【medical-news】生物降解镁支架早期临床试验诱人
Last Updated: 2007-06-01 17:20:15 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Temporary coronary artery stenting is feasible and addresses many of the concerns about permanent stents, an international research team reports in the June 2nd issue of The Lancet. However, design improvements are still needed.
Permanent, drug-eluting stents are associated with long-term impairment of endothelial response, late stent thrombosis, and hypersensitivity reactions, Dr. Raimund Erbel, from the West German Heart Center in Essen, and his co-investigators write.
These issues may be averted by biodegradable stents, the authors maintain. The mechanical characteristics of absorbable magnesium alloy stents resemble those of stainless steel stents, except that they are degraded within 4 months.
In this first trial for treating coronary atherosclerosis with absorbable stents, Dr. Erbel and associates placed 71 magnesium stents in 63 patients with single de novo lesions in a coronary artery.
"All patients achieved device and procedural success," the authors report. The residual diameter of the stenosis was reduced from 61.5% to 12.6%.
However, during the first 4 months, 24% of patients experienced major adverse cardiac events that required target lesion revascularization. Stenosis diameter in the targeted lesions was back up to 50%.
During the 12-month follow-up, no stent thromboses, MIs, or deaths were observed. On the other hand, restenosis developed in 47% of patients, versus reported rates of 28% for bare metal stents and 6% after drug-eluting stents. Recurrent ischemia due to neointimal growth and negative remodeling necessitated target lesion vascularization in 45%.
In an accompanying Comment, Dr. John Ormiston and Dr. Mark Webster, from Auckland City Hospital in New Zealand, contend that the magnesium stents may be absorbed too quickly. They suggest that negative remodeling could be resolved by slower stent absorption, and that "the excessive healing response could be limited by the controlled release from the stent of an antiproliferative drug."
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