Femoropopliteal Balloon Angioplasty vs. Bypass Surgery for CLI: A Propensity Score Analysis

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1 Eur J Vasc Endovasc Surg (), 78e8 Femoropopliteal Balloon vs. Bypass Surgery for CLI: A Propensity Score Analysis M. Korhonen a,b, *, F. Biancari c,m.söderström a, E. Arvela a, K. Halmesmäki a, A. Albäck a, M. Lepäntalo a, M. Venermo a a Department of Vascular Surgery, Helsinki University Central Hospital, Helsinki, Finland b Department of Radiology, Päijät-Häme Central Hospital, Lahti, Finland c Division of Cardio-thoracic and Vascular Surgery, Department of Surgery, Oulu University Hospital, Oulu, Finland Submitted 8 September ; accepted November Available online December KEYWORDS CLI; Bypass; ; Femoropopliteal; Propensity score Abstract Objectives: To compare the outcomes of femoropopliteal percutaneous transluminal angioplasty (PTA) and bypass surgery for critical limb ischaemia (CLI). Design: The study is retrospective in nature. Materials and methods: This study included 88 consecutive patients, who underwent femoropopliteal revascularisation for CLI at Helsinki University Central Hospital during e7. As many as 7 patients (6%) underwent PTA and (%) bypass surgery. Propensity score analysis was used for risk adjustment in multivariable analysis and for one-to-one matching. Results: In the overall series, PTA had poorer long-term results than bypass (-year leg salvage, 78.% vs. 9.8%, p <.; survival 9.% vs. 7.%, p Z.8; amputation-free survival,.% vs..7%, p Z.; freedom from surgical re-intervention 86.% vs. 9.%, p <.). When treatment method was adjusted for propensity score as well as in the propensity score-matched pairs, leg salvage and freedom from surgical re-intervention were worse after PTA than after bypass (among the propensity score-matched pairs, 7.% vs. 88.%, p Z., and 86.% vs. 89.8%, p Z., respectively). Differences in survival, amputation-free survival and freedom from any re-intervention were not observed. Conclusions: In CLI patients, femoropopliteal PTA seems to be associated with poorer longterm leg salvage and freedom from surgical re-intervention than bypass surgery. However, the treatment method did not affect long-term amputation-free survival. ª European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. * Corresponding author. Department of Vascular Surgery, Helsinki University Central Hospital, POB, 9 Helsinki, Finland. Tel.: þ8 66; fax: þ address: maria.korhonen@helsinki.fi (M. Korhonen) /$6 ª European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. doi:.6/j.ejvs...

2 vs. Bypass Surgery for CLI 79 Introduction Infrainguinal bypass surgery has traditionally been considered the approach of choice to treat critical limb ischaemia (CLI) to avoid major amputation. However, there are increasing data on the efficacy of endovascular revascularisation procedures to achieve good leg salvage rates. e Indeed, the use of endovascular procedures has rapidly increased during the last decade. As yet, there is only one large, randomised controlled trial comparing the two treatment methods, the Bypass or for Severe Ischaemic Leg (BASIL) e Trial. The comparison of surgical and endovascular techniques in randomised controlled trials is difficult due to problems of forming comparable groups. To overcome this issue, we have analysed our longterm results in the treatment of femoropopliteal occlusive lesions in CLI patients, by adjusting the differences between the two treatment arms using propensity score analysis. 6,7 Material and Methods A total of patients with CLI underwent lower-limb revascularisation at the Department of Vascular Surgery, Helsinki University Central Hospital, between and 7. Unilateral, femoropopliteal revascularisation was performed in 88 patients, of whom 7 patients (6.%) underwent percutaneous transluminal angioplasty (PTA) and (9.7%) bypass surgery. No other arterial segments were treated simultaneously. All cases and angiographies were reviewed and discussed for decision making at the daily integrated vascular meetings of vascular surgeons and interventional radiologists. Clinical characteristics, operative data and immediate postoperative outcome data of these patients were prospectively collected in our institutional database and scrutinised retrospectively (Table ). Dates of death were retrieved from the Finnish national registry (Statistics Finland). Data on late, major lower amputation and re-interventions have been completed retrospectively from files of the National Research and Development Centre for Health and Welfare. The study protocol was approved by the Institutional Review Board of the Helsinki University Central Hospital, Finland (Department of Surgery). Preoperative estimated glomerular filtration rate (egfr) was calculated according to the Modification of Diet in Renal Disease study equation. 