Treatment of Atherosclerotic Disease of the Femoral Artery: Randomized Controlled Trials and Meta-Analyses. Should You Be Sceptical?

Raymond Englund

St George Private Hospital, Kogarah, Sydney.

DOI: 10.4236/ss.2019.107026                

Abstract

A narrative review of the data provided by Randomised Controlled clinical trials and meta-analyses was undertaken to assess how much reliance a clinician could place on these in selecting a treatment for patients with disease of the Femoral artery. An attempt was made to detect and review every clinical trial and meta-analysis published on treatments relating to disease of the femoral artery but not relating to drug treatment. Disease of the femoral artery in >65 years age group occurs in approximately 20% of the population but symptomatology was present in <2%. Associated morbidity was high and the 5-year mortality rate was >40%. In almost all trials the predominant (>90%) indication for treatment was intermittent claudication. In this setting, clinical benefit was limited and did not extend beyond 12 months. Mortality, from co-morbidities was high. The Basil Trial was the only one to examine intervention for critical limb ischemia. The results for Bypass surgery and Percutaneous transarterial balloon angioplasty (PTA) were equivalent. There is little evidence to support the use of PTA or stenting other than in the treatment of patients with critical limb ischemia.

Keywords

Femoral Artery, Stent (Nitinol, Drug-Eluting, Covered), Percutaneous Balloon Angioplasty, Drug Eluting Balloons, Randomised Controlled Trials, Meta-Analyses, Intermittent Claudication, Critical Limb Ischemia, Patency, Clinical Benefit

1. Background

Atherosclerotic disease of the femoral Artery is a marker for the presence of systemic atherosclerotic disease. It may manifest in any one of 3 ways; asymptomatic, as intermittent claudication (IC-the disability of being able to walk only a limited distance before the development of calf pain induces the necessity of stopping to rest before being able to carry on usually for a similar distance) and as critical limb ischemia (CLI) evidenced by rest pain, ulceration or gangrene.

Diehm C, Schuster A, Allenberg JR et al. [1] reported on 6880, unselected patients, older than 65 years of age in the German Epidemiological Trial. In this cross-sectional study 344 general practitioners measured bilateral Doppler ultrasound ankle brachial systolic pressure Indices (ABSPI) bilaterally, recorded history, physical examination, and the WHO questionnaire on Claudication. Males accounted for 42% of the cohort, 19.8% had low ABPSI (indicating atherosclerotic disease-PAD) and 16.8% were women with reduced ABSPI and PAD. Patients with PAD had Odds Ratio (OR) of diabetes x 1.8, hypertension x 2.2, lipid disorders x 1.3, cerebrovascular event x 1.8 and any cardiovascular event x 1.8.

Similarly, Meijer WT, Hoes AW, Rutgers D et al. [2] , in the Rotterdam study, investigated 7715 patients over 55 years of age (40% men, 60% women) and found the prevalence of PAD to be 19.1%, but symptoms of IC were present in only 1.6% of the study population (men-2.2%, women-1.2%). When PAD was detected, 6.8% reported IC. This study highlighted that the increased incidence of PAD in the elderly was not associated with frequent symptomatology.

Therefore, question arises as to when PAD in the femoral artery should be treated and what form should this treatment take. It is clear from the quoted studies that the co-morbidities of hypertension, diabetes, lipid disorders and smoking should be addressed as baseline management of any patient with peripheral vascular disease.

2. Methodology

The format of this research was by narrative review. This study was not a meta-analysis or systematic review but was designed to include information that would have been excluded by these techniques. Figure 1 shows the Flow diagram of literature selection process.

I formulated research questions such as “what is the natural history of atherosclerotic disease of the femoral artery?”, “supervised exercise therapy and intermittent claudication”, “trials of supervised exercise therapy compared to

Figure 1. Flow diagram of literature selection process.

intervention”, “treatment of atherosclerotic disease of the femoral artery by percutaneous balloon angioplasty (PTA) and stenting”, “drug eluting balloons (DEB) in PTA and drug eluting stents and the femoral artery” and cross referenced these with clinical trials and meta-analyses. Within each question, the initial objective was to identify all published meta-analyses that addressed the given research question. A meta-analysis that addressed the given research then became a source of references with respect to that research question. Studies used in the given meta-analysis were obtained. Where possible studies that were excluded from the meta-analysis were also obtained. Cochrane reviews were particularly useful in this respect because they contained a complete list of references that were not included in the ultimate review.

The data extraction method used was by searching for keywords PTA, DEB, DES, balloon angioplasty, covered stent, standardized exercise programs and peripheral artery disease. These keywords were cross reference with disease of the femoral artery and superficial femoral artery. Search engines used include PUBMED, Clinical Knowledge Network, Medline and The Cochrane Review.

