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Study Overview
Objective. To compare the benefit of percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) versus OMT alone on the health status of patients with chronic total occlusions (CTOs).
Design. Multicenter, open-label, prospective randomized control trial.
Setting and participants. 396 patients with at least 1 CTO were assigned to PCI or OMT with a 2:1 randomization ratio.
Main outcome measures. The primary endpoint was the change in health status as assessed by the Seattle Angina Questionnaire (SAQ) between baseline and 12-month follow-up.
Main results. At 12 months, greater improvement of 3 SAQ domains was observed with PCI compared to OMT: angina frequency (5.23, 95% confidence interval [CI], 1.75-8.31, P = 0.0003), physical limitation (P = 0.02), and quality of life (6.62, 95% CI 1.78-11.46, P = 0.0007). More patients in the PCI group than in the OMT group had complete freedom from angina (71.6% vs. 57.8%, P = 0.008). There were no occurrences of periprocedural death or myocardial infarction.
Conclusion. Among patients with stable angina and CTO, PCI leads to significant health status improvement compared with OMT alone.
Commentary
CTOs are present in 15% to 25% of patients undergoing coronary angiogram1 and are associated with increased mortality.2 The benefits of successful CTO intervention observed in multiple large-scale registries include improvement in quality of life, left ventricular function, and survival as well as avoidance of coronary bypass surgery. The main indication for CTO intervention is improvement in quality of life,3 although this has not been confirmed by a randomized controlled trial comparing medical therapy to CTO-PCI.
Previous studies have assessed the health status benefits associated with CTO-PCI.4,5 Most recently, the OPEN CTO study showed significant improvement in health status in 1000 consecutive patients undergoing CTO-PCI in 12 experienced U.S. centers.6 Similarly, in a Canadian registry, revascularization of CTO was associated with greater health status benefit compared to medical therapy alone.4 However, these studies compared CTO-PCI success to failure, rather than to medical therapy.
In this context, Werner and colleagues investigated the value of PCI versus OMT for CTO by performing a well-designed randomized clinical trial in patients with CTO by assessing their health status with the SAQ.7 The SAQ is a 19-item questionnaire with a 4-week recall period that measures 5 domains of health status in patients with coronary artery disease (CAD).8,9 Scores in each domain range from 0 to 100, with higher scores indicating fewer symptoms and better quality of life. The SAQ has undergone extensive reliability and validity testing and is associated with long-term survival and health care utilization among patients with chronic CAD.10,11 At 12 months follow-up, patients who underwent CTO-PCI had greater improvement in SAQ subscales, including angina frequency and quality of life, reaching the pre-specified significance level of 0.01. There was also numerical improvement in physical limitation (P = 0.02)
The strengths of this current study include the randomized design and the careful treatment of non-CTO- PCI lesions before enrollment into the study. These non-CTO lesions were treated before the baseline health status assessment so that the additional health status benefit of non-CTO-PCI would not affect the results. This was one of multiple major limitations of the recently presented DECISION-CTO trial, as the non-CTO lesions were treated after the randomization and baseline assessment, leading to inaccurate comparison between medical therapy and CTO-PCI.12
Another interesting point of the current study is the patient selection. Since the treatment sites included were all expert centers in Europe, many patients who were referred to their institution for CTO-PCI were excluded from the study. For example, among the 1980 patients with screening log, 1381 were excluded because they were referred for CTO-PCI and 122 were excluded because they were “too symptomatic.” This suggests that the population studied were less symptomatic than the overall symptomatic CTO population from previous registries, as evidenced by about 40% of patients having Canadian Cardiovascular Society (CCS) class I/II angina at baseline. In the recent consecutively enrolled OPEN CTO registry, only 26% of patients reported CCS class I/II angina at baseline.6 These observations likely represent biases to the null, and thus one can reasonably speculate that the impact among unselected patients would be greater. Degree of baseline angina has been reported to be a predictor in patients with stable angina.13 Moreover, the degree of health status improvement is significantly larger in patients with refractory angina undergoing CTO- PCI.14
In this study, the success rate of CTO PCI was 83.1% at the initial attempt and 86.6% at the final attempt. The in-hospital complication rate was 2.9%, which included pericardial tamponade, vascular surgical repair, and need for blood transfusion. The success rate and complication rates were consistent with previous observational studies from expert centers.1,6
Applications for Clinical Practice
In patients presenting with stable angina with CTO, the health status improvement is larger with CTO-PCI plus medical therapy compared to medical therapy alone. CTO-PCI should be offered to symptomatic patients in conjunction with OMT.
