Yangsoo Jang, M.D. Ph. D On behalf of CTO-IVUS investigator

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1 Yangsoo Jang, M.D. Ph. D On behalf of CTO-IVUS investigator
Clinical impact of IVUS-guided CTO intervention on the clinical outcomes after new generation DES implantation; Randomized CTO-IVUS study Yangsoo Jang, M.D. Ph. D On behalf of CTO-IVUS investigator Division of Cardiology, Severance Cardiovascular Hospital Yonsei University College of Medicine, Seoul, Korea

2 Study at a glance and flow chart
Total 467 patients with CTO were initially screened Exclusion Wiring failure ; 61 patients Refusal of study enrollment ; 4 patients A total of 402 patients were finally enrolled after successful guidewire-crossing 1:1 randomization IVUS-guided group (n=201) Angiography-guided group (n=201) 1:1 randomization R-ZES vs. N-BES Clinical follow-up for 12 months # Primary endpoint; Composite of Cardiac death, MI, & TVR at 12 months

3 Primary endpoint (Cardiac death, MI, TVR)
10 Angiography-guided group IVUS-guided group (No. of events) 8 7.1% (14) HR=0.35, 95% CI = 0.13 – 0.97 p = 0.035 6 Cumulative incidence (%) 12-month 4 2.6% (5) 2 >> in-hospital event가 angio군에서 3명 (1 cardiac death + 2 MI) 발생 >> 한 명은 sudden death (시술 다음날), 한명은 시술후 dissect 있었으나 시술 그냥 종료 했는데 다음날 가슴 통증 있고 심전도 심근경색 & 심근 효소 상승 >> 환자는 추적 검사 거부 >> MI로 카운트 (시술후 다음날) 한명은 시술 후 가슴 통증이 있고 10일째 혈관 조영술 다시 시행 >> 큰 이상은 없었지만 심전도 변화와 CK-MB가 올라서 상승해서 MI 발생으로 카운트 (시술 10일째 … 차팅은 10일째로 되어 있습니다.) Mean duration은 제외 ! 3 6 9 12 Follow-up duration (months) Number at risk Angiography-guided 201 198 179 IVUS-guided 201 198 186

4 Cardiac death or MI TVR *p = 0.045 p = 0.186 Cumulative incidence (%)
Angiography-guided group 10 10 IVUS-guided group 8 8 HR=0.48, 95% CI = 0.17–1.42 p = 0.186 *p = 0.045 6 6 Cumulative incidence (%) 12-month 5.2% (10) 4 4 2.6% (5) 2.0% (4) 2 2 0% (0) 3 6 9 12 3 6 9 12 Follow-up duration (months) Follow-up duration (months) Number at risk Angiography-guided 201 198 187 201 199 180 IVUS-guided 201 199 190 201 198 186 *Not calculable HR or CI because of no occurrence of the event

5 Summary of CTO-IVUS study
This CTO-IVUS study is the first randomized trial investigating the clinical benefits of IVUS guidance for CTO intervention after successful guidewire crossing in the era of new generation DES. This study demonstrated that … As compared to conventional angiography-guided CTO intervention, IVUS-guided CTO intervention caused a more frequent use of high-pressure post-dilation and a larger post-procedural MLD finally, significantly improved clinical outcomes after DES implantation 결론에