(UPDATED) The European Society of Cardiology and European Association for Cardio-Thoracic Surgery (ESC/EACTS) have agreed to review the latest evidence supporting their current revascularization recommendations for patients with left main coronary artery disease.
The decision adds yet another wrinkle to a yearlong and frequently hostile dispute between the surgical and interventional cardiology communities over the EXCEL trial, a study of PCI versus CABG for patients with left main CAD. That trial has come under repeated fire since one of the studys surgeons broke with the research team following a disagreement over the study findings.
The European Society of Cardiology and the European Association for Cardio-Thoracic Surgery have agreed to collaborate in reviewing the most up-to-date evidence for the treatment of patients with left main coronary artery stenosis as soon as it is available, according to a press release announcing the review. In particular, the organizations wish to review their joint guidelines in the light of emerging, longer-term outcome data from the trials of CABG vs PCI, and an independent patient-level meta-analysis of these trials that is currently under way. The two organizations will establish a robust and transparent process to review this new evidence.
Colin Baigent, BMBCh (University of Oxford, England), the chair of the ESC committee on practice guidelines, stressed the collaborative working relationship between the two organizations, adding that the soon-to-be assembled review committee will look in detail at all available studies of PCI versus CABG surgery in patients with left main CAD. The individual-patient-data meta-analysis, which is being conducted by an academic medical group outside the auspices of the ESC/EACTS review, includes EXCEL, NOBLE, SYNTAX, and PRECOMBAT. That meta-analysis will also be made available to the task force charged with reviewing the left main chapter of the 2018 ESC myocardial revascularization guidelines.
That will be able to give us a much clearer insight into the effects of treatment, not just according to the definitions of MI where the main discussion is at the moment but particularly the long-term outcomes, said Baigent. One of the concerns is that the survival curves crossed over in EXCEL at 5 years such that surgery was favored, he said, and the only way youre going to gain any more insight into the balance of benefit for a particular treatment is to carry on following people.
Under the ESC/EACTS guidelines on myocardial revascularization, which were published in 2018, both PCI and CABG are currently class IA recommendations for patients with left main CAD and a low SYNTAX score (0 to 22). CABG surgery is a class IA recommendation for all patients regardless of anatomical complexity, while PCI is only a class IIa recommendation in left main CAD patients with an intermediate SYNTAX score (23 to 32), meaning it can be considered given that the weight of evidence/opinion is in favor of usefulness/efficacy. In patients with highly complex anatomy (SYNTAX score 33), PCI is not recommended.
A Year On, Still Controversial
The firestorm surrounding EXCEL ignited last year when David Taggart, MD, PhD (University of Oxford, England), the chairman of the EXCEL surgical committee, accused the researchers of downplaying the risk of death with PCI and of concealing data. As a result, EACTS withdrew their support for the guidelines and have long called for an independent statistical review of the data underpinning the 2018 guidelines. Up until now, the ESC had said they stood by the treatment recommendations.
Taggart, who withdrew his name from the New England Journal of Medicine follow-up paper, faulted the EXCEL investigators for failing to publish the UDMI data, which was one of the studys secondary endpoints. In his opinion, the EXCEL group oversold the merits of PCI based on a composite primary endpoint that included a periprocedural MI definition skewed against surgery. On the heels of his presentation at EACTS, BBC Newsnight followed up with reporting showing that the risk of periprocedural MI was higher with PCI when the Universal Definition was used to ascertain events.
For their part, the EXCEL investigators have long contended they were unable to publish complete UDMI data because cardiac troponin measurementsthe preferred biomarker for the Universal Definitionwerent routinely collected. Just last week, the researchers published a long-anticipated analysis showing that the rates of periprocedural MI after PCI and CABG did indeed vary substantially depending on how infarctions were defined, and as such, so did the primary composite endpoint of death, stroke, and MI.
Overall, the rate of UDMI was significantly higher with PCI than with surgery, although the researchers reported that these events didnt translate into worse long-term outcomes. On the other hand, their protocol-defined MI endpoint, which combined the Society for Cardiovascular Angiography and Interventions (SCAI) definition for periprocedural MI and the Third Universal Definition for spontaneous MI, was prognostically significant, according to the EXCEL analysis.