—Taishi Hirai, MD, and J. Aaron Grantham, MD, St. Luke’s Mid America Heart Institute, Kansas City, MO
1. Fefer P, Knudtson ML, Cheema AN, et al. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am Coll Cardiol. 2012;59:991-997.
2. Ramunddal T, Hoebers LP, Henriques JP, et al. Prognostic impact of chronic total occlusions: a report from SCAAR (Swedish Coronary Angiography and Angioplasty Registry). JACC Cardiovasc Interv. 2016;9:1535-1544.
3. Grantham JA, Marso SP, Spertus J, et al. Chronic total occlusion angioplasty in the United States. JACC Cardiovasc Interv. 2009;2:479-486.
4. Wijeysundera HC, Norris C, Fefer P, et al. Relationship between initial treatment strategy and quality of life in patients with coronary chronic total occlusions. EuroIntervention. 2014;9:1165-1172.
5. Grantham JA, Jones PG, Cannon L, Spertus JA. Quantifying the early health status benefits of successful chronic total occlusion recanalization: Results from the FlowCardia’s Approach to Chronic Total Occlusion Recanalization (FACTOR) Trial. Circ Cardiovasc Qual Outcomes. 2010;3:284-290.
6. Sapontis J, Salisbury AC, Yeh RW, C et al. Early procedural and health status outcomes after chronic total occlusion angioplasty: a report from the OPEN-CTO registry (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures). JACC Cardiovasc Interv. 2017;10:1523-1534.
7. Werner GS, Martin-Yuste V, Hildick-Smith D, et al. A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions. Eur Heart J. 2018;39:2484-2993.
8. Spertus JA, Winder JA, Dewhurst TA, et al. Monitoring the quality of life in patients with coronary artery disease. Am J Cardiol. 1994;74:1240-1244.
9. Spertus JA, Winder JA, Dewhurst TA, et al. Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease. J Am Coll Cardiol. 1995;25:333-341.
10. Mozaffarian D, Bryson CL, Spertus JA, et al. Anginal symptoms consistently predict total mortality among outpatients with coronary artery disease. Am Heart J. 2003;146:1015-1022.
11. Spertus JA, Jones P, McDonell M, et al. Health status predicts long-term outcome in outpatients with coronary disease. Circulation. 2002;106:43-49.
12. Park S. Drug-eluting stent versus optimal medical therapy in patients with coronary chronic total occlusion: DECISION CTO randomized trial. Presented at the American College of Cardiology Annual Scientific Session (ACC 2017), Washington, DC, March 18, 2017.
13. Spertus JA, Salisbury AC, Jones PG, et al. Predictors of quality-of-life benefit after percutaneous coronary intervention. Circulation. 2004;110:3789-3794.
14. Hirai T, Grantham JA, Gosch K, L et al. Quality of life in patients with refractory angina after chronic total occlusion angioplasty. J Am Coll Cardiol. 2018;72(13 supplement):TCT-79.
Study Overview
Objective. To compare the benefit of percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) versus OMT alone on the health status of patients with chronic total occlusions (CTOs).
Design. Multicenter, open-label, prospective randomized control trial.
Setting and participants. 396 patients with at least 1 CTO were assigned to PCI or OMT with a 2:1 randomization ratio.
Main outcome measures. The primary endpoint was the change in health status as assessed by the Seattle Angina Questionnaire (SAQ) between baseline and 12-month follow-up.
Main results. At 12 months, greater improvement of 3 SAQ domains was observed with PCI compared to OMT: angina frequency (5.23, 95% confidence interval [CI], 1.75-8.31, P = 0.0003), physical limitation (P = 0.02), and quality of life (6.62, 95% CI 1.78-11.46, P = 0.0007). More patients in the PCI group than in the OMT group had complete freedom from angina (71.6% vs. 57.8%, P = 0.008). There were no occurrences of periprocedural death or myocardial infarction.
Conclusion. Among patients with stable angina and CTO, PCI leads to significant health status improvement compared with OMT alone.
Commentary
CTOs are present in 15% to 25% of patients undergoing coronary angiogram1 and are associated with increased mortality.2 The benefits of successful CTO intervention observed in multiple large-scale registries include improvement in quality of life, left ventricular function, and survival as well as avoidance of coronary bypass surgery. The main indication for CTO intervention is improvement in quality of life,3 although this has not been confirmed by a randomized controlled trial comparing medical therapy to CTO-PCI.
