# Abstract

 

## Background and Objectives This trial evaluated the safety and efficacy of the Genoss drug-eluting coronary stent. 

## Methods This study was a prospective, multicenter, randomized trial with a 1:1 ratio of Genoss drug-eluting stent (DES)™ and Promus Element™. Inclusion criteria were the presence of stable angina, unstable angina, or silent ischemia. Angiographic inclusion criteria were de novo coronary stenotic lesion with diameter stenosis >50%, reference vessel diameter of 2.5--4.0 mm, and lesion length ≤40 mm. The primary endpoint was in-stent late lumen loss at 9-month quantitative coronary angiography follow-up. Secondary endpoints were in-segment late lumen loss, binary restenosis rate, death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis during 9 months of follow-up. 

## Results We enrolled 38 patients for the Genoss DES™ group and 39 patients for the Promus Element™ group. In-stent late lumen loss at 9 months was not significantly different between the 2 groups (0.11±0.25 vs. 0.16±0.43 mm, p=0.567). There was no MI or stent thrombosis in either group. The rates of death (2.6% vs. 0%, p=0.494), TLR (2.6% vs. 2.6%, p=1.000), and TVR (7.9% vs. 2.6%, p=0.358) at 9 months were not significantly different. 

## Conclusion This first-in-patient study of the Genoss DES™ stent showed excellent angiographic outcomes for in-stent late lumen loss and major adverse cardiac events over a 9-month follow-up. # RESULTS Between March 2013 and April 2015, 85 patients were screened for enrollment in the study. Five patients did not meet inclusion criteria and a total of 80 patients were randomly assigned to the Genoss DES™ or Promus Element™ group at a 1:1 ratio. In the Genoss DES™ group, 2 patients were excluded as one patient did not receive stent implantation and the other patient had a protocol violation. In the Promus Element™ group, 1 patient was excluded owing to the patient's withdrawal from the study ([Figure 1](#)). <figure> <p><img src="" /></p> <figcaption>Flow chart of patient enrollment.<br /> DES = drug-eluting stent.</figcaption> </figure> Baseline clinical and angiographic characteristics are shown in [Tables 1](#) and [2](#), respectively. There were no significant differences in clinical characteristics including age and clinical diagnosis between the 2 groups ([Table 1](#)). Target vessels were not significantly different, but the left anterior descending artery was targeted more often in the Promus Element™ group. Stent overlap was performed in 8 (21.1%) patients in the Genoss DES™ group and in 3 (7.7%) patients in the Promus Element™ group ([Table 2](#)). ::::table-wrap

::: caption



##

##

## Baseline clinical characteristics

:::

![](<>)

```
               Genoss DES™ (n=38)   Promus Element™ (n=39)   p
```

______________________________________________________________________

Age (years) 64±8 63±8 0.591
Male 31 (81.6) 31 (79.5) 1.000
Diabetes 12 (31.6) 12 (30.8) 1.000
Hypertension 24 (63.2) 29 (74.4) 0.332
Hyperlipidemia 15 (39.5) 13 (33.3) 0.640
Current smoker 9 (23.7) 13 (33.3) 0.451
Diagnosis 0.549
Stable angina 17 (44.7) 19 (48.7)
Unstable angina 21 (55.3) 19 (48.7)
Silent ischemia 0 1 (2.6)

Data are shown as mean±standard deviation or number (%).

DES = drug-eluting stent.:::: ::::table-wrap
::: caption



##

##

## Angiographic and procedural characteristics

:::

![](<>)

```
                       Genoss DES™ (n=38)         Promus Element™ (n=39)   p
```

______________________________________________________________________

Target vessel 0.068
Left anterior descending 18 (47.3) 26 (66.7)
Left circumflex 4 (10.5) 6 (15.4)
Right coronary 16 (42.1) 7 (17.9)
AHA/ACC classification 0.089
A 4 (10.5) 7 (17.9)
B1 6 (15.8) 14 (35.9)
B2 10 (26.3) 8 (20.5)
C 18 (47.4) 10 (25.6)
Stent diameter (mm) 3.14±0.26 3.15±0.30 0.970
Stent length (mm) 25.5±8.6 24.1±5.0 0.395
Mean stent number 1.2 1.1 0.099
Stent overlap 8 (21.1) 3 (7.7) 0.114

Data are shown as mean±standard deviation or number (%).

