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TCT-15 Use of Antegrade Dissection Re-entry in Coronary Chronic Total Occlusion Percutaneous Coronary Intervention in a Contemporary Multicenter Registry
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
B6
CTO TECHNIQUES AND OUTCOMES I Abstract nos: 13 - 16 TCT-13 Outcomes of chronic total occlusion percutaneous coronary intervention according to dissection/re-entry versus wire escalation techniques Lorenzo Azzalini,1 Rustem Dautov,2 Soledad Ojeda,3 Barbara Bellini,4 Susanna Benincasa,5 Jorge Chavarria Viquez,6 Manuel Pan,7 Mauro Carlino,8 Antonio Colombo,9 Stéphane Rinfret10 1 San Raffaele Scientific Institute, Milano, Italy; 2McGill University Health Center, Montreal, Quebec, Canada; 3Reina Sofia Hospital, Cordoba, Spain; 4San Raffaele Scientific Institute; 5Ospedale S. Raffaele, MILANO, Milan, Italy; 6Hospital Reina Sofia, Córdoba, Spain; 7 Unknown, Cordoba, Spain; 8San Raffaele Hospital, Milan, Milan, Italy; 9 Columbus Hospital/San Raffaele Hospital, Milan, Milan, Italy; 10 Quebec Heart and Lung Institute, Quebec City, Quebec, Canada BACKGROUND Few studies have investigated the outcomes of patients with a chronic total occlusion (CTO) undergoing percutaneous coronary intervention (PCI) using dissection/re-entry (DR) vs. wire escalation (WE) techniques. METHODS We combined consecutive patient data from 3 CTO PCI specialized centers. Only patients in whom successful CTO wiring was achieved were considered. Subjects were divided in DR (antegrade or retrograde) and WE (antegrade or retrograde). Major adverse cardiac events (MACE: cardiac death, target-vessel MI and target-vessel revascularization) on follow-up were the primary endpoint. Multivariable Cox regression analysis was performed to identify independent predictors of MACE. RESULTS We included 792 patients (n¼323 DR, n¼469 WE). In the WE group, 83.6% were antegrade procedures, whereas 16.4% were retrograde cases. In DR, these figures were 43.0% and 57.0%, respectively. Among antegrade DR procedures, a wire-based technique was utilized in 58.3% and CrossBoss/Stingray (Boston Scientific, Marlborough, MA) in 41.7%; among retrograde DR cases, reverse CART was used in 84.2%. DR patients had a higher prevalence of prior MI, prior PCI and prior CABG, but a lower prevalence of severe chronic kidney disease. As compared with WE, DR was used more frequently on the right coronary artery (68.8% vs. 40.5%) and less frequently on the left anterior descending (15.9% vs. 36.4%, p<0.001). The J-CTO score was higher in DR (2.421.18 vs. 1.431.11, p<0.001). Total stent length was also higher in DR (89.742.1 vs. 57.736.7 mm, p<0.001). Procedural complications were more frequent in DR group (3.4% vs. 1.1%, p¼0.02), driven by coronary perforation. After a median follow-up of 454 (354-822) days, MACE rates were similar (15.0% in DR vs. 10.8% in WE, p¼0.10). On multivariable analysis, DR was not independently associated with MACE. Independent predictors of MACE were: prior CABG, worse renal function, lower ejection fraction, CTO PCI indicated for acute coronary syndrome, higher number of diseased vessels, in-stent CTO and higher J-CTO score. CONCLUSION Although CTO PCI with DR, as compared with WE, was used in more challenging clinical and angiographic scenarios, DR was not associated with adverse clinical outcomes on follow-up. CATEGORIES CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP) TCT-14 Specialist Chronic Total Occlusion (CTO) Programmes and Outcomes after CTO Percutaneous Coronary Interventions: An observational study of 5,496 patients from the Pan-London CTO Cohort Daniel Jones,1 Krishnaraj Rathod,2 Roshan Weerackody,3 Andrew Wragg,4 Elliot Smith5 1 London chest, London, United Kingdom; 2London Chest Hospiral, Hornchurch, United Kingdom; 3Unknown, London, United Kingdom; 4 Barts and The London NHS Trust, London, United Kingdom; 5Barts Health NHS Trust, London, United Kingdom BACKGROUND Chronic total occlusions (CTO) are commonly encountered in patients undergoing coronary angiography. However percutaneous coronary intervention (PCI) for CTO is infrequently performed owing to technical difficulty, the perceived risk of complications, and a lack of randomized data. In this study we describe the frequency and outcomes of CTO-PCI from a large multi-centre cohort of consecutive patients in London. We assessed whether developments in the field of CTO PCI had influenced both uptake and outcomes in clinical practice.
