Drug-Coated Balloon for De Novo Coronary Artery Lesions: A Systematic Review and Trial Sequential Meta-analysis of Randomized Controlled Trials

Table 1

The baseline characteristics of included randomized clinical trials.

Study, year

Sample size, DCB/control

Patients’ indication

Types of DCB

Bailout stenting

Control group

Male (%), DCB/control

Age

HBP (%), DCB/control,

DM (%), DCB/control

Maximum FU

Jadad scores

DCB

Control

BASKET-SMALL2, 2018 [18]

382/376

SVD

SQP

5.10%

PES/EES

77%/70%

85%/89%

32%/35%

12 months

3

BELLO, 2012 [12]

90/92

SVD

IN.PACT falcon

20.20%

PES

80%/77.2%

80%/81.5%

43.3%/38.0%

3 years

3

DEBUT, 2019 [10]

102/106

HRB

SQP

2%

BMS

62%/64%

87%/91%

26%/49%

3 years

3

Funatsu，2017 [20]

92/41

SVD

SQP

2.90%

POBA

78%/68%

84%/73%

48%/32%

6 months

3

Gobić, 2017 [19]

38/37

STEMI

SQP

7.30%

SES

70.7%/73%

31.7%/35.1%

4.9%/10.8%

6 months

3

Nishiyama, 2016 [21]

27/33

De novo

SQP

10%

EES

74.1%/72.7%

76.7%/90%

40.0%/43.3%

8 month s

3

PEPCAD-BIF, 2015 [22]

32/32

BIF-SVD

SQP

0%

POBA

75.0%/71.9%

NA

34.4%/37.5%

9 months

3

PEPCAD-NSTEMI, 2019 [9]

104/106

NSTEMI

SQP

14.60%

BMS/DES

66.3%/67.9%

78.7%/87.7%

26.9%/35.8%

9 months

3

PICCOLETO, 2010 [13]

28/29

SVD

Dior

34.50%

PES

78.6%/75.9%

75.0%/70.8%

37.9%/46.4%

9 months

3

RESTORE SVD China, 2018 [17]

116/114

SVD

Restore

4.00%

ZES

66.4%/77.2%

67.2%/75.4%

39.7%/42.1%

1 year

3

REVELATION, 2019 [11]

59/61

STEMI

Pantera Lux

18%

SES

87%/87%

30%/32%

13%/17%

9 months

3

Shin, 2019 [16]

20/20

HRB

SQP

0%

BMS

70.0%/75%

40%/45%

35%/25%

12 months

3

Drug-coated balloons investigated: SQP=SeQuent Please (B.Braun, Melsungen, Germany), In.Pact Falcon (Medtronic, Galway, Ireland), Pantera Lux (Biotronik, Berlin, Germany), Dior (Eurocor, Bonn, Germany), and Restore (Cardionovum, Bonn, Germany). BMS: bare-metal stent; DES: drug-eluting stent; EES: verolimus-eluting stent; FU: follow-up; HBR: patients at high bleeding risk; NSTEMI: non-ST-segment elevation myocardial infarction; PES: paclitaxel-eluting stent; POBA: plain old balloon angioplasty; BIF-SVD: side branch bifurcation lesion with small vessel disease; SES: sirolimus-eluting stents; STEMI: ST-segment elevation myocardial infarction; SVD: small vessel disease; ZES: zotarolimus-eluting stent; HBP: hypertension; DM: diabetes mellitus; NA: not available.