Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment - PICCOLETO II

Apr 25, 2023
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Italian Society of Interventional Cardiology GISE
Date Published:
04/19/2023
Date Updated:
04/25/2023
Original Posted Date:
11/25/2020
References

Contribution To Literature:

Highlighted text has been updated as of April 25, 2023.

The PICCOLETO II trial showed that a drug-coated balloon was superior to an everolimus-eluting stent among patients with small vessels.

Description:

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.

Study Design

  • Randomized
  • Parallel
  • Open-label

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%

Inclusion criteria:

  • Patients hospitalized for stable coronary artery disease or an acute coronary syndrome
  • Lesion ≥70% in a target vessel 2.0-2.75 mm

Exclusion criteria:

  • 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

Principal Findings:

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).

Secondary outcomes:

  • Major adverse cardiovascular events (MACE) 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)

Three-year outcomes:

  • All-cause death: 3.9% with drug-coated balloon vs. 4.0% with drug-eluting stent (p = 0.98)
  • Myocardial infarction: 2.0% with drug-coated balloon vs. 6.9% with drug-eluting stent (p = 0.14)
  • Target lesion revascularization: 8.8% with drug-coated balloon vs. 14.8% with drug-eluting stent (p = 0.18)
  • MACE: 10.8% with drug-coated balloon vs. 20.8% with drug-eluting stent (p = 0.046)

Interpretation:

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. At 3 years, MACE was less frequent in the drug-coated balloon vs. the drug-eluting stent 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.

References:

Cortese B, Testa G, Rivero F, Erriquez A, Alfonso F. Long-Term Outcome of Drug-Coated Balloon vs Drug-Eluting Stent for Small Coronary Vessels: PICCOLETO-II 3-Year Follow-Up. JACC Cardiovasc Interv 2023;Apr 19:[Epub ahead of print].

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, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and SIHD, 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, Myocardial Revascularization, Paclitaxel, Platelet Aggregation Inhibitors, ST Elevation Myocardial Infarction, Stents, Thrombosis


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