Comparison of clinical outcomes following single versus multivessel percutaneous coronary intervention using biodegradable polymer coated sirolimus-eluting stent in an all-comers patient population

Prakash Chandwani, Puneet Verma, Sudheer Saxena, Padma K. Ramachandran, Atul Abhyankar, Manjinder S. Sandhu, Nikhil Parikh, Ashok Bhupali, Sharad Jain, Jayesh Prajapati

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: Drug-eluting stents (DES) have been shown to reduce the rate of acute complications and the need for subsequent revascularization in cases where single-vessels are treated. The performance of DES in patients with multivessel disease and complex lesions, however, remains controversial. This study assessed and compared clinical outcomes following single vs. multivessel percutaneous coronary intervention (PCI), using the Supraflex sirolimus-eluting stent (SES), in an all-comers patient population. Methods: We conducted retrospective, multicenter, all-comers, observational study of 995 patients, who underwent either single-vessel PCI (n=769 patients; group-I) or multivessel PCI (n=226 patients; group-II), treated with the biodegradable polymer coated Supraflex SES, between July-2013 and May-2014 at nine different centers in India. Pre-specified primary endpoint, rate of major adverse cardiac events (MACE) [defined as composite of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and non-target lesion target vessel revascularization (non-TL TVR)], was analyzed during 12 months after the post-index procedure. We also analyzed the incidence of stent thrombosis (ST) as a safety endpoint during the follow-up period, as defined by the Academic Research Consortium (ARC). Results: Of the whole study group, 1,242 lesions were treated in 995 patients (mean age 61.6±10.8 years; 80.0% male) with average stent length of 26.8±9.3 mm. Multivessel PCI patients were older, had a higher prevalence of arterial hypertension, were smoker, had a family history of coronary artery disease, previous stroke and previous PCI compared to single-vessel PCI patients. Follow-up was available in 99.0% (761/769) of patients with single-vessel intervention and 96.9% (219/226) of patients with multivessel intervention at the end of 12 months. In-hospital MACE was similar for both the groups [group-I, 3 (0.4%) vs. group-II, 1 (0.4%); p=1.000]. The observed MACE for group-I and group-II, at 30 days, 6 and 12 months follow-up were 9 (1.2%) vs. 2 (0.9%); p=1.000, 15 (2.0%) vs. 7 (3.2%); p=0.302 and 24 (3.2%) vs. 12 (5.5%); p=0.109, respectively. The cumulative incidence curves for MACE showed no significant differences between the two groups, at the end of 12 months (p=0.109). Conclusion: Our study shows that use of the Supraflex SES in single and multivessel coronary artery disease produces good clinical outcomes during 12 months of follow-up with a low rate of revascularization, despite complex lesion morphology.

Original languageEnglish
Pages (from-to)39-48
Number of pages10
JournalCardiovascular and Hematological Agents in Medicinal Chemistry
Volume14
Issue number1
DOIs
Publication statusPublished - 01-04-2016
Externally publishedYes

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Sirolimus
Percutaneous Coronary Intervention
Stents
Polymers
Population
Drug-Eluting Stents
Coronary Artery Disease
Incidence
Observational Studies
India
Thrombosis
Stroke
Myocardial Infarction
Hypertension
Safety

