PTA versus carbofilm-coated stents in infrapopliteal arteries: Pilot study
ABSTRACT To determine the primary success and short-term patency of stent application as a primary treatment modality for high-grade lesions of the infrapopliteal arteries compared with treatment with percutaneous transluminal angioplasty (PTA) in critical limb ischemia in a randomized prospective study.
Endovascular therapy was performed on 95 lesions in 51 patients (mean age 72.0 years, range 47-80 years) who presented clinically with Fontaine stages III and IV. One patient underwent treatment in both limbs. After angiographic lesion identification, patients were randomized for treatment by PTA (53 lesions in 27 patients) or stent application (42 lesions in 24 patients). Follow-up by clinical investigation and conventional angiography or spiral CT angiography was performed in 37 patients (57 lesions) 6 to 12 months after the procedure, or when clinically indicated. Evaluation was performed by two observers, double-blinded, with thresholds for lesion restenosis of 50% and 70%. Statistical evaluation was performed on a lesion basis by Kaplan-Meier estimated probability rates, and log-rank and Wilcoxon tests. The primary endpoint was the angiographic patency rate of treated lesions.
The inter-reader agreement was high (kappa = 0.82). For the stent group the cumulative primary patency at 6 months was 83.7% at the 70% restenosis threshold, and 79.7% at the 50% restenosis threshold. For PTA, the primary patency at 6 months was 61.1% at the 70% restenosis threshold and 45.6% at the 50% restenosis threshold. Both results were statistically significant (p < 0.05).
Infrapopliteal stent application is an effective treatment modality for high-grade lesions in chronic critical limb ischemia. Compared with PTA, higher patency rates can be expected after 6 months.
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ABSTRACT: Purpose: The need for specialty devices to improve the technical Outcome of endovascular interventions is dependent On the rate of early failure in such procedures. This meta-analysis assessed procedural outcomes of such intervention to elucidate the rate of early procedural failures and the need for such specialty devices. Materials and Methods: MEDLINE and EMBASE were searched for contemporary studies (2000-2012) reporting procedural or short-term outcomes for revascularization of infrapopliteal atherosclerotic lesions. A random-effects metaanalysis was performed, Which included post hoc comparisons among treatment groups. Results: A total of 42 studies with 52 treatment arms representing 3,660 unique patients were included. Technical success rates were higher with bare metal stents (BMSs; 98.6%) than with atherectomy (92.2%; P < .05) or percutaneous transltuninal angioplasty (PTA; 91.2%; P = .01), and higher with drug-eluting stents (DESs) than with PTA (P < .001). DES use had higher primary patency rates than atherectomy (P < .05), BMS use (P < .001), and PTA (P < .01). The 30-day rate of target lesion revascularization was significantly higher with PTA (8.1%) than with BMSs (2.2%; P < .05) and DESs (1.1%; P < .05). Thirty-day rates of major unplanned amputation (range, 1.5%-4.4%) and mortality (range, 0.9%-3.3%) were comparable among treatment groups. Significant heterogeneity among studies was noted for most PTA outcomes. Publication bias was evident for most PTA and DES outcomes. Conclusions: Early failure of percutaneous therapies in patients with infrapopliteal atherosclerotic lesions is device- and technique-dependent. Specialty devices designed to reduce technical failure rates may therefore be of benefit in this selected group of patients. Study results are confounded by inconsistent data reporting, heterogeneity of treatment effects, and publication bias.Journal of vascular and interventional radiology: JVIR 08/2014; 25(10). DOI:10.1016/j.jvir.2014.06.018 · 2.15 Impact Factor
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ABSTRACT: Patients with infrapopliteal occlusive disease may present with limb threatening ischemia. Femoro-distal bypass used to be the only line of treatment. Over the last two decades there was a growing interest in short popliteo-distal (PD) bypasses. Infrapopliteal percutaneous transluminal angioplasty (PTA) is another attractive alternative treatment; however its role is not well defined yet. 27 patients TASC (TransAtlantic Inter-Society Consensus) types C&D infrapopliteal disease, falling into Fountain III & IV categories, were included in this study. 13 were offered a PD bypass (group A) and 14 were offered infrapopliteal PTA (group B). Patients of group B had a contraindication to open surgery. Primary success rates in groups A and B were 70% and 64% respectively. Limb salvage rates in groups A and B were 85% and 78% respectively. PD bypass has primary success rate and limb salvage rates comparable to published results of femoro-distal bypass. Infrapopliteal PTA is a safe and effective alternative especially in high risk patients and in patients with severe foot infection. Both lines of treatment give comparable results. PTA carries a lower morbidity and mortality, shorter hospital stay and does not preclude surgery. Prospective, randomized, multicenter trials will be needed to further establish the role of endovascular intervention in this challenging patient group.
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ABSTRACT: Fighting major amputation has been one out of the four priorities of the World Health Organization (WHO) for a decade. If we consider that according to all epidemiological studies, the number of diabetic people is expected to double by 2030, the worse complication of this disease could represent a big sanitary, social, and economic problem in the near future. In developed countries, the cost of treatment for diabetic disease-related foot problems represents 15 - 25 % of available resources for the treatment of diabetes in general, but in some developing countries, the same cost may reach up to 40 % of available resources for diabetic disease. On the positive side, currently over 90 % of all diabetes-related amputations may be prevented thanks to the education of diabetic patients as primary prevention, and mainly to the new non-surgical revascularization techniques, which effectively fight the consequences of diabetic arteriopathy as a secondary prevention. The virtual pathway in reducing lower limb amputations starts with a better comprehension of critical limb ischemia (CLI), particularly its diagnostic aspects and consequent revascularization treatment. For 15 years we have assisted in a spectacular improvement of revascularization modalities and particularly of endovascular interventions. As a consequence, a large series of treated patients have shown the possibility to reduce the risk of limb loss in subjects at a higher risk to a rate of 1.7 - 2.4 %. Management of CLI requires integrating clinical, interventional, and surgical competencies together to a significant cultural advancement of every single physician involved in reducing the risk of limb loss. Consensus documents and international guidelines are, in general, precious opportunities to promote cultural and scientific upgrading of the involved specialist, but their results sometimes do not meet the physician's expectations. A close look into the available scientific literature adopted for scientific statements reveals an urgent need for standardized reporting of demographic data, severity of disease, and outcome of the studied population.Current Treatment Options in Cardiovascular Medicine 09/2014; 16(9):332. DOI:10.1007/s11936-014-0332-3