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Published on: May 9, 2012
Heparin-coated Wiktor stents in human coronary arteries (MENTOR trial). MENTOR Trial Investigators
M C Vrolix1, V M Legrand, J H Reiber
1AZ St Jan, Genk, Belgium. m.vrolix@ping.be
Insights
This study shows elective stenting with heparin-coated Wiktor stents is safe and effective for coronary artery disease. The procedure demonstrated low subacute thrombosis and good clinical outcomes at 12 months.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Heparin coating on stents is known to reduce thrombosis and restenosis.
- A novel, stable heparin coating method was developed for stent devices.
- This study marks the first human application of this advanced heparin coating on Wiktor stents.
Purpose of the Study:
- To assess the feasibility, safety, and efficacy of elective stenting using heparin-coated Wiktor stents.
- To evaluate the performance of this new stent technology in patients with coronary artery disease.
- To compare outcomes with historical data and other stent types.
Main Methods:
- A multicenter international trial involving 132 patients with coronary artery disease.
- Implantation of heparin-coated Wiktor stents from September 1996 to February 1997.
- 12-month follow-up for major adverse cardiovascular events and 6-month quantitative angiography.
Main Results:
- Successful stent deployment in 95.5% of lesions.
- Significant increase in minimal lumen diameter and decrease in diameter stenosis.
- Low subacute thrombosis rate (0.8%) and favorable clinical outcomes at 12 months (85% event-free survival).
Conclusions:
- Heparin-coated Wiktor stents are an effective device for treating coronary artery lesions.
- The stent demonstrated angiographic and clinical results comparable to other coated stents.
- This technology shows promise for reducing thrombosis, even in complex lesions.
Abstract:
The purpose of this study was to determine the feasibility, safety, and efficacy of elective stenting with heparin-coated Wiktor stents in patients with coronary artery disease. In experimental studies, heparin coating has been shown to prevent subacute thrombosis and restenosis. Recently, a new method of heparin coating was developed, resulting in a more stable and predictable heparin layer on stent devices. This trial constitutes the first in-human use of this coating procedure, applied on the well-known Wiktor stent device. Heparin-coated Wiktor stent implantation was performed in 132 consecutive patients (132 lesions) in a multicenter international trial from September 1996 to February 1997. Forty-three percent of patients had unstable angina, 33% had previous myocardial infarction, and 10% had diabetes mellitus. Patients were followed for 12 months for occurrence of major adverse cardiovascular events, and 96% of the eligible patients underwent quantitative angiographic control at 6 months. Stent deployment was successful in 95.5% of lesions. Minimal lumen diameter increased by 1.67 +/- 0.48 mm (from 1.02 +/- 0.38 mm before to 2.69 +/- 0.37 mm after the stent implantation). Mean percent diameter stenosis decreased from 67.4 +/- 11.3% before to 18.9 +/- 7.7% after the intervention. A successful intervention (<50% diameter stenosis and no major adverse cardiac events within 30 days) occurred in 97% of the patients. The subacute thrombosis rate was 0.8%, which compares favorably with historical controls of this stent, and a low incidence of postprocedural increase in creatine kinase-MB was noted. At 6 months, event-free survival was 85% and angiographic restenosis rate was 22% with late loss of 0.78 +/- 0.69 mm and a loss index of 0.48 +/- 0.44. Heparin-coated Wiktor stents appeared to be an efficacious device to treat Benestent-like lesions, yielding angiographic and clinical results comparable to a heparin-coated Palmaz-Schatz stent. Despite its use in more complex lesions, the incidence of subacute thrombosis appeared to be lower than historical controls with a similar noncoated stent.
