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TCT-354 Angiographic and Clinical Outcomes after Everolimus-Eluting Stenting for Unprotected Left Main Disease and High Anatomic Coronary Complexity
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany; 14 Wellmont CVA Heart Institute, Kingsport, Tennessee, United States; 15 Cedars Sinai Heart Institute, Los Angeles, California, United States; 16 Lehigh Valley Health Network, Bethlehem, Pennsylvania, United States; 17FirstHealth Cardiology Services, Pinehurst, North Carolina, United States; 18Ohio State University Medical Center, Columbus, Ohio, United States; 19Cardiovascular Research Foundation; 20Zena and Michael A. Weiner Cardiovascular Institute at Mount Sinai School of Medicine, New York, New York, United States; 21Cardiovascular Research Foundation, Washington, District of Columbia, United States; 22 Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, United States BACKGROUND Risk scores, such as the recently proposed PARIS score, can identify pts at high risk of thrombotic events who could potentially benefit from intensified antiplatelet therapy; however, more potent antiplatelet therapy would be expected to only overcome risk that is mediated by high platelet reactivity (PR) on conventional antiplatelet agents. Using mediation analysis, we sought to determine the contribution of high PR on clopidogrel to the increased risk of thrombotic events after PCI with DES in pts enrolled in the large-scale, multicenter ADAPT-DES study. METHODS Among 8449 pts successfully treated with DES, we assessed the direct (independent of platelet reactivity) and indirect (mediated through high platelet reactivity) effects of a high PARIS score on the risk of MACE, defined as the composite of CV death, MI, or stent thrombosis. We applied mediation analysis, using Cox proportional hazards regression. PR, as measured by the VerifyNow point-of-care assay, was included in the models as a continuous linear mediator variable. Pts were categorized according to their PARIS score as low (0-2 points), intermediate (3-4 points), or high (5 points) risk. RESULTS PR explained a limited proportion of the 2-year MACE risk associated with intermediate and high PARIS scores (assignable risk 4.3% and 6.3%, respectively; Figure). CONCLUSION Among pts treated with clopidogrel after successful PCI with DES, high residual PR mediates only a small proportion of the 2year MACE risk associated with the PARIS risk score. Intensifying antiplatelet therapy may therefore not substantially mitigate this risk. CATEGORIES CORONARY: Stents: Drug-Eluting TCT-353 Underweight Status, Platelet Reactivity, and 2-Year Clinical Outcomes in Patients Undergoing PCI With DES: An ADAPT-DES Study Analysis 1
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Puja Parikh, Ajay Kirtane, Giora Weisz, Thomas Stuckey, M. Ozgu Ozan,5 Bernhard Witzenbichler,6 Michael Rinaldi,7 Franz-Josef Neumann,8 D. Christopher Metzger,9 Timothy Henry,10 David Cox,11 Peter L. Duffy,12 Bruce Brodie,13 Ernest Mazzaferri, Jr.,14 Roxana Mehran,15 Gregg Stone16 1 Stony Brook Medicine, New York, New York, United States; 2NewYorkPresbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 3Shaare Zedek Medical Center, Jerusalem, Israel; 4Cone Health Heart and Vascular Center, Greensboro, North Carolina, United States; 5Cardiovascular Research Foundation, New York, New York, United States; 6Helios Amper-Klinikum, Dachau, Germany; 7Sanger Heart and Vascular Institute/Carolinas Medical Center, Charlotte, North Carolina, United States; 8UniversitätsHerzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany; 9 Wellmont CVA Heart Institute, Kingsport, Tennessee, United States; 10 Cedars Sinai Heart Institute, Los Angeles, California, United States; 11 Lehigh Valley Health Network, Bethlehem, Pennsylvania, United States; 12FirstHealth Cardiology Services, Pinehurst, North Carolina, United States; 13Moses Cone Heart and Vascular Center, Greensboro, North Carolina, United States; 14Ohio State University Medical Center, Columbus, Ohio, United States; 15Zena and Michael A. Weiner Cardiovascular Institute at Mount Sinai School of Medicine, New York, New York, United States; 16Columbia University Medical Center/ NewYork-Presbyterian Hospital, New York, New York, United States BACKGROUND The relationships between underweight status, platelet reactivity, and clinical outcomes after PCI with DES are not well understood. METHODS ADAPT-DES was a prospective, multicenter study of 8582 pts treated with aspirin and clopidogrel in whom routine measurement of P2Y12 reaction units (PRU) by VerifyNow testing was performed following successful DES implantation. Pts were classified