METHODS We undertook an observational cohort study of 48,234 patients with stable angina of which 5496 (11.4%) procedures were performed for chronic total occlusions between 2005 and 2015 at 9 tertiary cardiac centres across London, UK. Patient’s details were recorded at the time of the procedure into local databases using the British Cardiac Intervention Society (BCIS) PCI dataset. Anonymous datasets from the 9 centres were merged for analysis. Outcome was assessed by in hospital major adverse cardiac events (MACE) and all-cause mortality. The primary end-point was all-cause mortality at a median follow-up of 4.8 years (IQR range: 2.2-6.4 years). The impact of designated specialist CTO programmes at 3 of the participating hospitals was investigated. RESULTS Over time, there was an increase in the proportion of elective PCI procedures performed for CTOs but no increase in the absolute number. Over the study period case complexity increased with higher frequencies of diabetes, renal failure, previous CABG and left ventricular impairment. Overall success rates increased over time (74.3% in 2005 to 81.5% in 2015 (p¼0.0003) driven by centres that introduced a specialist CTO services (86.2% specialist vs 75.4% non-specialist centres, p¼<0.0001), despite an increase in case complexity. Successful CTO PCI was associated with improved mortality (9.5% 95% CI: 8.1-11.6 vs. 15.3% 95% CI 13.7-20.6), p < 0.0001). Multivariate cox analysis (hazard ratio 0.37 (95% confidence intervals 0.25-0.62) and propensity matching (HR¼0.36, 95% CI: 0.18-0.73, p¼0.0005) both revealed that procedural success was independently predictive of mortality. CONCLUSION Among centres adopting a specialist approach to CTO PCI, significantly higher rates of procedural success were achieved, despite treating more complex patients. Successful procedures were associated with improved mortality suggesting that the greater uptake of CTO PCI with specialist CTO training may be expected to improve clinical outcomes in a wider population than are currently being offered therapy. CATEGORIES CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP) TCT-15 Use of Antegrade Dissection Re-entry in Coronary Chronic Total Occlusion Percutaneous Coronary Intervention in a Contemporary Multicenter Registry Barbara Anna Danek,1 Aris Karatasakis,2 Dimitri Karmpaliotis,3 Khaldoon Alaswad,4 Robert Yeh,5 Farouc Jaffer,6 Mitul Patel,7 John Bahadorani,8 William Lombardi,9 R. Michael Wyman,10 J. Aaron Grantham,11 Anthony Doing,12 David Kandzari,13 Nicholas Lembo,14 Santiago Garcia,15 Catalin Toma,16 Jeffrey Moses,17 Ajay Kirtane,18 Manish Parikh,19 Ziad Ali,20 Judit Karacsonyi,21 Aya Alame,22 Phuong-Khanh Nguyen-Trong,23 Jose Roberto Martinez-Parachini,24 Pratik Kalsaria,25 Bavana Rangan,26 Craig Thompson,27 Subhash Banerjee,28 Emmanouil Brilakis29 1 Dallas VA Medical Center/UT Southwestern, Dallas, Texas, United States; 2Dallas VAMC and UT Southwestern, Dallas, Texas, United States; 3Columbia University Medical Center, New York, New York, United States; 4Henry Ford Hospital, Detroit, Michigan, United States; 5 Massachusetts General Hospital, Boston, Massachusetts, United States; 6Massachusetts General Hospital, Boston, Massachusetts, United States; 7UCSD Health System, La Jolla, California, United States; 8 UCSD Sulpizio Cardiovascular Center, San Diego, California, United States; 9University of Washington Medical Center, Seattle, Washington, United States; 10Torrance Memorial Medical Center, Torrance, California, United States; 11University of Missouri Kansas City and Mid America Heart Institute, Kansas City, Missouri, United States; 12Heart Center of the Rockies, Fort Collins, Colorado, United States; 13Piedmont Heart Institute, Atlanta, Georgia, United States; 14N/A, Alys