The bottom line in one paragraph
TRT cardiovascular risk in 2026 looks meaningfully different from TRT cardiovascular risk in 2022. The TRAVERSE trial (Lincoff et al., New England Journal of Medicine, 2023, DOI 10.1056/NEJMoa2215025) closed the headline question — does testosterone raise major adverse cardiovascular events (MACE) in middle-aged hypogonadal men with pre-existing CV risk on transdermal gel — with a non-inferiority answer. What has been published since is the more useful clinical content. The European Expert Panel position statement (issued through the European Academy of Andrology and the European Society of Endocrinology), the TRAVERSE older-men and bone subgroup analyses, several 2024–2025 commentaries in JAMA Cardiology and Circulation, and the AUA 2024 amendment to its testosterone deficiency guideline together reframe the conversation around three narrower signals — atrial fibrillation, venous thromboembolism, and erythrocytosis — that TRAVERSE flagged but did not resolve. This article walks through what is genuinely new since TRAVERSE, how the European Panel codifies risk stratification, and what practical monitoring looks like in 2026.
For the original TRAVERSE primary analysis, see the standalone TRAVERSE trial explained post. For the fracture signal from the same parent trial, see the TRAVERSE bone substudy article. This post focuses on what the cardiovascular literature has added after TRAVERSE.
Educational disclaimer: This article synthesizes peer-reviewed clinical research and current professional guidance for educational purposes. It is not medical advice, not a substitute for evaluation by a licensed clinician, and not a recommendation for or against testosterone therapy. Cardiovascular risk on TRT is individualized. Decisions about starting, continuing, modifying, or stopping therapy should be made with your prescriber based on your full history, current labs, and clinical picture.
Where the evidence stood after TRAVERSE
The June 2023 TRAVERSE publication was a regulatory and clinical inflection point. The randomized, double-blind, placebo-controlled trial enrolled 5,246 men aged 45 to 80 with hypogonadism and either established cardiovascular disease or high cardiovascular risk. Participants received either 1.62% transdermal testosterone gel titrated to 350–750 ng/dL or matching placebo for a mean of approximately 33 months. The pre-specified primary composite MACE endpoint (cardiovascular death, nonfatal MI, nonfatal stroke) occurred in 7.0% of the testosterone arm versus 7.3% of placebo (hazard ratio 0.96, 95% CI 0.78–1.17). Testosterone met the pre-specified non-inferiority margin of 1.5.
That result tempered — but did not erase — the 2015 FDA cardiovascular warning. It cleared the regulatory hurdle the FDA had set in 2015 when it added the cardiovascular risk warning to testosterone product labels in response to the Vigen JAMA 2013 and Finkle PLOS ONE2014 observational signals. The FDA updated testosterone labeling in early 2024 to reflect the TRAVERSE primary finding while retaining VTE warnings consistent with the trial's secondary signals.
What TRAVERSE flagged but did not resolve
The 2023 primary publication itself called out three secondary findings that have driven most of the post-publication conversation:
- Pulmonary embolism: 0.9% in the testosterone arm vs 0.5% in placebo — roughly a doubling of relative risk on a low baseline.
- Atrial fibrillation: 3.5% vs 2.4% — roughly one additional AFib case per 100 men over three years.
- Acute kidney injury: 2.3% vs 1.5% — clinically meaningful in men with baseline renal dysfunction.
None of these moved the MACE composite enough to fail the primary endpoint. All three carry biological plausibility. All three have driven the post-TRAVERSE commentary literature.
Conceptual schematic based on Lincoff et al., NEJM 2023, and the European Expert Panel position statement.
The European Expert Panel position statement
The European Expert Panel position statement on testosterone therapy and cardiovascular safety was developed under the European Academy of Andrology (EAA) and the European Society of Endocrinology, with contributing authors including Giovanni Corona, Mario Maggi, and other European andrology and endocrinology leaders. It is the most detailed post-TRAVERSE synthesis published by a major society, and it is the document that several 2024–2025 commentaries in JAMA Cardiology, Circulation, and European Heart Journal have used as a reference framework.
What the European Panel does that TRAVERSE alone does not
TRAVERSE is a single randomized trial reporting one primary endpoint and a handful of pre-specified secondary endpoints. A position statement is a different document type — it integrates randomized data, observational meta-analyses, mechanistic evidence, and clinical experience into a working framework for prescribers. The European Expert Panel position statement does five things TRAVERSE alone cannot.
- It places TRAVERSE inside the broader RCT and observational literature. The Panel weighs TRAVERSE against the Testosterone Trials (Snyder et al., NEJM 2016, PMID 26886521), the TEAAM trial (Basaria et al., JAMA 2015, PMID 26284720), the TOM trial (Basaria NEJM 2010, PMID 20592293), and meta-analyses including Corona et al. European Journal of Endocrinology.
- It codifies a risk-stratified monitoring framework. The Panel provides specific recommendations for baseline AFib screening, baseline VTE risk assessment, hematocrit thresholds, blood pressure follow-up cadence, and reassessment intervals.
- It addresses route extrapolation explicitly. The Panel flags transdermal-versus-intramuscular as an open question and counsels route-specific caution.