8 Severity of renal failure was classified according to the chronic kidney disease (CKD) classification. 8 Endovascular revascularisation Balloon angioplasty was the method of choice for endovascular approach. Stents were placed selectively in cases in which there was a flow-limiting dissection or a significant residual stenosis after balloon angioplasty. A stent was placed in % of the primary interventions. Intra-arterial heparin ( IU) was routinely administered just before the endovascular procedure. After successful endovascular intervention, patients received mg of clopidogrel orally and were maintained on 7 mg day for at least month, except for those on continued anticoagulation already before revascularisation. In addition, the patients were indefinitely put on mg aspirin orally. This medication scheme became routine in ; before that, patients were put only on aspirin. Routine follow-up included one clinical examination and an ankleebrachial index (ABI) measurement at month after the procedure. Duplex Doppler (DD) ultrasound scan was done when needed. Surgical revascularisation Non-reversed vein grafts were mostly used. A prosthetic graft had to be used in.% of the patients because of the lack of suitable veins. The patients received low-molecular-weight heparin during their postoperative hospital stay, in addition to mg of aspirin orally, which was continued indefinitely. Routine surveillance included a clinical examination, ABI measurement and a DD scan at, 6 and months. Angiographic status of runoff arteries Periprocedural angiographies were retrospectively reviewed by three authors (M.V., K.H. and M.K.). The angiographic status of the runoff vessels was quantified at the site of angioplasty/distal anastomosis downwards, and the runoff score was calculated according to the Society for Vascular Surgery/International Society for Cardiovascular Surgery (SVS/ISCVS) criteria. 9 Outcome end points Overall survival, major lower-limb amputation, (major) amputation-free survival, freedom from any further reintervention (including all open and endovascular re-interventions done to maintain the original revascularisation and redo procedures done due to occlusion of the original revascularisation) and freedom from surgical re-intervention (redo bypass, that is, bypass that comprises more than half of the graft) were considered the main outcome measures of this study. Statistical analysis Statistical analysis was performed using Statistical Package for Social Sciences (SPSS) statistical software (SPSS v. 6.., SPSS Inc., Chicago, IL, USA). Continuous variables are reported as the mean standard deviation. Pearson s chi-square test, Fisher s exact test and the ManneWhitney test were used for univariate analysis. Logistic regression with backward selection was performed to calculate the risk of these patients to be included either in the angioplasty or bypass surgery group. HosmereLemeshow s test was used to assess the regression model fit. Variables listed in Table and having a p <. in univariate analysis were included into the regression model. Receiver operating characteristic (ROC) curve analysis was used to estimate the area under the curve of the model predicting the probability of being included into the angioplasty or bypass surgery group. The calculated propensity score was employed for one-to-one

3 8 M. Korhonen et al. Table Baseline characteristics and operative data on patients who underwent femoropopliteal bypass surgery and percutaneous transluminal angioplasty (PTA) for critical limb ischaemia. Data are reported for the overall population and for one-toone propensity score-matched pairs. Overall series Propensity score-matched pairs PTA Bypass p-value PTA Bypass p-value 7 patients (%) patients (%) patients (%) patients (%) Age (years)* < Females* (8.9) 7 (.7). (6.) (.6).9 Pulmonary disease* 78 (.) 7 (.).7 (6.6) 9 (6.).9 Diabetes* (8.) 7 (.) <. (.) (.).8 Hypertension 9 (76.) 7 (69.9).6 79 (7.) 7 (7.).66 Coronary artery disease 8 (6.) 7 (6.9).8 (6.) 9 (6.8).7 Cerebrovascular disease* (.) (.). 9 (6.) 6 (.9).7 Smoking habit* (.6) 7 (7.7) <. 6 (.7) 79 (.9).8 Previous lower-limb 6 (.8) 6 (6.). (9.) (.).9 revascularisation* Previous revascularisation (8.7) (8.8).96 6 (6.6) 6 (6.6). on the same segment Serum creatinine (micromol/l) < egfr (ml/min/.7 m ) 6 7 < CKD classes* <.. 9 (8.) 