Cardiol Res

Cardiology Research, ISSN 1923-2829 print, 1923-2837 online, Open Access

Article copyright, the authors; Journal compilation copyright, Cardiol Res and Elmer Press Inc

Journal website https://www.cardiologyres.org

Original Article

Volume 9, Number 5, October 2018, pages 284-292

Deflated Balloon-Facilitated Direct Stenting in Primary Angioplasty (The DBDS Technique): A Pilot Study

Figure 2. RCA total occlusion treated with the DBDS technique. (a) Complete thrombotic occlusion of proximal RCA with no distal flow (TIMI 0). (b) After wiring, a deflated balloon is gently crossed beyond the lesion and pulled back. (c) Direct stent placement is done after visualization of the distal end of lesion (≥ TIMI grade 1 flow achieved by DBDS technique). (d) Final result with a TIMI flow of 3 after stenting. RCA: right coronary artery; TIMI: thrombolysis in myocardial infarction.

**Table 1.** Patient Characteristics
	DS group (n = 336)	PD group (n = 118)	P value
Values shown represent numbers (percentages), except where otherwise noted. DS: direct stenting; PD: pre-dilatation; BMI: body mass index; CAD: coronary artery disease; MI: myocardial infarction; PCI: percutaneous coronary intervention; LVEF: left ventricular ejection fraction.
Age (years), mean ± SD	53.9 ± 10	52.8 ± 11	0.31
Male sex	264 (78.5)	95 (80.5)	0.65
BMI, mean ± SD	26.5 ± 6.2	25.9 ± 6.7	0.37
Diabetes	97 (28.8)	44 (37.2)	0.08
Hypertension	207 (61.6)	68 (57.6)	0.44
Dyslipidemia	131 (38.9)	42 (35.5)	0.51
Current smoker	151 (45)	71 (60.1)	0.004
Family history of CAD	41 (12.2)	16 (13.5)	0.70
Prior MI	24 (7.1)	10 (8.4)	0.63
Prior PCI	9 (2.6)	4 (3.3)	0.58
LVEF, mean ± SD	39.9 ± 6.4	38.2 ± 7.3	0.01

Table 1. Patient Characteristics

DS group (n = 336)

PD group (n = 118)

P value

Values shown represent numbers (percentages), except where otherwise noted. DS: direct stenting; PD: pre-dilatation; BMI: body mass index; CAD: coronary artery disease; MI: myocardial infarction; PCI: percutaneous coronary intervention; LVEF: left ventricular ejection fraction.

Age (years), mean ± SD

53.9 ± 10

52.8 ± 11

0.31

Male sex

264 (78.5)

95 (80.5)

0.65

BMI, mean ± SD

26.5 ± 6.2

25.9 ± 6.7

0.37

Diabetes

97 (28.8)

44 (37.2)

0.08

Hypertension

207 (61.6)

68 (57.6)

0.44

Dyslipidemia

131 (38.9)

42 (35.5)

0.51

Current smoker

151 (45)

71 (60.1)

0.004

Family history of CAD

41 (12.2)

16 (13.5)

0.70

Prior MI

24 (7.1)

10 (8.4)

0.63

Prior PCI

9 (2.6)

4 (3.3)

0.58

LVEF, mean ± SD

39.9 ± 6.4

38.2 ± 7.3

0.01

**Table 2.** Procedural Characteristics and Outcomes
	DS group (n = 336)	PD group (n = 118)	P value
Values shown represent numbers (percentages), except where otherwise noted. DS: direct stenting; PD: pre-dilatation; LAD: left anterior descending artery; LCX: left circumflex artery; RCA: right coronary artery; TIMI: thrombolysis in myocardial infarction. ^‡No-reflow was seen in the DBDS subset. Bail-out Gp IIb/IIIa inhibitor use. *Excluding stent cost. ^§Contrast media Visipaque (GE Healthcare, Chicago, IL, USA) was used in all cases.
Door-to-balloon time (min)	57 ± 18	59 ± 17	0.29
Radial access	329 (98)	115 (97.4)	0.77
Infarct related artery
Left main	4 (1.2)	2 (1.6)	0.67
LAD/diagonal	156 (46.4)	57 (48.3)	0.72
LCX/marginal	57 (16.9)	17 (14.4)	0.51
RCA	119 (35.4)	42 (35.6)	0.97
Multi-vessel disease	89 (26.4)	37 (31.3)	0.3
TIMI 3 flow	325 (96.7)	109 (92.3)	0.04
Procedural complications	2 (0.6)	9 (7.6)	< 0.001
No-reflow	1 (0.29)^‡	3 (2.5)	0.02
Abrupt closure	0 (0)	2(1.7)	0.01
Dissection	0 (0)	3 (2.5)	0.003
Stent length (mm)	24.15 ± 6.35	25.1 ± 5.5	0.14
Stent diameter (mm)	2.88 ± 0.28	2.93 ± 0.26	0.08
Multiple stents used	47 (13.9)	18 (15.2)	0.73
Gp IIb/IIIa inhibitors*	14 (4.1)	31 (26.2)	< 0.001
Contrast volume^§ (mL)	112 ± 16	123 ± 18	< 0.001
Procedural time	33 ± 19	41 ± 17	< 0.001
Fluoroscopy time	6.2 ± 3.4	7.8 ± 32	< 0.001
Procedural cost** (dollars)	310 ± 45	402 ± 56	< 0.001

