A key theme among the late-breaking trial data presented at LINC 2021 (The Leipzig Interventional Course; 25–29 January, online) was the emergence of long-term evidence on paclitaxel devices in the femoropopliteal segment. Results out to five years shows good efficacy and safety.
Thomas Zeller (University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany) presented five-year outcomes of the IN.PACT Global trial, assessing the IN.PACT Admiral drug-coated balloon (DCB; Medtronic), followed by Young-Guk Ko (Yonsei University College of Medicine, Seoul, Korea), who announced results from the IN.PACT Global Asian cohort. Also presenting data out to five years, Marianne Brodmann (University of Graz, Graz, Austria) detailed new findings from the ILLUMENATE randomised controlled trials (RCTs) of the Stellarex DCB (Philips).
The EffPac study of the Luminor DCB (iVascular) now has data out to three and a half years, which Dierk Scheinert (University of Leipzig, Leipzig, Germany) shared with the LINC audience. Finally, Michael Lichtenberg (Karolinen Hospital, Arnsberg, Germany) relayed three-year data from the first-in-human KANSHAS 1 study of the novel Kanshas DCB (Terumo).
“Robust, real-world data”: IN.PACT Global five-year outcomes
First to present was Zeller, who informed LINC viewers that the IN.PACT Global study, “remains the largest and only reported real-world DCB study with independent Clinical Events Committee (CEC) adjudication through five years”. The results demonstrate the sustained efficacy of the IN.PACT Admiral DCB through five years and show evidence of long-term safety.
Zeller noted that patients with complex lesions are usually excluded from randomised controlled trials (RCTs), however, they are reflected in real-world studies. “RCTs and global registries have demonstrated the superiority of DCBs over percutaneous transluminal angioplasty (PTA) for the treatment of peripheral arterial disease (PAD) in real-world patients,” he remarked, adding, however, that long-term evidence in complex real-world patients is limited.
The IN.PACT Global study is a real-world, prospective, multicentre, single-arm, independently-adjudicated femoropopliteal study. A total of 1,416 patients were included across 64 sites in the EU, Middle-East, Latin America, and Asia.
In terms of efficacy, Zeller reported that the five-year freedom from clinically-driven target lesion revascularisation (CD-TLR) rate was 69.4%. He compared this to the rates at one, two, three and four years: 92.%, 83.3%, 76.9%, and 73.4%, respectively. Considering additional efficacy outcomes, Zeller noted that the rate of CD-TRL was 30.6% and that the rate of any TLR was 31.3%.
Regarding the primary safety composite endpoint—which consists of freedom from device- and procedure-related deaths out to 30 days, freedom from major target limb amputation within 60 months, and freedom from clinically-driven target vessel revascularisation (CD-TVR) within 60 months—the rate was 67.4% at five years.
In addition, there was a 78.9% rate of freedom from all-cause mortality out to five years, and 96.4% follow-up was achieved with vital status collection.
Zeller concluded: “Robust, real-world data continue to demonstrate durable results, indicating the IN.PACT Admiral DCB as a viable solution for the treatment of femoropopliteal disease.”
IN.PACT Admiral demonstrates “consistent treatment effect” in complex geographic subset
Honing in on the Asian subset of the IN.PACT Global study, Ko revealed that this subgroup showed more complex baseline clinical and lesion characteristics than the global clinical cohort. However, he also informed the audience that the Asian subset showed a consistently lower CD-TLR rate of 22.9% at five years for complex femoropopliteal lesions, with a mean length of 17.4±12.4cm and 51.4% total occlusions.
“These results demonstrate a consistent treatment effect with the IN.PACT Admiral DCB across IN.PACT studies, including this complex geographic subset,” he concluded.
Five-year ILLUMENATE outcomes show continued efficacy and safety of Stellarex DCB
Brodmann announced the final, five-year results of two RCTs that show no difference in all-cause mortality between patients treated with the Stellarex DCB and those treated with PTA, the current standard of care. Moreover, the studies showed no difference in mortality between the Stellarex DCB and PTA at every 12-month endpoint over the course of the study.
The ILLUMENATE EU RCT and ILLUMENATE Pivotal RCT together comprised approximately 600 patients in Europe and the USA. After five years, the ILLUMENATE EU RCT showed 19.3% mortality among patients treated with the Stellarex DCB compared to 19.4% mortality for those treated with PTA.
The five-year results for the ILLUMENATE Pivotal study also show no statistically significant difference among patients treated with the Stellarex DCB (21.2%) compared to those treated with PTA (20.2%). Both studies had a high vital status follow-up compliance, with the status of over 90% of patients known.
“The five-year final results show favourable overall safety of the Stellarex low-dose paclitaxel DCB, and are applicable within an extensive patient cohort,” said Brodmann. “Every year, the Stellarex programme has demonstrated low mortality rates with no difference in rates between the two patient cohorts.”
Luminor DCB results in “significant haemodynamic improvement” out to 3.5 years in EffPac study
Presenting new findings from the EffPac trial, Scheinert outlined 3.5-year outcomes with the Luminor-35 DCB (iVascular). A total of 166 patients were included in this study; 82 were treated with the Luminor DCB, while 84 were treated with PTA.
He concluded that at the 3.5-year timepoint, DCB angioplasty with the Luminor-35 DCB of medium length superficial femoral and popliteal artery lesions results in a, “significant haemodynamic improvement from baseline,” with a lower TLR rate, and an all-cause mortality rate similar to PTA.
Three-year findings of the first-in-human KANSHAS 1 study demonstrates “good safety and efficacy” of novel Kanshas device
Finally, Lichtenberg presented results of the first-in-human KANSHAS study of the novel Kanshas DCB (Terumo), for which there are results for 31 patients.
The speaker concluded: “Angioplasty using the novel Kanshas DCB for the treatment of de novo femoropopliteal artery lesions displays good safety and efficacy throughout the period of 36-month follow-up.” In addition, he noted that haemodynamic and clinical improvement was maintained in the majority of patients, and that no sign of an abnormal late mortality signal was observed in the studied population, with only a few TLRs noted.