9 (7.) 6 (.9) 9 (.) 9 (.8) 6 (9.9) 9 (7.8) 89 (6.9) 7 (.8) 87 (.) 7 (9.9) 7 (.) (8.) (.) (.6) (.) 6 (8.9) (.9) 7 (.9) 7 (.9) Indication for revascularisation <.. Rest pain (9.9) 9 (.7) 6 (6.) 6 (6.6) Ulcer* (6.6) 7 (.) 8 (6.) 8 (6.6) Gangrene* 8 (.) (6.) (.) 9 (7.9) Angiographic score* < Target vessel patent downward 76 (.) 7 (7.) <. 6 (68.) 6 (68.).9 to the pedal arteries* Most distal target artery Below-the-knee 9 (7.6) (68.) <. (8.) 6 (68.) <. popliteal artery Bypass graft e e Vein graft e 6 (78.7) e 9 (8.) Prosthetic graft e 7 (.) e 7 (9.) PTA: percutaneous transluminal angioplasty, CKD classes: Chronic kidney disease classes (class (normal): egfr > 9 ml/min/.7 m; class (mild): egfr 6e89 ml/min/.7 m; class (moderate): egfr e9 ml/min/.7 m; class (severe); egfr e9 ml/min/.7 m, class (kidney failure): egfr < ml/min/.7 m.); egfr: estimated glomerular filtration rate (egfr (ml/min/.7 m ) Z 86 (serum creatinine (mg/dl)). (age)..7 (if the subject is female). (if the subject is black)); *: variable included into regression model for estimation of the propensity score. matching as well as to adjust for other variables in estimating their impact on the postoperative outcome. We did not performed analysis in propensity score percentiles because of the relatively small number of patients. Oneto-one propensity score matching between study groups was done according to a difference in the propensity score <.. Cox regression with the help of backward selection was used to adjust the effect of treatment method for propensity score as well as other variables in evaluating continuous outcome end points. Long-term outcome was assessed by the KaplaneMeier s method with the log-rank test and the Cox regression method. Outcome in the propensity matched pairs was evaluated by KaplaneMeier s methods as well as the Cox regression method. In the latter, the treatment method was adjusted, as suggested by Austin, for other important variables, that is, age, gender, diabetes, presence of foot ulcer/gangrene, coronary artery disease, egfr and patent target vessel down to the pedal arteries. A p <. was considered statistically significant. Results The mean length of the follow-up was.6. years. Leg salvage rates of the overall population at -day, -year, -year and -year intervals were 98.%, 9.%, 8.9% and 8.%, respectively (standard error (SE) <.8). At the

4 vs. Bypass Surgery for CLI 8 Figure Flow-chart summarising need of intervention and amputation-free survival after femoropopliteal percutaneous transluminal angioplasty and bypass surgery for critical limb ischaemia in the overall population. same intervals, survival rates were 96.8%, 78.%, 6.% and.%, respectively (SE <.) and amputation-free survival rates were 9.%, 7.9%,.6% and 6.%, respectively (SE <.). Fig. summarises the need for re-interventions and amputation-free survival after PTA and bypass surgery in the overall population. Results of angioplasty vs. bypass surgery in the overall series PTA had poorer long-term results than bypass surgery (Table ). There was a significant difference at years in survival (9.% vs. 7.%, p Z.8), amputation-free survival (.% vs..7%, p Z.) (Fig. (a)) and leg salvage (78.% vs. 9.8%, p <.) (Fig. (a)). Freedom from any reintervention did not differ between the study groups (at years: PTA 77.% vs. bypass 7.%, p Z.7), whereas freedom from surgical re-intervention was significantly worse after PTA (at years: 86.% vs. 9.%, p <.). Propensity score analysis Patients who underwent PTA had significantly more comorbidities, such as diabetes and decreased egfr, and poorer runoff. As the study groups differed markedly from each other, we calculated the propensity score to estimate the risk of these Table KaplaneMeier s estimates of early and late outcome in the overall series. Number of patients entering intervals are reported in parentheses. -day -year -year -year -year -year p-value Overall survival.8 PTA 9.9% (86) 7.7% (6) 67.% (66) 8.9% ().% () 9.% () 97.6% () 8.% (9) 76.% (6) 6.% (6) 9.7% (9) 7.% (7) Leg salvage <. PTA 96.8% (7) 87.% (9) 8.% () 8.% (8) 79.7% (6) 78.% (96) 99.7% (9) 9.% () 9.% () 9.8% (7) 9.8% (8) 9.8% () Amputation-free survival. PTA 9.% (7) 7.% (9) 6.% ().% (8).% (6).% (97) 97.% (9) 79.9% () 7.6% () 6.% (7) 6.% (8).7% () Freedom from any re-intervention. PTA 9.9% (7) 76.% (7) 7.% () 7.7% (69) 7.7% (6) 7.% (9) 9.7% (9) 8.% (9) 79.7% () 78.% (9) 7.% (66) 7.% (9) Freedom from surgical re-intervention <. PTA 9.7% (6) 86.% () 8.7% () 8.7% (8) 8.7% (6) 8.7% () 99.% (9) 96.% () 9.% () 9.% (8) 9.% (8) 9.% ()

