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TCT-307: Angiographic Predictors Of Recurring Stent Thrombosis: An Outcome Of PCI For Stent-thrombosis Multicentre Study (OPTIMIST) Substudy
http://www.aievolution.com/tct0901/
TUESDAY, SEPTEMBER 22, 2009, 8:00AM - 10:00AM
TCT-306
TCT-307
One Year Outcomes of Primary Angioplasty in Acute Anterior Myocardial Infarction with Bivalirudin Compared to Unfractionated Heparin plus GpIIb/IIIa Inhibitors: The HORIZONS-AMI Trial
Angiographic Predictors Of Recurring Stent Thrombosis: An Outcome Of PCI For Stent-thrombosis Multicentre Study (OPTIMIST) Substudy
Jochen Wöhrle1, Bernhard Witzenbichler2, Giulio Guagliumi2, Bruce R Brodie2, Dariusz Dudek2, Ran Kornowski2, Franz Hartmann2, Helen Parise2, Alexandra J Lansky2, Roxana Mehran2, Brendon Ryan2, Alison Kellock2, Carol Moore2, Gregg W Stone3 1 University of Ulm, Ulm, Germany2Cardiovascular Research Foundation, New York, NY;3Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY Background: STEMI pts undergoing primary percutaneous coronary intervention (PCI) of LAD compared to non-LAD lesions have a higher rate of major adverse cardiac events (MACE). We evaluated the impact of bivalirudin versus unfractionated heparin (UFH) plus glycoprotein IIb/IIIa inhibitor (GPI) on clinical outcomes in pts with STEMI undergoing primary PCI of the LAD. Methods: In the HORIZONS-AMI trial, 3,602 pts were randomized to bivalirudin monotherapy vs. heparin + GPI. Of these, 1,445 pts underwent primary PCI of the LAD, whereas 1,884 pts underwent primary PCI of only non-LAD lesions. The occurrence of MACE (death, reinfarction, ischemic WDUJHW YHVVHO UHYDVFXODUL]DWLRQ RU VWURNH PDMRU EOHHGLQJ DQG QHW DGYHUVH clinical events (NACE = MACE or major bleeding) at 12 months was assessed in the 2 groups. Results: Comparing patients undergoing LAD versus non-LAD primary PCI, the rates of NACE (19.3% vs 15.4%), MACE (14.1% vs 10.3%), death YV DQGFDUGLDFGHDWK YV ZHUHVLJQL¿FDQWO\KLJKHU DOO p<0.05), whereas of the rates of major bleeding (8.4% vs 7.3%, p=0.27) and VWHQWWKURPERVLV ERWK GLGQRWVLJQL¿FDQWO\GLIIHU3DWLHQWVZLWK/$' lesions were randomized to treatment with bivalirudin (N=699) or UFH+GPI (N=746). The baseline clinical and angiographic features were well matched between these groups. Clinical outcomes at 12 months are shown in the Table. Patients with LAD lesions treated with primary Bivalirudin UFH+GPI p-value PCI n=699 n=746 NACE
18.3%
20.2%
0.31
MACE
14.0%
14.2%
0.90
4.8%
6.3%
0.19
Cardiac death
3.0%
5.3%
0.04
Reinfarction
3.7%
5.3%
0.15
Target vessel revascularization for ischemia
8.5%
7.1%
0.32
Stroke
1.0%
0.8%
0.71
'H¿QLWHRUSUREDEOHVWHQWWKURPERVLV
3.3%
3.6%
0.81
Major bleeding (Non-CABG)
