One year clinical outcomes of contemporary PCI in patients with chronic coronary syndrome: experience from large scale e-ULTIMASTER registry

Abstract

Abstract Background The 2019 ESC guideline on chronic coronary syndromes (CCS) provided insights on the management of patients with stable angina. Purpose To explore one-year outcomes of CCS patients undergoing percutaneous revascularisation representing daily clinical practice. Methods We investigated CCS patients enrolled in e-Ultimaster registry (NCT02188355), which is a prospective, multicentre, worldwide, all-comers registry enrolled >36, 000 patients treated with a thin strut (80μm) bioresorbable polymer sirolimus-eluting stents (Ultimaster). The primary endpoint was target lesion failure (TLF) at 1 year (defined as a composite of cardiac death, target-vessel related myocardial infarction (TV-MI) and clinically-driven target lesion revascularization (CD-TLR). An independent Clinical Event Committee adjudicated all end-point related events. Results Our analysis included in total 15540 patients presented with stable angina (n=12300, 79.2%) or silent ischemia (n=3240, 20.9%) at enrolment. The mean age of CCS patients was 65.7±10.5 years and 76.1% were male. Regarding comorbidities, 69.9% of CCS patient were hypertensive, 30.9% had diabetes, 62.2% had high cholesterol, and 7.5% had renal impairment. The percentage of current smokers was 15.7%. Among CCS patients, 28.1% reported previous MI while 35.2% had history of PCI and 7.4% of CABG. Among CCS patients, 42.4% were diagnosed with multivessel disease. The average number of lesions identified per patient was 1.8±1.0, and the number of treated lesions was 1.5±0.8. The left main artery was treated in 4.1% of CCS patients, 8.1% for chronic total occlusion, 6.1% for instent restenosis, while 14% of the patients were treated in one or more bifurcation lesions. Approximately 80% of the procedures were preformed via radial access. The rate of TLF at one year was 2.9%, with 0.95% of cardiac death, 0.8% of TV-MI and 1.5% of CD-TLR. Definite or probable stent thrombosis (ST) rate was 0.42%, and any bleeding occurred in 1.8% of the patients. 71.3% of the patients were already on dual antiplatelet therapy (DAPT) before procedure, 93.3% were on DAPT at 3 months follow up, while DAPT was continued in 64.9% of patients at 1 year. At 3 months after index PCI, 91.4% of the treated CCS patients were angina free, 7.6% reported stable angina, and 0.5% unstable angina. The similar result was observed at 1 year, with 90.9% of the patients remaining angina free, 7.5% of patients with stable angina, while only 0.6% reported unstable angina. In a stepwise regression model, we identified risk factors of TLF in CCS patients including age, body mass index, diabetes, renal failure, lesion complexity such as target vessel LM or bifurcation, and number of stents implanted. Conclusions In this large, international all-comers registry, more than 90% of CCS patients treated with PCI remain angina free at one year, with low rate of TLF and ST, adding further evidence to ongoing debate about CCS treatment strategy. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Limted study funding by Terumo