SAN DIEGO, CA — Five years after patients with left main coronary stenosis either underwent PCI with a sirolimus-eluting stent or had CABG, there was no difference in major adverse cardiac or cerebrovascular events (MACCE) in the two groups, in the Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease (PRECOMBAT) trial.
There was no between-group difference in the primary end point of MACCE (a composite of death from any cause, MI, stroke, or ischemia-driven target vessel revascularization [TVR]), or in rates of death, MI, or stroke. But patients who had PCI—especially those who had left main and three-vessel disease—were more likely to have ischemia-driven TVR.
"Our findings support current clinical guidelines stating that left main stenting is a feasible revascularization strategy for patients with suitable coronary anatomy," said Dr Jung-Min Ahn (Asan Medical Center, Seoul, South Korea), presenting these findings at a featured clinical-research session here at the American College of Cardiology 2015 Scientific Sessions.
"However, considering the limited power of our study, our results should be interpreted with caution," Ahn and colleagues warn in the study, which was simultaneously published in the Journal of the American College of Cardiology.
"It's an impressive study in terms of completeness of follow-up [and excellence of the operators] and shows that . . . left main stenting does have quite similar outcomes to bypass surgery," session comoderator Dr John D Carroll (University of Colorado, Denver) told heartwire from Medscape. "However, it doesn't help us decide in an individual patient which is the best route to go, [and] the surgical group may not have had the same intensity of medical therapy," he noted.
Does PCI Match CABG at 5 Years?
As reported by heartwire , in 2011 the group published 1–year results of PRECOMBAT showing that PCI was not inferior to CABG for MACCE. The current study presents 5-year results.
From 2004 to 2009, PRECOMBAT randomized 600 adult patients at 13 sites in Korea to undergo PCI with a sirolimus-eluting Cypher stent (n=300) or CABG (n=300); the patients had angina, silent ischemia, or non-ST elevation MI, were newly diagnosed with unprotected left main coronary artery stenosis, and judged to be suitable candidates for either procedure.
Of the randomized patients, 93% in the PCI group and 91.7% of patients in the CABG group completed 5 years of follow-up.
At baseline, the patients had a mean age of 62. One-third had diabetes and one-half had stable angina. On average, they had a normal ejection fraction (61%) and a EuroSCORE of about 2.7. About 70% had left main artery stenosis with two-vessel or three-vessel disease. The SYNTAX score was around 25 in both groups.
At 5 years, more than 90% of the patients were receiving aspirin, and about 50% were receiving a statin and/or a beta-blocker. More patients in the PCI arm than in the CABG group were receiving dual antiplatelet therapy with a thienopyridine: 70% vs 54%, respectively.
Patients in the PCI group received an average of 2.7 stents, and intravascular ultrasound (IVUS) was used to guide the procedure in more than 90% of the cases. Patients in the CABG group had an average of 2.7 grafts, and 63% of patients had off-pump surgery.
At 5 years, the primary end point was not significantly different in the PCI vs CABG groups.
|Outcome||PCI (%)||CABG (%)||HR (95%CI)||P|
|MACCE||17.5||14.3||1.27 (0.84 - 1.90)||0.26|
|Death, MI, or stroke||8.4||9.6||0.89 (0.52 - 1.52)||0.66|
|Ischemia-driven TVR||11.4||5.5||2.11 (1.16 - 3.84||0.012|
There was also no significant difference between the PCI group and the CABG group for rates of all-cause death (5.7% vs 7.9%, respectively), MI (2.0% vs 1.7%, respectively), or stroke (0.7% in each group).
However, the rate of ischemia-driven TVR was significantly higher in the group that underwent PCI.
"Given a higher rate of repeat revascularization even after the use of second-generation drug-eluting stents for [unprotected left main coronary artery] stenosis, frequent repeat revascularization could be an inherent weakness of stent-related treatments," Ahn and colleagues write. "However, the observed increase in repeat revascularization in the PCI group did not appear to translate into an increase in hard end points, such as death, myocardial infarction, or stroke, although a further study with a longer follow-up and larger number of subjects will be needed."
Only two patients had stent thrombosis. In each SYNTAX score tertile, the rates of MACCE or the composite of death, MI, and stroke were not significantly different in patients who had PCI or CABG.
In reply to a question asking if newer-generation stents would provide better outcomes, Ahn agreed that "better stents, better outcomes" is true, "but even now, left main stenting is quite good."
The study was supported the Cardiovascular Research Foundation, Seoul, Korea; Cordis; Johnson & Johnson; and the Health 21 R&D Project, Ministry of Health & Welfare, Korea. The authors have no relevant financial relationships.
Heartwire from Medscape © 2015 Medscape, LLC
Cite this: PCI as Good as CABG for Left Main CAD: 5-Year PRECOMBAT Data - Medscape - Mar 23, 2015.