This new device consists of a novolimus releasing bioabsorbable polylactic acid platform that in vitro studies has shown equivalence to a Cypher stent. This device, also in vitro , showed a degradation time of one year and safety during post expansion, reaching 4.8 mm without fracturing. This is the first human trial and follow-up with different imaging modalities. We included 126 patients in 13 centers in Europe, New Zealand and Brazil with single de novo coronary lesions having a reference diameter between 2.75 and 3 mm and a length not exceeding 12 mm. The primary endpoint was late lumen loss at six months and secondary points (MACE) a combination of death, myocardial infarction related to the vesse, clinically justified revascularization, device thrombosis or evaluation by image parameters.
Late lumen loss by quantitative angiography was 0.21 ± 0.34 mm with a binary restenosis rate of 3.4%. All restenosis were focal over device edges. We observed an increase in vessel size of 16.8% (p <.001) and an increased device area at six months of 15.7% (p <.001) confirmed by both IVUS and OCT. There was an OCT platform coverage of 98.6%. MACE was 3.25% without spotting device thrombosis. Lumen loss in diabetic patients was similar to non-diabetics.
Conclusion: The study DESolveNx showed the safety and efficacy of the new device.
Alexandre Abizaid, MD, PHD.
2013-05-21
Original title: First report of results from the pivotal DESolveNx trial: 6-month clinical and multimodality imaging results