Improved clinical outcome with biodegradable polymer drug-eluting stents compared to durable polymer drug-eluting stents for primary percutaneous coronary intervention

BackgroundStudies comparing the clinical outcomes of second-generation biodegradable polymer drug-eluting stents (BP-DES) and second-generation durable polymer drug-eluting stents (DP-DES) in patients with ST-segment elevation myocardial infarction (STEMI) with follow-up duration of more than 1 year are still limited.ObjectiveThis study aimed to compare the 2-year clinical outcome of BP-DES with second-generation DP-DES in patients undergoing primary percutaneous coronary intervention (PPCI).MethodsThis is a retrospective cohort study in patients with STEMI, the primary endpoint was major adverse cardiac events (MACE) defined as recurrent myocardial infarction, total repeat revascularisation and cardiac death. The secondary endpoint was stent thrombosis (ST) defined as definite, probable or possible.ResultsA total of 400 patients were analysed (197 BP-DES groups and 203 DP-DES groups). BP-DES were independently associated with lower incidence of MACE (adjusted HR 0.67, 95% CI 0.21 to 0.91, p=0.005) and ST (adjusted HR 0.62, 95% CI 0.19 to 0.73, p<0.016) within 2 years of follow-up. Subgroup analysis of MACE individual components showed that BP-DES were associated with lower cardiac deaths (HR 0.35; 95% CI 0.18 to 0.94; p<0.001) compared to DP-DES, but not recurrent myocardial infarction and total repeat revascularisation.ConclusionsBP-DES were associated with better clinical outcomes compared to second-generation DP-DES in patients with STEMI undergoing PPCI.

A novel endothelial damage inhibitor for the treatment of vascular conduits in coronary artery bypass grafting: protocol and rationale for the European, multicentre, prospective, observational DuraGraft registry

Background Vein graft disease (VGD) impairs graft patency rates and long-term outcomes after coronary artery bypass grafting (CABG). DuraGraft is a novel endothelial-damage inhibitor developed to efficiently protect the structural and functional integrity of the vascular endothelium. The DuraGraft registry will evaluate the long-term clinical outcomes of DuraGraft in patients undergoing CABG procedures. Methods This ongoing multicentre, prospective observational registry will enrol 3000 patients undergoing an isolated CABG procedure or a combined procedure (ie, CABG plus valve surgery or other surgery) with at least one saphenous vein grafts or one free arterial graft (ie, radial artery or mammary artery). If a patient is enrolled, all free grafts (SVG and arterial will be treated with DuraGraft. Data on baseline, clinical, and angiographic characteristics as well as procedural and clinical events will be collected. The primary outcome measure is the occurrence of a major adverse cardiac event (MACE; defined as death, non-fatal myocardial-infarction, or need for repeat-revascularisation). Secondary outcome measures are the occurrence of major adverse cardiac and cerebrovascular events (MACCE; defined as death, non-fatal myocardial-infarction, repeat-revascularisation, or stroke), patient-reported quality of life, and health-economic data. Patient assessments will be performed during hospitalisation, at 1-month, 1-year, and annually thereafter to 5 years post-CABG. Events will be adjudicated by an independent clinical events committee. This European, multi-institutional registry will provide detailed insights into clinical outcome associated with DuraGraft. Discussion This European, multi-institutional registry will provide detailed insights into clinical outcome associated with the use of DuraGraft. Beyond that, and given the comprehensive data sets comprising of patient, procedural, and graft parameters that are being collected, the registry will enable for multiple subgroup analyses targeting focus groups or specific clinical questions. These may include analysis of subpopulations such as patients with diabetes or multimorbid high-risk patients (patient level), evaluation of relevance of harvesting technique including endoscopic versus open conduit harvesting (procedural level), or particular graft-specific aspects (conduit level). Trial registration ClinicalTrials.gov NCT02922088. Registered October 3, 2016. Ethics and dissemination The regional ethics committees have approved the registry. Results will be submitted for publication.