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LINC 23: POPCORN Registry: DCB Treatment for Peripheral Artery Disease

Published: 08 Jun 2023

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LINC 23 - We are joined by Dr Yoshimitsu Soga (Kokura Memorial Hospital, JP) to discuss the POPCORN Registry, an ongoing prospective multicenter observational study of drug-coated balloons (DCBs) in patients with peripheral artery disease (PAD). This is the largest Japanese DCB registry, with 81 institutions enrolled in the trial.

The primary objective of this registry is to compare the performance of two prominent DCBs, Lutonix and IN.PACT Admiral, in a cohort of 2507 patients over a span of 5 years. The 2-year results suggest that primary patency after drug-coated balloon stenting for femoropopliteal lesions in a real-world setting was favourable. The study also suggested that an accumulation of primary restenosis risk factors was associated with lower patency, and a lower freedom from target lesion revascularization rate. 

Interview Questions: 

  1. What was the reasoning behind the POPCORN Registry?
  2. What are the differences between the Lutonix and IN.PACT Admiral DCBs?
  3. What was the patient population and study design?
  4. What are the key findings revealed at LINC 23?
  5. How should these findings impact both clinical practice and future research?
  6. What are the next steps?

Recorded remotely from Belgium, 2023.
Editor: Jordan Rance
Video Specialist: Dan Brent

Transcript

" I'm Yoshimitu Soga from Japan. I’m working at the Kokura Memorial Hospital. I’m an interventional cardiologist.

Reasoning Behind the POPCORN Registry

I’d like to introduce the POPCORN Registry which is the largest prospective multicenter observational Japanese DCB registry.81 institutions were enrolled in this study. More than 3000 lesions were registered to verify the new findings from Japan. Japanese situation and the vast situation are a bit different from the Western countries. So, we do not use bailout stents, we do not have the various atherectomy devices there. So also, a high rate of IVUS usage. So, we need to investigate the Japanese data. Therefore, we started the POPCORN registry. I believe that this data is very helpful and useful in our daily practice for fempop population.

The LUTONIX and IN.PACT Admiral DCBs

The primary endpoint of this study is a twelvemonth primary patency, but subgroup analysis shows us the difference of the two types of DCB Lutonix and IN.PACT. This registry includes only two kinds of DCB, IN.PACT and Lutonix. Comparing these two DCBs the primary patency was significantly higher in the IN.PACT at the mineral high dose DCB. Also, freedom from TLR was also significantly higher in the high-dose DCB IN.PACT compared to the low-dose DCB Lutonix. In a clinical setting, high-dose DCB is very useful to keep the patency to avoid restenosis or reintervention. Therefore, so risk stratification is very important if we can choose the two different DCBs for high-risk lesion high-dose DCB is more effective from this registry.

Patient Population and Study Design
I think unlike a western countries’ registry, so the Japanese registry shows the very different patient and the lesion background. The first is more elderly patients enrolled, the mean age was 74 higher elderly so also non-ambulatory patient were also enrolled maybe around 13%.The CLTI was 32% in this registry, the CTO was 26%.Mean lesion length was 13 or 14.Interestingly, IVUS usage was high, 73% in this registry therefore so we usually choose the optimal volume size by using by measured by IVUS. It's a very interesting result.

Key Findings

So, I already reported the one-year clinical outcome from JAHA last year. But in LINC we also reported the two-year results, the more longer-term result from the POPCORN registry. The POPCORN registry shows us the clinical risk factor independent of the risk factor of the one-year restenosis such as the history of EVT, the smaller vessel, severely calcified lesions, CTO, the low dose DCB and the residual stenosis these six independent risk factors for one-year stenosis were affected longer term from this registry. Therefore, I emphasize that the POPCORN demonstrates that six risk factors of the restenosis and effect in the chronic phase.

Impact on Clinical Practice and Future Research

So before using the DCB, I personally believe the DCB is a perfect device so also leave nothing behind. Concept is ideal, but in a clinical setting in daily practice it's not perfect in all cases. Therefore, risk stratification is very important to choose the optimal patient, to choose the optimal lesion for the DCB quality is a good outcome therefore so high risk or more complex lesion. So, we sometimes start considering putting a stent not to depend on the power result. We think there are two-steps. The first: more longer-term follow-up is needed. Only one or two-year results were presented in LINC, but the longer-term effect is needed. Other DCB devices also enrolled in this registry the actual Ranger DCB from Boston Scientific where we start it's called POPCORN type R. Soon, we like to compare POPCORN with POPCORN type R so far and more other new DCBs will be approved soon in Japan. So, unless we'd like to compare among the various DCBs which is better, which is not better from the POPCORN registry.”

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