Two-year results after coronary stenting of small vessels in Japanese population using 2.25-mm diameter sirolimus-eluting stent with bioresorbable polymer: primary and long-term outcomes of CENTURY JSV study

Abstract

Percutaneous coronary intervention (PCI) in coronary artery disease (CAD) with very small vessels remains challenging. The aim of this study is to evaluate the safety and effectiveness of the 2.25-mm diameter Ultimaster sirolimus-eluting stent in the treatment of Japanese patients with CAD due to lesions in very small vessels. The CENTURY JSV study is a prospective, multicentre, single-arm study. Seventy patients with lesions deemed suitable for implantation of a 2.25-mm diameter stent were enrolled at seven hospitals in Japan. Patients underwent clinical follow-up at 1-, 9-month, 1-, and 2-year after the PCI procedure. The primary endpoint was the major adverse cardiac event (MACE), a composite of cardiac death, target vessel myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) free rate at 9-month following the procedure. The MACE-free rate was 97.1%, and the lower limit of the two-sided 95% confidence interval (CI) was 90.1%, which exceeded the threshold of 80% set as the performance goal. Angiographic in-stent and in-segment late loss at 9-month were 0.22 ± 0.31 and − 0.02 ± 0.34 mm, respectively. Between 9 months and 2 years, two additional TLRs occurred. Stent thrombosis, bleeding and vascular complication did not occur throughout 2 years. The 2.25-mm diameter Ultimaster ® bioresorbable-polymer sirolimus-eluting stent is safe and effective for treating lesions in very small coronary arteries throughout 2 years after stent implantation. Clinical trial registration: UMIN000012928.

Small Vessel Coronary Artery Disease: Rationale for Standardized Definition and Critical Appraisal of the Literature

“…Of note, none of these studies used intracoronary imaging to determine vessel size before study inclusion, which might have contributed to the important observed differences between the vessel size-based inclusion criteria and actual reference vessel diameters (Tables 1 [17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33] and 2 [10][11][12][34][35][36][37] ).…”

Five-year clinical outcomes of a 2.25 mm sirolimus-eluting stent in Japanese patients with very small coronary artery disease: final results of the CENTURY JSV study

“…The design of the CENTURY JSV study has been published earlier [11]. Briefly, it was a prospective, multicenter, single-arm study that enrolled patients with a minimum age of 20 years with asymptomatic myocardial ischemia, stable or unstable angina pectoris with a lesion suitable for implantation of a single 2.25 mm-diameter Ultimaster stent.…”

“…The current CENTURY JSV study was initiated to evaluate the safety and efficacy of the 2.25 mm-diameter Ultimaster stent and the 9-month angiographic and 2-year clinical outcomes have been reported earlier [11]. This update report has the final 5-year outcomes.…”

Impact of optical coherence tomography‐derived neointimal tissue morphology on development of very late in‐stent restenosis

“…Clinical in-stent restenosis within 1 year after percutaneous coronary intervention has been remarkably reduced with the advent of drugeluting stents (DESs). [1][2][3] However, very late in-stent restenosis (VL-ISR) is occasionally observed few years after implantation. A previous study reported that VL-ISR develops in 3% of cases after DES implantation; this incidence is approximately five times higher than that of very late stent thrombosis.…”

“…Clinical in‐stent restenosis within 1 year after percutaneous coronary intervention has been remarkably reduced with the advent of drug‐eluting stents (DESs) . However, very late in‐stent restenosis (VL‐ISR) is occasionally observed few years after implantation.…”