A multicenter prospective randomized trial to determine the optimal treatment of patients with claudication and isolated superficial femoral artery occlusive disease: Conservative versus endovascular versus surgical therapy

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4. Karp RB, Wylie EJ. Recurrent thrombosis after ilio-femoral venous thrombosis. Surg Forum 1966;17:147. 5. Lansing AM, David WM. Five-year follow-up study of iliofemoralvenous thrombectomy. Ann Surg 1968;168:620-8. 6. Rutherford R. The role of thrombectomy in the management of iliofemoral venous thrombosis. In: Rutherford R, ed. Vascular surgery. 3rd ed. Philadelphia: WB Saunders, 1989: 1569-74.

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7. Plate G, Einarsson E, OhLin I?, et al. Thrombectomy with temporary arteriovenous fistula: the treatment of choice in iliofemoral venous thrombosis. J VASC SURG 1984; 12367. 8. Itismer RL, SparkuhlMD. Surgery in acute and chronic venous disease. Surgery 1979;85:31-43. 9. Hyers

TM,

Hull

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venous thromboembolic

Weg

JG. Antithrombotic

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disease. Chest 1989;95:37S-51s.

A MULTICENTER PROSPECTIVE RANDOMIZED TRIAL TO DETERMINE THE OPTIMAL TREATMENT OF PATIENT’S WITH CLAUDICATION AND ISOLATED SUPERFICIAL FEMORAL ARTERY OCCLUSIVE DISEASE: CONSERVATIVE VERSUS ENDOVASCULAR VERSUS SURGICAL THERAPY Currently accepted management of treatment of patients with claudication caused by short segmental superficial femoral artery occlusive disease includes exercise, various endovascular procedures (including percutaneous transluminal balloon angioplasty [PTA], atherectomy, and laser-assisted balloon angioplasty [LABA]), and surgical therapy (femoral popliteal bypass or endarterectomy). The optimal method of treatment in terms of patient risk, benefit and cost has not been established and remains controversial. Conservative therapy of patients with claudication has long been advocated because of the low risk of limb loss. Boyd et al.’ reported this risk to be only 8% at 5 years, and 12% at 10 years. Imparato et al.’ reported that 75% of patients with claudication will remain stable or their symptoms will even improve with conservative therapy, and that only 25% will ultimately have progressive disease requ.iring surgical intervention. Added to this good prognosis is the major improvement in claudication distance that a formal graded exercise program will produce in 40% to 60% of patients. Recently, Creasy et al.3 reported a prospective randomized study that showed that patients with claudication with discrete femoropopliteal occlusive lesions, when placed on a supervised exercise regimen, walked significantly (about three times) farther on average than similar patients treated with percutaneous balloon angioplasty at the l-year follow-up point. However, with the advent and development of various endovascular procedures in the past decade, some physicians, particularly interventional radiologists, now advocate percutaneous transluminal balloon angioplasty (PTA) as the preferred treatment for patients with claudication with discrete superficial femoral artery occlusive disease. Reports of this approach claim a low complication rate of less than 5%, a technical success rate of 72% to 97%, and l- to 3-year patency rates of 73% to 90%.4-9 It is claimed these patencies rival those for femoropopliteal bypass, but carry a much lower morbidity and mortality rate. Furthermore, the recent advent of laser technology has