Beach, Florida, United States; 15University of Minnesota, Minneapolis, Minnesota, United States; 16University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States; 17NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 18NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 19NewYorkPresbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 20Columbia University Medical Center, New York, New York, United States; 21UT Southwestern Medical Center, Dallas, VA North Texas Healthcare System, Dallas, Texas, United States; 22 Dallas VA Medical Center; 23UT Southwestern, Dallas, Texas, United States; 24University General Hospital of Ciudad Real. Spain; 25Institute of Cardiology, Wsraw, Centre for Cardiovascular Research, Wasraw; 26UT Southwestern Medical Center/ VA North Texas Health Care System, Dallas, Texas, United States; 27Boston Scientific Corporation, Hamden, Connecticut, United States; 28VA North Texas Health Care System, Dallas, Texas, United States; 29VA North Texas Health Care System and UT Southwestern Medical Center, Dallas, Texas, United States
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
BACKGROUND We assessed the efficacy and safety of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using antegrade dissection re-entry (ADR). METHODS We examined outcomes of ADR CTO PCI cases among 1794 procedures performed at 14 experienced US centers from 2012-2016. RESULTS Mean age was 6510 years; 85% were men; prevalence of prior coronary artery bypass graft surgery was 36%. Overall technical and procedural success were 88.6% and 87.1%, respectively. In-hospital major adverse cardiovascular events (MACE) occurred in 46 patients (2.6%). ADR was used in 623 cases (35%), and was the first strategy used in 203 cases (11%). ADR cases were more angiographically complex than non-ADR cases (lesion length 4026 vs. 3325mm, p<0.001; moderate/ severe calcification 63% vs. 53%, p<0.001; moderate/severe tortuosity 43% vs. 32%, p<0.001; J-CTO score: 2.81.2 vs. 2.31.2, p<0.001) (Figure). Compared with non-ADR cases, ADR cases had lower technical (84% vs. 91%, p<0.001) and procedural success (83% vs. 89%, p<0.001), but similar risk for MACE (2.5% vs. 2.7%, p¼0.73). ADR was associated with longer procedure and fluoroscopy time, and higher patient air kerma dose and contrast volume (all p<0.001) compared with non-ADR cases. After adjusting for comorbidities and angiographic complexity, use of ADR was not associated with procedural outcome or MACE.
B7
METHODS We analyzed baseline patient and procedural characteristics and in-hospital outcomes from 881 patients in a contemporary, multicenter US CTO PCI registry. Data on patient demographics, risk factor prevalence, anatomic lesion characteristics and in-hospital outcomes of all patients were collected and analyzed using t-tests or Fisher’s exact tests. RESULTS The mean age of all patients was 65 years, of whom 80% were male. In this group of 881 patients (428 antegrade-only and 453 any retrograde), procedural success was achieved more often in the antegrade-only group than in the retrograde group (396 patients, 92.5% versus 352 patients, 77.7%; p<0.001). Patients in the retrograde group had a significantly higher prevalence of diabetes mellitus (45.5% vs 36.2%, p¼0.005) and were more frequently post coronary bypass surgery (42.5% vs 24%, p<0.001). Retrograde group patients more often had a bypass graft to the target vessel (12.6% vs 5.1%, p<0.001). Lesions in the retrograde group were longer overall (68.8 mm vs 54.4 mm, p<0.001) and more complex, with higher average J-CTO scores (2.7 vs 1.9, p<0.001). Procedures in the retrograde group were longer, with both higher use of radiation (3.02 Gy vs 1.86 Gy, p<0.001) and contrast (278cc vs 235cc, p<0.001) than those in the antegrade-only group.
