Does stent strut design impact clinical outcomes: comparative safety and efficacy of Endeavor Resolute versus Resolute Integrity zotarolimus-eluting stents

Clin Invest Med. 2015 Oct 7;38(5):E296-304. doi: 10.25011/cim.v38i5.25686.

Abstract

Percutaneous coronary intervention is the most commonly performed method of revascularizing obstructive coronary artery disease. The impact of stent strut design on clinical outcomes remains unclear. The Endeavour Resolute (ER-ZES) and the Resolute Integrity (RI-ZES) zotarolimus-eluting stents utilize identical polymers and anti-proliferative agents, differing only in their respective strut design. This study assessed the comparative safety and efficacy of these two stents in unrestricted contemporary real-world practice.

Methods: A total of 542 patients were identified, corresponding to 340 ER-ZES and 480 RI-ZES. The primary endpoint was major adverse cardiac events (MACE) defined by a composite of death, nonfatal myocardial infarction and stroke. Secondary endpoints included post-procedural length of stay, in-stent restenosis, target lesion revascularization, target vessel revascularization, coronary artery bypass grafting and stent thrombosis.

Results: MACE occurred in 3.2% of the ER-ZES cohort and 5.0% of the RI-ZES cohort (p= 0.43). Adjusted analysis utilizing propensity score-adjusted odds ratio for MACE, was 1.37 (95% CI 0.46-4.07, p=0.57). The mortality rate (0.9% ER-ZES vs. 1.9% RI-ZES, p=0.59), non-fatal MI (2.3% ER-ZES vs. 3.1% RI-ZES, p=0.75) and stroke (0.0% ER-ZES vs. 0.3% RI-ZES, p=0.85) were not different. Additionally, there was no difference in any of secondary outcomes.

Conclusions: The clinical performance and safety of both ER-ZES and RI-ZES were not statistically different, despite differences in stent strut design.

Publication types

  • Comparative Study

MeSH terms

  • Coronary Artery Disease / drug therapy*
  • Coronary Artery Disease / surgery*
  • Drug-Eluting Stents / standards*
  • Humans
  • Percutaneous Coronary Intervention / standards*
  • Sirolimus / administration & dosage
  • Sirolimus / analogs & derivatives*
  • Treatment Outcome

Substances

  • zotarolimus
  • Sirolimus