Multicenter Ultrasound Guided Stent Implantation in the Coronaries - MUSIC

Description:

Safety and feasibility of IVUS-guided stenting without anticoagulation.

Hypothesis:

To validate the safety and feasibility of intravascular ultrasound-guided stenting without subsequent anticoagulation, and its impact on the 6-month restenosis rate.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 161
Mean Follow Up: 198 days
Mean Patient Age: 60
Female: 18

Patient Populations:

Stable angina
De novo coronary lesion in vessel supplying normally functioning myocardium
Target lesion < 15mm long
Vessel suitable for 3.0mm diameter stent

Exclusions:

Intolerance or contraindication to aspirin or anticoagulant therapy
Unstable angina
Evolving myocardial infarction
Angiographic evidence of thrombus
Multiple focal lesions or diffuse disease
Left main stem stenosis
Ostial and bifurcated lesions
Severe vessel tortuosity

Primary Endpoints:

Death, myocardial infarction, coronary artery bypass surgery, or repeat PTCA of the previously treated lesion, and clinically and/or angiographically documented thrombotic stent occlusion at 30 days after stent implantation.

Secondary Endpoints:

Death (all cause), myocardial infarction, coronary artery bypass surgery, or repeat PTCA of the previously treated lesion, and clinically and/or angiographically documented thrombotic stent occlusion at 6 months.
Incidence of restenosis at 6-month repeat angiography.

Drug/Procedures Used:

Palmaz-Schatz 14 mm stent (with spiral bridge); IVUS by 20, 25, or 30 MHz transducer-tipped catheter.

Concomitant Medications:

Aspirin, 100 mg qd. Twenty-two patients with suboptimal stent expansion received aspirin and acenocoumarol (3 months, INR 2.5-3.5); these patients received heparin until a therapeutic level of anticoagulation had been obtained.

Principal Findings:

One hundred and sixty-one patients were enrolled. In four patients, the implantation of a Palmaz-Schatz (with spiral bridge) stent had failed. One of these four patients died 3 days following bypass surgery. In two other patients, intravascular ultrasound assessment was not performed.

One hundred and twenty-five of the remaining 155 patients (81%) were treated with aspirin (100mg x day(-1)), because all three criteria for optimized stent expansion were met. Twenty-two of the remaining 38 patients (25%), in whom at least one criterion was not met were treated with aspirin and acenocoumarol (3 months, INR 2.5-3.5), while 16 patients only received aspirin.

Stent thrombosis was documented in two patients (1.3%) for which repeat angioplasty was performed. During the hospital stay, there were no deaths or Q-wave myocardial infarctions. Five patients (3.2%) sustained a non-Q-wave myocardial infarction.

During the follow-up period (198+/-38 days, complete for all patients, except one), one patient (0.6%) sustained a Q-wave myocardial infarction, one (0.6%) underwent bypass surgery, and repeat angioplasty was performed in nine patients (5.7%). In two of the nine patients, repeat angioplasty involved another lesion. Therefore, the target lesion revascularization rate during follow-up was 4.5% (seven patients).

Restenosis (diameter stenosis of 50% or more) was documented in 12 patients or 8.3%. When the two patients with documented stent thrombosis are included, the restenosis rate was 9.7%.

Interpretation:

These data confirm that, in selected patients, stents can safely be implanted without the use of systemic anticoagulation, provided optimal stent expansion is achieved.

References:

1. European Heart Journal 1998;19:1214-23. Final results

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Interventions and Coronary Artery Disease, Chronic Angina

Keywords: International Normalized Ratio, Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Angina, Stable, Thrombosis, Constriction, Pathologic, Angioplasty, Stents, Length of Stay


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