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TCT-322 The Smoker’s Paradox Revisited: A 5-Year Patient-Level Pooled Analysis of 17 Randomized Controlled Trials
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
B133
CONCLUSION Risk of very late definite stent thrombosis in stents with biodegradable polymer did not differ between the SES-Orsiro and BES-Nobori. However, the thin strut SES-Orsiro stent was associated with a lower risk of early stent thrombosis. CATEGORIES CORONARY: PCI Outcomes TCT-322 The Smoker’s Paradox Revisited: A 5-Year Patient-Level Pooled Analysis of 17 Randomized Controlled Trials mayank yadav,1 Philippe Généreux,2 Bjorn Redfors,3 Mahesh Madhavan,4 Ajay Kirtane,5 Rupa Parvataneni,6 Gregg Stone7 1 CRF, south richmond hill, New York, United States; 2Columbia University Medical Center/Hôpital du Sacré-Coeur de Montréal, New York, New York, United States; 3CRF, New York, New York, United States; 4New York-Presbyterian Hospital/ Columbia University Medical Center, New York, New York, United States; 5NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 6crf, new york, New York, United States; 7Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, United States CONCLUSION Mini crush stenting is more effective technique in patients with bifurcation lesions in chronic coronary artery occlusions compared to T-provisional stenting. CATEGORIES CORONARY: PCI Outcomes TCT-321 Definite and probable stent thrombosis after revascularization with drug-eluting stents with a biodegradable polymer. From the randomized SORT OUT VII Trial Lisette Okkels Jensen,1 Michael Maeng,2 Bent Raungaard,3 Knud Noerregaard Hansen,4 Johnny Kahlert,5 Svend Eggert Jensen,6 Hans Erik Bøtker,7 Henrik Hansen,8 Jens Flensted Lassen,9 Evald Christiansen10 1 Odense University Hospital, Odense, Denmark; 2Aarhus University Hospital, Aarhus N, Denmark; 3Aalborg University Hospital, Aalborg, Denmark; 4Odense Universitets Hospital, Odense, Denmark; 5Rutgers Robert Wood Johnson Medical School; 6Aalborg University Hospital, Aalborg, Denmark; 7Weatherhead PET Center, McGovern Medical School at UTHealth; 8Unknown, Odense, Denmark; 9The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; 10 Aarhus University Hospital, Aarhus, Denmark
BACKGROUND Studies on the effects of smoking and outcomes among patients undergoing percutaneous coronary intervention (PCI) have reported conflicting results. We sought to examine this relationship from a large pooled patient-level study. METHODS Patient-level data from 17 prospective, randomized trials (RAVEL, E-SIRIUS, SIRIUS, C-SIRIUS, TAXUS II, TAXUS IV-V, ENDEAVOR II-IV, SPIRIT II-IV, HORIZONS-AMI and COMPARE I-II, PLATINUM) were pooled. Patients were stratified by smoking status at time of enrollment. Study stratified Kaplan Meier event rates and Cox regression analysis modeled time to event outcomes. Five year ischemic outcomes were compared between the two groups. RESULTS Among 21,549 patients, 6,038 (28.01%) were current smokers. Smokers were younger and less likely to have diabetes, hypertension, hyperlipidemia, or prior myocardial infarction (MI), PCI, or coronary artery bypass grafting. Angiographically, smokers had longer lesions but less calcification. At 5 years, smokers had similar unadjusted rates of death and cardiac death but higher rates of MI and stent thrombosis than nonsmokers; however, after multivariable adjustment for potential confounders, smoking was a strong independent predictor of all-cause death, cardiac death, MI, and stent thrombosis (Table). Table. Five-Year Outcomes After Percutaneous Coronary Intervention Stratified by Smoking Status
