Safety and Efficacy of New-Generation Drug-Eluting Stents in Women Undergoing Complex Percutaneous Coronary Artery Revascularization from the WIN-DES Collaborative Patient-Level Pooled Analysis

Gennaro Giustino, Usman Baber, Melissa Aquino, Samantha Sartori, Gregg W. Stone, Martin B. Leon, Philippe Genereux, George D. Dangas, Jaya Chandrasekhar, Takeshi Kimura, Olga Salianski, Giulio G. Stefanini, P. Gabriel Steg, Stephan Windecker, William Wijns, Patrick W. Serruys, Marco Valgimigli, Marie Claude Morice, Edoardo Camenzind, Giora Weisz & 14 others Pieter C. Smits, David E. Kandzari, Soren Galatius, Clemens Von Birgelen, Robert Saporito, Raban V. Jeger, Ghada W. Mikhail, Dipti Itchhaporia, Laxmi Mehta, Rebecca Ortega, Hyo Soo Kim, Adnan Kastrati, Alaide Chieffo, Roxana Mehran

Research output: Contribution to journalArticle

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Abstract

Objectives The purpose of this study was to investigate the safety and efficacy of new-generation drug-eluting stents (DES) versus early-generation DES in women undergoing complex percutaneous coronary intervention (CPCI). Background Whether the benefits of new-generation DES are preserved in women undergoing complex percutaneous revascularization is unknown. Methods We pooled patient-level data from women enrolled in 26 randomized trials of DES. Study population was categorized according to the presence or absence of CPCI, which was defined as the composite of total stent length >30 mm, ≥2 stents implanted, ≥2 lesions treated, or bifurcation lesion as target vessel. The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. Results Of 10,241 women included in the pooled database, 4,629 (45%) underwent CPCI. Compared with non-CPCI, women who underwent CPCI had a higher 3-year risk of MACE (adjusted hazard ratio [HR]: 1.63; 95% confidence interval [CI]: 1.45 to 1.83; p < 0.0001). In women who underwent CPCI, use of new-generation DES was associated with significantly lower 3-year risk of MACE (adjusted HR: 0.81; 95% CI: 0.68 to 0.96), target lesion revascularization (adjusted HR: 0.74; 95% CI: 0.57 to 0.95), and definite or probable stent thrombosis (ST) (adjusted HR: 0.50; 95% CI: 0.30 to 0.83). The benefit of new-generation DES on efficacy and safety outcomes was uniform between CPCI and non-CPCI groups, without evidence of interaction. By landmark analysis, new-generation DES were associated with low rates (≤0.4%) of very-late ST irrespective of procedural complexity. Conclusions Women undergoing CPCI remain at higher risk of adverse events. The long-term ischemic benefits of new-generation DES platforms are uniform among complex and non-complex percutaneous revascularization procedures in women.

Original languageEnglish (US)
Pages (from-to)674-684
Number of pages11
JournalJACC: Cardiovascular Interventions
Volume9
Issue number7
DOIs
StatePublished - Apr 11 2016

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Drug-Eluting Stents
Percutaneous Coronary Intervention
Coronary Vessels
Safety
Stents
Confidence Intervals
Thrombosis
Myocardial Infarction
Databases
Mortality