To TCTMD, Baigent said that when revelations by the BBC Newsnight program first emerged, it was based largely on rumors and claims that the news organization had access to information that wasnt in the public realm. At the time, it wasnt sensible to act without concrete information, he said. Of course, whats happened since then is that weve had the publication of data from EXCEL that incorporates the Universal Definition of MI and we also have more long-term follow-up data, Baigent told TCTMD. I think the long-term follow-up data are really critical for understanding how to advise patients on what treatments are appropriate.
In addition, the meta-analysiswill help inform the review process. Lots of the discussion has been around EXCEL, but EXCEL is just half the data, said Baigent. We mustnt lose sight of the importance of looking at all the data, to make judgements based on the totality of the evidence, and to make sure all the issues about bias and so forth are considered by the panel. Then we can come up with a fresh, sober revised recommendation. It is entirely for the panel to decide if changes need to be made.
Baigent said the ESC/EACTS committee reviewing the data will include surgeons, interventionalists, general cardiologists, statisticians, and clinical epidemiologists, among others. The plan is to have a report completed by summer 2021.
Review Welcomed
Contacted by TCTMD, Taggart said he welcomes the new initiative. A collaborative review by the ESC/EACTS of the most up-to-date evidence will enhance the robustness of guideline recommendations and restore the confidence of heart teams in making recommendations to individual patients, he said in an email.
While the ESC/EACTS review is underway, the European organizations recommend treatment decisions for patients with left main CAD take into account all available published information. The organizations continue to recommend a discussion with the heart team and patient, as per the current clinical guidelines, for the best individualized treatment option.
Evald Christiansen, MD, PhD (Aarhus University Hospital, Denmark), who led the NOBLE trial, told TCTMD today that he and his colleagues are most happy to contribute with the NOBLE trial results for the revision of the guidelines and that they support the individual patient-level-data meta-analysis put forth by the ESC/EACTS. NOBLE was released at the same time as EXCEL in 2016 but found that CABG was superior to PCI at 5 years for a combined MACCE endpoint that did not include periprocedural MIs. He added that the yearlong EXCEL controversy has not been an issue in his everyday interactions with surgeons. We now have better and much stronger evidence for tailored decision-making at the heart team conference and to have the informed discussion with the patient, he said in an email.
In the US guidelines, CABG surgery alone has a class I indication for myocardial revascularization of left main CAD. PCI is considered a reasonable option (class IIa) in patients with favorable anatomy, such as a low SYNTAX score and ostial or trunk left main CAD, who are at higher risk of surgery. There is a class IIb recommendationmay be consideredfor patients with low-to-intermediate SYNTAX scores and a higher risk of surgical complications.
The rest is here:
ESC and EACTS Announce Review of Left Main Revascularization Guidelines - TCTMD
- Interventional Cardiology Fellowship - Massachusetts General Hospital ... - April 8th, 2018 [April 8th, 2018]
- Dr. Eric Lo - Daytona Beach FL, Interventional Cardiology - April 18th, 2018 [April 18th, 2018]
- Interventional Cardiology | Cardiology Associates of East ... - April 19th, 2018 [April 19th, 2018]
- ECU Interventional Cardiology Fellowship - May 26th, 2018 [May 26th, 2018]
- Interventional Cardiology | Knoxville Heart Group - June 6th, 2018 [June 6th, 2018]
- Interventional Cardiology Fellowship - Massachusetts ... - June 14th, 2018 [June 14th, 2018]
- Scottsdale Interventional Forum | Cardiology Conference ... - June 21st, 2018 [June 21st, 2018]
- Interventional Cardiology - Terumo Europe - August 12th, 2018 [August 12th, 2018]
- Interventional Cardiology Fellowship | Cardiovascular Fellowship - September 20th, 2018 [September 20th, 2018]
