Randomized Trial Evaluating Percutaneous Coronary Intervention for the Treatment of Chronic Total Occlusion

Seung Whan Lee, Pil Hyung Lee, Jung Min Ahn, Duk Woo Park, Sung Cheol Yun, Seungbong Han, Heejun Kang, Soo Jin Kang, Young Hak Kim, Cheol Whan Lee, Seong Wook Park, Seung Ho Hur, Seung-Woon Rha, Sung Ho Her, Si Wan Choi, Bong Ki Lee, Nae Hee Lee, Jong Young Lee, Sang Sig Cheong, Moo Hyun KimYoung Keun Ahn, Sang Wook Lim, Sang Gon Lee, Shirish Hiremath, Teguh Santoso, Wasan Udayachalerm, Jun Jack Cheng, David J. Cohen, Toshiya Muramatsu, Etsuo Tsuchikane, Yasushi Asakura, Seung Jung Park

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

BACKGROUND: Procedural results for percutaneous coronary intervention (PCI) in coronary vessels with chronic total occlusion (CTO) have improved in recent years, and PCI strategies have moved toward more complete revascularization with more liberal use of CTO-PCI. However, evidence evaluating CTO-PCI is limited to observational studies and small clinical trials. METHODS: In this open-label, multicenter, randomized, noninferiority trial, PCI-eligible patients were assigned to receive either 1 of 2 strategies: PCI or no PCI for the qualifying de novo CTO lesion with the option for PCI of obstructive non-CTO lesions at the discretion of the operator. The primary end point was a composite of death, myocardial infarction, stroke, or any revascularization. Health-related quality of life was assessed at baseline and at 1, 6, 12, 24, and 36 months. Because of slow recruitment, the trial was stopped before completion of the 1284 planned enrollments. RESULTS: Between March 2010 and September 2016, 834 patients were randomly assigned to the CTO-PCI (n=417) or no CTO-PCI (n=398) strategy. Among the patients assigned to the no CTO-PCI strategy, 78 (19.6%) crossed over to receive staged CTO-PCI within 3 days of randomization. The overall CTO-PCI success rate was 90.6%. Serious nonfatal complications associated with CTO-PCI occurred in 3 patients (1 stroke, 1 cardiac tamponade, and 1 patient with recurrent episodes of ventricular tachyarrhythmia induced by intracoronary thrombus). Approximately half of the patients in each group underwent PCI for an average of 1.3 non-CTO lesions, resulting in a comparable residual SYNTAX score (Synergy Between PCI With TAXUS and Cardiac Surgery; 3.7±5.4 versus 4.0±5.9, P=0.42) confined to non-CTO vessels. During a median follow-up of 4.0 years (interquartile range, 2.4 to 5.1 years), there was no significant difference between the CTO-PCI and the no CTO-PCI strategies in the incidence of the primary end point (22.3% versus 22.4%, hazard ratio, 1.03; 95% CI, 0.77 to 1.37; P=0.86). Both CTO-PCI and no CTO-PCI strategy were associated with significant improvements but without between-group differences in disease-specific health status that was sustained through 36 months. CONCLUSIONS: CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01078051.

Original languageEnglish
Pages (from-to)1674-1683
Number of pages10
JournalCirculation
Volume139
Issue number14
DOIs
Publication statusPublished - 2019 Apr 2

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Percutaneous Coronary Intervention
Therapeutics
Stroke
Clinical Trials
Cardiac Tamponade

Keywords

  • arterial occlusive diseases
  • outcome
  • percutaneous coronary intervention
  • randomized controlled trial

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Lee, S. W., Lee, P. H., Ahn, J. M., Park, D. W., Yun, S. C., Han, S., ... Park, S. J. (2019). Randomized Trial Evaluating Percutaneous Coronary Intervention for the Treatment of Chronic Total Occlusion. Circulation, 139(14), 1674-1683. https://doi.org/10.1161/CIRCULATIONAHA.118.031313

Randomized Trial Evaluating Percutaneous Coronary Intervention for the Treatment of Chronic Total Occlusion. / Lee, Seung Whan; Lee, Pil Hyung; Ahn, Jung Min; Park, Duk Woo; Yun, Sung Cheol; Han, Seungbong; Kang, Heejun; Kang, Soo Jin; Kim, Young Hak; Lee, Cheol Whan; Park, Seong Wook; Hur, Seung Ho; Rha, Seung-Woon; Her, Sung Ho; Choi, Si Wan; Lee, Bong Ki; Lee, Nae Hee; Lee, Jong Young; Cheong, Sang Sig; Kim, Moo Hyun; Ahn, Young Keun; Lim, Sang Wook; Lee, Sang Gon; Hiremath, Shirish; Santoso, Teguh; Udayachalerm, Wasan; Cheng, Jun Jack; Cohen, David J.; Muramatsu, Toshiya; Tsuchikane, Etsuo; Asakura, Yasushi; Park, Seung Jung.

In: Circulation, Vol. 139, No. 14, 02.04.2019, p. 1674-1683.