5 l l 8 M. Korhonen et al. a, Overall series a, Overall series survival Amputation-free v a g e L e g s a,, Log-rank p=. Log-rank: p<. b, Propensity score matched pairs b, Propensity score matched pairs Amputation-free survival v a g e L e g s a,, Log-rank p=. Log-rank test: p=. Figure Amputation-free survival after femoropopliteal percutaneous transluminal angioplasty and bypass surgery for critical limb ischaemia a) in the overall series and b) in propensity score-matched pairs. patients to undergo either PTA or bypass surgery. Variables included in the logistic regression model for calculation of propensity score are listed in Table. Pulmonary disease (b-coefficient.7), female gender (b-coefficient.66), diabetes (b-coefficient.6), cerebrovascular disease (b-coefficient.6), egfr (b-coefficient.), leg status (rest pain vs. ulcer or gangrene, b-coefficient.8) and patent target vessel down to the pedal artery (b-coefficient.) were used as independent predictors for assigning patients with CLI to the femoropopliteal PTA or bypass surgery group (constant b-coefficient.6, HosmereLemeshow s test p Z.). The obtained propensity score had an area under the ROC curve of.7 (9% confidence interval (CI).7e.76, SE.7, p <.). Results of PTA vs. bypass surgery according to propensity score analysis In the overall series, when treatment method was adjusted for propensity score, PTA was associated with significantly poorer leg salvage (p Z., risk ratio (RR).8, 9%CI.e.97) and freedom from surgical re-intervention (p Z., RR., 9%CI.e.9). When adjusted for propensity score, survival (p Z.), amputation-free Figure Leg salvage after femoropopliteal percutaneous transluminal angioplasty and bypass surgery for critical limb ischaemia a) in the overall series and b) in propensity score-matched pairs. survival (p Z.89) and freedom from any re-intervention procedure (p Z.9) did not statistically significantly differ between the study groups. One-to-one propensity score matching provided pairs of patients, who underwent either PTA or bypass surgery (Table ). Amputation-free survival was similar in propensity score-matched pairs (Fig. (b)). During the - year follow-up, bypass surgery was associated with significantly better leg salvage in the matched pairs analysis (88.% vs. 7.%, log-rank: p Z.; adjusted RR.7, 9%CI.e.9, p Z.) (Fig. (b)) and freedom from surgical re-intervention (89.8% vs. 86.%, log-rank: p Z.; adjusted RR.8, 9%CI.6e.99, p Z.) (Table ). However, bypass surgery and PTA achieved similar rates of survival (.% vs..%, log-rank: p Z.8; adjusted p Z.8), amputation-free survival (7.6% vs..6%, log-rank: p Z.; adjusted p Z.96) and freedom from any re-intervention (76.% vs. 7.%, logrank: p Z.; adjusted p Z.8). Discussion Comparison of endovascular and surgical revascularisation in CLI is difficult because patient groups tend to differ in

6 vs. Bypass Surgery for CLI 8 Table KaplaneMeier s estimates of early and late outcome in propensity score-matched pairs. Number of patients entering intervals are reported in parentheses. -day -year -year -year -year -year p-value Overall survival.8 PTA 9.% (6) 76.6% (6) 7.6% () 6.% () 6.% (78).% (6) 97.9% () 8.% (6) 7.% (6) 6.6% (8) 6.% (6).% (9) Leg salvage. PTA 96.6% () 87.7% () 8.7% () 8.8% (9) 8.% (7) 77.% (8) 99.6% () 9.9% () 89.% (99) 88.% (77) 88.% () 88.% (6) Amputation-free survival. PTA 9.9% () 7.% () 6.7% () 6.% (9) 8.7% (7).6% (8) 97.% () 76.8% () 68.% (99) 7.% (77).% () 7.6% (6) Freedom from any re-intervention. PTA 9.% (9) 7.7% (8) 7.% (8) 7.% (8) 7.% (6) 7.% (8) 96.7% (7) 86.% () 8.8% (86) 8.7% (67) 76.% (6) 76.% (9) Freedom from surgical re-intervention. PTA 9.% (9) 86.7% () 86.% (9) 86.% (9) 86.% (7) 86.% () 99.% () 9.6% (9) 9.9% () 9.9% (79) 89.8% () 89.8% () terms of risk factors as well as arterial lesions requiring treatment. In non-randomised observational studies, investigators have no control over treatment assignment. This difficulty may be partially avoided if information of measured covariates, that is, risk factors, is incorporated into the study design. Propensity score is a measure of the likelihood that a patient would have been treated using their covariate scores. Propensity scores are used for reducing bias and increasing precision by making adjustments to risk factors prior or while calculating the effect of the treatment. 