TY - JOUR
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 - 2019/2/15
Y1 - 2019/2/15
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
KW - Aged
KW - Aged, 80 and over
KW - Coronary Angiography/trends
KW - Coronary Artery Disease/diagnostic imaging/surgery
KW - Drug-Eluting Stents/adverse effects/trends
KW - Female
KW - Hemorrhage/diagnostic imaging/etiology
KW - Humans
KW - Internationality
KW - Male
KW - Myocardial Ischemia/diagnostic imaging/etiology
KW - Percutaneous Coronary Intervention/adverse effects/instrumentation/trends
KW - Risk Factors
KW - Single-Blind Method
KW - Sirolimus/administration & dosage/analogs & derivatives
KW - Stents/adverse effects/trends
KW - Treatment Outcome
U2 - 10.1016/j.ijcard.2018.09.120
DO - 10.1016/j.ijcard.2018.09.120
M3 - Article
VL - 277
SP - 60
EP - 65
JO - International Journal of Cardiology
JF - International Journal of Cardiology
SN - 0167-5273
ER -