%, 73.3%, 80.5% at 5 years, P=0.55; logrank test, Figure 3D). During the observation period, only 18 patients (0.9%) required major amputation, consisting of 12 CLI patients (3.3%, 12/361) and 6 claudicant patients (0.3%, 6/1,735). In addition, 318 patients (15.2%) required some sort of revascularization after treatment: re-intervention was performed for restenosis in 133 patients; additional treatment was performed for an infrainguinal lesion that was not improved sufficiently by treatment for the AI lesion in 167 patients; and revascularization was performed for a new lesion in 48 patients (some patients received multiple treatments). Surgical revascularization was performed for 28 patients (1.3%), including 15 who received treatment for restenosis (re-obstruction), 8 who underwent femoropopliteal bypass surgery as additional treatment to improve symptoms, 2 who received endoatherectomy, and 3 who received treatment for a new lesion. On multivariate analysis, female gender, diabetes, renal failure, absence of aspirin, RVD <8.0 mm and outflow lesion were found to be independent predictors of primary patency (Table 3). Lesion length (hazard ratio [HR], 1.00; 95% confidence interval [CI]: , P=0.89) and use of cilostazol (HR, 1.11; 95% CI: , P=0.35) were not predictors of primary patency for AI lesion, and the type of stent (balloon-expandable or self-expandable) also had no influence on patency (HR, 1.00; 95% CI: , P=0.99). The overall survival rate was 95.0%, 87.6%, and 79.3% at 1, 3 and 5 years (Figure 4). Among 238 patients who died, the cause of death was cardiac in 80 patients (33.6%), vascular in 25 patients (10.5%) and non-cardiovascular in 104 patients (43.7%). Freedom from MACE was 93.3%, 84.4%, and 74.9% at 1, 3 and 5 years. Freedom from MACLE was 89.9%, 76.7%, and 66.8% at 1, 3 and 5 years (Figure 4). On multivariate analysis to define the predictors of all-cause mortality (Table 4), CLI, renal failure, HF, elderly age (>75 years), pre-procedural ABI <0.66 and use of ACEI/ARB were found to be independent predictors. CAD and BMI <25 tended to be predictors of mortality. Discussion In this study, the success rate of surgery was 97.6%. Among 51 patients with unsuccessful procedure (Figure 1), 3 and 48 received EVT for stenosis and occlusion, respectively; therefore, the success rate for stenosis was significantly higher than that for occlusion (99.8% vs. 92.8%, P<0.001). A low success rate of recanalization for occlusion in a long lesion has been reported previously, but the success rate has also recently increased due to improvement of therapeutic devices. 2,13 The success rate of EVT for TASCII CD lesions is %, 14 which is similar in the present study (92.8%). In addition, the endovascular mortality was 0.3% and the 30-day mortality was 0.7% in the present study. All complications that caused prolonged hospitalization occurred in 6.4% of patients. A previous study reported that 30-day mortality in patients with AI disease was 3.3% and non-fatal major complications occurred in 8.3% of patients. 15 Given the potential for perioperative complications during surgical revascularization for AI lesions, the results of the EVT in high-risk patients were acceptable. Previous studies have found a 5-year patency rate after iliac stenting of 64 82%. 8,16,17 Similarly, in the present study, the 5-year patency rate was 77.5% and that for occlusion only was 76.5%. Favorable 5-year primary patency rates after surgical revascularization for occlusion with anatomic bypass (aortic bifurcation graft) of 91% and 87.5% were obtained in claudicant and CLI patients, respectively. In contrast, the 5-year primary patency with extra-anatomic bypass is 51 75%, 10 which is lower than that with anatomic bypass. In particular, the 5- year primary patency with axillofemoral bypass is only 51% (44 79%), which is clinically insufficient. Extra-anatomic bypass, however, is often selected for patients with many comorbidities to avoid the risk of abdominal surgery. We believe that the present results suggest that EVT could be used as first-line or complementary treatment to improve the patency with extraanatomic bypass (eg, EVT with femorofemoral bypass in an inflow lesion) in patients with occlusive disease in whom surgery with anatomic bypass is difficult. In addition, the assisted primary patency at 5 years after stenting was 91.9%. This suggests that revision is not necessarily required for all restenosis. Based on these findings, we suggest that EVT after stent placement is useful for various lesions and patients as a therapeutic strategy for AI lesions, and that the indication of EVT should be discussed further based on accumulation of data from more cases. Furthermore, the present result suggests that EVT may be a valid alternative to surgery for atherosclerotic AI lesions, but it is considered that not all AI lesions are suitable for EVT. For patients with renal insufficiency or shaggy aorta, or history of severe complication after catheterization, the indications for and