For the very first time in Singapore, a locally developed drug-eluting stent was implanted in a Singaporean patient as part of a series of human trials conducted in the Asia Pacific region, South America and Europe.
For the very first time in Singapore, a locally developed drug-eluting stent was implanted in a Singaporean patient as part of a series of human trials conducted in the Asia Pacific region, South America and Europe.
The patient, a 56 year-old woman with a history of hypertension (high blood pressure) and hyperlipidemia (high cholesterol), experienced angina (chest pains) and underwent a coronary angiogram in March and showed that she has two blockages. The clearing of both blockages as well as the implantation of the drug-eluting stent was performed on 29 March 2004.
Professor Eberhard Grube, Principal Investigator of the human trials dubbed STEALTH (Stealth Eluting A9 Biolimus Trial in Humans) performed the implantation at the National Heart Centre and this was transmitted live to the 13th Singapore Live Interventions in Vascuar Endotherapy (LIVE) Course on 29 March 2004. The Singapore LIVE Course is a premier international scientific meeting in interventional cardiology held annually.
The locally developed drug-eluting stent, known as the Biolimus stent, is the brainchild of local company Biosensors International Pte Ltd. To combat the common recurrence of symptoms due to the side effect of stent implantation of restenosis, the Biolimus stent releases an immuno-suppressant drug to stunt the growth of scar tissue around the treated vessel.
Prior to the human trials first launched in Germany in September last year, an animal study for the stent was conducted at the National Heart Centre in late September 2003. 12 pigs were implanted with the Biolimus stent and kept at the SingHealth Experimental Surgery Laboratories for observation.
Six months later, the pigs were operated on and the results so far are encouraging as no restenosis was found in the vessels. According to Dr Mak Koon Hou, Director of Clinical Trials, NHC and Principal Investigator of the animal study, pigs were used for the study as their organs are similar to humans.
A follow up of the Singaporean patient implanted with the Biolimus stent will be done. In addition, a six-month repeat X-ray examination of the heart vessels will be performed to assess the efficacy of the stent implant.
