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

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: Aggressive plaque preparation with RA and CB seems to be safe and effective for patients with severely calcified coronary lesions. TRIAL REGISTRATION: Current Controlled Trials ChiCTR-INR-16008274 . Retrospectively registered 12 April 2016.