Twelve months clinical outcomes of ultrathin strut sirolimus-eluting stent in real-world Indian patients with coronary artery disease

• Published in: American journal of cardiovascular disease Vol. 12; no. 5; pp. 262 - 271
• Main Authors: Ajmera, Prakash, Pothineni, Ramesh, Chawla, Kamal Kumar, Mantravadi, Sai Sudhakar, Jariwala, Pankaj, Vijan, Vinod, Vijan, Vikrant
• Format: Journal Article
• Language: English
• Published: e-Century Publishing Corporation 01-01-2022
• Subjects: Original
• ISSN: 2160-200X; 2160-200X

PURPOSEAlthough 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). METHODSThis 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. RESULTSMean 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%. CONCLUSIONTwelve 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.