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Stent Parameters Predict Major Adverse Clinical Events and the Response to Platelet Glycoprotein IIb/IIIa Blockade Findings of the ESPRIT Trial.
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Stent Parameters Predict Major Adverse Clinical Events and the Response to Platelet Glycoprotein IIb/IIIa BlockadeFindings of the ESPRIT Trial James E. Tcheng, MD; Ing Haan Lim, MBBS; Shankar Srinivasan, PhD; Joseph Jozic, MD; C. Michael Gibson, MS, MD; J. Conor O’Shea, MD; Joseph A. Puma, MD; Daniel I. Simon, MD Circulation Cardiovascular Interventions. 2009;2:43-51
Stent Parameters and MACE Post-hoc analysis of the 1983 pts in ESPRIT receiving a stent MACE (48 hr, 1 yr) by nominal stent parameters Number of stents implanted (1, 2, >3) Total length of stent (quartiles of mm) Stent diameter (<2.5, >2.5-<3.5, >3.5 mm) Stented vessel area (quartiles of mm2) Analysis by randomization Placebo versus eptifibatide Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
Study Design 1999-2000 placebo (bailout permitted) + heparin60 U/kg bolus(ACT 200-300 sec) eptifibatide180+180 µg/kg bolus (boluses 10 min apart)2.0 µg/kg-min infusion x18-24° + heparin60 U/kg bolus(ACT 200-300 sec) vs. ASA, thienopyridine pre-rx; randomization in cath lab elective (non-urgent) stent PCI 48 hour, 30 day, 6 month, 1 year follow-up primary endpoint: 48° death, MI, urg revasc, thrombotic bailout O’Shea JC et al., Am Heart J. 2000;140:834–839
Primary Endpoint AnalysisEvents to 48 Hours 37% p=0.0015 40% p=0.0015 n=2064 33% p=0.064 40% p=NS 52% p=0.029 50% p=NS (MB >5x) ESPRIT Investigators. Lancet. 2000;356:2037–2044
Efficacy by Clinical Syndrome30 Day death, MI, urgent TVR, bailout IIb/IIIa 44% p=NS NNT=11 50% p=0.034 NNT=14 41% p=0.028 NNT=18 31% p=NS 23% p=0.30 n=794 (38%) n=664 (32%) n=279 (14%) n=93 (5%) n=187 (9%) Puma JA et al. J Am Coll Cardiol. 2006;47:715–718.
MACE at 48ºby Number of Stents 40% Eptifibatide Placebo 30% P=0.001 Death, MI, urgent TVR 20% 10% 0 1 2 ≥3 Number of stents Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
MACE at 48ºby Stent Length 40% Eptifibatide Placebo 30% P=0.003 Death, MI, urgent TVR 20% P=0.030 10% 0 <15 15 to <18 mm 18 to <30 mm ≥30 mm Total length of implanted stent(s) Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
MACE at 48ºby Stent Diameter 40% Eptifibatide Placebo 30% Death, MI, urgent TVR 20% P=0.002 10% 0 ≤2.5 mm >2.5 to <3.5 mm ≥3.5 mm Stent diameter Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
MACE at 48ºby Stented Vessel Area 40% Eptifibatide Placebo 30% P=0.002 Death, MI, urgent TVR 20% P=0.039 10% 0 <141 141 to <188 188 to <292 ≥292 Stented vessel area (mm2) Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
Mean stent diameter (mm) 20 40 60 80 100 120 Total stent length (mm) Stent Diameter vs. Length 6 5 4 3 2 1 0 Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
MACE at 1 yearby Number of Stents 40% Eptifibatide Placebo 30% Death, MI, TVR 20% P=0.005 10% 0 1 2 ≥3 Number of stents Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
MACE at 1 yearby Stent Length 40% Eptifibatide Placebo P=0.024 30% P=0.034 Death, MI, TVR 20% 10% 0 <15 15 to <18 mm 18 to <30 mm ≥30 mm Total length of implanted stent(s) Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
MACE at 1 yearby Stent Diameter 40% Eptifibatide Placebo 30% P=0.005 Death, MI, TVR 20% 10% 0 ≤2.5 mm >2.5 to <3.5 mm ≥3.5 mm Stent diameter Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
MACE at 48ºby Stented Vessel Area 40% Eptifibatide Placebo P=0.023 30% Death, MI, TVR 20% 10% 0 <141 141 to <188 188 to <292 ≥292 Stented vessel area (mm2) Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
Odds Ratios of MACE at 48º Eptifibatide Better Placebo Better • Number of Stents • 1 • 2 • ≥3 • Stent Length (mm) • <15 • 15 – <18 • 18 – <30 • ≥30 • Stent Diameter (mm) • ≤2.5 • >2.5 – <3.5 • ≥3.5 • Stented Vessel Area (mm2) • <141 • 141 – <188 • 188 – <292 • ≥292 1 10 0.1 Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
Odds Ratios of MACE at 1 year Eptifibatide Better Placebo Better • Number of Stents • 1 • 2 • ≥3 • Stent Length (mm) • <15 • 15 – <18 • 18 – <30 • ≥30 • Stent Diameter (mm) • ≤2.5 • >2.5 – <3.5 • ≥3.5 • Stented Vessel Area (mm2) • <141 • 141 – <188 • 188 – <292 • ≥292 1 10 0.1 Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
Stent Parameters and MACE In the placebo group, MACE rates increased as the number of stents increased, with increasing total length of stent, and with total stented vessel area relationship nearly linear with total stented vessel area Risk gradient significantly flattened by eptifibatide Eptifibatide had significant efficacy with: >2 stents >18 mm total stent length