horizons –ami
DESCRIPTION
HORIZONS –AMI A Prospective, Multicenter Randomized Trial of Heparin Plus GPIIb/ IIIa Inhibitors vs. Bivalirudiin STEMI: Final 3-year results from the HORIZONS-AMI Trial. Stone GW et al. Lancet 2011: Published online June 13, DOI:10.1016/S0140-6736(11)60764-2. Background. - PowerPoint PPT PresentationTRANSCRIPT
Harmonizing Outcomes with RevascularIZatiON and Harmonizing Outcomes with RevascularIZatiON and Stents (HORIZONS) TrialStents (HORIZONS) Trial
Harmonizing Outcomes with RevascularIZatiON and Harmonizing Outcomes with RevascularIZatiON and Stents (HORIZONS) TrialStents (HORIZONS) Trial
HORIZONS TrialHORIZONS TrialHORIZONS TrialHORIZONS Trial
www. Clinical trial results.org
HORIZONS Trial: Study DesignHORIZONS Trial: Study DesignHORIZONS Trial: Study DesignHORIZONS Trial: Study Design
Antithrombotic TherapyAntithrombotic TherapyRandomized 1:1Randomized 1:1
Antithrombotic TherapyAntithrombotic TherapyRandomized 1:1Randomized 1:1
UFH + IIb/IIIa InhibitorUFH + IIb/IIIa Inhibitorn=1700n=1700
UFH + IIb/IIIa InhibitorUFH + IIb/IIIa Inhibitorn=1700n=1700
3400 patients undergoing primary PCI first randomized 1:1 to anti-thrombotic therapy 3400 patients undergoing primary PCI first randomized 1:1 to anti-thrombotic therapy then ~88% (3000) patients randomized 3:1 to target vessel stenting then ~88% (3000) patients randomized 3:1 to target vessel stenting
1, 6, and 12 month follow-up for all patients undergoing primary randomization, angiography at 13 months for 1500 stent 1, 6, and 12 month follow-up for all patients undergoing primary randomization, angiography at 13 months for 1500 stent randomized patients only, yearly follow-up for 5 years for all patients.randomized patients only, yearly follow-up for 5 years for all patients.
3400 patients undergoing primary PCI first randomized 1:1 to anti-thrombotic therapy 3400 patients undergoing primary PCI first randomized 1:1 to anti-thrombotic therapy then ~88% (3000) patients randomized 3:1 to target vessel stenting then ~88% (3000) patients randomized 3:1 to target vessel stenting
1, 6, and 12 month follow-up for all patients undergoing primary randomization, angiography at 13 months for 1500 stent 1, 6, and 12 month follow-up for all patients undergoing primary randomization, angiography at 13 months for 1500 stent randomized patients only, yearly follow-up for 5 years for all patients.randomized patients only, yearly follow-up for 5 years for all patients.
Presented at TCT 2005Presented at TCT 2005Presented at TCT 2005Presented at TCT 2005
Bivalirudin + Bail-Out IIb/IIIa InhibitorBivalirudin + Bail-Out IIb/IIIa Inhibitorn=1700n=1700
Bivalirudin + Bail-Out IIb/IIIa InhibitorBivalirudin + Bail-Out IIb/IIIa Inhibitorn=1700n=1700
Hypothesis 1: Bivalirudin compared to UFH + routine IIb/IIIa will reduce the Hypothesis 1: Bivalirudin compared to UFH + routine IIb/IIIa will reduce the composite rate of death, reinfarction, TVR, stroke, and major bleeding at 30 dayscomposite rate of death, reinfarction, TVR, stroke, and major bleeding at 30 days
Hypothesis 1: Bivalirudin compared to UFH + routine IIb/IIIa will reduce the Hypothesis 1: Bivalirudin compared to UFH + routine IIb/IIIa will reduce the composite rate of death, reinfarction, TVR, stroke, and major bleeding at 30 dayscomposite rate of death, reinfarction, TVR, stroke, and major bleeding at 30 days
Target Vessel Stenting to DES vs Target Vessel Stenting to DES vs BMS BMS Randomized 3:1Randomized 3:1
Target Vessel Stenting to DES vs Target Vessel Stenting to DES vs BMS BMS Randomized 3:1Randomized 3:1
www. Clinical trial results.org
HORIZONS Trial: Study DesignHORIZONS Trial: Study DesignHORIZONS Trial: Study DesignHORIZONS Trial: Study Design
Hypothesis 2: Use of polymer-based slow-release paclitaxel-eluting TAXUS stent Hypothesis 2: Use of polymer-based slow-release paclitaxel-eluting TAXUS stent will safely reduce the 1 year rate of ischemia-driven TLRwill safely reduce the 1 year rate of ischemia-driven TLR
Hypothesis 2: Use of polymer-based slow-release paclitaxel-eluting TAXUS stent Hypothesis 2: Use of polymer-based slow-release paclitaxel-eluting TAXUS stent will safely reduce the 1 year rate of ischemia-driven TLRwill safely reduce the 1 year rate of ischemia-driven TLR
Presented at TCT 2005Presented at TCT 2005Presented at TCT 2005Presented at TCT 2005
Target Vessel StentingTarget Vessel StentingRandomized 3:1Randomized 3:1
Target Vessel StentingTarget Vessel StentingRandomized 3:1Randomized 3:1
TAXUS stentTAXUS stentn=2250n=2250
TAXUS stentTAXUS stentn=2250n=2250
Bare metal Express stentBare metal Express stentn=750n=750
Bare metal Express stentBare metal Express stentn=750n=750
Antithrombotic TherapyAntithrombotic TherapyRandomized 1:1Randomized 1:1
Antithrombotic TherapyAntithrombotic TherapyRandomized 1:1Randomized 1:1
3400 patients undergoing primary PCI first randomized 1:1 to anti-thrombotic therapy 3400 patients undergoing primary PCI first randomized 1:1 to anti-thrombotic therapy then ~88% (3000) patients randomized 3:1 to target vessel stenting then ~88% (3000) patients randomized 3:1 to target vessel stenting
1, 6, and 12 month follow-up for all patients undergoing primary randomization, angiography at 13 months for 1500 stent 1, 6, and 12 month follow-up for all patients undergoing primary randomization, angiography at 13 months for 1500 stent randomized patients only, yearly follow-up for 5 years for all patients.randomized patients only, yearly follow-up for 5 years for all patients.
3400 patients undergoing primary PCI first randomized 1:1 to anti-thrombotic therapy 3400 patients undergoing primary PCI first randomized 1:1 to anti-thrombotic therapy then ~88% (3000) patients randomized 3:1 to target vessel stenting then ~88% (3000) patients randomized 3:1 to target vessel stenting
1, 6, and 12 month follow-up for all patients undergoing primary randomization, angiography at 13 months for 1500 stent 1, 6, and 12 month follow-up for all patients undergoing primary randomization, angiography at 13 months for 1500 stent randomized patients only, yearly follow-up for 5 years for all patients.randomized patients only, yearly follow-up for 5 years for all patients.