31 Stenting or Surgery for De Novo Common Femoral Artery Stenosis Yann Gouëffic et al. J Am Coll Cardiol Intv 2017;10:1344 54) OBJECTIVES The TECCO (Traitement des Lésions Athéromateuses de l'artère Fémorale Commune par Technique Endovasculaire Versus Chirurgie Ouverte [Endovascular Versus Open Repair of the Common Femoral Artery]) trial is a randomized comparison of safety and efficacy of stenting versus open surgery for de novo common femoral artery (CFA) stenosis. BACKGROUND Surgery for CFA lesions is considered effective and durable. Despite the widespread use of endovascular repair for infrainguinal disease, the value of this procedure for such lesions is uncertain. METHODS From February 23, 2011, to September 5, 2013, a total of 117 patients with de novo atherosclerotic lesions of the CFA were randomly assigned to undergo surgery (n = 61) or stenting (n = 56). The main exclusion criteria were asymptomatic disease, restenosis, and thrombosis of the CFA. The primary outcome was the morbidity and mortality rate within 30 days. This includes any general complications or local complications that caused or prolonged hospitalization and/or re-intervention, lymphorrhea of more than 3 days, and post-operative paresthesia that required drugs. The median duration of follow-up was 2 years (interquartile range [IQR]: 19.8 to 24.9 years). RESULTS Primary outcome events occurred in 16 of 61 patients (26%) in the surgery group and 7 of 56 patients (12.5%) in the stenting group (odds ratio: 2.5; 95% confidence interval: 0.9 to 6.6; p = 0.05). The mean duration of hospitalization was significantly lower in the stenting group (3.2±2.9 days vs. 6.3±3 days; p < 0.0001). At 24 months, the sustained clinical improvement, the primary patency rate, and the target lesion and extremity revascularization rates were not different in the 2 groups. CONCLUSIONS In patients with de novo atherosclerotic lesions of the CFA, the perioperative morbidity and mortality rate was significantly lower among patients who underwent endovascular therapy by stenting compared with surgery, whereas clinical, morphological, and hemodynamic outcomes were comparable at mid-term.
32 Level 4, Grade C TECCO Traitment des Lésions Athéromateusesde l'artère Fémorale Commune par Technique Endovasculaire with the Chirurgie Ouverte [ ] TECCO 17 1 1 Rutherford 3 6 4 I ; II ; III ; IV 1 2 3 30 3
33 (ABI) 1, 6, 12, 24 2011 2 23 2013 9 5 120 1 3 61 56 1 24 30 112 2 86 73.5% 2 100% 94.6% III ( 1 3 15 8 10 9 1 ; 1 ; 30 61 16 26% 56 7 12.5% ( 3) (odds ratio: 2.5; 95% CI: 0.9 to 6.6; p = 0.05) 3.2±2.9 6.3±3.0 p <0.001 Rutherford p <0.0001 p = 0.89 2 (HR:1.3; 95%CI:0.3~5.7; p = 0.77 HR 0.99; 95%CI 0.35~2.86; p = 0.99 (HR:1.3; 95%CI:0.5~3.1; p = 0.60HR 0.79; 95%CI:0.25~2.50; p = 0.68 3 (ABI) 4 24 1 Nguyen 15% 3.4% Linni 18% 6% 1 30 5% 7.2% III III
34 Bonvini 1 Bonvini 1 Baumann (debulking devices) (atherectomy) ( head-tohead comparison) 2 85% 100% 82.3±5.9 1 82% 90% 90% 2 TECCO
35 FIGURE 1 Randomization and Follow-Up 1
