- Email: [email protected]
TCT-260 Outcomes of Chronic Total Occlusion PCI in Patients with Diabetes – Insights from the OPEN CTO Registry
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
RAO at band removal (12% vs 13%, P ¼ 0.51) were observed between Group I and II. Incidence of 24-hour RAO was significantly lower in Group II compared to Group I (8.6% vs 3.7%, P ¼ 0.001). Post-procedural ACT <200 seconds was associated with a significantly higher incidence of RAO compared to ACT > 200 seconds (7.8% vs 2%, P ¼ 0.0001). CONCLUSION A higher post-procedural ACT is associated with lower RO incidence. Administration of UFH at the end of the procedure might lower the incidence of RAO without increasing rebound bleeding. CATEGORIES CORONARY: Complications TCT-258 Clinical significance of peri-procedural myocardial infarction following percutaneous coronary intervention for multi-vessel coronary artery disease Min Soo Cho,1 Do-yoon Kang,2 Ungjeong Do,3 Jung Ae Hong,4 Osung Kwon,5 Cheol Hyun Lee,6 Jaeseok bae,7 Yu Na Kim,8 Se Hun Kang,9 Sung-Han Yoon,10 Pil Hyung Lee,11 Jung-Min Ahn,12 Duk-Woo Park,13 Soo-Jin Kang,14 Seung-Whan Lee,15 Young-Hak Kim,16 Cheol Whan Lee,17 Seong-Wook Park,18 Seung-Jung Park19 1 Asan medical center, Seoul, Korea, Republic of; 2Asan Medical Center, Seoul, Korea, Republic of; 3Seoul National University Hospital, Seoul, Korea, Republic of; 4Asan Medical Center, Seoul, Korea, Republic of; 5 Asan Medical Center, Seoul, Korea, Republic of; 6Asan medical center, seoul, Korea, Republic of; 7Asan medical center, Seoul, Korea, Republic of; 8Asan Medical Center, Seoul, Korea, Republic of; 9Asan Medical Center, Seoul, Korea, Republic of; 10Asan Medical Center, Seoul, Korea, Republic of; 11Columbia University Medical Center, Seoul, Korea, Republic of; 12Asan Medical Center, Seoul, Korea, Republic of; 13Asan Medical Center, Seoul, Korea, Republic of; 14Asan Medical Center, Seoul, Korea, Republic of; 15Asan Medical Center, Seoul, Korea, Republic of; 16Asan Medical Center, Seoul, Korea, Republic of; 17Asan Medical Center, Seoul, Korea, Republic of; 18Asan Medical Center, Seoul, Korea, Republic of; 19Asan Medical Center, Seoul, Korea, Republic of BACKGROUND The prevalence and prognostic implications of current peri-procedural myocardial infarction (periMI) definitions in realworld practice were not well evaluated to date. METHODS The Asan-MV registry was consisted of consecutive patients whose peri-procedural creatinine kinase-MB mass was routinely measured and clinical outcomes were prospectively collected. From this population, data from 4514 patients who underwent percutaneous coronary intervention for multi-vessel coronary artery disease were analyzed. The periMI was diagnosed according to the 2nd universal (2nd), 3rd universal (3rd), and clinically relevant (SCAI) definitions of periMI. The primary outcome of the study was major cardiovascular adverse event (MACE), defined as composite of death, myocardial infarction, and repeat revascularization. RESULTS The periMI was diagnosed in 842, 142, 248 patients according to the 2nd, 3rd, and SCAI criteria, respectively. After multivariable adjustment, the patients with perMI with each definition was at higher risk of MACE compared to those without (hazard ratio [HR] 1.48 [95% confidence interval [CI] 1.28 -1.70] for 2nd, HR 1.43 [1.081.91] for 3rd, HR 1.82 [1.48-2.25] for SCAI perMI, respectively). All definitions of periMI were specific (83.0%, 97.2%, 95.6%, respectively), but not sensitive (24.1%, 4.7%, 9.1%, respectively) for future MACE. Overall discriminating performances were poor at C-static of 0.536, 0.509, and 0.523, respectively.
