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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 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
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Stent Parameters and MACE n Post-hoc analysis of the 1983 pts in ESPRIT receiving a stent n MACE (48 hr, 1 yr) by nominal stent parameters l Number of stents implanted (1, 2, >3) l Total length of stent (quartiles of mm) l Stent diameter ( 2.5- 3.5 mm) l Stented vessel area (quartiles of mm 2 ) n Analysis by randomization l Placebo versus eptifibatide Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
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eptifibatide 180+180 µg/kg bolus (boluses 10 min apart) 2.0 µg/kg-min infusion x18-24° + heparin 60 U/kg bolus (ACT 200-300 sec) eptifibatide 180+180 µg/kg bolus (boluses 10 min apart) 2.0 µg/kg-min infusion x18-24° + heparin 60 U/kg bolus (ACT 200-300 sec) placebo (bailout permitted) + heparin 60 U/kg bolus (ACT 200-300 sec) placebo (bailout permitted) + heparin 60 U/kg bolus (ACT 200-300 sec) vs.vs. Study Design 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 elective (non-urgent) stent PCI 48 hour, 30 day, 6 month, 1 year follow-up primary endpoint: 48° death, MI, urg revasc, thrombotic bailout 1999-2000 O’Shea JC et al., Am Heart J. 2000;140:834–839
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Primary Endpoint Analysis Events to 48 Hours 52% p=0.029 52% p=0.029 40% p=NS 40% p=NS 33% p=0.064 33% p=0.064 40% p=0.0015 40% p=0.0015 37% p=0.0015 37% p=0.0015 (MB >5x) n=2064 50% p=NS 50% p=NS ESPRIT Investigators. Lancet. 2000;356:2037–2044
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Efficacy by Clinical Syndrome 30 Day death, MI, urgent TVR, bailout IIb/IIIa 50% p=0.034 NNT=14 50% p=0.034 NNT=14 41% p=0.028 NNT=18 41% p=0.028 NNT=18 23% p=0.30 23% p=0.30 44% p=NS NNT=11 44% p=NS NNT=11 31% p=NS 31% p=NS 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.
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Death, MI, urgent TVR Number of stents 40% 30% 20% 10% 0 12≥3 P=0.001 MACE at 48º by Number of Stents Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51 Eptifibatide Placebo
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<1515 to <18 mm18 to <30 mm P=0.030 ≥30 mm P=0.003 MACE at 48º by Stent Length 40% 30% 20% 10% 0 Eptifibatide Placebo Total length of implanted stent(s) Death, MI, urgent TVR Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
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≤2.5 mm>2.5 to <3.5 mm≥3.5 mm P=0.002 40% 30% 20% 10% 0 Eptifibatide Placebo Death, MI, urgent TVR Stent diameter MACE at 48º by Stent Diameter Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
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<141141 to <188188 to <292≥292 P=0.039 P=0.002 40% 30% 20% 10% 0 Eptifibatide Placebo MACE at 48º by Stented Vessel Area Death, MI, urgent TVR Stented vessel area (mm 2 ) Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
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Total stent length (mm) Mean stent diameter (mm) 20 6 5 4 3 2 1 0 406080100120 Stent Diameter vs. Length Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
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12≥3 P=0.005 40% 30% 20% 10% 0 Eptifibatide Placebo MACE at 1 year by Number of Stents Death, MI, TVR Number of stents Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
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P=0.034 P=0.024 <1515 to <18 mm18 to <30 mm≥30 mm 40% 30% 20% 10% 0 Eptifibatide Placebo MACE at 1 year by Stent Length Death, MI, TVR Total length of implanted stent(s) Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
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≤2.5 mm>2.5 to <3.5 mm≥3.5 mm P=0.005 40% 30% 20% 10% 0 Eptifibatide Placebo MACE at 1 year by Stent Diameter Death, MI, TVR Stent diameter Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
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<141141 to <188188 to <292≥292 P=0.023 40% 30% 20% 10% 0 Eptifibatide Placebo MACE at 48º by Stented Vessel Area Death, MI, TVR Stented vessel area (mm 2 ) Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
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0.1 110 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 (mm 2 ) <141 141 – <188 188 – <292 ≥292 Odds Ratios of MACE at 48º Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
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0.1 110 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 (mm 2 ) <141 141 – <188 188 – <292 ≥292 Eptifibatide Better Placebo Better Odds Ratios of MACE at 1 year Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51
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Stent Parameters and MACE n 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 l relationship nearly linear with total stented vessel area n Risk gradient significantly flattened by eptifibatide n Eptifibatide had significant efficacy with: l >2 stents l >18 mm total stent length
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