increased the ability to treat totally occluded as well as stenotic lesions, albeit as a prelude to balloon angioplasty. Sanborn et al.” have reported an initial success rate for LABA of more than 90%, including a 56% successll recanalization rate in patients with lesions “impossible” to treat with conventional balloon angioplasty.‘@” The various new atherectomy catheters also have increased the range of lesions treatable with transluminal percutaneous methods, in particular, the eccentric hard calcified plaques. The initial (technical) sticcess rates have been 87% for the Simpson athrectomy catheter,12 92% for the Auth (Auth Co., Deer Park, N.Y.) Rotablator, (Ahn SS. 1989. Unpublished data), and 92% for the Transluminal Extraction Catheter (Wholey MH, 1990. Personal communication). However, these devices, like LABA, carry a 20% to 40% restenosis rate within 6 to 12 months. Surgical therapy (bypass or endarterectomy) has traditionally been reserved for severe disabling claudication or limb threat and carries 57% to 72% 5-year overall patency rates. l3 Results of surgery for patients with isolated femoral popliteal lesions with moderate to stable claudication have not been analyzed in large numbers. Abstracting from larger series, patients with claudication and good distal runoff generally have better results with a 5-year patency rate of as high as 82% and operative mortality rate of less than 3%.14-15 Advocates of surgery point out that patients have much better overall long-term results when treated with surgical procedures than with percutaneous techniques and that morbidity and mortality rates have steadily been reduced. However, the controversy over the optimal therapy for patients with claudication with isolated femoral popliteal disease cannot be settled by comparing such reports. Patients vary significantly in lesion severity, runoff status, and risk factors. Many of the reports of endovascular procedures disregard initial failure, which may be as high as 25%, and use symptomatic improvement rather than objective noninvasive criteria for estimating patency. Wiison et al.16 reported a prospective randomized study

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comparing transluminal balloon angioplasty versus surgical therapy for aortoiliac occlusive disease and showed that the results of the two methods were similar. A comparable study looking at isolated femoral popliteal occlusive disease has not yet been conducted in this country and is clearly needed. The problem with any study comparing endovascular approaches with each other or, as in this case with surgery or noninterventional treatment, is that rapid technologic advancements have spawned quite a number of devices that are constantly being improved along with the guidance systems that ultimately determine their degree of technical success. Thus if a single endovascular device, be it a balloon, laser or atherectomy device, were to be chosen for randomized comparison, interventionalists would likely declare the results of any long-term study invalid and point to the new and better technology now in use. It is therefore recommended that we compare the results of (1) the best available endovascular techniques for the lesion in question with (2) the best nonoperative approach and (3) the most appropriate direct surgical revascularization. This will require the cooperation of experienced and skilled personnel in vascular medicine, interventional radiology, and vascular surgeons in each participating center. Relatively healthy, active “disabled claudicators” with isolated femoropopliteal occlusive lesions less than 10 cm in length with less than 40% popliteal narrowing and at least two-vessel runoff would be eligible. Standard noninvasive hemodynamic criteria should be used to assess the presence and severity of arterial insufficiency. l7 Specifically excluded would be (1) Those with serious associated diseases, specifically symptomatic coronary artery disease, renal insufliciency, COPD or known coagulopathies. (2) Those with previous failed revascularization in the same or other leg. (3) Those with bilateral femoropopliteal disease in whom disease in the contralateral extremity would obscure assessment of symptomatic relief in rhe treated extremity. Randomization would occur after arteriograpb All patients would be treated with long-term aspirin therapy (325 mg/day), and those treated with intervention (open surgical or endovascular) would be heparinized during the procedure. Oral anticoagulation with warfarin has been advocated by some to enhance patency after interventional procedures. However, no strong evidence exists, pro or con, that warfarin anticoagulation is beneficial in this circumstance. ‘* Because it might confound interpretation of outcomes, antithrombotic therapy with warfarin would be specifically prohibited. The treatment groups require careful consideration and would have to be agreed on by all of the participating centers. The best conservative therapy appears to be that described by Creasy et al.,3 which consists of a supervised exercise program, on a treadmill three times per week. The best percutaneous method remains controversial, but currently the gold standard remains percutaneous balloon angioplasty. Despite the promising early technical success rate of atherectomy and LABA, the long-term