CONCLUSION The patients with periMI were at higher risk of future MACE. Current definitions of periMI were specific, but their discriminating performances were poor. CATEGORIES CORONARY: PCI Outcomes
B105
TCT-259 Coronary artery perforation during percutaneous coronary intervention: incidence and outcomes Oliver Guttmann,1 Daniel Jones,2 Ankur Gulati,3 Tom Crake,4 Muhiddin Ozkor,5 Andrew Wragg,6 Elliot Smith,7 Roshan Weerackody,8 Charles Knight,9 Anthony Mathur,10 Costas O’Mahony11 1 London, United Kingdom; 2London chest, london, United Kingdom; 3 Barts Heart Centre, London, United Kingdom; 4Unknown, London, United Kingdom; 5The Heart Hospital / UCLH, LONDON, United Kingdom; 6Barts and The London NHS Trust, London, United Kingdom; 7 Barts Health NHS Trust, London, United Kingdom; 8Unknown, London, United Kingdom; 9London Chest Hospital, London, United Kingdom; 10Barts and the London NHS Trust, London, United Kingdom; 11Northwell Health BACKGROUND Coronary artery perforation during PCI is a rare but severe complication with a high morbidity and mortality. The incidence of this complication is reported to range from 0.1 to 1%. The aim of this study was to examine the clinical outcome following percutaneous coronary intervention [PCI] complicated by vessel perforation. METHODS The procedural records of 28,537 patients undergoing coronary intervention were reviewed. Mortality data were obtained from the UK Office of National Statistics. RESULTS Vessel perforation affected 103 patients (0.36%), ranging from wire exit to free flow into the pericardial space. Fifty three (51.9%) perforations occurred during elective procedures, 22 (21.6%) in chronic occlusions. In 26 of 103 (25.2%) a significant pericardial effusion ensued requiring surgical or percutaneous drainage. Six of the 26 patients were referred for emergency bypass surgery (23.1%), 2 of which subsequently died. Three patients died despite pericardial drains being inserted. In all, 24 patients had covered stents (CS) inserted and five did not survive to discharge. Ten of the 24 (41.7%) that had CS had drains compared to 16/79 (20.3%) who did not. Of the 19 patients with a covered stent that survived to hospital discharge, 6 (30.0%) had definite stent thrombosis, 2 (10.0%) had possible/probable stent thrombosis. CONCLUSION Coronary artery perforation during intervention is rare. The development of pericardial tamponade carries a high mortality. While the use of covered stents may provide a valuable rescue option acutely, high rates of stent thrombosis suggest more potent antiplatelet agents may be needed. CATEGORIES CORONARY: Complications
DIABETES
Abstract nos: 260 - 272 TCT-260 Outcomes of Chronic Total Occlusion PCI in Patients with Diabetes – Insights from the OPEN CTO Registry Adam Salisbury,1 James Sapontis,2 J. Aaron Grantham,3 Mohammed Qintar,4 Kensey Gosch,5 William Lombardi,6 Dimitrios Karmpaliotis,7 Jeffrey Moses,8 John Spertus,9 David Cohen,10 Mikhail Kosiborod11 1 Saint Lukes Mid America Heart Institute, Parkville, Missouri, United States; 2MonashHeart, Victoria, Victoria, Australia; 3University of Missouri Kansas City and Mid America Heart Institute, Kansas City, Missouri, United States; 4Saint Lukes Mid America Heart Institute, Overland Park, Kansas, United States; 5Imperial College London; 6 University of Washington Medical Center, Seattle, Washington, United States; 7Interventional Cardiologist, Atlanta, Georgia, United States; 8 NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 9Mid America Heart Institute, Kansas City, Missouri, United States; 10Saint Luke’s Mid America Heart Institute, Kansas City, Missouri, United States; 11St. Luke’s Mid America Heart Institute, Kansas City, Missouri, United States BACKGROUND Chronic total occlusions (CTOs) are more common among diabetic than non-diabetic patients, and are associated with high symptom burden, yet CTO PCI is less often attempted in this group. This may reflect greater disease complexity (small vessels, diffuse disease), higher perceived complication risk, or lack of data
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
B106
describing benefits of CTO PCI among diabetic patients. Few studies have evaluated the relationship of diabetes with technical success or periprocedural complications, and no prior studies have compared patient-reported health status (symptoms, function and quality of life) after CTO PCI in patients with and without diabetes. METHODS In a 12-center prospective CTO PCI registry, patients were assessed for technical success, periprocedural complications, and health status using the Seattle Angina Questionnaire Summary, Angina Frequency and Quality of Life scores at baseline and 30-day follow-up. Hierarchical Poisson regression was used to examine the association between diabetes and technical success adjusting for patient and angiographic factors, while multivariable linear regression was used to assess the association between diabetes and 30day health status adjusting for baseline health status and patient factors. RESULTS Diabetes was common (41.2%), and associated with a lower crude rate of technical success (83.0% vs. 88.1%, p¼0.02). After adjusting for angiographic complexity and other factors, there was no significant difference between diabetic and non-diabetic patients (RR 0.95, 95% CI 0.90-1.01), and there were no significant differences in complication rates or adjusted follow-up health status scores (Table).
