Clinical Investigation
Interventional Cardiology
ComparisOn of neointimal coVerage betwEen zotaRolimus-eluting stent and everolimus-eluting stent using Optical Coherence Tomography (COVER OCT)

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Background

Data on strut surface coverage of second-generation drug-eluting stents (DES) are limited. We investigated stent strut coverage of resolute zotarolimus-eluting stent (ZES-R) or everolimus-eluting stent (EES) at 9 months after implantation using optical coherence tomography (OCT).

Methods

ComparisOn of neointimal coVerage betwEen zotaRolimus-eluting stent and everolimus-eluting stent using Optical Coherence Tomography (COVER OCT) is a prospective, randomized, multicenter trial comparing ZES-R to EES using OCT at 9 months after stent implantation. The primary end point was the rate of stent strut coverage at 9 months.

Results

A total of 51 patients were randomized to receive either ZES-R (ZES-R group) or EES (EES group), and 47 stents (24 ZES-R and 23 EES) in 44 of 51 patients were evaluated by OCT both immediately after stent implantation and at 9 months. The neointimal thickness was not significantly different between the 2 groups at 9 months (ZES-R vs EES: 139 ± 58 vs 124 ± 42 μm, P = .31). The mean percentages of uncovered stent struts were 3.3% for ZES-R versus 3.4% for EES at 9 months (P = .51). The proportions of malapposed struts immediately after stent implantation (P = .89) and at 9-month follow-up (P = .34) were 0.8% and 0.7% for ZES-R versus 1.0% and 0.1% for EES, respectively. Thrombi were documented in 1 stent (1 [4.2%] in ZES-R vs 0 [0%] in EES).

Conclusion

According to the sequential OCT evaluation, ZES-R and EES showed comparable neointimal thickness and the rate of uncovered stent strut at 9 months after stent implantation.

Section snippets

Study design and patients

ComparisOn of neointimal coVerage betwEen zotaRolimus-eluting stent and everolimus-eluting stent using OCT (COVER OCT) is a prospective, multicenter study to investigate the vascular healing pattern of EES (Xience V, Abbott Vascular, Santa Clara, CA) or ZES-R (Endeavor Resolute, Medtronic CardioVascular, Santa Rosa, CA) using OCT at 9 months after implantation (Figure 1). This trial was performed at 3 university hospitals in Korea.

The study protocols for the current report were separately

Patient characteristics

From December 2008 to August 2009, 51 patients who were enrolled to the study protocol were randomly assigned to an EES group (28 stents in 26 patients) or a ZES-R group (27 stents in 25 patients) (Figure 1). Among them, 7 patients were excluded because they refused to receive a follow-up angiography at 9 months. Baseline patient characteristics between the 2 groups were compared and presented in Table I. Half of the patients had ACS (5 patients [11.4%] with ST-elevation myocardial infarction

Discussion

This study was a prospective randomized trial comparing the in vivo vascular response at 9 months between ZES-R and EES using serial OCT examination. The strength of the current study is that intravascular imaging with OCT was sequentially performed on the same stents immediately after stent implantation and at 9 months after stent implantation. Our study demonstrated that the rate of strut stent coverage was similar between the 2 second-generation DESs at 9 months after stent implantation. In

Conclusion and clinical implications

This is the first prospective randomized study to compare the in vivo vascular response at 9 months between ZES-R and EES using sequential OCT examination. Our study demonstrated that strut stent coverage was comparable between the 2 second-generation DESs at 9 months after stent implantation. The rates of malapposition and thrombus were not different and quite low with both stents. This study suggested that vascular responses to ZES-R and EES at 9 months might be similarly favorable compared

Acknowledgements

The authors thank Hyun Sun Lim, PhD, of the Medical Research Support Section at Yonsei University, for statistical support.

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Clinical trial registration information: Unique identifier: NCT00894062 (COVER OCT).

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