Coronary drug-coated balloons: Current evidence and emerging trends

Table 1 Important points to consider for using drug-coated balloon implantation

Guide catheter support: Proper guide catheter support or use of guide catheter extension to ensure DCB delivery in one attempt
Optimal lesion preparation: Non-compliant/scoring balloon/debulking with rota-ablation if needed
Device delivery: Quick and smooth delivery of DCB to the target site
Deployment: Prolonged inflation of a fully inflated balloon of the correct size
End results: < 30% residual stenosis; TIMI flow > 3; absence of flow limiting dissections

DCB: Drug coated balloon; TIMI: Thrombolysis in myocardial infarction.

Table 2 Trials of drug-coated balloon in various clinical settings (n)

Trial	Setting	Numbers of patients	Design	Primary end points	Secondary endpoints
PACCOCATH ISR, Scheller et al[24], 2006	ISR	52	DCB vs POBA in BMS ISR	LLL: 0.003 ± 0.48 mm vs 0.74 ± 0.86 mm in 6 months	Binary stenosis: 5% vs 43% in 6 months	TLR: 0% vs 23%		ST: 0% vs 0%
PEPCAD II ISR, Unverdorben et al[36], 2009	ISR	131	DCB vs PES in BMS ISR	LLL: 0.17 ± 0.42 mm vs 0.38 ± 0.61 mm in 6 months	Binary stenosis: 7% vs 20% in 36 months	TLR: 6.3% vs 15.4% in 36 months		ST: 0% vs 0%
PATENE-C, Scheller et al[49], 2016	ISR	61	PCSB vs USB in BMS ISR	LLL: 0.17 ± 0.40 mm vs 0.48 ± 0.51 mm in 6 months	Binary stenosis: 7% vs 41% in 12 months	TLR: 3% vs 32% in 36 months		ST: 0% vs 0%
PEPCAD DES, Rittger et al[50], 2012; Rittger et al[51], 2012	ISR	110	DCB vs POBA	LLL: 0.43 ± 0.61 mm vs 1.03 ± 0.77 mm in 6 months	Binary stenosis: 17.2% vs 58.1% in 36 months	TLR: 19.4% vs 36.8% in 36 months		ST: 1% vs 4%
ISAR DESIRE-3, Byrne et al[37], 2013; Giacoppo et al[38], 2013	ISR	402	DCB vs PES vs POBA	DS %: 38% in DCB vs 37.4% in PES vs 54.1% in POBA in 6-8 months	NA	TLR: 22.1% in DCB vs 13.5% in PES; 43.5% in POBA vs 33.3% in DCB; 24.2% in PES vs 50.8% POBA		ST: 1% vs 1% vs 0% (12 months); 1% vs 2% vs 0% (36 months)
ISAR DESIRE 4, Kufner et al[52], 2017	ISR	252	DCB vs SB-DCB	DS %: 40.4 ± 21.4% vs 35 ± 16.8 in 6-8 months	Binary stenosis: 32.0% vs 18.5%	TLR: 21.8% vs 16.2% in 12 months		ST: 0% vs 0% in 12 months
PICCOLETO, Cortese et al[53], 2010	Small vessel disease	57	PCB vs DES in small vessel disease	DS %: 43.6% vs 24.3%	MACE: 35.7% vs 13.8% in 6-9 months
SeQuent SVD registry, Cortese et al[54], 2012	Small vessel disease	420 vs 27	PCB	TLR: 3.6% vs 4%	MACE: 4.7% vs 4.0% in 9 months
BELLO, Latib et al[31], 2012	Small vessel disease	182	PEB vs PES	LLL: 0.08 ± 0.38 mm vs 0.29 ± 0.44 mm in 6-36 months	MACE: 10% vs 16%; 14.4% vs 30.4%	Restenosis rate: 10% vs 14.6%		TLR: 4.4% vs 7.6%
PEPCAD I, Unverdorben et al[29], 2015	Small vessel disease	118	DCB	LLL: 0.16 ± 0.38 mm with DCB vs 0.62 0.73 mm in DCB + BMS 6 months	6.1% (DCB) vs 37.5% in DCB + DCB	6% in DCB vs 45% in DCB + BMS at 36 months		TLR: 4.9% vs 28.1% at 36 months
BASKET-SMALL 2, Jeger et al[34], 2018	Small vessel disease	758	DCB vs DES	MACE: 7.5% vs 7.3% at 12 months	MACE: 15% vs 15% at 36 months
PICCOLETO II Cortese et al[54], 2020	Small vessel disease	232	DCB vs EES	LLL: 0.04% vs 0.17% in 6-12 months	MACE: 5.6 vs 7.5%
FALCON, Widder et al[55], 2015	De novo lesions	326	DCB	TLR: -4.9% at 12 months	MACE: 8% at 12 months
DEBUT, Rissanen et al[45], 2017	High bleeding risk	208	DCB vs BMS	MACE: 1% vs 14%, at 9 months	TVR: 0% vs 6% at 9 months
FALCON, Widder et al[55], 2019	ISR	405	DCB	TLR: -7.5% at 12 months	MACE: -11.1% at 12 months
DEBIUT, Stella et al[41], 2012	Bifurcation	20	PCB in SB and MB plus BMS in MB, BMS in MB, PES in MB	LLL in proximal MB, distal MB and SB were lowest in PES arm	Binary restenosis rates: -24.2%, 28.6%, and 15%		MACE rates: -20%, 29.7%, and 17.5%
PEPCAD V, Mathey et al[56], 2011	Bifurcation	28	DCB in SB and MB followed by BMS in MB	Procedural success in 100%	LLL at 9 months -0.38 ± 0.46 mm MB and 0.21 ± 0.48 mm in SB; binary restenosis rates -3.8% in MB and 7.7% in SB
Herrador et al[40], 2012	Bifurcation	100	DES in MB, PCB in SB vs DES in MB, POBA in SB	LLL in SB: 0.09 ± 0.4 mm vs 0.40 ± 0.5 mm at 12 months	MACE: 11% vs 24%; TLR: 12% vs 22%
BABILON, López Mínguez et al[42], 2014	Bifurcation	108	BMS in MB, PCB in SB vs DES in MB	LLL in MB: 0.31 ± 0.48mm vs 0.16 ± 0.38 mm; LLL in SB: -0.03 ± 0.51 mm vs 0.04 ± 0.76 mm at 9 months	MACE: 17.3% vs 7.1%; TLR: 15.4% vs 7.6%
PEPCAD-BIF, Kleber et al[44], 2016	Bifurcation	64	DCB vs POBA in SB	LLL in SB: 0.13 ± 0.51 mm	Re-stenosis rate: 6% vs 26%
DCB-BIF, Gao et al[57], 202	Bifurcation	784	DES in MB, DCB vs NCB in SB	MACE: 7.2% vs 12.5%; P = 0.013	MACE without periprocedural MI: -2.6% vs 5.1%; target vessel MI: 5.6% vs 10.9%

ISR: In-stent restenosis; PEPCAD: Peptide coassembly design; DCB: Drug coated balloon; LLL: Late lumen loss; TLR: Target lesion revascularization; ST: Stent thrombosis; PCSB: Paclitaxel coated scoring balloon; USB: Uncoated scoring balloon; POBA: Plain old balloon angioplasty; PES: Paclitaxel eluting stent; DS: Percent diameter stenosis; NA: Not applicable; MB: Main branch; SB: Side branch; MACE: Major adverse cardiac events; EES: Everolimus eluting stent; PCB: Paclitaxel coated balloon; BMS: Bare metal stent; DES: Drug eluting stent; TVR: Target vessel revascularization.