Previous studies have assessed the health status benefits associated with CTO-PCI.4,5 Most recently, the OPEN CTO study showed significant improvement in health status in 1000 consecutive patients undergoing CTO-PCI in 12 experienced U.S. centers.6 Similarly, in a Canadian registry, revascularization of CTO was associated with greater health status benefit compared to medical therapy alone.4 However, these studies compared CTO-PCI success to failure, rather than to medical therapy.
In this context, Werner and colleagues investigated the value of PCI versus OMT for CTO by performing a well-designed randomized clinical trial in patients with CTO by assessing their health status with the SAQ.7 The SAQ is a 19-item questionnaire with a 4-week recall period that measures 5 domains of health status in patients with coronary artery disease (CAD).8,9 Scores in each domain range from 0 to 100, with higher scores indicating fewer symptoms and better quality of life. The SAQ has undergone extensive reliability and validity testing and is associated with long-term survival and health care utilization among patients with chronic CAD.10,11 At 12 months follow-up, patients who underwent CTO-PCI had greater improvement in SAQ subscales, including angina frequency and quality of life, reaching the pre-specified significance level of 0.01. There was also numerical improvement in physical limitation (P = 0.02)
The strengths of this current study include the randomized design and the careful treatment of non-CTO- PCI lesions before enrollment into the study. These non-CTO lesions were treated before the baseline health status assessment so that the additional health status benefit of non-CTO-PCI would not affect the results. This was one of multiple major limitations of the recently presented DECISION-CTO trial, as the non-CTO lesions were treated after the randomization and baseline assessment, leading to inaccurate comparison between medical therapy and CTO-PCI.12
Another interesting point of the current study is the patient selection. Since the treatment sites included were all expert centers in Europe, many patients who were referred to their institution for CTO-PCI were excluded from the study. For example, among the 1980 patients with screening log, 1381 were excluded because they were referred for CTO-PCI and 122 were excluded because they were “too symptomatic.” This suggests that the population studied were less symptomatic than the overall symptomatic CTO population from previous registries, as evidenced by about 40% of patients having Canadian Cardiovascular Society (CCS) class I/II angina at baseline. In the recent consecutively enrolled OPEN CTO registry, only 26% of patients reported CCS class I/II angina at baseline.6 These observations likely represent biases to the null, and thus one can reasonably speculate that the impact among unselected patients would be greater. Degree of baseline angina has been reported to be a predictor in patients with stable angina.13 Moreover, the degree of health status improvement is significantly larger in patients with refractory angina undergoing CTO- PCI.14
In this study, the success rate of CTO PCI was 83.1% at the initial attempt and 86.6% at the final attempt. The in-hospital complication rate was 2.9%, which included pericardial tamponade, vascular surgical repair, and need for blood transfusion. The success rate and complication rates were consistent with previous observational studies from expert centers.1,6
Applications for Clinical Practice
In patients presenting with stable angina with CTO, the health status improvement is larger with CTO-PCI plus medical therapy compared to medical therapy alone. CTO-PCI should be offered to symptomatic patients in conjunction with OMT.
—Taishi Hirai, MD, and J. Aaron Grantham, MD, St. Luke’s Mid America Heart Institute, Kansas City, MO
Study Overview
Objective. To compare the benefit of percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) versus OMT alone on the health status of patients with chronic total occlusions (CTOs).
Design. Multicenter, open-label, prospective randomized control trial.
Setting and participants. 396 patients with at least 1 CTO were assigned to PCI or OMT with a 2:1 randomization ratio.
Main outcome measures. The primary endpoint was the change in health status as assessed by the Seattle Angina Questionnaire (SAQ) between baseline and 12-month follow-up.
Main results. At 12 months, greater improvement of 3 SAQ domains was observed with PCI compared to OMT: angina frequency (5.23, 95% confidence interval [CI], 1.75-8.31, P = 0.0003), physical limitation (P = 0.02), and quality of life (6.62, 95% CI 1.78-11.46, P = 0.0007). More patients in the PCI group than in the OMT group had complete freedom from angina (71.6% vs. 57.8%, P = 0.008). There were no occurrences of periprocedural death or myocardial infarction.
Conclusion. Among patients with stable angina and CTO, PCI leads to significant health status improvement compared with OMT alone.
Commentary
CTOs are present in 15% to 25% of patients undergoing coronary angiogram1 and are associated with increased mortality.2 The benefits of successful CTO intervention observed in multiple large-scale registries include improvement in quality of life, left ventricular function, and survival as well as avoidance of coronary bypass surgery. The main indication for CTO intervention is improvement in quality of life,3 although this has not been confirmed by a randomized controlled trial comparing medical therapy to CTO-PCI.