Table 2. Procedural Characteristics and Outcomes

DS group (n = 336)

PD group (n = 118)

P value

Values shown represent numbers (percentages), except where otherwise noted. DS: direct stenting; PD: pre-dilatation; LAD: left anterior descending artery; LCX: left circumflex artery; RCA: right coronary artery; TIMI: thrombolysis in myocardial infarction. ^‡No-reflow was seen in the DBDS subset. *Bail-out Gp IIb/IIIa inhibitor use. **Excluding stent cost. ^§Contrast media Visipaque (GE Healthcare, Chicago, IL, USA) was used in all cases.

Door-to-balloon time (min)

57 ± 18

59 ± 17

0.29

Radial access

329 (98)

115 (97.4)

0.77

Infarct related artery

Left main

4 (1.2)

2 (1.6)

0.67

LAD/diagonal

156 (46.4)

57 (48.3)

0.72

LCX/marginal

57 (16.9)

17 (14.4)

0.51

RCA

119 (35.4)

42 (35.6)

0.97

Multi-vessel disease

89 (26.4)

37 (31.3)

0.3

TIMI 3 flow

325 (96.7)

109 (92.3)

0.04

Procedural complications

2 (0.6)

9 (7.6)

< 0.001

No-reflow

1 (0.29)^‡

3 (2.5)

0.02

Abrupt closure

0 (0)

2(1.7)

0.01

Dissection

0 (0)

3 (2.5)

0.003

Stent length (mm)

24.15 ± 6.35

25.1 ± 5.5

0.14

Stent diameter (mm)

2.88 ± 0.28

2.93 ± 0.26

0.08

Multiple stents used

47 (13.9)

18 (15.2)

0.73

Gp IIb/IIIa inhibitors*

14 (4.1)

31 (26.2)

< 0.001

Contrast volume^§ (mL)

112 ± 16

123 ± 18

< 0.001

Procedural time

33 ± 19

41 ± 17

< 0.001

Fluoroscopy time

6.2 ± 3.4

7.8 ± 32

< 0.001

Procedural cost** (dollars)

310 ± 45

402 ± 56

< 0.001

**Table 3.** Clinical Outcomes
	DS group (n = 336)	PD group (n = 118)	P value
Values shown represent numbers (percentages), except where otherwise noted. DS: direct stenting; PD: pre-dilatation; LVEF: left ventricular ejection fraction; PCI: percutaneous coronary intervention; MI: myocardial infarction; TLR: target lesion revascularization; MACE: major adverse cardiac events. ST-segment resolution > 50% after PCI. *Composite of cardiac death, myocardial infarction and target lesion revascularization.
In-hospital outcomes
LVEF at discharge	49.2 ± 8.8	48.9 ± 9.2	0.75
Cardiogenic shock	27 (8)	12 (10.1)	0.47
Ventricular fibrillation	3 (0.9)	2 (1.7)	0.47
Stroke	1 (0.3)	0 (0)	0.55
All-cause mortality	2 (0.6)	2 (1.7)	0.27
ST-segment resolution*	288 (85.7)	84 (71.1)	< 0.001
30 day outcomes
Total death	3 (0.9)	3 (2.5)
Cardiac death	1 (0.3)	2 (1.7)	0.10
MI	4 (1.2)	4 (3.3)	0.11
TLR	3 (0.9)	5 (4.2)	0.01
Stent thrombosis	1 (0.3)	1 (0.8)	0.43
MACE**	8 (2.4)	11 (9.3)	0.02

Table 3. Clinical Outcomes

DS group (n = 336)

PD group (n = 118)

P value

Values shown represent numbers (percentages), except where otherwise noted. DS: direct stenting; PD: pre-dilatation; LVEF: left ventricular ejection fraction; PCI: percutaneous coronary intervention; MI: myocardial infarction; TLR: target lesion revascularization; MACE: major adverse cardiac events. *ST-segment resolution > 50% after PCI. **Composite of cardiac death, myocardial infarction and target lesion revascularization.

In-hospital outcomes

LVEF at discharge

49.2 ± 8.8

48.9 ± 9.2

0.75

Cardiogenic shock

27 (8)

12 (10.1)

0.47

Ventricular fibrillation

3 (0.9)

2 (1.7)

0.47

Stroke

1 (0.3)

0 (0)

0.55

All-cause mortality

2 (0.6)

2 (1.7)

0.27

ST-segment resolution*

288 (85.7)

84 (71.1)

< 0.001

30 day outcomes

Total death

3 (0.9)

3 (2.5)

Cardiac death

1 (0.3)

2 (1.7)

0.10

4 (1.2)

4 (3.3)

0.11

TLR

3 (0.9)

5 (4.2)

0.01

Stent thrombosis

1 (0.3)

1 (0.8)

0.43

MACE**

8 (2.4)

11 (9.3)

0.02