Medtronic’s In.Pact Admiral Evaluated in Pooled Analysis of DCB Effectiveness

November 9, 2021—A pooled analysis of the predictors of drug-coated balloon (DCB) effectiveness in patients treated with Medtronic’s In.Pact Admiral DCB was presented by Prakash Krishnan, MD, in an Endovascular Featured Clinical Research session at TCT 2021 in Orlando, Florida.

Dr. Krishnan, who is with The Mount Sinai Hospital in New York, New York, explained that although there is a body of evidence on predictors of DCB efficacy for coronary artery disease, questions remain regarding the clinical, anatomic, and procedural factors associated with best DCB outcomes in PAD.

Thus, the objective of this IN.PACT Admiral DCB Outcomes Predictors analysis was to examine the factors contributing to 12-month effectiveness outcomes when DCBs are used for the treatment of femoropopliteal disease, noted Medtronic.

Investigators pooled analyses of four studies evaluating the In.Pact Admiral DCB for femoropopliteal disease. Data were combined from 557 patients treated with DCBs in the IN.PACT SFA and IN.PACT Japan randomized controlled trials, as well as the prespecified long lesion and chronic total occlusion imaging cohorts of IN.PACT Global. The goal was to examine the clinical, anatomic, and procedural factors using core laboratory–adjudicated data.

Using a regression analysis method, 28 clinical factors, 14 anatomic factors, and 82 procedural factors were evaluated.

According to Medtronic’s announcement, residual stenosis > 30%, Rutherford category > 3, and smaller preprocedure reference vessel diameter (RVD) were identified to be the only significant multivariable predictors of DCB failure.

Dr. Krishnan also remarked that the analysis demonstrated the importance of achieving maximal luminal gain. 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% CI, 2.32-13.85) and a 1.7-fold higher risk of binary restenosis (HR, 2.73; 95% CI, 1.60-4.65) through 12-month follow-up compared to patients with residual stenosis ≤ 30%.

Other findings through 12-month follow-up included the following:

• Rutherford class > 3 was associated with a significantly increased risk of CD-TLR (HR, 4.19; 95% CI, 1.68-10.46).
• Smaller preprocedure RVD was associated with a higher risk of binary restenosis (HR, 1.57; 95% CI, 1.01-2.46).
• Longer lesion length, severe calcification, and total occlusion were not statistically significant predictors of DCB outcomes.

Dr. Krishnan concluded in his TCT presentation, “This is the first large, empirically driven evaluation of DCB outcomes using a broad set of clinical, anatomical, and procedural predictors in a rigorous data set. What we can conclude is DCBs definitely work well across a wide range of clinical and anatomical scenarios. Patency can be optimized by procedural factors under the operator’s control—specifically, achieving a postprocedural residual stenosis < 30%.”