Clinical trial NCT01348022: Evaluation of Outcomes of EES Implantation for Unprotected Left Main Coronary Artery Stenosis (PRE-COMBAT 2)
Official title: Prospective Evaluation of Outcomes of Everolimus-Eluting Stent (XIENCE V) Implantation for Unprotected Left Main Coronary Artery Stenosis: Multicenter Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
name: Abbott
First posted: 2011-05-05
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Coronary artery disease requiring drug eluting stents

Brief summary: This study is a multicenter, open label, prospective, single arm trial

Single arm group; following angiography, eligible patients with unprotected LMCA stenosis \>50% by visual estimation, which is equally treatable by the both treatment strategy (EES stenting or CABG), will be treated with EES

Detailed description: The primary objective of the PRECOMBAT-2 trial is to establish the safety and effectiveness of coronary stenting with the everolimus-eluting Xience V stent (EES) compared with the historical control (PRE-COMBAT-1) of bypass surgery and sirolimus-eluting stent (SES) for the treatment of an unprotected LMCA stenosis. The primary alternative hypothesis is that the experimental starategy (coronary stenting with the everolimus-eluting stents) is not inferior to the standard strategy (CABG) or SES.

All consecutive patients with unprotected LMCA diseases at participating centers, who are treated with Xience V stent, will be evaluated for the entry into the study.

Eligibility criteria: Inclusion Criteria:

1. The patient must be at least 18 years of age.
2. Significant de novo left main stenosis (\>50% by visual estimation) with or without any additional target lesions (\>70% by visual estimation)
3. Left main lesion and lesions outside LMCA (if present) potentially equally treatable with coronary stenting and CABG
4. 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
5. 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:

1. The patient has a known hypersensitivity or contraindication to any of the following medications:

   * Heparin
   * Aspirin
   * Both Clopidogrel and TIclopidine
   * Everolimus, 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).
2. Systemic (intravenous) Everolimus, paclitaxel or ABT-578 use within 12 months.
3. Any previous PCI within 1 year
4. Previous bypass surgery
5. Any previous PCI of a LMCA or ostial left circumflex artery or ostial left anterior descending artery lesion within 1 year
6. Intention to treat more than one totally occluded major epicardial vessel
7. Acute MI patients within 1 week
8. Patients with EF\<30%.
9. Patients with cardiogenic shock
10. Any disabled stroke with neurological deficit or any cerebrovascular accident within 6 months
11. Creatinine level 2.0mg/dL or dependence on dialysis.
12. Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).
13. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
14. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
15. Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL.
16. An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 1 year post enrollment.
17. 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).
18. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
19. Subject unable or unwilling to follow-up with visits required by protocol
20. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study

Primary outcomes:
measure: MACCE free survival
timeFrame: at 2 year
Secondary outcomes:
measure: Death(all cause and cardiac)
timeFrame: 5 years
measure: Myocardial Infarction
timeFrame: 5 years
measure: Cerebrovascular accident
timeFrame: 5 years
measure: Target vessel revascularization
timeFrame: 5 years
measure: Target lesion revascularization
timeFrame: 5 years
measure: Stent thrombosis
timeFrame: 5 years
measure: Binary restenosis in both in-stent and in-segment
timeFrame: 9 months
measure: Late luminal loss in both in-stent and in-segment
timeFrame: 9 months
measure: pattern of restenosis
timeFrame: 9 months
measure: Angina status
timeFrame: 5 years
measure: Re-hospitalization with a cardiac cause
timeFrame: 5 years
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon ST. Mary's Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Kwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Veterans Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim YH, Park DW, Ahn JM, Yun SC, Song HG, Lee JY, Kim WJ, Kang SJ, Lee SW, Lee CW, Park SW, Jang Y, Jeong MH, Kim HS, Hur SH, Rha SW, Lim DS, Her SH, Seung KB, Seong IW, Park SJ; PRECOMBAT-2 Investigators. Everolimus-eluting stent implantation for unprotected left main coronary artery stenosis. The PRECOMBAT-2 (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) study. JACC Cardiovasc Interv. 2012 Jul;5(7):708-17. doi: 10.1016/j.jcin.2012.05.002.