Randomized Trial of Stents Versus Bypass Surgery for Left Main Coronary Artery

Disease : 5-Year Outcomes of the PRECOMBAT Study

Journal of the American College of Cardiology

Volume 65, Issue 20, 26 May 2015

PRECOMBAT

Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-

Eluting Stent in Patients with Left Main Coronary Artery Disease

Background

Percutaneous coronary intervention (PCI) was not inferior to coronary artery bypass grafting (CABG) for the treatment of unprotected left main coronary artery stenosis at 1 year.

Study design and patients

• PRECOMBAT trial was a prospective, open-label, randomized trial conducted at 13 sites in South Korea

• Patients were randomly assigned to undergo PCI with sirolimus-eluting stents or CABG in a 1:1 ratio

Study design and patients

• Between April 2004 and August 2009, a total of 1454 patients with unprotected left main coronary artery stenosis were enrolled.

• 600 eligible patients were randomly assigned to undergo PCI with sirolimus-eluting stents (n = 300) or CABG (n = 300). Of those, 279 patients (93%) in the PCI group and 275 patients (91.7%) in the CABG group completed 5 years of follow-up

Inclusion Criteria

• Atleast 18 years of age.• The patient must have significant de novo unprotected

left main coronary artery (ULMCA) stenosis (>50% by visual estimation) with or without any additional target lesions (>70% by visual estimation).

• Patients with stable angina or acute coronary syndromes(UA & NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia may be enrolled.

• The patient or guardian must agree to the study protocol and the schedule of clinical and angiographic follow up, and must provide informed, written consent.

Exclusion Criteria

1. Known hypersensitivity or contraindication to any of the following medications:

• Heparin• Aspirin• Both clopidogrel and ticlopidine• Sirolimus• Stainless steel and/or• Contrast media

2. Systemic (intravenous) sirolimus use within 12 months.

3. Any previous percutaneous coronary intervention (PCI) within 1 year

4. Previous bypass surgery

Exclusion Criteria

5. Any previous PCI of a ULMCA 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 within 1 week

8. Ejection fraction <30%.

9. Cardiogenic shock

10. Any stroke with a persistent neurological deficit or any cerebrovascular accident within 6 months

11. Creatinine level≥2.0mg/dL or dependence on dialysis.

Exclusion Criteria

• 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.

• Unable or unwilling to follow-up with visits required by protocol

• 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.

Procedures

• Sirolimus-eluting stents were the default drug-eluting stents

• Use of IVUS, adjunctive devices, or glycoprotein IIb/IIIa inhibitors was at the operator’s discretion

• All patients undergoing PCI took aspirin plus clopidogrel (300-mg loading dose) or ticlopidine (500-mg loading dose) before or during the procedure

• After PCI, all patients were prescribed 100 mg/day aspirin indefinitely and 75 mg/day clopidogrel or 250 mg/day ticlopidine for at least 1 year

• During CABG, the internal thoracic artery was preferred for bypass of the left anterior descending artery

Follow-up and endpoints

• After PCI, all patients were asked to undergo follow-up angiography 8 to 10 months after the procedure or earlier if they were experiencing symptoms of angina

• Routine follow-up angiography was not performed for patients who underwent CABG

• Other follow-up assessments were performed at 1, 6, 9, and 12 months and yearly

• Primary endpoint: major adverse cardiac or cerebrovascular event (MACCE) (a composite of death from any cause, MI, stroke, or ischemia-driven target vessel revascularization [TVR]) after randomization.

• Secondary endpoints included the individual components of the primary endpoint

Results

AT 5 YEAR FOLLOW UP

• At 5 years, the cumulative incidence of MACCE was 17.5% in the PCI group and 14.3% in the CABG group (HR: 1.27; 95% CI: 0.84 to 1.90; p = 0.26).

LIMITATIONS

• Selected patients with relatively low-risk profiles

• limited sample size• Systematic performance of follow-up

angiography in the PCI group may have increased the rate of TVR

CONCLUSION

• During the 5-year follow-up, study did not show a significant difference in the rate of MACCE between patients who underwent PCI with a sirolimus-eluting stent and those who underwent CABG, supporting current guidelines stating that left main stenting is a feasible revascularization strategy for patients with suitable coronary anatomy.