The TRAVERSE trial answered the big question: does testosterone therapy cause heart attacks? No. The FDA agreed and pulled its 2014 boxed warning in February 2025. End of story?
Not quite. On April 23, 2026, the Andrology journal published the European Expert Panel for Testosterone Research's full position statement on what TRAVERSE actually settled — and what it did not. The headline is reassuring, but the fine print matters: there is one cardiovascular signal TRAVERSE did detect, and the European panel is not letting it slip past unmentioned.
Key Takeaways
- European Expert Panel for Testosterone Research issued formal 2026 position statement in Andrology
- Confirms TRAVERSE finding: TRT does not increase heart attacks, strokes, or cardiovascular death
- Flags atrial fibrillation as a real signal: 3.5% vs 2.4% on placebo (p=0.02)
- Maintains European hematocrit intervention threshold at 54% (vs US AUA at 50% caution / 54% intervention)
- Emphasizes pulmonary embolism and acute kidney injury as secondary signals worth monitoring
- Endorses TRT for symptomatic hypogonadal men when properly selected and monitored
Who Wrote This and Why It Matters
The European Expert Panel for Testosterone Research is a working group of European andrology and endocrinology specialists organized to issue clinical consensus on testosterone-related questions. The 2026 statement was authored by a team led by Professor Michael Zitzmann (Centre for Reproductive Medicine and Andrology, University Hospital of Münster, Germany) along with Giulia Rastrelli, Robert D. Murray, and others.
This is not a new clinical trial. It is the European response to the TRAVERSE results plus subsequent meta-analyses — published as a synthesis document with practical recommendations for prescribers. In Europe, where hypogonadism prescribing has historically been more conservative than in the US, this statement effectively sets the tone for the next round of national guideline updates.
Why a European Statement After TRAVERSE?
TRAVERSE was a US-led trial conducted under FDA postmarketing requirements. European prescribers have used different formulations, different hematocrit thresholds, and a tighter definition of who qualifies for therapy. The panel's job was to translate TRAVERSE's findings into the European clinical context — and to flag what TRAVERSE did not put to rest.
What TRAVERSE Settled
The big numbers from TRAVERSE held up to European scrutiny.
| Endpoint |
TRT group |
Placebo |
Verdict |
| Major adverse cardiovascular events (MACE) |
7.0% |
7.3% |
Non-inferior |
| Cardiovascular death |
2.7% |
2.7% |
No difference |
| Nonfatal myocardial infarction |
1.8% |
2.1% |
No increase |
| Nonfatal stroke |
1.4% |
1.5% |
No increase |
The panel endorsed these findings without caveat. For the standard composite cardiovascular endpoints, testosterone therapy in appropriately selected hypogonadal men is non-inferior to placebo over roughly 27 months of follow-up.
This matters because the cardiovascular boxed warning that sat on testosterone product labels from 2014 to 2025 was based on far weaker observational data. The TRAVERSE-plus-meta-analysis evidence base now substantially exceeds the evidence that prompted the original warning.
What TRAVERSE Did Not Settle: The AFib Signal
This is the part of the statement that deserves attention. TRAVERSE pre-specified its primary endpoint as MACE. But it also tracked secondary endpoints, and one came back positive in the testosterone arm.
The Atrial Fibrillation Numbers
In TRAVERSE, atrial fibrillation occurred in 3.5% of testosterone-treated men versus 2.4% of placebo-treated men. That is a difference of 1.1 percentage points, statistically significant at p=0.02. Translated: for every roughly 90 men treated for about 2 years, there is one extra new AFib diagnosis attributable to testosterone.
The European panel did three things with this finding:
- Acknowledged it explicitly. They did not dismiss the signal as a chance secondary finding. Two independent lines of evidence — TRAVERSE plus separate observational data linking high-normal endogenous testosterone to AFib in older men — point in the same direction.
- Recommended pre-treatment screening. Men with prior AFib, structural heart disease, hypertension, or other arrhythmia risk factors warrant a more careful risk-benefit conversation before starting therapy.
- Did not recommend against TRT in patients with these risk factors. They recommended informed consent and closer monitoring, not exclusion.
If you are considering TRT and you have any history of palpitations, irregular heartbeat, or known arrhythmia, this is the conversation to have with your prescriber. A good clinic will know about this signal. If you want help finding one that does, our TRT clinic comparison and questions to ask your TRT clinic guides walk through what a thorough intake should look like.
Other Secondary Signals
The panel also called out two more findings that pooled meta-analyses have flagged:
- Pulmonary embolism. Slightly elevated in some pooled analyses, plausible biologically through the hematocrit-thrombosis pathway.
- Acute kidney injury. Modest signal in pooled data, mechanism unclear, may relate to hematocrit and viscosity.
Neither rises to the level of contraindication for most patients, but the panel asked clinicians to keep them on the radar in high-risk men.
Hematocrit: Where Europe and the US Quietly Disagree
The single most concrete clinical difference between European and American TRT practice is the hematocrit threshold. The European panel's 2026 position kept the European number where it has been.
| Threshold |
European guidance |
US (AUA) guidance |
| Caution / consider workup |
n/a |
50% |
| Intervention / discontinuation |
54% |
54% |
| Recommended monitoring |
Baseline, 3 months, 6 months, annually |
Baseline, 3 months, 6 months, annually |
Why does this matter? Because hematocrit is the single most common reason men have to interrupt or modify TRT, and where you draw the line determines how aggressive your clinic gets with dose changes, phlebotomy referrals, or pauses.
