World's First Abluminal Biodegradable Polymer Drug-Eluting S

Helen.zhang SG

Better treatment option for coronary heart disease patients following Hospital Authority approval

HONG KONG, June 29 /PRNewswire-Asia/ -- BioMatrix, the world's first abluminal biodegradable polymer drug-eluting stent (DES), coated with Biolimus A9 only to the abluminal (outer) surface of the stent, has been approved by the Hong Kong Hospital Authority in December 2009. This new innovation can offer a better coronary stent implantation treatment choice with improved safety and efficacy. The feature of abluminal biodegradable polymer provides patients with both drug-eluting stent's efficacy and bare metal stent's safety profile. This has been proven in various clinical data including LEADERS, a 2-year all-comers prospective randomized trial.

"We are delighted that the Hospital Authority approved this new generation drug-eluting stent, which will greatly benefit coronary heart disease patients in Hong Kong," said Jeff Lee, Chairman of Care For Your Heart. "Though coronary heart disease is the second leading cause of death in Hong Kong, according to the in-depth analysis derived from our survey conducted among 616 Hong Kong people which includes 302 coronary heart disease patients, the level of awareness on the stent implementation and drug-eluting stent are low -- only one quarter of the respondents have heard of stent.(1) Hence, it is important to provide patients with up-to-date information on the different type of coronary stents available in order to choose a suitable stent the patients need."

Coronary heart disease (CHD) is a major health problem worldwide and is very common in Hong Kong. It is caused by the arteries that supply blood to heart muscle become hardened and narrowed, which will result in acute myocardial infarction, commonly known as heart attack. Around 3.8 million men and 3.4 million women worldwide die each year from CHD.(2) In Hong Kong, CHD has been the second leading cause of death since 1960s,(3) and accounted for 70,300 hospitalization and 6,777 deaths in 2008.(4) Stent implantation is a common method in the treatment of CHD; over 5,000 such procedures are performed yearly in Hong Kong.(3)

"In Hong Kong, drug-eluting stent is extensively used for the treatment of blockage of arteries in angioplasty among coronary heart disease patients," said Dr Wong Bun-lap, Specialist in Cardiology. "Patients need to consult their doctor about the pros and cons of various stents when selecting a stent."

"The additional advantage of abluminal biodegradable polymer drug-eluting stent compare to the original drug-eluting stents currently available is that the new stent's polymer can be completely absorbed after 6 to 9 months. Although there is no conclusive evidence that the original durable polymer is the culprit for stent thrombosis, there is circumferential evidence that the durable polymer induces persistent inflammation," said Dr Lee Pui Yin, Specialist in Cardiology.

"Now patients especially those who are not suitable for or are low compliant in taking anti-platelet therapy can choose to use a drug-eluting stent with biodegradable polymer, which reduces the risk of stent thrombosis after the procedure," added Dr Wong.

"The results from the LEADERS trial confirm the benefits of the new abluminal biodegradable polymer drug-eluting stent. The new generation drug-eluting stent demonstrates excellent procedural performance and clinical outcome. We believe this new generation drug-eluting stent has created a new standard for coronary stent implantation," concluded Dr Lee.

History of stent development

In the past before the invention of a coronary stent, patients were treated with balloon dilatation to open up the blocked vessel, but approximately 40% of them had to return for another procedure due to re-occurrence of the blockage.(5) After bare metal stent became available in 1994, this situation had been improved but around 20% to 30% of patients still needed to be treated again for artery re-narrowing on the same lesion.(5) Between 2003 and 2007, many companies thus coated a drug to their bare metal stent to address the issue and developed various type of DES. However, the late or very late stent thrombosis (thrombosis occurs 1 month after the procedure) caused by durable polymer DES becomes a major concern as it can cause heart attack again or even death.

