Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease (PRECOMBAT)
PREmier of Randomized COMparison of Bypass Surgery Versus AngioplasTy Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease
The primary objective of the PRE-COMBAT trial is:
To establish the safety and effectiveness of coronary stenting with the sirolimus-eluting balloon expandable stent (Cordis Johnson & Johnson, Warren, New Jersey) compared with bypass surgery for the treatment of an unprotected LMCA stenosis. The alternative hypothesis is that the experimental strategy (coronary stenting with the sirolimus-eluting stents) is not inferior to the standard strategy (bypass surgery).
연구 개요
상세 설명
Despite bypass surgery has been considered as the standard strategy for the treatment of unprotected left main coronary artery (LMCA) lesions, several studies have demonstrated that percutaneous coronary intervention (PCI) of the unprotected LMCA is feasible and appears to be an alternative strategy in selected patients. However, the safety and efficacy of PCI in patients with unprotected LMCA stenosis are still a matter of debate.
Previous studies have demonstrated the safety and feasibility of unprotected LMCA intervention using bare metal stents (BMS). There was a favorable initial outcome after LMCA intervention using BMS in low-risk patients. However, in-stent restenosis after BMS implantation has emerged as the interference to widely perform PCI for unprotected LMCA lesions and the most important reason for selection of bypass surgery as the first choice for treating LMCA stenosis. In-stent restenosis in these patients not only influences long-term survival, but also make repeat intervention more complex. Despite endeavors to decrease in-stent restenosis after LMCA intervention using BMS, such as aggressive debulking atherectomy, the restenosis rate still remains at 20-30%. The sirolimus-eluting stent (SES) (Cypher, Cordis, Johnson & Johnson Corp, Miami, Florida) markedly decreases in-stent restenosis in elective patients with relatively simple coronary lesions. In real-world practice using SES, patients undergoing SES implantation were treated with a less restrictive interventional approach. However, the results are very promising similar to the randomized controlled trials. These findings warrant new studies to compare the efficacy of SES for more complex lesion subsets including LMCA disease with coronary artery bypass graft (CABG).
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Daegu, 대한민국
- Daegu Catholic University Medical Center
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Daejeon, 대한민국
- Chungnam National University Hospital
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Gwangju, 대한민국
- Chonnam National University Hospital
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Seongnam, 대한민국
- Seoul National University Bundang Hospital
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Seoul, 대한민국
- Seoul National University Hospital
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Seoul, 대한민국, 138-736
- Asan Medical Center
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Seoul, 대한민국
- Samsung Medical Center
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Seoul, 대한민국
- Korea University Guro Hospital
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Seoul, 대한민국
- Korea University Anam Hospital
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Seoul, 대한민국
- Yonsei University Medical Center
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Seoul, 대한민국
- St.Mary's Catholic Medical Center
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Suwon, 대한민국
- Ajou University Hospital
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Ulsan, 대한민국
- Ulsan University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- The patient must be at least 18 years of age.
- Significant de novo left main stenosis (>50% by visual estimation) with or without any additional target lesions (>70% by visual estimation)
- Left main lesion and lesions outside LMCA (if present) potentially equally treatable with coronary stenting and bypass surgery
- Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion Criteria:
The patient has a known hypersensitivity or contraindication to any of the following medications:
- Heparin
- Aspirin
- Both Clopidogrel and TIclopidine
- Sirolimus, paclitaxel, ABT 578
- Stainless steel and/or
- Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
- Systemic (intravenous) Sirolimus, paclitaxel or ABT-578 use within 12 months.
- Any previous PCI within 1 year
- Previous bypass surgery
- Any previous PCI of a LMCA or ostial left circumflex artery or ostial left anterior descending artery lesion within 1 year
- Intention to treat more than one totally occluded major epicardial vessel
- Acute MI patients within 1 week
- Patients with EF<30%.
- Patients with cardiogenic shock
- Any disabled stroke with neurological deficit or any cerebrovascular accident within 6 months
- Creatinine level > 2.0mg/dL or dependence on dialysis.
- Severe hepatic dysfunction (AST and ALT > 3 times upper normal reference values).
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
- An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 1 year post enrollment.
