Biological effect of orbital atherectomy and adjunctive paclitaxel-coated balloon therapy on vascular healing and drug retention: early experimental insights into the familial hypercholesterolaemic swine model of femoral artery stenosis

Téllez, Armando; Dattilo, Raymond; Mustapha, Jihad; Góngora, Carlos; Hyon, Chelsea M.; Palmieri, Taylor; Rousselle, Serge; Kałuża, Greg L.; Granada, Juan F.

doi:10.4244/eijy14m10_03

Cited by 24 publications

(13 citation statements)

References 20 publications

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“…Additional data from these imaging techniques would have been highly informative and could have provided insights on the therapeutic mechanisms and effects of OAS. 28,29 Third, 49 sites randomized 443 patients, with a mean of w8 patients enrolled per site. Because the OAS device was a novel therapeutic tool and most of the investigators had no previous experience with this device, learning curve issues must be considered, and improved outcomes may be expected with increased operator experience.…”

Section: Discussionmentioning

confidence: 99%

Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial)

Généreux

Lee

Kim

et al. 2015

The American Journal of Cardiology

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Percutaneous coronary intervention of severely calcified lesions has historically been associated with major adverse cardiac event (MACE) rates as high as 30%. In the ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial, treatment of de novo severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) resulted in low rates of procedural and 30-day adverse ischemic events. The long-term results from this trial have not been reported. We sought to determine the 1-year outcomes after orbital atherectomy of severely calcified coronary lesions. ORBIT II was a single-arm trial enrolling 443 subjects at 49 US sites with severely calcified lesions usually excluded from randomized trials. OAS utilizes a centrifugal differential sanding mechanism of action for plaque modification prior to stent implantation. After OAS drug-eluting stents were implanted in 88.2% of the patients. The primary safety end point was 30-day MACE, the composite of cardiac death, myocardial infarction, or target vessel revascularization [TVR]. The present analysis reports the 1-year follow-up results from ORBIT II. One-year data were available in 433 of 443 patients (97.7%), with median follow-up time of 16.7 months. The 1-year MACE rate was 16.4%, including cardiac death (3.0%), myocardial infarction (9.7%), and target vessel revascularization (5.9%). The 1-year target lesion revascularization rate was 4.7%, and stent thrombosis occurred in 1 patient (0.2%). Independent predictors of 1-year MACE and target vessel revascularization were diameter stenosis at baseline and the use of bare-metal stents. In patients with severely calcified lesions who underwent percutaneous coronary intervention, the use of OAS was associated with low rates of 1-year adverse ischemic events compared with historical controls. This finding has important clinical implications for the selection of optimum treatment strategies for patients with severely calcified lesions.

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Section: Discussionmentioning

confidence: 99%

Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial)

Généreux

Lee

Kim

et al. 2015

The American Journal of Cardiology

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“…However, RA reduces the calcific burden, which probably helps paclitaxel penetrate vessel layers. Experimental studies suggest that atherectomy does not compromise vascular healing after DCB treatment . Importantly, atherectomy followed by DCB is already an established method in the percutaneous treatment of calcified femoro‐popliteal lesions in man …”

Section: Discussionmentioning

confidence: 99%

“…Experimental studies suggest that atherectomy does not compromise vascular healing after DCB treatment. 34 Importantly, atherectomy followed by DCB is already an established method in the percutaneous treatment of calcified femoro-popliteal lesions in man. 35 To achieve a low rate of restenosis with DCB, it is essential that stenting is limited to bailout situations (flow-limiting dissection [TIMI flow <3] or significant recoil >30%).…”

Section: Discussionmentioning

confidence: 99%

Percutaneous Coronary Intervention of Complex Calcified Lesions With Drug‐Coated Balloon After Rotational Atherectomy

Rissanen

Uskela

Siljander

et al. 2017

J Interven Cardiology

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“…Preclinical experiments are better suited for examining the barrier effect of plaque on drug absorption and distribution with or without atherectomy. Unfortunately, induction of mineralization in animal models has proven difficult and a recent study in atheromatous arteries in the pig model exhibited comparable paclitaxel deposition 30 days post PCB treatment in OAS-pretreated vs native femoral arteries[15]. …”

Section: Introductionmentioning

confidence: 99%

Calcified plaque modification alters local drug delivery in the treatment of peripheral atherosclerosis

Tzafriri

García-Polite

Zani³

et al. 2017

Journal of Controlled Release

102

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A B S T R A C TBackground: Calcific atherosclerosis is a major challenge to intraluminal drug delivery in peripheral artery disease (PAD). Objectives: We evaluated the effects of orbital atherectomy on intraluminal paclitaxel delivery to human peripheral arteries with substantial calcified plaque. Methods: Diagnostic angiography and 3-D rotational imaging of five fresh human lower limbs revealed calcification in all main arteries. The proximal or distal segment of each artery was treated using an orbital atherectomy system (OAS) under simulated blood flow and fluoroscopy. Explanted arterial segments underwent either histomorphometric assessment of effect or tracking of 14 C-labeled or fluorescent-labeled paclitaxel.Radiolabeled drug quantified bulk delivery and fluorescent label established penetration of drug over finer spatial domain in serial microscopic sections. Results were interpreted using a mathematical model of bindingdiffusion mediated arterial drug distribution. Results: Lesion composition affected paclitaxel absorption and distribution in cadaveric human peripheral arteries. Pretreatment imaging calcium scores in control femoropopliteal arterial segments correlated with a loglinear decline in the bulk absorption rate-constant of 14 C-labeled, declining 5.5-fold per calcified quadrant (p = 0.05, n = 7). Compared to controls, OAS-treated femoropopliteal segments exhibited 180 μm thinner intima (p < 0.001), 45% less plaque calcification, and 2 log orders higher paclitaxel bulk absorption rate-constants. Correspondingly, fluorescent paclitaxel penetrated deeper in OAS-treated femoropopliteal segments compared to controls, due to a 70% increase in diffusivity (p < 0.001).Conclusions: These data illustrate that calcified plaque limited intravascular drug delivery, and controlled OAS treatment of calcific plaques resulted in greater drug permeability and improved adjunct drug delivery to diseased arteries.

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Biological effect of orbital atherectomy and adjunctive paclitaxel-coated balloon therapy on vascular healing and drug retention: early experimental insights into the familial hypercholesterolaemic swine model of femoral artery stenosis

Abstract: In the experimental setting, the combination of OAS+PCB appears to be safe by demonstrating a vascular healing profile and drug tissue levels comparable to PCB only. The vascular effect of PCB may be enhanced by the use of OAS by decreasing plaque burden and cholesterol crystals.

Cited by 24 publications

References 20 publications

Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial)

Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial)

Percutaneous Coronary Intervention of Complex Calcified Lesions With Drug‐Coated Balloon After Rotational Atherectomy

Calcified plaque modification alters local drug delivery in the treatment of peripheral atherosclerosis

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