title: Intensive plaque modification with rotational atherectomy and cutting balloon before drug-eluting stent implantation for patients with severely calcified coronary lesions: a pilot clinical study.
abstract: This study investigated whether, for patients with severely calcified coronary lesions, use of a cutting balloon (CB) during rotational atherectomy (RA) before placing a drug-eluting stent will improve periprocedural outcomes, compared to RA with a conventional plain balloon.
  
  
  
  In a randomized controlled trial, patients with severely calcified lesions of calcium arc ≥180° were apportioned to receive intensive plaque modification with RA and CB (RA + CB; n = 35) or RA with conventional plain balloon (RA; n = 36). Intravascular ultrasound was applied for quantitative or qualitative analyses of percutaneous coronary intervention outcomes. The primary outcome was acute lumen gain after drug-eluting stent.
  
  
  
  The RA + CB and RA groups were similar in baseline mean arcs of superficial calcium, and minimum lumen cross-sectional areas (CSAs). The mean minimum stent CSA after percutaneous coronary intervention (PCI) of the RA + CB group (5.9 ± 1.7 mm(2)) was significantly larger than that of the RA group (5.0 ± 1.4 mm(2); P = 0.021). Patients in the RA + CB group achieved significantly larger acute CSA gain after PCI (4.5 ± 1.5 mm(2)) relative to the RA group (3.8 ± 1.5 mm(2); P = 0.035). The groups were similar in rates of periprocedural complications, but at the 1-year follow-up the RA + CB had a lower rate of revascularization for restenosis of the target vessel and MACE (5.7 %) than did the RA group (22.2 %, P = 0.046).
  
  
  
  Aggressive plaque preparation with RA and CB seems to be safe and effective for patients with severely calcified coronary lesions.
  
  
  
  Current Controlled Trials ChiCTR-INR-16008274 . Retrospectively registered 12 April 2016.
authors.affiliation: Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China.|Department of Cardiology, Sichuan Provincial People's Hospital & Sichuan Academy of Medical Science, Chengdu, China.
authors.forename: Qiyong
authors.initials: Q
authors.lastname: Li
authors.affiliation: Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Yong
authors.initials: Y
authors.lastname: He
authors.affiliation: Department of Physiology, West China School of Preclinical and Forensic Medicine, Sichuan University, Chengdu, China.
authors.forename: Li
authors.initials: L
authors.lastname: Chen
authors.affiliation: Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China. hmaochen@vip.sina.com.
authors.forename: Mao
authors.initials: M
authors.lastname: Chen
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D017225:Atherectomy, Coronary / Q000009:adverse effects / Q000379:methods; D002681:China; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D058226:Plaque, Atherosclerotic; D011474:Prosthesis Design; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D061205:Vascular Calcification / Q000000981:diagnostic imaging / Q000628:therapy*
keywords: Coronary calcification; Cutting balloon; Randomized controlled trial; Rotational atherectomy