Coronary Artery Disease
Conditions
Brief summary
The optimal treatment of calcified coronary lesion remained to be elucidated. A Prospective, randomized controlled trial was perform to explore the immediate effect and long-term outcome of rotational atherectomy in patients with balloon resistant coronary lesion.
Detailed description
The inclusion criteria included patients presenting drug-resistant angina pectoris who underwent balloon resistant angioplasty. The exclusion criteria included: 1. Acute myocardial infarction within the 28 days; 2. Intolerance to aspirin, clopidogrel, contrast media, or statins; 3. Angiographic visible thrombus, or dissection; 4. Left ventricular ejection fraction (LVEF)\<35%; 5. Any type of cancer 6. Hemorrhagic stroke
Interventions
DEVICERotablator
Rotablator, Boston Scientific, Maple Grove, MN, USA. Rotablator will be used in the Rotablator arm.
PROCEDUREconventional angioplasty
Conventional angioplasty was used in both arms.
PROCEDUREstenting
Stenting was implanted in both arms.
DEVICECutting balloon
Flextome cutting balloon(Boston Scientific, Natick, MA, USA) was used in both arms.
DRUGAspirin
Aspirin will be administrated in participants in both arms.
DRUGClopidogrel
Clopidogrel will be administrated to participants in both arms.
DEVICEPaclitaxel-eluting stent
Paclitaxel-eluting stent will be used in both arms.
Zotarolimus-eluting stent will be implanted in participants in both arms.
DEVICEEverolimus-eluting stent
Everolimus-eluting stent will be used in both arms.
DEVICESirolimus-eluting stent
Sirolimus-eluting stent will be used in both arms.
Sponsors
Beijing Anzhen Hospital
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Drug-resistant angina pectoris * Balloon resistant and angiographic calcified coronary lesion
Exclusion criteria
* Acute myocardial infarction within 28 days; * Intolerance to aspirin, clopidogrel, contrast media, or statins; * Angiographic visible thrombus, dissection; * LVEF \<35%; * Any type of cancer; * Hemorrhagic stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events including death, myocardial infarction (MI), target vessel revascularization (TVR) and coronary artery bypass grafting | Participants will be followed for 2 years after the procedure, an expected average of 24 months. | Follow-up study was performed by experienced doctors through telephone interviews or clinic visits at 1, 3, 6, and 12 months after the procedure, and at every 6 months thereafter. The average duration of follow up was anticipated to be 24 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In hospital endpoints including death, periprocedural MI | In hospital endpoints were doucmented for the duration of hospital stay, an expected average 2 weeks. | Baseline characteristics were measured on the day of admission to the hospital(baseline).An electrocardiogram was performed 2 h after the procedure. electrocardiograms were required to document any suspicious cardiac ischemic episodes. If any cardiac biomarker elevation was noted after the procedure, further measurements were performed as needed. During their hospital stays, patients were clinically monitored for the occurrence of any adverse events and the need for any additional coronary interventional treatment (In hospital endpoints including death, periprocedural MI). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Procedural complications | Participants will be followed during the process of the procedure, an expected average of 4 hours. | Procedural complications including death, vessel perforation, dissection, ventricular fibrillation, no reflow, side branch loss. The specific unit of measure will be number of participants with any above mentioned procedural complications. |
Countries
China
Outcome results
None listed