Impact of angiographic coronary artery disease complexity on ischemic and bleeding risks and on the comparative effectiveness of zotarolimus-eluting vs. bare-metal stents in uncertain drug-eluting stent candidates

Giuseppe Gargiulo, Athanasios Patialiakas, Raffaele Piccolo, Attila Thury, Salvatore Colangelo, Gianluca Campo, Matteo Tebaldi, Imre Ungi, Stefano Tondi, Marco Roffi, Alberto Menozzi, Nicoletta de Cesare, Roberto Garbo, Emanuele Meliga, Luca Testa, Henrique Mesquita Gabriel, Marco Ferlini, Francesco Liistro, Antonio Dellavalle, Pascal Vranckx & 3 others Carlo Briguori, Stephan Windecker, Marco Valgimigli

Research output: Contribution to journalArticle

Abstract

Background: The impact of coronary artery disease (CAD) extension/complexity on outcomes and on the comparative benefits/risks of zotarolimus-eluting stent (ZES) versus bare-metal stents (BMS) remains unclear in patients at high risk of bleeding or thrombosis or at low restenosis risk. Methods: We performed a post-hoc analysis of the ZEUS trial. The impact of coronary anatomic complexity measured by the SYNTAX score on the differences in outcomes following ZES and BMS was assessed at 1 year. Results: The mean SYNTAX score was 16.3 ± 13.1 with a median of 12 (IQR: 7 to 22). We stratified patients according to SYNTAX tertiles (0–8: n = 563; >8–19 n = 532; >19: n = 511), and observed that the higher the score, the correspondingly higher was the rate of the primary endpoint of major adverse cardiovascular events (MACE) and other ischemic events, but not bleeding after adjustment. The superior efficacy of ZES versus BMS for MACE was consistent across SYNTAX tertiles (tertile 1: HR 0.71, 95% CI 0.44–1.13; tertile 2: HR 0.71, 95% CI 0.46–1.09; tertile 3: HR 0.83, 95% CI 0.61–1.10) without significant heterogeneity (p for trend = 0.55). This between-groups difference mainly reflected a reduction in MI and TVR without effect on mortality. There was no significant interaction between the SYNTAX score and allocated stent type with respect to ischemic and bleeding endpoints. Conclusions: The SYNTAX score was predictor of major adverse cardiovascular events but not bleeding and ZES provided superior efficacy and safety than BMS across the whole spectrum of CAD complexity. SYNTAX score may be routinely used for the assessment of the ischemic risk (but not bleeding) after PCI and should not guide the decision-making for DES versus BMS in patients undergoing PCI.

Original languageEnglish
JournalInternational Journal of Cardiology
DOIs
Publication statusAccepted/In press - Jan 1 2018

Fingerprint

Drug-Eluting Stents
Stents
Coronary Artery Disease
Metals
Hemorrhage
zotarolimus
Social Adjustment
Decision Making
Thrombosis
Safety

Keywords

  • Bare-metal stent
  • Ischemic events
  • Randomized trial
  • SYNTAX score
  • Zotarolimus-eluting stent

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Impact of angiographic coronary artery disease complexity on ischemic and bleeding risks and on the comparative effectiveness of zotarolimus-eluting vs. bare-metal stents in uncertain drug-eluting stent candidates. / Gargiulo, Giuseppe; Patialiakas, Athanasios; Piccolo, Raffaele; Thury, Attila; Colangelo, Salvatore; Campo, Gianluca; Tebaldi, Matteo; Ungi, Imre; Tondi, Stefano; Roffi, Marco; Menozzi, Alberto; de Cesare, Nicoletta; Garbo, Roberto; Meliga, Emanuele; Testa, Luca; Gabriel, Henrique Mesquita; Ferlini, Marco; Liistro, Francesco; Dellavalle, Antonio; Vranckx, Pascal; Briguori, Carlo; Windecker, Stephan; Valgimigli, Marco.

In: International Journal of Cardiology, 01.01.2018.

