Drug-Coated Balloons for CAD: Some International Consensus

An international drug-coated balloon (DCB) consensus group has issued updated guidance on the use of these devices in coronary arteries, with an emphasis on emerging indications and forthcoming technologies.

Speaking on behalf of the group, co-author Azeem Latib, MD (Montefiore Medical Center, Bronx, NY), said this third document was spurred by recent randomized clinical trial data and new DCBs for the coronaries that are expected to hit the US market soon. It also stemmed from a desire on the part of the international group members to share their clinical experiences with their American colleagues.

“We thought this would be the right time to publish an updated guideline that US physicians would have access to and that would be useful for them,” Latib said in an interview with TCTMD. “We wanted to summarize the clinical data and to highlight the indications for use. Most people accept using a drug-coated balloon in in-stent restenosis, but we wanted to highlight the data in novel disease, especially small-vessel disease.”

In the paper, published online May 27, 2020, in JACC: Cardiovascular Interventions, Latib and colleagues led by Raban V. Jeger, MD (University Hospital Basel, Switzerland), note that the recent BASKET-SMALL 2 study comparing a paclitaxel-coated DCB (SeQuent Please, B. Braun Melsungen) and a second-generation DES demonstrated noninferiority in a 758-patient cohort with de novo coronary lesions measuring 2 to less than 3 mm in diameter and an indication for PCI. Those results were corroborated by the RESTORE SVD China randomized trial, and the stability of DCB therapy in small-vessel disease out to 3 years has been confirmed in several studies, including BELLO and PEPCAD.

The document also reviews available evidence on the efficacy of a DCB-only strategy in larger de novo lesions (≥ 3.0 mm). “Based on these reports, the treatment of de novo lesions in large coronary segments seems to be both safe and efficient with low risk rates of clinical events and acute vessel closure, which may be due to the lack of foreign material and its inherent thrombogenicity. However, randomized data for the comparison between DCB and DES for this indication is still lacking,” the group writes. Additionally, while there is evidence to support attempting a DCB-only strategy in bifurcation lesions, the data suggest that a DCB-only in the main branch is often adequate and that a combination intervention of DES to the main branch with DCB to the side branch may be superior.

The writing group also delves into considerations for special patient populations, including those with diabetes, increased risk of bleeding, and ACS, noting that RCTs in these populations are needed to understand if DCB treatment might be efficacious.

Future Considerations

For Latib, the resurgence in interest in DCBs will be interesting to watch over the next few years as additional data accumulate in larger, more diverse populations.

“This year we are supposed to see the start of at least four different drug-coated balloon trials in the United States,” he observed. “Two with a paclitaxel-coated balloon and two with a sirolimus-coated balloon.” Just in the last year, both the Selution DCB (Med Alliance) and SeQuent Please ReX (B. Braun) received breakthrough designation from the US Food and Drug Administration, he added, which allows for an expedited regulatory process.

Another consideration is the use of paclitaxel, which Latib and colleagues note is still the drug of choice, with typical dosage on the balloon of between 2 and 3.5 μg/mm². Paclitaxel has come under intense scrutiny since a 2018 meta-analysis reported increased long-term mortality risks in patients with peripheral artery disease who were treated with a paclitaxel-coated balloon or stent compared with an uncoated device. But despite the controversy in the endovascular world, mortality associated with paclitaxel in coronary interventions has not been shown in registries or RCTs. Recent meta-analyses in patients treated for in-stent restenosis as well as those with de novo stenosis have shown no increase, with one study even suggesting lower mortality at 3 years in CAD patients treated with a paclitaxel DCB versus DES.

“We have a lot of good data for coronary drug-coated balloons, including long-term data and we have not seen the signal [for mortality],” Latib said. “One positive thing, I suppose, is that the concern about the signal has actually helped push forward the sirolimus-coated balloons, which I think we will see being developed more rapidly now.”

The writing group maintains that a DCB technique “with optimal lesion preparation, functional testing, use of antiproliferative drugs to inhibit intimal hyperplasia, and short-term dual antiplatelet therapy” is a valid option for CAD in many clinical situations. Latib added that he believes US interventionalists will be happy to eventually have the option available to them.

“As someone who worked in Europe and now works in the US, it's probably one of the devices that I miss the most,” he concluded.