This advertorial is sponsored by B Braun Melsungen AG
Diabetic patients with coronary artery disease represent a challenging population to treat. With the incidence of diabetes increasing globally, interventional cardiologists can expect to see more of these patients presenting in cath labs, meaning that strategies to effectively manage coronary artery disease in diabetic patients will become increasingly important.
“It varies from country to country, but on average you may expect to have at least 30%—around one in three—of patients coming into the cath lab with diabetes,” Pedro Lemos (Hospital Israelita Albert Einstein, São Paulo, Brazil) tells Cardiovascular News. “There is almost an epidemic increase of diabetes all over the world, especially in some regions—USA, Brazil, Western Europe—there is an increase in diabetes that comes together with an increase in ageing, obesity and these types of risk factors.”
According to Lemos, the risk of having coronary disease is increased by the presence of diabetes, and the prognosis of patients with coronary artery disease is worse for those with diabetes than those who do not have the disease—further elevating the harmful impact of the disease. “The mortality rate of diabetics with coronary disease is higher than for non-diabetics, and the chances of having complications after you have had percutaneous coronary intervention (PCI) are higher in diabetics. That is related to restenosis as well as disease progression,” he explains. “Diabetes invariably escalates various risks in comparison to non-diabetics.”
Turning to the specific lesion characteristics often present in diabetic patients, Lemos details that they tend to have more diffuse coronary atherosclerosis and more negative remodelling. As a consequence, diabetics tend to have longer lesions and a higher incidence of small vessel disease, which potentially makes the delivery of a drug-eluting stent more challenging, as well as reduces the safety and the efficacy of the intervention.
A higher risk or restenosis and thrombosis also means that the prognosis for diabetic patients can be worse when considering the use of drug-eluting stents, Lemos explains, whilst the lower efficacy of antiplatelet therapy in these patients can also make this treatment pathway less favourable. Compared to patients without diabetes, challenging anatomy also means that diabetic patients may require more stents, of longer lengths and smaller diameter.
Whilst PCI with a drug-eluting stent can be challenging, Lemos explains that there are some data from randomised trials showing that the use of drug-coated balloons (DCBs) may be the better choice for diabetic patients.
“DCBs don’t leave any permanent implant in the coronaries and with a DCB you may treat a longer segment as compared to stents,” says Lemos of why this may make the use of a DCB a suitable strategy for PCI in patients with diabetes. And, he comments, even if a restenosis occurs with a DCB, in the long run this may be easier to treat than in-stent restenosis after a drug-eluting stent has been implanted.
“Those may be the mechanisms that may explain why in some studies the outcomes of patients with diabetes treated with DCBs were better than with coronary stents,” says Lemos, referring specifically to a sub-study of the BASKET-SMALL 2 trial which evaluated the impact of diabetes mellitus on three-year clinical outcomes in patients undergoing PCI with a DCB (SeQuent Please/NEO) or a drug-eluting stent for de novo coronary artery disease.
The study showed that rates of combined major adverse events (MACE) are similar between DCBs and stents, both in diabetic and nondiabetic patients. However, when analysing specifically the need for target vessel revascularisation among diabetics, the rate of that event was significantly reduced when using a DCB versus a drug-eluting stent.
“The data are very compelling,” says Lemos. “If you look at the Kaplan Meier curves, first of all, this does not seem to be a small effect. It is a very clear signal. Secondly, it is not restricted to the first months of the treatment, the curves get separated up to three years, and the separation between the two curves of DCB for diabetics as compared to stenting get larger as time passes by. Putting all this together, these are very interesting data.”
Lemos does point out however that, though interesting, these data only represent a small population of patients as part of a sub-study of a much larger trial. Furthermore, physicians should be aware that these data do not infer the presence of a class effect.
“Globally, the most studied DCB around is the SeQuent Please/NEO® (B. Braun),” he explains, noting that the device was the investigational DCB device used in the BASKET-SMALL 2 trial. “DCBs vary a lot, there are differences in terms of the drugs, and there are differences in terms of carriers.”
More head-to-head trials comparing DCBs are beginning to emerge, he notes, and so far these have painted a favourable picture of the performance of the SeQuent Please/NEO paclitaxel-coated DCB. Recently the TRANSFORM I trial, a prospective randomised trial comparing the sirolimus-coated MagicTouch (Concept Medical) to SeQuent Please NEO in de novo small-vessel disease, in which the investigational device failed to demonstrate non-inferiority compared to the SeQuent Please NEO at six months. Additionally, the REFORM study, that pitted the Biolimus A9-coated balloon (Biosensors) against the SeQuent Please/NEO for the treatment of in-stent restenosis, also failed to meet non-inferiority against a primary endpoint of percentage in-segment diameter stenosis at six months.
“The fact is that the studies that have been done more recently support the idea that the SeQuent Please NEO performed better than the DCBs against which it was compared,” says Lemos, weighing up these results. “It is not by coincidence that this is also the most studied DCB that is available. For now most of the data that we have for DCBs in terms of efficacy and safety is with the SeQuent Please family.”
Offering his advice to colleagues on when they should consider reaching for a DCB from the shelf for patients with diabetes who require PCI, Lemos says: “If the patient has small vessel, or long diffuse disease, and if you did vessel preparation with balloon dilatation that looks OK from an angiographic point of view, you may try to use a DCB in those types of patients,” he says. “The data show that this may be at least as good as implanting a stent, without leaving a permanent implant in the coronaries. I think that this is a very nice strategy.”