BACKGROUND Definite stent thrombosis definition maximizes specificity, but it may be insufficiently sensitive to capture completely this relatively rare event. Sensitivity can be increased by including probable stent thrombosis in the analysis. There is limited head-to-head data on late stent thromboses for drug-eluting stents with biodegradable polymers. In accordance with the Academic Research Consortium we assessed definite and probable stent thrombosis events in the SORT OUT VII trial, among patient treated with the thin strut cobalt-chromium sirolimus-eluting Orsiro stent (Biotronik, Bülach, Switzerland) and the stainless steel biolimus-eluting Nobori stents (Terumo, Tokyo, Japan). METHODS Of 2,525 patients, 1,261 patients were assigned to receive the SES-Orsiro, and 1,264 patients were assigned to receive the BES-Nobori. Definite and probable stent thromboses were assessed within 2 years. RESULTS Definite stent thrombosis occurred within 2 years in 27 patients (1.1%) and definite/probable stent thrombosis occurred in 38 patients (1.5%). Definite stent thrombosis occurred within 2 years in 9 patients [07%] in the SES-Orsiro group and in 18 patients [1.4%] in the BES-Nobori group (p ¼ 0.09). Probable stent thrombosis occurred within 2 years in 6 patients [0.5%] in the SES-Orsiro group and in 5 patients [0.4%] in the BES-Nobori group (p ¼ 0.75). Probable stent thrombosis was caused by 11 unexplained deaths within the first 30 days. SES-Orsiro
BES-Nobori
RR 95% CI
9 (0.7%)
18 (1.4%)
0.50 (0.23 - 1.12)
1 (0.1%)
2 (0.2%)
0.50 (0.05 - 5.52)
Subacute
1 (0.1%)
8 (0.6%)
0.12 (0.02 - 1.00)
Late
3 (0.2%)
5 (0.4%)
0.60 (0.14 - 2.52)
Definite stent thrombosis Acute
Very Late
4 (0.3%)
3 (0.2%)
1.34 (0.30 - 6.01)
Within 1Y
5 (0.4%)
15 (1.2%)
0.33 (0.12 – 0.92)
Probable stent thrombosis
6 (0.5%)
5 (0.4%)
1.21 (0.37 - 3.97)
Definite/probable stent
15 (1.2%)
23 (1.8%)
0.66 (0.34 - 1.26)
thrombosis
Outcomes
Smokers
Non-smokers
Unadjusted HR
(n[6038)
(n[15,511)
[95% CI]; p-value
CI]; p-value
253 (8.9)
743 (8.4)
1.08 [0.93-1.24];
2.02 [1.72-2.38];
105 (3.8)
326 (3.7)
1.01 [0.81-1.26];
223 (7.9)
489 (5.5)
1.37 [1.17-1.61];
264 (14.2)
871 (15.7)
0.94 [0.82-1.08];
88 (3.1)
140 (1.6)
1.78 [1.36-2.33];
499 (18.0)
1487 (17.2)
1.05 [0.94-1.16];
Death
p¼0.32 Cardiac death
p¼0.96 Myocardial reinfarction Target vessel
p¼0.0001
revascularization
p¼0.4
Stent thrombosis (def/ prob) Major adverse cardiac
p<0.0001
events
p¼0.39
Adjusted HR [95%
p<0.0001 1.85 [1.45-2.38]; p<0.0001 1.43 [1.19-1.71]; p¼0.0001 0.95 [0.84-1.07]; p¼0.37 1.70 [1.24-2.32]; p¼0.001 1.16 [1.03-1.30]; p¼0.01
Data presented as n (%). Major adverse cardiac events includes cardiac death, myocardial reinfarction or target lesion revascularization. Variables included in multivariable analysis: age, male, diabetes, hyperlipidemia, hypertension, prior myocardial infarction, prior PCI, prior coronary artery bypass graft surgery, lesion length, and current smoking.
