<p>Real-World Use Of Ultrathin-Strut Biodegradable Polymer–Coated Sirolimus-Eluting Stents In Patients With Coronary Artery Disease: 6-Month Clinical Outcomes</p>

Abstract

BackgroundAlthough a number of drug-eluting stents have been developed with different design, composition, and polymers, the search for an ideal drug-eluting stent is ongoing. The Tetriflex (Sahajanand Medical Technology, Surat, India) is a newer-generation, ultrathin (60 µm) biodegradable polymer–coated sirolimus-eluting stent (SES) designed with a unique long dual Z-link on a cobalt–chromium alloy. The present registry aimed to evaluate the safety and clinical outcomes of the Tetriflex SES at 6-month post-implantation.MethodsThis was an investigator-initiated, retrospective, multicenter, single-arm, observational registry conducted at five tertiary-care centers in India. A total of 1,269 consecutive patients with coronary artery disease who underwent implantation of at least one Tetriflex SES between March 2017 and March 2018 were included. The primary outcome was considered a composite of cardiac death, myocardial infarction and target-lesion revascularization (TLR) at 6-month follow-up. Stent thrombosis was evaluated as a safety outcome at 6-month follow-up.ResultsThe mean age of patients was 54.99±10.80 years. Among 1,515 lesions treated with 1,682 Tetriflex SES, 58.3% were type C lesions. Six-month follow-up was done for 1,245 of 1,269 (98.1%) patients. At 6 months, composite events had occurred in 31 (2.5%) patients, consisting of ten (0.8%) cardiac deaths, 16 (1.3%) myocardial infarctions, and five (0.4%) TLRs. Stent thrombosis was observed in seven (0.56%) cases at 6 months. A subgroup analysis between diabetic and nondiabetic patients did not reveal any statistically significant difference for clinical outcomes at 6-month follow-up.ConclusionThe results of the current registry outline the safety and effectiveness of the Tetriflex SES in real-world patients, as it displayed favorable clinical outcomes at 6-month follow-up, with low incidence of TLR and stent thrombosis.

Sirolimus-Eluting Electrospun-Produced Matrices as Coatings for Vascular Stents: Dependence of Drug Release on Matrix Structure and Composition of the External Environment

“…The Tetriflex (Sahajanand Medical Technology, Surat, India) is a new-generation, ultrathin (60 µm), biodegradable SRL-eluting stent with coating composed of a combination of hydrophilic and hydrophobic polymers for controlled and prolonged release of SRL. Clinical studies have demonstrated the safety and effectiveness of the Tetriflex stent [22].…”

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][21][22][23][25][26][27][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].…”

Percutaneous Coronary Intervention of a Diffusely Degenerated Saphenous Vein Graft: A Road Less Taken

“…A newer-generation, ultrathin (60 µm) DESbiodegradable polymer-coated SES has been designed to substantially minimise the ISR and MACE, including composite of cardiac death, myocardial infarction, and target-lesion revascularisation. 20 Another possible cause for ISR is the premature, untimely release of cytostatic drugs, which contribute to overdose and further delay the restoration of the endothelium. 21 The antiproliferative drugs have no specificity, which not only inhibits the proliferation of vascular SMC, but also blocks the proliferation of VEC and slows the endothelialisation in an inverse relationship.…”