Improving Balloon Angioplasty: Lessons Learned from the DCB and Stent Trials



Ronald Solar
Research, ThermopeutiX, Inc., USA

For over 40 years, balloon angioplasty (POBA) has been used to treat vascular disease. Numerous randomized clinical trials (RCTs) confirmed superior outcomes of stents — bare-metal (BMS), and drug eluting (DES) — and paclitaxel-coated balloons (DCB) over POBA. But often, much can be learned by “looking behind the data,” by analyzing the control group. All DCB randomized trials, and many of the stent studies, used the same control — POBA. So, if patient/lesion characteristics were similar, it would be reasonable to expect that results for the POBA control groups would be similar in these studies.

An analysis was made of RCTs concerning BMS, DES and DCB, in both coronary and peripheral vascular applications, in which POBA served as the control. The studies were published between 1996 and 2015, and those with similar endpoints, patient and lesion characteristics were included in this analysis. In these studies, standard POBA catheters were used in accordance with the investigators “standard technique”.

While most studies reported superior outcomes of the experimental group (stent or DCB), endpoints in the POBA control groups varied by as much as a factor of 4, suggesting significant differences in POBA technique amongst the various investigators. POBA outcomes were superior when techniques employing a gradual step-wise expansion of the vessel were used.

“Plain Old Balloon Angioplasty” remains to be a very important tool in the catheter lab, and like most tools, results are related to how they are used. Techniques that employ slow, gradual, low-pressure balloon inflations may help improve outcomes.

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Ronald Solar

President & CEO
ThermopeutiX, Inc.