Paclitaxel-Eluting Balloon Versus Standard Balloon Angioplasty in In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Artery

Kinstner, Christian; Lämmer, Johannes; Willfort-Ehringer, Andrea; Matzek, Wolfgang; Gschwandtner, Michael E.; Javor, Domagoj; Funovics, Martin; Schoder, Maria; Koppensteiner, Renate; Loewe, Christian; Ristl, Robin; Wolf, Florian

doi:10.1016/j.jcin.2016.04.012

Cited by 94 publications

(74 citation statements)

References 26 publications

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“…RR, relative risk; CI, confidence interval [Color figure can be viewed at wileyonlinelibrary.com] this, DEBELLUM15 and FAIR 28 showed lower TLR rates in patients with DCB when compared to POBA. Finally, PACUBA29 showed similar results with DCBs showing significant reduction of TLR but without clinical improvement (68.8% vs. 54.5%, P = 0.87). It is interesting to note that the presence of stents did not alter outcomes with DCBs.TLR and binary stenosis rates were much lower in patients who presented with ISR and who received DCB therapy when compared to POBA.…”

mentioning

confidence: 55%

“…Seventeen trials compared DCB to POBA in FPD 4,5,9,[13][14][15][16][17][18][19][20][21][22][23][24][25][26] and five RCTs compared DCB to POBA in patients with ISR with a previous stent to FPD. [27][28][29][30][31]…”

Section: Data Extractionmentioning

confidence: 99%

“…This study differs from previously published meta-analysis that compared DCB to POBA analyzing eight RCTs. 33 We have included more studies 9,[14][15][16][17]20,[24][25][26][27][29][30][31]34 in our study, making this the most updated and comprehensive analysis to date. Additionally, we have performed secondary analyses to determine the effect of DCB use on ISR.…”

Section: Primary Safety Endpointmentioning

confidence: 99%

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Drug‐coated balloon versus plain old balloon angioplasty in femoropopliteal disease: An updated meta‐analysis of randomized controlled trials

Narayanan

Shah

Jelani

et al. 2019

Cathet Cardio Intervent

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Background Drug‐coated balloon (DCB) angioplasty has emerged as a mainstay of therapy for the treatment of peripheral arterial disease (PAD) involving the superficial femoral and popliteal arteries. We performed a meta‐analysis including all available randomized controlled trials (RCTs) to date which compare DCB to plain balloon angioplasty (POBA) in femoropopliteal disease (FPD). Methods Five databases were analyzed including EMBASE, PubMed, Cochrane, Scopus, and Web‐of‐Science from January 2000 to September 2018 for RCTs comparing DCB to POBA in patients with FPD. Heterogeneity was determined using Cochrane's Q‐statistics. Random effects model was used. Results Twenty‐two RCTs, including five trials of in‐stent restenosis (ISR) intervention, with 3,217 patients were included in the analysis. Mean follow‐up was approximately 21.6 ± 14.4 months. Overall, DCB use was associated with a 51% reduction in target vessel revascularization (TLR) when compared to POBA at follow‐up (relative risk [RR]: 0.49, 95% confidence interval [CI]: 0.40–0.61, P < 0.0001). Rates of TLR were 45% lower in the DCB group when compared to POBA in patients with ISR (RR: 0.55, 95% CI: 0.37–0.81, P = 0.002). DCB was associated with lower rates of binary stenosis, late lumen loss and higher primary safety endpoints. Major amputation and mortality were not different between DCB and POBA. Conclusions Use of DCBs is associated with improved vessel patency and a lower risk of TLR when compared to POBA in patients with FPD, especially in the setting of ISR. There was no difference in mortality between DCB and POBA in our meta‐analysis. Extended follow‐up of the available RCT data will be essential to analyze long‐term device‐related mortality.

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mentioning

confidence: 55%

Section: Data Extractionmentioning

confidence: 99%

Section: Primary Safety Endpointmentioning

confidence: 99%

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Drug‐coated balloon versus plain old balloon angioplasty in femoropopliteal disease: An updated meta‐analysis of randomized controlled trials

Narayanan

Shah

Jelani

et al. 2019

Cathet Cardio Intervent

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“…9 Drug coated balloon (DCB) angioplasty has been one of the most well-studied methods to treat FP-ISR with a number of studies showing 1-year superiority compared to BA, [10][11][12][13] however the ability to treat long-segment FP-ISR and the ability to sustain patency over the long term have been viewed as a limitation of DCB angioplasty. 14,15 Debulking with atherectomy devices and especially laser atherectomy (LA) may play a role in the treatment of FP-ISR [16][17][18][19][20][21][22][23] However, the combination of debulking with an antirestenotic agent (paclitaxel) has the potential to further improve the outcomes of FP-ISR by combining vessel preparation and maximum paclitaxel effectiveness. 1,2 Previous studies have linked the combination of DCB and LA superior results compared to LA + BA for 1-year outcomes.…”