When those studies from meta-analysis had been obtained, they then became a source further to obtain references. The bulk of this work was performed by hand and requests to libraries for reprints of publications. Reference was made to trials registry and when a trial was identified an attempt was made to obtain the published results of that trial. In some cases, references to abstracts from clinical meetings are obtained from the reference section of a publication. Where possible a copy of the abstract was obtained.

References that were excluded were those that pertained to treatment of atherosclerotic disease of the aortoiliac or infra-popliteal segments of the vascular system where data relating to the femoropopliteal segment could not be separated.

Analysis of the data obtained through the above process was then cross-tabulated in chronological order. Data points of particular interest were year of publication and authors. This produced a number of cases of double, complete and fragmentary publication and the publication of some trial results outside the ultimate declaration of trial results. The type of study that had been conducted, the number of patients at recruitment and number of patients on which the analysis was made and the type of intervention was also noted. The trial endpoints and the stated conclusions of the trial investigators were also included in these cross-referencing tables. Finally, the involvement of industry in the conduct of the trial and declared conflict of interests of authors was noted. What soon became obvious was that while financial conflict of interest was readily declared, few authors recognised the possibility of intellectual conflicts of interest.

3. Supervised Exercise Training for Intermittent Claudication

Hobbs SD, Bradbury AW [3] outlined the difficulties associated with conducting RCT’s of supervised exercise training versus no treatment. However, some researchers managed to overcome these problems. Ratcliff DA et al. [4] demonstrated that clinical benefit of supervised exercise training gained at 12 weeks could be sustained for up to 3 years. This was not a RCT. An update of the Cochrane Data Base [5] in 2017 came to the following conclusions based on 32 studies involving 1835 patients: maximum walking distance could be significantly improved from 82.11 meters to 92.48 in studies where no exercise was compared to exercise treatment, improvements were seen for up to 2 years. Exercise provided no benefit for outcomes of amputation or mortality. The authors commented on significant heterogeneity between trials. Although this review found statistical benefit and cost-effectiveness for supervised exercise therapy, one could reasonably question what lifestyle benefit patients would gain from this small improvement in walking distance gained by supervised exercise therapy. Mazari et al. [6] , in a study comparing PTA to exercise therapy, RCT for claudication patients, showed that PTA conferred a benefit related to physical function and bodily pain but no benefit for general overall health and no benefit beyond 12 months.

Table 1 lists a number of RCT’s comparing PTA to supervised exercise therapy and one trial of PTA to SEP alone and PTA combined with SEP. These trials

Table 1. Supervised exercise therapy SET vs. PTA.

dealt with patients in whom the focal arterial disease was in the femoral artery. There are a number of trials that include disease in the aortoiliac segment which have not been included in this table. However, Aherne T et al. [7] have conducted a meta-analysis of 11 RCT’s (969 patients) comparing SET with intervention, but with disease involving multiple levels. Their conclusion was that all trials should include SET and optimal medical therapy. As will be outlined below this is a recommendation that is rarely included in most interventional RCT trials.

4. PTA (with Stent Bailout) versus Routine Stenting

There are six meta-analyses which examine this question covering RCT’s between 1997 and 2014. Essentially all came to the same conclusion; that there is no durable benefit for routine stenting and that any initial benefit is lost within 12 months.

None of the RCT’s contains control groups of optimal medical treatment and SET. The number of RCT’s in each meta-analysis varies depending on the inclusion criteria chosen by the authors. There is a suggestion of double publishing among RCT’s and double counting in the meta-analyses. Taken together they produce little evidence to support either PTA or stenting of the femoral artery particularly in patients suffering from IC. Table 2(a) lists these meta-analyses while Table 2(b) is a list of references for RCT’s included in the meta-analyses of Table 2(a). At Least 2 of these meta-analyses have significant contributions of data from cohort studies, the remainder relies entirely on RCT’s. The most reliable appears to be the Cochrane Meta-analysis from 2014 which took data from 11 trials and 1387 patients. Their conclusions were that any initial advantage for stenting routinely was lost within 24 months. Further, there was no improvement in quality of life from a physical or mental viewpoint. This meta-analysis included both patients with intermittent claudication and critical limb ischemia but excluded trials of new technology such as drug eluting balloons (DEB) and stents (DES).

The last meta-analysis included in Table 2(a) is performed by Antonopoulos et al. [88] . This meta-analysis compared 11 treatments for femoral artery occlusive disease. The authors selected 33 studies to compare primary patency and binary restenosis at 12 months follow up. They concluded that DES and bypass surgery maintain roles as the principal intervention. The data for DES was based on 1 study [68] . The data for bypass surgery was based on 3 studies [72] [73] [89] . One trial [72] had been terminated prematurely with 44 patients recruited because an interim analysis had shown that only 4% of lesions were amenable to the study. Another study [73] concluded that percutaneous treatment with stent graft was comparable to bypass revascularization at 12 months. The last study [72] made the following statement “Despite 18 participating centres, only 56 patients were randomized to PTA or bypass surgery”.

