Safety and efficacy of new-generation drug-eluting stents in women at high risk for atherothrombosis: From the women in innovation and drug-eluting stents collaborative patient-level pooled analysis

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

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Background - The safety and efficacy of new-generation drug-eluting stents (DES) in women with multiple atherothrombotic risk (ATR) factors is unclear. Methods and Results - We pooled patient-level data for women enrolled in 26 randomized trials. Study population was categorized based on the presence or absence of high ATR, which was defined as having history of diabetes mellitus, prior percutaneous or surgical coronary revascularization, or prior myocardial infarction. The primary end point was major adverse cardiovascular events defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. Out of 10 449 women included in the pooled database, 5333 (51%) were at high ATR. Compared with women not at high ATR, those at high ATR had significantly higher risk of major adverse cardiovascular events (15.8% versus 10.6%; adjusted hazard ratio: 1.53; 95% confidence interval: 1.34-1.75; P=0.006) and all-cause mortality. In high-ATR risk women, the use of new-generation DES was associated with significantly lower risk of 3-year major adverse cardiovascular events (adjusted hazard ratio: 0.69; 95% confidence interval: 0.52-0.92) compared with early-generation DES. The benefit of new-generation DES on major adverse cardiovascular events was uniform between high-ATR and non-high-ATR women, without evidence of interaction (Pinteraction=0.14). At landmark analysis, in high-ATR women, stent thrombosis rates were comparable between DES generations in the first year, whereas between 1 and 3 years, stent thrombosis risk was lower with new-generation devices. Conclusions - Use of new-generation DES even in women at high ATR is associated with a benefit consistent over 3 years of follow-up and a substantial improvement in very-late thrombotic safety.

Original languageEnglish (US)
JournalCirculation: Cardiovascular Interventions
Volume9
Issue number1
DOIs
StatePublished - Jan 1 2016

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Drug-Eluting Stents
Safety
Stents
Thrombosis
Myocardial Infarction
Confidence Intervals
Mortality
Diabetes Mellitus

