Outcomes of paclitaxel-coated balloon angioplasty for in-stent calcified nodule: An optical coherence tomography study

Catheter Cardiovasc Interv. 2022 Nov;100(6):990-999. doi: 10.1002/ccd.30418. Epub 2022 Oct 13.


Background: Paclitaxel-coated balloon (PCB) angioplasty emerges as an effective therapeutic option for in-stent restenosis (ISR). However, whether PCB angioplasty would be effective for in-stent calcified nodule (ISCN) lesions remain fully understood. This study aimed to evaluate the frequency and outcomes of ISCN in patients undergoing PCB angioplasty for ISR after second-generation drug-eluting stents (G2-DES) implantation.

Methods: This study enrolled 179 lesions (160 patients) undergoing PCB angioplasty for G2-DES restenosis with optical coherence tomography guidance. According to the presence of ISCN at the minimum lumen area, the lesions were divided into two groups: the ISCN (n = 16) and the non-ISCN groups (n = 163). The primary study endpoint was the cumulative 3-year incidence of target lesion failure (TLF; a composite of cardiac death, clinically driven target vessel revascularization, and definite stent thrombosis) on a lesion basis.

Results: ISCN was observed in 16 of 179 lesions (8.9%). Cumulative 3-year incidence of TLF was significantly higher in the ISCN group than in the non-CN group (85.3% vs. 16.9%, inverse probability weighted hazard ratio [HR] 4.46, 95% confidence intervals [CIs]: 2.42-8.22, p < 0.001). Risk factors associated with TLF were ISCN (HR 4.55, 95% CI: 1.56-13.3, p = 0.005), recurrent ISR (HR 2.82, 95% CI: 1.50-3.30, p = 0.001), and early ISR (HR 2.18, 95% CI: 1.21-3.92, p = 0.009).

Conclusion: ISCN was observed in 8.3% of G2-DES restenosis. PCB angioplasty had little effect on ISCN lesions compared with non-ISCN lesions, suggesting the need for careful clinical follow-up of patients with ISCN lesions after PCB angioplasty.

Keywords: drug-coated balloon; drug-eluting stent; in-stent calcified nodule; percutaneous coronary intervention.

MeSH terms

  • Angioplasty, Balloon* / adverse effects
  • Coronary Angiography / adverse effects
  • Coronary Restenosis* / diagnostic imaging
  • Coronary Restenosis* / etiology
  • Coronary Restenosis* / therapy
  • Humans
  • Paclitaxel / adverse effects
  • Stents / adverse effects
  • Tomography, Optical Coherence / adverse effects
  • Treatment Outcome


  • Paclitaxel