ACC = American College of Cardiology; AHA = American Heart Association;
DES = drug-eluting stent.:::: Angiographic follow-up at 9 months was performed for all patients, and IVUS follow-up was performed in 35 (92%) patients in the Genoss DES™ group and in 37 (95%) patients in the Promus Element™ group. QCA results are shown in [Table 3](#). There were no significant differences in RVD. For the primary endpoint, in-stent late lumen loss at 9 months was not significantly different between the groups (0.11±0.25 mm for Genoss DES™ vs. 0.16±0.43 mm for Promus Element™, p=0.567) nor was in-segment late lumen loss (0.11±0.26 mm for Genoss DES™ vs. 0.15±0.43 mm for Promus Element™, p=0.558). Angiographic restenosis at 9 months was observed in 1 (2.6%) patient in the Genoss DES™ group and in 2 (5.1%) patients in the Promus Element™ group (p=1.000). IVUS minimal lumen area after stenting during the index procedure (6.95±1.98 vs. 7.47±2.47 mm^2^, p=0.272) and after 9 months (6.95±1.98 vs. 7.29±2.34 mm^2^, p=0.508) were not significantly different ([Table 4](#)). For clinical outcomes, there were no MI or stent thrombosis events during 9-month follow-up. One death occurred in the Genoss DES™ group due to aggravated renal function 6 months after the index procedure. However, the rate of death, MI, TLR, and TVR at 9 months were not significantly different ([Table 5](#)). ::::table-wrap
::: caption



##

##

## QCA analysis

:::

![](<>)

```
                            Genoss DES™ (n=38)   Promus Element™ (n=39)   p                          
```

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RVD (mm)\
Pre-procedure 3.24±0.41 3.12±0.43 0.199
Post-procedure 3.30±0.30 3.33±0.30 0.652
9-month follow-up 3.17±0.35 3.16±0.39 0.932
Minimal lumen diameter (mm)\
In-stent\
Pre-procedure NA NA NA
Post-procedure 2.95±0.35 3.03±0.30 0.269
9-month follow-up 2.84±0.42 2.87±0.56 0.743
In-segment\
Pre-procedure 0.83±0.29 0.88±0.45 0.572
Post-procedure 2.90±0.27 3.00±0.36 0.159
9-month follow-up 2.79±0.40 2.85±0.56 0.615
DS %\
In-stent\
Pre-procedure NA NA NA
Post-procedure 10.6±3.48 9.16±4.85 0.140
9-month follow-up 14.18±9.31 13.73±14.30 0.871
In-segment\
Pre-procedure 74.41±8.62 72.65±12.14 0.465
Post-procedure 12.10±3.93 10.12±4.94 0.056
9-month follow-up 15.46±9.39 14.54±14.08 0.738
Acute gain (mm)\
In-stent 1.79±0.40 1.82±0.36 0.742\
In-segment 1.74±0.39 1.78±0.38 0.579\
Late loss (mm)\
In-stent 0.11±0.25 0.16±0.43 0.567\
In-segment 0.11±0.26 0.15±0.43 0.558\
Lesion length (mm) 23.8±8.1 22.8±4.9 0.531\
Restenosis 1 (2.6) 2 (5.1) 1.000

Data are shown as mean±standard deviation or number (%).

DES = drug-eluting stent; DS = diameter stenosis; NA = not available;
QCA = quantitative coronary angiography; RVD = reference vessel
diameter.:::: ::::table-wrap
::: caption



##

##

## IVUS analysis results

:::

![](<>)

```
                           Genoss DES™ (n=35)   Promus Element™ (n=37)   p            
```

______________________________________________________________________

Minimal lumen area (mm^2^)\
Post-procedure 6.71±1.74 7.28±2.41 0.255
9-month follow-up 6.30±1.78 6.72±2.28 0.387
Minimal stent area (mm^2^)\
Post-procedure 6.90±1.77 7.47±2.47 0.272
9-month follow-up 6.95±1.98 7.29±2.34 0.508
EEM\
Post-procedure 14.87±3.23 14.91±4.40 0.963
9-month follow-up 15.42±3.27 14.74±3.90 0.423

Data are shown as mean±standard deviation.

DES = drug-eluting stent; EEM = external elastic membrane; IVUS =
intravascular ultrasound.:::: ::::table-wrap
::: caption



##

##

## Clinical outcomes

:::

![](<>)

```
                 Genoss DES™ (n=38)   Promus Element™ (n=39)   p       
```

______________________________________________________________________

Death 1 (2.6) 0 0.494\
Cardiac 0 0 1.000
Non-cardiac 1 (2.6) 0 0.494
MI 0 0 1.000\
TLR 1 (2.6) 1 (2.6) 1.000\
TVR 3 (7.9) 1 (2.6) 0.358\
Stent thrombosis 0 0 1.000

Data are shown as number (%).

DES = drug-eluting stent; MI = myocardial infarction; TLR = target
lesion revascularization; TVR = target vessel revascularization.::::


Extracted trial result:
Outcome: In-stent late lumen loss at 9 months (continuous)
Intervention: Genoss drug-eluting stent (DES)
Comparator: Promus Element
Intervention group size: 38
Intervention mean: 0.11
Intervention standard deviation: 0.25
Comparator group size: 39
Comparator mean: 0.16
Comparator standard deviation: 0.43