Research output: Contribution to journalArticle

Gargiulo, G, Patialiakas, A, Piccolo, R, Thury, A, Colangelo, S, Campo, G, Tebaldi, M, Ungi, I, Tondi, S, Roffi, M, Menozzi, A, de Cesare, N, Garbo, R, Meliga, E, Testa, L, Gabriel, HM, Ferlini, M, Liistro, F, Dellavalle, A, Vranckx, P, Briguori, C, Windecker, S & Valgimigli, M 2018, 'Impact of angiographic coronary artery disease complexity on ischemic and bleeding risks and on the comparative effectiveness of zotarolimus-eluting vs. bare-metal stents in uncertain drug-eluting stent candidates', International Journal of Cardiology. https://doi.org/10.1016/j.ijcard.2018.09.120
Gargiulo, Giuseppe ; Patialiakas, Athanasios ; Piccolo, Raffaele ; Thury, Attila ; Colangelo, Salvatore ; Campo, Gianluca ; Tebaldi, Matteo ; Ungi, Imre ; Tondi, Stefano ; Roffi, Marco ; Menozzi, Alberto ; de Cesare, Nicoletta ; Garbo, Roberto ; Meliga, Emanuele ; Testa, Luca ; Gabriel, Henrique Mesquita ; Ferlini, Marco ; Liistro, Francesco ; Dellavalle, Antonio ; Vranckx, Pascal ; Briguori, Carlo ; Windecker, Stephan ; Valgimigli, Marco. / Impact of angiographic coronary artery disease complexity on ischemic and bleeding risks and on the comparative effectiveness of zotarolimus-eluting vs. bare-metal stents in uncertain drug-eluting stent candidates. In: International Journal of Cardiology. 2018.
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abstract = "Background: The impact of coronary artery disease (CAD) extension/complexity on outcomes and on the comparative benefits/risks of zotarolimus-eluting stent (ZES) versus bare-metal stents (BMS) remains unclear in patients at high risk of bleeding or thrombosis or at low restenosis risk. Methods: We performed a post-hoc analysis of the ZEUS trial. The impact of coronary anatomic complexity measured by the SYNTAX score on the differences in outcomes following ZES and BMS was assessed at 1 year. Results: The mean SYNTAX score was 16.3 ± 13.1 with a median of 12 (IQR: 7 to 22). We stratified patients according to SYNTAX tertiles (0–8: n = 563; >8–19 n = 532; >19: n = 511), and observed that the higher the score, the correspondingly higher was the rate of the primary endpoint of major adverse cardiovascular events (MACE) and other ischemic events, but not bleeding after adjustment. The superior efficacy of ZES versus BMS for MACE was consistent across SYNTAX tertiles (tertile 1: HR 0.71, 95{\%} CI 0.44–1.13; tertile 2: HR 0.71, 95{\%} CI 0.46–1.09; tertile 3: HR 0.83, 95{\%} CI 0.61–1.10) without significant heterogeneity (p for trend = 0.55). This between-groups difference mainly reflected a reduction in MI and TVR without effect on mortality. There was no significant interaction between the SYNTAX score and allocated stent type with respect to ischemic and bleeding endpoints. Conclusions: The SYNTAX score was predictor of major adverse cardiovascular events but not bleeding and ZES provided superior efficacy and safety than BMS across the whole spectrum of CAD complexity. SYNTAX score may be routinely used for the assessment of the ischemic risk (but not bleeding) after PCI and should not guide the decision-making for DES versus BMS in patients undergoing PCI.",
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T1 - Impact of angiographic coronary artery disease complexity on ischemic and bleeding risks and on the comparative effectiveness of zotarolimus-eluting vs. bare-metal stents in uncertain drug-eluting stent candidates