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Giustino, Gennaro ; Baber, Usman ; Aquino, Melissa ; Sartori, Samantha ; Stone, Gregg W. ; Leon, Martin B. ; Genereux, Philippe ; Dangas, George D. ; Chandrasekhar, Jaya ; Kimura, Takeshi ; Salianski, Olga ; Stefanini, Giulio G. ; Steg, P. Gabriel ; Windecker, Stephan ; Wijns, William ; Serruys, Patrick W. ; Valgimigli, Marco ; Morice, Marie Claude ; Camenzind, Edoardo ; Weisz, Giora ; Smits, Pieter C. ; Kandzari, David E. ; Galatius, Soren ; Von Birgelen, Clemens ; Saporito, Robert ; Jeger, Raban V. ; Mikhail, Ghada W. ; Itchhaporia, Dipti ; Mehta, Laxmi ; Ortega, Rebecca ; Kim, Hyo Soo ; Kastrati, Adnan ; Chieffo, Alaide ; Mehran, Roxana. / Safety and Efficacy of New-Generation Drug-Eluting Stents in Women Undergoing Complex Percutaneous Coronary Artery Revascularization from the WIN-DES Collaborative Patient-Level Pooled Analysis. In: JACC: Cardiovascular Interventions. 2016 ; Vol. 9, No. 7. pp. 674-684.
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title = "Safety and Efficacy of New-Generation Drug-Eluting Stents in Women Undergoing Complex Percutaneous Coronary Artery Revascularization from the WIN-DES Collaborative Patient-Level Pooled Analysis",
abstract = "Objectives The purpose of this study was to investigate the safety and efficacy of new-generation drug-eluting stents (DES) versus early-generation DES in women undergoing complex percutaneous coronary intervention (CPCI). Background Whether the benefits of new-generation DES are preserved in women undergoing complex percutaneous revascularization is unknown. Methods We pooled patient-level data from women enrolled in 26 randomized trials of DES. Study population was categorized according to the presence or absence of CPCI, which was defined as the composite of total stent length >30 mm, ≥2 stents implanted, ≥2 lesions treated, or bifurcation lesion as target vessel. The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. Results Of 10,241 women included in the pooled database, 4,629 (45{\%}) underwent CPCI. Compared with non-CPCI, women who underwent CPCI had a higher 3-year risk of MACE (adjusted hazard ratio [HR]: 1.63; 95{\%} confidence interval [CI]: 1.45 to 1.83; p < 0.0001). In women who underwent CPCI, use of new-generation DES was associated with significantly lower 3-year risk of MACE (adjusted HR: 0.81; 95{\%} CI: 0.68 to 0.96), target lesion revascularization (adjusted HR: 0.74; 95{\%} CI: 0.57 to 0.95), and definite or probable stent thrombosis (ST) (adjusted HR: 0.50; 95{\%} CI: 0.30 to 0.83). The benefit of new-generation DES on efficacy and safety outcomes was uniform between CPCI and non-CPCI groups, without evidence of interaction. By landmark analysis, new-generation DES were associated with low rates (≤0.4{\%}) of very-late ST irrespective of procedural complexity. Conclusions Women undergoing CPCI remain at higher risk of adverse events. The long-term ischemic benefits of new-generation DES platforms are uniform among complex and non-complex percutaneous revascularization procedures in women.",
author = "Gennaro Giustino and Usman Baber and Melissa Aquino and Samantha Sartori and Stone, {Gregg W.} and Leon, {Martin B.} and Philippe Genereux and Dangas, {George D.} and Jaya Chandrasekhar and Takeshi Kimura and Olga Salianski and Stefanini, {Giulio G.} and Steg, {P. Gabriel} and Stephan Windecker and William Wijns and Serruys, {Patrick W.} and Marco Valgimigli and Morice, {Marie Claude} and Edoardo Camenzind and Giora Weisz and Smits, {Pieter C.} and Kandzari, {David E.} and Soren Galatius and {Von Birgelen}, Clemens and Robert Saporito and Jeger, {Raban V.} and Mikhail, {Ghada W.} and Dipti Itchhaporia and Laxmi Mehta and Rebecca Ortega and Kim, {Hyo Soo} and Adnan Kastrati and Alaide Chieffo and Roxana Mehran",
year = "2016",
month = "4",
day = "11",
doi = "10.1016/j.jcin.2015.12.013",
language = "English (US)",
volume = "9",
pages = "674--684",
journal = "JACC: Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "7",

}

Giustino, G, Baber, U, Aquino, M, Sartori, S, Stone, GW, Leon, MB, Genereux, P, Dangas, GD, Chandrasekhar, J, Kimura, T, Salianski, O, Stefanini, GG, Steg, PG, Windecker, S, Wijns, W, Serruys, PW, Valgimigli, M, Morice, MC, Camenzind, E, Weisz, G, Smits, PC, Kandzari, DE, Galatius, S, Von Birgelen, C, Saporito, R, Jeger, RV, Mikhail, GW, Itchhaporia, D, Mehta, L, Ortega, R, Kim, HS, Kastrati, A, Chieffo, A & Mehran, R 2016, 'Safety and Efficacy of New-Generation Drug-Eluting Stents in Women Undergoing Complex Percutaneous Coronary Artery Revascularization from the WIN-DES Collaborative Patient-Level Pooled Analysis', JACC: Cardiovascular Interventions, vol. 9, no. 7, pp. 674-684. https://doi.org/10.1016/j.jcin.2015.12.013

Safety and Efficacy of New-Generation Drug-Eluting Stents in Women Undergoing Complex Percutaneous Coronary Artery Revascularization from the WIN-DES Collaborative Patient-Level Pooled Analysis. / Giustino, Gennaro; Baber, Usman; Aquino, Melissa; Sartori, Samantha; Stone, Gregg W.; Leon, Martin B.; Genereux, Philippe; Dangas, George D.; Chandrasekhar, Jaya; Kimura, Takeshi; Salianski, Olga; Stefanini, Giulio G.; Steg, P. Gabriel; Windecker, Stephan; Wijns, William; Serruys, Patrick W.; Valgimigli, Marco; Morice, Marie Claude; Camenzind, Edoardo; Weisz, Giora; Smits, Pieter C.; Kandzari, David E.; Galatius, Soren; Von Birgelen, Clemens; Saporito, Robert; Jeger, Raban V.; Mikhail, Ghada W.; Itchhaporia, Dipti; Mehta, Laxmi; Ortega, Rebecca; Kim, Hyo Soo; Kastrati, Adnan; Chieffo, Alaide; Mehran, Roxana.

