doi: 10.1161/CIRCULATIONAHA.106.682203
(Circulation. 2007;115:550-552.)
© 2007 American Heart Association, Inc.
Editorial |
Peripheral Endovascular Revascularization
Some Proof in the Pudding?
From the Cardiovascular Division, Brigham and Women’s Hospital, Boston, Mass.
Correspondence to Joshua A. Beckman, MD, MS, Cardiovascular Division, Brigham and Women’s Hospital, 75 Francis St, Boston, MA 02115.
Key Words: Editorials • angioplasty • claudication • peripheral vascular diseases • quality of life • stents
The diagnosis of peripheral arterial disease (PAD) provides an opportunity for significant medical intervention. All patients with PAD are at high risk of cardiovascular events, with mortality ranging from 15% to 50% in 5 years, depending on the severity of presenting symptoms.1 Beyond this atherosclerotic risk, 
50% of patients have leg pains and limitations in their ability to walk.
Article p 569
There are 2 major symptomatic manifestations of PAD: intermittent claudication and critical limb ischemia. Derived from the Latin word claudicatio, signifying a limp, intermittent claudication is an exertion-mediated leg muscle discomfort caused by arterial blood flow that is inadequate to meet the demands of exercising skeletal muscle. Patients may get relief from pain with exercise cessation, which restores the blood supply-demand equilibrium as the skeletal muscle oxygen requirements abate. Claudication is the most common symptom in PAD and the most common reason for which patients with PAD seek medical attention. The rarer and more serious complication of PAD is critical limb ischemia, which causes pain in the foot, a nonhealing ulceration, or frank gangrene, each signifying inadequate arterial blood supply to meet basal metabolic requirements. Without revascularization, patients with critical limb ischemia have a high risk of amputation. In contrast to the severe consequences of critical limb ischemia, the leg prognosis in intermittent claudication is benign. Nondiabetic patients with intermittent claudication have a <1% per year rate of developing critical limb ischemia.2 However, the reduction in function remains stable for years, leaving patients with a chronic severe reduction in their quality of life.
With the advent of catheter-based interventional therapies for PAD, endovascular physicians have become able to improve arterial perfusion in the lower extremity through the use of balloon angioplasty and stenting. Low procedural morbidity and high procedural success have led to an enormous increase in the use of these therapies in the treatment of intermittent claudication. Between 1980 and 2000, catheter-based interventions for symptomatic PAD increased 500-fold, from 0.1 to 58.3 procedures per 100 000 people for a total of 164 417 in the year 2000.3 During the same period, however, the rate of amputation increased 21%, suggesting little impact of catheter-based interventions on limb salvage in critical limb ischemia. The application of catheter-based therapies has been directed primarily at improving patients’ walking distance and quality of life, not preventing amputation or cardiovascular complications.
Catheter-based therapies have a mixed long-term record in revascularization. According to the recent American College of Cardiology/American Heart Association PAD guidelines, the 1-year patency rate of iliac artery revascularization ranges from 66% to 90%, depending on the presence of critical limb ischemia, the use of a stent, and iliac arterial stenosis or occlusion.2 The results in the femoral artery are less favorable. Although procedural success rates are 75% to 90%, the 1-year patency ranges from 26% to 80%, depending on the presence of critical limb ischemia, use of a stent, and nature of the arterial occlusive disease. Thus, approximately half of the patients undergoing femoral artery percutaneous revascularization are likely to have procedural failure or recurrent arterial occlusive disease by the end of 1 year. Nevertheless, vascular and endovascular physicians are increasing their use of endovascular therapies because of the low attendant cardiovascular risk and the perceived reduction in symptoms. Remarkably, despite the conviction that these procedures provide benefit to patients, few investigations have been performed to suggest a long-term salutary effect on quality of life.4–7
It is in this context that the report by Safley and colleagues8 in this issue of Circulation should be viewed. These authors are to be congratulated for devising a prospective quality-of-life evaluation in 300 patients undergoing percutaneous lower-extremity revascularization. Revascularization was performed for relief of intermittent claudication in 95% of the subjects, individualized according to the patients’ treating physician. Adequate health status data were available in 86% of the enrolled population.
The authors used 4 questionnaires to determine quality-of-life outcomes: the PAD-specific Peripheral Artery Questionnaire; the Short Form-12, which generates a physical and mental summary score; the EuroQol to measure generic quality of life; and the Patient Health Questionnaire as a tool to measure depression. They report significant improvements in Peripheral Artery Questionnaire scores by 30 days that were maintained to 1 year. Similarly, the physical function component of the Short Form-12 and quality of life as measured by EuroQol also increased at 1 year, whereas the Short Form-12 mental component and the Patient Health Questionnaire measure of depression were unchanged.