7 Herein, we used the propensity score for regression adjustment and for matching. Importantly, we have adjusted the treatment method for the most relevant covariates also in the one-to-one propensity matched pairs analysis as suggested by Austin. Yet, we were unable to include the characteristics of treated lesions as an unambiguous covariate. Indeed, The Inter-Society Consensus for Management of PAD (TASC II) classification for femoropopliteal lesions allows rather wide individual interpretations, and the common use of this classification as a basis for reporting outcomes can therefore be questioned. The lesions treated by angioplasty were probably shorter and less severe than those in the bypass surgery group. As previous randomised trials have demonstrated, only e9% of the lesions have been considered equally well treatable by either method,, which worsens the generalisability of the findings of randomised controlled trials in CLI. On the other hand, the strength of a registry based study is the large coverage of the patients in daily practice. Amputation-free survival is considered the most important outcome end point in the treatment of CLI. After adjusting the groups by propensity score, no significant difference in the amputation-free survival between the treatments was observed, but bypass surgery was associated with significantly better long-term leg salvage. The mortality of CLI patients is very high due to the generalised nature of their atherosclerosis. Indeed, the high mortality might have masked the effect of the better long-term leg salvage after bypass on amputation-free survival. A similar difference in leg salvage between PTA and bypass was not observed in our previous study on revascularisation of infrapopliteal arteries with or without simultaneous treatment of femoropopliteal segment lesions. PTA was associated with better limb salvage in a subgroup analysis on patients who underwent isolated infrapopliteal PTA, that is, in patients free of marked femoropopliteal disease. The results of that study as well as of the present study suggest that bypass surgery may do better in the longterm in terms of leg salvage, when significant femoropopliteal arterial lesions are treated. Further, in the intention-to-treat analysis of the BASIL trial, for those patients surviving more than years after the randomisation, the bypass surgery s first strategy was associated with a significant increase in subsequent overall survival and a trend towards improved amputation-free survival. This further supports the long-term benefits of bypass surgery over PTA in the treatment of CLI, at least in patients with longevity exceeding years. In the overall series as well as in the propensity scorematched pairs, the rate of surgical re-intervention was significantly higher after PTA than bypass surgery. This is highly due to our general practice: if CLI symptoms do not relieve and the endovascularly treated segment has occluded, threshold for surgical re-intervention is relatively low. Redo-PTA is done only in cases with mild-to-moderate recurrent symptoms. However, freedom from any re-intervention was the same after both treatment methods. Most probably, our active surveillance policy on venous grafts and the predominantly endovascular treatment of graft stenoses were the reasons for equal rates of any re-interventions between the treatment groups. A possible limitation of the current study is the difference in the routine surveillance protocol of the two revascularisation strategies during the study period. All patients were followed until their symptoms subsided and/ or wounds healed. Routine clinical examination and ABI measurements were done up to weeks postprocedurally

7 8 M. Korhonen et al. for the PTA group, whereas they were done up to months alongside with DD for the bypass surgery group. Thus, it might be that first signs of restenosis were found earlier in the bypass surgery group. No resources were directed formerly on routine long-term follow-up for the PTA patients because of the lack of evidence of its benefits compared with the scheme we were following. On the other hand, at that time, studies on benefits of routine surveillance of vein grafts had been published. 6 Even though there is still today no consensus on how endovascularly treated patients should best be followed, we have recently changed our surveillance protocols so that they are now identical for both, surgical and endovascular revascularisation strategies. Another limitation is the nature of registry based studies, that is, concern regarding data validity and completeness. We have made an effort to minimise these limitations. Our vascular registry includes all patients who have undergone any revascularisation, endovascular or surgical. The completeness of the registry data has been checked against hospital registries and missing data have been entered into the registry afterwards. The key outcome end points