36 TABLE 1 Characteristics of the Patients Surgery (n ¼ 61) Stenting (n ¼ 56) p Value Age, yrs 68 8 68 9 0.93 Male 51 (84) 48 (86) 0.75 Hypertension 44 (72) 45 (80) 0.30 Hyperlipidemia 40 (66) 37 (66) 0.96 Diabetes mellitus 25 (41) 17 (31) 0.23 Smoking at baseline 28 (46) 26 (46) 0.95 Coronary artery disease 28 (46) 27 (48) 0.81 Renal insufficiency 8 (13) 6 (11) 0.69 On dialysis 1 (13) 1 (17) Obesity (BMI >25 kg/m 2 ) 39 (64) 31 (58) 0.55 Statin treatment 50 (82) 38 (68) 0.08 Antiplatelet drug 57 (93) 50 (89) 0.32 ACE inhibitor 19 (31) 22 (39) 0.23 Rutherford stage of PAD 0.23 2 2 (3) 1 (2) 3 54 (89) 44 (80) 4 5 (8) 7 (13) 5 0 (0) 3 (5) Type of lesion 0.33 I 6 (10) 9 (16) II 21 (34) 13 (23) III 34 (56) 34 (61) Degree of stenosis 0.17 70% to 90% 43 (70) 35 (63) $90% 14 (23) 20 (36) TASC II for femoropopliteal disease 0.76 A 11 (18) 10 (18) B 13 (21) 12 (21) C 6 (10) 10 (18) D 11 (18) 9 (16) Runoff vessels, n 0.98 0 2 (3) 2 (4) 1 5 (9) 6 (11) 2 15 (25) 14 (25) 3 37 (63) 33 (60) Values are mean SD or n (%). Rutherford stage 2 corresponds to moderate intermittent claudication, stage 3 to severe intermittent claudication, stage 4 to ischemic pain while the patient is resting, and stage 5 to ischemic ulcers. ACE ¼ angiotensin-converting-enzyme; BMI ¼ body mass index; PAD ¼ peripheral artery disease; TASC ¼ Trans-Atlantic Inter-Society Consensus document II. 1
37 TABLE 2 Baseline Angiographic and Interventional Data Surgery (n ¼ 58) Stenting (n ¼ 54) p Value Type of anesthesia <0.001 Local 1 (2) 41 (75) Loco-regional 11 (19) 4 (7) General 46 (78) 9 (16) Surgery technique Endarterectomy 46 (69) NA With venous patch 7 (12) NA With prosthetic patch 37 (64) NA Direct suture 2 (3) NA Bypass with a prosthesis 11 (19) NA Eversion 1 (2) NA Crossover access NA 43 (78) Brachial access NA 7 (13) Femoral ipsilateral NA 4 (7) Self-expandable stents NA 48 (67.5) Mean diameter, mm NA 7 1 Mean length, mm NA 41 17 Balloon-expandable stents NA 23 (32.5) Mean diameter, mm NA 6 1 Mean length, mm NA 25 11 Duration of the procedure, min NA 82 53 Amount of contrast agent, ml NA 70 53 Pre-dilatation realized NA 34 (62) Arterial closure devices used NA 15 (27) Concomitant endovascular procedures 0.67 None 33 (57) 37 (68) Inflow 13 (22) 8 (15) Outflow 11 (19) 8 (15) In- and outflow 1 (2) 1 (2) Values are n (%) or mean SD. TASC range from A to D for femoropopliteal disease, with higher classes indicating more complex lesions. NA ¼ not applicable; TASC ¼ Trans-Atlantic Inter-Society Consensus document II. 2
38 表3 圖2
39 FIGURE 3 Kaplan Meier Estimates Kaplan-Meier estimates of the rates of death from any cause, freedom from target lesion revascularization, freedom from target extremity revascularization, and primary patency are shown. (A) Death from any cause. (B) Freedom from target lesion revascularization. (C) Freedom from target extremity revascularization. (D) Primary patency. CI ¼ confidence interval; TER ¼ target extremity revascularization; TLR ¼ target lesion revascularization. 3 FIGURE 4 Resting ABI ABI ¼ ankle brachial index; other abbreviations as in Figures 2 and 3. 4