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)
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