The meta-analysis in question included only 200 patients, this was less than

(a) (b)

Table 2. Meta-analysis of trials of PTA vs. stent.

half the number of patients recruited to the BASIL trial [90] which showed no difference for PTA compared to bypass surgery for critical ischemia.

5. Treatment of Femoral Artery Disease in the Presence of Severe Ischemia

Trials so far listed have demonstrated little benefit in reducing mortality or limb loss because the bulk of the patients entering these trials suffered from IC. The reason for this is that it is easier to recruit patients with IC for a RCT.

“The Bypass versus angioplasty in severe ischemia of the leg (BASIL): multicentre, randomised controlled trial” [90] directly addressed the issue of treatment of CLI caused by femoral artery disease. The original trial randomised 452 patients to either bypass surgery first (n = 228) or PTA first (n = 224). At the end of follow up in the initial report in 2005, there was no difference in amputation free survival or overall survival between the two groups but cost and length of hospital stay were significantly greater for surgery first group and 37% of patients were dead (8% after amputation, 29% without amputation). In 2010 the trial investigators published further follow up data [91] suggesting that for patients who survived more than 2 years after randomization, surgery first was associated with better overall survival. They claimed better amputation free survival, this did not reach statistical significance. During a subsequent mean follow up of 3.1 years 56% of all patients were dead (59% in PTA group and 53% in surgery group). This suggested that the possibility of selecting which patients would survive 2 years could have been predicted by the toss of a coin and their analysis suffered from retrospectivity. Trial investigators indulged in further retrospective analysis [92] and used this to justify further RCT [93] comparing 3 different endovascular treatments for femoral artery disease causing CLI. The results are yet to be published.

6. Trials Driven by Technology

There are a number of trials driven by advances in technology and these are most often industry supported. Table 3 lists trials of nitinol stents. Some are RCT’s and some are cohort studies. The overwhelming number of participants in these trials suffered from IC. Examination of these trials suggests little benefit for routine stenting with nitinol stents.

Table 4 lists trials of covered stent technology. There are two trials, one of which was closed due to device failure, then restarted. The other showed no benefit for this type of technology compared to PTA.

Table 5 lists trials of Drug-eluting Balloons (DEB) and Drug-eluting Stents (DES). These devices are coated with Sirolimus [97] or Pacxlitaxel which are drugs that prevent the ingrowth of smooth muscle cells and therefore the development of stricture formation. These drugs are released from the balloon or stent over a variable period of time. The trials are mostly conducted on patients with IC, they frequently have questionable endpoints (freedom from binary

Table 3. Trial of nitinol stents.

Table 4. Trials of covered stent technology.

Table 5. Drug eluting technology.

restenosis or Target lesion revascularization, change of Rutherford class) or have complicated and questionable randomisation processes. A recent meta-analysis [98] came to the conclusion that there was little benefit from DEB’s and there is only one trial showing benefit for DES. This trial had a questionable randomisation process, 40% of the patients were lost to follow up and the trial was industry driven. There is no substantial evidence that new technologies have a role to play in the treatment of IC caused by atherosclerotic disease of the femoral artery.

7. Conclusions

Atherosclerotic disease of the femoral artery is a marker for advanced systemic cardiovascular disease. It is most prevalent in the population of individuals greater than 65 years of age. Most frequently it is an asymptomatic condition. Its detection and management should remain in the realm of primary care physicians.

Many RCT which address treatment of this condition are flawed because of commercial objectives to demonstrate equivalence to an already approved procedure, because of the use of clinically fallacious end points, because the use of follow up periods that do not extend beyond expired advantage and because the sample population is too small or unrepresentative.

While meta-analyses of these RCT’s are designed to increase sample size, what is in fact achieved is a compounding and magnification of these flaws.

Most trials that address treatment of this condition are conducted on patients who have claudication and do not have an indication for intervention other than the conduct of the trial. Industry funding of these trials makes it highly unlikely that the results will be challenged after a positive result has been obtained. There is profound profit motive to obtain and publish only trials with positive results. Investigators often have a similar conflict of interest. Authors rarely declare the intellectual ownership of a positive result from a previous trial. Meta-analyses of these trials are often flawed by compounding these biases [99] [100] .

Abbreviations

PTA Percutaneous transluminal angioplasty

CLI Critical limb ischemia

ABSPI Ankle brachial systolic pulsatility index

IC Intermittent claudication

PAD Peripheral artery disease

DEB Drug eluting balloon

DES Drug eluting stent

SEP Standardized exercise program

RCT Randomised control trial

Conflicts of Interest

The authors declare no conflicts of interest regarding the publication of this paper.

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