Clinical and quantitative angiographic outcomes following elective implantation of the self-expanding Wallstent for longer coronary artery lesions--final results of the Wellstent native study
Autor: | David P. Foley, Claude Hanet, Harry Suryapranata, Patrick W, Amann Fw, Bernhard Meier, Benno J. Rensing, Harald Mudra, Antonio Colombo, Michel Pieper, Carlos Macaya, Guy R. Heyndrickx |
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Rok vydání: | 2003 |
Předmět: |
Aspirin
medicine.medical_specialty medicine.diagnostic_test business.industry Unstable angina medicine.medical_treatment medicine.disease Balloon Surgery Angina Angioplasty Angiography medicine Radiology Nuclear Medicine and imaging cardiovascular diseases Radiology Ticlopidine Cardiology and Cardiovascular Medicine business Mace medicine.drug |
Zdroj: | International journal of cardiovascular interventions. 2(3) |
ISSN: | 1462-8848 |
Popis: | BACKGROUND: Implantation of short balloon-expandable stents provides superior clinical and angiographic outcome compared with balloon angioplasty in selected patients. The purpose of the Wellstent study was to evaluate the safety and efficacy of the self-expanding Wallstent combined with aspirin and ticlopidine in patients with stable or unstable angina related to a native coronary lesion up to 45 mm in length. METHODS: 105 patients (111 lesions) with stable (57%) or unstable (43%) angina were included in this prospective multicentre evaluation. Angiography before and after Wallstent implantation and at 6-month follow-up was analysed at the core lab using the CAAS 2 system. The primary end-point was incidence of major adverse cardiac events (MACE) at 30 days. Secondary end-points were angiographic outcome at 6 months and MACE at 6 months and 1 year. RESULTS: Acute procedural success (successful stent implantation with residual stenosis20%) was achieved in 99%. Mean reference diameter was 3.18 +/- 0.66 mm, minimal luminal diameter was 1.00 +/- 0.50 mm pre- and 2.84 +/- 0.47 mm poststent (diameter stenosis 16 +/- 6%). The mean hospital stay was 2.2 days. At 30 days, 95% of patients were free of MACE. At 6 month and 1 year clinical follow-up, 75% and 71% of patients, respectively, remained free of MACE, the majority of which (19 of 30) were re-interventions at re-angiography. In 90% of eligible patients, MLD at follow-up was 1.65 +/- 0.75 mm (late loss 1.20 +/- 0.66 mm, loss index 0.66), diameter stenosis 42 +/- 15%, with a restenosis rate of 32%. Longer stents were associated with greater luminal loss (P = 0.001) and less-favourable clinical outcome. CONCLUSIONS: Wallstent implantation, combined with aspirin and ticlopidine, achieved excellent acute and 30 day clinical results in a heterogenous high-risk patient group. Clinical outcome at 6 months and 1 year remained good, and most adverse events were re-PTCA during follow-up angiography. The loss index of 0.66 and restenosis rate of 32%, related in part to the use of longer stents, emphasizes the continuing need for effective anti-proliferative therapy. |
Databáze: | OpenAIRE |
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