Everolimus-Eluting Stent for Patients With Critical Limb Ischemia and Infrapopliteal Arterial Occlusive Disease

Giaquinta, Alessia; Ardita, Vincenzo; Marco, Ester; Veroux, Massimiliano

doi:10.1177/1538574416689429

Cited by 8 publications

(11 citation statements)

References 22 publications

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“…The 24-month freedom from CD-TLR of 96.6% in our study was similar to that found in the long-term in previous studies using non-resorbable DES (81–91%). 18,19,21,22…”

Section: Discussionmentioning

confidence: 99%

“…This is equivalent to historical results from studies that evaluated non-resorbable DES. The primary patency rates with the Xience-Prime Everolimus-Eluting Stent (Abbott Laboratories, Abbot Park, IL, USA) and a combination of Xience Everolimus Eluting Stent (Abbott) and Promus Everolimus Eluting Stent (Boston Scientific, Marlborough, MA, USA) in BTK disease was approximately 80% 18 and 74%, 19 respectively, at 24 months. Although the patency rates of historical studies on DES are comparable with the patency rates of BVS, the BVS has the advantage of being temporary.…”

Section: Discussionmentioning

confidence: 99%

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Mid-term outcomes of an everolimus-eluting bioresorbable vascular scaffold in patients with below-the-knee arterial disease: A pooled analysis of individual patient data

et al. 2021

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Previous studies on everolimus-eluting bioresorbable vascular scaffolds (BVS) have shown promising 1-year primary patency rates in infrapopliteal arteries. Literature from large cohorts on long-term outcomes with the infrapopliteal Absorb BVS (Abbott Vascular) is lacking. The aim of this study is to pool published and unpublished data to provide a more precise estimate of the 24-month outcomes of Absorb BVS for the treatment of infrapopliteal disease. For the pooled analysis, updated original and newly collected data from three cohorts on treatment with the Absorb BVS for de novo infrapopliteal lesions were combined. The primary endpoint was freedom from restenosis. Secondary endpoints were freedom from clinically driven target lesion revascularization (CD-TLR), major amputation and survival. The pooled analysis included a total of 121 patients with 161 lesions, treated with 189 Absorb BVS in 126 limbs. The mean age of the patients was 73 years, 57% had diabetes mellitus, and 75% were classified as Rutherford–Becker class 5 or 6. Of the 161 lesions, 101 (63%) were calcified and 36 (22%) were occlusions. Successful deployment was achieved with all scaffolds. Freedom from restenosis was 91.7% and 86.6% at 12 and 24 months, respectively, and freedom from CD-TLR was 97.2% and 96.6%. Major amputation occurred in 1.6% of the limbs. Overall survival was 85% at 24 months. In conclusion, this pooled analysis represents the largest reported analysis of mid-term results of the Absorb BVS for the management of chronic limb-threatening ischemia. At 24 months, the Absorb BVS was safe with promising clinical outcomes for the treatment of infrapopliteal disease.

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“…The 24-month freedom from CD-TLR of 96.6% in our study was similar to that found in the long-term in previous studies using non-resorbable DES (81–91%). 18,19,21,22…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Mid-term outcomes of an everolimus-eluting bioresorbable vascular scaffold in patients with below-the-knee arterial disease: A pooled analysis of individual patient data

et al. 2021

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“…The ratio of CLI patients significantly impacted the rates. It is clear that the amputation rate of the DES group was increased by the results from three of the DES cohorts, which showed the highest amputation rates within the DES group and which included CLI patients only [ 20 , 24 , 25 ]. In fact, all three of these studies included a higher rate of Rutherford class 5 and 6 patients: 82% in McMillan’s study, 61% in Etna Registry, and 87% in PADI study.…”

Section: Discussionmentioning

confidence: 99%

“…Those conditions might have led to the low pp in the PADI study [ 25 ]. It is important to address the fact that pp of McMillan’s study and Etna Registry were aligned with those of other DES cohorts even though they showed high rates of amputation [ 20 , 24 ]. As described previously, those studies included high rates of Rutherford class 5 and 6 patients, the same as the PADI study.…”

Section: Discussionmentioning

confidence: 99%

Comparative performance analysis of interventional devices for the treatment of ischemic disease in below-the-knee lesions: a systematic review and meta-analysis

Matsuoka

Hasebe

Ishii

et al. 2021

Cardiovasc Interv and Ther

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This meta-analysis aimed to evaluate the device performance of conventional balloon catheters (POBA), drug-coated balloons (DCB), bare-metal stents (BMS), and drug-eluting stents (DES) in below-the-knee (BTK) ischemic lesions with regard to lesion characteristics. Online searches of PubMed, Web of Science, and Cochrane databases (2010–2019) were conducted for each of the test devices. Primary patency rates (pp) and major amputation rates 1 year after the use of each device were analyzed using a random-effects meta-analysis model. Meta-regression analysis was conducted to test associations between the outcomes and lesion characteristics. The analysis included 18 studies reporting on 24 separate cohorts comprising 2,438 patients. DES demonstrated the best pp among the test devices (83.6%; 95% confidence interval = 78.4–88.8%, studies = 8; I2 = 66%, P = 0.005). A negative coefficient between lesion length and pp (P = 0.002) was obtained. The ratio of critical limb ischemia (CLI) patients impacted the amputation rates (P = 0.031), whereas no statistically significant difference was found between the devices. DES showed favorable pp in BTK lesions; however, as the lesion lengths using DES were short, pp in long lesions still needs to be evaluated. Shorter lesions gained better pp. A higher ratio of CLI patients resulted in increased amputation rates.

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“…Newer treatment options, most notably drug-coated balloons and drug-eluting stents, have shown great promise in the femoropopliteal arteries 18–20 . Their effectiveness in the tibial vessels, particularly with respect to wound healing, is not well studied, though wound healing rates exceeding 80% have been described with drug-eluting tibial stents 17,21 . There will certainly always be a role for surgical bypass, particularly in younger, lower-risk patients with favorable anatomy and available conduit.…”

Section: Discussionmentioning

confidence: 99%

Bypass versus endovascular intervention for healing ischemic foot wounds secondary to tibial arterial disease

Mohapatra

Henry

Avgerinos

et al. 2018

Journal of Vascular Surgery

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Everolimus-Eluting Stent for Patients With Critical Limb Ischemia and Infrapopliteal Arterial Occlusive Disease

Abstract: The results of our study suggest that a conservative approach, with EES, seems feasible in selected patients with CLI and infrapopliteal artery occlusive disease.

Cited by 8 publications

References 22 publications

Mid-term outcomes of an everolimus-eluting bioresorbable vascular scaffold in patients with below-the-knee arterial disease: A pooled analysis of individual patient data

Mid-term outcomes of an everolimus-eluting bioresorbable vascular scaffold in patients with below-the-knee arterial disease: A pooled analysis of individual patient data

Comparative performance analysis of interventional devices for the treatment of ischemic disease in below-the-knee lesions: a systematic review and meta-analysis

Bypass versus endovascular intervention for healing ischemic foot wounds secondary to tibial arterial disease

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