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.
Highlights
Over the history of percutaneous coronary intervention (PCI), in the era of plain old balloon angioplasty (POBA) and the following period in which bare metal stents (BMS) were used, clinical outcomes in small vessels were less favorable than those in large vessels and were far from1 3 Vol.:(0123456789)satisfactory
Considering that a higher percentage of small-diameter stents are used in such patients, it is important to verify the clinical outcomes associated with 2.25-mm diameter stents when establishing a treatment policy for PCI in Japanese patients
In terms of lesion characteristics, as the target lesions were small-diameter vessels, most of them were located in the distal part of the left anterior descending artery and circumflex artery, and bifurcation lesions were slightly more prevalent (Table 2)
Summary
Over the history of percutaneous coronary intervention (PCI), in the era of plain old balloon angioplasty (POBA) and the following period in which bare metal stents (BMS) were used, clinical outcomes in small vessels were less favorable than those in large vessels and were far from1 3 Vol.:(0123456789)satisfactory. Over the history of percutaneous coronary intervention (PCI), in the era of plain old balloon angioplasty (POBA) and the following period in which bare metal stents (BMS) were used, clinical outcomes in small vessels were less favorable than those in large vessels and were far from. A few multicenter clinical studies have reported both clinical and angiographic outcomes for all enrolled patients at follow-up using stents smaller than 2.5 mm in diameter [2,3,4,5,6,7]. Considering that a higher percentage of small-diameter stents are used in such patients, it is important to verify the clinical outcomes associated with 2.25-mm diameter stents when establishing a treatment policy for PCI in Japanese patients
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