6.5%
10.1%
0.01
Conclusions: In the international large-scale prospective HORIZONSAMI trial, patients undergoing primary PCI of LAD as compared to QRQ/$'OHVLRQVKDGVLJQL¿FDQWO\KLJKHU\HDUUDWHVRI1$&(0$&( death and cardiac death. In patients undergoing PCI of LAD lesions, anticoagulation with bivalirudin monotherapy rather than heparin + GPI UHVXOWHGLQVLJQL¿FDQWORZHUUDWHVRIPDMRUEOHHGLQJDQGFDUGLDFGHDWK
The American Journal of Cardiology®
| September 21-25, 2009
Introduction: Stent thrombosis (ST) is a catastrophic occurrence burdened by a high mortality rate, and with tendency to recur. We sought to evaluate WKH DQJLRJUDSKLF ULVN IDFWRUV IRU UHFXUULQJ VWHQW WKURPERVLV U67 LQ D subpopulation of 91 OPTIMIST patients who underwent quantitative angiographic evaluation. Methods: Angiographic analysis was performed by an independent core lab. Academic Research Consortium criteria were used for ST adjudication. A multivariable Cox proportional hazards model was applied to estimate WKH KD]DUG UDWLRV +5 DQG WKH FRUUHVSRQGLQJ FRQ¿GHQFH LQWHUYDOV (CI). The variables which were predictive of 6-month mortality in the main analysis (very late thrombosis, absence of reperfusion, and additional stent LPSODQWDWLRQ ZHUHLQFOXGHGDVZHOODVEDFNJURXQGYDULDEOHV DJHDQGJHQGHU Regarding angiographic variables, post-PCI reference vessel diameter, minimal lumen diameter, plus residual thrombus score >=3, were included as they were associated with rST at univariate analysis. Further models were ¿WWHG IRU YDOLGDWLRQ FRQVLGHULQJ HYHQWV ZLWK $5& FULWHULD ³GH¿QLWH´ DQG ³SUREDEOH´DVHYHQWYDULDEOHDQG¿QDOO\FRQVLGHULQJDQ\SRVVLEOHU67 $5& ³GH¿QLWH´³SUREDEOH´DQG³SRVVLEOH´ Results: 7KHUHZHUH³GH¿QLWH´U67GXULQJDYHUDJHIROORZXSRI GD\V of which 5 were “early” (3 leading to cardiac death preceded by cardiogenic VKRFNDQGUHVROYHGZLWKUH3&, DQG³ODWH´,QWKHPXOWLYDULDWHPRGHO only residual thrombus (multivariate HR=7.4, 95% CI 2.3-24.1, p=0.02) UHPDLQHGVLJQL¿FDQWO\DVVRFLDWHGZLWKWKHRXWFRPH:KHQWKHVDPHPRGHO ZDVDSSOLHGWRWKH´GH¿QLWHDQGSUREDEOH´U67DJDLQRQO\UHVLGXDOWKURPEXV PXOWLYDULDWH+5 &,S ZDVVLJQL¿FDQWO\DVVRFLDWHG with rST. Finally, when even “possible” rST were considered (18 patients), residual thrombus score >=3 remained associated with the dependent variable (multivariate HR=7.4, 95% CI 2.3-24.1, p=0.001). Variables related to vessel VL]HORVWVLJQL¿FDQFHLQWKHPXOWLYDULDWHDQDO\VHV Conclusions: When performing PCI for stent thrombosis, residual thrombus EXUGHQ LV D VLJQL¿FDQW ULVN IDFWRU IRU UHFXUULQJ WKURPERVLV ,Q SDUWLFXODU WKH DEVROXWH DPRXQW RI WKURPEXV LQÀXHQFHG E\ YHVVHO VL]H PLJKW EH prognostically important. Every effort should be made to reduce the thrombotic burden during PCI for stent thrombosis.