METHODS In total 2,525 patients (471 with diabetes, 18.6%) were randomized to stent implantation with O-SES (n¼1,261, diabetes: n¼236) or N-BES (n¼1,264, diabetes: n¼235). Randomization was stratified by presence/absence of diabetes. The primary end point, target lesion failure, was a composite of cardiac death, target-lesion myocardial infarction (MI) (not related to other than index lesion), or target lesion revascularization (TLR) within 2 years. RESULTS At 2-year, target lesion failure was higher in diabetic than in nondiabetic patients (9.3% vs 6.3%, rate ratio [RR] 1.53, 95% confidence interval [CI] 1.09-2.17). Risk of cardiac death (3.4% versus 1.8%; RR 1.91, 95% CI 1.06-3.44), MI (5.7% versus 3.2%; RR 1.83, 95% CI 1.172.87) and TLR (5.7% versus 3.7%; RR 1.59, 95% CI 1.02-2.48) were higher in diabetics than in nondiabetics. Definite stent thrombosis (1.5% versus 1.0%; RR 1.55, 95% CI 0.65-3.68) and definite/probable stent thrombosis (1.9% versus 1.4%; RR 1.37, 95% CI 0.65-2.92) did not differ significantly between the two groups. At 2 years, target lesion failure did not differ between O-SES versus N-BES in diabetic (9.3% versus 9.4%; RR 0.98, 95% CI 0.54-1.78) and nondiabetic patients (6.0% versus 6.5%; RR 0.93, 95% CI 0.66-1.32). In diabetics, cardiac death occurred in 3.0% of O-SES-treated and in 3.8% of N-BES-treated patients (RR 0.77, 95% CI 0.29-2.08), MI in 5.1% of O-SES-treated and in 6.4% of N-BES-treated patients (RR 0.78, 95% CI 0.37-1.68), and TLR in 5.5% of O-SES-treated and in 6.0% of N-BES-treated patients (RR 0.91, 95% CI 0.43-1.95).
Diabetes (n[412)
No Diabetes (n[588)
MACCE
14 (3.4%)
30 (5.1%)
0.195
CONCLUSION Target lesion failure was higher in patients with than without diabetes but did not differ between O-SES and N-BES treated diabetic patients.
