Leading experts from the various fields of interventional cardiology from across the globe recently participated and shared clinical trials researches, latest evidence-based medicine, latest technologies and innovations in the field of intervention at the 32nd global annual scientific symposium on Transcatheter Cardiovascular Therapeutics (TCT).
One of the key topics discussed at the global platform was the result of clinical trial on imaging iOPTICO from India. iOPTICO is based on Optical Coherence Tomography (OCT), the latest imaging technology in the field of coronary intervention.
For many years, angiography has been the medium of guidance for percutaneous coronary interventions (PCI) but could only provide limited information of the diseased coronary arteries. But, the latest imaging technology, OCT comes with an enhanced visualization and high-resolution imaging, which helps in accurate decision making, strategizing the procedure precisely and optimize the outcome, thus leading to a PRECESION PCI with better patient outcomes.
The trial involved 500 patients, who were enrolled between November 2018 to March 2020 from nine locations across India and Bangladesh. The patients were selected based on their medical history with a preference for those who had major adverse cardiac issues in six months and one year prior to the time when the clinical trials begun. The primary objective was to assess the change in treatment strategy pre and post PCI (percutaneous coronary intervention). Pre-PCI strategy change involved need for lesion preparation, change in the intended stent length and size, and intended device landing zone. Post-PCI strategy change involved the intended need for additional interventional procedures for PCI optimization after identification of stent malaposition, edge dissections, and stent under expansion. This was the first South Asian study reporting the outcomes of OCT-ACR (Angiographic co-registered) guided PCI in patients with coronary artery disease.
The key findings of the study were that when OCT was used along with angiography, it changed the angiographic based decisions in 90 per cent of the lesions in the patients who underwent the trial. Cardiologists changed their strategy in 86 per cent of lesions before PCI and 30 per cent of lesions after PCI.
The primary investigator (PI) of iOPTICO, Dr. Rony Mathew (HOD & Senior Consultant, Lisie Cardiology Dept) shed light on the technology and said, “OCT is the new approach to PCI procedure as it helps an operator see better and get all the information inside the diseased coronary artery. In this study, when OCT was used along with angiography, it changed the angiographic based decision in 90% of the lesions in trial patients. It enhances decision making through precision and accuracy.”
Referring to a recently presented US clinical trial LightLab data, site investigator of the trial Dr. Balbir Singh, chairman and head, cardiology for Max Healthcare group highlighted, “The field of Interventional cardiology is getting more advanced and is culminating towards perfection or PRECESION PCI and both Indian iOPTICO and US LightLab data shows similar change in the PCI strategy in spite of varied demography and clinical setup. The LightLab data has shown a cumulative impact of decision change with OCT on 88% of the lesions, with pre-PCI OCT impact of 83% and post-PCI OCT impact of 31% of the lesions in the study patients compared to angiography.”
Another site investigator Dr Samuel Mathew, director - Cardiac Cath Lab, Apollo Hospitals, Chennai (Chief consultant & IC Lilavati Hosp) who is known as the pioneer of Angioplasty in India emphasized, “Intravascular imaging (IVI) guided percutaneous coronary intervention (PCI) has shown to be associated with superior outcomes compared to angiography-based PCI. Optical coherence tomography (OCT) is a high-resolution IVI modality used widely for PCI optimization. However, the current technology is limited by difficulties in matching the OCT cross sectional information with coronary angiographic images. The current iOPTICO study was designed to evaluate the utility newer angiography – OCT co-registration (ACR) workflow in PCI optimization in a population of 500 Indian patients. This first South Asian study iOPTICO will open up new dimensions in the field of intervention cardiology and will solely benefit the patients with coronary artery disease as cardiologists will see with clarity and treat with certainty leading to excellent clinical outcome.”
Other investigators from India and Bangladesh included eminent cardiologists such as Dr Jabir A, senior consultant and director of clinical research (cardiology) at Lisie Cardiology Dept, Dr. Tejas Patel, chairman and chief interventional cardiologist at Apex Heart Institute, Dr. Balbir Singh, chairman & head, cardiology at Max Healthcare, Dr. Nagendra Swamy SC, sr. president, group medical director & chairman - Quality Control, Manipal Hospitals, Bengaluru, Prof Fazila-Tun-Nesa Malik, cardiology specialist at National Heart Foundation Hospital and Research Institute, Dhaka, Dr. Shirish(M.S) Hiremath, director, cathlab, Ruby Hall Pune, Dr. G. Sengottuvelu is a senior consultant and interventional cardiologist at Apollo Hospitals, Chennai, Dr. Samuel Mathew, chief interventional cardiologist, Apollo Hospital Chennai and Lilavati Hospital and Research Centre, Mumbai, Dr. Viveka Kumar, principal director & chief of Cath Labs, Dr. Vijayakumar, cardiologist at The Madras Medical Mission Hospital and Dr. Shivakumar, senior consultant cardiologist at Sri Sri Holistic Hospital and Vaishnavi Heart Clinic for their continuous support and efforts for making this clinical trial successful.