Journal of VASCULAR SURGERY

patency rates have been disappointing, with a 6-month restenosis rate of at least 36% to 50%.10-‘2 Furthermore, with the availability of the Teruma guide wire, many total occlusions can be recanalized with use of standard balloon angioplasty techniques. Thus balloon angioplasty should be given first consideration and used preferentially, particularly in short (~3 cm) lesions. However, evolving technology may change this. Furthermore, recognizing the limitations of balloon angioplasty in totally occluded and calcified arteries, the adjunctive use of lasers or atherectomy devices should be allowed as indicated. Thus the “best” endovascular therapy may require a combination of techniques The best surgical therapy is also somewhat controversial. Because there has been no statistically significant difference in most clinical trials between PTFE and saphenous vein for above-knee femoropopliteal bypass, both techniques will be used. The decision regarding choice of bypass conduit will be left to individual participating surgeons. Some have advocated endarterectomy of these isolated femoral popliteal lesions.19,20 This may be appropriate for accessible, short ( < 3 m) lesions with a normal appearing vessel back to the femoral bifurcation. In brief, as with endovascular therapy, “best” surgical treatment may involve a variety of acceptable techniques. All patients should have their status documented by clinical symptoms, segmental Doppler pressures, plethysmography, treadmill exercise, and angiograms on entry into the study. All patients in the study should undergo follow-up symptomatic evaluation with noninvasive testing (including treadmill exercise) at 1, 3, 6,9, 12, 15, and 18 months, and then, every 6 months up to 3 years. Each patient will undergo a follow-up angiogram at 1 month and whenever noninvasive testing suggests deteriorization. Determination of primary and secondary patency and reporting of complications will be by suggested SVS/ISCVS Reporting Standards criteria.17 The total health care cost for the patient would be determined at 1 month and for each 1Zmonth interval. Study end points need precise definition and consideration. “Successful outcome” will require change in clinical classification and objective evidence of hemodynamic improvement and of patency (e.g., the initial technical failures of percutaneous procedures will count as a failure of primary patency). In addition to symptomatic and hemodynamic improvement, morbidity and mortality rates,2 complication severity index,’ and total costs will be recorded. At entry, documentation for a number of variables will be necessary to ensure balanced groups. Runoff status and other factors potentially affecting outcome, such as smoking, sex, hyperlipidemia, and diabetes mellitus should be monitored to document random distribution. On the basis of the currently available data of patients treated with conservative therapy, one would expect that the exercise group would show significant improvement in walking distance but not with hemodynamic studies. Less than 25% of these patients would have progressive

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symptoms and require crossover into the endovascular or surgical treatment arms. The immediate technical success rate of percutaneous procedures is expected to be 80% to 90%. However, the 3-year primary patency rate, including technical failures, will likely be less than 40%, although the secondary patency rate may be approximately 65%. Repeat procedures may drive up the total cost of the percutaneous methods and eventually match the total cost of surgical therapy. The surgical group should achieve a 3-year primary patency rate of approximately 70%, with a secondary patency rate of 80% to 85%. Complication rates of surgical and percutaneous methods will probably be similar. The total cost in the endovascular and surgical groups may well be similar, but both of these therapeutic approaches will probably be much more costly than exercise during the first year. However, it would not be surprising if the surgical group has the least cost at the end of a 5-year follow-up period. Since it involves three randomization groups, this study will require a large number of patients and multiple institutions. To show a 15% to 20% difference between any two of the groups, one would need at least 400 patients. Stratification based on runoff and risk factors would dramatically increase the number of patients required. Sam Ahn, MD Robe@ B. Rs&e@ord, MD REFERENCES 1. Boyd AM. Natural course of arteriosclerosis of lower extremities. Proc R Sot Med 1962;53:591. 2. Imparato AM, Kim GE, Davidson T, et al. Intermittent claudication: its natural course. Surgery 1975;78:795. 3. Creasy TS, McMillan PJ, Fletcher EWL, et al. Is percutaneous transluminal angioplasty better than exercise for claudication? Eur J Vast Surg 1990;4: 135-40. 4. Gruntzig A. Die perkutane transluminale Rekanatisation chronischer arterienverschlusse mit einer neuen Dilatationstechnik. Baden-Baden: Verlag Gerhard Witzstrock, 1977:24. 5. Johnson KW, Colapinto RF. Transluminal dilatation-a surgeon’s viewpoint. Vast Diagn Ther 1981;2:15. 6. Spence RK, Freeman DB, Gatenby R, et al. Long-term results of transluminal angioplasty of the iliac and femoral arteries. Arch Surg 1981;116:1377.