Death
1 (0.2%)
4 (0.7%)
0.654
CATEGORIES CORONARY: Diabetes
24 (5.8%)
37 (6.3%)
0.761
Perforation
P-value
Emergency Surgery
1 (0.2%)
5 (0.9%)
0.409
Periprocedural MI
11 (2.7%)
15 (2.6%)
0.907
Multivariable adjusted Health Status Change in SAQ Summary Score Change in SAQ Quality of Life Score Change in SAQ Angina Frequency
1.31 points (95% CI
0.250
-0.92, 3.53) 2.61 points (95% CI
0.097
-0.48, 5.69) 0.26 points (95% CI
0.848
-2.40, 2.92)
CONCLUSION While patients with diabetes have more complex CAD, technical success, complication rates, and symptom improvement is comparable after of CTO PCI in diabetic vs. non-diabetic patients, suggesting that diabetes should not be viewed as a deterrent to CTO PCI. CATEGORIES CORONARY: Diabetes TCT-261 Impact of Diabetes on Clinical Outcomes after Revascularization with Sirolimus-eluting and Birolimus-Eluting Stents with biodegradable polymer. From the SORT OUT VII Trial Julia Ellert,1 Evald Christiansen,2 Michael Maeng,3 Bent Raungaard,4 Christian Juhl Christian Juhl Terkelsen,5 Svend Eggert Jensen,6 Steen Dalby Kristensen,7 Johnny Kahlert,8 Hans Erik Bøtker,9 Anton Boel Villadsen,10 Karsten Veien,11 lars jakobsen,12 Jens Aaroe,13 Lisette Okkels Jensen14 1 OUH, Esbjerg, Denmark; 2Aarhus University Hospital, Aarhus, Denmark; 3Aarhus University Hospital, Aarhus N, Denmark; 4Aalborg University Hospital, Aalborg, Denmark; 5Hammel; 6Aalborg University Hospital, Aalborg, Denmark; 7Unknown, Aarhus N, Denmark; 8Rutgers Robert Wood Johnson Medical School; 9Weatherhead PET Center, McGovern Medical School at UTHealth; 10Aalborg University Hospital, Aalborg, Denmark; 11Odense University Hospital, Odense, Denmark; 12 Aarhus University Hospital Skejby; 13Aalborg University Hospital, Aalborg, Denmark; 14Odense University Hospital, Odense, Denmark BACKGROUND Diabetes is associated with increased risk of target lesion failure after percutaneous coronary intervention. In this substudy of the SORT OUT VII (NCT01879358) trial we compared the clinical outcome among patient with and without diabetes mellitus treated with sirolimus-eluting stent (O-SES, Orsiro; Biotronik, Bülach, Switzerland) or biolimus-eluting stent (N-BES, Nobori; Terumo, Tokyo, Japan).
TCT-262 Clinical Outcomes of Deferred Revascularisation Using Fractional Flow Reserve in Patients With and Without Diabetes Mellitus Mark Kennedy,1 Eliza Kaplan,2 Rik Hermanides,3 Enrico Fabris,4 Veemal Hemradj,5 Petra Koopmans,6 Jan-Henk Dambrink,7 Marcel Gosselink,8 Arnoud van’t Hof,9 Jan Paul Ottervanger,10 Vincent Roolvink,11 Wouter Remkes,12 Aize van der Sluis,13 Harry Suryapranata,14 Elvin Kedhi15 1 Cork University Hospital, Portarlington, Laois, Ireland; 2Isala; 3Isala, Zwolle, Netherlands; 4Isala; 5Isala; 6Diagram CRO; 7Isala Klinieken, Zwolle, Netherlands; 8Unknown, zwolle, Netherlands; 9Isala, Zwolle, Zwolle, Netherlands; 10Isala; 11Isala klinieken, Zwolle, Netherlands; 12 Isala Heartcentre Zwolle, Zwolle, Netherlands; 13Isala, Zwolle, Netherlands; 14Zwolle, Netherlands; 15Isala Klinieken Zwolle, Zwolle, Netherlands BACKGROUND Deferred revascularisation based upon fractional flow reserve (FFR >0.80), is associated with a low incidence of target lesion failure (TLF). Whether deferred revascularisation is also as safe in diabetes mellitus (DM) patients is unknown. METHODS All DM patients and the next consecutive Non-DM patients that underwent an FFR-assessment between 1/01/2010 and 31/12/2013 were included, and followed until 1/7/2015. Patients with only FFR>0.80 lesions were analysed according to the presence vs. absence of DM, while patients that underwent revascularisation in FFR-assessed or other lesions were excluded. The primary endpoint was the incidence of TLF; a composite of target lesion revascularisation (TLR) and target vessel myocardial infarction (TVMI). RESULTS A total of 250 patients (122 DM, 128 non-DM) who underwent deferred revascularisation of all lesions (FFR>0.80) were compared. At a mean follow up of 39.8 16.3 months, DM patients compared to non-DM had a higher TLF rate, 18.1.% vs 7.5%, logrank p¼ <0.01, Cox regression-adjusted HR: 3.65 (95% CI:1.40-9.53, p<0.01), which was largely driven by a higher incidence of TLR (17.2% vs. 7.5%, HR: 3.52, 95%CI:1.34-9.30, p¼0.01), whilst a non-significant but numerically higher incidence of TVMI (6.1% vs. 2.0%, HR: 3.34, 95%CI:0.64-17.30, p¼0.15) was observed.
