Evidence map›Paper›PMID 34622785›Full record

ArticleAnatolian journal of cardiology2021

Clinical outcomes of ultrathin biodegradable polymer-coated sirolimus-eluting stents in an all-comer population: One-year results from the T-FLEX registry including high-risk subgroups.

Ramesh Babu Pothineni, Vikrant Vijan, Anil Potdar, Manohar K Inamdar, Abhijit Pathak, Sai Sudhakar Mantravadi, Prakash Ajmera

Abstract readMulticenter Study
In one paragraph

Article in Anatolian journal of cardiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Ramesh Babu PothineniDepartment of Cardiology, Ramesh Hospitals; Andhra Pradesh-India.
Vikrant VijanDepartment of Cardiology, Vijan Hospital and Research Centre; Maharashtra-India.
Anil PotdarDepartment of Cardiology, Parisoha Foundation Pvt. Ltd.; Mumbai-India.
Manohar K InamdarDepartment of Cardiology, Ashwini Hospital; Maharashtra-India.
Abhijit PathakDepartment of Cardiology, Swasthya Hospital and Medical Research Center; Maharashtra-India.
Sai Sudhakar MantravadiDepartment of Cardiology, Gleneagles Global Hospital; Telangana-India.
Prakash AjmeraDepartment of Cardiology, Malla Reddy Narayana Multispeciality Hospital; Telangana-India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveT-Flex registry was designed to investigate the safety and clinical performance of the ultrathin (60 µm) strut biodegradable polymer-coated sirolimus-eluting stent (SES) with a unique long dual Z (LDZ) link design on a cobalt-chromium stent platform (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in a real-world all-comer population including high-risk subgroups.

methodsThis was an observational, multicenter, single-arm, and investigator-initiated retrospective registry. A total of 1,203 patients treated with an ultrathin biodegradable polymer-coated SES, irrespective of lesion complexity, comorbidities, and acute presentation were analyzed from May 2016 to January 2017. The primary endpoint was the one-year incidence of target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction (TV-MI), and clinically-indicated target lesion revascularization (CI-TLR). Stent thrombosis was assessed as an additional safety endpoint.

resultsAt the one-year follow-up, TLF was observed in 3.8% [95% confidence interval (CI) 2.9-5.1] patients, composed of 0.6% (95% CI: 0.3-1.3) cardiac death, 1.3% (95% CI: 0.8-2.2) TV-MI, and 1.9% (95% CI: 1.3-2.9) CI-TLR. In the high-risk subgroups, TLF at one-year was 6.8% (95% CI: 4.6-9.8) in patients with diabetes, 5.2% (95% CI: 3.4-8) in patients with small-vessel disease, 6.1% (95% CI: 3.9-9.6) in patients with ST-elevation myocardial infarction, and 4.5% (95% CI: 2.4-8.3) in patients with total occlusion. During follow-up, stent thrombosis was reported in 0.8% (95% CI: 0.4-1.5) patients in the overall population.

conclusionLow event rates of TLF and stent thrombosis at one-year follow-up indicate that this ultrathin biodegradable polymer-coated SES has encouraging safety and clinical performance in real-world all-comer populations as well as in high-risk subgroups.

Indexed as

Cardiovascular AgentsCoronary Artery DiseaseDrug-Eluting StentsPercutaneous Coronary InterventionAbsorbable ImplantsHumansPolymersRegistriesRetrospective StudiesRisk FactorsSirolimusTreatment OutcomeCardiovascular AgentsPolymersSirolimus

Identifiers

PMID34622785
PMCPMC8504675

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.