A US-trained prescriber may flag a hematocrit of 51% and tell you to drop your dose. A European-trained prescriber looking at the same number may simply recheck in 3 months. Neither is wrong — they are using different consensus thresholds. The European panel's 2026 statement reaffirmed 54% as the actionable line.
If you are on TRT, the practical takeaway is the same on both continents: get a CBC at baseline, 3 months, 6 months, and yearly thereafter. Our TRT bloodwork schedule covers what to test and when, and TRT polycythemia and hematocrit walks through what to do if your numbers climb.
What This Means for Patient Selection
The panel's bottom line on patient selection is more nuanced than "TRT is safe." It is closer to: TRT is safe for the right patient, monitored properly, and the criteria for "right patient" are tighter than they were before TRAVERSE.
Good Candidates
- Symptomatic hypogonadism with documented low testosterone on two morning measurements
- No active or recent major cardiovascular event (within 6 months)
- Hematocrit below 50% at baseline
- No active venous thromboembolism
- No active or untreated AFib
Patients Who Need a Closer Look
- History of atrial fibrillation or significant arrhythmia
- Baseline hematocrit between 50% and 54%
- Strong cardiovascular risk profile (uncontrolled hypertension, severe sleep apnea, recent MI)
- Prior unprovoked deep vein thrombosis or pulmonary embolism
- Active prostate cancer (separate consideration, not addressed in this statement)
For men in the second category, the panel's framing is that TRT is not off the table — it just needs more thorough informed consent, baseline workup, and closer follow-up.
How This Compares to Other Recent Evidence
The 2026 European position statement does not exist in a vacuum. It joins:
The European statement is the European synthesis. It does not contradict the others. It adds caution about AFib and reaffirms slightly tighter European patient-selection norms.
What to Do With This Information
If you are considering TRT, three practical things changed for you with this statement:
- Ask about AFib screening. A baseline ECG is reasonable for men over 50 or anyone with risk factors. Most clinics do not do this routinely. It is a fair ask.
- Know your baseline hematocrit. If yours is already at 50% before therapy, you should be having a conversation about why and whether starting now is the right move.
- Plan your follow-up. A clinic that wants to put you on TRT and then check labs once a year is not following any 2026 consensus. Get the 3-month and 6-month checks.
If you are already on TRT and well-monitored, this statement does not change what you should be doing. If you are on TRT and your prescriber checks labs once a year and never asked about your cardiovascular history, this is the statement to bring to your next visit.
Limitations of the Statement
Three things the statement does not resolve:
- Long-term outcomes. TRAVERSE ran for about 27 months. We still do not have good 10+ year cardiovascular data on testosterone therapy.
- The AFib mechanism. The signal is real, but the panel did not propose a definitive mechanism. Whether it is direct electrophysiologic effect, indirect via hematocrit and blood pressure, or unmasking of subclinical disease in older men remains open.
- Subgroup data. TRAVERSE was not powered to identify specifically which patients are at highest AFib risk. The recommendation to screen high-risk men is precaution-based, not evidence-graded.
The panel called for further research on each of these in their conclusion section.
Bottom Line
The 2026 European Expert Panel statement is the most recent, most senior European voice on testosterone cardiovascular safety. The verdict: yes, TRAVERSE settled the heart-attack-and-stroke question. No, it did not settle everything. The atrial fibrillation signal is real, the hematocrit thresholds matter, and patient selection still requires judgment.
For most symptomatic hypogonadal men, TRT remains an appropriate option with careful monitoring. The European panel agrees with the FDA's 2025 boxed warning removal. They just want clinicians to remember which signals are still on the table.
If you want to see how this safety framework translates into actual prescribing practice, our best online TRT clinics review covers which providers do thorough cardiovascular screening at intake — and which do not.
References
- Zitzmann M, Rastrelli G, Murray RD, et al. Cardiovascular safety of testosterone therapy—Insights from the TRAVERSE trial and beyond: A position statement of the European Expert Panel for Testosterone Research. Andrology. 2026;14(2):294-302. doi:10.1111/andr.70062
- Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023;389(2):107-117. (TRAVERSE primary results)
- Yeap BB, Marriott RJ, Antonio L, et al. Testosterone and the risk of incident atrial fibrillation in older men: further analysis of the ASPREE study. eClinicalMedicine. 2024.
- Lincoff AM, Bhasin S, Flevaris P, et al. Atrial fibrillation findings in TRAVERSE secondary endpoints. (As reviewed in the 2026 European position statement.)
- Mulhall JP, Trost LW, Brannigan RE, et al. Evaluation and Management of Testosterone Deficiency: AUA Guideline. (US hematocrit threshold reference, 2018, current edition.)
- Sahin O, Bhasin S, Frangos C, et al. Long-Term Cardiovascular Safety of Testosterone-Replacement Therapy in Middle-Aged and Older Men: A Meta-analysis of Randomized Controlled Trials. PubMed. PMID: 40694252.
- FDA. Boxed warning removal for testosterone products. February 2025 label revision.
- Corona G, Goulis DG, Huhtaniemi I, et al. European Academy of Andrology (EAA) guidelines on investigation, treatment and monitoring of functional hypogonadism in males. PMID: 32026626.