Coronary Drug-Coated Balloons in the U.S. – A Boon or Burden to Rising Health Care Cost?
Focusing on intravascular image-guided stent placement may offer a more cost-effective approach
Focusing on intravascular image-guided stent placement may offer a more cost-effective approach
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Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of Cath Lab Digest or HMP Global, their employees, and affiliates.
Ivana Kumar1; Anshita Kumari, MBBS2; Kusum Lata, MD, FACC, FSCAI3
1Research Associate, Sutter Health, Tracy, California; Quarry Lane School, Dublin, California; 2Kasturba Medical College, Manipal, India; Research Associate, Sutter Health Tracy, California; 3Interventional Cardiology, Sutter Health, Tracy, California; Board of Trustees, SCAI
Disclosures: The authors report no conflicts of interest regarding the content herein
The authors can be contacted via Kusum Lata, MD, FACC, FSCAI, at lata.drkusum@gmail.com
Coronary stents have traditionally served as a primary method for treating significant coronary blockages. However, their effectiveness can be compromised when restenosis occurs. Even with the progress made in stenting technology, treating in-stent restenosis (ISR) remains challenging. In the United States, the main approach for treating coronary ISR continues to be re-stenting, a method that has seen little modification over the years. Recently, a promising alternative has arisen with the development of coronary drug-coated balloons (DCBs), offering an innovative approach to address ISR. The balloon is coated with medication, typically paclitaxel, which is slowly released into the artery tissue to prevent the recurrence of artery narrowing, or restenosis, ultimately reducing the need for additional treatments. After a thorough evaluation spanning almost ten years, coronary DCBs received FDA approval in March 2024 for treating ISR.1 In Europe, coronary DCBs have been endorsed since 2014 in the European Society of Cardiology guidelines as a first-line treatment for ISR management, gaining widespread acceptance.2 The introduction of this groundbreaking technology in the United States is good news for patients dealing with restenosis. Nevertheless, there are worries about the price of coronary DCBs, posing a potential obstacle to the broad implementation of coronary DCB use.
In-Stent Restenosis and Coronary DCBs
The biggest downside of coronary stents is their failure rate. Advancements in imaging technology have greatly improved our knowledge of the factors that contribute to ISR, a condition marked by multiple clinical risk factors and also resulting from mechanical aspects around placing a stent. We know that the use of image guidance such as intravascular ultrasound (IVUS) or optical coherence tomography (OCT) for the placement of coronary stents helps decrease the occurrence of stent failure. Yet even with improvements in stent technology such as adding polymer coatings, the problem of ISR, while reduced, still remains. ISR results in increased healthcare costs and is associated with higher readmission rates. Current recommendations advise the use of a different drug-eluting stent for managing ISR. Coronary DCB have been shown to be a successful option instead of using stents for treating ISR.3 Currently, the cost of DCB treatment for ISR is around eight times higher than the standard drug-eluting stent therapy. Coronary DCBs could provide an affordable treatment option for certain patients by lowering the likelihood of future issues, need for multiple procedures, and overall impact of their disease. Hospitals and proceduralists must carefully consider the costs linked to integrating advanced technologies with the potential benefits.
Video 1. Intravascular ultrasound (IVUS) of a left anterior descending artery with in-stent restenosis.
Cost
In the U.S., the price of coronary DCB is approximately eight times more expensive than that of a stent. For restenosis within a stent, it is strongly advised to utilize intravascular imaging to customize the best course of treatment. Intravascular imaging helps strengthen the DCB procedure by assisting in understanding the mechanism of the ISR, helping the operator to select the appropriate balloon size, and when performing pre-dilation with a different balloon. The price of intravascular ultrasound (IVUS) and any extra expense for balloons would bring the basic cost of DCB use to approximately ten times greater than that of drug-eluting stents in the United States. In Europe, the cost gap between coronary DCB and drug-eluting stents is +321 euros.4
Intravascular Imaging Use
The United States lags in the use of intracoronary imaging for the initial placement of coronary stents. Even though coronary imaging is accessible in 85% of cath labs in the U.S., it is only used, on average, around 6.3% of the time.5 Encouraging intracoronary imaging during initial stent placement would likely be a cost-effective way to reduce the occurrence rate of ISR. With coronary DCB use increasing in popularity, we should all remain aware of the financial impact. Widespread use of coronary DCB in ISR could be costly for our patients. More evidence is needed to confirm the advantages of using coronary DCB as the standard treatment for ISR. Focusing on intravascular image-guided stent placement may offer a more cost-effective approach, reducing the occurrence of ISR and the need for any related treatment with the placement of an additional stent or DCB use.
References
1. Yeh RW, Shlofmitz R, Moses J, et al; AGENT IDE Investigators. Paclitaxel-coated balloon vs uncoated balloon for coronary in-stent restenosis: the AGENT IDE randomized clinical trial. JAMA. 2024 Mar 26;331(12):1015-1024. doi: 10.1001/jama.2024.1361
2. Giustino G, Colombo A, Camaj A, et al. Coronary in-stent restenosis: JACC state-of-the-art review. J Am Coll Cardiol. 2022 Jul 26;80(4):348-372. doi: 10.1016/j.jacc.2022.05.017
3. Merinopoulos I, Gunawardena T, Corballis N, et al. Cost effectiveness analysis of drug coated balloon only angioplasty for de novo coronary artery disease. Catheter Cardiovasc Interv. 2023 Nov;102(6):987-996. doi: 10.1002/ccd.30878
4. Dorenkamp M, Boldt J, Leber AW, et al. Cost-effectiveness of paclitaxel-coated balloon angioplasty in patients with drug-eluting stent restenosis. Clin Cardiol. 2013 Jul;36(7):407-13. doi: 10.1002/clc.22130
5. Malik AO, Saxon JT, Spertus JA, et al. Hospital-level variability in use of intracoronary imaging for percutaneous coronary intervention in the United States. J Soc Cardiovasc Angiogr Interv. 2023 May 19;2(4):100973. doi: 10.1016/j.jscai.2023.100973
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