Clinical Outcomes of Successful Sirolimus-Eluting Stent Implantation in Patients with Chronic Total Occlusion in the Real Clinical Practice: Outcomes of SES in CTO

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Chronic Total Occlusion (CTO) (n=170). Intervention: Indolimus sirolimus-eluting stent. Primary outcome: Target lesion failure (TLF) at 9 months.

Q: What does this research mean for the field?

Treatment of chronic total occlusion with the Indolimus biodegradable polymer sirolimus-eluting stent results in a cumulative target lesion failure rate of 2.9% at 9-month follow-up. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Vijaya Pamidimukkala; Murali Babu Rao Rachaputi; Michael Noronha; Srinivasa Rao Chinta; Veera Prasada Rao Ravela; Maruthi Prasad Immadisetty; Lakshmi Sudha Prasanna; Anurag Polavarapu; Sravanthi Byrapaneni; Naren Polavarapu; Sirichandana Gangasani; RAMESH NELLURI; Nutakki Srinivas Rao; Soma Srinivas; Jangamasetty Mohan Murali; Meghana Chilukuri; Gadicharla Rajasekhar; Kurgodu Math Manjunath; Nagam Raghu; Elamandala Sree Charan; Ramanaboina Venkata Subbaiah; Tino Baby; Pamidi Rajendra Kumar; Katkojvala Ranjith Kumar; Marella Rajya Lakshmi; Raghava Sarma Polavarapu; Asif Raheem; Kamlesh Thakkar; Prajapati Jayesh

doi:10.7439/ijbar.v10i2.5051

February 13, 2019International Journal of Biomedical and Advance ResearchOpen Access

Clinical Outcomes of Successful Sirolimus-Eluting Stent Implantation in Patients with Chronic Total Occlusion in the Real Clinical Practice: Outcomes of SES in CTO

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Key result

Indolimus sirolimus-eluting stent shows ~3% target lesion failure at 9 months in CTO lesions.

n=170

Why the study?

Clinical outcomes of biodegradable polymer coated sirolimus-eluting stents in patients with chronic total occlusion in real clinical practice were not well established.

Does Indolimus sirolimus-eluting stent implantation improve clinical outcomes in patients with chronic total occlusion?

Key Points

To evaluate the nine-month clinical outcomes and safety of the Indolimus biodegradable polymer-coated sirolimus-eluting stent in patients undergoing recanalization of chronic total occlusions in real clinical practice.
Assessed 170 patients with 170 chronic total occlusion lesions (all type C) who underwent successful recanalization with Indolimus stents between April 2012 and June 2014.
Tracked the primary endpoint of target lesion failure at 9-month follow-up, defined as a composite of cardiac death, myocardial infarction, target lesion revascularization, and target vessel revascularization, alongside stent thrombosis.
The cumulative target lesion failure rate at 9 months was 2.9% (n=5), consisting of 1 cardiac death (0.6%), 1 target lesion revascularization (0.6%), and 3 myocardial infarctions (1.8%; 2 Q-wave and 1 non-Q-wave).
No cases of stent thrombosis (0%) or non-cardiac death (0%) occurred during the 9-month follow-up period.

Study Design

Type

Observational (n=170)

Multicenter

Yes

Structured PICO

Does Indolimus sirolimus-eluting stent implantation improve clinical outcomes in patients with chronic total occlusion?

P

Population

170 patients (mean age 50.7 years, 16.5% female) with chronic total occlusion undergoing percutaneous coronary intervention with Indolimus sirolimus-eluting stents, followed for 9 months.

I

Intervention

Indolimus biodegradable polymer coated sirolimus-eluting stent (SES) implantation, with dual antiplatelet therapy for at least 6 months.

O

Outcome

Target lesion failure (TLF) at 9-month follow-up, defined as a composite of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularisation (TVR).composite

Limitations

Non-randomized, retrospective, observational design
Lack of a control or comparator group
Relatively short follow-up duration of 9 months requiring longer-term data to further confirm safety and efficacy

Implication

In real-world clinical practice, treatment of chronic total occlusion with the Indolimus biodegradable polymer-coated sirolimus-eluting stent demonstrated a low 9-month target lesion failure rate of 2.9% and no stent thrombosis.

Abstract

Objectives: We aimed to evaluate the clinical outcomes in patients with chronic total occlusion treated with Indolimus, biodegradable polymer coated sirolimus-eluting stent, in real clinical practice. Methods: We evaluated clinical outcomes in 170 patients, who underwent successful recanalization of chronic total occlusion with Indolimus between April-2012 and June-2014. During 9-month, primary endpoint was target lesion failure (TLF), a miscellany of cardiac death, myocardial infarction (MI), target lesion revascularization(TLR) and target vessel revascularisation. We considered stent thrombosis as a clinical outcome parameter. Results: The mean age was 50.7 years and 142(83.5%) patients were predominantly male. The average stent length and diameter were 30.8

Discussion

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Cite This Study

Pamidimukkala et al. (2019) conducted an observational in Chronic Total Occlusion (CTO) (n=170). Indolimus sirolimus-eluting stent was evaluated on Target lesion failure (TLF) at 9 months. Treatment of chronic total occlusion with the Indolimus sirolimus-eluting stent resulted in a cumulative target lesion failure rate of 2.9% at 9-month follow-up.

synapsesocial.com/papers/6ac1abb2cc6172083c928afb https://doi.org/10.7439/ijbar.v10i2.5051

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Clinical Outcomes of Successful Sirolimus-Eluting Stent Implantation in Patients with Chronic Total Occlusion in the Real Clinical Practice: Outcomes of SES in CTO

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

Clinical Outcomes of Successful Sirolimus-Eluting Stent Implantation in Patients with Chronic Total Occlusion in the Real Clinical Practice: Outcomes of SES in CTO

Key Points

Study Design

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

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