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Giustino, Gennaro ; Baber, Usman ; Salianski, Olga ; Sartori, Samantha ; Stone, Gregg W. ; Leon, Martin B. ; Aquino, Melissa ; Stefanini, Giulio G. ; Steg, P. Gabriel ; Windecker, Stephan ; O'Donoghue, Monica ; Wijns, William ; Serruys, Patrick W. ; Valgimigli, Marco ; Morice, Marie Claude ; Camenzind, Edoardo ; Weisz, Giora ; Smits, Pieter C. ; Kandzari, David ; Von Birgelen, Clemens ; Dangas, George D. ; Cha, Jin Y. ; Galatius, Soren ; Jeger, Raban V. ; Kimura, Takeshi ; Mikhail, Ghada W. ; Itchhaporia, Dipti ; Mehta, Laxmi ; Ortega, Rebecca ; Kim, Hyo Soo ; Kastrati, Adnan ; Genereux, Philippe ; Chieffo, Alaide ; Mehran, Roxana. / Safety and efficacy of new-generation drug-eluting stents in women at high risk for atherothrombosis : From the women in innovation and drug-eluting stents collaborative patient-level pooled analysis. In: Circulation: Cardiovascular Interventions. 2016 ; Vol. 9, No. 1.
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abstract = "Background - The safety and efficacy of new-generation drug-eluting stents (DES) in women with multiple atherothrombotic risk (ATR) factors is unclear. Methods and Results - We pooled patient-level data for women enrolled in 26 randomized trials. Study population was categorized based on the presence or absence of high ATR, which was defined as having history of diabetes mellitus, prior percutaneous or surgical coronary revascularization, or prior myocardial infarction. The primary end point was major adverse cardiovascular events defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. Out of 10 449 women included in the pooled database, 5333 (51{\%}) were at high ATR. Compared with women not at high ATR, those at high ATR had significantly higher risk of major adverse cardiovascular events (15.8{\%} versus 10.6{\%}; adjusted hazard ratio: 1.53; 95{\%} confidence interval: 1.34-1.75; P=0.006) and all-cause mortality. In high-ATR risk women, the use of new-generation DES was associated with significantly lower risk of 3-year major adverse cardiovascular events (adjusted hazard ratio: 0.69; 95{\%} confidence interval: 0.52-0.92) compared with early-generation DES. The benefit of new-generation DES on major adverse cardiovascular events was uniform between high-ATR and non-high-ATR women, without evidence of interaction (Pinteraction=0.14). At landmark analysis, in high-ATR women, stent thrombosis rates were comparable between DES generations in the first year, whereas between 1 and 3 years, stent thrombosis risk was lower with new-generation devices. Conclusions - Use of new-generation DES even in women at high ATR is associated with a benefit consistent over 3 years of follow-up and a substantial improvement in very-late thrombotic safety.",
author = "Gennaro Giustino and Usman Baber and Olga Salianski and Samantha Sartori and Stone, {Gregg W.} and Leon, {Martin B.} and Melissa Aquino and Stefanini, {Giulio G.} and Steg, {P. Gabriel} and Stephan Windecker and Monica O'Donoghue 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 David Kandzari and {Von Birgelen}, Clemens and Dangas, {George D.} and Cha, {Jin Y.} and Soren Galatius and Jeger, {Raban V.} and Takeshi Kimura and Mikhail, {Ghada W.} and Dipti Itchhaporia and Laxmi Mehta and Rebecca Ortega and Kim, {Hyo Soo} and Adnan Kastrati and Philippe Genereux and Alaide Chieffo and Roxana Mehran",
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doi = "10.1161/CIRCINTERVENTIONS.115.002995",
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Giustino, G, Baber, U, Salianski, O, Sartori, S, Stone, GW, Leon, MB, Aquino, M, Stefanini, GG, Steg, PG, Windecker, S, O'Donoghue, M, Wijns, W, Serruys, PW, Valgimigli, M, Morice, MC, Camenzind, E, Weisz, G, Smits, PC, Kandzari, D, Von Birgelen, C, Dangas, GD, Cha, JY, Galatius, S, Jeger, RV, Kimura, T, Mikhail, GW, Itchhaporia, D, Mehta, L, Ortega, R, Kim, HS, Kastrati, A, Genereux, P, Chieffo, A & Mehran, R 2016, 'Safety and efficacy of new-generation drug-eluting stents in women at high risk for atherothrombosis: From the women in innovation and drug-eluting stents collaborative patient-level pooled analysis', Circulation: Cardiovascular Interventions, vol. 9, no. 1. https://doi.org/10.1161/CIRCINTERVENTIONS.115.002995

Safety and efficacy of new-generation drug-eluting stents in women at high risk for atherothrombosis : From the women in innovation and drug-eluting stents collaborative patient-level pooled analysis. / Giustino, Gennaro; Baber, Usman; Salianski, Olga; Sartori, Samantha; Stone, Gregg W.; Leon, Martin B.; Aquino, Melissa; Stefanini, Giulio G.; Steg, P. Gabriel; Windecker, Stephan; O'Donoghue, Monica; Wijns, William; Serruys, Patrick W.; Valgimigli, Marco; Morice, Marie Claude; Camenzind, Edoardo; Weisz, Giora; Smits, Pieter C.; Kandzari, David; Von Birgelen, Clemens; Dangas, George D.; Cha, Jin Y.; Galatius, Soren; Jeger, Raban V.; Kimura, Takeshi; Mikhail, Ghada W.; Itchhaporia, Dipti; Mehta, Laxmi; Ortega, Rebecca; Kim, Hyo Soo; Kastrati, Adnan; Genereux, Philippe; Chieffo, Alaide; Mehran, Roxana.

In: Circulation: Cardiovascular Interventions, Vol. 9, No. 1, 01.01.2016.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety and efficacy of new-generation drug-eluting stents in women at high risk for atherothrombosis

T2 - From the women in innovation and drug-eluting stents collaborative patient-level pooled analysis

AU - Giustino, Gennaro

AU - Baber, Usman

AU - Salianski, Olga

AU - Sartori, Samantha

AU - Stone, Gregg W.

