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Feasibility

Feasibility

Objective

The objective of this study was to assess the non-inferiority, in terms of anti-restenotic efficacy, of  YUKON Choice PC and YUKON Choice (Polymer Free) stents compared with permanent polymer Rapamycin eluting (PP; Cypher) stent.

Methods and Results

Patients with de novo coronary lesions in native vessels were randomly assigned to receive a YUKON Choice PC, a YUKON Choice (polymer free) or a PP stent. The primary endpoint was in-stent late lumen loss at follow-up angiogram.

A total of 605 patients were enrolled: 202 patients received YUKON Choice PC, 202 were treated with PP stents and 201 received YUKON Choice (polymer free). Repeat angiography was available for 492 patients (81.3%). Mean late lumen loss at 6-8-month angiographic follow up was 0.17 ± 0.45 mm in the YUKON Choice PC group, 0.23 ± 0.46 mm in the PP cohort and 0.47 ± 0.56 mm in the YUKON Choice (polymer free) group. The YUKON Choice PC met pre-specified criteria for non-inferiority (p<0.001) whereas the YUKON Choice (polymer free) did not (p=0.94). There were no differences in safety outcomes.

Conclusion

Both YUKON Choice PC  and YUKON Choice (polymer free) have a 1-year safety profile similar to that of the PP stent. Whereas the YUKON Choice (polymer free) provided an inferior efficacy, the YUKON Choice PC is at least as effective as the PP stent in terms of anti-restenotic efficacy.