The authors then report that 20% of the subjects did not respond to the therapy and failed to enjoy the improvements in quality of life experienced by the other 80%. This group of "nonresponders" had similar Transatlantic Inter-Society Consensus lesion type, lesion location, frequency of stenting, number of lesions stented, stent length, and stent diameter similar to those of "responders." The authors speculate that the lack of benefit may be related to procedural and anatomic characteristics, although no differences are cited to support that contention.
The authors did not take advantage of all of the information available to explain the presence or absence of benefit. Neither ankle brachial indexes nor duplex ultrasonography was used to determine whether the revascularized artery remained patent. As reported above, the 1-year patency of femoral artery angioplasty and stenting is 50% to 60%. Thus, it is likely that at least one third of the patients suffered restenosis. It would be natural to assume that the nonresponders were the cohort that suffered arterial restenosis; however, even if this were the case, many fewer patients reported no response than would have had restenosis.
A second possibility for lack of benefit would be the frequent overlap of other comorbidities in patients with PAD. McDermott and colleagues9 have shown that most patients with symptomatic PAD have atypical symptoms. Patients in this age group commonly suffer from other conditions that may cause walking-associated leg pain such as lumbar spine radiculopathy, degenerative joint disease, and venous insufficiency. As a result, revascularization in these patients may not provide symptom relief or improve their quality of life despite procedural success. No information is provided to describe the methods used to make the diagnosis of claudication, the criteria used for referral for an endovascular procedure, or the mode of confirmation of claudication as the cause of walking limitation (eg, exercise testing with before-and-after ankle brachial index measurement).
Another important issue with this report is the generalizability of its findings. In evaluating the data, one should pose the question, Would it be fair to conclude that 80% of the percutaneous interventions yield significant improvements in quality of life at 1 year in all comers with claudication? Because the authors were adherent to established PAD guidelines,2 the results do not likely represent outcomes for the typical patient with intermittent claudication. Nearly 70% of the patients in the study by Safley and colleagues had Transatlantic Inter-Society A lesions, indicating a stenosis of 
3 cm in the common or external iliac, superficial femoral, or popliteal arteries. Yet, when consecutive patients with intermittent claudication have been studied previously with arteriography, >60% have evidence of total arterial occlusion.10,11 One would expect the results of femoral artery intervention in this study to be better than in patients with arterial lesions with long-segment stenosis, short-segment occlusion, and long-segment occlusion.12 In addition, endovascular physicians are expanding the use of these techniques beyond established guidelines to more complex disease, including restoration of flow in long-segment occlusions,13 use of endovascular therapy as initial therapy in infrapopliteal arterial occlusive disease,14 and use in patients with critical limb ischemia.15 Long-term patency rates will likely be even lower in these patient populations, making outcome determinations even more important.
Despite these limitations, physicians dedicated to the care of patients with PAD must hope that investigators follow the lead of Safley and colleagues and continue to prove the value of these techniques to physicians and patients. Investigators in this field should standardize the outcome measures used to evaluate the benefits and risk of the procedure. In addition to periprocedural complications and quality-of-life measures, future investigations should incorporate evidence of revascularization durability. The relationship between the reduction in arterial perfusion pressure (decreased ankle brachial index) and walking distance is poor, and improvement mediated by flow restoration varies. Currently, treating physicians cannot reliably provide patients with an understanding of the relationship between the success of the procedure and the amount of walking distance improvement. Determining the relationship between stent patency and quality-of-life enhancements is the only way to understand the benefit of revascularization, stent surveillance, and importance of durable patency.
I would propose that 5 elements be included in future evaluations of percutaneous revascularization of intermittent claudication: (1) major adverse cardiovascular events, including myocardial infarction, stroke, and death; (2) quality-of-life surveys for both walking impairment and overall health quality; (3) ultrasonographic evaluation of revascularization patency at the end of follow-up; (4) ankle brachial index; and (5) reintervention and procedural complication rates. In concert, these elements will provide the information that vascular and endovascular physicians require for adequate risk-to-benefit analysis and appropriate use of the treatments.
Physicians who participate in the care of patients with intermittent claudication have a range of therapeutic options to improve patient quality of life. Randomized trials have made clear the benefits and limitations of exercise and medical therapy. Surgical revascularization has been limited most often to the treatment of critical limb ischemia and limb salvage. Unfortunately, the first 25 years of percutaneous therapies has not made clear the benefits of the interventional strategy beyond a limited set of circumstances. With investigators like Safley and colleagues, that tide is turning.
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Acknowledgments |
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Source of Funding
This work was supported by a grant from the American Diabetes Association (1-06-CD-01).
Disclosures
None.
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Footnotes |
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The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.
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