Adverse Outcome MACCE Death during
Retrograde N
Antegrade-only N
(percentage)
(percentage)
p-value
33 (7.3%)
9 (2.1%)
<0.001
5 (1.1%)
0 (0.0%)
0.062
9 (2.0%)
0 (0.0%)
0.003
19 (4.2%)
6 (1.4%)
0.012
7 (1.5%)
0 (0.0%)
0.015
0 (0.0%)
0 (0.0%)
1.00
procedure Death during hospitalization Post-procedure MI Need for emergency surgery Stroke
CONCLUSION Retrograde CTO PCI strategies appear to be required more often for the treatment of challenging lesion subsets and are important to achieving procedural success. Given the higher MACCE rates, operators should keep a high threshold for the use of these techniques and patients should be appropriately counseled about the higher risks involved. CATEGORIES CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP) CONCLUSION ADR is used relatively frequently in contemporary CTO PCI, especially for challenging lesions. ADR is associated with similar success and risk for complications as compared with non-ADR cases, and is important for achieving high procedural success. CATEGORIES CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP) TCT-16 Patient and Procedural Characteristics and In-Hospital Outcomes Associated With the Use of Retrograde Recanalization Techniques for Chronic Total Occlusion PCI: A Report from the Open CTO Registry Sanjog Kalra,1 James Sapontis,2 Robert Riley,3 Mohammed Qintar,4 Philip Jones,5 Ajay Kirtane,6 Manish Parikh,7 Jeffrey Moses,8 Ziad Ali,9 William Lombardi,10 William Nicholson,11 J. Aaron Grantham,12 Dimitri Karmpaliotis13 1 CIVT - Columbia University Medical Center, New York, New York, United States; 2MonashHeart, Victoria, Victoria, Australia; 3University of Washington, Seattle, Washington, United States; 4Saint Lukes Mid America Heart Institute, Overland Park, Kansas, United States; 5Interventional Cardiology Unit, University of Palermo; 6NewYork-Presbyterian Hospital/ Columbia University Medical Center, New York, New York, United States; 7 NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 8NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 9Columbia University Medical Center, New York, New York, United States; 10 University of Washington Medical Center, Seattle, Washington, United States; 11York Hospital - Wellspan Health, York, Pennsylvania, United States; 12University of Missouri Kansas City and Mid America Heart Institute, Kansas City, Missouri, United States; 13Columbia University Medical Center, New York, New York, United States BACKGROUND Since the introduction of the Hybrid Algorithm for Chronic Total Occlusion (CTO) PCI, the use of retrograde recanalization techniques has become more common. We sought to identify patient and procedural characteristics necessitating use of retrograde CTO techniques using a multicenter, adjudicated, prospective CTO PCI registry.
ENDOVASCULAR INTERVENTIONS
Abstract nos: 17 - 20 TCT-17 The Lutonix Global DCB Registry Real World Patients with Complex Femero-popliteal Lesions – 24 Month Outcomes D. Christopher Metzger,1 Joseph Giorgianni2 Wellmont CVA Heart Institute, Kingsport, Tennessee, United States; 2 IntactVascular, Wayne, Pennsylvania
1
BACKGROUND Drug-coated balloons (DCBs) have emerged as an effective treatment for patients with symptomatic peripheral arterial disease in the femero-popliteal arteries. They have been shown to be superior to balloon angioplasty (PTA) in large, multi-center randomized trials. These data come from carefully selected patients at high volume global centers. DCBs are also a potential therapy for more challenging patients, and as a possible alternative to permanent implanted devices (stents). Long term data in challenging patients in a “real world setting” treated with DCBs is needed. Objective of the study is to demonstrate safety and assess the clinical use and outcomes of the LUTONIXÒ Drug Coated PTA Dilatation Catheter in a heterogeneous patient population in real world clinical practice. METHODS The Lutonix Global SFA Registry is a prospective, global multicenter, single arm real-world registry investigating the clinical use and safety of the LutonixÒ 035 Drug Coated PTA Dilatation Catheter. The primary end points were efficacy defined as freedom from TLR at 12 months and safety defined as freedom at 30 days from TVR, major index limb amputation, and device or procedure-related death. All SAEs and TLRs were adjudicated. Subjects were followed for 24 months post-DCB. Patients with complex treatment lengths of >150 mm were enrolled. Between December 2012 and July 2014, 691 patients were enrolled at 38 centers in 10 European countries. Patients were followed at pre-specified visits for a follow-up of 24 months, with the primary endpoint at 12 months. RESULTS Six hundred ninety one (691) patients were enrolled and will complete the 24 month follow up in August 2016. Mean lesion