In: JACC: Cardiovascular Interventions, Vol. 9, No. 7, 11.04.2016, p. 674-684.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety and Efficacy of New-Generation Drug-Eluting Stents in Women Undergoing Complex Percutaneous Coronary Artery Revascularization from the WIN-DES Collaborative Patient-Level Pooled Analysis

AU - Giustino, Gennaro

AU - Baber, Usman

AU - Aquino, Melissa

AU - Sartori, Samantha

AU - Stone, Gregg W.

AU - Leon, Martin B.

AU - Genereux, Philippe

AU - Dangas, George D.

AU - Chandrasekhar, Jaya

AU - Kimura, Takeshi

AU - Salianski, Olga

AU - Stefanini, Giulio G.

AU - Steg, P. Gabriel

AU - Windecker, Stephan

AU - Wijns, William

AU - Serruys, Patrick W.

AU - Valgimigli, Marco

AU - Morice, Marie Claude

AU - Camenzind, Edoardo

AU - Weisz, Giora

AU - Smits, Pieter C.

AU - Kandzari, David E.

AU - Galatius, Soren

AU - Von Birgelen, Clemens

AU - Saporito, Robert

AU - Jeger, Raban V.

AU - Mikhail, Ghada W.

AU - Itchhaporia, Dipti

AU - Mehta, Laxmi

AU - Ortega, Rebecca

AU - Kim, Hyo Soo

AU - Kastrati, Adnan

AU - Chieffo, Alaide

AU - Mehran, Roxana

PY - 2016/4/11

Y1 - 2016/4/11

N2 - Objectives The purpose of this study was to investigate the safety and efficacy of new-generation drug-eluting stents (DES) versus early-generation DES in women undergoing complex percutaneous coronary intervention (CPCI). Background Whether the benefits of new-generation DES are preserved in women undergoing complex percutaneous revascularization is unknown. Methods We pooled patient-level data from women enrolled in 26 randomized trials of DES. Study population was categorized according to the presence or absence of CPCI, which was defined as the composite of total stent length >30 mm, ≥2 stents implanted, ≥2 lesions treated, or bifurcation lesion as target vessel. The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. Results Of 10,241 women included in the pooled database, 4,629 (45%) underwent CPCI. Compared with non-CPCI, women who underwent CPCI had a higher 3-year risk of MACE (adjusted hazard ratio [HR]: 1.63; 95% confidence interval [CI]: 1.45 to 1.83; p < 0.0001). In women who underwent CPCI, use of new-generation DES was associated with significantly lower 3-year risk of MACE (adjusted HR: 0.81; 95% CI: 0.68 to 0.96), target lesion revascularization (adjusted HR: 0.74; 95% CI: 0.57 to 0.95), and definite or probable stent thrombosis (ST) (adjusted HR: 0.50; 95% CI: 0.30 to 0.83). The benefit of new-generation DES on efficacy and safety outcomes was uniform between CPCI and non-CPCI groups, without evidence of interaction. By landmark analysis, new-generation DES were associated with low rates (≤0.4%) of very-late ST irrespective of procedural complexity. Conclusions Women undergoing CPCI remain at higher risk of adverse events. The long-term ischemic benefits of new-generation DES platforms are uniform among complex and non-complex percutaneous revascularization procedures in women.

AB - Objectives The purpose of this study was to investigate the safety and efficacy of new-generation drug-eluting stents (DES) versus early-generation DES in women undergoing complex percutaneous coronary intervention (CPCI). Background Whether the benefits of new-generation DES are preserved in women undergoing complex percutaneous revascularization is unknown. Methods We pooled patient-level data from women enrolled in 26 randomized trials of DES. Study population was categorized according to the presence or absence of CPCI, which was defined as the composite of total stent length >30 mm, ≥2 stents implanted, ≥2 lesions treated, or bifurcation lesion as target vessel. The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. Results Of 10,241 women included in the pooled database, 4,629 (45%) underwent CPCI. Compared with non-CPCI, women who underwent CPCI had a higher 3-year risk of MACE (adjusted hazard ratio [HR]: 1.63; 95% confidence interval [CI]: 1.45 to 1.83; p < 0.0001). In women who underwent CPCI, use of new-generation DES was associated with significantly lower 3-year risk of MACE (adjusted HR: 0.81; 95% CI: 0.68 to 0.96), target lesion revascularization (adjusted HR: 0.74; 95% CI: 0.57 to 0.95), and definite or probable stent thrombosis (ST) (adjusted HR: 0.50; 95% CI: 0.30 to 0.83). The benefit of new-generation DES on efficacy and safety outcomes was uniform between CPCI and non-CPCI groups, without evidence of interaction. By landmark analysis, new-generation DES were associated with low rates (≤0.4%) of very-late ST irrespective of procedural complexity. Conclusions Women undergoing CPCI remain at higher risk of adverse events. The long-term ischemic benefits of new-generation DES platforms are uniform among complex and non-complex percutaneous revascularization procedures in women.

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DO - 10.1016/j.jcin.2015.12.013

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JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

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