麻豆传媒

Newer investigational drug-coated balloons (DCBs) may be moving away from paclitaxel, but mechanistic studies suggest that the antiproliferative agent of choice in percutaneous coronary intervention (PCI) may depend on lesion characteristics.

Although no coronary DCB has been FDA approved yet, this technology potentially offers a way for operators to treat narrowing arteries without leaving any metal behind and provoking an inflammatory response.

Promising early data for the sirolimus-eluting SeQuent SCB and biolimus-eluting BA9 DCB were presented at the Transcatheter Cardiovascular Therapeutics (TCT) meeting held in Orlando, Florida, and broadcast online.

The SeQuent SCB was deemed noninferior to the paclitaxel-coated SeQuent Please Neo for treating de novo lesions and in-stent restenosis -- though the paclitaxel device showed more late lumen enlargement in de novo lesions -- while the BA9 showed superiority over plain old balloon angioplasty (POBA) for native lesions in small coronary arteries.

"A combination of stents and DCBs can make interventionalists do a better job for patients while leaving less metal behind," such as in the case of dual stents in bifurcation lesions, said Roxana Mehran, MD, of Mount Sinai School of Medicine in New York City, at a TCT press conference.

"I think the future is strong for DCBs, we just need more and more data," she said, urging a focus on safety in particular.

SeQuent SCB in De Novo Lesions

The sirolimus-eluting SeQuent SCB met noninferiority criteria in terms of in-segment late lumen loss (LLL) at 6 months following treatment of coronary de novo lesions, according to Wan Azman Wan Ahmad, MBBS, of University Malaya Medical Center in Kuala Lumpur.

In-segment LLL at 6 months reached 0.10 mm with the sirolimus device versus 0.01 mm with the comparator device, paclitaxel-coated SeQuent Please Neo. The noninferiority margin was 0.35 mm, Azman Wan Ahmad noted.

Notably, late lumen enlargement was more frequent with the paclitaxel device (58% vs 32%, P=0.019).

The was conducted at several centers in Malaysia, and investigators randomized 35 people into each group.

Clinical outcomes at 12 months were no different between study arms. There were two major adverse cardiac events in the SeQuent Please Neo group compared with none in SeQuent SCB.

SeQuent SCB for In-Stent Restenosis

SeQuent SCB again met noninferiority against SeQuent Please Neo in a small trial, this time in patients requiring intervention for coronary in-stent restenosis in a drug-eluting stent.

In-segment LLL at 6 months was observed to be 0.26 mm versus 0.25 mm, allowing SeQuent SCB to meet the noninferiority margin of 0.35 mm, according to Bruno Scheller, MD, of University Hospital of Saarland in Germany.

This randomized trial counted 10 participating centers in Malaysia, Germany, and Switzerland with 101 patients undergoing PCI.

Scheller stressed the need for longer follow-up and larger trials powered for clinical endpoints.

"For now, paclitaxel remains drug of choice for DCB," he said.

BA9 in Small Vessels

People requiring PCI in small coronary arteries saw better results with the biolimus-coated BA9 than POBA alone, according to a small trial from China.

In-segment LLL at 9 months reached 0.16 mm with the BA9 DCB versus 0.30 mm with POBA (P=0.001), supporting superiority of the former on per-protocol analysis, reported Kai Xu, MD, of the General Hospital of Northern Theater Command in Shenyang, China.

This finding persisted on intention-to-treat analysis also capturing people who had the device withdrawn, missed their 9-month follow-up angiogram, or needed a bail-out stent.

Late lumen enlargement also favored the BA9 (29.7% vs 9.7%, P=0.0007), according to Xu.

The had 212 patients with either stable or unstable angina randomized at 10 centers in China. Small vessels were required to be 2.0-2.75 mm in reference vessel diameter and lesions no longer than 25 mm.

Xu said that future study with an active control, such as a paclitaxel-coated DCB, is warranted.