Section: Introductionmentioning

confidence: 99%

Laser atherectomy and drug‐coated balloons for the treatment of femoropopliteal in‐stent restenosis: 2‐Year outcomes

Kokkinidis

Behan

Jawaid

et al. 2019

Cathet Cardio Intervent

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Background Femoropopliteal (FP) artery is one of the most anatomically challenging areas for sustained stent patency. The incidence of FP in‐stent restenosis (ISR) is estimated at 50% at 24 months. Prior studies have shown that lesion debulking with laser atherectomy (LA) combined with drug coated balloon (DCB) have superior outcomes compared to LA + balloon angioplasty (BA) ISR, but there have not been studies evaluating 2‐year outcomes. Methods This was a dual‐center retrospective cohort study that compared patients with FP‐ISR treated with LA + DCB versus LA + BA. Cox regression analysis was used to examine 2‐year outcomes of target lesion revascularization (TLR) and the composite outcome of TLR or restenosis. Multivariable analysis was performed for clinical and statistically significant (in the univariate analysis) variables. Results One hundred and seventeen consecutive patients with Tosaka II (n = 32) and III (n = 85) ISR were analyzed. Sixty‐six patients were treated with LA + DCB and 51 with LA + BA. The LA + DCB group had more lesions with moderate to severe calcification (58% vs. 13%; p < .0001). The LA + DCB group was more likely to be treated with the use of embolic protection devices (64% vs. 23%, p < .001) and cutting balloons (61% vs. 6%, p < .001). Bail‐out stenting rates were lower in the LA + DCB group (32% vs. 57%, p = .008). LA + DCB was superior (HR: 0.57; 95% CI: 0.34–0.9, p = .027) for the composite outcome of 2‐year TLR or restenosis. The 12‐month KM estimates for freedom from TLR or restenosis were 66% in the LA + DCB group versus 46% in the LA + BA group. The 24‐month KM estimates were 45% in the LA + DCB group versus 24% in the LA + BA group. Conclusions The combination of DCB + LA was associated with decreased rates of bail‐out stenting and improved 2‐year TLR or restenosis rates. Randomized clinical trials examining the DCB + LA combination for FP‐ISR are needed.

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“…Balloon angioplasty is a common treatment for calcification in the arteries, working as an immediate clearing of vessels to allow blood flow [65]. By modifying this design and using drug-coated balloons, obstructions in the vessels can be immediately broken up while also delivering various agents to prevent the return blockage without leaving a permanent implant behind [66]. Paclitaxel-coated balloons have been used because of the drug's ability to stop cell division so that when it is delivered to regions with increased plaque buildup, further growth is inhibited.…”

Section: Drug-coated Stents and Balloon Angioplastymentioning

confidence: 99%

Calcification of Biomaterials and Diseased States

Mosier¹,

Nguyen²,

Parker³

et al. 2018

Biomaterials - Physics and Chemistry - New Edition

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Calcification is one of the most common issues that arise concerning biocompatibility, known to affect many systems in the body. It is often associated with an increase in free phosphate and calcium particles in the serum that leads to mineral deposition. Calcification is problematic both in the naturally occurring state of the body, as well as when it exists as result of biomaterial implants. While calcification is prominent in many different forms, not all mechanisms and processes associated with the phenomenon are completely understood. In this chapter, materials affected by calcification, potential mechanisms of action, and potential treatments will be discussed. Both bioprosthetic and polymer heart valves and urinary implants will be evaluated for material composition, application, and failure. Current research on the assessment of these materials will be reported, with the associated chemical and biological mechanisms explained. The chapter will also detail diseased states of the arteries that induce calcification and what treatments can be used for both arterial and bioprosthetic calcification. Finally, the chapter will conclude by detailing future designs for biomaterials to prevent and treat calcification in both natural and synthetic applications.

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Paclitaxel-Eluting Balloon Versus Standard Balloon Angioplasty in In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Artery

Cited by 94 publications

References 26 publications

Drug‐coated balloon versus plain old balloon angioplasty in femoropopliteal disease: An updated meta‐analysis of randomized controlled trials

Drug‐coated balloon versus plain old balloon angioplasty in femoropopliteal disease: An updated meta‐analysis of randomized controlled trials

Laser atherectomy and drug‐coated balloons for the treatment of femoropopliteal in‐stent restenosis: 2‐Year outcomes

Calcification of Biomaterials and Diseased States

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