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according to the following body mass index (BMI) groups: Underweight (BMI <20 kg/m2), normal weight (20 kg/m2 BMI <25 kg/m2), overweight (25 kg/m2 BMI <30 kg/m2), and obese (BMI 30 kg/m2). RESULTS Underweight pts were more often female, smokers, had higher rates of peripheral arterial disease and renal insufficiency, and more frequently presented with an acute coronary syndrome than those with higher BMI. Underweight pts had significantly lower PRU and lower rates of high on-treatment platelet reactivity (HPR), while obese pts had higher PRU and higher rates of HPR. Underweight pts had higher 2-year rates of clinically relevant bleeding and mortality compared to normal weight patients (Figure). By multivariable analysis, underweight status was independently associated with higher rates of bleeding compared to normal weight status (HR 1.88 [1.023.47], p¼0.04), with a trend toward greater all-cause mortality (HR 2.18 [0.99-4.79], p¼0.053). CONCLUSION In this large, prospective, observational study of DEStreated patients, underweight status was associated with lower PRU on clopidogrel and significantly higher rates of bleeding at 2 years. CATEGORIES CORONARY: Stents: Drug-Eluting TCT-354 Angiographic and Clinical Outcomes after Everolimus-Eluting Stenting for Unprotected Left Main Disease and High Anatomic Coronary Complexity Renato Valenti,1 Angela Migliorini,2 Ruben Vergara,3 Guido Parodi,4 Eleonora Gabrielli,5 Maria Grazia De gregorio,6 Elena De Vito,7 Maria Raffaella Aicale,8 Nazzario Carrabba,9 David Antoniucci10 1 Careggi Hospital, Florence, Italy; 2careggi Hospital, Florence, Florence, Italy; 3DivCardiology-Careggi Hospital, Florence, Italy; 4Unknown, Florence, Italy; 5Division of Cardiology Careggi Hospital; 6Division of Cardiology Careggi Hospital; 7Division of Cardiology Careggi Hospital; 8 Division of Cardiology Careggi Hospital; 9Careggi Hospital, Cardiologia I, Florence, Italy; 10Careggi Hospital, Florence, Italy BACKGROUND The SYNergy between Percutaneous Coronary Intervention with TAXus and Cardiac Surgery (SYNTAX) trial has shown the superiority of coronary surgery over percutaneous coronary intervention (PCI) in patients with unprotected left main disease (ULMD) and complex coronary anatomy. It has been hypothesized that if newer-generation drug-eluting stents had been used in the SYNTAX trial, there would have been a significant reduction in clinical events. Angiographic and clinical outcome after everolimus-eluting stent (EES) supported PCI for ULMD and high SYNTAX score ( 33). METHODS Patients had angiogram scored according to the SYNTAX score algorithm and were divided in 2 groups: SYNTAX score 33 and < 33. The main end points were ULMD restenosis and 3-year cardiac mortality. RESULTS From May 2008 to July 2014, 393 patients underwent EES implantation for ULMD (181patients had a SYNTAX score 33 while 212 had a SYNTAX score < 33). Overall, the restenosis rate was 4.9% (6% in SYNTAX score 33 and 4.1% in SYNTAX score < 33, p ¼ 0.399). At multivariable analysis, the only variable related to restenosis was stent length (OR 1.06, 95% CI 1.02-1.09, p ¼0.002). The 3-year cardiac survival rate were 99 1% and 98 2% in patients with EuroSCORE < 6 and SYNTAX < 33 and 33, respectively, and 90 3% and 87 3% in patients with a EuroSCORE > 6 and SYNTAX score < 33 and 33, respectively. The EuroSCORE was strongly related to cardiac mortality, while the SYNTAX score 33 was not both in patients with a EuroSCORE < 6 or 6, and there were no interactions between EuroSCORE and SYNTAX score 33. CONCLUSION For ULMD patients, a SYNTAX score 33 should be no more considered to determine the optimal revascularization modality. CATEGORIES CORONARY: Stents: Drug-Eluting TCT-355 Clinical and Angiographic Outcome of Double Crush Versus Provisional-Stenting Technique in Patients With Distal Unprotected Left Main Disease in the Everolimus Eluting Stent Generation Era Angela Migliorini,1 Renato Valenti,2 Ruben Vergara,3 Maria Grazia De gregorio,4 Eleonora Gabrielli,5 Maria Raffaella Aicale,6 Elena De Vito,7 Guido Parodi,8 Nazzario Carrabba,9 David Antoniucci10 1 Azienda Ospedaliero Universitaria Careggi, Firenze, Florence, Italy; 2 Careggi Hospital, Florence, Italy; 3DivCardiology-Careggi Hospital, Florence, Italy; 4Division of Cardiology Careggi Hospital; 5Division of Cardiology Careggi Hospital; 6Division of Cardiology Careggi Hospital;
Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany; 14 Wellmont CVA Heart Institute, Kingsport, Tennessee, United States; 15 Cedars Sinai Heart Institute, Los Angeles, California, United States; 16 Lehigh Valley Health Network, Bethlehem, Pennsylvania, United States; 17FirstHealth Cardiology Services, Pinehurst, North Carolina, United States; 18Ohio State University Medical Center, Columbus, Ohio, United States; 19Cardiovascular Research Foundation; 20Zena and Michael A. Weiner Cardiovascular Institute at Mount Sinai School of Medicine, New York, New York, United States; 21Cardiovascular Research Foundation, Washington, District of Columbia, United States; 22 Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, United States BACKGROUND Risk scores, such as the recently proposed PARIS score, can identify pts at high risk of thrombotic events who could potentially benefit from intensified antiplatelet therapy; however, more potent antiplatelet therapy would be expected to only overcome risk that is mediated by high platelet reactivity (PR) on conventional antiplatelet agents. Using mediation analysis, we sought to determine the contribution of high PR on clopidogrel to the increased risk of thrombotic events after PCI with DES in pts enrolled in the large-scale, multicenter ADAPT-DES study. METHODS Among 8449 pts successfully treated with DES, we assessed the direct (independent of platelet reactivity) and indirect (mediated through high platelet reactivity) effects of a high PARIS score on the risk of MACE, defined as the composite of CV death, MI, or stent thrombosis. We applied mediation analysis, using Cox proportional hazards regression. PR, as measured by the VerifyNow point-of-care assay, was included in the models as a continuous linear mediator variable. Pts were categorized according to their PARIS score as low (0-2 points), intermediate (3-4 points), or high (5 points) risk. RESULTS PR explained a limited proportion of the 2-year MACE risk associated with intermediate and high PARIS scores (assignable risk 4.3% and 6.3%, respectively; Figure). CONCLUSION Among pts treated with clopidogrel after successful PCI with DES, high residual PR mediates only a small proportion of the 2year MACE risk associated with the PARIS risk score. Intensifying antiplatelet therapy may therefore not substantially mitigate this risk. CATEGORIES CORONARY: Stents: Drug-Eluting TCT-353 Underweight Status, Platelet Reactivity, and 2-Year Clinical Outcomes in Patients Undergoing PCI With DES: An ADAPT-DES Study Analysis 1
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Puja Parikh, Ajay Kirtane, Giora Weisz, Thomas Stuckey, M. Ozgu Ozan,5 Bernhard Witzenbichler,6 Michael Rinaldi,7 Franz-Josef Neumann,8 D. Christopher Metzger,9 Timothy Henry,10 David Cox,11 Peter L. Duffy,12 Bruce Brodie,13 Ernest Mazzaferri, Jr.,14 Roxana Mehran,15 Gregg Stone16 1 Stony Brook Medicine, New York, New York, United States; 2NewYorkPresbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 3Shaare Zedek Medical Center, Jerusalem, Israel; 4Cone Health Heart and Vascular Center, Greensboro, North Carolina, United States; 5Cardiovascular Research Foundation, New York, New York, United States; 6Helios Amper-Klinikum, Dachau, Germany; 7Sanger Heart and Vascular Institute/Carolinas Medical Center, Charlotte, North Carolina, United States; 8UniversitätsHerzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany; 9 Wellmont CVA Heart Institute, Kingsport, Tennessee, United States; 10 Cedars Sinai Heart Institute, Los Angeles, California, United States; 11 Lehigh Valley Health Network, Bethlehem, Pennsylvania, United States; 12FirstHealth Cardiology Services, Pinehurst, North Carolina, United States; 13Moses Cone Heart and Vascular Center, Greensboro, North Carolina, United States; 14Ohio State University Medical Center, Columbus, Ohio, United States; 15Zena and Michael A. Weiner Cardiovascular Institute at Mount Sinai School of Medicine, New York, New York, United States; 16Columbia University Medical Center/ NewYork-Presbyterian Hospital, New York, New York, United States BACKGROUND The relationships between underweight status, platelet reactivity, and clinical outcomes after PCI with DES are not well understood. METHODS ADAPT-DES was a prospective, multicenter study of 8582 pts treated with aspirin and clopidogrel in whom routine measurement of P2Y12 reaction units (PRU) by VerifyNow testing was performed following successful DES implantation. Pts were classified
