Malaysia – Germany joint heart research project launched
Six top Malaysian cardiologists to participate in study on Coronary Artery Disease treatment options, reports June Nguyễn Nam Trân
The SCB DE-NOVO STUDY, a two-country study between Malaysia and Germany was launched in conjunction with the 16th International Cardiovascular Society of Malaysia’s annual scientific conference (MyLIVE). In Petaling Jaya.
The study will compare two devices – paclitaxel coated balloon and sirolimus coated balloon – under the same conditions to learn more about their efficacy and safety for patients with coronary artery disease. It will be conducted over a period of 1.5 years.
The Malaysian cardiologists from six hospitals who will be involved as principal investigators are :
>Datuk Dr Rosli Mohd Ali, Senior Consultant Cardiologist, Cardiac Vascular Sentral Kuala Lumpur;
>Prof Dato Dr Wan Azman Wan Ahmad, Head of Cardiac Catherization Lab and Senior Consultant Cardiologist, University Malaya Medical Center;
>Dato Dr Amin Ariff Nuruddin, Head of Cardiology Department and Senior Consultant Cardiologist, Institut Jantung Negara;
>Dr Muhamad Ali Sheikh Abdul Kader, Head of Cardiology Department and Consultant Cardiologist, Hospital Pulau Pinang;
> Dr Liew Houng Bang, Head of Cardiology Department and Consultant Cardiologist Hospital Queen Elizabeth II, Sabah;
and Dr Ong Tiong Kiam, Head of Cardiology Department and Senior Consultant Cardiologist Sarawak Heart Center.
Representing the German counterparts at the launch was Prof. Bruno Scheller, Consultant Cardiologist, University Hospital of Saarland, Homburg, Germany.
According to Prof Dato Dr Wan Azman Wan Ahmad, the study is significant as no previous study has been performed to directly compare the efficacy and safety of the two coated balloon catheters in de novo stenosis (lesions that have not been treated with angioplasty or stenting). This study is aimed at improving the future treatment strategies for coronary artery disease and allow healthcare professionals to better decide on the best treatment options for patients.
“Clinical trials are necessary to learn about the safety, treatment efficacy and to gain further insights about a device. As required by law, this clinical trial has received approvals from the Medical Research Ethics Committee, the Medical Research Ethics Committee of University Malaya Medical Centre and the Research Ethics Committee of National Heart Institute. In the planned study, we will use devices that already have the CE marking which means that they have been approved for clinical use and are routinely used for treatment,” Prof Dato Dr Wan Azman added.
In Malaysia, the study will be conducted across six hospitals involving 70 Malaysian patients. 35 will be randomly assigned to the paclitaxel-coated balloon catheter group while another 35 assigned to the sirolimus-coated balloon catheter group. In Germany, the study will be conducted in multi-centres involving 70 patients with Prof Scheller heading the initiative. He is also one of the co-founders of the drug coated balloon.
Datuk Dr Rosli Mohd Ali shared that a previous study, the First In Man LIMUS DCB Study, involving 50 patients registered positive results with 100% patient follow-up. It has since been published in the leading Journal of the American College of Cardiology. This prompted the second and larger SCB DE-NOVO STUDY which will also involve the next generation of cardiologists in the country who will serve as investigators alongside their senior peers.
Commenting on the joint initiative, Prof. Bruno Scheller said, “Germany is indeed pleased to collaborate with Malaysian doctors who have the most experience with drug coated balloon only percutaneous coronary intervention (PCI). They are indeed the pioneering medical professionals, having used drug coated balloon since SeQuent® Please was launched 10 years ago. We are confident that working with the similar team of investigators for this upcoming SCB DE-NOVO STUDY will result in equal success with quality outcomes.”
Dato’ Dr Amin Ariff Nuruddin explained that the study will adopt the use of SeQuent Please Neo which is a paclitaxel-coated balloon catheter for treating coronary artery disease. Paclitaxel is an approved medication that slows the growth of vascular smooth muscle cells and helps keep the artery open. Balloon catheters coated with paclitaxel have been used successfully for the treatment of narrowed or blocked arteries since 2009. The paclitaxel-coated balloon catheter is CE-marked for treating arteries of the heart muscle and in the legs. To simplify to layman terms, Dr Amin likened the DCB as “highways”.
In both treatment options, the drug – paclitaxel or sirolimus – sticks to the surface of the balloon and is pressed into the vessel wall while the balloon is being expanded inside the vessel at the site of narrowing. In this way, the drug acts at the desired site (where the artery is narrowed) without any apparent or measurable effects elsewhere in the body.