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Background <p>Sirolimus-coated balloons (SCB) may offer improved antiproliferative efficacy over paclitaxel-coated balloons; however, data regarding their performance in de novo coronary lesions are limited.</p> Objectives <p>The GINGER study aimed to evaluate the angiographic efficacy and clinical safety of a SCB (Magic Touch®) in the treatment of long (≥ 25&#xa0;mm) de novo coronary artery lesions.</p> Methods <p>This observational, prospective, multicenter, single-arm cohort study enrolled patients with at least one long de novo lesion treated with SCB. Co-primary endpoints were late lumen loss (LLL) and net lumen gain at 9&#xa0;months. Secondary endpoints included: procedural success, periprocedural myocardial infarction, binary restenosis and a device-oriented composite endpoint (DOCE), defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI) and clinically-driven target lesion revascularization (CD-TLR). The study was registered at ClinicalTrials.gov (NCT05471245).</p> Results <p>A total of 104 patients was enrolled at 8 centers. Mean lesion length was 28.9 ± 16.0&#xa0;mm and reference vessel diameter was 2.3 ± 0.6&#xa0;mm. Procedural success was achieved in all cases. At 9-month angiographic follow-up, LLL was 0.28 ± 0.68&#xa0;mm, net lumen gain 0.62 ± 0.63&#xa0;mm, and binary restenosis was observed in 33.3% of lesions. Clinical events at 12-month included DOCE in 6.7% of patients, cardiac death in 1.0%, TV-MI in 4.8% and CD-TLR in 3.8%. No lesion thrombosis was reported.</p> Conclusions <p>In a real-world cohort of patients with long de novo coronary lesions, the Magic Touch SCB was associated with a LLL of 0.28&#xa0;mm, which should be interpreted in light of the high complexity of treated lesions. Future randomized trials are warranted to evaluate its clinical efficacy in comparison with new-generation drug-eluting stents.</p> Graphical abstract <p>Abbreviations: ACS, acute coronary syndrome; CD-TLR, clinically-driven target lesion revascularization; CV, cardiovascular; CTO, chronic total occlusion; DOCE, device-oriented composite endpoint; LLL, late lumen loss; RVD, reference vessel diameter; SCB, sirolimus-coated balloon; TV-MI, target vessel myocardial infarction.</p> <p></p>

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Performance of a sirolimus-eluting balloon with phospholipid nanocarriers in the treatment of long de novo coronary artery disease: the prospective GINGER trial

  • 期刊论文

  • 发表日期：

    2026年8月4日

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  • Alfonso Ielasi,
  • Mauro Gitto,
  • Stefano Galli,
  • Giuseppe Massimo Sangiorgi,
  • Rodolfo Caminiti,
  • Pier Pasquale Leone,
  • Antonio Mangieri,
  • Gerlando Preti,
  • Francesco Grigioni,
  • Matteo Montorfano,
  • Maurizio Tespili,
  • Antonio Colombo

摘要

Background

Sirolimus-coated balloons (SCB) may offer improved antiproliferative efficacy over paclitaxel-coated balloons; however, data regarding their performance in de novo coronary lesions are limited.

Objectives

The GINGER study aimed to evaluate the angiographic efficacy and clinical safety of a SCB (Magic Touch®) in the treatment of long (≥ 25 mm) de novo coronary artery lesions.

Methods

This observational, prospective, multicenter, single-arm cohort study enrolled patients with at least one long de novo lesion treated with SCB. Co-primary endpoints were late lumen loss (LLL) and net lumen gain at 9 months. Secondary endpoints included: procedural success, periprocedural myocardial infarction, binary restenosis and a device-oriented composite endpoint (DOCE), defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI) and clinically-driven target lesion revascularization (CD-TLR). The study was registered at ClinicalTrials.gov (NCT05471245).

Results

A total of 104 patients was enrolled at 8 centers. Mean lesion length was 28.9 ± 16.0 mm and reference vessel diameter was 2.3 ± 0.6 mm. Procedural success was achieved in all cases. At 9-month angiographic follow-up, LLL was 0.28 ± 0.68 mm, net lumen gain 0.62 ± 0.63 mm, and binary restenosis was observed in 33.3% of lesions. Clinical events at 12-month included DOCE in 6.7% of patients, cardiac death in 1.0%, TV-MI in 4.8% and CD-TLR in 3.8%. No lesion thrombosis was reported.

Conclusions

In a real-world cohort of patients with long de novo coronary lesions, the Magic Touch SCB was associated with a LLL of 0.28 mm, which should be interpreted in light of the high complexity of treated lesions. Future randomized trials are warranted to evaluate its clinical efficacy in comparison with new-generation drug-eluting stents.

Graphical abstract

Abbreviations: ACS, acute coronary syndrome; CD-TLR, clinically-driven target lesion revascularization; CV, cardiovascular; CTO, chronic total occlusion; DOCE, device-oriented composite endpoint; LLL, late lumen loss; RVD, reference vessel diameter; SCB, sirolimus-coated balloon; TV-MI, target vessel myocardial infarction.