Case and Plan:
77 year-old male with stable class II angina and exertional dyspnea was noted to have calcified 90-95% left internal carotid artery stenosis on carotid duplex for ongoing neurological symptoms. A Cardiac Cath on November 18, 2019 as the part of pre-op evaluation for carotid endarterectomy revealed calcified severe 2V (RCA and LCx) and 90% distal left main disease with SYNTAX Score of 26, LVEF 60% and moderate AS (MG 15 mmHg, AVA 1.2 cm2). After Heart Team discussion, CABG was declined due to ongoing neurological issues & moderate AS and PCI was recommended. Patient is now planned for IVUS guided high risk PCI of calcified distal LM using rotational atherectomy and single crossover stent approach.
Q What is the source of such big controversy about EXCEL?
A. It was all started by one of the earlier EXCEL investigator Dr David Taggart, claiming that definition of MI was changed to favor PCI after the conduct of trial. That clearly was false and Dr Taggart has retracted his claim now. Himself as well as European CT surgical committee continue to claim that not enough emphasis was done on higher mortality at 5-yrs observed in the PCI arm of EXCEL trial (not included as a separate statement in the conclusion of NEJM paper).
Q What is your opinion about the outcomes?
A. I personally believe that while overall primary endpoints were similar between PCI and CABG at 5-yrs in the EXCEL trial, a separate statement outlining the observed higher mortality in the PCI group should have been included in the conclusion section of abstract in the NEJM paper.
Q Is death not the most important parameter?
A. Absolutely agree that Death is the ultimate parameter in any trial and if different should be underscored and reported in the results and conclusion.
Q Has the NEJM failed in its oversight?
A. Apparently, it is the NEJM policy to present only the primary endpoint results in the conclusion. But I still think that NEJM reviewers should have forced the EXCEL authors to include a statement about higher PCI mortality in the conclusion section.
Q Are there lessons for sponsors from this controversy?
A. In this case Abbott Vasc inc, the main sponsor of the EXCEL trial is not directly involved in the controversy. Hence they are not at fault.
Q Are you planning more discussions about this controversy in future sessions?
A. Yes including few statements in our December webcast.
Q So, which LMCA should go for PCI?
A. LMCA pts with Syntax score below 32 and expectation of optimal angiographic results, should get PCI. Also more complex LM lesions with Syntax score above 32, who have multiple Co-morbidities (STS >5), are also appropriate for PCI after Heart team discussion.
Q And which for surgery?
A. Young patients (<65yrs) and complex LM lesion with high Syntax score and low STS score, are the ideal candidate for CABG.
Q For LMCA, should there not be skilled facilities with high volume of complex PCI, who should do such procedures?
A. I agree that complex LM lesions (calcified, bifurcation and additional 2-3 V CAD) should be done at a skilled tertiary care facility who performs >200 LM PCIs annually. This was emphasized by our Chinese investigators in the DK Crush V trial.
Q What is Dr. Stone's role at your facility? We thought he worked at Columbia.
A. Dr Gregg Stone has joined Mount Sinai Hospital as the full time faculty as of Sept 16, 2019. He no longer works at Columbia university hospital. He will continue to serve at CRF as the consultant and take active part in the TCT/CRF Trials.
EXACELLENT performance and good teaching tips for learners
I am always enjoyed watching cases and learned so may useful tips and helped in my daily practice in interventions