Previous studies have assessed the health status benefits associated with CTO-PCI.4,5 Most recently, the OPEN CTO study showed significant improvement in health status in 1000 consecutive patients undergoing CTO-PCI in 12 experienced U.S. centers.6 Similarly, in a Canadian registry, revascularization of CTO was associated with greater health status benefit compared to medical therapy alone.4 However, these studies compared CTO-PCI success to failure, rather than to medical therapy.
In this context, Werner and colleagues investigated the value of PCI versus OMT for CTO by performing a well-designed randomized clinical trial in patients with CTO by assessing their health status with the SAQ.7 The SAQ is a 19-item questionnaire with a 4-week recall period that measures 5 domains of health status in patients with coronary artery disease (CAD).8,9 Scores in each domain range from 0 to 100, with higher scores indicating fewer symptoms and better quality of life. The SAQ has undergone extensive reliability and validity testing and is associated with long-term survival and health care utilization among patients with chronic CAD.10,11 At 12 months follow-up, patients who underwent CTO-PCI had greater improvement in SAQ subscales, including angina frequency and quality of life, reaching the pre-specified significance level of 0.01. There was also numerical improvement in physical limitation (P = 0.02)
The strengths of this current study include the randomized design and the careful treatment of non-CTO- PCI lesions before enrollment into the study. These non-CTO lesions were treated before the baseline health status assessment so that the additional health status benefit of non-CTO-PCI would not affect the results. This was one of multiple major limitations of the recently presented DECISION-CTO trial, as the non-CTO lesions were treated after the randomization and baseline assessment, leading to inaccurate comparison between medical therapy and CTO-PCI.12
Another interesting point of the current study is the patient selection. Since the treatment sites included were all expert centers in Europe, many patients who were referred to their institution for CTO-PCI were excluded from the study. For example, among the 1980 patients with screening log, 1381 were excluded because they were referred for CTO-PCI and 122 were excluded because they were “too symptomatic.” This suggests that the population studied were less symptomatic than the overall symptomatic CTO population from previous registries, as evidenced by about 40% of patients having Canadian Cardiovascular Society (CCS) class I/II angina at baseline. In the recent consecutively enrolled OPEN CTO registry, only 26% of patients reported CCS class I/II angina at baseline.6 These observations likely represent biases to the null, and thus one can reasonably speculate that the impact among unselected patients would be greater. Degree of baseline angina has been reported to be a predictor in patients with stable angina.13 Moreover, the degree of health status improvement is significantly larger in patients with refractory angina undergoing CTO- PCI.14
In this study, the success rate of CTO PCI was 83.1% at the initial attempt and 86.6% at the final attempt. The in-hospital complication rate was 2.9%, which included pericardial tamponade, vascular surgical repair, and need for blood transfusion. The success rate and complication rates were consistent with previous observational studies from expert centers.1,6
Applications for Clinical Practice
In patients presenting with stable angina with CTO, the health status improvement is larger with CTO-PCI plus medical therapy compared to medical therapy alone. CTO-PCI should be offered to symptomatic patients in conjunction with OMT.
—Taishi Hirai, MD, and J. Aaron Grantham, MD, St. Luke’s Mid America Heart Institute, Kansas City, MO
1. Fefer P, Knudtson ML, Cheema AN, et al. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am Coll Cardiol. 2012;59:991-997.
2. Ramunddal T, Hoebers LP, Henriques JP, et al. Prognostic impact of chronic total occlusions: a report from SCAAR (Swedish Coronary Angiography and Angioplasty Registry). JACC Cardiovasc Interv. 2016;9:1535-1544.
3. Grantham JA, Marso SP, Spertus J, et al. Chronic total occlusion angioplasty in the United States. JACC Cardiovasc Interv. 2009;2:479-486.
4. Wijeysundera HC, Norris C, Fefer P, et al. Relationship between initial treatment strategy and quality of life in patients with coronary chronic total occlusions. EuroIntervention. 2014;9:1165-1172.
5. Grantham JA, Jones PG, Cannon L, Spertus JA. Quantifying the early health status benefits of successful chronic total occlusion recanalization: Results from the FlowCardia’s Approach to Chronic Total Occlusion Recanalization (FACTOR) Trial. Circ Cardiovasc Qual Outcomes. 2010;3:284-290.
