Positive 12-month outcomes for the Selution Sustained Limus Release (SLR; Cordis) drug-eluting balloon (DEB) were observed, with consistent haemodynamic, functional and clinical improvements irrespective of lesion location or Rutherford classification in both above-the-knee (ATK) and below-the-knee (BTK) arteries.
Michael Lichtenberg (Klinikum Hochsauerland, Arnsberg, Germany), presenting on behalf of the SUCCESS PTA study research team at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress (13–17 September, Barcelona, Spain), stated that these results support the utility of the Selution DEB in everyday clinical practice for a “wider spectrum of patients and peripheral arterial disease [PAD] presentations”.
“With this stratified analysis we can now conclude that patients with complex BTK lesions have a very good outcome after sirolimus technology usage—these are the first data to prove that,” said Lichtenberg.
In the trial, investigators included the full SUCCESS PTA cohort of 720 patients, stratified by ATK or BTK lesions: 666 patients to ATK and 156 to BTK.
Among the overall cohort, 74% were identified with claudication and 26% with chronic limb-threatening ischaemia (CLTI). Within these subgroups, 78% of claudicants had ATK lesions compared with 54% with BTK lesions; 22% of patients in the ATK group were identified with CLTI compared with 46% in the BTK group. The patient population had an average age of 70.7 years, 37.9% had diabetes mellitus and 16.8% had renal failure or impairment, Lichtenberg highlighted.
Concerning procedural characteristics, Lichtenberg emphasised that 98.6% of ATK and 99.3% of BTK patients received lesion preparation, largely using plain balloon angioplasty or, to a lesser extent, atherectomy/thrombectomy.
Device success was reported in 99% of ATK lesions and 99.1% of BTK lesions, with procedural success rates of 98% and 97.6%, respectively.
At 12 months, freedom from clinically driven target lesion revascularisation (CD-TLR) was achieved in 91.4% of ATK lesions and 89.3% of BTK lesions. “This is very convincing data for patients,” Lichtenberg commented, also underlining the 1.7% and 5.2% rates of target limb amputation in the ATK and BTK groups, respectively.
Following his presentation, a question from the audience focused on the near-identical CD-TLR rates between ATK and BTK lesions, the latter of which are generally assumed to have inferior outcomes. Lichtenberg responded that this discrepancy may have arisen due to the lack of emphasis placed on “proper lesion preparation” in previous datasets concerning BTK disease.
“All of these randomised, prospective DEB or paclitaxel trials didn’t use proper preparation strategies, and I can show you here that a lot of colleagues and centres [in the SUCCESS PTA dataset] used BTK lesion preparation strategies. I think this is an important aspect here in combination with DEB technology and this is a shift we need to concentrate on,” he said.
He went on to add that plain balloon angioplasty is “not the way to go” for lesion preparation in future, highlighting instead that new strategies using intravascular lithotripsy, atherectomy or scoring devices in combination with DEBs will produce “much better outcomes” in BTK lesions.
