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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
Rotablator, Boston Scientific, Maple Grove, MN, USA. Rotablator will be used in the Rotablator arm.
Conventional angioplasty was used in both arms.
Stenting was implanted in both arms.
Xinguo Wang
Beijing, Beijing Municipality, China
Major Adverse Cardiac Events including death, myocardial infarction (MI), target vessel revascularization (TVR) and coronary artery bypass grafting
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.
Time frame: Participants will be followed for 2 years after the procedure, an expected average of 24 months.
In hospital endpoints including death, periprocedural MI
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).
Time frame: In hospital endpoints were doucmented for the duration of hospital stay, an expected average 2 weeks.
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Flextome cutting balloon(Boston Scientific, Natick, MA, USA) was used in both arms.
Aspirin will be administrated in participants in both arms.
Clopidogrel will be administrated to participants in both arms.
Paclitaxel-eluting stent will be used in both arms.
Zotarolimus-eluting stent will be implanted in participants in both arms.
Everolimus-eluting stent will be used in both arms.
Sirolimus-eluting stent will be used in both arms.