- Interventional > Cardiovascular Medicine | Internal Medicine ... - September 20th, 2018 [September 20th, 2018]
- Interventional Cardiology Journal | Peer reviewed Journal - September 24th, 2018 [September 24th, 2018]
- Interventional Cardiology | North Florida Regional Medical ... - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology | Department of Medicine ... - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology | Medical City Fort Worth - October 4th, 2018 [October 4th, 2018]
- Cardiology and Interventional Cardiology | Texas Tech ... - October 4th, 2018 [October 4th, 2018]
- Invasive & Interventional Cardiology Section | Cleveland Clinic - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology - Crozer-Keystone Health System - PA - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology - Florida Medical Clinic - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology | Heart Hospital of New Mexico - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology | ColumbiaDoctors - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiologist Jobs | Glassdoor - October 4th, 2018 [October 4th, 2018]
- What are Invasive, Non-Invasive, and Interventional Cardiology? - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology Fellowship | Internal Medicine - October 25th, 2018 [October 25th, 2018]
- Interventional Cardiology | Community Health Network - October 25th, 2018 [October 25th, 2018]
- Interventional Cardiology | Ohio State Medical Center - October 25th, 2018 [October 25th, 2018]
- Interventional Cardiology | Stanford Health Care - October 25th, 2018 [October 25th, 2018]
- Interventional Cardiology - Montefiore Medical Center - November 10th, 2018 [November 10th, 2018]
- Interventional Cardiologists near Brooklyn, NY - Healthgrades - November 10th, 2018 [November 10th, 2018]
- Cardiac Catheterization | Interventional Cardiology in New ... - November 20th, 2018 [November 20th, 2018]
- What are Invasive, Non-Invasive, and Interventional ... - November 27th, 2018 [November 27th, 2018]
- Dr. Jaffar A Raza - Secaucus NJ, Interventional Cardiology - November 30th, 2018 [November 30th, 2018]
- Interventional cardiology - Wikipedia - December 13th, 2018 [December 13th, 2018]
- Interventional Cardiology | St. Francis - December 21st, 2018 [December 21st, 2018]
- Interventional Cardiologists near Secaucus, NJ - Healthgrades - December 21st, 2018 [December 21st, 2018]
- Interventional Cardiology Conferences & Meetings - December 25th, 2018 [December 25th, 2018]
- Interventional Cardiology - Baylor Heart and Vascular Hospital - January 18th, 2019 [January 18th, 2019]
- Interventional Cardiology - nationwidechildrens.org - January 18th, 2019 [January 18th, 2019]
- General & Interventional Cardiology - WakeMed - January 18th, 2019 [January 18th, 2019]
- Interventional Cardiology - University of Mississippi Medical ... - January 18th, 2019 [January 18th, 2019]
- Interventional Cardiologists in Austin, TX | Austin Heart - February 22nd, 2019 [February 22nd, 2019]
- Interventional Cardiology | Sutter Health - February 22nd, 2019 [February 22nd, 2019]
- Interventional Cardiology - St. Mary's Hospital and Health ... - February 22nd, 2019 [February 22nd, 2019]
- London & Milan - Cardiology Fellowships - February 22nd, 2019 [February 22nd, 2019]
- Interventional Cardiology | Saint Luke's Health System - February 22nd, 2019 [February 22nd, 2019]
- Interventional Cardiology | American Medical Association - February 22nd, 2019 [February 22nd, 2019]
- Interventional Cardiology | Piedmont Heart Institute ... - March 12th, 2019 [March 12th, 2019]
- Interventional Cardiology | UCSF Cardiology - March 18th, 2019 [March 18th, 2019]
- If You Are Referred to an Interventional Cardiologist - April 1st, 2019 [April 1st, 2019]
- Cardiology and Interventional Medicine | Veterinary ... - April 5th, 2019 [April 5th, 2019]
- Interventional Cardiology | AdventHealth Cardiovascular ... - May 11th, 2019 [May 11th, 2019]
- APSIC - Asian Pacific Society of Interventional Cardiology - May 13th, 2019 [May 13th, 2019]
- Interventional Cardiology | UNC REX Healthcare | Raleigh ... - May 20th, 2019 [May 20th, 2019]
- Interventional Cardiology - montefiore.org - May 20th, 2019 [May 20th, 2019]