B6
CTO TECHNIQUES AND OUTCOMES I Abstract nos: 13 - 16 TCT-13 Outcomes of chronic total occlusion percutaneous coronary intervention according to dissection/re-entry versus wire escalation techniques Lorenzo Azzalini,1 Rustem Dautov,2 Soledad Ojeda,3 Barbara Bellini,4 Susanna Benincasa,5 Jorge Chavarria Viquez,6 Manuel Pan,7 Mauro Carlino,8 Antonio Colombo,9 Stéphane Rinfret10 1 San Raffaele Scientific Institute, Milano, Italy; 2McGill University Health Center, Montreal, Quebec, Canada; 3Reina Sofia Hospital, Cordoba, Spain; 4San Raffaele Scientific Institute; 5Ospedale S. Raffaele, MILANO, Milan, Italy; 6Hospital Reina Sofia, Córdoba, Spain; 7 Unknown, Cordoba, Spain; 8San Raffaele Hospital, Milan, Milan, Italy; 9 Columbus Hospital/San Raffaele Hospital, Milan, Milan, Italy; 10 Quebec Heart and Lung Institute, Quebec City, Quebec, Canada BACKGROUND Few studies have investigated the outcomes of patients with a chronic total occlusion (CTO) undergoing percutaneous coronary intervention (PCI) using dissection/re-entry (DR) vs. wire escalation (WE) techniques. METHODS We combined consecutive patient data from 3 CTO PCI specialized centers. Only patients in whom successful CTO wiring was achieved were considered. Subjects were divided in DR (antegrade or retrograde) and WE (antegrade or retrograde). Major adverse cardiac events (MACE: cardiac death, target-vessel MI and target-vessel revascularization) on follow-up were the primary endpoint. Multivariable Cox regression analysis was performed to identify independent predictors of MACE. RESULTS We included 792 patients (n¼323 DR, n¼469 WE). In the WE group, 83.6% were antegrade procedures, whereas 16.4% were retrograde cases. In DR, these figures were 43.0% and 57.0%, respectively. Among antegrade DR procedures, a wire-based technique was utilized in 58.3% and CrossBoss/Stingray (Boston Scientific, Marlborough, MA) in 41.7%; among retrograde DR cases, reverse CART was used in 84.2%. DR patients had a higher prevalence of prior MI, prior PCI and prior CABG, but a lower prevalence of severe chronic kidney disease. As compared with WE, DR was used more frequently on the right coronary artery (68.8% vs. 40.5%) and less frequently on the left anterior descending (15.9% vs. 36.4%, p<0.001). The J-CTO score was higher in DR (2.421.18 vs. 1.431.11, p<0.001). Total stent length was also higher in DR (89.742.1 vs. 57.736.7 mm, p<0.001). Procedural complications were more frequent in DR group (3.4% vs. 1.1%, p¼0.02), driven by coronary perforation. After a median follow-up of 454 (354-822) days, MACE rates were similar (15.0% in DR vs. 10.8% in WE, p¼0.10). On multivariable analysis, DR was not independently associated with MACE. Independent predictors of MACE were: prior CABG, worse renal function, lower ejection fraction, CTO PCI indicated for acute coronary syndrome, higher number of diseased vessels, in-stent CTO and higher J-CTO score. CONCLUSION Although CTO PCI with DR, as compared with WE, was used in more challenging clinical and angiographic scenarios, DR was not associated with adverse clinical outcomes on follow-up. CATEGORIES CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP) TCT-14 Specialist Chronic Total Occlusion (CTO) Programmes and Outcomes after CTO Percutaneous Coronary Interventions: An observational study of 5,496 patients from the Pan-London CTO Cohort Daniel Jones,1 Krishnaraj Rathod,2 Roshan Weerackody,3 Andrew Wragg,4 Elliot Smith5 1 London chest, London, United Kingdom; 2London Chest Hospiral, Hornchurch, United Kingdom; 3Unknown, London, United Kingdom; 4 Barts and The London NHS Trust, London, United Kingdom; 5Barts Health NHS Trust, London, United Kingdom BACKGROUND Chronic total occlusions (CTO) are commonly encountered in patients undergoing coronary angiography. However percutaneous coronary intervention (PCI) for CTO is infrequently performed owing to technical difficulty, the perceived risk of complications, and a lack of randomized data. In this study we describe the frequency and outcomes of CTO-PCI from a large multi-centre cohort of consecutive patients in London. We assessed whether developments in the field of CTO PCI had influenced both uptake and outcomes in clinical practice.
