In patients with symptomatic peripheral vascular disease, the paclitaxel coated balloon showed superior efficacy at 3 years compared to the conventional balloon, in addition to very good results at one year when tested in the real world outside strict trial inclusion/exclusion criteria.

Both the IN.PACT SFA trial and the IN.PACT SFA global registry showed very good results with the paclitaxel coated balloon and the authors are attempting not just to show these results, but also to separate them from class effect. Not all drug coated balloons are the same and each of them should get tested for their particular outcomes in pertinent studies.

At present, the only drug coated balloons (DCB) approved by the FDA to treat vascular peripheral disease are the IN.PACT Admiral (Medtronic) and the Lutonix (Bard Peripheral Vascular).

For the IN.PACT SFA trial, 331 patients with severe symptomatic lesions up to 18 cm long in the superficial femoral artery (Rutherford class 2 to 4) were randomized to receiving IN.PACT Admiral DCB (n=220) vs. standard percutaneous transluminal angioplasty (PTA) (n=111).

At 3 years, DCB primary patency was superior to that of conventional PTA.

DCB primary patency: 69.5%

Standard PTA: 45.1%

[p<0.001]

Similarly, ischemia driven TLR rate was lower:

DCB primary patency: 15.2%

Standard PTA: 31.1%

[p=0.002]

As for safety, there were no differences in global adverse events rate but, separately, all-cause death resulted higher in the DCB group.

All cause death

DCB primary patency: 10.9%

Standard PTA: 1.9%

[p=0.006]

Death occurred at median of 1.8 years after procedure and, according to the authors, it is highly unlikely any of these deaths be associated to the device.

Even though at 3 years the six minute walk test resulted similar between the groups, those receiving DCB reached this functional level with 43% less reinterventions.

For the IN.PACT global registry, freedom form TLR was reported at one year in 92.6% despite the fact that among its 1,406 patients, many would had never been eligible for a randomized study, due to their complex lesions. This speaks of safety and efficacy in the real world.

For the IN.PACT global registry, provisional stent rate was 24%, which should be added to procedural cost.

Conclusion

These two presentations contribute with evidence in favor of paclitaxel DCBs in the superficial femoral.

Original Title: IN.PACT SFA randomized trial y IN.PACT SFA Global Registry

Reference: Krishnan P. VIVA 2016. Las Vegas, NV.

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