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.

Abstract

BACKGROUND:

Paclitaxel-eluting balloons (PEBs) are a promising alternative to drug-eluting stent (DES) in the treatment of coronary stenoses. The aim of our study was to compare the 9-month restenosis rates of a strategy of predilatation with PEB followed by bare-metal CoCr stent (PEB + BMS group) versus implantation of everolimus DES (DES group).

METHODS:

This randomized, single-center study planned to enroll 366 patients with stable angina (183 patients per arm) undergoing percutaneous coronary intervention of a de novo, native coronary artery stenosis ≤ 15 mm in length. Primary end point, in a noninferiority study design, was 9-month binary angiographic restenosis. A frequency-domain optical coherence tomography substudy investigated the percentage of uncovered stent struts per lesion, the percentage of malapposed/uncovered struts per lesion, and the percentage of net volume obstruction at 9-month follow-up among the first consecutive 30 patients enrolled in the PEB + BMS group.

RESULTS:

The study was prematurely halted after enrollment of 125 patients, 59 in the PEB + BMS group and 66 in the DES group, because of excess of ischemia-driven target lesion revascularization in the PEB + BMS group. When all the enrolled patients completed their follow-up, IDLTR rates were 14% in the PEB + BMS versus 2% in DES group (P = .001). Binary restenosis, either in-stent or in-segment, was significantly higher in the PEB + BMS compared with DES group (17% vs 3% [P = .01] and 25% vs 4% [P = .009] respectively). Frequency-domain optical coherence tomography demonstrated important neointimal regrowth in the PEB + BMS group, similar to historical BMS data.

CONCLUSION:

In the treatment of de novo coronary stenosis, a strategy of predilatation with PEB before BMS implantation was significantly inferior to implantation of an everolimus DES stent in terms of 9-month target lesion revascularization. Frequency-domain optical coherence tomography data confirm the lack of efficacy of this strategy.

• Authors: Francesco Liistro, Italo Porto, Paolo Angioli, Simone Grotti, Kenneth Ducci, Giovanni Falsini, Leonardo Bolognese
• Journal: American heart journal (Am Heart J) Vol. 166 Issue 5 Pg. 920-6 (Nov 2013) ISSN: 1097-6744 [Electronic] United States
• PMID: 24176449 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: © 2013.

Chemical References

• Everolimus
• Paclitaxel
• Sirolimus

Topics

• Aged
• Aged, 80 and over
• Angina, Stable (drug therapy)
• Angioplasty, Balloon, Coronary (adverse effects, methods)
• Coronary Angiography
• Coronary Restenosis (diagnostic imaging, epidemiology, therapy)
• Coronary Stenosis (diagnostic imaging, therapy)
• Coronary Vessels (pathology)
• Drug-Eluting Stents (adverse effects)
• Everolimus
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Paclitaxel (therapeutic use)
• Percutaneous Coronary Intervention (adverse effects, methods)
• Prospective Studies
• Prosthesis Design
• Sirolimus (analogs & derivatives, therapeutic use)
• Stents (adverse effects)
• Tomography, Optical Coherence
• Treatment Outcome