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Chandwani, Prakash ; Verma, Puneet ; Saxena, Sudheer ; Ramachandran, Padma K. ; Abhyankar, Atul ; Sandhu, Manjinder S. ; Parikh, Nikhil ; Bhupali, Ashok ; Jain, Sharad ; Prajapati, Jayesh. / Comparison of clinical outcomes following single versus multivessel percutaneous coronary intervention using biodegradable polymer coated sirolimus-eluting stent in an all-comers patient population. In: Cardiovascular and Hematological Agents in Medicinal Chemistry. 2016 ; Vol. 14, No. 1. pp. 39-48.
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abstract = "Background: Drug-eluting stents (DES) have been shown to reduce the rate of acute complications and the need for subsequent revascularization in cases where single-vessels are treated. The performance of DES in patients with multivessel disease and complex lesions, however, remains controversial. This study assessed and compared clinical outcomes following single vs. multivessel percutaneous coronary intervention (PCI), using the Supraflex sirolimus-eluting stent (SES), in an all-comers patient population. Methods: We conducted retrospective, multicenter, all-comers, observational study of 995 patients, who underwent either single-vessel PCI (n=769 patients; group-I) or multivessel PCI (n=226 patients; group-II), treated with the biodegradable polymer coated Supraflex SES, between July-2013 and May-2014 at nine different centers in India. Pre-specified primary endpoint, rate of major adverse cardiac events (MACE) [defined as composite of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and non-target lesion target vessel revascularization (non-TL TVR)], was analyzed during 12 months after the post-index procedure. We also analyzed the incidence of stent thrombosis (ST) as a safety endpoint during the follow-up period, as defined by the Academic Research Consortium (ARC). Results: Of the whole study group, 1,242 lesions were treated in 995 patients (mean age 61.6±10.8 years; 80.0{\%} male) with average stent length of 26.8±9.3 mm. Multivessel PCI patients were older, had a higher prevalence of arterial hypertension, were smoker, had a family history of coronary artery disease, previous stroke and previous PCI compared to single-vessel PCI patients. Follow-up was available in 99.0{\%} (761/769) of patients with single-vessel intervention and 96.9{\%} (219/226) of patients with multivessel intervention at the end of 12 months. In-hospital MACE was similar for both the groups [group-I, 3 (0.4{\%}) vs. group-II, 1 (0.4{\%}); p=1.000]. The observed MACE for group-I and group-II, at 30 days, 6 and 12 months follow-up were 9 (1.2{\%}) vs. 2 (0.9{\%}); p=1.000, 15 (2.0{\%}) vs. 7 (3.2{\%}); p=0.302 and 24 (3.2{\%}) vs. 12 (5.5{\%}); p=0.109, respectively. The cumulative incidence curves for MACE showed no significant differences between the two groups, at the end of 12 months (p=0.109). Conclusion: Our study shows that use of the Supraflex SES in single and multivessel coronary artery disease produces good clinical outcomes during 12 months of follow-up with a low rate of revascularization, despite complex lesion morphology.",
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Comparison of clinical outcomes following single versus multivessel percutaneous coronary intervention using biodegradable polymer coated sirolimus-eluting stent in an all-comers patient population. / Chandwani, Prakash; Verma, Puneet; Saxena, Sudheer; Ramachandran, Padma K.; Abhyankar, Atul; Sandhu, Manjinder S.; Parikh, Nikhil; Bhupali, Ashok; Jain, Sharad; Prajapati, Jayesh.

In: Cardiovascular and Hematological Agents in Medicinal Chemistry, Vol. 14, No. 1, 01.04.2016, p. 39-48.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Comparison of clinical outcomes following single versus multivessel percutaneous coronary intervention using biodegradable polymer coated sirolimus-eluting stent in an all-comers patient population

AU - Chandwani, Prakash

AU - Verma, Puneet

AU - Saxena, Sudheer

AU - Ramachandran, Padma K.

AU - Abhyankar, Atul

AU - Sandhu, Manjinder S.