METHODS We undertook an observational cohort study of 48,234 patients with stable angina of which 5496 (11.4%) procedures were performed for chronic total occlusions between 2005 and 2015 at 9 tertiary cardiac centres across London, UK. Patient’s details were recorded at the time of the procedure into local databases using the British Cardiac Intervention Society (BCIS) PCI dataset. Anonymous datasets from the 9 centres were merged for analysis. Outcome was assessed by in hospital major adverse cardiac events (MACE) and all-cause mortality. The primary end-point was all-cause mortality at a median follow-up of 4.8 years (IQR range: 2.2-6.4 years). The impact of designated specialist CTO programmes at 3 of the participating hospitals was investigated. RESULTS Over time, there was an increase in the proportion of elective PCI procedures performed for CTOs but no increase in the absolute number. Over the study period case complexity increased with higher frequencies of diabetes, renal failure, previous CABG and left ventricular impairment. Overall success rates increased over time (74.3% in 2005 to 81.5% in 2015 (p¼0.0003) driven by centres that introduced a specialist CTO services (86.2% specialist vs 75.4% non-specialist centres, p¼<0.0001), despite an increase in case complexity. Successful CTO PCI was associated with improved mortality (9.5% 95% CI: 8.1-11.6 vs. 15.3% 95% CI 13.7-20.6), p < 0.0001). Multivariate cox analysis (hazard ratio 0.37 (95% confidence intervals 0.25-0.62) and propensity matching (HR¼0.36, 95% CI: 0.18-0.73, p¼0.0005) both revealed that procedural success was independently predictive of mortality. CONCLUSION Among centres adopting a specialist approach to CTO PCI, significantly higher rates of procedural success were achieved, despite treating more complex patients. Successful procedures were associated with improved mortality suggesting that the greater uptake of CTO PCI with specialist CTO training may be expected to improve clinical outcomes in a wider population than are currently being offered therapy. CATEGORIES CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP) TCT-15 Use of Antegrade Dissection Re-entry in Coronary Chronic Total Occlusion Percutaneous Coronary Intervention in a Contemporary Multicenter Registry Barbara Anna Danek,1 Aris Karatasakis,2 Dimitri Karmpaliotis,3 Khaldoon Alaswad,4 Robert Yeh,5 Farouc Jaffer,6 Mitul Patel,7 John Bahadorani,8 William Lombardi,9 R. Michael Wyman,10 J. Aaron Grantham,11 Anthony Doing,12 David Kandzari,13 Nicholas Lembo,14 Santiago Garcia,15 Catalin Toma,16 Jeffrey Moses,17 Ajay Kirtane,18 Manish Parikh,19 Ziad Ali,20 Judit Karacsonyi,21 Aya Alame,22 Phuong-Khanh Nguyen-Trong,23 Jose Roberto Martinez-Parachini,24 Pratik Kalsaria,25 Bavana Rangan,26 Craig Thompson,27 Subhash Banerjee,28 Emmanouil Brilakis29 1 Dallas VA Medical Center/UT Southwestern, Dallas, Texas, United States; 2Dallas VAMC and UT Southwestern, Dallas, Texas, United States; 3Columbia University Medical Center, New York, New York, United States; 4Henry Ford Hospital, Detroit, Michigan, United States; 5 Massachusetts General Hospital, Boston, Massachusetts, United States; 6Massachusetts General Hospital, Boston, Massachusetts, United States; 7UCSD Health System, La Jolla, California, United States; 8 UCSD Sulpizio Cardiovascular Center, San Diego, California, United States; 9University of Washington Medical Center, Seattle, Washington, United States; 10Torrance Memorial Medical Center, Torrance, California, United States; 11University of Missouri Kansas City and Mid America Heart Institute, Kansas City, Missouri, United States; 12Heart Center of the Rockies, Fort Collins, Colorado, United States; 13Piedmont Heart Institute, Atlanta, Georgia, United States; 14N/A, Alys