Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment - PICCOLETO II
Contribution To Literature:
The PICCOLETO II trial showed that a drug-coated balloon was superior to an everolimus-eluting stent among patients with small vessels.
The goal of the trial was to evaluate a drug-coated balloon compared with an everolimus-eluting stent among patients with small vessel coronary artery disease.
Patients with small vessel coronary artery disease were randomized to a paclitaxel-coated balloon (Elutax SV/Emperor; n = 118) versus an everolimus-eluting stent (Xience; n = 114). Patients who received a drug-coated balloon were treated with dual antiplatelet therapy for 30 days (stable disease) or 12 months (acute coronary syndrome). Patients who received a drug-eluting stent were treated with dual antiplatelet therapy for 6 months (stable disease) or 12 months (acute coronary syndrome).
- Total number of enrollees: 232
- Duration of follow-up: 12 months
- Mean patient age: 64 years
- Percentage female: 30%
- Percentage with diabetes: 38%
- Patients hospitalized for stable coronary artery disease or an acute coronary syndrome
- Lesion ≥70% in a target vessel 2.0-2.75 mm
- Inability to provide written informed consent
- Unwillingness to come back for systematic angiographic follow-up
- Age <18 years
- Life expectancy <1 year
- ST-segment elevation myocardial infarction (STEMI) <72 hours
- Left ventricular ejection fraction <30%
- Creatinine clearance <30 ml/min
- Left main stenosis
- Presence of stent at target vessel or previously treated target lesion
- Chronic total occlusion
- Severe calcification or tortuosity of the target vessel
- Untreatable thrombus
- Bifurcation lesion
- Lesion length >25 mm
Other salient features/characteristics:
- Stable angina, 54.2%
- Unstable angina, 14.4%
- NSTEMI, 21.1%
- STEMI (late presenter), 10.3%
- Reference vessel diameter, 2.2 mm
- Lesion length, 14 mm
The primary outcome, in-lesion late lumen loss at 6 months, was 0.04 mm in the drug-coated balloon group compared with 0.17 mm in the drug-eluting stent group (p for noninferiority = 0.01, p for superiority = 0.03).
- Major adverse cardiovascular events at 12 months: 5.6% of the drug-coated balloon group compared with 7.5% of the drug-eluting stent group (p = 0.55)
- Spontaneous myocardial infarction at 12 months: 1.9% of the drug-coated balloon group compared with 4.7% of the drug-eluting stent group (p = 0.23)
- Vessel thrombosis at 12 months: 0% of the drug-coated balloon group compared with 1.9% of the drug-eluting stent group (p = 0.15)
Among patients with small vessel coronary artery disease, a drug-coated balloon met criteria for noninferiority (and superiority) for late lumen loss compared with a drug-eluting stent. The primary outcome was an angiographic endpoint; however, clinical events were numerically lower in the drug-coated balloon group. Small vessel coronary artery disease is challenging to treat and a drug-coated balloon strategy may represent a novel treatment approach for this lesion subset.
Cortese B, Di Palma G, Garcia Guimaraes M, et al. Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial. JACC Cardiovasc Interv 2020;13:2840-9.
Editorial Comment: Kereiakes DJ. “Leave Nothing Behind”: Strategy of Choice for Small Coronaries? JACC Cardiovasc Interv 2020;13:2850-2.
Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Interventions and ACS, Interventions and Coronary Artery Disease, Interventions and Imaging, Interventions and Vascular Medicine, Angiography, Nuclear Imaging, Chronic Angina
Keywords: Acute Coronary Syndrome, Angina, Stable, Angina, Unstable, Angiography, Angioplasty, Balloon, Coronary Artery Disease, Drug-Eluting Stents, Myocardial Infarction, Myocardial Ischemia, Paclitaxel, Platelet Aggregation Inhibitors, ST Elevation Myocardial Infarction, Stents, Thrombosis
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