Study Shows Drug-Eluting Balloons Minimize In-Stent Restenosis

"It's an effective therapy that has been demonstrated nicely around the world and is just going through the approval process in the U.S.," said Spencer King III, MD, MACC.

A small study found that a drug-eluting balloon angioplasty catheter showed promise in preventing restenosis. The study was published in JACC: Cardiovascular Interventions, and found that a combination of the short-term mechanical action of the balloon and prolonged pharmacologic activity of paclitaxel contribute to the therapeutic benefits produced by drug-eluting balloons for in-stent restenotic lesions.

A prospective observational study with 25 patients used a combination of angiography, fractional flow reserve and optical coherence tomography to examine physical, dynamic flow and clinical changes before and after drug-eluting balloon use, and again six months later. A comparison of before-and-after measurements showed: "lumen volume 75.1 percent increase [43.7 to 115.0], and 8 percent increase [-14.0 to 25.8]; stent volume 23.7 percent increase [15.5 to 40.0], and -1.2 percent decrease [-6.9 to 5.9]; and neointimal volume -14.4 percent decrease [-29.2 to -9.5], and -15.8% decrease [-38.1 to 28.3]."


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Further, "the FFR gradient along the treated stent (difference in FFR between the distal and the proximal stent edge) was 0.37 ± 0.18 pre-procedure, 0.06 ± 0.04 post-procedure, and 0.05 ± 0.05 at follow-up. In all post-procedural OCT images, intrastent dissections were seen, which were sealed at follow-up OCT."

"Drug-eluting balloons restore coronary blood flow by means of short-term mechanical effect," wrote lead author Pierfrancesco Agostoni, MD, PhD, University Medical Center Utrecht, Utrecht, The Netherlands. "Due to local drug effect, patency persists and may even improve at follow-up, with further increase in lumen volume, decrease in neointimal volume and complete sealing of neointimal dissections."

While these findings support the results of other drug-eluting balloon studies, the study was small and individual patients were subject to selection bias. The authors conclude that moving forward, more work is needed to compare the clinical results of drug-eluting balloons with drug-eluting stents, currently the standard of care for in-stent restenosis.

"[This] might be the break through we’ve been waiting for," said Spencer King III, MD, MACC. "There are good publications on the clinical outcome of the drug eluting balloon for in-stent restenosis. Elsewhere in the world this is becoming standard of care." Watch a CardioSource Video News  interview with Dr. King on the study's findings.

Keywords: Neointima, Paclitaxel, Follow-Up Studies, Selection Bias, Drug-Eluting Stents, Standard of Care, Tomography, Optical Coherence

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