| TCT Abstracts/POSTER
115D
P O S T E R A B S T R AC T S
Death, all-cause
Italo Porto1, Francesco Burzotta1, Enrico Romagnoli2, A Manzoli3, C Pristipino4, F Belloni5, Gennaro Sardella6, Stefano Rigattieri7, G Gioffrè8, P Mazzarotto9, F Summaria2, A Parma10, A Danesi11, Francesco Prati3, Carlo Trani1, Filippo Crea1 1 Department of Cardiovascular Medicine, Catholic University of the Sacred Heart, Rome, Italy2Department of Cardiovascular Medicine, Policlinico Casilino, Rome, Italy3Department of Cardiovascular Medicine, Ospedale San Giovanni, Rome, Italy4Department of Cardiovascular Medicine, San Filippo Neri, Rome, Italy5Department of Cardiovascular Medicine, Ospedale San Pietro, Rome, Italy6Department of Cardiovascular Medicine, Università La Sapienza, Rome, Italy7Department of Cardiovascular Medicine, Ospedale Pertini, Rome, Italy8Department of Cardiovascular Medicine, Tor Vergata University, Rome, Italy9Department of Cardiovascular Medicine, Ospedale San Carlo, Rome, Italy10Department of Cardiovascular Medicine, Ospedale San Camillo, Rome, Italy11Department of Cardiovascular Medicine, Ospedale Santo Spirito, Rome, Italy
TUESDAY, SEPTEMBER 22, 2009, 8:00AM - 10:00AM
TCT-306
TCT-307
One Year Outcomes of Primary Angioplasty in Acute Anterior Myocardial Infarction with Bivalirudin Compared to Unfractionated Heparin plus GpIIb/IIIa Inhibitors: The HORIZONS-AMI Trial
Angiographic Predictors Of Recurring Stent Thrombosis: An Outcome Of PCI For Stent-thrombosis Multicentre Study (OPTIMIST) Substudy
Jochen Wöhrle1, Bernhard Witzenbichler2, Giulio Guagliumi2, Bruce R Brodie2, Dariusz Dudek2, Ran Kornowski2, Franz Hartmann2, Helen Parise2, Alexandra J Lansky2, Roxana Mehran2, Brendon Ryan2, Alison Kellock2, Carol Moore2, Gregg W Stone3 1 University of Ulm, Ulm, Germany2Cardiovascular Research Foundation, New York, NY;3Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY Background: STEMI pts undergoing primary percutaneous coronary intervention (PCI) of LAD compared to non-LAD lesions have a higher rate of major adverse cardiac events (MACE). We evaluated the impact of bivalirudin versus unfractionated heparin (UFH) plus glycoprotein IIb/IIIa inhibitor (GPI) on clinical outcomes in pts with STEMI undergoing primary PCI of the LAD. Methods: In the HORIZONS-AMI trial, 3,602 pts were randomized to bivalirudin monotherapy vs. heparin + GPI. Of these, 1,445 pts underwent primary PCI of the LAD, whereas 1,884 pts underwent primary PCI of only non-LAD lesions. The occurrence of MACE (death, reinfarction, ischemic WDUJHW YHVVHO UHYDVFXODUL]DWLRQ RU VWURNH PDMRU EOHHGLQJ DQG QHW DGYHUVH clinical events (NACE = MACE or major bleeding) at 12 months was assessed in the 2 groups. Results: Comparing patients undergoing LAD versus non-LAD primary PCI, the rates of NACE (19.3% vs 15.4%), MACE (14.1% vs 10.3%), death YV DQGFDUGLDFGHDWK YV ZHUHVLJQL¿FDQWO\KLJKHU DOO p<0.05), whereas of the rates of major bleeding (8.4% vs 7.3%, p=0.27) and VWHQWWKURPERVLV ERWK GLGQRWVLJQL¿FDQWO\GLIIHU3DWLHQWVZLWK/$' lesions were randomized to treatment with bivalirudin (N=699) or UFH+GPI (N=746). The baseline clinical and angiographic features were well matched between these groups. Clinical outcomes at 12 months are shown in the Table. Patients with LAD lesions treated with primary Bivalirudin UFH+GPI p-value PCI n=699 n=746 NACE
18.3%
20.2%
0.31
MACE
14.0%
14.2%
0.90
4.8%
6.3%
0.19
Cardiac death
3.0%
5.3%
0.04
Reinfarction
3.7%
5.3%
0.15
Target vessel revascularization for ischemia
8.5%
7.1%
0.32
Stroke
1.0%
0.8%
0.71
'H¿QLWHRUSUREDEOHVWHQWWKURPERVLV
3.3%
3.6%
0.81
Major bleeding (Non-CABG)
6.5%
10.1%
0.01