AU - Parikh, Nikhil

AU - Bhupali, Ashok

AU - Jain, Sharad

AU - Prajapati, Jayesh

PY - 2016/4/1

Y1 - 2016/4/1

N2 - Background: Drug-eluting stents (DES) have been shown to reduce the rate of acute complications and the need for subsequent revascularization in cases where single-vessels are treated. The performance of DES in patients with multivessel disease and complex lesions, however, remains controversial. This study assessed and compared clinical outcomes following single vs. multivessel percutaneous coronary intervention (PCI), using the Supraflex sirolimus-eluting stent (SES), in an all-comers patient population. Methods: We conducted retrospective, multicenter, all-comers, observational study of 995 patients, who underwent either single-vessel PCI (n=769 patients; group-I) or multivessel PCI (n=226 patients; group-II), treated with the biodegradable polymer coated Supraflex SES, between July-2013 and May-2014 at nine different centers in India. Pre-specified primary endpoint, rate of major adverse cardiac events (MACE) [defined as composite of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and non-target lesion target vessel revascularization (non-TL TVR)], was analyzed during 12 months after the post-index procedure. We also analyzed the incidence of stent thrombosis (ST) as a safety endpoint during the follow-up period, as defined by the Academic Research Consortium (ARC). Results: Of the whole study group, 1,242 lesions were treated in 995 patients (mean age 61.6±10.8 years; 80.0% male) with average stent length of 26.8±9.3 mm. Multivessel PCI patients were older, had a higher prevalence of arterial hypertension, were smoker, had a family history of coronary artery disease, previous stroke and previous PCI compared to single-vessel PCI patients. Follow-up was available in 99.0% (761/769) of patients with single-vessel intervention and 96.9% (219/226) of patients with multivessel intervention at the end of 12 months. In-hospital MACE was similar for both the groups [group-I, 3 (0.4%) vs. group-II, 1 (0.4%); p=1.000]. The observed MACE for group-I and group-II, at 30 days, 6 and 12 months follow-up were 9 (1.2%) vs. 2 (0.9%); p=1.000, 15 (2.0%) vs. 7 (3.2%); p=0.302 and 24 (3.2%) vs. 12 (5.5%); p=0.109, respectively. The cumulative incidence curves for MACE showed no significant differences between the two groups, at the end of 12 months (p=0.109). Conclusion: Our study shows that use of the Supraflex SES in single and multivessel coronary artery disease produces good clinical outcomes during 12 months of follow-up with a low rate of revascularization, despite complex lesion morphology.

AB - Background: Drug-eluting stents (DES) have been shown to reduce the rate of acute complications and the need for subsequent revascularization in cases where single-vessels are treated. The performance of DES in patients with multivessel disease and complex lesions, however, remains controversial. This study assessed and compared clinical outcomes following single vs. multivessel percutaneous coronary intervention (PCI), using the Supraflex sirolimus-eluting stent (SES), in an all-comers patient population. Methods: We conducted retrospective, multicenter, all-comers, observational study of 995 patients, who underwent either single-vessel PCI (n=769 patients; group-I) or multivessel PCI (n=226 patients; group-II), treated with the biodegradable polymer coated Supraflex SES, between July-2013 and May-2014 at nine different centers in India. Pre-specified primary endpoint, rate of major adverse cardiac events (MACE) [defined as composite of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and non-target lesion target vessel revascularization (non-TL TVR)], was analyzed during 12 months after the post-index procedure. We also analyzed the incidence of stent thrombosis (ST) as a safety endpoint during the follow-up period, as defined by the Academic Research Consortium (ARC). Results: Of the whole study group, 1,242 lesions were treated in 995 patients (mean age 61.6±10.8 years; 80.0% male) with average stent length of 26.8±9.3 mm. Multivessel PCI patients were older, had a higher prevalence of arterial hypertension, were smoker, had a family history of coronary artery disease, previous stroke and previous PCI compared to single-vessel PCI patients. Follow-up was available in 99.0% (761/769) of patients with single-vessel intervention and 96.9% (219/226) of patients with multivessel intervention at the end of 12 months. In-hospital MACE was similar for both the groups [group-I, 3 (0.4%) vs. group-II, 1 (0.4%); p=1.000]. The observed MACE for group-I and group-II, at 30 days, 6 and 12 months follow-up were 9 (1.2%) vs. 2 (0.9%); p=1.000, 15 (2.0%) vs. 7 (3.2%); p=0.302 and 24 (3.2%) vs. 12 (5.5%); p=0.109, respectively. The cumulative incidence curves for MACE showed no significant differences between the two groups, at the end of 12 months (p=0.109). Conclusion: Our study shows that use of the Supraflex SES in single and multivessel coronary artery disease produces good clinical outcomes during 12 months of follow-up with a low rate of revascularization, despite complex lesion morphology.

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