What is the clinical evidence from this study?

Study design: Other. Population: Coronary artery disease with very small vessels (n=70). Intervention: Ultimaster 2.25-mm sirolimus-eluting stent with bioresorbable polymer vs. Historical control (POBA performance goal). Primary outcome: MACE-free rate at 9 months (composite of cardiac death, target vessel MI, and clinically driven TLR) (95% CI 90.1-99.7).

January 18, 2018Open Access

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

Key Result

The 2.25-mm diameter Ultimaster sirolimus-eluting stent achieved a 97.1% MACE-free rate at 9 months, exceeding the 80% performance goal in Japanese patients with very small coronary vessels.

Structured PICO

Does the 2.25-mm diameter Ultimaster sirolimus-eluting stent with bioresorbable polymer improve the 9-month MACE-free rate in Japanese patients with very small coronary vessel lesions?

Population

70 Japanese patients with ischemic heart disease due to significant stenosis in single lesions shorter than 38 mm, suitable for 2.25-mm diameter stent implantation. Mean age 70.4 years, 77.1% male.

Intervention

2.25-mm diameter Ultimaster sirolimus-eluting stent with bioresorbable polymer, implanted via percutaneous coronary intervention, followed by dual antiplatelet therapy for 9 months.

Comparator

Historical control (plain old balloon angioplasty) with a performance goal of 80% 9-month MACE-free rate.

Outcome

Major adverse cardiac event (MACE) free rate, defined as a composite of cardiac death, target vessel myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) at 9-month follow-up.composite

The 2.25-mm bioresorbable-polymer sirolimus-eluting stent is safe and effective for treating very small coronary artery lesions, demonstrating high MACE-free rates and no stent thrombosis at 2 years.

Main Result

Absolute Event Rate: 97.1% vs 80%

Limitations

Small single-arm study making comparisons with other stents difficult
Relatively short follow-up period reported
Small diameter lesions might have weaker ischemic symptoms, potentially overestimating performance
Enrolled Japanese patients only, limiting generalizability to other regions

Abstract

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.

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