Stent thrombosis in randomized clinical trials of drug-eluting stents

Article Abstract:

A hierarchical classification of stent thrombosis is used for uniform evaluation of events in a pooled analysis of randomized trials of the U.S. Food and Drug Administration (FDA) approved sirolimus- and paclitaxel-eluting stents, as compared with their respective bare-metal stents. The results have shown that the incidence of stent thrombosis did not differ much between patients with drug-eluting stents and those with bare-metal stents in randomized clinical trials.

Evaluation, United States. Food and Drug Administration, Clinical report

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Safety issues involving medical devices: Implications of recent implantable cardioverter-difibrillator malfunctions

Article Abstract:

Device safety issues would undoubtedly become more prevalent as physicians and patients increasingly rely on technological advances to treat medical conditions and prolong life. It is discussed that it would be critical to ensure that continued advances in medical science will enhance or maintain device reliability with expanding patient populations, more device implants, and increasing device complexity.

Medical Instruments and Supplies, Medical Instruments & Equipment, Medical Equipment and Supplies Manufacturing, Usage, Medical equipment, Implantable cardioverter-defibrillators, Physiological apparatus

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Unanswered questions--Drug-eluting stents and the risk of late thrombosis

Article Abstract:

Drug-eluting stents were approved by the U.S. Food and Drug Administration (FDA) in 2003 and used in nearly 80% of percutaneous coronary interventions in the U.S. The academic and clinical investigators are concerned about the increased risk of late stent thrombosis, as the long-term safety of the device is still unknown.

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