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Drug-coated balloons not a ‘game changer,’ but promising
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Vascular Interventional Advances
Drug-eluting balloons have demonstrated reductions in restenosis and significantly lowered late lumen loss. But despite positive results from trials like THUNDER, it may be too soon to say the technology will change practice.
“It’s too early to say that drug-eluting balloons are going to be the game changer in the future, but [it is] in fact a promising technology in the future to bring us one step further in this very challenging environment for interventions,” said Dierk Scheinert, MD, of the Heart Center and Park Hospital of the University of Leipzip, Germany.
In THUNDER, which Scheinert said was the most important trial for this technology, late lumen loss at six months of angiographic follow-up with a paclitaxel-coated balloon was significantly lower than that in control groups (plain balloon angioplasty and plain balloon angioplasty plus an infusion of lopromide). This result was sustained at one and two years, he said. There was also a signficiant reduction in binary restenosis at six months, one and two years with the coated balloon compared with controls.
A German study called PACCOCATH confirmed the results seen with THUNDER, Scheinert said.
“Despite the fact that this is very encouraging, and certainly a lot of companies are doing [work] to bring that to practice, there are some open questions,” Scheinert said.
In THUNDER, Scheinert said that the lesions studied were perhaps not the ideal and cited an uneven distribution between treatment and control groups. He questioned how comparable THUNDER is when clinicians are typically encountering longer lesions, more total occlusions, more calcified lesions and more frequent multivessel disease. He also questioned how effective drug-eluting balloons would be in the presence of stents.
“Stent use was low in THUNDER, but if you go for more challenging lesions, you may need to stent some of those,” Scheinert said.
The consensus, he added, is that drug-eluting balloons should be used as much as possible without stenting.
A new, evolving concept is atherectomy with drug-eluting balloons which Scheinert described as a “meaningful concept.”
In a patient with a popliteal artery, typically a poor place to stent, favorable results may be seen post atherectomy. Adding a drug-eluting balloon may lower the rate of restenosis. However, Scheinert said, the question remains as to whether this is cost-effective or whether atherectomy would affect drug delivery.
Scheinert also discussed a paclitaxel-eluting percutaneous transluminal angioplasty catheter (In.Pact Amphirion, Invatec), a novel treatment currently in trial in Europe. He said the concept has a complicated study design but has shown early promise at six months. – by Judy Rusk
For more information:
- Scheinert D. Drug-coated balloons: Is this the game changer? Presented at: Vascular Interventional Advances; Oct. 20-23, 2009; Las Vegas.