This advertorial is sponsored by B Braun
For many decades the axiom ‘the more you gain, the more you lose’ has dominated thinking on luminal enlargement after balloon angioplasty in the coronary arteries, with the fear that a certain amount of arterial dissection carries the likelihood of restenosis later down the line. However, in recent years the advent of drug-coated balloon (DCB) technologies has opened the door to the idea that coronary dissections may not, after all, have to be a cause for alarm, and in fact present the opportunity for effective drug delivery to treat coronary lesions.
The National Heart, Lung, and Blood Institute’s (NHLBI) Coronary Artery Dissection classification system describes six ascending grades of severity determined by angiography assessment.1 “About 25 years ago in Circulation, I described what I call the ‘therapeutic’ dissection,” Patrick W Serruys (National University of Ireland, Galway, Ireland), a thought leader in interventional cardiology research, tells Cardiovascular News, discussing how he has long held the view that some dissections in fact have the potential to aid vessel healing.2
The latest report of the International DCB Consensus Group, published in 2020, underscores that type A and B dissections may be safe to leave after balloon angioplasty provided that they do not limit flow and meet other criteria around adequate lesion preparation, acceptable residual stenosis and have a good angiographic result.3 However, beyond this level of dissection severity, the Consensus Group’s report states that the decision to leave the lesion without a stent may be more open to debate.
Type C dissections, which Serruys describes as appearing as a “small line parallel to the vessel” upon angiography, have features that he says can be considered therapeutic—i.e. conducive to aiding healing within the vessel wall following DCB percutaneous coronary intervention (PCI)—contrasted to more severe, flow-limiting dissections, which are more likely to be harmful.
Non-flow limiting dissections (type A–C) tend to heal over time after DCB treatment. This was demonstrated in a study by Lin Hui (Ulsan Medical Center, Ulsan, Korea) published in 2020 in Yonsei Medical Journal, which assessed 227 patients undergoing DCB treatment of de novo coronary lesions using the SeQuent® Please NEO (B Braun) paclitaxel DCB, which included 95 patients with and 132 patients without dissections.4 At six-month angiographic follow-up, 93.9% of dissections were completely healed, with no new dissections observed. Importantly, even type C dissections resolved entirely or improved to at least type B (see Fig 1). The study found no significant differences in late lumen loss or target vessel failure between patients with and without dissections after a median follow-up of 3.4 years.
Similar findings were observed in a 2015 JACC: Cardiovascular Interventions paper by Bernardo Cortese (Fondazione Ricerca e Innovazione Cardiovascolare, Lodi, Italy and Harrington Heart & Vascular Institute, Cleveland, USA) and colleagues, which demonstrated the safety of leaving non-flow limiting dissections (type A–C) uncovered, with a low rate of restenosis and late lumen loss after DCB treatment in 156 patients.5
In a study of balloon angioplasty using the SeQuent Please DCB (B Braun) for the treatment of small vessel coronary artery disease in 171 patients, published in Cardiovascular Intervention and Therapeutics in 2019, Atsushi Funatsu (Kyoto Katsura Hospital, Kyoto, Japan) et al described how four in every five lesions treated with the DCB had a documented dissection immediately after treatment, but all of the followed-up (67% of the total) lesions were completely healed after seven months.6 Those with a type B dissection, they reported, had the highest percentage of late lumen enlargement as well as the largest net gain, the study’s authors report.
The positive clinical effects of dissections can also be viewed from the opposite perspective—in fact, absence of a medial dissection was shown to be among the factors linked to increased target lesion failure (TLF) after DCB PCI in de novo coronary artery lesions in a study by Tetsumin Lee (Japanese Red Cross Musashino Hospital, Tokyo, Japan) and colleagues, published in EuroIntervention in 2024.7 Their study in 328 patients found that the presence of a medial dissection identified using OCT was a “powerful predictor” of a better outcome, with TLF occurring in 60.9% of patients with vessels that showed no signs of medial dissection, compared to 16.1% in those that did.
