In a pooled analysis of the predictors of drug-coated balloon (DCB) effectiveness, the IN.PACT Admiral DCB (Medtronic) performed well across a broad range of clinical, anatomical and procedural scenarios. This is according to Prakash Krishnan, MD, an interventional cardiologist at Mount Sinai Hospital in New York, who presented key findings of the investigation in a featured clinical research session at Transcatheter Cardiovascular Therapeutics (TCT) 2021 (Nov. 4–6 , Orlando, Florida).
The analysis combined data from 557 patients treated with DCBs in the IN.PACT superficial femoral artery (SFA) randomized controlled trial (RCT), the IN.PACT Japan RCT and the prespecified long lesion and chronic total occlusion imaging cohorts of the IN.PACT Global study.
The objective of this pooled IN.PACT analysis was to examine the factors contributing to 12-month effectiveness outcomes when DCBs are used for the treatment of femoropopliteal disease. While several studies have evaluated the predictors of DCB efficacy in smaller populations, Medtronic claims that the IN.PACT analysis is the first large-scale collaborative effort to evaluate a broad set of clinical, anatomical and procedural factors using rigorous, core-laboratory-adjudicated data.
Krishnan informed the TCT audience that only residual stenosis >30%, Rutherford category >3, and smaller preprocedure reference vessel diameter were significant multivariable predictors of decreased DCB effectiveness.
He also stressed the importance of vessel preparation, noting that patients with postprocedure residual stenosis <30% had a 4.7-fold higher risk of clinically-driven target lesion revascularization (CD-TLR; hazard ratio [HR], 5.67; 95% confidence interval [CI], 2.32–13.85) and a 1.7-fold higher risk of binary restenosis (HR, 2.73; 95% CI, 1.6–4.65 through 12-month follow-up compared to patients who had residual stenosis ≤30%.
Other key findings included the following:
- Rutherford category >3 was associated with a significantly increased risk of CD-TLR (HR, 4.19; 95% CI, 1.68–10.46) while smaller preprocedure reference vessel diameter was associated with a higher risk of binary restenosis (HR, 1.57; 95% CI; 1.01–2.46) through 12-month follow-up
- Longer lesion length, severe calcification, and total occlusion were not statistically significant predictors of DCB outcomes in this multivariate analysis
In his presentation, Krishnan concluded that DCBs work well across a wide range of clinical and anatomical scenarios, adding that patency can be optimized by procedural factors under the operators control, specifically, achieving a postprocedural residual stenosis <30%.