The novel SeQuent sirolimus coated balloon (SCB) proved to be non-inferior at treating new coronary lesions versus the best-in-class paclitaxel-coated balloon (PCB), SeQuent Please Neo, in a new Malaysian trial. The findings were presented Saturday at Transcatheter Cardiovascular Therapeutics (TCT) 2021 in Orlando, Florida, by Wan Azman Wan Ahmad, MRCP, MBBS, from the University Malaya Medical Center. PCB is a “recommended and commonly used device” for the treatment of blocked or narrow coronary arteries that were provisionally treated with stents (in-stent restenosis [ISR]), said Wan Ahmad. PCB has also been accepted as a treatment option for de novo coronary lesions, he said. However, the role of alternative drugs for balloon coatings, such as sirolimus, has remained unclear, he said. Nevertheless, in recent years, sirolimus has been established as a “drug of choice” for stent-based local drug delivery, said Wan Ahmad. Because drug-coated balloons do not leave a “foreign body implant” following a procedure, their use is the “preferred approach” for the avoidance of “inflammatory foreign body reactions,” he said. The current trial was, therefore, set up to test SCB against PCB in de novo coronary lesions, with the primary endpoint of late lumen loss (LLL) – the difference in lumen diameter between post-procedure and follow-up at 6 months. A total of 70 patients were randomized at four Malaysian sites, 35 to receive B. Braun’s SeQuent SCB (sirolimus 4 μg/mm²) using a crystalline sirolimus coating and 35 to receive B. Braun’s SeQuent Please Neo (paclitaxel 3 μg/mm²) in the treatment of coronary de novo lesions. At 6 months, LLL, as measured by angiography, was 0.10 ± 0.32 mm in the SCB group versus 0.01 ± 0.33 in the PCM subjects. The researchers also reviewed minimal lumen diameter distribution in-segment and found that negative LLL was significantly more frequent in the PCB group (58% of lesions) compared to the SCB group (32% of lesions) (p=0.019). “At 12-month follow-up, the clinical outcomes did not differ between patients who received PCB or SCB,” according to Wan Ahmad. There were two deaths in the PCB group and none in SCB (p=0.493), two unscheduled angiographies in PCB and three in SCB (p=1.000) and two major adverse cardiac events (MACE) – defined as the occurrence of cardiac death, target vessel myocardial infarction or clinically driven target lesion revascularization – in PCB but none for SCV (p=0.493). Asked during his presentation whether the results reflect a true difference related to the drug, or whether the finding’s significance is limited due to the small sample size, Wan Ahmad replied: “My impression is that this finding is significant,” noting “this was also shown in the previous first-in-man trial.” Still, the study’s coordinating principal investigator, Bruno Scheller, MD, from Saarland University, Germany, who also attended the presentation and presented results from two randomized trials comparing the same two DCBs in drug-eluting stent in-stent restenosis lesions, noted that the results are “mechanistic” and feed from previous studies into whether the new type of crystalline sirolimus coating could have a longer-lasting effect. Confirmatory trials are now being conducted in Europe “to see if we can reproduce these outcomes,” he said.