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NOBLE: CABG shows better clinical outcomes for treatment of left main CAD vs. PCI
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WASHINGTON — PCI with a drug-eluting stent was inferior to CABG for the outcome of MACCE at 5 years, according to data presented at TCT 2016 and published in The Lancet.
“The study showed that PCI was not noninferior to CABG; in fact, CABG was superior to PCI,” Evald H. Christiansen, MD, PhD, from Aarhus University Hospital in Skejby, Denmark, said in a presentation.
The prospective, randomized, open-label, noninferiority NOBLE study was conducted at 36 hospitals in Europe between Dec. 9, 2008 and Jan. 21, 2015.
Christiansen and colleagues randomly assigned 1,201 eligible patients with left main CAD to treatment with PCI (n = 598; mean age, 66 years; 20% women) or CABG (n = 603; mean age, 66 years; 24% women). Initially, operators could use any DES on patients assigned PCI, but in March 2010, they were advised to use a biolimus-eluting stent (Biomatrix Flex, Biosensors).
Patients were included if they had stable angina pectoris, unstable angina pectoris or non-STEMI, but excluded if they had an expected survival of less than 1 year or STEMI within 24 hours, according to the researchers.
The primary endpoint was MACCE, a composite of all-cause mortality, nonprocedural MI, repeat coronary revascularization and stroke.
For PCI to be classified as noninferior to CABG, the lower end of the 95% CI could not exceed an HR of 1.35 after a follow-up of 5 years.
At 5 years, Kaplan-Meier estimates of MACCE were 29% for PCI and 19% for CABG. The 1.48 HR exceeded the limit for noninferiority (95% CI, 1.11-1.96), and CABG was superior PCI (P = .0066), according to the researchers.
At 5 years, there was no significant difference between the groups in all-cause mortality (PCI, 12%; CABG, 9%; HR = 1.07; 95% CI, 0.67-1.72) or stroke (PCI, 5%; CABG, 2%; HR = 2.25; 95% CI, 0.93-5.48).
However, at 5 years, PCI was inferior to CABG in nonprocedural MI (7% vs. 2%; HR = 2.88, 95% CI, 1.4-5.9), and revascularization (16% vs. 10%; HR = 1.5; 95% CI, 1.04-2.17).
Contrast with EXCEL
During a panel discussion at a press conference, the NOBLE findings were contrasted with those from the EXCEL trial, which found PCI was noninferior to CABG in patients with left main disease.
Panelist Gregg W. Stone, MD, presenter of the EXCEL trial, said vast differences between the two studies made them “unfortunately not comparable.
“The late increasing MI, we also saw in EXCEL, and I do believe that is real. The 5% or 6% difference in [target lesion revascularization] is also not that different in what we saw, but the much higher stroke rates in NOBLE, the much higher stent thrombosis rates in NOBLE and the lack of considering periprocedural MI, I think biased the trial against PCI,” said Stone, professor of medicine at Columbia University, director of cardiovascular research and education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center, co-director of medical research and education at the Cardiovascular Research Foundation and a member of the Cardiology Today’s Intervention Editorial Board.
Complex disease
In a related editorial published in The Lancet, Michael Mack, MD, from Baylor Scott & White Health, Plano, Texas, and David R. Holmes, MD, from Mayo Clinic, wrote that patients in the study with more complex disease tended to do better with CABG, and “81% of the patients in NOBLE had bifurcation left main disease, which is more difficult to treat than ostial or trunk left main disease and might be associated with a worse outcome with PCI.”
Mack, a member of the Cardiology Today’s Intervention Editorial Board, and Holmes, a member of the Cardiology Today Editorial Board, said the take-home message might be that “If a patient is a good surgical candidate, CABG should remain the mainstay of treatment ... [but in] patients who are not good surgical candidates, PCI is a reasonable alternative to CABG, albeit with a higher incidence of subsequent clinical events.” – by Dave Quaile
References:
Christiansen EH, et al. Late-Breaking Clinical Trials 2. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2016; Washington.
Mack M, Holmes DR. Lancet. 2016;doi:10.1016/S0140-6736(16)32067-0.
Mäkikallio T, et al. Lancet. 2016;doi:1016/S0140-6736(16)32052-9.
Disclosure: The study was funded in part by Biosensors. Christiansen reports receiving grants from Biosensors to his institution. Holmes and Mack report no relevant financial disclosures. Stone reports relationships with multiple pharmaceutical and device companies.