strategy of revascularization should be carefully considered, taking into account the comorbidities, general status and life expectancy. Interestingly, severity of ischemia, TASCII classification or any type of stent were not found to be clinically useful in this analysis, despite the difference in patients or lesion background. This may be because the impact of stent deployment on vessel patency may be stronger than that of other clinical variables. The incidence of restenosis was very low after successful stent placement for AI lesion compared to that for infrainguinal lesion. Thus, it would be difficult to assess the slight difference among patients or lesions statistically. Further investigation is required to verify these findings. Severity of ischemia, lesion length, and conditions of the outflow vessel have been reported as factors that may affect patency after EVT for lesions in the iliac artery. 18 In the present study, TASCII classification, lesion length, occlusive disease, and other factors related to the lesion type did not have a major influence on stent patency. Even in the most complicated and challenging cases, such as AI occlusive disease in the lower part of the renal artery, these factors had no particular effect on the patency rate when stent placement was successful (HR, 1.31; 95% CI: , P=0.52), although we note that there were only a few such cases in the present study. In contrast, we found that an AI bifurcation lesion tended to cause restenosis (HR, 1.34; 95% CI: , P=0.08). A comparatively favorable patency for lesions in the bifurcation area has been reported in a small number of patients, but a uniform type of stent and placement method have not been established. Thus, closer examination of individual lesions should be performed in the future. As found in previous studies, outflow lesions had a large effect on the patency, especially those of common femoral artery disease (HR, 2.13; 95% CI: , P=0.0002), which is located immediately after the outflow tract, and femoropopliteal disease (HR, 1.91; 95% CI: , P<0.0001), compared to infrapopliteal lesions (HR, 1.42; 95% CI: , P=0.03). Approximately 50% of patients with symptomatic PAD may concomitantly develop CAD, 22 and subsequent MI and stroke

8 2704 SOGA Y et al. occurs in many cases. 23 In this study, we also found that 50% of the patients developed CAD, and that the mortality and the incidence of MACE (death, MI and stroke) after 1, 3, and 5 years were 5.0%, 12.4%, and 20.7%, and 6.7%, 15.6%, and 25.1%, respectively. Cardiovascular death occurred in approximately half of the patients (44.5%; Table 3). ACEI/ARB treatment had an independent effect on prognosis and the efficacy of statins was confirmed on univariate analysis. There is considerable evidence that ACEI/ARBs and statins are effective in primary and secondary prevention of cardiac disease, which suggests that these drugs may improve the prognosis of PAD patients. Based on these findings, AI lesions should be considered as generalized arteriosclerosis lesions, rather than as a local lesion in a part of the body. Intervention mainly by drug treatment may be important for prevention of postoperative events, and further discussion of the optimal drug therapy for PAD patients is required. Regarding prognosis in relation to the lower extremities, as mentioned, major amputation was performed in 0.9%. Surgical revascularization was performed for 1.3%. The 1-, 3- and 5-year incidences of MACLE, in which events in the lower extremities were added to MACE, were 10.1%, 25.3%, and 33.2%, respectively. These results suggest that 1 out of 4 patients with AI lesions who receive EVT might develop events requiring additional treatment within 3 years. There were several limitations of this analysis. First, we performed a retrospective analysis, although this was a large-scale, multicenter study. In addition, asymptomatic acute or subacute limb ischemia was not able to be excluded from the analysis. Second, the study was performed in medical facilities and by operators with expertise in EVT. We also note that the AI artery is located in the pelvis, and thus care is required regarding complications, which may become serious. Finally, the present subjects were all Japanese, and their physical constitution and muscle strength as well as lipid metabolism 24 often differ from those of Western patients. Therefore, a further study is needed to evaluate whether similar results are obtained in other races. Conclusion The safety and efficacy of stent placement in patients with AI lesions are feasible compared to surgical reconstraction. Most PAD patients who require revascularization in clinical practice, however, have multiple diseases and lesions, and thus it is important to recognize that the applicability of the present results, given the present evaluation of AI lesions only, is limited. A large-scale prospective study is required to confirm the findings. Disclosures Financial Support: None. 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