Notable findings came from the TRANSFORM I trial, which provides perhaps some of the most compelling evidence to date of the possible ‘healing’ effect of a dissection following paclitaxel-coated balloon treatment, while also highlighting the substantial differences between various DCB technologies. This showed the inferiority of the MagicTouch sirolimus-coated balloon (SCB, Concept Medical) compared to the paclitaxel-based SeQuent Please NEO balloon (B Braun) in de novo small vessel disease, demonstrating a lower angiographic net lumen gain at six months and higher binary restenosis rates with the MagicTouch SCB.8 Serruys, one of the lead investigators in the trial, explains that a sub-study of the trial using OCT to assess the relationship between late lumen loss and dissection volume threw up further enlightening findings.
“We started to measure the volume of the dissections, and we realised that the more you dissect, the better the result is at the long term, which is a little bit counterintuitive, because we were always afraid of dissection previously,” he comments. The analysis demonstrates that, in contrast to MagicTouch, SeQuent Please NEO demonstrated a stronger relationship between acute gain and late lumen enlargement, while MagicTouch shows a strong association between acute gain and late lumen loss. These findings underscore that device selection is an important consideration as the evidence makes clear that there is an absence of a class effect that would allow these findings to be applied across all DCB technologies.
SeQuent Please NEO is coated with 3μg/mm2 crystalline paclitaxel with the excipient iopromide and is recognised as the most widely studied DCB currently available in today’s market.
“What is critical is the retention of the drug in the vessel wall,” Serruys says of the importance of the coating in delivering the drug efficiently and with a long-lasting effect to the lesion site within a short time window. “Basically, the drug has to be there for three months at the inhibitory level.” According to Serruys, with these new data accumulated using the SeQuent Please NEO, the adage “the more you gain, the more you lose” may no longer apply in the era of the paclitaxel-coated balloon. “It is a balloon, so you think [of] dilating, but no! It is drug delivery. You have to do the work of preparing the lesion, dilating the lesion before,” he says of how clinicians should change their mindset when taking this concept into practice. “The drug-coated balloon keeps access to plaque, so you have the option to work on the plaque. You have the possibility for late expansion, late luminal enlargement, that is very important.”
References
1. Rogers JH, Lasala JM. Coronary artery dissection and perforation complicating percutaneous coronary intervention. J Invasive Cardiol. 2004 Sep;16(9):493–9
2. Serruys PW, Luijten HE, Beatt KJ, et al. Incidence of restenosis after successful coronary angioplasty: a time-related phenomenon. Circulation. 1988;77(2):361–71
3. Jeger RV, Eccleshall S, Ahmad WA, et al. Drug-coated balloons for coronary artery disease: third report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391–1402. doi: 10.1016/j.jcin.2020.02.043
4. Hui L, Shin ES, Jun EJ, et al. Impact of Dissection after Drug-Coated Balloon Treatment of De Novo Coronary Lesions: Angiographic and Clinical Outcomes. Yonsei Med J. 2020 Nov 25;61(12):1004-1012. doi:10.3349/ymj.2020.61.12.1004
5. Cortese B, Di Palma G, Guimaraes MG, et al. Effect of drug-coated balloons in native coronary artery disease left with a dissection. JACC Cardiovasc Interv. 2015;8(1):57–64. doi:10.1016/j.jcin.2015.08.029
6. Funatsu A, Kobayashi T, Mizobuchi M, et al. Clinical and angiographic outcomes of coronary dissection after paclitaxel-coated balloon angioplasty for small vessel coronary artery disease. Cardiovasc Interv Ther. 2019 Oct;34(4):317–324. doi: 10.1007/s12928-019-00571-3
7. Lee T, Ashikaga T, Nozato T, et al. Predictors of target lesion failure after percutaneous coronary intervention with a drug-coated balloon for de novo lesions. EuroIntervention. 2024 Jul 1; 20(13): e818–25. doi:10.4244/ EIJ-D-23-01006
8. Ninomiya K, Serruys PW, Colombo A, et al. A prospective randomized trial comparing sirolimus-coated balloon with paclitaxel-coated balloon in de novo small vessels. JACC Cardiovasc Interv. 2023;16(23):2884-2896. doi: 10.1016/j.jcin.2023.09.026
