CBS - The 17th Left Main & Coronary Bifurcation Summit, CBS2025

科学研究

Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients Long-Term Coronary Functional Assessment of the Infarct-Related Artery Treated With Everolimus-Eluting Bioresorbable Scaffolds or Everolimus-Eluting Metallic Stents: Insights of the TROFI II Trial Canadian spontaneous coronary artery dissection cohort study: in-hospital and 30-day outcomes Improved Outcomes Associated with the use of Shock Protocols: Updates from the National Cardiogenic Shock Initiative Incidence and prognostic implication of unrecognized myocardial scar characterized by cardiac magnetic resonance in diabetic patients without clinical evidence of myocardial infarction Nonculprit Lesion Myocardial Infarction Following Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents Optical coherence tomography findings: insights from the “randomised multicentre trial investigating angiographic outcomes of hybrid sirolimus-eluting stents with biodegradable polymer compared with everolimus-eluting stents with durable polymer in chronic total occlusions” (PRISON IV) trial Red Cell Distribution Width in Patients with Diabetes and Myocardial Infarction: an analysis from the EXAMINE trial Anatomical plaque and vessel characteristics are associated with hemodynamic indices including fractional flow reserve and coronary flow reserve: A prospective exploratory intravascular ultrasound analysis

Sort by hits |<<... 18 19 20 21 22 23 24 ...>>|

Clinical Trial2018 Feb 3;391(10119):431-440.

JOURNAL：Lancet. Article Link

A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial

de Winter RJ, Katagiri Y, Serruys PW et al. Keywords: sirolimus-eluting bioabsorbable polymer-coated stent; everolimus-eluting durable polymer stent;non-inferiority

ABSTRACT

BACKGROUND - MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population.

METHODS - We did a randomised, single-blind, multicentre, phase 3 study (DESSOLVE III) at 20 hospitals in Germany, France, Netherlands, and Poland. Eligible participants were any patients aged at least 18 years who underwent percutaneous coronary intervention in a lesion and had a reference vessel diameter of 2·50-3·75 mm. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting bioresorbable polymer stent (MiStent) or an everolimus-eluting durable polymer stent (Xience). Randomisation was done by local investigators via web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint (DOCE)-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between the groups at 12 months after the procedure assessed by intention-to-treat. A margin of 4·0% was defined for non-inferiority of the MiStent group compared with the Xience group. All participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02385279.

FINDINGS - Between March 20, and Dec 3, 2015, we randomly assigned 1398 patients with 2030 lesions; 703 patients with 1037 lesions were assigned to MiStent, of whom 697 received the index procedure, and 695 patients with 993 lesions were asssigned to Xience, of whom 690 received the index procedure. At 12 months, the primary endpoint had occurred in 40 patients (5·8%) in the sirolimus-eluting stent group and in 45 patients (6·5%) in the everolimus-eluting stent group (absolute difference -0·8% [95% CI -3·3 to 1·8], p_{non-inferiority}=0·0001). Procedural complications occurred in 12 patients (1·7%) in the sirolimus-eluting stent group and ten patients (1·4%) in the everolimus-eluting stent group; no clinical adverse events could be attributed to these dislodgements through a minimum of 12 months of follow-up. The rate of stent thrombosis, a safety indicator, did not differ between groups and was low in both treatment groups.

INTERPRETATION - The sirolimus-eluting bioabsorbable polymer stent was non-inferior to the everolimus-eluting durable polymer stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. MiStent seems a reasonable alternative to other stents in clinical practice.

FUNDING - The European Cardiovascular Research Institute, Micell Technologies (Durham, NC, USA), and Stentys (Paris, France).

科研文章

荐读文献

A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial

ABSTRACT