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7. Waltman AC, Greenfield AJ, Novelline RA, et al. Transhuninal angioplasty of the iliac and femoropopliteal arteries. Current status. Arch Surg 1982;117:1218. 8. Zeitler E, Richter EI, Roth F J, et al. Results of percutaneous transluminal angioplasty. Radiology 1983;146:57-60. 9. Harris RW. Percutaneous transluminal angioplasty of the lo&er extremities by the vascular surgeon. Presented at the Fifth Annual Meeting of the Western Vascular Society Meeting January 25-28, 1990; Coronado, CA. 10. Sanborn TA, Greenfield AJ, Gruben JK, et al. Human percutaneous and intraoperative laser thermal angioplasty: Initial clinical results as an adjunct to balloon angioplasty. J VASC SURG 1987;5:83-90. 11. Cumberland DC, Sanborn TA, Taylor DA, et al. Percutaneous laser thermal angioplasty: initial clinical results with a laser probe in total peripheral artery occlusion. Lancet 1986;l: 1457-9. 12. Simpson JP, Selman MR, Robertson GC, et al. Transluminal atherectomy for occlusive peripheral vascular disease. Am Coli Cardiol 1988;61:96-101. 13. Bernhard VM. Bypass to the popliteal and infrapopliteal arteries. In: Rutherford RB, ed. Vascular surgery. 2nd ed. Philadelphia: WB Saunders, 1984:607-19. 14. Darling RC, Linton RR. Durability of femoropopliteal reconstructions. Am J Surg 1972;123:472. 15. Cutler BS, Thompson JE, Kleinsasser LJ, et al. Autologous saphenous vein femoropopliteal bypass: analysis of 298 cases. Surgery 1976;79:325. 16. Wilson SE, Wolf GL, Cross Al?. Veteran’s Administration Cooperative Study No. 199. Percutaneous transluminal angioplasty vs operation for peripheral arteriosclerosis: report of a prospective randomized trial in a selected group of patients. J VASC SURG 1989;9:1-9. 17. Rutherford RB,Flanigan DP, Gupta SK, et al. Ad Hoc Committee on Reporting Standards, Society for Vascular Surgery/North American Chapter, International Society for Cardiovascular Surgery. Suggested standards for reports dealing with lower extremity ischemia. J VASC SURG 1986; 4:80-94. 18. Clagett GP, Genton E, Salzman EW. Antithrombotic ther;;; in peripheral vascular disease. Chest 1989;95:128319. Inahara T, Scott CM. Endarterectomy for segmental occlusive disease of the superficial femoral artery. Arch Surg 1981;116: 1547. 20. Walker PM, Imparato AM, Riles TS, et al. Long-term results in superficial femoral artery endarterectomy. Surgery 1981; 89:231.

STAGED VERSUS SIMULTANEOUS AORTOBIFEMORAL BYPASS AND INFRAINGUINAL BYPASS Despite numerous

advances in lower extremity arterial treatment of patients with multilevel arterial occlusive disease involving both the aortoiliac and femoropopliteal segments remains controversial. Although the exact incidence of such multilevel disease (MLD) is unknown, it has been estimated to be reconstruction,

the

proper

from 25% to 70% of patients undergoing arterial reconstruction, depending on the patient population and the indications for operation. l-7 Although the clinical presentation and subsequent management of such patients will vary, depending on the precise location and severity of the occlusive process,