Ajmera Prakash, Pothineni Ramesh, Chawla Kamal Kumar, Mantravadi Sai Sudhakar, Jariwala Pankaj, Vijan Vinod, Vijan Vikrant
Department of Cardiology, Malla Reddy Narayana Multi-speciality Hospital Hyderabad, Telangana 500055, India.
Department of Cardiology, Ramesh Hospitals Vijayawada, Andhra Pradesh 520008, India.
Am J Cardiovasc Dis. 2022 Oct 15;12(5):262-271. eCollection 2022.
Although the field of interventional cardiology has witnessed extraordinary progression, the search of an ideal coronary drug-eluting stent is still going on. Tetriflex (Sahajanand Medical Technologies Limited, Surat, India) is a latest generation biodegradable polymer-coated ultrathin (60 µm) sirolimus-eluting stent (SES) with unique Long Dual Z-link (LDZ) design. The present registry reports the 12 months clinical follow-up results of Tetriflex SES in unselected, real-world patients with coronary artery disease (CAD).
This was an investigator-initiated, retrospective, multi-center, single-arm, observational registry conducted in India between March-2017 and March-2018. The registry included 1269 consecutive patients with CAD who underwent implantation of at least one Tetriflex SES. The primary outcome was considered as target lesion failure (TLF), which was a composite of cardiac death, target-vessel myocardial infarction (TV-MI) and clinically-driven target lesion revascularisation (CD-TLR) at 12 months follow-up. The safety outcome, at 12 months follow-up, was stent thrombosis.
Mean age of patients was 54.99±10.80 years. Among all, 36.6% patients had diabetes and 51.7% patients had multi-vessel disease. A total of 1515 lesions were treated with 1682 Tetriflex SES of which 73.2% lesions were complex B2/C type and 14.7% were totally occluded. At 12 months, the cumulative incidence of TLF was 5.75% comprising 0.8% cardiac death, 3.20% TV-MI and 1.72% CD-TLR. All the incidences of definite/probable stent thrombosis (n = 4, 0.32%) were reported within 30 days of the index procedure. Twelve-month cumulative incidence of TLF in diabetic subgroup was 7.10%.
Twelve months clinical follow-up results of an ultrathin (60 µm), biodegradable polymer-coated Tetriflex SES, with unique LDZ-link, further clarify its safety and effectiveness in real-world, unselected Indian patients.
尽管介入心脏病学领域取得了非凡进展，但对理想的冠状动脉药物洗脱支架的探索仍在继续。Tetriflex（印度苏拉特萨哈贾南德医疗技术有限公司）是新一代可生物降解聚合物涂层的超薄（60微米）西罗莫司洗脱支架（SES），具有独特的长双Z型连接（LDZ）设计。本注册研究报告了Tetriflex SES在未经选择的真实世界冠心病（CAD）患者中的12个月临床随访结果。
这是一项由研究者发起的、回顾性、多中心、单臂观察性注册研究，于2017年3月至2018年3月在印度进行。该注册研究纳入了1269例连续的CAD患者，这些患者接受了至少一枚Tetriflex SES植入。主要结局被视为靶病变失败（TLF），即12个月随访时的心源性死亡、靶血管心肌梗死（TV-MI）和临床驱动的靶病变血运重建（CD-TLR）的复合结局。12个月随访时的安全性结局为支架血栓形成。
患者的平均年龄为54.99±10.80岁。其中，36.6%的患者患有糖尿病，51.7%的患者患有多支血管病变。共使用1682枚Tetriflex SES治疗了1515处病变，其中73.2%的病变为复杂B2/C型，14.7%为完全闭塞病变。12个月时，TLF的累积发生率为5.75%，包括0.8%的心源性死亡、3.20%的TV-MI和1.72%的CD-TLR。所有明确/可能的支架血栓形成事件（n = 4，0.32%）均在首次手术的30天内报告。糖尿病亚组中TLF的12个月累积发生率为7.10%。
具有独特LDZ连接的超薄（60微米）、可生物降解聚合物涂层的Tetriflex SES的12个月临床随访结果，进一步阐明了其在真实世界、未经选择的印度患者中的安全性和有效性。