RAO at band removal (12% vs 13%, P ¼ 0.51) were observed between Group I and II. Incidence of 24-hour RAO was significantly lower in Group II compared to Group I (8.6% vs 3.7%, P ¼ 0.001). Post-procedural ACT <200 seconds was associated with a significantly higher incidence of RAO compared to ACT > 200 seconds (7.8% vs 2%, P ¼ 0.0001). CONCLUSION A higher post-procedural ACT is associated with lower RO incidence. Administration of UFH at the end of the procedure might lower the incidence of RAO without increasing rebound bleeding. CATEGORIES CORONARY: Complications TCT-258 Clinical significance of peri-procedural myocardial infarction following percutaneous coronary intervention for multi-vessel coronary artery disease Min Soo Cho,1 Do-yoon Kang,2 Ungjeong Do,3 Jung Ae Hong,4 Osung Kwon,5 Cheol Hyun Lee,6 Jaeseok bae,7 Yu Na Kim,8 Se Hun Kang,9 Sung-Han Yoon,10 Pil Hyung Lee,11 Jung-Min Ahn,12 Duk-Woo Park,13 Soo-Jin Kang,14 Seung-Whan Lee,15 Young-Hak Kim,16 Cheol Whan Lee,17 Seong-Wook Park,18 Seung-Jung Park19 1 Asan medical center, Seoul, Korea, Republic of; 2Asan Medical Center, Seoul, Korea, Republic of; 3Seoul National University Hospital, Seoul, Korea, Republic of; 4Asan Medical Center, Seoul, Korea, Republic of; 5 Asan Medical Center, Seoul, Korea, Republic of; 6Asan medical center, seoul, Korea, Republic of; 7Asan medical center, Seoul, Korea, Republic of; 8Asan Medical Center, Seoul, Korea, Republic of; 9Asan Medical Center, Seoul, Korea, Republic of; 10Asan Medical Center, Seoul, Korea, Republic of; 11Columbia University Medical Center, Seoul, Korea, Republic of; 12Asan Medical Center, Seoul, Korea, Republic of; 13Asan Medical Center, Seoul, Korea, Republic of; 14Asan Medical Center, Seoul, Korea, Republic of; 15Asan Medical Center, Seoul, Korea, Republic of; 16Asan Medical Center, Seoul, Korea, Republic of; 17Asan Medical Center, Seoul, Korea, Republic of; 18Asan Medical Center, Seoul, Korea, Republic of; 19Asan Medical Center, Seoul, Korea, Republic of BACKGROUND The prevalence and prognostic implications of current peri-procedural myocardial infarction (periMI) definitions in realworld practice were not well evaluated to date. METHODS The Asan-MV registry was consisted of consecutive patients whose peri-procedural creatinine kinase-MB mass was routinely measured and clinical outcomes were prospectively collected. From this population, data from 4514 patients who underwent percutaneous coronary intervention for multi-vessel coronary artery disease were analyzed. The periMI was diagnosed according to the 2nd universal (2nd), 3rd universal (3rd), and clinically relevant (SCAI) definitions of periMI. The primary outcome of the study was major cardiovascular adverse event (MACE), defined as composite of death, myocardial infarction, and repeat revascularization. RESULTS The periMI was diagnosed in 842, 142, 248 patients according to the 2nd, 3rd, and SCAI criteria, respectively. After multivariable adjustment, the patients with perMI with each definition was at higher risk of MACE compared to those without (hazard ratio [HR] 1.48 [95% confidence interval [CI] 1.28 -1.70] for 2nd, HR 1.43 [1.081.91] for 3rd, HR 1.82 [1.48-2.25] for SCAI perMI, respectively). All definitions of periMI were specific (83.0%, 97.2%, 95.6%, respectively), but not sensitive (24.1%, 4.7%, 9.1%, respectively) for future MACE. Overall discriminating performances were poor at C-static of 0.536, 0.509, and 0.523, respectively.
