Effect of Rotablator on Balloon Resistant Calcified Coronary Lesion

Study Overview
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Brief Summary
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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
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The inclusion criteria included patients presenting drug-resistant angina pectoris who underwent balloon resistant angioplasty. The exclusion criteria included: Acute myocardial infarction within the 28 days; Intolerance to aspirin, clopidogrel, contrast media, or statins; Angiographic visible thrombus, or dissection; Left ventricular ejection fraction (LVEF)<35%; Any type of cancer Hemorrhagic stroke

Official Title
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Effect of Rotational Atherectomy on Balloon-resistant Calcified Coronary Lesion the During a Long-term Follow-up Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Rotablator
* Procedure: conventional angioplasty
* Procedure: stenting
* Device: Cutting balloon
* Drug: Aspirin
* Drug: Clopidogrel
* Device: Paclitaxel-eluting stent
* Device: zotarolimus-eluting stent
* Device: Everolimus-eluting stent
* Device: Sirolimus-eluting stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rotablator<br>Rotablator plus conventional angioplasty and/or stenting was performed in 120 patients in the R group. Rotablator using 140, -160, 000 rpm, small rota burr (burr-to-artery ratio, 0.6:1), avoid drop of >5000 rpm for 5s. Conventional intervention will be performed in the rotablator group. All subjects were given 100 mg/day aspirin and clopidogrel (300 mg loading dose and 75 mg/day maintenance dosage) at least 24 h before the procedure. A cutting balloon, buddy wire balloon, buddy wire, or DES (including sirolimus-eluting stent, paclitaxel-eluting stent, everolimus-eluting stent,zotarolimus-eluting stent) was implemented at the discretion of the operator in both groups. | Device: Rotablator<br>* Rotablator, Boston Scientific, Maple Grove, MN, USA. Rotablator will be used in the Rotablator arm.<br>* Other names: Rotational atherectomy; High-speed rotational atherectomy;Procedure: conventional angioplasty<br>* Conventional angioplasty was used in both arms.<br>* Other names: percutaneous transluminal coronary angioplasty;Procedure: stenting<br>* Stenting was implanted in both arms.<br>* Other names: Implantation of coronary stent;Device: Cutting balloon<br>* Flextome cutting balloon(Boston Scientific, Natick, MA, USA) was used in both arms.<br>* Other names: Flextome Cutting balloon;Drug: Aspirin<br>* Aspirin will be administrated in participants in both arms.<br>* Other names: Bayaspirin, 100mg, tablet, oral, Germany;Drug: Clopidogrel<br>* Clopidogrel will be administrated to participants in both arms.<br>* Other names: Plavix, Clopidogrel Bisulfate, 100mg, tablet, oral;Device: Paclitaxel-eluting stent<br>* Paclitaxel-eluting stent will be used in both arms.<br>* Other names: Taxus;Device: zotarolimus-eluting stent<br>* Zotarolimus-eluting stent will be implanted in participants in both arms.<br>* Other names: Resolute, Medtronic CardioVascular;Device: Everolimus-eluting stent<br>* Everolimus-eluting stent will be used in both arms.<br>* Other names: Xience V;Device: Sirolimus-eluting stent<br>* Sirolimus-eluting stent will be used in both arms.<br>* Other names: Firebird, Shanghai, China;|
| Active Comparator: Conventional<br>Conventional angioplasty and/or stenting was performed in 120 patients in the C group. Conventional intervention without rotablator was performed in the C group. All subjects were given 100 mg/day aspirin and clopidogrel (300 mg loading dose and 75 mg/day maintenance dosage) at least 24 h before the procedure. A cutting balloon, buddy wire balloon, buddy wire, or DES (including sirolimus-eluting stent, paclitaxel-eluting stent, everolimus-eluting stent,zotarolimus-eluting stent) was implemented at the discretion of the operator in both groups. | Procedure: conventional angioplasty<br>* Conventional angioplasty was used in both arms.<br>* Other names: percutaneous transluminal coronary angioplasty;Procedure: stenting<br>* Stenting was implanted in both arms.<br>* Other names: Implantation of coronary stent;Device: Cutting balloon<br>* Flextome cutting balloon(Boston Scientific, Natick, MA, USA) was used in both arms.<br>* Other names: Flextome Cutting balloon;Drug: Aspirin<br>* Aspirin will be administrated in participants in both arms.<br>* Other names: Bayaspirin, 100mg, tablet, oral, Germany;Drug: Clopidogrel<br>* Clopidogrel will be administrated to participants in both arms.<br>* Other names: Plavix, Clopidogrel Bisulfate, 100mg, tablet, oral;Device: Paclitaxel-eluting stent<br>* Paclitaxel-eluting stent will be used in both arms.<br>* Other names: Taxus;Device: zotarolimus-eluting stent<br>* Zotarolimus-eluting stent will be implanted in participants in both arms.<br>* Other names: Resolute, Medtronic CardioVascular;Device: Everolimus-eluting stent<br>* Everolimus-eluting stent will be used in both arms.<br>* Other names: Xience V;Device: Sirolimus-eluting stent<br>* Sirolimus-eluting stent will be used in both arms.<br>* Other names: Firebird, Shanghai, China;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Participants will be followed for 2 years after the procedure, an expected average of 24 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | In hospital endpoints were doucmented for the duration of hospital stay, an expected average 2 weeks. |