A new hydrodynamic ultrathin strut sirolimus drug-eluting-stent (DES) shows a high percutaneous coronary intervention (PCI) success rate without acute stent thrombosis or early repeat revascularization, according to a new study. Presenting data detailing the performance of the ihtDEStiny coronary stent (IHT Cordynamic) after an average follow-up of 1 year, Armando Pérez de Prado, MD, PhD, revealed the device demonstrated a low target lesion failure (TLF) rate at the mid-term follow-up. “The Epic26 Velazquez study is a real-world, observational study that recruited 400 patients in 19 centers in Spain and Portugal, testing the clinical results of ihtDEStiny drug-eluting stent,” Pérez de Prado. “This is an ultra-low width strut (with a hydrodynamic oval cross-section), permanent fluoropolymer, sirolimus eluting stent. “With a mean follow-up of 16 months, the clinical results are outstanding with a target lesion failure of 1.75% of cases,” added Pérez de Prado, who is head of interventional cardiology at Hospital Universitario de Leon in Spain. “No cases of stent thrombosis have been reported. The planned follow-up period extends to two years in all of the population.” Study details Presenting at Sunday’s Late Breaking Early Feasibility Study Clinical Trials session, Dr Pérez de Prado revealed that out of the 198 patients who completed the 1-year follow-up, the primary endpoint (TLF) rate was 2.52%. This equated to five of the patients suffering complications, with three cardiovascular deaths recorded, one target vessel myocardial infarction due to perforation and covered-stent implantation and one case of in-stent restenosis. The total mortality rate was therefore recorded at 3.03%. “No target vessel myocardial infarction during follow-up or definite/probable thrombosis has been communicated,” he said during the session at Cardiovascular Research Technologies (CRT) 2024 in Washington, D.C. “None of the cardiovascular deaths are directly related to the stent (free wall rupture after myocardial infarction during index hospitalization, non-ischemic acute heart failure 7 months after percutaneous coronary intervention [PCI] and unexplained sudden death 12 months after PCI). BARC [Bleeding Academic Research Consortium] 3-5 bleeding rate was 8.16% (8/198).” Next-gen coronary stent The ihtDEStiny coronary stent is a new-generation coronary sirolimus eluting-stent with novel features such as an ultra-thin struts (68 µm) in an open-cell platform. In addition, the stent features a two-layer abluminal drug-controlled release with permanent fluoropolymer and a low-profile oval-shaped hydrodynamic strut known as EndoBoost. This new coronary stent was previously tested in a prospective multicenter study of 65 patients with significant coronary stenosis in chronic/acute coronary syndromes. These patients underwent angiographic follow-up and examination with optical coherence tomography (OCT) at 9 months after the procedure, in which definite or probable stent thrombosis rate was 0%. Methodology The Epic26 Velazquez study enrolled 400 patients aged 65±13.2 years, of whom 75.5% (302) were male. A total of 502 stents were implanted in 479 lesions. In total, 26,5% of these patients presented with ST-segment elevation myocardial infarction (STEMI) with 73.5%, patients presented with one-vessel coronary artery disease, and in 83.5% of patients, PCI was performed in one lesion, with 81.5% of patients receiving a unique stent. Successful device implantation rate was 99.5% (398/400), with two patients presenting with a final Thrombolysis in Myocardial Infarction flow at grade 2. No residual stent stenosis >30% was noted, with two lesions presenting with proximal stent edge dissection requiring an overlapped stent, but not residual dissection ≥C. Procedural success rate was 99% (396/400) with patients presenting with coronary perforation after stent post dilatation (Ellis type I and Ellis type III perforation). The patient who suffered an Ellis type III perforation also presented with a periprocedural myocardial infarction due to side branch occlusion after covered-stent implantation to solve the complication. No patient required emergency surgery or died during procedure. No acute definite or probable stent thrombosis or repeated revascularization within the first 3 days were reported. The primary endpoint of the study was TLF at 2 years (composite endpoint of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization). Photo Credit: Jason Wermers/CRTonline.org Photo Caption: Armando Pérez de Prado, MD, PhD, presents results from the Epic26 Velazquez study Sunday at CRT 2024 in Washington, D.C.