Femoropopliteal In-stent Restenosis Repair: Midterm Outcomes After Paclitaxel Eluting Balloon Use (PLAISIR Trial)

Bague, Nicolas; Julia, Pierre; Sauguet, Antoine; Pernès, Jean-Marc; Chatelard, P.; Garbé, Jean-François; Penillon, Sébastien; Cardon, Jean-Marie; Commeau, Philippe; Planché, O.; Guyomarch, Béatrice; Gouëffic, Yann

doi:10.1016/j.ejvs.2016.10.002

Cited by 26 publications

(12 citation statements)

References 30 publications

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“…Similar results were reported from the PLAISIR study [ 22 ], which is a prospective and multicentre cohort study including 53 symptomatic patients with femoropopliteal in-stent restenosis (mean length: 86 ±32 mm) treated by paclitaxel-eluting balloon angioplasty (In Pact Admiral, Medtronic, Santa Rosa, CA, USA). At 1 year freedom from TLR and target extremity revascularization (TER) were 90.2 ±4.2% and 85 ±5%, respectively, and the primary patency rate was 83.7 ±5.0%.…”

Section: Drug-coated Balloon (Dcb) In Superficial Femoral Artery In-ssupporting

confidence: 82%

Drug-coated balloon in superficial femoral artery in-stent restenosis

Gerardi

Alfani

Tesorio³

et al. 2018

pwki

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The femoropopliteal artery is one of the commonest sites of involvement in peripheral artery disease (PAD) leading to intermittent claudication and/or critical limb ischemia. Endovascular therapy for superficial femoral artery (SFA) disease has been recognized as a safe and efficient therapy and is recommended by current guidelines as the first-line approach. Although the widespread use of new-generation, self-expanding, nitinol stents in SFA stenosis has reduced the shortcomings associated with plain old balloon angioplasty (POBA), lumen renarrowing at the stented (in-stent restenosis – ISR) level still represents a relevant clinical problem, because of higher risk of recurrent ISR, occlusion and surgical revascularization compared to de-novo lesions. In this setting, different treatment options are available and drug-coated balloons (DCBs) have shown good results in terms of safety and effectiveness. In this review we examine the results of different trials exploring the outcome of using DCBs for the treatment of SFA ISR. The available data demonstrate that SFA ISR can be safely treated with percutaneous transluminal angioplasty with a DCB, with a reduction in recurrent restenosis and target lesion revascularization (TLR) at least at 1 year after POBA. The consistent and positive results of different registries and randomized trials support the use of DCB to reduce SFA ISR recurrence.

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Section: Drug-coated Balloon (Dcb) In Superficial Femoral Artery In-ssupporting

confidence: 82%

Drug-coated balloon in superficial femoral artery in-stent restenosis

Gerardi

Alfani

Tesorio³

et al. 2018

pwki

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“…The EuroQol-5D and the EuroQol VAS (visual analog scale) have been used in several CLI studies to derive health state utilities (Table 7). 35,41,47,50–53 The EuroQol-5D index population norm in the United States is 0.825 (on a 0 to 1 scale) and the EuroQol VAS population norm is 80 (on a 0 to 100 scale) 54. A study by Pisa and colleagues (2012) was one of the few recently published studies which assessed the impact of CLI on a patient’s quality of life that was not derived from an interventional study 35.…”

