• Vol. 48 No. 5
  • 15 May 2019

Three-Year Outcomes of Biodegradable Polymer-Coated Ultra-Thin (60 μm) Sirolimus-Eluting Stents in Real-World Clinical Practice

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ABSTRACT

Although drug-eluting stents (DES) have outclassed the use of bare metal stents, the safety and efficacy of DES at long-term follow-up has still been conflicting because of increased occurrence of late or very late restenosis and stent thrombosis after DES implantation. Hence, the present study was aimed to evaluate the 3-year safety and clinical performance of biodegradable polymer-coated ultra-thin (60 μm) sirolimus-eluting stent (SES) in real-world patients with coronary artery disease (CAD). Materials and Methods: This was a physician-initiated, retrospective, single-centre, observational study that included 237 consecutive patients who had previously undergone implantation of only Supraflex SES (Sahajanand Medical Technologies Pvt Ltd, Surat, India) for the treatment of CAD. Follow-up was received after 1 year and 3 years of stent implantation. The primary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and target lesion revascularisation (TLR). Stent thrombosis was considered as a safety endpoint. Results: The mean age of patients was 64.1 ± 10.2 years, and 192 (81.0%) patients were male. The average stent length and diameter were 24.4 ± 9.0 mm and 3.1 ± 0.4 mm, respectively. The cumulative MACE rate at 3 years follow-up was 6.5% which included 4 (1.8%) cardiac deaths, 6 (2.8%) MI, and 4 (1.8%) TLR. There were 2 (0.9%) cases of stent thrombosis. Conclusion: Treatment of patients with CAD in real-world clinical practice was associated with sustained clinical safety and low rates of restenosis, stent thrombosis and MACE up to 3 years after Supraflex SES implantation.


Coronary artery disease (CAD) has been found to be
a cause of around 17.9 million global deaths per year,
accounting for around 75% of deaths in developing
countries.1 In the 1970s, percutaneous coronary intervention
(PCI) with balloon angioplasty was used for the management
of CAD. However, due to the several adverse events of plain
old balloon angioplasty, bare metal stents (BMS)—which
scaffold the atherosclerotic plaque in the diseased vessel—
came into use in the 1980s. Although, the advent of coronary
stents had reduced the incidences of restenosis, in-stent
restenosis (ISR) continued to develop in 20% to 30% of
lesions due to neointimal hyperplasia and proliferation of
vascular smooth muscle cells.

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