CONCLUSION The patients with periMI were at higher risk of future MACE. Current definitions of periMI were specific, but their discriminating performances were poor. CATEGORIES CORONARY: PCI Outcomes
B105
TCT-259 Coronary artery perforation during percutaneous coronary intervention: incidence and outcomes Oliver Guttmann,1 Daniel Jones,2 Ankur Gulati,3 Tom Crake,4 Muhiddin Ozkor,5 Andrew Wragg,6 Elliot Smith,7 Roshan Weerackody,8 Charles Knight,9 Anthony Mathur,10 Costas O’Mahony11 1 London, United Kingdom; 2London chest, london, United Kingdom; 3 Barts Heart Centre, London, United Kingdom; 4Unknown, London, United Kingdom; 5The Heart Hospital / UCLH, LONDON, United Kingdom; 6Barts and The London NHS Trust, London, United Kingdom; 7 Barts Health NHS Trust, London, United Kingdom; 8Unknown, London, United Kingdom; 9London Chest Hospital, London, United Kingdom; 10Barts and the London NHS Trust, London, United Kingdom; 11Northwell Health BACKGROUND Coronary artery perforation during PCI is a rare but severe complication with a high morbidity and mortality. The incidence of this complication is reported to range from 0.1 to 1%. The aim of this study was to examine the clinical outcome following percutaneous coronary intervention [PCI] complicated by vessel perforation. METHODS The procedural records of 28,537 patients undergoing coronary intervention were reviewed. Mortality data were obtained from the UK Office of National Statistics. RESULTS Vessel perforation affected 103 patients (0.36%), ranging from wire exit to free flow into the pericardial space. Fifty three (51.9%) perforations occurred during elective procedures, 22 (21.6%) in chronic occlusions. In 26 of 103 (25.2%) a significant pericardial effusion ensued requiring surgical or percutaneous drainage. Six of the 26 patients were referred for emergency bypass surgery (23.1%), 2 of which subsequently died. Three patients died despite pericardial drains being inserted. In all, 24 patients had covered stents (CS) inserted and five did not survive to discharge. Ten of the 24 (41.7%) that had CS had drains compared to 16/79 (20.3%) who did not. Of the 19 patients with a covered stent that survived to hospital discharge, 6 (30.0%) had definite stent thrombosis, 2 (10.0%) had possible/probable stent thrombosis. CONCLUSION Coronary artery perforation during intervention is rare. The development of pericardial tamponade carries a high mortality. While the use of covered stents may provide a valuable rescue option acutely, high rates of stent thrombosis suggest more potent antiplatelet agents may be needed. CATEGORIES CORONARY: Complications
DIABETES
Abstract nos: 260 - 272 TCT-260 Outcomes of Chronic Total Occlusion PCI in Patients with Diabetes – Insights from the OPEN CTO Registry Adam Salisbury,1 James Sapontis,2 J. Aaron Grantham,3 Mohammed Qintar,4 Kensey Gosch,5 William Lombardi,6 Dimitrios Karmpaliotis,7 Jeffrey Moses,8 John Spertus,9 David Cohen,10 Mikhail Kosiborod11 1 Saint Lukes Mid America Heart Institute, Parkville, Missouri, United States; 2MonashHeart, Victoria, Victoria, Australia; 3University of Missouri Kansas City and Mid America Heart Institute, Kansas City, Missouri, United States; 4Saint Lukes Mid America Heart Institute, Overland Park, Kansas, United States; 5Imperial College London; 6 University of Washington Medical Center, Seattle, Washington, United States; 7Interventional Cardiologist, Atlanta, Georgia, United States; 8 NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 9Mid America Heart Institute, Kansas City, Missouri, United States; 10Saint Luke’s Mid America Heart Institute, Kansas City, Missouri, United States; 11St. Luke’s Mid America Heart Institute, Kansas City, Missouri, United States BACKGROUND Chronic total occlusions (CTOs) are more common among diabetic than non-diabetic patients, and are associated with high symptom burden, yet CTO PCI is less often attempted in this group. This may reflect greater disease complexity (small vessels, diffuse disease), higher perceived complication risk, or lack of data
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
B106
describing benefits of CTO PCI among diabetic patients. Few studies have evaluated the relationship of diabetes with technical success or periprocedural complications, and no prior studies have compared patient-reported health status (symptoms, function and quality of life) after CTO PCI in patients with and without diabetes. METHODS In a 12-center prospective CTO PCI registry, patients were assessed for technical success, periprocedural complications, and health status using the Seattle Angina Questionnaire Summary, Angina Frequency and Quality of Life scores at baseline and 30-day follow-up. Hierarchical Poisson regression was used to examine the association between diabetes and technical success adjusting for patient and angiographic factors, while multivariable linear regression was used to assess the association between diabetes and 30day health status adjusting for baseline health status and patient factors. RESULTS Diabetes was common (41.2%), and associated with a lower crude rate of technical success (83.0% vs. 88.1%, p¼0.02). After adjusting for angiographic complexity and other factors, there was no significant difference between diabetic and non-diabetic patients (RR 0.95, 95% CI 0.90-1.01), and there were no significant differences in complication rates or adjusted follow-up health status scores (Table).
