Long-term safety and efficacy of sirolimus-eluting stents versus bare-metal stents in real world clinical practice in Japan

Abstract

Long-term safety and efficacy of drug-eluting stents remains controversial. The CREDO-Kyoto registry cohort-2 is a physician-initiated non-company sponsored multi-center registry enrolling consecutive patients undergoing first coronary revascularization in 26 centers in Japan. We compared 3-year outcome between patients treated with sirolimus-eluting stent (SES) only (5092 patients) and bare-metal stent (BMS) only (5405 patients). SES-use as compared with BMS-use was associated with significantly lower adjusted risk for all-cause death [hazard ratio (HR) [95% confidence interval (CI)] 0.72 (0.59-0.87), P = 0.0007], which was mainly driven by the reduction in non-cardiac death [HR (95% CI) 0.64 (0.48-0.85), P = 0.002]. The risk of cardiac death [HR (95% CI) 0.82 (0.63-1.07), P = 0.15], myocardial infarction [HR (95% CI) 0.73 (0.51-1.03), P = 0.07] and definite stent thrombosis [HR (95% CI) 0.62 (0.35-1.09), P = 0.1] was not different between the two groups. Despite longer duration of thienopyridine administration, SES-use was associated with significantly lower risk for bleeding [HR (95% CI) 0.75 (0.6-0.95), P = 0.02] and similar risk for stroke [HR (95% CI) 1.0 (0.75-1.34), P = 1.0]. The risk for target-lesion revascularization (TLR) was markedly lower in the SES group [HR (95% CI) 0.42 (0.36-0.48), P < 0.0001]. The direction and magnitude of the effect of SES relative to BMS in patients presenting acute myocardial infarction (AMI) were similar to those in patients presenting otherwise. In conclusion, SES-use as compared with BMS-use was associated with marked reduction of TLR without any increases in death, myocardial infarction, stent thrombosis, stroke and bleeding in real world clinical practice regardless of clinical presentation including AMI.

Intravascular Ultrasound Guidance vs. Angiographic Guidance in Primary Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction – Long-Term Clinical Outcomes From the CREDO-Kyoto AMI Registry –

“…Consistent with our previous reports, we used a multivariate Cox proportional hazards model stratified by participating centers to estimate the hazard ratio (HR) of IVUS-guided PCI for the primary and secondary outcome measures by incorporating IVUS-guided PCI together with 38 clinically relevant risk-adjusting variables (Table 1). 15,16 Consistent with our previous reports, continuous variables were dichotomized using clinically meaningful reference values or medians. Adjusted HR and 95% CI were calculated.…”

Predictive Performance of SYNTAX Score II in Patients With Left Main and Multivessel Coronary Artery Disease

“…17 Briefly, this was a physician-initiated non-industry-sponsored multicenter registry enrolling consecutive patients undergoing first coronary revascularization among 26 centers in Japan between January 2005…”

Long-Term Efficacy and Safety Outcomes After Unrestricted Use of Drug-Eluting Stents in Patients With Acute Coronary Syndrome

“…Consistent with previous reports from other countries, 11 the CREDOKyoto registry cohort-2 reported significantly lower cumulative incidence of TLR with comparable risk of definite ST after DES implantation compared with BMS implantation in patients with AMI in real-world practice (TLR at 3 years: 12.3% vs. 23.0%, P<0.0001, and definite ST at 3 years: 1.4% vs. 2.5%, P=0.06, respectively). 12 However, only patients with low risk profiles tend to be selected as candidates for DES use in observational studies, which hampers assessment of the feasibility of DES in real-world clinical practice. From this point of view, the current study of unrestricted DES use for ACS patients showed a comparable low rate of definite ST even compared with that in BMS patients in the CREDO-Kyoto registry cohort-2, suggesting a comparable safety outcome of DES use in real-world clinical practice.…”