Research output: Contribution to journalArticle

Lee, SW, Lee, PH, Ahn, JM, Park, DW, Yun, SC, Han, S, Kang, H, Kang, SJ, Kim, YH, Lee, CW, Park, SW, Hur, SH, Rha, S-W, Her, SH, Choi, SW, Lee, BK, Lee, NH, Lee, JY, Cheong, SS, Kim, MH, Ahn, YK, Lim, SW, Lee, SG, Hiremath, S, Santoso, T, Udayachalerm, W, Cheng, JJ, Cohen, DJ, Muramatsu, T, Tsuchikane, E, Asakura, Y & Park, SJ 2019, 'Randomized Trial Evaluating Percutaneous Coronary Intervention for the Treatment of Chronic Total Occlusion', Circulation, vol. 139, no. 14, pp. 1674-1683. https://doi.org/10.1161/CIRCULATIONAHA.118.031313
Lee, Seung Whan ; Lee, Pil Hyung ; Ahn, Jung Min ; Park, Duk Woo ; Yun, Sung Cheol ; Han, Seungbong ; Kang, Heejun ; Kang, Soo Jin ; Kim, Young Hak ; Lee, Cheol Whan ; Park, Seong Wook ; Hur, Seung Ho ; Rha, Seung-Woon ; Her, Sung Ho ; Choi, Si Wan ; Lee, Bong Ki ; Lee, Nae Hee ; Lee, Jong Young ; Cheong, Sang Sig ; Kim, Moo Hyun ; Ahn, Young Keun ; Lim, Sang Wook ; Lee, Sang Gon ; Hiremath, Shirish ; Santoso, Teguh ; Udayachalerm, Wasan ; Cheng, Jun Jack ; Cohen, David J. ; Muramatsu, Toshiya ; Tsuchikane, Etsuo ; Asakura, Yasushi ; Park, Seung Jung. / Randomized Trial Evaluating Percutaneous Coronary Intervention for the Treatment of Chronic Total Occlusion. In: Circulation. 2019 ; Vol. 139, No. 14. pp. 1674-1683.
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abstract = "BACKGROUND: Procedural results for percutaneous coronary intervention (PCI) in coronary vessels with chronic total occlusion (CTO) have improved in recent years, and PCI strategies have moved toward more complete revascularization with more liberal use of CTO-PCI. However, evidence evaluating CTO-PCI is limited to observational studies and small clinical trials. METHODS: In this open-label, multicenter, randomized, noninferiority trial, PCI-eligible patients were assigned to receive either 1 of 2 strategies: PCI or no PCI for the qualifying de novo CTO lesion with the option for PCI of obstructive non-CTO lesions at the discretion of the operator. The primary end point was a composite of death, myocardial infarction, stroke, or any revascularization. Health-related quality of life was assessed at baseline and at 1, 6, 12, 24, and 36 months. Because of slow recruitment, the trial was stopped before completion of the 1284 planned enrollments. RESULTS: Between March 2010 and September 2016, 834 patients were randomly assigned to the CTO-PCI (n=417) or no CTO-PCI (n=398) strategy. Among the patients assigned to the no CTO-PCI strategy, 78 (19.6{\%}) crossed over to receive staged CTO-PCI within 3 days of randomization. The overall CTO-PCI success rate was 90.6{\%}. Serious nonfatal complications associated with CTO-PCI occurred in 3 patients (1 stroke, 1 cardiac tamponade, and 1 patient with recurrent episodes of ventricular tachyarrhythmia induced by intracoronary thrombus). Approximately half of the patients in each group underwent PCI for an average of 1.3 non-CTO lesions, resulting in a comparable residual SYNTAX score (Synergy Between PCI With TAXUS and Cardiac Surgery; 3.7±5.4 versus 4.0±5.9, P=0.42) confined to non-CTO vessels. During a median follow-up of 4.0 years (interquartile range, 2.4 to 5.1 years), there was no significant difference between the CTO-PCI and the no CTO-PCI strategies in the incidence of the primary end point (22.3{\%} versus 22.4{\%}, hazard ratio, 1.03; 95{\%} CI, 0.77 to 1.37; P=0.86). Both CTO-PCI and no CTO-PCI strategy were associated with significant improvements but without between-group differences in disease-specific health status that was sustained through 36 months. CONCLUSIONS: CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01078051.",
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TY - JOUR

T1 - Randomized Trial Evaluating Percutaneous Coronary Intervention for the Treatment of Chronic Total Occlusion

AU - Lee, Seung Whan

AU - Lee, Pil Hyung

AU - Ahn, Jung Min

AU - Park, Duk Woo

AU - Yun, Sung Cheol

AU - Han, Seungbong

AU - Kang, Heejun

AU - Kang, Soo Jin

AU - Kim, Young Hak

AU - Lee, Cheol Whan

AU - Park, Seong Wook

AU - Hur, Seung Ho

AU - Rha, Seung-Woon

AU - Her, Sung Ho

AU - Choi, Si Wan

AU - Lee, Bong Ki

AU - Lee, Nae Hee

AU - Lee, Jong Young

AU - Cheong, Sang Sig

AU - Kim, Moo Hyun

AU - Ahn, Young Keun

AU - Lim, Sang Wook

AU - Lee, Sang Gon

AU - Hiremath, Shirish

AU - Santoso, Teguh

AU - Udayachalerm, Wasan

AU - Cheng, Jun Jack

AU - Cohen, David J.

