Coronary Artery Disease
Conditions
Keywords
coronary artery disease, percutaneous coronary intervention, rotational atherectomy
Brief summary
Rotational atherectomy (RA) facilitates percutaneous coronary intervention for complex de novo lesions with severe calcification. Some observational studies and a small randomized trial indicated that a strategy of routine RA did not conferred reduction in restenosis or MACE, but these studies are limited by missing follow-up, insufficient power to compare outcomes, and confounding factors in the RA group (long lesion length, etc.). With recent developments in medical therapy, advances in design and delivery of drug-eluting stents (DES), and advances in noninvasive and intravascular coronary imaging, the use of RA in current real-world practice remains to be well determined. We aimed to compile real-world clinical outcomes data for the RotablatorTM Rotational Atherectomy System in routine clinical practice in China.
Interventions
PROCEDURERotational Atherectomy
Patients with severe calcified lesions will receive rotational atherectomy during index PCI
Sponsors
BSC International Medical Trading (Shanghai) Co., Ltd.
Beijing Anzhen Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| TVR 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 | — |
| 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 |
| All-cause death, MI, or TVR 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 | — |
| 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 | — |
| 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 | — |
Other
| Measure | Time frame |
|---|---|
| Rate of consistent no reflow | 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 arterial perforation (rotational atherectomy related or non-related) | Peri-procedural |
Countries
China
Outcome results
None listed