CONCLUSION The present large patient-level pooled analysis with 5year follow-up clearly demonstrates that smoking remains an important predictor of poor outcomes after PCI and should be strongly discouraged. CATEGORIES CORONARY: Stents: Drug-Eluting TCT-323 Predictors of clinical outcome and subsequent target lesion revascularization after percutaneous coronary procedures with drug eluting stents and everolimus eluting bioresorbable scaffolds for cardiac allograft vasculopathy Valentina Vaccaro,1 Irene Maria Bossi,2 Margherita D’Anna,3 Giacomo Piccalo,4 Maria Paola Caria,5 Giovanna Pedrazzini,6 Enrico Ammirati,7 Fabio Turazza,8 Fabrizio Oliva,9 Andrea Rueda10
B133
CONCLUSION Risk of very late definite stent thrombosis in stents with biodegradable polymer did not differ between the SES-Orsiro and BES-Nobori. However, the thin strut SES-Orsiro stent was associated with a lower risk of early stent thrombosis. CATEGORIES CORONARY: PCI Outcomes TCT-322 The Smoker’s Paradox Revisited: A 5-Year Patient-Level Pooled Analysis of 17 Randomized Controlled Trials mayank yadav,1 Philippe Généreux,2 Bjorn Redfors,3 Mahesh Madhavan,4 Ajay Kirtane,5 Rupa Parvataneni,6 Gregg Stone7 1 CRF, south richmond hill, New York, United States; 2Columbia University Medical Center/Hôpital du Sacré-Coeur de Montréal, New York, New York, United States; 3CRF, New York, New York, United States; 4New York-Presbyterian Hospital/ Columbia University Medical Center, New York, New York, United States; 5NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 6crf, new york, New York, United States; 7Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, United States CONCLUSION Mini crush stenting is more effective technique in patients with bifurcation lesions in chronic coronary artery occlusions compared to T-provisional stenting. CATEGORIES CORONARY: PCI Outcomes TCT-321 Definite and probable stent thrombosis after revascularization with drug-eluting stents with a biodegradable polymer. From the randomized SORT OUT VII Trial Lisette Okkels Jensen,1 Michael Maeng,2 Bent Raungaard,3 Knud Noerregaard Hansen,4 Johnny Kahlert,5 Svend Eggert Jensen,6 Hans Erik Bøtker,7 Henrik Hansen,8 Jens Flensted Lassen,9 Evald Christiansen10 1 Odense University Hospital, Odense, Denmark; 2Aarhus University Hospital, Aarhus N, Denmark; 3Aalborg University Hospital, Aalborg, Denmark; 4Odense Universitets Hospital, Odense, Denmark; 5Rutgers Robert Wood Johnson Medical School; 6Aalborg University Hospital, Aalborg, Denmark; 7Weatherhead PET Center, McGovern Medical School at UTHealth; 8Unknown, Odense, Denmark; 9The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; 10 Aarhus University Hospital, Aarhus, Denmark
BACKGROUND Studies on the effects of smoking and outcomes among patients undergoing percutaneous coronary intervention (PCI) have reported conflicting results. We sought to examine this relationship from a large pooled patient-level study. METHODS Patient-level data from 17 prospective, randomized trials (RAVEL, E-SIRIUS, SIRIUS, C-SIRIUS, TAXUS II, TAXUS IV-V, ENDEAVOR II-IV, SPIRIT II-IV, HORIZONS-AMI and COMPARE I-II, PLATINUM) were pooled. Patients were stratified by smoking status at time of enrollment. Study stratified Kaplan Meier event rates and Cox regression analysis modeled time to event outcomes. Five year ischemic outcomes were compared between the two groups. RESULTS Among 21,549 patients, 6,038 (28.01%) were current smokers. Smokers were younger and less likely to have diabetes, hypertension, hyperlipidemia, or prior myocardial infarction (MI), PCI, or coronary artery bypass grafting. Angiographically, smokers had longer lesions but less calcification. At 5 years, smokers had similar unadjusted rates of death and cardiac death but higher rates of MI and stent thrombosis than nonsmokers; however, after multivariable adjustment for potential confounders, smoking was a strong independent predictor of all-cause death, cardiac death, MI, and stent thrombosis (Table). Table. Five-Year Outcomes After Percutaneous Coronary Intervention Stratified by Smoking Status
