To our knowledge, no randomised study has compared rates of uncovered
stent struts in
everolimus (EES) vs. new-generation
zotarolimus-eluting (ZES-R)
stents in
acute coronary syndrome (ACS). The aim of our study was to evaluate the completeness of neointimal coverage with optical coherence tomography (OCT) in ACS patients treated with
drug-eluting stents (DES) comparing EES versus new-generation ZES-R.
METHODS AND RESULTS: All eligible ACS patients admitted to four Italian centres with a clinical indication for culprit lesion intervention were randomised 1:1 to EES or ZES-R. The primary study endpoint was the percentage of uncovered
stent struts evaluated by optical coherence tomography (OCT) at six months. Secondary endpoints were the percentage of malapposed
stent struts, percent neointimal
hyperplasia cross-sectional area (CSA) and
major adverse cardiac events (
MACE) at six months. A total of 60 patients were randomised to EES (n=29) or ZES-R (n=31). No differences were observed in baseline characteristics between the two groups. Overall, 31.7% presented with
STEMI, of which 68.4% were anterior. The other patients comprised 41.7%
NSTEMI and 26.7%
troponin-negative ACS. A mean of 1.3±0.6 lesions were treated per patient, with a mean of 1.3±0.5
stents per lesion. At 30 days there was one
sudden death. Six-month OCT analysis was performed in 25 lesions in the EES group and in 24 lesions in the ZES-R group. There was no difference in the primary endpoint of uncovered
stent struts between groups (EES 6.42% [3.27, 9.57] vs. ZES-R 7.07% [3.22, 10.92]; p=0.80). Furthermore, there were no differences between groups in the percentage of malapposed
stent struts, either with (EES 1.19% [0.34, 2.04] vs. ZES-R 0.85% [0.40, 1.30]; p=0.49) or without coverage (EES 1.06% [0.12, 2.01] vs. ZES-R 0.24% [0.05, 0.44]; p=0.09). Percent
neointima CSA was similar in both groups (EES 37.0% [18.6, 55.3] vs. ZES-R 26.6% [18.4, 34.8]; p=0.31). At six-month clinical follow-up, no additional patients died or suffered MI. There were four
MACE in the EES group and one in the ZES-R group.
CONCLUSIONS: In our study, in patients presenting with ACS, both EES and ZES-R had low percentages of malapposed and uncovered
stent struts at six-month OCT analysis.