Section: Resultsmentioning

confidence: 99%

<p>The burden of critical limb ischemia: a review of recent literature</p>

Duff

Mafilios²,

Bhounsule

et al. 2019

VHRM

243

154

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Peripheral arterial disease is a chronic vascular disease characterized by impaired circulation to the lower extremities. Its most severe stage, known as critical limb ischemia (CLI), puts patients at an increased risk of cardiovascular events, amputation, and death. The objective of this literature review is to describe the burden of disease across a comprehensive set of domains—epidemiologic, clinical, humanistic, and economic—focusing on key studies published in the last decade. CLI prevalence in the United States is estimated to be approximately 2 million and is likely to rise in the coming years given trends in important risk factors such as age, diabetes, and smoking. Hospitalization for CLI patients is common and up to 60% are readmitted within 6 months. Amputation rates are unacceptably high with a disproportionate risk for certain demographic and socioeconomic groups. In addition to limb loss, CLI patients also have reduced life expectancy with mortality typically exceeding 50% by 5 years. Given the poor clinical prognosis, it is unsurprising that the quality of life burden associated with CLI is significant. Studies assessing quality of life in CLI patients have used a variety of generic and disease-specific measures and all document a substantial impact of the disease on the patient’s physical, social, and emotional health status compared to population norms. Finally, the poor clinical outcomes and increased medical resource use lead to a considerable economic burden for national health care systems. However, published cost studies are not comprehensive and, therefore, likely underestimate the true economic impact of CLI. Our summary documents a sobering assessment of CLI burden—a poor clinical prognosis translating into diminished quality of life and high costs for millions of patients. Continued prevention efforts and improved treatment strategies are the key to ameliorating the substantial morbidity and mortality associated with this disease.

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“…In the most recent study (PLAISIR), 14 53 patients with symptomatic ISR (mean lesion length 86±32 mm) underwent DCB angioplasty with the IN.PACT DCB. One year after the intervention, freedom from TLR and primary patency estimates were 90.2% and 83.7%, respectively.…”

Section: Discussionmentioning

confidence: 99%

Rotational Atherectomy Plus Drug-Coated Balloon Angioplasty for the Treatment of Total In-Stent Occlusions in Iliac and Infrainguinal Arteries

Milnerowicz

Kuliczkowski

et al. 2019

J Endovasc Ther

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Purpose: To analyze the long-term outcomes of a hybrid treatment method combining rotational atherectomy with drug-coated balloon (DCB) angioplasty in patients with total in-stent occlusion in the iliac and/or infrainguinal arteries. Materials and Methods: Between April 2014 and June 2017, 74 consecutive patients (mean age 66.7±9.7 years; 49 men) with total occlusion of a previously implanted stent underwent endovascular recanalization using the Rotarex system and DCB angioplasty. Half (37, 50%) of the patients had critical limb ischemia (CLI), and 30 (41%) of the procedures were performed in emergency. Mean lesion length was 22±15 cm. Results: Overall procedure success was achieved in 73 (98.6%) patients. Six (8.1%) CLI patients developed distal embolism that responded to thrombolysis. Three (4.1%) dissections did not require treatment, while 1 (1.4%) perforation necessitated stent-graft implantation. In all, 33 (44.6%) patients had an additional stent implanted, mainly due to a suboptimal outcome (n=28) or complications (n=5 including the stent-graft). The restenosis rate assessed by duplex ultrasound at 12 months was 20.5% (15/73); 4 (5.5%) patients underwent target lesion revascularization. Recurrent restenosis was more frequent in patients with Rutherford category 5 ischemia (p=0.005), in emergency procedures (p=0.021), after extensive procedures involving 3 independent vessel segments (p=0.016), and if a complication arose during the procedure (p<0.001). In multivariate analysis, only occurrence of a procedural complication was an independent predictor of recurrent restenosis at 1 year (OR 63.3, 95% CI 5.7 to 701.5). Conclusion: These findings imply that rotational atherectomy and DCB angioplasty may provide satisfactory outcomes in the treatment of total in-stent occlusion, with a satisfactory recurrent restenosis rate at 12 months.

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Femoropopliteal In-stent Restenosis Repair: Midterm Outcomes After Paclitaxel Eluting Balloon Use (PLAISIR Trial)

Abstract: PEB for the treatment of FP ISR is associated with a low rate of re-interventions and restenosis. Clinical improvement is maintained at 18 months.

Cited by 26 publications

References 30 publications

Drug-coated balloon in superficial femoral artery in-stent restenosis

Drug-coated balloon in superficial femoral artery in-stent restenosis

<p>The burden of critical limb ischemia: a review of recent literature</p>

Rotational Atherectomy Plus Drug-Coated Balloon Angioplasty for the Treatment of Total In-Stent Occlusions in Iliac and Infrainguinal Arteries

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