AU - Gargiulo, Giuseppe

AU - Patialiakas, Athanasios

AU - Piccolo, Raffaele

AU - Thury, Attila

AU - Colangelo, Salvatore

AU - Campo, Gianluca

AU - Tebaldi, Matteo

AU - Ungi, Imre

AU - Tondi, Stefano

AU - Roffi, Marco

AU - Menozzi, Alberto

AU - de Cesare, Nicoletta

AU - Garbo, Roberto

AU - Meliga, Emanuele

AU - Testa, Luca

AU - Gabriel, Henrique Mesquita

AU - Ferlini, Marco

AU - Liistro, Francesco

AU - Dellavalle, Antonio

AU - Vranckx, Pascal

AU - Briguori, Carlo

AU - Windecker, Stephan

AU - Valgimigli, Marco

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Background: The impact of coronary artery disease (CAD) extension/complexity on outcomes and on the comparative benefits/risks of zotarolimus-eluting stent (ZES) versus bare-metal stents (BMS) remains unclear in patients at high risk of bleeding or thrombosis or at low restenosis risk. Methods: We performed a post-hoc analysis of the ZEUS trial. The impact of coronary anatomic complexity measured by the SYNTAX score on the differences in outcomes following ZES and BMS was assessed at 1 year. Results: The mean SYNTAX score was 16.3 ± 13.1 with a median of 12 (IQR: 7 to 22). We stratified patients according to SYNTAX tertiles (0–8: n = 563; >8–19 n = 532; >19: n = 511), and observed that the higher the score, the correspondingly higher was the rate of the primary endpoint of major adverse cardiovascular events (MACE) and other ischemic events, but not bleeding after adjustment. The superior efficacy of ZES versus BMS for MACE was consistent across SYNTAX tertiles (tertile 1: HR 0.71, 95% CI 0.44–1.13; tertile 2: HR 0.71, 95% CI 0.46–1.09; tertile 3: HR 0.83, 95% CI 0.61–1.10) without significant heterogeneity (p for trend = 0.55). This between-groups difference mainly reflected a reduction in MI and TVR without effect on mortality. There was no significant interaction between the SYNTAX score and allocated stent type with respect to ischemic and bleeding endpoints. Conclusions: The SYNTAX score was predictor of major adverse cardiovascular events but not bleeding and ZES provided superior efficacy and safety than BMS across the whole spectrum of CAD complexity. SYNTAX score may be routinely used for the assessment of the ischemic risk (but not bleeding) after PCI and should not guide the decision-making for DES versus BMS in patients undergoing PCI.

AB - Background: The impact of coronary artery disease (CAD) extension/complexity on outcomes and on the comparative benefits/risks of zotarolimus-eluting stent (ZES) versus bare-metal stents (BMS) remains unclear in patients at high risk of bleeding or thrombosis or at low restenosis risk. Methods: We performed a post-hoc analysis of the ZEUS trial. The impact of coronary anatomic complexity measured by the SYNTAX score on the differences in outcomes following ZES and BMS was assessed at 1 year. Results: The mean SYNTAX score was 16.3 ± 13.1 with a median of 12 (IQR: 7 to 22). We stratified patients according to SYNTAX tertiles (0–8: n = 563; >8–19 n = 532; >19: n = 511), and observed that the higher the score, the correspondingly higher was the rate of the primary endpoint of major adverse cardiovascular events (MACE) and other ischemic events, but not bleeding after adjustment. The superior efficacy of ZES versus BMS for MACE was consistent across SYNTAX tertiles (tertile 1: HR 0.71, 95% CI 0.44–1.13; tertile 2: HR 0.71, 95% CI 0.46–1.09; tertile 3: HR 0.83, 95% CI 0.61–1.10) without significant heterogeneity (p for trend = 0.55). This between-groups difference mainly reflected a reduction in MI and TVR without effect on mortality. There was no significant interaction between the SYNTAX score and allocated stent type with respect to ischemic and bleeding endpoints. Conclusions: The SYNTAX score was predictor of major adverse cardiovascular events but not bleeding and ZES provided superior efficacy and safety than BMS across the whole spectrum of CAD complexity. SYNTAX score may be routinely used for the assessment of the ischemic risk (but not bleeding) after PCI and should not guide the decision-making for DES versus BMS in patients undergoing PCI.

KW - Bare-metal stent

KW - Ischemic events

KW - Randomized trial

KW - SYNTAX score

KW - Zotarolimus-eluting stent

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