Rota China Registry

• Rotational Atherectomy (Procedure): Patients with severe calcified lesions will receive rotational atherectomy during index PCI

Primary outcomes

• Major adverse cardiovascular event (MACE) (primary safety endpoint) [30 days]: The composite of any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI), or cardiac death. Periprocedural myocardial infarction, defined as in patients with normal baseline CK-MB, the peak CK-MB measured within 48 hours of the procedure rises to ≥ 10 x the local laboratory ULN, or to ≥ 5 x ULN with new pathologic Q-waves in ≥ 2 contiguous leads or new persistent LBBB (according to SCAI definition. J Am Coll Cardiol 2013;62:1563-70)
• Procedural success rate (primary efficacy endpoint) [Peri-procedural]: A mean lesion diameter stenosis <30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of in-hospital MI, target vessel revascularization (TVR), or cardiac death

Secondary outcomes

• TLR rate [At 30 days and 12 months post-index procedure]
• Target lesion failure (TLF) rate [At 30 days and 12 months post-index procedure]
• TVR rate [At 30 days and 12 months post-index procedure]
• Target vessel failure (TVF) rate [At 30 days and 12 months post-index procedure]
• MI rate [At 30 days and 12 months post-index procedure]
• Cardiac death rate [At 30 days and 12 months post-index procedure]
• Non-cardiac death rate [At 30 days and 12 months post-index procedure]
• All-cause death rate [At 30 days and 12 months post-index procedure]
• Cardiac death or MI rate [At 30 days and 12 months post-index procedure]
• All-cause death or MI rate [At 30 days and 12 months post-index procedure]
• All-cause death, MI, or TVR rate [At 30 days and 12 months post-index procedure]
• Stent thrombosis (ST) rate [At 30 days and 12 months post-index procedure]
• Subgroup analyses of MACE [At 30 days and 12 months post-index procedure]: 1\. Age (< 65 years vs. ≥ 65 years), 2. Female, 3. Hypertension, 4. Diabetes, 5. CKD, 6. Left ventricular ejection fraction (≤ 50% vs. > 50%), 7. LM lesion, 8. Long lesion, 9. CTO, 10. Bifurcation lesion, 11. Speed of rotation, 12. Maximal burr size, 13. IVUS or OCT use

Other outcomes

• Rate of arterial perforation (rotational atherectomy related or non-related) [Peri-procedural]
• Rate of abrupt coronary occlusion (including dissection and thrombosis) [Peri-procedural]
• Rate of significant coronary dissection (NHLBI types C-F) [Peri-procedural]
• Rate of consistent no reflow [Peri-procedural]

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age ≥18 years old
* Subject who is clinically indicated for PCI/stenting
* Written informed consent
* Subject is willing to comply with all protocol-required follow-up evaluation
* Subject must meet one of following angiographic/procedural inclusion criteria:

  * Target lesion is moderately to severely calcified by visual estimate
  * Unsuccessful balloon dilatation of the target lesion
  * Unsuccessful passage of device(s) (microcatheter, balloon, or stent) across the target lesion

Exclusion Criteria:

* Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI within 2 weeks
* Subject has any of the following angiographic findings:

  * Thrombus present in the target vessel (by visual estimate)
  * Significant dissection present in the target vessel (NHLBI types C-F)
  * Lesion angulation > 60°(by visual estimate)

• Results publication: Wang X, Zhang H, Bai X, Zhang L, Li C, Mao X, Chen J, Luo J, Zhao Y, Zhou B, You B, Zhang Y, Ma L, Du Z, Chen Y, Sun F, Qiu C, Shen Z, Wen S, Mintz GS, Ye F, Nie S; China Rota Elite Group. Practices and outcomes of rotational atherectomy in China: The Rota China registry. Catheter Cardiovasc Interv. 2024 Oct;104(4):664-675. doi: 10.1002/ccd.31211. Epub 2024 Sep 3. PMID 39223992