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Recent years have seen a surge of interest in the use of drug-coated balloons (DCBs) as an option to treat coronary artery disease. In clinical scenarios including in-stent restenosis (ISR) and de novo small vessel disease there is an increasing recognition that leaving nothing behind in the vessel is a favourable strategy to reduce stent burden by reducing the length and number of stents implanted.
As operators have become more proficient in using DCBs in their percutaneous coronary intervention (PCI) practice, there is a new impetus to determine whether these devices may offer an advantage in a broader set of clinical scenarios—including some of the most challenging lesion subsets.
In May, the PrevailTM paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter (Medtronic) gained a series of new CE mark indications, making it the DCB with the widest range of indications in the market. Broadening its use to include scenarios such as multivessel disease, acute coronary syndrome, diabetes and, most significantly, bifurcation lesions, the approvals offer interventional cardiologists the option to use this device in more challenging clinical cases.
Discussing why it is important to have new treatment options in bifurcation lesions in particular, which remains a challenging subset, Goran Stankovic (University of Belgrade, Belgrade, Serbia), a founding member of the European Bifurcation Club (EBC)—a pan European group of interventional cardiologists who consider latest evidence on the treatment of coronary bifurcations to disseminate best practice—tells Cardiovascular News that bifurcations represent a significant proportion of the coronary artery disease cases seen in contemporary practice. Research has suggested that these comprise as many as 15–20% of PCI cases, with some papers putting this figure as high as 30%.1
“Historical data, as well as new evidence, suggest that this is one of the lesion subsets with the highest rate of periprocedural complications, as well as adverse long-term outcomes. The vessel divides at the bifurcation point and plaque usually continues in the lateral walls of both branches, so treatment of one branch compromises flow in the other branch,” Stankovic comments. “If it is not done properly, implanting a stent in the main vessel—which is usually the main goal of bifurcation PCI—shifts this part of the plaque, but also carina, which reduces the flow into the side branch.”
Over years of research and refinement, numerous techniques have emerged for the treatment of coronary bifurcations often involving the use of one or more drug-eluting stents (DESs), with factors including anatomical and lesion complexity, operator experience and preference determining the approach. A typical provisional stenting technique sees a single DES deployed in the vessel’s main branch, with a side branch treated using an additional stent only if necessary.
“Treatment with two stents involves the main vessel and the side branch. Although we are seduced by the beauty of the procedural results you achieve by putting stents in both branches, there is a payoff in the long-term because the longer the follow-up, the higher the event rate with two stents compared to a single-stent strategy,” says Stankovic. Henceforth, he explains, the emergence of DCBs in coronary interventions has opened the door to so-called “hybrid” treatment strategies, which involve using a combination of DES and DCB, or even “puristic”—DCB-only—strategies in bifurcation lesions.
Bruno Scheller (University of Saarland, Homburg/Saar, Germany), a pioneer in the development and use of DCBs in coronary interventions tells Cardiovascular News that there are different ways to employ either the hybrid or puristic approach in the treatment of bifurcation lesions. “Number one is that the DCB is the tool for reducing late lumen loss and restenosis of the side branch and treating the main branch with a stent,” he explains. The operator has the option to treat the main branch with a stent and then cross the side branch, or alternatively to use the DCB first in the side branch, followed by stent implantation in the main branch.
The second approach is the puristic option, which Scheller also categorises in two ways. “Number one is to treat the main and the side branch with the DCB in a sequential way. If you already have disease in the origin of the side branch and the side branch is not very big then you can treat only the main branch and you can expect that the origin of the side branch will get better over time,” he explains.
At the recent EuroPCR meeting (20–23 May, Paris, France) new data were presented from a subgroup analysis of the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) comparing the use of PrevailTM DCB to other contemporary DCB platforms in the setting of bifurcations lesions.
These data, totalling 1,479 real-world PCI procedures performed in Sweden between August 2021 and 2024, including 462 using Prevail DCB and 1,017 using other DCB platforms, represent the largest analysis to date comparing different DCBs in bifurcation PCI including DCB-only and hybrid strategies.
The study demonstrated low mortality (3.7% for Prevail DCB vs. 4.2% for other DCB platforms) and target lesion revascularisation rates (2.8% for Prevail DCB vs. 3.4% for other DCB platforms), with Prevail DCB also performing favourably in terms of new myocardial infarction (2.3% vs. 3.7%), and target lesion definite thrombosis (0% vs. 4.2%) at one year, with event rates consistently low across the different bifurcation strategies. Comparing the performance of Prevail DCB as part of a DCB-only or hybrid strategy, the data also appear favourable. Investigators report an incidence of 4.4% all-cause mortality, 5.5% myocardial infarction and 5.8% target lesion revascularisation for Prevail DCB in the DCB-only arm (against rates of 4.7%, 5.2% and 5.6% respectively in the comparator arm). Using Prevail DCB in a hybrid strategy resulted in a 3.2% rate of all-cause mortality compared to 3.9% in the comparator arm, 0.7% vs. 1.8% target lesion revascularisation, and 0.4% vs. 3.7% myocardial infarction.
“In general, I think Prevail DCB is one of the best, if not the best available DCB on the market at the moment,” comments Scheller on the performance of the device. “Prevail DCB has excellent deliverability, the coating method is state of the art, the drug loss during implant is reduced, the drug transfer rate is very good and the dose is also appropriate,” he comments, noting that randomised study of the device in the setting of bifurcation lesions will be necessary before it is possible to draw firm conclusions from the SCAAR results.
Stankovic comments that the SCAAR data are encouraging but agrees that randomised study will be vital. “We have large datasets, coming from one of the best systems for follow-up in the world, showing that there are at least the signals for a lower rate of myocardial infarction in the group treated with Prevail DCB compared to other available systems, and on the other side you have good safety data with an extremely low rate of reported clinical events,” he comments. “Of course, we need to confirm that in a randomised fashion, but at least now we have approval for use of specific devices in coronary bifurcations, which really makes the thought process much simpler.”
With a desire for more evidence on the performance of DCB-PCI in the setting of bifurcation lesions, investigators are beginning enrolment in the EBC-DCB trial, a 750-patient randomised trial of stepwise provisional stenting versus DCB therapy for non-left main coronary bifurcations. Follow-up will take place at one, three, five, and eight years, with a bifurcation-orientated composite endpoint (BOCE) comprising cardiovascular death, target bifurcation-related MI and target bifurcation revascularisation.
“We have the feeling that this puristic DCB approach improves outcomes, but we do not know this for sure, therefore we have to do the trial,” comments Scheller. “If this trial is positive, this would change our complete understanding of how to treat bifurcations, because the DCB approach is much easier and faster to do. If both were equal it is clear I would select the simpler approach over the more complex procedure.”
References
- von Birgelen C, Zocca P, Buiten RA, et al. Thin composite wire strut, durable polymer-coated (Resolute Onyx) versus ultrathin cobalt-chromium strut, bioresorbable polymer-coated (Orsiro) drug-eluting stents in all-comers with coronary artery disease (BIONYX): an international, single-blind, randomised non-inferiority trial. Lancet. 2018 Oct 6;392(10154):1235-45.