Conclusions: In the international large-scale prospective HORIZONSAMI trial, patients undergoing primary PCI of LAD as compared to QRQ/$'OHVLRQVKDGVLJQL¿FDQWO\KLJKHU\HDUUDWHVRI1$&(0$&( death and cardiac death. In patients undergoing PCI of LAD lesions, anticoagulation with bivalirudin monotherapy rather than heparin + GPI UHVXOWHGLQVLJQL¿FDQWORZHUUDWHVRIPDMRUEOHHGLQJDQGFDUGLDFGHDWK
The American Journal of Cardiology®
| September 21-25, 2009
Introduction: Stent thrombosis (ST) is a catastrophic occurrence burdened by a high mortality rate, and with tendency to recur. We sought to evaluate WKH DQJLRJUDSKLF ULVN IDFWRUV IRU UHFXUULQJ VWHQW WKURPERVLV U67 LQ D subpopulation of 91 OPTIMIST patients who underwent quantitative angiographic evaluation. Methods: Angiographic analysis was performed by an independent core lab. Academic Research Consortium criteria were used for ST adjudication. A multivariable Cox proportional hazards model was applied to estimate WKH KD]DUG UDWLRV +5 DQG WKH FRUUHVSRQGLQJ FRQ¿GHQFH LQWHUYDOV (CI). The variables which were predictive of 6-month mortality in the main analysis (very late thrombosis, absence of reperfusion, and additional stent LPSODQWDWLRQ ZHUHLQFOXGHGDVZHOODVEDFNJURXQGYDULDEOHV DJHDQGJHQGHU Regarding angiographic variables, post-PCI reference vessel diameter, minimal lumen diameter, plus residual thrombus score >=3, were included as they were associated with rST at univariate analysis. Further models were ¿WWHG IRU YDOLGDWLRQ FRQVLGHULQJ HYHQWV ZLWK $5& FULWHULD ³GH¿QLWH´ DQG ³SUREDEOH´DVHYHQWYDULDEOHDQG¿QDOO\FRQVLGHULQJDQ\SRVVLEOHU67 $5& ³GH¿QLWH´³SUREDEOH´DQG³SRVVLEOH´ Results: 7KHUHZHUH³GH¿QLWH´U67GXULQJDYHUDJHIROORZXSRI GD\V of which 5 were “early” (3 leading to cardiac death preceded by cardiogenic VKRFNDQGUHVROYHGZLWKUH3&, DQG³ODWH´,QWKHPXOWLYDULDWHPRGHO only residual thrombus (multivariate HR=7.4, 95% CI 2.3-24.1, p=0.02) UHPDLQHGVLJQL¿FDQWO\DVVRFLDWHGZLWKWKHRXWFRPH:KHQWKHVDPHPRGHO ZDVDSSOLHGWRWKH´GH¿QLWHDQGSUREDEOH´U67DJDLQRQO\UHVLGXDOWKURPEXV PXOWLYDULDWH+5 &,S ZDVVLJQL¿FDQWO\DVVRFLDWHG with rST. Finally, when even “possible” rST were considered (18 patients), residual thrombus score >=3 remained associated with the dependent variable (multivariate HR=7.4, 95% CI 2.3-24.1, p=0.001). Variables related to vessel VL]HORVWVLJQL¿FDQFHLQWKHPXOWLYDULDWHDQDO\VHV Conclusions: When performing PCI for stent thrombosis, residual thrombus EXUGHQ LV D VLJQL¿FDQW ULVN IDFWRU IRU UHFXUULQJ WKURPERVLV ,Q SDUWLFXODU WKH DEVROXWH DPRXQW RI WKURPEXV LQÀXHQFHG E\ YHVVHO VL]H PLJKW EH prognostically important. Every effort should be made to reduce the thrombotic burden during PCI for stent thrombosis.
| TCT Abstracts/POSTER
115D
P O S T E R A B S T R AC T S
Death, all-cause
Italo Porto1, Francesco Burzotta1, Enrico Romagnoli2, A Manzoli3, C Pristipino4, F Belloni5, Gennaro Sardella6, Stefano Rigattieri7, G Gioffrè8, P Mazzarotto9, F Summaria2, A Parma10, A Danesi11, Francesco Prati3, Carlo Trani1, Filippo Crea1 1 Department of Cardiovascular Medicine, Catholic University of the Sacred Heart, Rome, Italy2Department of Cardiovascular Medicine, Policlinico Casilino, Rome, Italy3Department of Cardiovascular Medicine, Ospedale San Giovanni, Rome, Italy4Department of Cardiovascular Medicine, San Filippo Neri, Rome, Italy5Department of Cardiovascular Medicine, Ospedale San Pietro, Rome, Italy6Department of Cardiovascular Medicine, Università La Sapienza, Rome, Italy7Department of Cardiovascular Medicine, Ospedale Pertini, Rome, Italy8Department of Cardiovascular Medicine, Tor Vergata University, Rome, Italy9Department of Cardiovascular Medicine, Ospedale San Carlo, Rome, Italy10Department of Cardiovascular Medicine, Ospedale San Camillo, Rome, Italy11Department of Cardiovascular Medicine, Ospedale Santo Spirito, Rome, Italy