Beach, Florida, United States; 15University of Minnesota, Minneapolis, Minnesota, United States; 16University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States; 17NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 18NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 19NewYorkPresbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 20Columbia University Medical Center, New York, New York, United States; 21UT Southwestern Medical Center, Dallas, VA North Texas Healthcare System, Dallas, Texas, United States; 22 Dallas VA Medical Center; 23UT Southwestern, Dallas, Texas, United States; 24University General Hospital of Ciudad Real. Spain; 25Institute of Cardiology, Wsraw, Centre for Cardiovascular Research, Wasraw; 26UT Southwestern Medical Center/ VA North Texas Health Care System, Dallas, Texas, United States; 27Boston Scientific Corporation, Hamden, Connecticut, United States; 28VA North Texas Health Care System, Dallas, Texas, United States; 29VA North Texas Health Care System and UT Southwestern Medical Center, Dallas, Texas, United States
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
BACKGROUND We assessed the efficacy and safety of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using antegrade dissection re-entry (ADR). METHODS We examined outcomes of ADR CTO PCI cases among 1794 procedures performed at 14 experienced US centers from 2012-2016. RESULTS Mean age was 6510 years; 85% were men; prevalence of prior coronary artery bypass graft surgery was 36%. Overall technical and procedural success were 88.6% and 87.1%, respectively. In-hospital major adverse cardiovascular events (MACE) occurred in 46 patients (2.6%). ADR was used in 623 cases (35%), and was the first strategy used in 203 cases (11%). ADR cases were more angiographically complex than non-ADR cases (lesion length 4026 vs. 3325mm, p<0.001; moderate/ severe calcification 63% vs. 53%, p<0.001; moderate/severe tortuosity 43% vs. 32%, p<0.001; J-CTO score: 2.81.2 vs. 2.31.2, p<0.001) (Figure). Compared with non-ADR cases, ADR cases had lower technical (84% vs. 91%, p<0.001) and procedural success (83% vs. 89%, p<0.001), but similar risk for MACE (2.5% vs. 2.7%, p¼0.73). ADR was associated with longer procedure and fluoroscopy time, and higher patient air kerma dose and contrast volume (all p<0.001) compared with non-ADR cases. After adjusting for comorbidities and angiographic complexity, use of ADR was not associated with procedural outcome or MACE.
B7
METHODS We analyzed baseline patient and procedural characteristics and in-hospital outcomes from 881 patients in a contemporary, multicenter US CTO PCI registry. Data on patient demographics, risk factor prevalence, anatomic lesion characteristics and in-hospital outcomes of all patients were collected and analyzed using t-tests or Fisher’s exact tests. RESULTS The mean age of all patients was 65 years, of whom 80% were male. In this group of 881 patients (428 antegrade-only and 453 any retrograde), procedural success was achieved more often in the antegrade-only group than in the retrograde group (396 patients, 92.5% versus 352 patients, 77.7%; p<0.001). Patients in the retrograde group had a significantly higher prevalence of diabetes mellitus (45.5% vs 36.2%, p¼0.005) and were more frequently post coronary bypass surgery (42.5% vs 24%, p<0.001). Retrograde group patients more often had a bypass graft to the target vessel (12.6% vs 5.1%, p<0.001). Lesions in the retrograde group were longer overall (68.8 mm vs 54.4 mm, p<0.001) and more complex, with higher average J-CTO scores (2.7 vs 1.9, p<0.001). Procedures in the retrograde group were longer, with both higher use of radiation (3.02 Gy vs 1.86 Gy, p<0.001) and contrast (278cc vs 235cc, p<0.001) than those in the antegrade-only group.