B145
according to the following body mass index (BMI) groups: Underweight (BMI <20 kg/m2), normal weight (20 kg/m2 BMI <25 kg/m2), overweight (25 kg/m2 BMI <30 kg/m2), and obese (BMI 30 kg/m2). RESULTS Underweight pts were more often female, smokers, had higher rates of peripheral arterial disease and renal insufficiency, and more frequently presented with an acute coronary syndrome than those with higher BMI. Underweight pts had significantly lower PRU and lower rates of high on-treatment platelet reactivity (HPR), while obese pts had higher PRU and higher rates of HPR. Underweight pts had higher 2-year rates of clinically relevant bleeding and mortality compared to normal weight patients (Figure). By multivariable analysis, underweight status was independently associated with higher rates of bleeding compared to normal weight status (HR 1.88 [1.023.47], p¼0.04), with a trend toward greater all-cause mortality (HR 2.18 [0.99-4.79], p¼0.053). CONCLUSION In this large, prospective, observational study of DEStreated patients, underweight status was associated with lower PRU on clopidogrel and significantly higher rates of bleeding at 2 years. CATEGORIES CORONARY: Stents: Drug-Eluting TCT-354 Angiographic and Clinical Outcomes after Everolimus-Eluting Stenting for Unprotected Left Main Disease and High Anatomic Coronary Complexity Renato Valenti,1 Angela Migliorini,2 Ruben Vergara,3 Guido Parodi,4 Eleonora Gabrielli,5 Maria Grazia De gregorio,6 Elena De Vito,7 Maria Raffaella Aicale,8 Nazzario Carrabba,9 David Antoniucci10 1 Careggi Hospital, Florence, Italy; 2careggi Hospital, Florence, Florence, Italy; 3DivCardiology-Careggi Hospital, Florence, Italy; 4Unknown, Florence, Italy; 5Division of Cardiology Careggi Hospital; 6Division of Cardiology Careggi Hospital; 7Division of Cardiology Careggi Hospital; 8 Division of Cardiology Careggi Hospital; 9Careggi Hospital, Cardiologia I, Florence, Italy; 10Careggi Hospital, Florence, Italy BACKGROUND The SYNergy between Percutaneous Coronary Intervention with TAXus and Cardiac Surgery (SYNTAX) trial has shown the superiority of coronary surgery over percutaneous coronary intervention (PCI) in patients with unprotected left main disease (ULMD) and complex coronary anatomy. It has been hypothesized that if newer-generation drug-eluting stents had been used in the SYNTAX trial, there would have been a significant reduction in clinical events. Angiographic and clinical outcome after everolimus-eluting stent (EES) supported PCI for ULMD and high SYNTAX score ( 33). METHODS Patients had angiogram scored according to the SYNTAX score algorithm and were divided in 2 groups: SYNTAX score 33 and < 33. The main end points were ULMD restenosis and 3-year cardiac mortality. RESULTS From May 2008 to July 2014, 393 patients underwent EES implantation for ULMD (181patients had a SYNTAX score 33 while 212 had a SYNTAX score < 33). Overall, the restenosis rate was 4.9% (6% in SYNTAX score 33 and 4.1% in SYNTAX score < 33, p ¼ 0.399). At multivariable analysis, the only variable related to restenosis was stent length (OR 1.06, 95% CI 1.02-1.09, p ¼0.002). The 3-year cardiac survival rate were 99 1% and 98 2% in patients with EuroSCORE < 6 and SYNTAX < 33 and 33, respectively, and 90 3% and 87 3% in patients with a EuroSCORE > 6 and SYNTAX score < 33 and 33, respectively. The EuroSCORE was strongly related to cardiac mortality, while the SYNTAX score 33 was not both in patients with a EuroSCORE < 6 or 6, and there were no interactions between EuroSCORE and SYNTAX score 33. CONCLUSION For ULMD patients, a SYNTAX score 33 should be no more considered to determine the optimal revascularization modality. CATEGORIES CORONARY: Stents: Drug-Eluting TCT-355 Clinical and Angiographic Outcome of Double Crush Versus Provisional-Stenting Technique in Patients With Distal Unprotected Left Main Disease in the Everolimus Eluting Stent Generation Era Angela Migliorini,1 Renato Valenti,2 Ruben Vergara,3 Maria Grazia De gregorio,4 Eleonora Gabrielli,5 Maria Raffaella Aicale,6 Elena De Vito,7 Guido Parodi,8 Nazzario Carrabba,9 David Antoniucci10 1 Azienda Ospedaliero Universitaria Careggi, Firenze, Florence, Italy; 2 Careggi Hospital, Florence, Italy; 3DivCardiology-Careggi Hospital, Florence, Italy; 4Division of Cardiology Careggi Hospital; 5Division of Cardiology Careggi Hospital; 6Division of Cardiology Careggi Hospital;