Prospective randomized comparison of clinical and angiographic outcomes between everolimus-eluting vs. zotarolimus-eluting stents for treatment of coronary restenosis in drug-eluting stents: intravascular ultrasound volumetric analysis (RESTENT-ISR trial)

Eur Heart JPublished Randomised controlled trial

Authors' conclusion

Patients with first- and second-generation DES restenosis, both EES and ZES implantation were effective and safe in reducing neointima volume and late loss with a comparable rate of MACEs independent of cardiovascular risk factors.

Study context

Population
Patients aged 40–75 years with drug-eluting stent (DES) in-stent restenosis >50% (or within 5 mm of stent edges) with signs of ischaemia146 women · 158 men
Participants
304 patients
Comparison
Everolimus-eluting stent (EES) vs zotarolimus-eluting stent (ZES) for DES restenosis
  • EESn = 158
  • ZESn = 146reference
Primary endpoint
Neointima volume by IVUS
Follow-up
9 months
Methodological detailsprospective
  • Prospective

Primary result

As reported in the abstract

Neointima volume

P = 0.47

Further findings

Late lumen loss · 9 months · no significant difference

P = 0.57

Composite MACE (death, MI, stent thrombosis, TLR) · 3 years · comparable

P = 0.276

  • Composite MACE (death, myocardial infarction (MI), stent thrombosis, target lesion revascularization (TLR)): independent of de novo DES type, sex, age, BMI, DM, hypertension and dyslipidaemia

Original publication

Prospective randomized comparison of clinical and angiographic outcomes between everolimus-eluting vs. zotarolimus-eluting stents for treatment of coronary restenosis in drug-eluting stents: intravascular ultrasound volumetric analysis (RESTENT-ISR trial). Eur Heart J. Published 15 September 2016. doi:10.1093/eurheartj/ehw389

Summarised from the published abstract; every number is checked against it

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