Meta-analysis: DES Beneficial But May Not Save Limbs, Improve Survival in PAD Patients

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In patients with infrapopliteal occlusive disease, drug-eluting stents (DES) result in improved patency and greater freedom from target vessel revascularization (TVR) at 1 year compared with bare-metal stents (BMS), according to a meta-analysis published in the April 2013 issue of the Journal of Endovascular Therapy. However, the study found no differences in survival or limb salvage.

George A. Antoniou, MD, PhD, of Central Manchester University Hospitals (Manchester, UK), and colleagues conducted a meta-analysis of 544 patients with lower limb ischemia treated with DES (n = 287) or BMS (n = 257) from 2006 to 2012. Data were derived from 4 randomized clinical trials and 2 observational studies.

DES Hold the Lead

At 1 year, rates of primary and secondary patency, freedom from TVR, and clinical improvement (≥ 1 Rutherford category) all were higher in patients who received DES compared with BMS. However, researchers did not find disparities in limb salvage or survival between the device types (table 1).

Table 1. Outcomes at 1 Year

 

DES
(n = 287)

BMS
(n = 257)

OR (95% CI)

P Value

Primary Patency

80%

49%

4.511 (2.897-7.024)

< 0.001

Secondary Patencya

92%

71%

4.401 (1.764-10.977)

0.001

Freedom from TVR

89%

73%

3.238 (2.019-5.192)

< 0.001

Clinical Improvement

61%

52%

1.792 (1.039-3.090)

0.036

Limb Salvage

97%

95%

2.008 (0.722-5.585)

0.181

Survival

88%

84%

1.262 (0.605-2.634)

0.535

a Only reported by 1 study.                                                      

Sensitivity analyses confirmed the advantages associated with DES for primary patency (OR 3.861; 95% CI 2.274-6.556; P < 0.001) and freedom from TVR (OR 3.383; 95% CI 1.725 to 6.635; P < 0.001).

In addition, no differences were seen in 30-day morbidity, 30-day mortality, or technical failure between the 2 groups.                                                                                                  

Data Deserve Careful Interpretation

In an e-mail communication with TCTMD, Dr. Antoniou said emerging evidence suggests that endovascular treatment of below-the-knee arterial disease with DES has favorable results. “However, this evidence is derived from only a few studies [that have] enrolled relatively small numbers of patients,” he said. “Large-scale multicenter studies evaluating the effects of DES are lacking.”

Dr. Antoniou and colleagues attempted to circumvent this limitation of the literature by pooling data from existing studies. Even so, he stressed, “the combined outcome estimates of the analysis are based on preliminary results only, and no sufficient clinical information supporting the long-term efficacy of [DES] treatment is available. Therefore, enthusiasm should be tempered until long-term results of such treatment are available.”

Additionally, the studies included in the meta-analysis involved “rather short” lesions, Dr. Antoniou said, noting that outcomes in the complex lesions encountered in everyday practice remain unknown.

In an editorial accompanying the article, Giuseppe Biondi-Zoccai, MD, Mariangela Peruzzi, MD, PhD, and Giacomo Frati, MD, all of Sapienza University of Rome (Latina, Italy), write that “despite their overall favorable risk-benefit profile, not all coronary [DES] are equal.”

The meta-analysis looked at 3 randomized trials of SES and 1 of EES. Two of the SES studies used a permanent-polymer device “with a highly established risk-benefit profile,” the editorial notes, while the third study evaluated a “less well appraised” SES without a permanent polymer.

Other Options May Beat Stenting

Unfortunately, the prevalence of PAD is expected to increase due to the rising rates of diabetes and an aging of population, Fred Leya, MD, of Loyola University Medical Center (Maywood, IL), told TCTMD in a telephone interview. “More and more arterial blockages are developing below the knees,” he added.

The best ways to treat PAD are diabetes and cholesterol control, smoking cessation, exercise, and medical therapy, Dr. Leya said, noting, “Occasionally, this does not suffice and either peripheral angioplasty or peripheral vascular surgery is needed.”

According to Dr. Antoniou, catheter-based treatments of arterial disease affecting the small vessels of the lower limbs have been accompanied by poor results, mainly because of intimal hyperplasia causing in-stent stenosis and recurrent disease.

While bypass surgery has been the conventional treatment of infrapopliteal arterial disease, extensive surgical reconstruction of below-the-knee arteries is associated with increased morbidity and mortality in high-risk patients, who are often afflicted by cardiac comorbidity and pulmonary disease, he explained. Furthermore, a suitable vein to be used as a bypass conduit may not always exist.

Other alternative treatments include subintimal angioplasty, atherectomy, and brachytherapy, Dr. Antoniou said. However, no studies have compared their outcomes with those of DES.

Dr. Leya advised that, going forward, randomized trials should compare best medical therapy with individual devices rather than test various devices against each other. More aggressive risk control and optimal medical therapy may prove better than stenting, he predicted.

 


Sources:
1. Antoniou GA, Chalmers N, Kanesalingham K, et al. Meta-analysis of outcomes of endovascular treatment of infrapopliteal occlusive disease with drug-eluting stents. J Endovasc Ther. 2013;20:131-144.

2. Biondi-Zoccai G, Peruzzi M, Frati G. Which do you like better . . . a bowl of Cheerios or a Big Mac? Pros and cons of meta-analyses in endovascular research. J Endovasc Ther. 2013;20:145-148.

 

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Meta-analysis: DES Beneficial But May Not Save Limbs, Improve Survival in PAD Patients

In patients with infrapopliteal occlusive disease, drug-eluting stents (DES) result in improved patency and greater freedom from target vessel revascularization (TVR) at 1 year compared with bare-metal stents (BMS), according to a meta-analysis
Disclosures
  • Drs. Antoniou, Peruzzi, Frati, and Leya report no relevant conflicts of interest.
  • Dr. Biondi-Zoccai reports consulting and lecturing for several manufacturers of DES.

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