Elsevier

Annals of Vascular Surgery

Volume 70, January 2021, Pages 362-369
Annals of Vascular Surgery

Clinical Research
Optical Coherence Tomography Contribution Assessment in the Revascularization of Long Femoropopliteal Occlusive Lesions (TASC C and D): A Randomized Trial

https://doi.org/10.1016/j.avsg.2020.06.061Get rights and content

Background

Endovascular treatment has become the first-line revascularization technique for femoropopliteal lesions. This technique lacks reliable and accurate morphological control of the arterial segment treated. Intraoperative 2-dimensional angiogram consumes iodinated contrast media and increases X-ray exposure; this subsequently provides no 3-dimensional information on the quality of the revascularization completed, what could explain some of the early and late failures of the technique. We evaluated whether intraoperative optical coherence tomography (OCT) control in addition to standard angiogram could improve the primary patency rate at 12 months in comparison to standard angiogram alone in patients with occlusive femoropopliteal lesions.

Methods

The tomography by optical coherence in femoral artery trial is a multicentric, prospective, randomized, controlled, and single-blind study including patients with long de novo occlusive femoropopliteal lesions. The randomization will be achieved in 2 balanced groups of patients after crossing successfully the lesion: group 1 with intraoperative OCT control in addition to standard angiogram and group 2 with standard angiogram alone. The randomization will be stratified by center. The protocol has been submitted and approved by a French ethic's committee under reference number CPP2019-12-098. The study has been registered under the reference number NCT04434586 on the Web site of clinicaltrials.gov.

Results

The primary outcome of the study is the primary patency at 12 months. The number of patients who need to be treated is 166 (83 in each group) considering 5% of no workable data. Symptoms' improvement, target lesion revascularization, target vessel revascularization, quality-of-life questionnaires, cost utility, and cost effectiveness will be analyzed as secondary end-point variables at 12 months.

Conclusions

The present study is to evaluate the potential benefit for patients on the result of endovascular revascularization of long occlusive femoropopliteal lesion at 12 months when using intraoperative OCT control.

Introduction

Peripheral arterial disease is a frequent condition, with a prevalence estimated as high as 20% in people older than 65 years.1 The diagnosis is confirmed with the calculation of an ankle-brachial index (ABI) <0.9 associated with symptoms' severity graded accordingly to the Rutherford-Becker's classification.

Endovascular treatment for femoropopliteal lesions includes vessel preparation with balloon angioplasty (dilatation), followed or not by the implantation of one or several self-expansible stent (bare, covered, or drug eluting); as an alternative to stent implantation, recent publications exhibited also interesting results with the use of drug-eluting balloons.2, 3, 4

One of the current limitations of the endovascular technique is the lack of reliable and accurate intraoperative morphological control to assess the quality of the revascularization, especially in long lesions. After stent implantation or single-balloon angioplasty, a 2-dimensional (2D) digital subtraction angiography run is usually performed, requiring iodinated contrast media and X-ray exposure. This latter, as expected, does not deliver 3-dimensional information on arterial lumen reopening and/or on adequate stent application and/or conformation. This basic method of assessment may explain some of the early and late failures of the procedure.5, 6, 7

The current treatment benchmark for long femoropopliteal occlusive lesion superior to 25 cm is the saphenous femoropopliteal bypass with a 12-month patency around 75%8, 9, 10; nevertheless autologous saphenous veins are not always available, and patient frailty may discourage long open repair.11

Optical coherence tomography (OCT) is an endovascular imaging technique enclosed on an 4-French catheter developed during the last decade for vascular intraluminal analysis with higher resolution compared with intravascular ultrasound (IVUS) 1 μm in OCT vs. 100 μm in IVUS).12, 13, 14, 15 OCT has been initially developed to explore coronary lesions and is now routinely used in coronary disease.16 The principle is pretty similar to IVUS, although OCT uses light waves close to infrared (1,250–1,350 nm) rather than US.

A rotational acquisition within the vessel is automatically generated by the withdrawal of an optical sensor located at the end of the OCT catheter. Then, a dedicated software reconstructs the native images acquired and delivered fine details of the arterial wall through longitudinal and axial views. OCT in its original description, the use of OCT requires repeated injections of iodinated contrast medium boluses for flushing the vessel lumen to limit the interposition of blood elements that would prevent proper arterial wall analysis.17 To make OCT acquisitions acceptable in the lower limb arteries, we have recently proposed a standardized protocol where iodine was substituted by saline alone,18 reducing the risk of postoperative renal failure in that population at risk. Moreover, other studies have already confirmed the relevancy and safety of OCT use during recanalization procedures of lower limb arteries.19 The medicoeconomic issue balances the cost of this expensive technique (nearly 1,090 €/probe value-added tax excluded) and the contribution of the OCT on the optimization of the angioplasty procedure that could lead to a better life quality in reducing iterative reintervention along follow-up.

We thus propose here a study where the primary objective will be to evaluate the 12-month patency rate of the systematic use of OCT for long endovascular revascularization of femoropopliteal artery. A medicoeconomic evaluation of OCT will also be conducted.

Section snippets

Materials and Methods

We designed a multicentric, prospective, randomized, controlled, and single-blinded study that will include patients eligible for endovascular revascularization with long de novo femoropopliteal occlusive lesions (Trans-Atlantic Inter-Society Consensus C and D). The study protocol has been registered under the reference NCT04434586 on the Web site of clinicaltrials.gov. Three centers with large experience (>500 superficial femoral and/or popliteal artery cases/year) in peripheral endovascular

Study Oversight

Prof J. Sobocinski initiated the present study sponsoring by CHU Lille, which keeps possession of the whole responsibility for the conduct of the study and publication of the results. A recommending scientific committee has already been selected to oversee the study along its duration. Its members are familiar with clinical trial methodology and not involved in the study. This committee will review the trial data and be consulted in the case of any specific analytical or safety issues.

Discussion and Conclusion

Here is proposed an original and unique randomized prospective study that would explore and document the potential benefit of the use of OCT in the assessment of endovascular treatment of peripheral arterial occlusive lesions.

OCT is a quite recent imaging technology that is known to save radiation exposure at first and at the same time would be able to provide additional valuable data to better understand the initial (or during follow-up) quality of the arterial revascularization.

By proposing

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