One-year outcomes from the BELSTREAM trial add to a growing pool of data that covered stents are safe and effective in the treatment of complex aortoiliac occlusive disease (AIOD).
At the Leipzig Interventional Course (LINC) 2022 in Leipzig, Germany (June 6–9), Koen Deloose, MD, a vascular surgeon at Sint Blasius Hospital in Dendermonde, Belgium, reported a primary patency rate of 94% and freedom from target lesion revascularization (TLR) rate of 95% using the Lifestream balloon-expandable vascular covered stent (BD) in complex lesions.
Deloose highlighted that it was in 2008 when a study by Robert W. Chang, MD, then of Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, et al first showed some advantage of covered stents over bare metal stents in the aortoiliac field. The study was published in the Journal of Vascular Surgery. He also referenced the randomized COBEST trial, in which covered stents performed better than bare metal stents in a subgroup of patients with complex TASC C and D lesions.
In order to further investigate the use of covered stents in AIOD, Deloose and colleagues initiated the BELSTREAM trial with the Lifestream stent. The presenter noted that this stent has been studied in the treatment of AIOD once before, in the BOLSTER trial, but only in relatively uncomplicated lesions. This BOLSTER was a prospective, multicenter, single-arm study that included 155 patients from 17 sites across the world. The researchers of this study reported a freedom from TLR rate of 87.6% at two years, according to Kaplan Meier analysis. “It is important to say that these were mainly TASC A and B lesions,” said Deloose, noting that the mean lesion length was 3cm and that there were occlusions in 21% of the cases.
Deloose informed the LINC audience that BELSTREAM is a prospective study being carried out in six Belgian centers. Seventy patients, with 133 lesions in total, have been enrolled. The primary efficacy endpoint is primary patency of the target lesions and one year without reintervention. The primary safety endpoint is freedom from procedure- or device-related events—such as major amputation and clinically-driven TLR—at 30 days.
The presenter was keen to stress the complexity of the patients included in the BELSTREAM trial, noting that 41.4% had total occlusions, all of which were TASC C (20%) and D (20%). He added that the aortic bifurcation kissing configuration was performed in 77% of cases—in “very calcified” lesions—and that pre-dilation was carried out in almost 40% of the cases.
Presenting 12-month data from the trial for the first time, Deloose reported at LINC that the primary patency rate at one year in this “difficult” TASC C and D patient and lesion cohort was 94.5%. He noted that this figure rose to 97.4% in a subanalysis of the kissing stent cohort, which included 77% of the total patient population.
In addition, the speaker revealed that freedom from TLR in the complete cohort was 95.3%, and that the corresponding figure in the kissing configuration group was almost 98%. “I would like to remind you that the freedom from TLR in the BOLSTER trial of TASC A and B lesions was 94.5%,” he said.
Deloose also conveyed the latest clinical outcomes from the trial, noting a sustained ankle-brachial index (ABI) progression and “very good evolution” in Rutherford categorization. Speaking finally on safety outcomes, he said that there were three clinically-driven TLRs and four deaths at 12 months, however none were device or procedure related.
“There is now more evidence that covered stents are performing better in complex AIOD treatment,” Deloose concluded. He summarized that the Lifestream covered stent has already been shown to be safe and effective in treating “easier” TASC A and B lesions in the BOLSTER trial, and that the latest results from BELSTREAM “confirm these findings in complex lesions.”
A show of hands after Deloose’s talk suggested the audience were convinced by the data, with a majority of delegates in attendance at the session voting that they would use a covered stent as a primary option in AIOD pathology.