AU - Leon, Martin B.

AU - Aquino, Melissa

AU - Stefanini, Giulio G.

AU - Steg, P. Gabriel

AU - Windecker, Stephan

AU - O'Donoghue, Monica

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

AU - Von Birgelen, Clemens

AU - Dangas, George D.

AU - Cha, Jin Y.

AU - Galatius, Soren

AU - Jeger, Raban V.

AU - Kimura, Takeshi

AU - Mikhail, Ghada W.

AU - Itchhaporia, Dipti

AU - Mehta, Laxmi

AU - Ortega, Rebecca

AU - Kim, Hyo Soo

AU - Kastrati, Adnan

AU - Genereux, Philippe

AU - Chieffo, Alaide

AU - Mehran, Roxana

PY - 2016/1/1

Y1 - 2016/1/1

N2 - Background - The safety and efficacy of new-generation drug-eluting stents (DES) in women with multiple atherothrombotic risk (ATR) factors is unclear. Methods and Results - We pooled patient-level data for women enrolled in 26 randomized trials. Study population was categorized based on the presence or absence of high ATR, which was defined as having history of diabetes mellitus, prior percutaneous or surgical coronary revascularization, or prior myocardial infarction. The primary end point was major adverse cardiovascular events defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. Out of 10 449 women included in the pooled database, 5333 (51%) were at high ATR. Compared with women not at high ATR, those at high ATR had significantly higher risk of major adverse cardiovascular events (15.8% versus 10.6%; adjusted hazard ratio: 1.53; 95% confidence interval: 1.34-1.75; P=0.006) and all-cause mortality. In high-ATR risk women, the use of new-generation DES was associated with significantly lower risk of 3-year major adverse cardiovascular events (adjusted hazard ratio: 0.69; 95% confidence interval: 0.52-0.92) compared with early-generation DES. The benefit of new-generation DES on major adverse cardiovascular events was uniform between high-ATR and non-high-ATR women, without evidence of interaction (Pinteraction=0.14). At landmark analysis, in high-ATR women, stent thrombosis rates were comparable between DES generations in the first year, whereas between 1 and 3 years, stent thrombosis risk was lower with new-generation devices. Conclusions - Use of new-generation DES even in women at high ATR is associated with a benefit consistent over 3 years of follow-up and a substantial improvement in very-late thrombotic safety.

AB - Background - The safety and efficacy of new-generation drug-eluting stents (DES) in women with multiple atherothrombotic risk (ATR) factors is unclear. Methods and Results - We pooled patient-level data for women enrolled in 26 randomized trials. Study population was categorized based on the presence or absence of high ATR, which was defined as having history of diabetes mellitus, prior percutaneous or surgical coronary revascularization, or prior myocardial infarction. The primary end point was major adverse cardiovascular events defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. Out of 10 449 women included in the pooled database, 5333 (51%) were at high ATR. Compared with women not at high ATR, those at high ATR had significantly higher risk of major adverse cardiovascular events (15.8% versus 10.6%; adjusted hazard ratio: 1.53; 95% confidence interval: 1.34-1.75; P=0.006) and all-cause mortality. In high-ATR risk women, the use of new-generation DES was associated with significantly lower risk of 3-year major adverse cardiovascular events (adjusted hazard ratio: 0.69; 95% confidence interval: 0.52-0.92) compared with early-generation DES. The benefit of new-generation DES on major adverse cardiovascular events was uniform between high-ATR and non-high-ATR women, without evidence of interaction (Pinteraction=0.14). At landmark analysis, in high-ATR women, stent thrombosis rates were comparable between DES generations in the first year, whereas between 1 and 3 years, stent thrombosis risk was lower with new-generation devices. Conclusions - Use of new-generation DES even in women at high ATR is associated with a benefit consistent over 3 years of follow-up and a substantial improvement in very-late thrombotic safety.

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