Rotablation with or without other calcium debulking therapies is a safe adjunctive procedure for patients with severe coronary calcification requiring Percutaneous Coronary Intervention (PCI).
Able to understand and sign an informed consent form
Presence of clinical indication for percutaneous coronary intervention (PCI) and/or stent placement
Subjects willing to comply with all research and follow-up requirements.
Angiographic criteria (ONE of the following criteria MUST be met)
Decline to give consent
All patients with signed informed consent for percutaneous coronary intervention (PCI) and are eligible for calcium debulking treatment with rotational atherectomy with or without other forms of calcium debulking therapies will be enrolled into this study.
Cohort
Prospective
Rotational Atherectomy
Procedure/SurgeryRotational atherectomy (RA) has been the most used atherectomy modality since its first inception in1988. RA uses high speed rotation (140,000 - 180,000 rpm) to ablate inelastic plaque, resulting in debris averaging 5µm in size24. The main focus of RA in the era of DES stent has been on plaque modification rather that plaque debulking with more papers showing improved PCI success rates.
Primary efficacy endpoint (Procedural success)
Procedural success defined as \< 20% residual stenosis in treated segment without on-table mortality with TIMI 3 flow.
Death
in-hospital and at 1-year follow-up
Periprocedural myocardial infarction (MI)
1. Peak CK-MB ≥ 10x ULN OR ≥ 5x ULN + new pathologic Q waves in ≥ 2 contiguous leads/ new persistent LBBB2 OR 2. Peak Troponin T or I \> 5x ULN + new pathologic Q waves/ ischemic ECG changes
Complications
Significant coronary perforation at least Type II, III or III CS based on Ellis classification
Complication
no-reflow or slow flow
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National Heart Centre Singapore
Lead sponsor
Boston Scientific Corporation
Collaborator
