Mid‐term outcomes of orbital atherectomy combined with drug‐coated balloon angioplasty for treatment of femoropopliteal disease

Foley, T. Raymond; Cotter, Ryan; Kokkinidis, Damianos G.; Nguyen, Daniel; Waldo, Stephen W.

doi:10.1002/ccd.26984

Cited by 40 publications

(41 citation statements)

References 32 publications

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“…Our study showed that LA and DCB can decrease the bail‐out stenting rates (32% vs. 57%, p = .008), which is important in FP lesions given the very high rates of stent thrombosis and ISR in such lesions . However, our bail‐out stenting rates were still higher compared to rates reported by RCTs of DCBs for FP ISR .…”

Section: Discussioncontrasting

confidence: 49%

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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Section: Discussioncontrasting

confidence: 49%

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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“…9,46 Previous reports have suggested that the combination of DCB with orbital atherectomy could be a sufficient treatment option for these lesions. 9 The high rate of atherectomy used in our real-world cohort is justified by the belief of our operators that atherectomy devices and, subsequently, optimal vessel preparation, significantly improve DCB outcomes in calcified and complicated (restenosis, CTOs, diffusely diseased) vessels. 9,23 In one prior analysis, Zeller et al showed that the group treated with DCB (± stents as needed) resulted in non-inferior clinical outcomes (freedom from TLR and event free survival) when compared with the stented group for lesions longer than reported by our group.…”

Section: Discussionmentioning

confidence: 99%

“…6 With the evolving use of drug-coated balloons (DCB), these devices are now used in a significant number of endovascular interventions, since they provide improved long-term outcomes compared to PTA, while decreasing the need for permanent scaffold implantation. [7][8][9][10][11] DCB are associated with FP patency rates comparable to primary stenting for the treatment of de novo Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry FP PAD. 7,8,12 However, in a significant proportion of FP DCB interventions, a vascular scaffold placement may be necessary to treat vessel recoil, significant dissection, or otherwise suboptimal angioplasty.…”

Section: Introductionmentioning

confidence: 99%

Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry

et al. 2018

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With growing use of drug-coated balloons (DCB) for femoropopliteal (FP) artery interventions, there is limited information on rates of real-world adjunctive stent use and its association with short and long-term outcomes. We report on 225 DCB treated FP lesions in 224 patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) between 2014 and 2016. Cochran-Mantel-Haenszel and Wilcoxon rank sum statistics were used to compare stented (planned or 'bail-out') versus non-stented DCB treated lesions. Stents were implanted in 31% of FP DCB interventions. Among the 70 stents implanted, 46% were for 'bail-out' indications and 54% were planned. Lesions treated with stents were longer (mean 150 mm vs 100 mm; p < 0.001) and less likely to be in-stent restenosis lesions (10% vs 28%; p=0.003). Stenting was significantly more frequent in complex FP lesions, including chronic total occlusions (66% vs 34%; p < 0.001). For bail-out stenting, interwoven nitinol stents were the most common type (50%) followed by drug-eluting stents (34%) and bare-metal stents (22%). There were no differences in peri-procedural complication rates or 12-month target limb revascularization rates (18.6% vs 11.6%; p=0.162) or 12-month amputation rates (11.4% vs 11%; p=0.92) between lesions where adjunctive stenting was used versus lesions without adjunctive stenting, respectively. In conclusion, in a contemporary 'real-world' adjudicated multicenter US registry, adjunctive stenting was necessary in nearly a third of the lesions, primarily for the treatment of more complex FP lesions, with similar short and intermediate-term clinical outcomes compared with non-stented lesions. ClinicalTrials.gov Identifier: NCT01904851.

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“…In another similar single-centre trial, the value of orbital atherectomy combined with DCB angioplasty was evaluated for the treatment of calcified femoropopliteal lesions in 89 patients. 35 Despite the higher degree of calcification in patients who underwent atherectomy and DCB compared with those who underwent DCB alone (83% versus 42%; p<0.001), the rate of bailout stenting was lower in the combined therapy group (18% versus 39%; p=0.01). Furthermore, despite more complex lesions in the combined therapy group, patency rates were similar in both.…”

Section: Orbital Atherectomymentioning

confidence: 89%

The Role of Atherectomy in Peripheral Artery Disease: Current Evidence and Future Perspectives

Korosoglou¹,

Giuşcă²,

Andrassy³

et al. 2019

Vascular and Endovascular Review

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The prevalence of peripheral artery disease (PAD) has been rising consistently over the past few decades, along with increasing rates of type 2 diabetes. More than 200 million people are estimated to be affected by PAD worldwide. 1 Despite aggressive modifications of lifestyle and risk factors, and advances in the pharmacological management of patients with PAD using antiplatelet agents, statins, cilostazol, angiotensin-converting enzyme inhibitors, angiotensinreceptor blockers and low-dose anticoagulation with rivaroxaban, patients with PAD frequently require invasive procedures to improve the symptoms of claudication and prevent tissue damage or loss in those with critical limb ischaemia (CLI). 2 Due to recent technological advances in materials and devices for the endovascular treatment of PAD, a minimally invasive percutaneous approach is considered a first-choice strategy for the treatment of symptomatic patients and is given preference over older surgical options. According to current guidelines, endovascular therapy is the most favoured option for infrainguinal stenotic or occlusive lesions <25 cm, whereas open surgery may be associated with better longterm patency, especially when using saphenous vein grafts in patients with long occlusive lesions (>25 cm) that cross the knee. 3 Commonly used techniques include plain balloon angioplasty, drug-coated balloon (DCB) angioplasty, bare metal stents, drug-eluting stents and stent grafts for vessel perforation. Such endovascular approaches have been successfully used to alleviate symptoms in patients with claudication and have been associated with limb salvage in patients with CLI. [4][5][6] In many cases, such 'basic' approaches may be compromised by severe calcification. Calcification may be the reason for a poor primary outcome due to early recoil or extensive flow-limiting dissections after high-pressure angioplasty, culminating in the need for bailout stent placement. 7 Despite the most recent self-expandable nitinol stent technology, rates of re-stenosis may be high, resulting in primary patency rates of <50% for bare metal stents and <70% for drug-eluting stents at 5-year follow-up. 8 Even with dedicated stent devices, stent fractures may occur at sites of extensive movement and flexion as in the popliteal artery, resulting in stent thrombosis and subsequent occlusion. 9 With conventional open surgery, 5-year patency rates of more than 80% have been reported with saphenous vein grafts compared with 67% when using prosthetic conduits. 10 Although no randomised trials are currently available for a head-to-head comparison of endovascular versus surgical treatment for long and calcified femoropopliteal lesions, AbstractAn ageing population and the increasing prevalence of cardiovascular risk factors have aggravated the burden of peripheral artery disease (PAD). Despite advances in the pharmacological treatment of atherosclerosis, many patients with symptomatic PAD require invasive procedures to reduce the symptoms of claudication, salvage tissue and prevent a...

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Mid‐term outcomes of orbital atherectomy combined with drug‐coated balloon angioplasty for treatment of femoropopliteal disease

Cited by 40 publications

References 32 publications

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

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

Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry

The Role of Atherectomy in Peripheral Artery Disease: Current Evidence and Future Perspectives

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