BACKGROUND Definite stent thrombosis definition maximizes specificity, but it may be insufficiently sensitive to capture completely this relatively rare event. Sensitivity can be increased by including probable stent thrombosis in the analysis. There is limited head-to-head data on late stent thromboses for drug-eluting stents with biodegradable polymers. In accordance with the Academic Research Consortium we assessed definite and probable stent thrombosis events in the SORT OUT VII trial, among patient treated with the thin strut cobalt-chromium sirolimus-eluting Orsiro stent (Biotronik, Bülach, Switzerland) and the stainless steel biolimus-eluting Nobori stents (Terumo, Tokyo, Japan). METHODS Of 2,525 patients, 1,261 patients were assigned to receive the SES-Orsiro, and 1,264 patients were assigned to receive the BES-Nobori. Definite and probable stent thromboses were assessed within 2 years. RESULTS Definite stent thrombosis occurred within 2 years in 27 patients (1.1%) and definite/probable stent thrombosis occurred in 38 patients (1.5%). Definite stent thrombosis occurred within 2 years in 9 patients [07%] in the SES-Orsiro group and in 18 patients [1.4%] in the BES-Nobori group (p ¼ 0.09). Probable stent thrombosis occurred within 2 years in 6 patients [0.5%] in the SES-Orsiro group and in 5 patients [0.4%] in the BES-Nobori group (p ¼ 0.75). Probable stent thrombosis was caused by 11 unexplained deaths within the first 30 days. SES-Orsiro
BES-Nobori
RR 95% CI
9 (0.7%)
18 (1.4%)
0.50 (0.23 - 1.12)
1 (0.1%)
2 (0.2%)
0.50 (0.05 - 5.52)
Subacute
1 (0.1%)
8 (0.6%)
0.12 (0.02 - 1.00)
Late
3 (0.2%)
5 (0.4%)
0.60 (0.14 - 2.52)
Definite stent thrombosis Acute
Very Late
4 (0.3%)
3 (0.2%)
1.34 (0.30 - 6.01)
Within 1Y
5 (0.4%)
15 (1.2%)
0.33 (0.12 – 0.92)
Probable stent thrombosis
6 (0.5%)
5 (0.4%)
1.21 (0.37 - 3.97)
Definite/probable stent
15 (1.2%)
23 (1.8%)
0.66 (0.34 - 1.26)
thrombosis
Outcomes
Smokers
Non-smokers
Unadjusted HR
(n[6038)
(n[15,511)
[95% CI]; p-value
CI]; p-value
253 (8.9)
743 (8.4)
1.08 [0.93-1.24];
2.02 [1.72-2.38];
105 (3.8)
326 (3.7)
1.01 [0.81-1.26];
223 (7.9)
489 (5.5)
1.37 [1.17-1.61];
264 (14.2)
871 (15.7)
0.94 [0.82-1.08];
88 (3.1)
140 (1.6)
1.78 [1.36-2.33];
499 (18.0)
1487 (17.2)
1.05 [0.94-1.16];
Death
p¼0.32 Cardiac death
p¼0.96 Myocardial reinfarction Target vessel
p¼0.0001
revascularization
p¼0.4
Stent thrombosis (def/ prob) Major adverse cardiac
p<0.0001
events
p¼0.39
Adjusted HR [95%
p<0.0001 1.85 [1.45-2.38]; p<0.0001 1.43 [1.19-1.71]; p¼0.0001 0.95 [0.84-1.07]; p¼0.37 1.70 [1.24-2.32]; p¼0.001 1.16 [1.03-1.30]; p¼0.01
Data presented as n (%). Major adverse cardiac events includes cardiac death, myocardial reinfarction or target lesion revascularization. Variables included in multivariable analysis: age, male, diabetes, hyperlipidemia, hypertension, prior myocardial infarction, prior PCI, prior coronary artery bypass graft surgery, lesion length, and current smoking.
CONCLUSION The present large patient-level pooled analysis with 5year follow-up clearly demonstrates that smoking remains an important predictor of poor outcomes after PCI and should be strongly discouraged. CATEGORIES CORONARY: Stents: Drug-Eluting TCT-323 Predictors of clinical outcome and subsequent target lesion revascularization after percutaneous coronary procedures with drug eluting stents and everolimus eluting bioresorbable scaffolds for cardiac allograft vasculopathy Valentina Vaccaro,1 Irene Maria Bossi,2 Margherita D’Anna,3 Giacomo Piccalo,4 Maria Paola Caria,5 Giovanna Pedrazzini,6 Enrico Ammirati,7 Fabio Turazza,8 Fabrizio Oliva,9 Andrea Rueda10