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Scott: 12-Month Results of the REALITY Study of Directional Atherectomy Alone and With Drug-Coated Balloons
In a session devoted to atherectomy and its use in patients with critical limb ischemia (CLI), Eric C. Scott, MD (The Iowa Clinic, Des Moines, Iowa), shared the 12-month results of the REALITY study of directional atherectomy alone and with drug-coated balloons in patients with long, severely calcified lesions.
REALITY was a prospective study designed to assess the safety and effectiveness of vessel preparation using the HawkOne directional atherectomy system (Medtronic) prior to IN.PACT Admiral drug-coated balloon (DCB; Medtronic) angioplasty.
Sponsored and conducted by the VIVA Physicians, REALITY focused specifically on complex femoropopliteal lesion morphologies characterized by long lesion lengths and bilateral vessel wall calcification.
Regarding the choice to pair directional atherectomy with DCB, specifically in long and severely calcified lesions, Dr. Scott said, “You have to ask why would Medtronic do that? And the answer is they didn't. It was actually the VIVA physicians that sponsored this trial and Medtronic had enough faith in the technology and its power to actually go along with the trial.”
The trial enrolled 102 subjects at 13 centers (in the U.S. and Germany) and included patients with 8-36 cm femoropopliteal stenoses or occlusions with bilateral vessel wall calcification treated with DA prior to DCB angioplasty.
The primary effectiveness endpoint was 12-month primary patency, and the primary safety endpoint was freedom from major adverse events through 30 days.
Lesion morphology was defined using the novel Peripheral Arterial Calcium Scoring System (PACSS). The PACCS index calculated overall calcium burden by taking into consideration both calcification and lesion length.
As well, the trial benefited from independent core lab adjudication of all angiographic, duplex Doppler, and histology data and a clinical event committee. Complete data on 92 patients were available for one-year follow-up.
“Just to summarize these complex lesions, it was femoropopliteal lesions of 8 to 36 centimeters, chronic total occlusions had to be longer than 10 centimeters, and you had to have, on fluoroscopy, bilateral vessel wall calcification in order to be included in the trial.”
Clinical characteristics were as expected for this population, said Dr. Scott. “Mean age of approximately 70 years, a high preponderance of hypertension and hyperlipidemia, over half the patients were diabetic, and over half of them had required previous endovascular treatments in either leg for artery disease.”
Mean lesion length was 17.9 centimeters and chronic total occlusions accounted for almost 40% of the patients in the trial, he added.
“And over two-thirds of these patients had Grade 4 calcium on the lesions treated, meaning they had bilateral calcification that extended more than 5 centimeters on each side,” said Scott (Figure 1, below).
“I think when you pick off patients with the worst of our lesions, you have to take that into account when it comes time to look at the outcomes data,” noted Scott, showing a slide (Figure 2, below) depicting the extent to which the REALITY study included uniquely long and complex lesions.
Perforations were seen in 3.1% of patients (3/98) and dissections Grade C or higher in 14.3% (14/98). Provisional stents were implanted in 8.8% (9/102) of subjects.
“I think if you look at long, severely-calcified lesions and ask how many of these cases otherwise could you treat and not stent, you would anticipate that number to be far higher, but 8.8% was the number,” said Scott.
No device or procedure related deaths and one index-limb major amputation were reported.
The 12-month primary patency rate was 76.7% (66/86) and freedom from CD-TLR was 92.6% (87/94).
“And for those of you that take pictures of slides to capture all the data I've included this one, because I think it contains all of the key metrics from the reality data at 12 months.” (Figure 3, below)
Reflecting to an earlier trial, DEFINITIVE LE, Scott pointed out that the mean lesion length was almost two-fold longer in REALITY (17.9 cm instead of 7.5 cm), and the trial included severely calcified lesions, which were excluded from DEFINITIVE LE.
“And, yet, I find it interesting that the one-year primary patencies are almost identical…so I think this is actually some real data—and we don’t have much of this…that I think speaks to the power of paclitaxel and the IN.PACT drug-coated balloon…It's real evidence, albeit comparative, that the IN.PACT drug-coated balloon can add additional benefit to these patients with severely calcified and long lesions,” concluded Scott.
