Table 1.
Characteristics, Interventional Strategies, and Follow‐Up of the Included Trials
| Trial (Reference No.) | Year | Indication | Drug‐Coated Balloon Type | Control Group | Patients (n) | Clinical Follow‐Up (months) | Angiographic Follow‐Up (months) | Primary Outcome | Reference Vessel Diameter (mm) | Bailout Stenting in DCB Arm (%) |
|---|---|---|---|---|---|---|---|---|---|---|
| PICCOLETO II24 | 2019 | Small‐vessel disease | Elutax SV/Emperor | Second‐generation DES | 118/114 | 6 | 6 | Late lumen loss | 2.2/2.2 | 6.8 |
| RESTORE CVD10 | 2019 | Small‐vessel disease | Restore | Second‐generation DES | 116/114 | 12 | 9 | Diameter stenosis | 2.4/2.4 | 5.2 |
| BASKET‐SMALL 211 | 2019 | Small‐vessel disease | SeQuent Please | Second‐generation DES | 382/376 | 12 | NR | MACE | NR | NR |
| Funatsu et al25 | 2017 | Small‐vessel disease | SeQuent Please | POBA | 92/41 | 6 | 6 | TVF | 2.0/2.0 | 2.9 |
| BELLO26, 27 | 2012/2015 | Small‐vessel disease | IN.PACT Falcon | First‐generation DES | 90/92 | 36 | 6 | Late lumen loss | 2.4/2.4 | 20.2 |
| PICCOLETO22 | 2010 | Small‐vessel disease | Dior | First‐generation DES | 29/31 | 9 | 6 | Diameter stenosis | 2.4/2.4 | NR |
| PEPCAD NSTEMI13 | 2019 | Myocardial infarction |
SeQuent Please SeQuent Please Neo |
BMS/second‐generation DES | 104/106 | 9 | NR | Target lesion failure | NR | 7.3 |
| REVELATION14 | 2019 | Myocardial infarction | Pantera Lux | Second‐generation DES | 60/60 | 9 | 9 | FFR value | 3.3/3.2 | 18.0 |
| Gobic et al28 | 2017 | Myocardial infarction | SeQuent Please | Second‐generation DES | 41/37 | 6 | 6 | Late lumen loss | 2.6/3.0 | 7.3 |
| Shin et al29 | 2019 | High bleeding risk | SeQuent Please | BMS | 20/20 | 12 | 9 | Late lumen loss | 3.0/3.2 | NR |
| DEBUT12 | 2019 | High bleeding risk | SeQuent Please | BMS | 102/106 | 9 | NR | MACE | NR | 2.0 |
| PEPCAD‐BIF30 | 2016 | Bifurcational lesion | SeQuent Please | POBA | 32/32 | 9 | 9 | Late lumen loss | 2.4/2.4 | 0 |
| BABILON31 | 2014 | Bifurcational lesion | SeQuent Please | POBA | 52/56 | 24 | 9 | Late lumen loss | 2.3/2.3 | 7.8 |
| Nishiyama et al32 | 2016 | Unspecified | SeQuent Please | Second‐generation DES | 30/30 | 8 | 8 | Not specified | 2.9/2.7 | 10.0 |
Results are presented as drug‐coated balloon/control. ACS indicates acute coronary syndrome; BABILON, The Paclitaxel‐Coated Balloon in Bifurcated Lesions Trial; BASKET‐SMALL 2, The Basel Kosten Effektivitäts Trial–Drug‐Coated Balloons versus Drug‐eluting Stents in Small Vessel Interventions; BELLO, Balloon Elution and Late Loss Optimization; BMS, bare metal stent; DCB, drug‐coated balloon; DEBUT, Drug‐Eluting Balloon in Stable and Unstable Angina: A Randomized Controlled Non‐Inferiority Trial; DES, drug‐eluting stent; FFR, fractional flow reserve; MACE, major adverse cardiac events; NR, not reported; PEPCAD‐BIF, Drug eluting balloons as stand alone procedure for coronary bifurcational lesions; PEPCAD NSTEMI, Bare Metal Stent Versus Drug Coated Balloon With Provisional Stenting in Non‐ST–Elevation Myocardial Infarction; PICCOLETO, Paclitaxel‐coated balloon versus drug‐eluting stent during PCI of small coronary vessels; PICCOLETO II, Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment; POBA, “plain old” balloon angioplasty; RESTORE SVD, Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease; REVELATION, Revascularization With Paclitaxel‐Coated Balloon Angioplasty Versus Drug‐Eluting Stenting in Acute Myocardial Infarction; and TVF, target vessel failure.