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Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial.

Monday, November 7, 2016

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Author(s)

Mäkikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, Trovik T, Eskola M, Romppanen H, Kellerth T, Ravkilde J, Jensen LO, Kalinauskas G, Linder RB, Pentikainen M, Hervold A, Banning A, Zaman A, Cotton J, Eriksen E, Margus S, Sørensen HT, Nielsen PH, Niemelä M, Kervinen K, Lassen JF, Maeng M, Oldroyd K, Berg G, Walsh SJ, Hanratty CG, Kumsars I, Stradins P, Steigen TK, Fröbert O, Graham AN, Endresen PC, Corbascio M, Kajander O, Trivedi U, Hartikainen J, Anttila V, Hildick-Smith D, Thuesen L, Christiansen EH; NOBLE study investigators.

This is a prospective, randomised, open-label, non-inferiority trial comparing CABG versus PCI in patients with unprotected left main stenosis. The study was carried out at 36 hospitals in Latvia, Estonia, Lithuania, Germany, Norway, Sweden, Finland, the UK, and Denmark.  In total, 1201 patients were randomly assigned, 598 to PCI and 603 to CABG, and 592 in each group entered analysis by intention to treat up to 5 years of follow up. Interestingly, only 8% of the patients in the CABG group had the right internal mammary artery used as a graft (93% had the left ITA used). The primary endpoint was a composite of major adverse cardiac and cerebrovascular events (MACCE; death from any cause, non-procedural myocardial infarction,14 repeat revascularisation, or stroke). The key findings of the NOBLE study are that CABG was better than PCI for the composite endpoint of MACCE; all-cause mortality was similar between the two groups; non-procedural myocardial infarction and need for repeat revascularisation were increased after PCI; a higher rate of stroke was observed in the CABG group after 30 days than in the PCI group, but an unexpected, numerically higher rate of stroke was found in PCI-treated patients in 5 year estimates; maximum angina pectoris score was higher after PCI at up to 5 years follow-up.

Comments

Congratulations to The Lancet for publishing robust evidence on the dire limitations of catheter- coronary revascularisation. Until such time though that the compelling evidence is cascaded to the frontline of primary angioplasty and coronary MDT's, the evidence will remain of academic interest and will not improve patient outcomes.
Congratulations to The Lancet for publishing robust evidence on the dire limitations of catheter- coronary revascularisation. Until such time though that the compelling evidence is cascaded to the frontline of primary angioplasty and coronary MDT's, the evidence will remain of academic interest and will not improve patient outcomes.
I think is important to do a prospective, randomised, open-label, non-inferiority trial comparing PCI with a simple mammary to LAD operation off pump like MIDCAB or MINI OPCAB, in isolated low risk main left stenosis
When you do any trial also is important to point the specific type of coronary operation because is not the same CABG that OPCAB without touching the aorta in relation of the incidence of stroke
Also instead of compare PCI Vs CABG we need to do more trials between Hybrid (Mammary to LAD MIDCAB or MINI OPCAB operations for LIMA to LAD plus stents in the others arteries) vs conventional CABG and try to use more the best of the two worlds

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