Drug-Coated Balloon-Only Strategy for De Novo Coronary Artery Disease: A Meta-analysis of Randomized Clinical Trials

Table 1

Main characteristics of the included trials.

Trial/first author	Year	Indication	No. of patients ()	DCB type	Control group	Follow-up, months	Primary endpoint	Definition of MACE	Bailout stenting (%)
BABILON [13]	2014	Bifurcation lesions	108	SeQuent Please	2nd-DES/BMS	9 (angiographic); 24 (clinical)	LLL	Death, MI, TLR	7.8
BASKET-SMALL 2 [14–16]	2018	Small vessel disease	758	SeQuent Please	2nd-gen DES	6 (angiographic); 36 (clinical)	MACE	Cardiac death, MI, TVR	5.1
BELLO [17–19]	2012	Small vessel disease	182	IN.PACT Falcon	1st-gen DES	6 (angiographic); 36 (clinical)	LLL, MACE	Death, MI, TVR	20.2
BEYOND [20]	2020	Bifurcation lesions	222	Bingo	POBA	9 (angiographic); 9 (clinical)	TLS	Death, MI, stroke, TVR	0
BIO-RISE CHINA [21]	2022	Small vessel disease	212	Biolimus A9 (BA9)	POBA	9 (angiographic); 12 (clinical)	LLL	Death, MI, revascularization	2.8
DEBUT [22]	2019	High bleeding risk	208	SeQuent Please	BMS	9 (clinical)	MACE	Cardiac death, MI, TLR	2.0
Funatsu et al. [23]	2017	Small vessel disease	133	SeQuent Please	POBA	6 (angiographic); 6 (clinical)	TVF	Cardiac death, MI, TVR	2.9
Gobić et al. [24]	2017	De novo lesions (STEMI)	78	SeQuent Please	2nd-gen DES	6 (angiographic); 6 (clinical)	MACE, LLL	Cardiac death, MI, TLR, thrombosis	7.3
Nishiyama et al. [25]	2016	De novo lesions	60	SeQuent Please	2nd-gen DES	8 (angiographic); 8 (clinical)	TLR	NR	10.0
PEPCAD-BIF [26]	2016	Bifurcation lesions	64	SeQuent Please	POBA	9 (angiographic); 9 (clinical)	LLL	NR	0
PEPCAD China SVD [27]	2023	Small vessel disease	270	SeQuent Please	POBA	9 (angiographic); 12 (clinical)	LLL	Death, MI, revascularization	2.1
PEPCAD-NSTEMI [28]	2020	De novo lesions (NSTEMI)	210	SeQuent Please	BMS/2nd-DES	9 (clinical)	TLF	Death, MI, stroke, revascularization	14.6
PICCOLETO [29]	2010	Small vessel disease	60	Dior	1st-gen DES	6 (angiographic); 9 (clinical)	DS%	Death, MI, TLR	34.5
PICCOLETO II [30, 31]	2020	Small vessel disease	232	Elutax SV/Emperor	2nd-gen DES	6 (angiographic); 36 (clinical)	LLL	Cardiac death, MI, TLR	6.7
RESTORE SVD China [32, 33]	2018	Small vessel disease	230	Restore	2nd-gen DES	9 (angiographic); 24 (clinical)	DS%	Cardiac death, MI, TLR	5.2
REVELATION [34, 35]	2019	De novo lesions (STEMI)	120	Pantera Lux	2nd-gen DES	9 (angiographic); 24 (clinical)	FFR	Cardiac death, MI, TLR	18.0
Shin et al. [36]	2019	High bleeding risk	40	SeQuent Please	BMS	9 (angiographic); 12 (clinical)	LLL	NR	0
Yu et al. [37]	2021	De novo lesions	170	SeQuent Please	2nd-gen DES	9 (angiographic); 12 (clinical)	LLL MACE	Cardiac death, MI, TLR	2.4

Abbreviations: BMS: bare metal stent; DCB: drug-coated balloon; DES: drug-eluting stent; DS%: percentage diameter stenosis; FFR: fractional flow reserve; MACE: major adverse cardiovascular events; LLL: late lumen loss; MI: myocardial infarction; NR: not reported; NSTEMI: non-ST-segment elevation; POBA: plain-old balloon angioplasty; STEMI: ST-segment elevated myocardial infarction; TLF: target lesion failure; TLR: target lesion revascularization; TLS: target lesion stenosis; TVF: target vessel failure; TVR: target vessel revascularization.