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Subject unable or unwilling to follow-up with visits required by protocol
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: coronary artery bypass graft
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관상동맥우회술
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실험적: percutaneous coronary intervention
Using silorimus eluting stent
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Using silorimus eluting stent
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Major cardiac and cerebrovascular event (MACCE): the composite of death, myocardial infarction, stroke, and ischemica-driven target vessel revascularization
기간: one-year after treatment
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one-year after treatment
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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스텐트 내 및 분절 내 이원성 재협착
기간: 9개월 혈관 조영 추적
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9개월 혈관 조영 추적
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All-cause mortality
기간: at 30 days, 6 months, 1 year, and yearly to 5 years
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at 30 days, 6 months, 1 year, and yearly to 5 years
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Cardiac death
기간: at 30 days, 6 months, 1 year, and yearly to 5 years
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at 30 days, 6 months, 1 year, and yearly to 5 years
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Myocardial infarction
기간: at 30 days, 6 months, 1 year, and yearly to 5 years
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at 30 days, 6 months, 1 year, and yearly to 5 years
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Cerebrovascular accident
기간: at 30 days, 6 months, 1 year, and yearly to 5 years
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at 30 days, 6 months, 1 year, and yearly to 5 years
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Target vessel revascularization (all and ischemia-driven)
기간: at 30 days, 6 months, 1 year, and yearly to 5 years
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at 30 days, 6 months, 1 year, and yearly to 5 years
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Target lesion revascularization (all and ischemia-driven)
기간: at 30 days, 6 months, 1 year, and yearly to 5 years
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at 30 days, 6 months, 1 year, and yearly to 5 years
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Stent thrombosis in the PCI group
기간: at 30 days, 6 months, 1 year, and yearly to 5 years
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at 30 days, 6 months, 1 year, and yearly to 5 years
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Graft patency and reocclusion rate
기간: at 9 months angiographic follow-up
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at 9 months angiographic follow-up
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Late luminal loss in both in-stent and in-segment
기간: at 9 month angiographic follow-up
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at 9 month angiographic follow-up
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- Jeong YJ, Ahn JM, Hyun J, Lee J, Kim JH, Yang Y, Choe K, Park H, Kang DY, Lee PH, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park SJ, Park DW. Ten-year Outcomes After Drug-Eluting Stents or Bypass Surgery for Left Main Coronary Disease in Patients With and Without Diabetes Mellitus: The PRECOMBAT Extended Follow-Up Study. J Am Heart Assoc. 2021 Jul 20;10(14):e019834. doi: 10.1161/JAHA.120.019834. Epub 2021 Jul 9.
- Park DW, Ahn JM, Park H, Yun SC, Kang DY, Lee PH, Kim YH, Lim DS, Rha SW, Park GM, Gwon HC, Kim HS, Chae IH, Jang Y, Jeong MH, Tahk SJ, Seung KB, Park SJ; PRECOMBAT Investigators. Ten-Year Outcomes After Drug-Eluting Stents Versus Coronary Artery Bypass Grafting for Left Main Coronary Disease: Extended Follow-Up of the PRECOMBAT Trial. Circulation. 2020 May 5;141(18):1437-1446. doi: 10.1161/CIRCULATIONAHA.120.046039. Epub 2020 Mar 30.
- Sotomi Y, Onuma Y, Cavalcante R, Ahn JM, Lee CW, van Klaveren D, de Winter RJ, Wykrzykowska JJ, Farooq V, Morice MC, Steyerberg EW, Park SJ, Serruys PW. Geographical Difference of the Interaction of Sex With Treatment Strategy in Patients With Multivessel Disease and Left Main Disease: A Meta-Analysis From SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) Randomized Controlled Trials. Circ Cardiovasc Interv. 2017 May;10(5):e005027. doi: 10.1161/CIRCINTERVENTIONS.117.005027.
- Sotomi Y, Cavalcante R, van Klaveren D, Ahn JM, Lee CW, de Winter RJ, Wykrzykowska JJ, Onuma Y, Steyerberg EW, Park SJ, Serruys PW. Individual Long-Term Mortality Prediction Following Either Coronary Stenting or Bypass Surgery in Patients With Multivessel and/or Unprotected Left Main Disease: An External Validation of the SYNTAX Score II Model in the 1,480 Patients of the BEST and PRECOMBAT Randomized Controlled Trials. JACC Cardiovasc Interv. 2016 Aug 8;9(15):1564-72. doi: 10.1016/j.jcin.2016.04.023.
- Ahn JM, Roh JH, Kim YH, Park DW, Yun SC, Lee PH, Chang M, Park HW, Lee SW, Lee CW, Park SW, Choo SJ, Chung C, Lee J, Lim DS, Rha SW, Lee SG, Gwon HC, Kim HS, Chae IH, Jang Y, Jeong MH, Tahk SJ, Seung KB, Park SJ. Randomized Trial of Stents Versus Bypass Surgery for Left Main Coronary Artery Disease: 5-Year Outcomes of the PRECOMBAT Study. J Am Coll Cardiol. 2015 May 26;65(20):2198-206. doi: 10.1016/j.jacc.2015.03.033. Epub 2015 Mar 15.
- Park SJ, Kim YH, Park DW, Yun SC, Ahn JM, Song HG, Lee JY, Kim WJ, Kang SJ, Lee SW, Lee CW, Park SW, Chung CH, Lee JW, Lim DS, Rha SW, Lee SG, Gwon HC, Kim HS, Chae IH, Jang Y, Jeong MH, Tahk SJ, Seung KB. Randomized trial of stents versus bypass surgery for left main coronary artery disease. N Engl J Med. 2011 May 5;364(18):1718-27. doi: 10.1056/NEJMoa1100452. Epub 2011 Apr 4.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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