- Women and heart health: Heart attack signs and symptoms to know about - The Indian Express - September 26th, 2019 [September 26th, 2019]
- Tiara for Treatment of Mitral Regurgitation and Neovasc Reducer for Treatment of Refractory Angina to be Featured at TCT 2019 Conference - Canada... - September 26th, 2019 [September 26th, 2019]
- TherOx to Present on SuperSaturated Oxygen (SSO2) at TCT2019 Next Week - BioSpace - September 26th, 2019 [September 26th, 2019]
- Too tired? it can indicate heart failure - The New Indian Express - September 26th, 2019 [September 26th, 2019]
- Blue Sail Medical and Biosensors International enter the Structural Heart market with the acquisition of Switzerland based NVT AG. content= - PR... - September 26th, 2019 [September 26th, 2019]
- Global Diagnostic Interventional Cardiology Instruments Market forecast by 2025 : Numerous tactics accepted by industry participants in a bid to... - September 26th, 2019 [September 26th, 2019]
- UMA's Complete Conference Management Hosts "Full Spectrum of Heart Failure Therapy: Optimizing Outcomes" - Yahoo Finance - September 26th, 2019 [September 26th, 2019]
- Meet the best cardiologists at King's Interactive Heart Health Morning - Gulf News - September 26th, 2019 [September 26th, 2019]
- Lights, camera, action in Varnville - Bluffton Today - September 26th, 2019 [September 26th, 2019]
- Health Pro: Cardiologist takes pleasure in getting patients back on their feet - Florida Today - September 26th, 2019 [September 26th, 2019]
- From Ceiling Suspension to Eye-Tracking: Innovation Continues for Cath Lab Radiation Protection - TCTMD - September 26th, 2019 [September 26th, 2019]
- Robocath Successfully Carries Out Its First Robotic Coronary Angioplasties in Humans - TCTMD - September 26th, 2019 [September 26th, 2019]
- SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in ABIOMED, Inc. of Class Action Lawsuit and Upcoming... - September 28th, 2019 [September 28th, 2019]
- Study links childhood obesity with screen time - The Hindu - September 28th, 2019 [September 28th, 2019]
- Tiara for Treatment of Mitral Regurgitation and Neovasc Reducer for Treatment of Refractory Angina to be Featured at TCT 2019 Conference - BioSpace - September 28th, 2019 [September 28th, 2019]
- Five Atlantic Health System Team Members Lauded by NJ American Heart Association for Life-Saving Measures - TAPinto.net - September 28th, 2019 [September 28th, 2019]
- World Heart Day 2019: Cardiovascular Disease Is The World's Biggest Killer And Claims More Than 17.5 Million Lives - Outlook India - September 28th, 2019 [September 28th, 2019]
- Consulting Cardiologists Brings Exceptional Care to Heart of WH - Patch.com - September 28th, 2019 [September 28th, 2019]
- Diagnostic Interventional Cardiology Devices Market 2019| Global Forecast to 2026 with Key Players- B. Braun Medical, Boston Scientific, Cook Medical,... - September 28th, 2019 [September 28th, 2019]
- Surmodics Inc. (SRDX) and Its Competitors Comparing side by side. - MS Wkly - October 17th, 2019 [October 17th, 2019]
- Global Price, Sales and Revenue Analysis of Diagnostic Interventional Cardiology Devices Market by Regions, Manufacturers, Types and Applications -... - October 17th, 2019 [October 17th, 2019]
- Global Interventional Cardiology Devices Market Study by Price, Type and Application, Statistical Forecast and Competitive Landscape Research upto... - October 17th, 2019 [October 17th, 2019]
- Global Interventional Cardiology Market Report, Trends, CAGR Standing, Analysis and Forecasts (2019-2025) | Key Companies BIOTRONIK SE & Co.... - October 17th, 2019 [October 17th, 2019]
- Interventional Cardiology Market 2019 to Flourish with an Impressive CAGR of XX% in the year 2024, Predicts Market Research Future According to... - October 17th, 2019 [October 17th, 2019]
- FDA Approves Coronary ViperWire Advance With Flex Tip - Diagnostic and Interventional Cardiology - October 23rd, 2019 [October 23rd, 2019]
- Teleflex Announces Third Quarter 2019 Earnings Conference Call Information Live Webcast is scheduled at 8:00 am (ET) on Thursday, October 31, 2019 -... - October 23rd, 2019 [October 23rd, 2019]
- Global Interventional Cardiology Devices Market Analysis and CAGR during the Forecasting years of 2019-2025. - Air News Paper - October 23rd, 2019 [October 23rd, 2019]