Safety and Long-Term Efficacy of Drug-Coated Balloon Angioplasty following Rotational Atherectomy for Severely Calcified Coronary Lesions Compared with New Generation Drug-Eluting Stents

J Interv Cardiol. 2019 Mar 13:2019:9094178. doi: 10.1155/2019/9094178. eCollection 2019.

Abstract

Objectives: This study sought to assess the safety and long-term efficacy of drug-coated balloons (DCB) following aggressive intracoronary image-guided rotational atherectomy (iRA) for severe coronary artery calcification (CAC), and to compare this strategy with new generation drug-eluting stents (nDES) following iRA.

Background: Ischemic events following the treatment of CAC is still relatively high. Thus, more innovative strategies are required.

Methods: We evaluated 123 consecutive patients (166 lesions) with de novo CAC undergoing an iRA (burr size; 0.7 of the mean reference diameter by intracoronary imaging) followed by DCB (DCB-iRA; 54 patients, 68 lesions) or nDES (nDES-iRA; 69 patients, 98 lesions). Follow-up angiography was obtained at > 6 months.

Results: The target vessels (right coronary and circumflex), bifurcation (67.6% versus 47.9%), reference diameter (2.28mm versus 2.49mm), and lesion length (11.89mm versus 18.78mm) were significantly different between the two groups. The median follow-up was 732 days. TLR and TVR in DCB-iRA and nDES-iRA at 3 years were similar: 15.6% versus 16.3% (P=0.99) and 15.6% versus 23.3% (P=0.38). In 41 well-matched lesion pairs after propensity score analysis, the cumulative incidence of TLR and TVR in DCB-iRA and nDES-iRA at 3 years was 12.9% versus 16.3% (P=0.70) and 12.9% versus 26.1% (P=0.17), respectively. On QCA analysis, although the acute gain was smaller in DCB-iRA (0.85 mm versus 1.53 mm, P<0.001), the minimum lumen diameter at follow-up was similar (1.69 mm versus 1.87 mm, P=0.29). The late lumen loss was lower (0.09 mm versus 0.52 mm, P=0.009) in DCB-iRA.

Conclusions: DCB-iRA is feasible for CAC.

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary* / adverse effects
  • Angioplasty, Balloon, Coronary* / instrumentation
  • Angioplasty, Balloon, Coronary* / methods
  • Atherectomy, Coronary* / adverse effects
  • Atherectomy, Coronary* / methods
  • Coronary Angiography / methods
  • Coronary Artery Disease* / diagnosis
  • Coronary Artery Disease* / epidemiology
  • Coronary Artery Disease* / surgery
  • Coronary Vessels* / diagnostic imaging
  • Coronary Vessels* / pathology
  • Coronary Vessels* / surgery
  • Drug-Eluting Stents*
  • Female
  • Humans
  • Japan / epidemiology
  • Male
  • Middle Aged
  • Outcome and Process Assessment, Health Care
  • Postoperative Complications / epidemiology*
  • Prosthesis Design
  • Treatment Outcome