METHODS In total 2,525 patients (471 with diabetes, 18.6%) were randomized to stent implantation with O-SES (n¼1,261, diabetes: n¼236) or N-BES (n¼1,264, diabetes: n¼235). Randomization was stratified by presence/absence of diabetes. The primary end point, target lesion failure, was a composite of cardiac death, target-lesion myocardial infarction (MI) (not related to other than index lesion), or target lesion revascularization (TLR) within 2 years. RESULTS At 2-year, target lesion failure was higher in diabetic than in nondiabetic patients (9.3% vs 6.3%, rate ratio [RR] 1.53, 95% confidence interval [CI] 1.09-2.17). Risk of cardiac death (3.4% versus 1.8%; RR 1.91, 95% CI 1.06-3.44), MI (5.7% versus 3.2%; RR 1.83, 95% CI 1.172.87) and TLR (5.7% versus 3.7%; RR 1.59, 95% CI 1.02-2.48) were higher in diabetics than in nondiabetics. Definite stent thrombosis (1.5% versus 1.0%; RR 1.55, 95% CI 0.65-3.68) and definite/probable stent thrombosis (1.9% versus 1.4%; RR 1.37, 95% CI 0.65-2.92) did not differ significantly between the two groups. At 2 years, target lesion failure did not differ between O-SES versus N-BES in diabetic (9.3% versus 9.4%; RR 0.98, 95% CI 0.54-1.78) and nondiabetic patients (6.0% versus 6.5%; RR 0.93, 95% CI 0.66-1.32). In diabetics, cardiac death occurred in 3.0% of O-SES-treated and in 3.8% of N-BES-treated patients (RR 0.77, 95% CI 0.29-2.08), MI in 5.1% of O-SES-treated and in 6.4% of N-BES-treated patients (RR 0.78, 95% CI 0.37-1.68), and TLR in 5.5% of O-SES-treated and in 6.0% of N-BES-treated patients (RR 0.91, 95% CI 0.43-1.95).
Diabetes (n[412)
No Diabetes (n[588)
MACCE
14 (3.4%)
30 (5.1%)
0.195
CONCLUSION Target lesion failure was higher in patients with than without diabetes but did not differ between O-SES and N-BES treated diabetic patients.
