Real-world five-year outcomes of FlexyRap^® cobalt-chromium rapamycin-eluting stents with biodegradable polymer in patients with de-novo coronary artery disease

Abstract

BACKGROUND The use of biodegradable polymer drug-eluting stents (BP-DES) has been proven to minimize restenosis and stent thrombosis. The current post-marketing monitoring was observed at the 5-year clinical outcomes of individuals who had been treated with FlexyRap ® DES in the real world. AIM To assess the safety and effectiveness of FlexyRap ® DES at the 5-year follow-up in real-world settings. METHODS Findings from a retrospective, multi-center, observational, post-market clinical follow-up study of patients treated with FlexyRap ® DES for de novo coronary artery disease (CAD) were reported. During the 12-mo follow-up, the primary endpoint was target lesion failure, which was defined as the composite of cardiovascular death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization. RESULTS The data of 500 patients received with FlexyRap ® DES was obtained at the completion of the surveillance timeline of 5-year. After the implantation of FlexyRap ® DES, the device success rate was 100%. Adverse events that led to major bleeding, permanent disability, or death were not experienced in the patients. The major adverse cardiac event rate at 12-mo, 3-year, and 5-year follow-up was 1 (0.2%), 0 (0%), and 1 (0.2%) respectively with 0 (0%) cardiovascular death, 2 (0.4%) TV-MI, and 0 (0%) TLR compositely. Furthermore, late stent thrombosis was found in 2 (0.4%) patients at the follow-up of 12-mo, very late stent thrombosis was observed in 2 patients (0.4%) at 3-year follow-up. CONCLUSION FlexyRap ® DES was proved to be safe and efficacious in real-world patients with de novo CAD, indicating a lowered rate of cardiac events and stent thrombosis at 5-year follow-up.

Long-Term Assessment of Thin-Strut BioMime Coronary Stent System in Real-World Population at Single-Center: A Retrospective Observational Study

“…Comparable ST rates are observed with FlexyRap ® DES study [ 24 ] and BIOFLOW-VII registry [ 26 ], while lower rate of ST is observed when compared with other contemporary device studies [ 20 - 23 , 25 , 27 , 28 ]. BioMime SES also showed lower MACE rates (0.61%) [ 20 - 23 , 25 - 28 ] while the rates are comparable with FlexyRap ® DES study (0.4%) [ 24 ].…”

“…Another study (FOCUS registry) involving 4,720 patients who were implanted with a cobalt-chromium SES showed the rate of 3-year MACE of 7.37%, cardiac death 3.52%, TVR 2.08%, and ST 0.72% [19]. The comparison of outcomes of current registry with other contemporary devices is summarized in Table 5 [19][20][21][22][23][24][25][26][27]. In comparison to other contemporary devices, BioMime SES showed lower rates of cardiac death and MI [20][21][22][23][24][25][26][27][28].…”

“…The comparison of outcomes of current registry with other contemporary devices is summarized in Table 5 [19][20][21][22][23][24][25][26][27]. In comparison to other contemporary devices, BioMime SES showed lower rates of cardiac death and MI [20][21][22][23][24][25][26][27][28]. The rates of TLR are also lower with BioMime SES (0%) when compared with FLEX registry (0.7%) [20], Tetriflex SES (1.72%) [21], T-FLEX registry (1.9%) [22], Genoss DES prospective registry (0.5%) [25], BIOFLOW-VII registry (0.9%) [26], e-Cobra study (4.3%) [27] and LEADERS FREE III study (4.3%) [28], while the TLR rates are comparable with Thailand Orsiro registry (0%) [23] and FlexyRap ® DES study (0%) [24].…”

“…In comparison to other contemporary devices, BioMime SES showed lower rates of cardiac death and MI [ 20 - 28 ]. The rates of TLR are also lower with BioMime SES (0%) when compared with FLEX registry (0.7%) [ 20 ], Tetriflex SES (1.72%) [ 21 ], T-FLEX registry (1.9%) [ 22 ], Genoss DES prospective registry (0.5%) [ 25 ], BIOFLOW-VII registry (0.9%) [ 26 ], e-Cobra study (4.3%) [ 27 ] and LEADERS FREE III study (4.3%) [ 28 ], while the TLR rates are comparable with Thailand Orsiro registry (0%) [ 23 ] and FlexyRap ® DES study (0%) [ 24 ]. Comparable ST rates are observed with FlexyRap ® DES study [ 24 ] and BIOFLOW-VII registry [ 26 ], while lower rate of ST is observed when compared with other contemporary device studies [ 20 - 23 , 25 , 27 , 28 ].…”

“…The rates of TLR are also lower with BioMime SES (0%) when compared with FLEX registry (0.7%) [ 20 ], Tetriflex SES (1.72%) [ 21 ], T-FLEX registry (1.9%) [ 22 ], Genoss DES prospective registry (0.5%) [ 25 ], BIOFLOW-VII registry (0.9%) [ 26 ], e-Cobra study (4.3%) [ 27 ] and LEADERS FREE III study (4.3%) [ 28 ], while the TLR rates are comparable with Thailand Orsiro registry (0%) [ 23 ] and FlexyRap ® DES study (0%) [ 24 ]. Comparable ST rates are observed with FlexyRap ® DES study [ 24 ] and BIOFLOW-VII registry [ 26 ], while lower rate of ST is observed when compared with other contemporary device studies [ 20 - 23 , 25 , 27 , 28 ]. BioMime SES also showed lower MACE rates (0.61%) [ 20 - 23 , 25 - 28 ] while the rates are comparable with FlexyRap ® DES study (0.4%) [ 24 ].…”