6. Sapontis J, Salisbury AC, Yeh RW, C et al. Early procedural and health status outcomes after chronic total occlusion angioplasty: a report from the OPEN-CTO registry (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures). JACC Cardiovasc Interv. 2017;10:1523-1534.
7. Werner GS, Martin-Yuste V, Hildick-Smith D, et al. A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions. Eur Heart J. 2018;39:2484-2993.
8. Spertus JA, Winder JA, Dewhurst TA, et al. Monitoring the quality of life in patients with coronary artery disease. Am J Cardiol. 1994;74:1240-1244.
9. Spertus JA, Winder JA, Dewhurst TA, et al. Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease. J Am Coll Cardiol. 1995;25:333-341.
10. Mozaffarian D, Bryson CL, Spertus JA, et al. Anginal symptoms consistently predict total mortality among outpatients with coronary artery disease. Am Heart J. 2003;146:1015-1022.
11. Spertus JA, Jones P, McDonell M, et al. Health status predicts long-term outcome in outpatients with coronary disease. Circulation. 2002;106:43-49.
12. Park S. Drug-eluting stent versus optimal medical therapy in patients with coronary chronic total occlusion: DECISION CTO randomized trial. Presented at the American College of Cardiology Annual Scientific Session (ACC 2017), Washington, DC, March 18, 2017.
13. Spertus JA, Salisbury AC, Jones PG, et al. Predictors of quality-of-life benefit after percutaneous coronary intervention. Circulation. 2004;110:3789-3794.
14. Hirai T, Grantham JA, Gosch K, L et al. Quality of life in patients with refractory angina after chronic total occlusion angioplasty. J Am Coll Cardiol. 2018;72(13 supplement):TCT-79.
1. Fefer P, Knudtson ML, Cheema AN, et al. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am Coll Cardiol. 2012;59:991-997.
2. Ramunddal T, Hoebers LP, Henriques JP, et al. Prognostic impact of chronic total occlusions: a report from SCAAR (Swedish Coronary Angiography and Angioplasty Registry). JACC Cardiovasc Interv. 2016;9:1535-1544.
3. Grantham JA, Marso SP, Spertus J, et al. Chronic total occlusion angioplasty in the United States. JACC Cardiovasc Interv. 2009;2:479-486.
4. Wijeysundera HC, Norris C, Fefer P, et al. Relationship between initial treatment strategy and quality of life in patients with coronary chronic total occlusions. EuroIntervention. 2014;9:1165-1172.
5. Grantham JA, Jones PG, Cannon L, Spertus JA. Quantifying the early health status benefits of successful chronic total occlusion recanalization: Results from the FlowCardia’s Approach to Chronic Total Occlusion Recanalization (FACTOR) Trial. Circ Cardiovasc Qual Outcomes. 2010;3:284-290.
6. Sapontis J, Salisbury AC, Yeh RW, C et al. Early procedural and health status outcomes after chronic total occlusion angioplasty: a report from the OPEN-CTO registry (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures). JACC Cardiovasc Interv. 2017;10:1523-1534.
7. Werner GS, Martin-Yuste V, Hildick-Smith D, et al. A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions. Eur Heart J. 2018;39:2484-2993.
8. Spertus JA, Winder JA, Dewhurst TA, et al. Monitoring the quality of life in patients with coronary artery disease. Am J Cardiol. 1994;74:1240-1244.
9. Spertus JA, Winder JA, Dewhurst TA, et al. Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease. J Am Coll Cardiol. 1995;25:333-341.
10. Mozaffarian D, Bryson CL, Spertus JA, et al. Anginal symptoms consistently predict total mortality among outpatients with coronary artery disease. Am Heart J. 2003;146:1015-1022.
11. Spertus JA, Jones P, McDonell M, et al. Health status predicts long-term outcome in outpatients with coronary disease. Circulation. 2002;106:43-49.
12. Park S. Drug-eluting stent versus optimal medical therapy in patients with coronary chronic total occlusion: DECISION CTO randomized trial. Presented at the American College of Cardiology Annual Scientific Session (ACC 2017), Washington, DC, March 18, 2017.
13. Spertus JA, Salisbury AC, Jones PG, et al. Predictors of quality-of-life benefit after percutaneous coronary intervention. Circulation. 2004;110:3789-3794.
14. Hirai T, Grantham JA, Gosch K, L et al. Quality of life in patients with refractory angina after chronic total occlusion angioplasty. J Am Coll Cardiol. 2018;72(13 supplement):TCT-79.