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Coronary Artery DiseasePhase 3PRECOMBATNCT00422968

Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease

A Phase 3 study testing Percutaneous coronary intervention and coronary artery bypass graft in people with Coronary Artery Disease, run by Seung-Jung Park at 13 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Percutaneous coronary intervention and coronary artery bypass graft
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,454 participants
Where
13 sitesSouth Korea
Study dates
Mar 2005to Dec 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 26Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

South Korea13 sites

  • Daegu Catholic University Medical Center

    Daegu

  • Chungnam National University Hospital

    Daejeon

  • Chonnam National University Hospital

    Gwangju

  • Seoul National University Bundang Hospital

    Seongnam

  • Asan Medical Center

    Seoul, 138-736

  • Korea University Anam Hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • St.Mary's Catholic Medical Center

    Seoul

  • Yonsei University Medical Center

    Seoul

  • Ajou University Hospital

    Suwon

  • Ulsan University Hospital

    Ulsan

Other trials in South Korea

About this study

Official title: 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).

Read the detailed description

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).

Being tested
Percutaneous coronary intervention, coronary artery bypass graft
Keywords
Coronary artery disease, Stent, Bypass surgery, coronary artery
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous coronary interventionDevice

    Using silorimus eluting stent

  • coronary artery bypass graftProcedure or surgery

    coronary artery bypass graft

Study groups in NCT00422968
Study groupRoleWhat they receive
coronary artery bypass graftActive comparatorcoronary artery bypass graft
Receives: Procedure: coronary artery bypass graft
percutaneous coronary interventionExperimentalUsing silorimus eluting stent
Receives: Device: Percutaneous coronary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major cardiac and cerebrovascular event (MACCE): the composite of death, myocardial infarction, stroke, and ischemica-driven target vessel revascularization

    Measured: one-year after treatment

Secondary outcomes (10)

  1. All-cause mortality

    Measured: at 30 days, 6 months, 1 year, and yearly to 5 years

  2. Cardiac death

    Measured: at 30 days, 6 months, 1 year, and yearly to 5 years

  3. Myocardial infarction

    Measured: at 30 days, 6 months, 1 year, and yearly to 5 years

  4. Cerebrovascular accident

    Measured: at 30 days, 6 months, 1 year, and yearly to 5 years

  5. Target vessel revascularization (all and ischemia-driven)

    Measured: at 30 days, 6 months, 1 year, and yearly to 5 years

  6. Target lesion revascularization (all and ischemia-driven)

    Measured: at 30 days, 6 months, 1 year, and yearly to 5 years

  7. Stent thrombosis in the PCI group

    Measured: at 30 days, 6 months, 1 year, and yearly to 5 years

  8. Binary restenosis in both in-stent and in-segment

    Measured: at 9 month angiographic follow-up

  9. Graft patency and reocclusion rate

    Measured: at 9 months angiographic follow-up

  10. Late luminal loss in both in-stent and in-segment

    Measured: at 9 month angiographic follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2007 (estimated)
  2. Study startMar 2005
  3. Primary completionNov 2009
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,454 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00422968
Sponsor's protocol ID
2005-0012
Acronym
PRECOMBAT
Status last verified
Apr 2014
First submitted
16 Jan 2007
Last updated
1 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Gaba P, Sabik JF, Murphy SA, Bellavia A, O'Gara PT, Smith PK, Serruys PW, Kappetein AP, Park SJ, Park DW, Christiansen EH, Holm NR, Nielsen PH, Sabatine MS, Stone GW, Bergmark BA. Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Left Main Disease With and Without Diabetes: Findings From a Pooled Analysis of 4 Randomized Clinical Trials. Circulation. 2024 Apr 23;149(17):1328-1338. doi: 10.1161/CIRCULATIONAHA.123.065571. Epub 2024 Mar 11.

    PubMed 38465592

  • Kim TO, Kang DY, Ahn JM, Kim MJ, Lee PH, Kim H, Choi Y, Lee J, Lee JM, Jo HH, Park YS, Lim SM, Park SJ, Park DW. Impact of Target Lesion Revascularization on Long-Term Mortality After Percutaneous Coronary Intervention for Left Main Disease. JACC Cardiovasc Interv. 2024 Jan 8;17(1):32-42. doi: 10.1016/j.jcin.2023.10.068.

    PubMed 38199751

  • Gaba P, Christiansen EH, Nielsen PH, Murphy SA, O'Gara PT, Smith PK, Serruys PW, Kappetein AP, Park SJ, Park DW, Stone GW, Sabik JF, Sabatine MS, Holm NR, Bergmark BA. Percutaneous Coronary Intervention vs Coronary Artery Bypass Graft Surgery for Left Main Disease in Patients With and Without Acute Coronary Syndromes: A Pooled Analysis of 4 Randomized Clinical Trials. JAMA Cardiol. 2023 Jul 1;8(7):631-639. doi: 10.1001/jamacardio.2023.1177.

    PubMed 37256598

  • Kim T, Kang DY, Kim S, Lee JH, Kim AR, Lee Y, Oh HJ, Jang M, Lee J, Kim JH, Lee PH, Ahn JM, Park SJ, Park DW; PRECOMBAT Extended Study Investigators. Impact of Complete or Incomplete Revascularization for Left Main Coronary Disease: The Extended PRECOMBAT Study. JACC Asia. 2023 Jan 24;3(1):65-74. doi: 10.1016/j.jacasi.2022.10.007. eCollection 2023 Feb.

    PubMed 36873760

  • 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.

    PubMed 34238026

  • 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.

    PubMed 32223567

  • 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.

    PubMed 28495897

  • 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.

    PubMed 27491605

  • 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.

    PubMed 25787197

  • 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.

    PubMed 21463149

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Percutaneous coronary intervention and coronary artery bypass graft in people with Coronary Artery Disease, run by Seung-Jung Park at 13 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major cardiac and cerebrovascular event (MACCE): the composite of death, myocardial infarction, stroke, and ischemica-driven target vessel revascularization (time frame: one-year after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00422968, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2014.

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