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REALITY Check: New Evidence on Directional Atherectomy Plus DCB in Complex Lesions
Ravish Sachar, MD, FACC, UNC-REX Healthcare, Raleigh, North Carolina, joined others to tackle the harsh landscape of heavily calcified, complex lesions during a LINC 2021 session that included a live case transmission from University Hospital Leipzig, as well as a look at the latest in clinical evidence, strategies and techniques. LINC, the Leipzig Interventional Course, was held January 25-29, 2021.
Dr. Sachar presented findings from the REALITY (DiRectional AthErectomy + Drug CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions) trial, which evaluated the safety and effectiveness of directional atherectomy (DA) devices (HawkOne and TurboHawk; Medtronic, Dublin, Ireland) in combination with the IN.PACT Admiral drug coated balloon (DCB; Medtronic) in severely calcified femoropopliteal artery atherosclerotic lesions.1 Results of REALITY were presented at the Vascular Interventional Advances (VIVA) meeting in 2020.2
In conversation with LINC Today, Dr. Sachar provided some background to the study, noting that calcified, long lesions represent the most challenging lesion subset in the femoropopliteal segment in terms of both acute and long term outcomes. “In the past, these TASC D lesions have been something that we have tended not to approach endovascularly first, going more towards the surgical route,” he explained.
“However, with the advent of atherectomy and DCB, that has started to change. The question has been, if we approach these complex lesions with atherectomy to debulk and follow that with DCB, will we have better short term results because of the debulking and better long term results because of the DCB? Have we now found a way to address these complex lesions with an endovascular-first strategy?”
While a number of atherectomy devices are currently on the market, Dr Sachar noted that DA allows for the largest amount of debulking and hence maximal lumen gain. In the short term, debulking reduces the risk of recoil and dissection with subsequent balloon angioplasty. In the long term, a larger initial lumen gain may maintain patency for longer. Furthermore, DCBs may be more effective in terms of drug delivery following the removal of any calcium barrier present.
The combination of DA and DCB was first studied in a randomized trial in DEFINITIVE AR (Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency—A Pilot Study of Anti-Restenosis Treatment), results of which were published in 2017. Here, 102 patients were randomized to DA plus DCB or DCB alone, with the finding that technical success was superior for DA plus DCB. While the study was not powered to show significant differences between the two methods of revascularization at one-year follow-up, it generated the hypothesis that there was a benefit in a subset of patients with long (>10 cm) or heavily calcified lesions.3
This led to the development of the REALITY study, which prospectively enrolled 102 patients in an unrandomized fashion in 12 centers in the US and in Germany. “The results of this study are important because it addresses not only those patients who have heavy calcification and not just those with long lesions and CTOs; patients had to have both to be enrolled,” commented Dr Sachar. “In this lesion subset where the mean lesion length was 17.9±8.1 cm, and 39% of patients had CTOs and 54% were diabetic, at the end of the 12-month period patency was approximately 77% (66/86) as adjudicated by duplex ultrasound. The freedom from clinically-driven TLR was 92.9% (87/94).2
“These are excellent results in a really complex subset of patients that have not been studied in this manner prospectively before. Not only were excellent results achieved, but they were achieved with an 8.8% bail-out stent rate. If you look at studies where mean lesion lengths are 18 cm (as in this study), bail-out stenting is in the 40-45% range. In this case, because the angioplasty was preceded with atherectomy, the removal of plaque resulted in a lower rate of dissection and therefore also stenting. This means that as a vascular community we now have data to support what a lot of us already do, which is to employ this strategy of atherectomy followed by DCB.”
Studies of other atherectomy devices include the ongoing JET-RANGER study, which evaluates the use of the Jetstream rotational atherectomy (RA) device (Boston Scientific, MA, USA) followed by Ranger (Boston Scientific) or IN.PACT DCB against the use of plain old balloon angioplasty (POBA) followed by DCB alone.4
“The results of this trial are something that a lot of people are looking forward to,” commented Dr. Sachar. “There are several types of atherectomy devices and DCBs available. We need to study other atherectomy devices and other DCB and see if the data match up. Ideally, we would have randomized studies comparing strategies against each other.”
Dr. Sachar concluded with a word on atherectomy technique, advising that its learning curve be respected. “There are nuances with atherectomy that new operators need to be aware of. The more aggressive the debulking, the higher the risk for complications and therefore it is important to keep that in mind. But in general, it is a very safe procedure.
“I look at atherectomy from an artistic approach. It is like sculpting — especially DA. You are treating the areas that need to be treated and you don’t treat the areas that don’t need to be treated. Stenting is more like laying a carpet: you are agnostic to what is under there. And, if there is calcium present, sometimes the stents won’t expand either.
“In general, there has been a movement towards a ‘leave nothing behind’ strategy, minimizing the permanent change to vessel architecture that stenting creates. If you can achieve that with the same outcomes as a stent procedure, then most people would agree that the extra time spent upfront is worth it.”
1. DiRectional AthErectomy + Drug CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions (REALITY). ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02850107 (accessed Jan 2021).
2. Rocha-Singh K. REALITY Study: Directional Atherectomy Vessel Preparation Prior to DCB Angioplasty. 2020 Nov 2–5. [Conference presentation]. Vascular Interventional Advances, Las Vegas, NV, USA. https://vivaphysicians.org
3. Zeller T, Langhoff R, Rocha-Singh KJ, et al; DEFINITIVE AR Investigators. Directional atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis and maintain vessel patency: twelve-month results of the DEFINITIVE AR Study. Circ Cardiovasc Interv. 2017;10(9):e004848.
4. JET-RANGER Trial - JETStream Atherectomy With Adjunctive Paclitaxel-Coated Balloon Angioplasty vs Plain Old Balloon Angioplasty Followed by Paclitaxel-Coated Balloon. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03206762 (accessed Jan 2021).
