Translumina has announced the launch of the SPARX trial, an international, multicentre, randomised clinical trial comparing a first-line drug-coated balloon (DCB) strategy against contemporary drug-eluting stents (DES) in patients with complex coronary artery disease.
The study will enrol 1,380 patients across 10 countries with two-year follow-up and a one-year device-oriented composite endpoint (DOCE) as the primary endpoint. Components of the primary endpoint include cardiac death, new target vessel-related myocardial infarction (TV-MI) and ischaemia-driven targe lesion revascularisation (TLR).
The two DCB technologies being used in the study are the paclitaxel-coated Protégé (Translumina) and Agent (Boston Scientific) devices. According to the company, SPARX aims to address key unanswered clinical questions regarding the safety, efficacy, and long-term outcomes of a “leave nothing behind” treatment strategy, with the potential to shape future clinical practice and international guideline recommendations.
“Despite advances in drug-eluting stent technology, permanent metallic implants may be associated with late adverse events beyond the first year,” study chair Adnan Kastrati (German Heart Centre, Munich, Germany) commented. “Drug-coated balloons, which leave no permanent implant, offer a therapeutic alternative, supported by growing evidence across multiple lesion subsets. However, randomised evidence in complex coronary artery disease remains limited. SPARX has been designed with the aim to further define the role of drug-coated balloons in contemporary coronary intervention.”
“SPARX has been designed as a multinational randomised trial comparing a DCB-first strategy with contemporary drug-eluting stents across a broad spectrum of complex coronary lesions,” Florim Cuculi (Heart Centre Lucerne, Lucerne, Switzerland), global lead principal investigator for the trial, adds. “The study will enrol 1,380 patients across 10 countries with two-year follow-up and a one-year device-oriented composite endpoint as the primary endpoint. In addition, SPARX will provide randomised head-to-head comparative data between two established paclitaxel-coated balloon technologies. We believe SPARX aims to define the role of drug-coated balloons in contemporary coronary intervention.”