Death
1 (0.2%)
4 (0.7%)
0.654
CATEGORIES CORONARY: Diabetes
24 (5.8%)
37 (6.3%)
0.761
Perforation
P-value
Emergency Surgery
1 (0.2%)
5 (0.9%)
0.409
Periprocedural MI
11 (2.7%)
15 (2.6%)
0.907
Multivariable adjusted Health Status Change in SAQ Summary Score Change in SAQ Quality of Life Score Change in SAQ Angina Frequency
1.31 points (95% CI
0.250
-0.92, 3.53) 2.61 points (95% CI
0.097
-0.48, 5.69) 0.26 points (95% CI
0.848
-2.40, 2.92)
CONCLUSION While patients with diabetes have more complex CAD, technical success, complication rates, and symptom improvement is comparable after of CTO PCI in diabetic vs. non-diabetic patients, suggesting that diabetes should not be viewed as a deterrent to CTO PCI. CATEGORIES CORONARY: Diabetes TCT-261 Impact of Diabetes on Clinical Outcomes after Revascularization with Sirolimus-eluting and Birolimus-Eluting Stents with biodegradable polymer. From the SORT OUT VII Trial Julia Ellert,1 Evald Christiansen,2 Michael Maeng,3 Bent Raungaard,4 Christian Juhl Christian Juhl Terkelsen,5 Svend Eggert Jensen,6 Steen Dalby Kristensen,7 Johnny Kahlert,8 Hans Erik Bøtker,9 Anton Boel Villadsen,10 Karsten Veien,11 lars jakobsen,12 Jens Aaroe,13 Lisette Okkels Jensen14 1 OUH, Esbjerg, Denmark; 2Aarhus University Hospital, Aarhus, Denmark; 3Aarhus University Hospital, Aarhus N, Denmark; 4Aalborg University Hospital, Aalborg, Denmark; 5Hammel; 6Aalborg University Hospital, Aalborg, Denmark; 7Unknown, Aarhus N, Denmark; 8Rutgers Robert Wood Johnson Medical School; 9Weatherhead PET Center, McGovern Medical School at UTHealth; 10Aalborg University Hospital, Aalborg, Denmark; 11Odense University Hospital, Odense, Denmark; 12 Aarhus University Hospital Skejby; 13Aalborg University Hospital, Aalborg, Denmark; 14Odense University Hospital, Odense, Denmark BACKGROUND Diabetes is associated with increased risk of target lesion failure after percutaneous coronary intervention. In this substudy of the SORT OUT VII (NCT01879358) trial we compared the clinical outcome among patient with and without diabetes mellitus treated with sirolimus-eluting stent (O-SES, Orsiro; Biotronik, Bülach, Switzerland) or biolimus-eluting stent (N-BES, Nobori; Terumo, Tokyo, Japan).
TCT-262 Clinical Outcomes of Deferred Revascularisation Using Fractional Flow Reserve in Patients With and Without Diabetes Mellitus Mark Kennedy,1 Eliza Kaplan,2 Rik Hermanides,3 Enrico Fabris,4 Veemal Hemradj,5 Petra Koopmans,6 Jan-Henk Dambrink,7 Marcel Gosselink,8 Arnoud van’t Hof,9 Jan Paul Ottervanger,10 Vincent Roolvink,11 Wouter Remkes,12 Aize van der Sluis,13 Harry Suryapranata,14 Elvin Kedhi15 1 Cork University Hospital, Portarlington, Laois, Ireland; 2Isala; 3Isala, Zwolle, Netherlands; 4Isala; 5Isala; 6Diagram CRO; 7Isala Klinieken, Zwolle, Netherlands; 8Unknown, zwolle, Netherlands; 9Isala, Zwolle, Zwolle, Netherlands; 10Isala; 11Isala klinieken, Zwolle, Netherlands; 12 Isala Heartcentre Zwolle, Zwolle, Netherlands; 13Isala, Zwolle, Netherlands; 14Zwolle, Netherlands; 15Isala Klinieken Zwolle, Zwolle, Netherlands BACKGROUND Deferred revascularisation based upon fractional flow reserve (FFR >0.80), is associated with a low incidence of target lesion failure (TLF). Whether deferred revascularisation is also as safe in diabetes mellitus (DM) patients is unknown. METHODS All DM patients and the next consecutive Non-DM patients that underwent an FFR-assessment between 1/01/2010 and 31/12/2013 were included, and followed until 1/7/2015. Patients with only FFR>0.80 lesions were analysed according to the presence vs. absence of DM, while patients that underwent revascularisation in FFR-assessed or other lesions were excluded. The primary endpoint was the incidence of TLF; a composite of target lesion revascularisation (TLR) and target vessel myocardial infarction (TVMI). RESULTS A total of 250 patients (122 DM, 128 non-DM) who underwent deferred revascularisation of all lesions (FFR>0.80) were compared. At a mean follow up of 39.8 16.3 months, DM patients compared to non-DM had a higher TLF rate, 18.1.% vs 7.5%, logrank p¼ <0.01, Cox regression-adjusted HR: 3.65 (95% CI:1.40-9.53, p<0.01), which was largely driven by a higher incidence of TLR (17.2% vs. 7.5%, HR: 3.52, 95%CI:1.34-9.30, p¼0.01), whilst a non-significant but numerically higher incidence of TVMI (6.1% vs. 2.0%, HR: 3.34, 95%CI:0.64-17.30, p¼0.15) was observed.