EFFPAC 2-year safety and efficacy outcomes presented at EuroPcr.
EFFPAC trial 24-month safety results will be presented for the first time by Prof Ulf Teichgräber at EuroPcr 2019 in the Hot line/ Late breaking trials session, taking place in room 342 A, level 3 from 13:45 to 15:15.
The main objective of EFFPAC RCT was to assess the safety and effectiveness of luminor DCB vs. POBA, in the superficial femoral and popliteal arteries. The 12-months outcomes are all demonstrating high statistical significance versus POBA, being the best DCB outcomes at SFA:
- Primary endpoint: Late Lumen Loss (LLL) at 6 months: 0.14mm (vs 1.06mm in POBA group, p<0.001)
- Target Lesion Revascularization (TLR) at 12 months: 1.3% (vs 17.7% in POBA group, p<0.001)
- Primary Patency (PP) at 12 months: 90.3% (vs. 65.3% in POBA group, p<0.001)
- Rutherford stage improvement at 12- month: 90.6% Luminor group (p=0.006)
- No risk of death detected: RR=0.51
“At 12 months, luminor demonstrates to have the best efficacy outcomes with no higher incidence of all cause of death” said Prof Techgräber in a recent interview. “At EuroPCR we are going to present the 24-months outcomes and we are pretty sure that these good results are going to be maintained”.
The outstanding results of luminor DCB are proving that coating technology really matters therefore not all DCBs are the same
What differentiates luminor from other drug coated balloons is the proprietary coating nanotechnology, TransferTech. This technology uses paclitaxel in a microcrystalline structure and, together with the excipient, it is spread on the balloon by ultrasound spray pulse. The balloon surface is then covered with multiple and independent nanodrops layers. Such unique and innovative technology, provides a flexible coating, adapting to the balloon movement.
For further information of luminor and its clinical studies visit https://bit.ly/2C8pHsi