were double-checked against official national registries. Yet, no registry is immune from omissions and differences in the interpretation of the data. 7,8 Conclusions About half of the patients with CLI were alive and had not sustained major amputation years after revascularisation, irrespective of the mode of treatment. This underlines the malign nature of atherosclerotic disease in these patients. However, leg salvage and freedom from surgical re-intervention were significantly better after bypass surgery, but amputation-free survival was similar in the study group after risk adjustment. This suggests that when technically feasible, PTA can be considered a valid alternative first strategy to bypass surgery in patients with CLI and femoropopliteal disease. could likely be considered as a better alternative in patients with probable longevity. Conflict of Interest/Funding None. References Kudo T, Chandra FA, Kwun WH, Haas BT, Ahn SS. Changing pattern of surgical revascularization for critical limb ischemia over years: endovascular vs. open bypass surgery. J Vasc Surg 6;:e. Eskelinen E, Albäck A, Roth WD, Lappalainen K, Keto P, Railo M, et al. Infra-inguinal percutaneous transluminal angioplasty for limb salvage: a retrospective analysis in a single center. Acta Radiol ;6:e6. Faglia E, Dalla Paola L, Clerici G, Clerissi J, Graziani L, Fusaro M, et al. Peripheral angioplasty as the first-choice revascularization procedure in diabetic patients with critical limb ischemia: prospective study of 99 consecutive patients hospitalized and followed between 999 and. Eur J Vasc Endovasc Surg ;9:6e7. Cull DL, Langan EM, Gray BH, Johnson B, Taylor SM. Open versus endovascular intervention for critical limb ischemia: a population-based study. J Am Coll Surg ;:e6. 6e. Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, et al. BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet ;66:9e. 6 Blackstone EH. Comparing apples and oranges. J Thorac Cardiovasc Surg ;:8e. 7 D Agostino Jr RB. Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group. Stat Med 998;7:6e8. 8 Levey AS, Coresh J, Balk E, Kausz AT, Levin A, Steffes MW, et al. National Kidney Foundation. National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med ;9: 7e7. 9 Rutherford RB, Flanigan DB, Gupta SK, Johnston KW, Karmody A, Whittermore AD, et al. Suggested standards for reports dealing with lower extremity ischemia. Prepared by the Ad Hoc Committee on Reporting Standards, Society for Vascular Surgery/North American Chapter, International Society for Cardiovascular Surgery. J Vasc Surg 986;:8e9. Austin PC. Primer on statistical interpretation or methods report card on propensity-score matching in the cardiology literature from to 6: a systematic review. Circ Cardiovasc Qual Outcomes 8;:6e7. Kukkonen T, Korhonen M, Halmesmäki K, Lehti L, Tiitola M, Aho P, et al. Poor inter-observer agreement on the TASC II classification of femoropopliteal lesions. Eur J Vasc Endovasc Surg ;9:e. Lepäntalo M, Laurila K, Roth WD, Rossi P, Lavonen J, Mäkinen K, et al. Scandinavian Thrupass Study Group. PTFE bypass or thrupass for superficial femoral artery occlusion? A randomised controlled trial. Eur J Vasc Endovasc Surg 9;7:78e8. Norgren L, Hiatt WR, Dormandy JA, Hirsch AT, Jaff MR, Diehm C, et al. The Next years in the management of peripheral artery disease: perspectives from the PAD 9 conference. Eur J Vasc Endovasc Surg ;:7e8. Söderstrom M, Arvela E, Korhonen M, Halmesmäki K, Albäck A, Biancari F, et al. Infrapopliteal percutaneous transluminal angioplasty versus bypass surgery first strategies in critical leg ischemia: a propensity score analysis. Ann Surg ;: 76e7. Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, et al. BASIL Trial Participants. Bypass versus in Severe Ischaemia of the Leg (BASIL) trial: an intentionto-treat analysis of amputation-free and overall survival in patients randomized to a bypass surgery-first or a balloon angioplasty-first revascularization strategy. J Vasc Surg ; :Se7S. 6 Idu MM, Buth J, Cuypers P, Hop WC, van de Pavoordt ED, Tordoir JM. Economising vein-graft surveillance programs. Eur J Vasc Endovasc Surg 998;:e8. 7 Kantonen I, Lepäntalo M, Salenius JP, Forsström E, Hakkarainen T, Huusari H, et al. Auditing a nationwide vascular registry-the -year Finnvasc experience. Finnvasc Study Group. Eur J Vasc Endovasc Surg 997;:68e7. 8 Taha AG, Vikatmaa P, Albäck A, Aho PS, Railo M, Lepäntalo M. Are adverse events after carotid endarterectomy reported comparable in different registries? Eur J Vasc Endovasc Surg 8;:8e.

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