In 2008, the newest generation DES with biodegradable polymer and drug applied only to the abluminal (outer) surface of the stent obtained a CE mark for patient's safe use. The unique coating of this stent can be absorbed 6 to 9 months after its implantation and has addressed the concern on stent thrombosis that occurs more often among existing DESs with durable coating. The drug (Biolimus A9) coated only on the vessel touching side allows more targeted drug release and reduces systemic exposure. Recently, BioMatrix stent has been approved for a comprehensive range of indications, including ST-elevation myocardial infarction (STEMI), acute coronary syndromes and diabetes mellitus.

LEADERS trial

The 2-year results of the LEADERS trial showed an increasing trend towards a safety benefit for abluminal biodegradable polymer coated with Biolimus A9 (BES) as compared to a durable polymer DES coated with Sirolimus (SES).(6) LEADERS trial is the first head-to-head randomized study between the two drug-eluting stent systems in a 'real world, all-comers' population that reflects patients treated in routine clinical practice.

The study showed that in the overall study population there were similar outcomes for BES and SES, with an increasing advantage observed for BES in both Major Adverse Cardiac Events ("MACE") (BES: 13% vs. SES: 15.4%, p=0.18) and Cardiac Death/Myocardial Infarction (BES: 8.3% vs. SES: 9.1%, p=0.59) compared with both 9- and 12-month results. In the high risk sub-group of STEMI patients (ST Elevation Myocardial Infarction), a statistically significant improved MACE rate was demonstrated with BES compared to SES (8.1% vs. 19.3%, p<0.01). In the trial, patients were recommended to take a 1-year dual anti-platelet therapy (a combination of aspirin and clopidogrel to help prevent a blood clot from forming). The use of clopidogel had declined 68% by 1 year and a further 24% by 2 years. Patients who discontinued dual anti-platelet therapy show no very-late stent thrombosis up to 2 years.

Reference:

    1. Data on file. Care For Your Heart 2008 survey
    2. WHO. The Atlas of Heart Disease and Stroke. Available at
       http://www.who.int/cardiovascular_diseases/resources/atlas/en/
    3. The CUHK. Press Release. 13 January 2009. Available at
       http://www.cuhk.edu.hk/cpr/pressrelease/090113e2.htm
    4. Centre for Health Protection, Dept of Health, HKSAR. Available at
       http://www.chp.gov.hk/content.asp?lang=tc&info_id=57&id=25&pid=9
    5. Sir Run Run Shaw Heart & Diagnostic Center. Coronary Angioplasty
       (Balloon PTCA). Available at http://www.sth.org.hk/e/Cathlab.htm
    6. LEADERS Two-Year Results Indicate Improved Safety and Efficacy of
       Biodegradable Polymer Technology over Conventional Durable Polymers.
       Biosensors International news release 23 September 2009

About Care For Your Heart

Care For Your Heart is a cardiac patients mutual support association. Care For Your Heart's missions are to promote mutual support and self-help among cardiac patients in tackling psychosocial problems related to their illness, and to educate the patients and the public on cardiac diseases and other related issues. One of the pilot projects "Heart Concern Debriefing Program" is to assist patients to respond to the trauma due to cardiac disease.

About LEADERS Trial

LEADERS trial is the first head-to-head randomized study between the two limus drug-eluting stent systems in a 'real world, all-comers' population that reflects patients treated in routine clinical practice. It is a multi-centre randomized study in which 1,707 patients eligible for PCI for symptomatic coronary disease received either a Biosensors Biolimus A9-eluting stent with an abluminal biodegradable polymer coating, or a sirolimus-eluting stent with a durable polymer. Inclusion criteria were broad, reflecting routine clinical practice, without limitations regarding type of coronary vessel, lesion length or number of treated lesions. Its two-year results were released at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium held in September 2009 in San Francisco, USA, which was sponsored by the US Cardiovascular Research Foundation.

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     Edelman Public Relations Worldwide (Hong Kong)
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SOURCE　 Care For Your Heart