AU - Muramatsu, Toshiya

AU - Tsuchikane, Etsuo

AU - Asakura, Yasushi

AU - Park, Seung Jung

PY - 2019/4/2

Y1 - 2019/4/2

N2 - BACKGROUND: Procedural results for percutaneous coronary intervention (PCI) in coronary vessels with chronic total occlusion (CTO) have improved in recent years, and PCI strategies have moved toward more complete revascularization with more liberal use of CTO-PCI. However, evidence evaluating CTO-PCI is limited to observational studies and small clinical trials. METHODS: In this open-label, multicenter, randomized, noninferiority trial, PCI-eligible patients were assigned to receive either 1 of 2 strategies: PCI or no PCI for the qualifying de novo CTO lesion with the option for PCI of obstructive non-CTO lesions at the discretion of the operator. The primary end point was a composite of death, myocardial infarction, stroke, or any revascularization. Health-related quality of life was assessed at baseline and at 1, 6, 12, 24, and 36 months. Because of slow recruitment, the trial was stopped before completion of the 1284 planned enrollments. RESULTS: Between March 2010 and September 2016, 834 patients were randomly assigned to the CTO-PCI (n=417) or no CTO-PCI (n=398) strategy. Among the patients assigned to the no CTO-PCI strategy, 78 (19.6%) crossed over to receive staged CTO-PCI within 3 days of randomization. The overall CTO-PCI success rate was 90.6%. Serious nonfatal complications associated with CTO-PCI occurred in 3 patients (1 stroke, 1 cardiac tamponade, and 1 patient with recurrent episodes of ventricular tachyarrhythmia induced by intracoronary thrombus). Approximately half of the patients in each group underwent PCI for an average of 1.3 non-CTO lesions, resulting in a comparable residual SYNTAX score (Synergy Between PCI With TAXUS and Cardiac Surgery; 3.7±5.4 versus 4.0±5.9, P=0.42) confined to non-CTO vessels. During a median follow-up of 4.0 years (interquartile range, 2.4 to 5.1 years), there was no significant difference between the CTO-PCI and the no CTO-PCI strategies in the incidence of the primary end point (22.3% versus 22.4%, hazard ratio, 1.03; 95% CI, 0.77 to 1.37; P=0.86). Both CTO-PCI and no CTO-PCI strategy were associated with significant improvements but without between-group differences in disease-specific health status that was sustained through 36 months. CONCLUSIONS: CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01078051.

AB - BACKGROUND: Procedural results for percutaneous coronary intervention (PCI) in coronary vessels with chronic total occlusion (CTO) have improved in recent years, and PCI strategies have moved toward more complete revascularization with more liberal use of CTO-PCI. However, evidence evaluating CTO-PCI is limited to observational studies and small clinical trials. METHODS: In this open-label, multicenter, randomized, noninferiority trial, PCI-eligible patients were assigned to receive either 1 of 2 strategies: PCI or no PCI for the qualifying de novo CTO lesion with the option for PCI of obstructive non-CTO lesions at the discretion of the operator. The primary end point was a composite of death, myocardial infarction, stroke, or any revascularization. Health-related quality of life was assessed at baseline and at 1, 6, 12, 24, and 36 months. Because of slow recruitment, the trial was stopped before completion of the 1284 planned enrollments. RESULTS: Between March 2010 and September 2016, 834 patients were randomly assigned to the CTO-PCI (n=417) or no CTO-PCI (n=398) strategy. Among the patients assigned to the no CTO-PCI strategy, 78 (19.6%) crossed over to receive staged CTO-PCI within 3 days of randomization. The overall CTO-PCI success rate was 90.6%. Serious nonfatal complications associated with CTO-PCI occurred in 3 patients (1 stroke, 1 cardiac tamponade, and 1 patient with recurrent episodes of ventricular tachyarrhythmia induced by intracoronary thrombus). Approximately half of the patients in each group underwent PCI for an average of 1.3 non-CTO lesions, resulting in a comparable residual SYNTAX score (Synergy Between PCI With TAXUS and Cardiac Surgery; 3.7±5.4 versus 4.0±5.9, P=0.42) confined to non-CTO vessels. During a median follow-up of 4.0 years (interquartile range, 2.4 to 5.1 years), there was no significant difference between the CTO-PCI and the no CTO-PCI strategies in the incidence of the primary end point (22.3% versus 22.4%, hazard ratio, 1.03; 95% CI, 0.77 to 1.37; P=0.86). Both CTO-PCI and no CTO-PCI strategy were associated with significant improvements but without between-group differences in disease-specific health status that was sustained through 36 months. CONCLUSIONS: CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01078051.

KW - arterial occlusive diseases

KW - outcome

KW - percutaneous coronary intervention

KW - randomized controlled trial

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