Elutax paclitaxel-eluting balloon followed by bare-metal stent compared with Xience V drug-eluting stent in the treatment of de novo coronary stenosis: a randomized trial
Selected in American Heart Journal by R. El Mahmoud
Liistro F, Porto I, Angioli P, Grotti S, Ducci K, Falsini G, Bolognese L.
Am Heart J 2013;166:920-6
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Latest contributionsAmsterdam Investigator–initiateD Absorb strategy all-comers trial Elutax paclitaxel-eluting balloon followed by bare-metal stent compared with Xience V drug-eluting stent in the treatment of de novo coronary stenosis A multicenter randomized comparison of paclitaxel-coated balloon catheter with conventional balloon angioplasty in patients with bare-metal stent r...
The study aims to compare the 9-month restenosis rates of a strategy of predilatation with Paclitaxel-eluting balloons (PEB) followed by bare-metal CoCr stent (PEB + BMS group) versus implantation of everolimus DES (DES group).
- A randomised, single-center study with initially 366 patients with stable angina (183 patients per arm)
- PCI of a de novo, native coronary artery stenosis ≤15 mm in length.
- A noninferiority study design, where primary end-point was 9-month binary angiographic restenosis.
- A frequency-domain optical coherence tomography (FDOCT) substudy investigated the malapposed/ uncovered struts and the percentage of net volume obstruction at 9-month FU among the first 30 patients enrolled in the PEB + BMS group.
- The study was prematurely stopped after enrollment of 125 patients (59 in PEB + BMS group and 66 in DES group, because of excess of ischemia-driven TLR in PEB + BMS group.
- TLR rate was 14% in PEB + BMS versus 2% in DES group (P = 0.001).
- Binary restenosis, either in-stent or in-segment, was significantly higher in PEB + BMS compared with DES group (17% vs 3% [P =0.01] and 25% vs 4% [P =0.009] respectively).
- Frequency-domain OCT demonstrated important neointimal regrowth in the PEB + BMS group.
- Data suggest a lack of efficacy by second-generation Elutax PEB prior to BMS implantation
- Results can be compared with the data of PEPCAD III study comparing the Coroflex BMS with SeQuent Please PEB vs Cypher sirolimus-eluting stent where PEB-treated patients showed 3 times higher in-stent late lumen loss.
- Nevertheless, the study was prematurely stopped which can reduce the power and the applicability of the results.
- Biological studies demonstrating the role of pro-restenotic gene activation in the first 3 weeks after stent implantation explain more efficiency of a DES associated with a more delayed drug release, whereas paclitaxel is generally released by PEB in one time.
- The increase in PEB technologies with drug carriers capable to release drug with more favorable bioavailability in the vessel is needed for future studies.