REgistry of Paclitaxel Coated Drug Eluting Balloon in All Comers PaTients

Overview

A post marketing, observational , multi centre, prospective registry to assess safety and performance of the Drug Eluting Balloon in patients undergoing percutaneous coronary intervention. Rational : Although DEBs are generally considered safe, there remain many unanswered questions about DEB technology in a real-world population and only limited trial data from geographically or clinically diverse patient subgroups. To address some of the clinical and translational gaps in knowledge we thus plan a clinical registry to assess safety and performance of a novel design of a drug eluting A real-world, all-comers coronary artery disease (CAD) population undergoing percutaneous coronary intervention (PCI) and suitable for treatment with a Paclitaxel Coated Coronary Balloon Dilatation Catheter. Study Population - 500 Patients

Percutaneous coronary intervention (PCI) is a minimally invasive procedure treated as first line of treatment for symptomatic coronary artery disease (CAD). In 1977, Gruentzig performed the first balloon percutaneous transluminal coronary angioplasty (PTCA) but this was associated with acute dissection or elastic recoil and later restenosis (re-narrowing). Bare metal stents (BMS) were developed which helped address acute dissection or recoil but only modestly decreased the risk of restenosis (which still occurred in around 25% of people within six months). Drug eluting stents (DES), coated with polymers which released drugs such as sirolimus or paclitaxel were then developed to reduce restenosis. Second-generation DES incorporating new metal platforms (changing from stainless steel to thinner strut metal alloys such as cobalt-chromium or platinum-chromium), new more biocompatible polymers, and new drugs such as Zotarolimus, Everolimus and Novolimus were associated with reduction in myocardial infarction (MI), target lesion revascularisation (TLR) and stent thombosis compared with first-generation DES. However, even with second-generation DES, concerns remain regarding the risk of delayed healing, late stent thrombosis and in-stent restenosis (around 2% per year) and alteration of vascular physiology due to permanent caging by the stent. Hence, drug-eluting balloons (DEB), {also referred as Drug Coated Balloons (DCB)} were developed as a non-stent approach to circumvent some drawbacks of DES. Provided pre-dilatation does not induce excessive dissection or recoil requiring a stent, DEBs deliver rapid release and deposition of anti-restenotic drug in the vessel wall at the time of balloon inflation but without a permanent implant, thus enabling more rapid healing of the vessel, similar reduction in restenosis to DES but potentially reduced late complications. Currently, DEBs are used in treating In-stent restenosis (ISR), bifurcation lesions, Ostial lesions, long \& large lesions, De novo of small vessel disease, complex coronary interventions, and high bleeding risk situations. Although DEBs are generally safe and non-inferior to other contemporary treatment procedure there are many unanswered questions about DEB technology in real world population. Geographical distribution of clinical trials or sample size and diversification is an important criterion to evaluate the safety and efficacy of the DEBs in real- world settings. The trend indicates fewer domestic trials for DEB. In lieu of the above clinical and translational gaps a registry is planned to assess safety and performance of the Drug Eluting Balloon in CAD patients.