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.

Qiyong Li,Li Chen,Yong He,Mao Chen

doi:10.1186/s12872-016-0273-8

Abstract

BackgroundThis 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.MethodsIn 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.ResultsThe 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 mm2) was significantly larger than that of the RA group (5.0 ± 1.4 mm2; P = 0.021). Patients in the RA + CB group achieved significantly larger acute CSA gain after PCI (4.5 ± 1.5 mm2) relative to the RA group (3.8 ± 1.5 mm2; 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).ConclusionAggressive plaque preparation with RA and CB seems to be safe and effective for patients with severely calcified coronary lesions.Trial registrationCurrent Controlled Trials ChiCTR-INR-16008274. Retrospectively registered 12 April 2016.

Highlights

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
Demographic and clinical baseline characteristics of the patients Initially, 80 patients with coronary heart disease with severely calcified lesions in the target arteries and scheduled to receive a selective percutaneous coronary intervention (PCI) were enrolled in the study, and were apportioned to the RA + CB group or the RA group
The RA + CB and RA groups were similar for baseline characteristics including age, gender, coronary heart disease diagnosis and risk factors, comorbidities and past history of PCI and coronary artery bypass graft (P > 0.05, all), except that the prevalence of chronic kidney disease was significantly higher in the RA + CB group (28.6 %) than in the RA group (8.3 %; P = 0.027)

Summary

Introduction

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. Li et al BMC Cardiovascular Disorders (2016) 16:112 studies and clinical trials suggested that modification of severely calcified coronary lesions with rotational atherectomy (RA) may ease the process of angioplasty and PCI [11, 12]. Other clinical trials indicated that pre-modification of the calcified coronary lesions with RA improved acute periprocedural outcomes, such as acute gain of the lumen [13, 14], with relatively few major adverse cardiovascular events (MACE) [15]. RA may not be adequate for some patients with severe coronary calcification

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Discussion

Conclusion