Adverse Outcome MACCE Death during
Retrograde N
Antegrade-only N
(percentage)
(percentage)
p-value
33 (7.3%)
9 (2.1%)
<0.001
5 (1.1%)
0 (0.0%)
0.062
9 (2.0%)
0 (0.0%)
0.003
19 (4.2%)
6 (1.4%)
0.012
7 (1.5%)
0 (0.0%)
0.015
0 (0.0%)
0 (0.0%)
1.00
procedure Death during hospitalization Post-procedure MI Need for emergency surgery Stroke
CONCLUSION Retrograde CTO PCI strategies appear to be required more often for the treatment of challenging lesion subsets and are important to achieving procedural success. Given the higher MACCE rates, operators should keep a high threshold for the use of these techniques and patients should be appropriately counseled about the higher risks involved. CATEGORIES CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP) CONCLUSION ADR is used relatively frequently in contemporary CTO PCI, especially for challenging lesions. ADR is associated with similar success and risk for complications as compared with non-ADR cases, and is important for achieving high procedural success. CATEGORIES CORONARY: Complex and Higher Risk Procedures for Indicated Patients (CHIP) TCT-16 Patient and Procedural Characteristics and In-Hospital Outcomes Associated With the Use of Retrograde Recanalization Techniques for Chronic Total Occlusion PCI: A Report from the Open CTO Registry Sanjog Kalra,1 James Sapontis,2 Robert Riley,3 Mohammed Qintar,4 Philip Jones,5 Ajay Kirtane,6 Manish Parikh,7 Jeffrey Moses,8 Ziad Ali,9 William Lombardi,10 William Nicholson,11 J. Aaron Grantham,12 Dimitri Karmpaliotis13 1 CIVT - Columbia University Medical Center, New York, New York, United States; 2MonashHeart, Victoria, Victoria, Australia; 3University of Washington, Seattle, Washington, United States; 4Saint Lukes Mid America Heart Institute, Overland Park, Kansas, United States; 5Interventional Cardiology Unit, University of Palermo; 6NewYork-Presbyterian Hospital/ Columbia University Medical Center, New York, New York, United States; 7 NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 8NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 9Columbia University Medical Center, New York, New York, United States; 10 University of Washington Medical Center, Seattle, Washington, United States; 11York Hospital - Wellspan Health, York, Pennsylvania, United States; 12University of Missouri Kansas City and Mid America Heart Institute, Kansas City, Missouri, United States; 13Columbia University Medical Center, New York, New York, United States BACKGROUND Since the introduction of the Hybrid Algorithm for Chronic Total Occlusion (CTO) PCI, the use of retrograde recanalization techniques has become more common. We sought to identify patient and procedural characteristics necessitating use of retrograde CTO techniques using a multicenter, adjudicated, prospective CTO PCI registry.
ENDOVASCULAR INTERVENTIONS
Abstract nos: 17 - 20 TCT-17 The Lutonix Global DCB Registry Real World Patients with Complex Femero-popliteal Lesions – 24 Month Outcomes D. Christopher Metzger,1 Joseph Giorgianni2 Wellmont CVA Heart Institute, Kingsport, Tennessee, United States; 2 IntactVascular, Wayne, Pennsylvania
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BACKGROUND Drug-coated balloons (DCBs) have emerged as an effective treatment for patients with symptomatic peripheral arterial disease in the femero-popliteal arteries. They have been shown to be superior to balloon angioplasty (PTA) in large, multi-center randomized trials. These data come from carefully selected patients at high volume global centers. DCBs are also a potential therapy for more challenging patients, and as a possible alternative to permanent implanted devices (stents). Long term data in challenging patients in a “real world setting” treated with DCBs is needed. Objective of the study is to demonstrate safety and assess the clinical use and outcomes of the LUTONIXÒ Drug Coated PTA Dilatation Catheter in a heterogeneous patient population in real world clinical practice. METHODS The Lutonix Global SFA Registry is a prospective, global multicenter, single arm real-world registry investigating the clinical use and safety of the LutonixÒ 035 Drug Coated PTA Dilatation Catheter. The primary end points were efficacy defined as freedom from TLR at 12 months and safety defined as freedom at 30 days from TVR, major index limb amputation, and device or procedure-related death. All SAEs and TLRs were adjudicated. Subjects were followed for 24 months post-DCB. Patients with complex treatment lengths of >150 mm were enrolled. Between December 2012 and July 2014, 691 patients were enrolled at 38 centers in 10 European countries. Patients were followed at pre-specified visits for a follow-up of 24 months, with the primary endpoint at 12 months. RESULTS Six hundred ninety one (691) patients were enrolled and will complete the 24 month follow up in August 2016. Mean lesion