SIX CARDIOLOGISTS PARTICIPATE IN MALAYSIA - GERMANY STUDY ON TWO DRUG COATED BALLOON CATHETERS
JULY 27, 2019 @ 3.24PM
Professor Dato Wan Azman Wan Ahmad demonstrating on a simulator how a drug coated balloon is inserted into a patient’s heart. Looking on is (from left) Prof Bruno Scheller, Dr Muhamad Ali Sheikh Abdul Kader, Datuk Dr Rosli Mohd Ali and Dr Ong Tiong Kiam
The SCB De-Novo study; a two-country study between Malaysia and Germany was announced today in conjunction with the 16th Interventional Cardiovascular Society of Malaysia's annual scientific conference (MyLIVE).
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 one-and-a-half years.
According to Professor 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).
In Malaysia, the study will be conducted across six hospitals involving 70 Malaysian patients. Thirty five will be randomly assigned to the paclitaxel-coated balloon catheter group while another 35 will be assigned to the sirolimus-coated balloon catheter group.
The Malaysian cardiologists from six hospitals who will be involved as principal investigators are :
Representing the German counterparts at the launch was Professor Bruno Scheller, consultant Cardiologist, University Hospital of Saarland, Homburg, Germany. Professor Bruno will be heading the initiative in Germany which also involves 70 patients at multi-centres. He is also one of the co-founder of the drug coated balloon.
“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,” added Professor Dato Dr Wan Azman.
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 (JACC Vol. 71, No. 16, Suppl S, 2018). 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, Professor Bruno Scheller said that 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 study will result in equal success with quality outcomes.”
Drug coated balloon catheter
Dato’ Dr Amin Ariff Nuruddin explained that the study will adopt the use of SeQuent Please Neo which is a paclitaxel-coated balloon catheter manufactured by B. Braun 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.
The SeQuent SCB also manufactured by B. Braun is a balloon catheter coated with sirolimus. Sirolimus is a drug that has been approved for permanent systemic use to prevent organ rejection after transplantation. The dose is much higher than on sirolimus-coated stents, which have been in routine clinical use for the local treatment of narrowed coronary arteries since 2002. The sirolimus-coated balloon catheter was approved for the treatment of narrowed coronary arteries in December 2017 in Malaysia.
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.
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