Drug-eluting stent implantation in patients with acute coronary syndrome - the Activity of Platelets after Inhibition and Cardiovascular Events: Optical Coherence Tomography (APICE OCT) study.

Abstract

AIMS:

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.

• Authors: Alaide Chieffo, Gill Louise Buchanan, Guido Parodi, Francesco Versaci, Renato Maria Bianchi, Renato Valenti, Salvatore Saccà, Annalisa Mongiardo, Simonetta Span, Angela Migliorini, Carmen Spaccarotella, Bernhard Reimers, David Antoniucci, Ciro Indolfi, Angela Ferrari, Akiko Maehara, Gary S Mintz, Antonio Colombo
• Journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (EuroIntervention) Vol. 10 Issue 8 Pg. 916-23 (Dec 2014) ISSN: 1969-6213 [Electronic] France
• PMID: 24974806 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Video-Audio Media)

Chemical References

• Immunosuppressive Agents
• Everolimus
• zotarolimus
• Sirolimus

Topics

• Acute Coronary Syndrome (etiology, surgery)
• Aged
• Coronary Restenosis (prevention & control)
• Coronary Stenosis (complications, pathology, surgery)
• Coronary Vessels (pathology)
• Drug-Eluting Stents
• Everolimus
• Female
• Humans
• Immunosuppressive Agents (therapeutic use)
• Male
• Middle Aged
• Neointima (pathology)
• Percutaneous Coronary Intervention
• Single-Blind Method
• Sirolimus (analogs & derivatives, therapeutic use)
• Tomography, Optical Coherence