WASHINGTON, DC—Publication of a complete cohort of patients treated with a newly approved DCB for in-stent restenosis confirms the superiority of DCB over uncoated balloons, researchers say. A problem it states will eliminate the need to insert more metal stents to address common diseases.

“We see a lot of these patients, and many of them have to undergo bypass surgery and are told they don’t have a choice,” said AGENT IDE Research Chair Ajay Kirtane, M.D. (NewYork-Presbyterian/ Columbia University Irving Medical Center, New York, NY) and TCTMD.

Earlier this month, AGENT (Boston Scientific) became the first coronary DCB approved for the treatment of in-stent restenosis (ISR) in the United States. The product received breakthrough device designation by the U.S. Food and Drug Administration in 2021 based on unmet clinical need and is already available in ISR in Europe, parts of Asia Pacific, and Latin America. and for the treatment of previously untreated small vessel coronary artery disease. .

Late last year, AGENT IDE researchers found that for the first 480 randomized patients, TLF was lower at 12 months using DCB compared to using uncoated balloons. reported an interim analysis that showed a reduction, and that the difference was due to a relative halving of TLR and target vessel risk. Mr. Mi. This new data was presented here at CRT 2024 by principal investigator Robert Yeh, MD, PhD (Beth Israel Deaconess Medical Center, Boston, Massachusetts), and published concurrently. Japan Automobile Manufacturers Associationincluded an entire cohort of 600 patients, of whom 406 received DCB.

The 1-year TLF (composite of ischemia-induced TLR, target vessel-related MI, or cardiac death) incidence in patients treated with AGENT DCB was 17.9% compared to 28.6% in the uncoated balloon group, demonstrating superiority. met the criteria. (HR 0.59; 95% CI 0.42-0.84). Follow-up is planned for 5 years.

“These patients were treated aggressively to make sure all the stent dimensions and everything else was prepared very properly, and then those patients were finished with a drug-coated balloon. ,” Kirtan said.

Complete cohort results

For this study, Yeh, Kirtane et al. analyzed 600 randomized patients (mean age 68 years, 26% female, 7% black) with 1 year of clinical follow-up or death. did. There were high rates of diabetes (51%), multivessel CAD (79%), and history of CABG (30%). In 43% of patients, multiple previous stents were present at the target lesion site.

Patients had ISR of lesions previously treated with BMS or DES that were less than 26 mm in length and had baseline vessel diameters of 2.0 to 4.0 mm. Symptomatic patients were enrolled if the target lesion stenosis was <100% and >50%, and asymptomatic patients were enrolled if the target lesion stenosis was >70%.

Conventional angioplasty techniques were used in all patients before randomization to low-dose paclitaxel-coated DCB or uncoated balloons. Intravascular ultrasound was used in 74%.

The surgical success rate was 92.1% in the DCB group and 88.7% in the uncoated balloon group (P = 0.17), and the technical success rates were 93.4% and 89.7%, respectively (P = 0.12).

Compared with the uncoated balloon group, TLR was less frequent in the DCB group (13.0% vs 24.7%; HR 0.50; 95% CI 0.34-0.74), as was target vessel-related MI (5.8% vs 11.1 %; HR 0.51; 95% CI 0.34-0.74). 95% CI 0.28-0.92). The incidence of cardiac death was similar in both groups.

Definite or possible stent thrombosis was more common in the uncoated balloon group, occurring in six patients compared with zero in the DCB group at 1 year.

Prespecified subgroup analyzes showed that patients with multilevel ISR (23.8% vs 40.0%; HR 0.55; 95% CI 0.34-0.87) and patients with diabetes (21.6% vs 29.2%; HR 0.71; 95% CI 0.43-1.17) .

According to the researchers, DCBs may be particularly useful in patients with multilayer ISR, where “additional stent placement necessitates a stent with three or more layers, further reducing lumen area and further constraining the vessel wall.” “This may limit future treatment options,” the researchers wrote. .

“My opinion is that this is a big step forward, but it’s not a panacea,” Kirtan told TCMDD. “You still have to be a clinician to find the best treatment for each individual patient.”

The role of DES remains

Following Mr. Ye’s presentation here, co-moderator Antonio Colombo, MD (Humanitas IRCCS, Milan, Italy), said it is clear from the data that POBA should not be used in ISR, We echo Kirtan’s advice on the importance of optimizing the vessel before using DCB and selecting the most appropriate intervention tool.

“Some types of in-stent restenosis, such as diffuse [or] Proliferative cells do not respond well to DCB. We rarely use DCB alone for these lesions,” he said. Colombo also said that while multiple stent layers are not ideal, there are scenarios where another stent is warranted rather than choosing a DCB.

Panelist J. Dawn Abbott, MD (Brown University, Providence, Rhode Island) said the availability of DCB for ISR meant that many U.S. correspondents who had lists of patients who wanted to enroll in the AGENT IDE He said it is a relief for business operators. However, he said several practical factors will influence when the device comes to market.

“One of the big factors in the US is that the price of the AGENT device will be set at breakthrough technology costs, which will be very expensive,” she said. “We need to decide how to bring these in and utilize them.”

Although the price is estimated to be 10 times more expensive than DES, patients with ISR who are suitable for treatment with DES will likely continue to receive DES as a treatment option, he added.