Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry

Pedro A. Lemos, Prakash Chandwani, Sudheer Saxena, Padma Kumar Ramachandran, Atul Abhyankar, Carlos M. Campos, Julio Flavio Marchini, Micheli Zanotti Galon, Puneet Verma, Manjinder Singh Sandhu, Nikhil Parikh, Ashok Bhupali, Sharad Jain, Jayesh Prajapati

Research output: Contribution to journalArticle

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Abstract

Objectives: To evaluate, in the FLEX Registry, clinical outcomes of an ultrathin (60 μm) biodegradable polymer-coated Supraflex sirolimus-eluting stent (SES) for the treatment of coronary artery disease. Additionally, to determine the vascular response to the Supraflex SES through optical coherence tomography (OCT) analysis. Setting: Multicentre, single-arm, all-comers, observational registry of patients who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. Participants: 995 patients (1242 lesions) who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. A total of 47 participants underwent OCT analysis at 6 months' follow-up. Interventions: Percutaneous coronary intervention with Supraflex SES, Primary and secondary outcome measures: The primary endpoint-the rate of major adverse cardiac events (defined as a composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR))-was analysed during 12 months. Results: At 12 months, the primary endpoint occurred in 36 (3.7%) of 980 patients, consisting of 18 (1.8%) cardiac deaths, 16 (1.6%) MI, 7 (0.7%) TLR and 2 (0.2%) cases of non-target lesion target vessel revascularization. In a subset of 47 patients, 1227 cross-sections (9309 struts) were analysed at 6 months by OCT. Overall, a high percentage of struts was covered (98.1%), with a mean neointimal thickness of 0.13±0.06 μm. Conclusions: The FLEX Registry evaluated clinical outcomes in real-world and more complex cohorts and thus provides evidence that the Supraflex SEX can be used safely and routinely in a broader percutaneous coronary intervention population. Also, the Supraflex SES showed high percentage of stent strut coverage and good stent apposition during OCT follow-up.

Original languageEnglish
Article number010028
JournalBMJ Open
Volume6
Issue number2
DOIs
Publication statusPublished - 01-01-2016

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Sirolimus
Stents
Registries
Polymers
Optical Coherence Tomography
Percutaneous Coronary Intervention
India
Myocardial Infarction
Blood Vessels
Coronary Artery Disease
Outcome Assessment (Health Care)
Population

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Lemos, Pedro A. ; Chandwani, Prakash ; Saxena, Sudheer ; Ramachandran, Padma Kumar ; Abhyankar, Atul ; Campos, Carlos M. ; Marchini, Julio Flavio ; Galon, Micheli Zanotti ; Verma, Puneet ; Sandhu, Manjinder Singh ; Parikh, Nikhil ; Bhupali, Ashok ; Jain, Sharad ; Prajapati, Jayesh. / Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent : 12-month results from the FLEX Registry. In: BMJ Open. 2016 ; Vol. 6, No. 2.
@article{78ffa83210eb40b79b3dfa1b2d2cd1f2,
title = "Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry",
abstract = "Objectives: To evaluate, in the FLEX Registry, clinical outcomes of an ultrathin (60 μm) biodegradable polymer-coated Supraflex sirolimus-eluting stent (SES) for the treatment of coronary artery disease. Additionally, to determine the vascular response to the Supraflex SES through optical coherence tomography (OCT) analysis. Setting: Multicentre, single-arm, all-comers, observational registry of patients who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. Participants: 995 patients (1242 lesions) who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. A total of 47 participants underwent OCT analysis at 6 months' follow-up. Interventions: Percutaneous coronary intervention with Supraflex SES, Primary and secondary outcome measures: The primary endpoint-the rate of major adverse cardiac events (defined as a composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR))-was analysed during 12 months. Results: At 12 months, the primary endpoint occurred in 36 (3.7{\%}) of 980 patients, consisting of 18 (1.8{\%}) cardiac deaths, 16 (1.6{\%}) MI, 7 (0.7{\%}) TLR and 2 (0.2{\%}) cases of non-target lesion target vessel revascularization. In a subset of 47 patients, 1227 cross-sections (9309 struts) were analysed at 6 months by OCT. Overall, a high percentage of struts was covered (98.1{\%}), with a mean neointimal thickness of 0.13±0.06 μm. Conclusions: The FLEX Registry evaluated clinical outcomes in real-world and more complex cohorts and thus provides evidence that the Supraflex SEX can be used safely and routinely in a broader percutaneous coronary intervention population. Also, the Supraflex SES showed high percentage of stent strut coverage and good stent apposition during OCT follow-up.",
author = "Lemos, {Pedro A.} and Prakash Chandwani and Sudheer Saxena and Ramachandran, {Padma Kumar} and Atul Abhyankar and Campos, {Carlos M.} and Marchini, {Julio Flavio} and Galon, {Micheli Zanotti} and Puneet Verma and Sandhu, {Manjinder Singh} and Nikhil Parikh and Ashok Bhupali and Sharad Jain and Jayesh Prajapati",
year = "2016",
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doi = "10.1136/bmjopen-2015-010028",
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Lemos, PA, Chandwani, P, Saxena, S, Ramachandran, PK, Abhyankar, A, Campos, CM, Marchini, JF, Galon, MZ, Verma, P, Sandhu, MS, Parikh, N, Bhupali, A, Jain, S & Prajapati, J 2016, 'Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry', BMJ Open, vol. 6, no. 2, 010028. https://doi.org/10.1136/bmjopen-2015-010028

Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent : 12-month results from the FLEX Registry. / Lemos, Pedro A.; Chandwani, Prakash; Saxena, Sudheer; Ramachandran, Padma Kumar; Abhyankar, Atul; Campos, Carlos M.; Marchini, Julio Flavio; Galon, Micheli Zanotti; Verma, Puneet; Sandhu, Manjinder Singh; Parikh, Nikhil; Bhupali, Ashok; Jain, Sharad; Prajapati, Jayesh.

In: BMJ Open, Vol. 6, No. 2, 010028, 01.01.2016.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent

T2 - 12-month results from the FLEX Registry

AU - Lemos, Pedro A.

AU - Chandwani, Prakash

AU - Saxena, Sudheer

AU - Ramachandran, Padma Kumar

AU - Abhyankar, Atul

AU - Campos, Carlos M.

AU - Marchini, Julio Flavio

AU - Galon, Micheli Zanotti

AU - Verma, Puneet

AU - Sandhu, Manjinder Singh

AU - Parikh, Nikhil

AU - Bhupali, Ashok

AU - Jain, Sharad

AU - Prajapati, Jayesh

PY - 2016/1/1

Y1 - 2016/1/1

N2 - Objectives: To evaluate, in the FLEX Registry, clinical outcomes of an ultrathin (60 μm) biodegradable polymer-coated Supraflex sirolimus-eluting stent (SES) for the treatment of coronary artery disease. Additionally, to determine the vascular response to the Supraflex SES through optical coherence tomography (OCT) analysis. Setting: Multicentre, single-arm, all-comers, observational registry of patients who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. Participants: 995 patients (1242 lesions) who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. A total of 47 participants underwent OCT analysis at 6 months' follow-up. Interventions: Percutaneous coronary intervention with Supraflex SES, Primary and secondary outcome measures: The primary endpoint-the rate of major adverse cardiac events (defined as a composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR))-was analysed during 12 months. Results: At 12 months, the primary endpoint occurred in 36 (3.7%) of 980 patients, consisting of 18 (1.8%) cardiac deaths, 16 (1.6%) MI, 7 (0.7%) TLR and 2 (0.2%) cases of non-target lesion target vessel revascularization. In a subset of 47 patients, 1227 cross-sections (9309 struts) were analysed at 6 months by OCT. Overall, a high percentage of struts was covered (98.1%), with a mean neointimal thickness of 0.13±0.06 μm. Conclusions: The FLEX Registry evaluated clinical outcomes in real-world and more complex cohorts and thus provides evidence that the Supraflex SEX can be used safely and routinely in a broader percutaneous coronary intervention population. Also, the Supraflex SES showed high percentage of stent strut coverage and good stent apposition during OCT follow-up.

AB - Objectives: To evaluate, in the FLEX Registry, clinical outcomes of an ultrathin (60 μm) biodegradable polymer-coated Supraflex sirolimus-eluting stent (SES) for the treatment of coronary artery disease. Additionally, to determine the vascular response to the Supraflex SES through optical coherence tomography (OCT) analysis. Setting: Multicentre, single-arm, all-comers, observational registry of patients who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. Participants: 995 patients (1242 lesions) who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. A total of 47 participants underwent OCT analysis at 6 months' follow-up. Interventions: Percutaneous coronary intervention with Supraflex SES, Primary and secondary outcome measures: The primary endpoint-the rate of major adverse cardiac events (defined as a composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR))-was analysed during 12 months. Results: At 12 months, the primary endpoint occurred in 36 (3.7%) of 980 patients, consisting of 18 (1.8%) cardiac deaths, 16 (1.6%) MI, 7 (0.7%) TLR and 2 (0.2%) cases of non-target lesion target vessel revascularization. In a subset of 47 patients, 1227 cross-sections (9309 struts) were analysed at 6 months by OCT. Overall, a high percentage of struts was covered (98.1%), with a mean neointimal thickness of 0.13±0.06 μm. Conclusions: The FLEX Registry evaluated clinical outcomes in real-world and more complex cohorts and thus provides evidence that the Supraflex SEX can be used safely and routinely in a broader percutaneous coronary intervention population. Also, the Supraflex SES showed high percentage of stent strut coverage and good stent apposition during OCT follow-up.

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