COMMENTARY

Feb 21, 2020 This Week in Cardiology Podcast

John M. Mandrola, MD

Disclosures

February 21, 2020

Please note that the text below is not a full transcript and has not been copyedited. For more insight and commentary, subscribe to the This Week in Cardiology podcast.

Podcast Highlights

EXCEL Controversy

This week, the BBC Newsnight has aired a second program on EXCEL. Their title provokes the reader: Heart doctors “held back stent data” (see reference below).

Presumably using the same leaked dataset, Nick Freemantle explained that in 2016 when NEJM published the primary analysis of the 3-year data, the results were truncated at exactly 3 years—for all patients. But the trial started recruiting 5 years before in 2011. Thus, patients recruited early had longer follow-up than just 3 years. If you truncate data at 3 years, and someone dies at 3 years and one day, that death is not counted, even though it is known to those who have the data.

In the BBC article and video, Freemantle said he was appalled that the authors did this. Here is why: even at 3 years, there was a trend towards higher death in the PCI arm. It was not significant, but people were discussing it at the time. The next year, during a presentation at TCT (Transcatheter Cardiovascular Therapeutics), the trend in higher death in the PCI arm looked stronger at 4 years. And, of course we know at 5 years, death was statistically higher in the PCI arm. Freemantle’s point is that if they had not truncated all follow-up at 3 years, the trend at 3 years may have been more notable. (BBC reported that EXCEL authors said they followed the protocol and did nothing wrong).

The second point made in the newest BBC program was that they had seen information shared between people involved with the safety of the trial. This info suggested things were starting to look worse for PCI after 3 years. Get this: Dr Lars Wallentin, the head of the EXCEL safety committee wrote to the study authors: "It might be very concerning if in the future, suspicions were raised that already available information on mortality was withheld from the cardiology and thoracic surgery community."

The third point BBC made was that an external reviewer was brought in by the European Society of Cardiology to look at a number of trials and resolve the debate. Newsnight somehow has seen the review. The reviewer wrote” "I think most patients would find these differences to be clinically meaningful, I do not believe that both these procedures should receive the same class of recommendation."

The program reached out to Professor Ioannidis from Stanford who was highly critical of the conflicts of interest. "You have the same people who run the show at all levels. They design the trials. They set the agenda, they choose what to present. They are involved in disseminating the information and running the large conferences that are attended by tens of thousands of people, specialists in the field. And then they also populate the guideline panels that reach the recommendations,"

Finally, during the last 2 minutes of the video interview, which was shown in the UK, the BBC anchor interviews BMJ editor in chief Dr Fiona Godlee who was utterly and remarkably candid in criticizing the NEJM for how it handled EXCEL.

Reference

  1. Heart doctors 'held back stent death data'

Good News About GI Bleeding on Oral AC

In this real-world data base, a younger patient with a lower GI bleed while taking oral anticoagulation had a 24-fold greater risk of having colorectal cancer than a person who did not have a GI bleed. The rate was 12-fold higher for older patients who bled.

This a really important concept. Old teaching isn’t always proven wrong. Sometimes old teaching is proven right.

This is a worthy paper for medical education.

Wait, Medical Education Is the Next Topic!

This is huge news because this test of what one can recall about the first two years of basic science education in medical school has been used to select students for residency programs.

To the program directors who complain that it will be harder to select residents, I say, tough. Get over it. If you were using scores on this test to pick the best potential docs, you were doing it wrong.

Speaking of Being Bamboozled: Revascularization

The rates of PCI and CABG declined – a lot. The percentage of revascularization for (MI) increased in both the PCI group (22.8% to 53.1%) and in the CABG group (19.5% to 28.2%). However, risk-adjusted mortality for PCI either increased slightly or stayed steady; while CABG mortality declined significantly over the period.

Half of the data in this paper is not useful—the half that includes PCI.

The CABG part can be believed. Why? Because the dataset used comes from the Nationwide Inpatient database. All CABG surgery is done as an inpatient. So, good. Mortality is down. That’s probably a good sign—and it’s plausible: For heart surgery, myocardial protection is better along with more complete revascularization.

Nonetheless, there is room here for skepticism on surgical outcomes. Remember, there is a huge push to make patients sicker on paper. The mortality rate is risk adjusted. So good coding could potentially hide poor surgical outcomes.

Another potential explanation for declining CABG mortality is the unintended effect of surgeon scorecards. I’ve seen high risk patients simply turned down. This happens more now than it did in the past.

Now to the real problem: this paper cannot make any claims on PCI data. Why? Because huge amounts of PCI are done as an outpatient. This database looks only at inpatients.

You simply cannot study PCI by looking at inpatients.

Comments

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