- It integrates OSA, obesity, and metabolic context. Because obstructive sleep apnea worsens both AFib and erythrocytosis risk, the Panel makes OSA screening more prominent than the original Endocrine Society 2018 guideline did.
- It articulates when to pause therapy. Specific triggers — new AFib, confirmed VTE, hematocrit ≥54%, decompensated heart failure, recent MI — are enumerated as evaluation events rather than absolute discontinuations.
What the Panel does not do
The European Expert Panel position statement is not a clinical practice guideline in the strict sense. It does not carry the formal GRADE evidence ratings of the Endocrine Society 2018 guideline (Bhasin et al., JCEM 2018, DOI 10.1210/jc.2018-00229) or the AUA 2018/2024 guideline (Mulhall et al.). It is consensus expert opinion synthesized from the published evidence. That distinction matters when prescribers and regulators consider strength of recommendation, but the practical content is the most coherent framework currently available for 2026 cardiovascular monitoring on TRT.
European Panel vs TRAVERSE — what is genuinely new
The table below summarizes the deltas. TRAVERSE answered one prospective question definitively. The European Panel takes the broader literature and converts it into operational recommendations.
| Topic | TRAVERSE (2023) position | European Expert Panel (post-TRAVERSE) position |
|---|---|---|
| MACE composite | Non-inferior to placebo in studied population (HR 0.96, 95% CI 0.78–1.17) | Reassuring; population- and route-specific; not extrapolated to all men |
| Atrial fibrillation | Numerical increase: 3.5% vs 2.4% over ~33 months | Explicit baseline AFib screening recommended; higher caution in men >65 and those with OSA |
| Venous thromboembolism | PE 0.9% vs 0.5%; flagged as adverse event of special interest | Personal/family VTE history elicited at baseline; thrombophilia considered; closer monitoring in high-risk men |
| Hematocrit threshold | Did not set a threshold; reported lab data | Endorses ≥54% as pause/dose-reduction threshold; treats erythrocytosis as amplifier of AFib + VTE risk |
| Delivery route | 1.62% transdermal gel only | Route extrapolation flagged as open; route-specific caution for high-peak injection protocols |
| OSA and CV risk | Not a pre-specified focus | OSA screening integrated as CV risk amplifier; STOP-BANG or polysomnography in high-risk men |
| Pause/discontinue triggers | Not codified in the primary paper | Enumerated: new AFib, confirmed VTE, Hct ≥54%, decompensated HF, recent MI |
| Monitoring cadence | Trial protocol — not generalized guidance | Baseline, 3-month, 6-month, then annual minimum; tighter in high-risk subgroups |
What "position statement" really means: A position statement carries less formal evidentiary weight than a GRADE-graded clinical practice guideline, but more practical specificity than a single trial report. The European Expert Panel statement is best read as how leading European andrologists and endocrinologists are operationalizing TRAVERSE — not as a regulatory pronouncement.
The atrial fibrillation signal in 2026
The AFib finding in TRAVERSE — 3.5% on testosterone vs 2.4% on placebo, hazard ratio approximately 1.49 with confidence intervals consistent with a real effect — was the most-discussed secondary signal in the post-publication literature. Three published analyses since 2023 have refined the interpretation.
The age subgroup pattern
Subgroup analyses of TRAVERSE participants by age decade, presented in conference proceedings and discussed in the European Expert Panel statement, suggest the absolute AFib excess is concentrated in men over 65 with pre-existing risk factors. In younger men with hypogonadism and no atrial disease at baseline, the absolute AFib increase is smaller. This is consistent with the broader cardiology literature: AFib incidence climbs steeply with age, and any modest pro-arrhythmic effect of testosterone is more clinically meaningful when baseline risk is already elevated. Our TRT for older men after 65 article discusses this subgroup in detail.
The OSA overlap
Obstructive sleep apnea is an independent risk factor for both AFib and erythrocytosis. Untreated OSA is a known AFib trigger in the cardiology literature (Gami et al., Journal of the American College of Cardiology, multiple studies). Testosterone can worsen OSA in susceptible men, particularly during dose titration. The European Panel makes the OSA–AFib link more explicit than prior U.S. guidance and recommends STOP-BANG screening at baseline and consideration of polysomnography in high-risk men. Our TRT and sleep apnea article covers the OSA mechanism in depth.
The hematocrit and blood pressure pathway
Even in men without diagnosable OSA, the combination of rising hematocrit, rising blood pressure, and potential direct androgen effects on atrial electrophysiology gives the AFib signal mechanistic plausibility. The European Panel framework treats AFib screening and hematocrit monitoring as linked rather than separate exercises.
Mechanistic schematic synthesized from Lincoff et al., NEJM 2023 and the European Expert Panel position statement. Mechanism is candidate, not proven.
The VTE and pulmonary embolism signal in 2026
The TRAVERSE PE finding — 0.9% testosterone vs 0.5% placebo, with a relative risk roughly twice baseline — has been reinforced rather than diluted by post-publication analysis. The U.S. and European labels carry VTE warnings. The European Expert Panel position statement treats VTE risk assessment as a baseline requirement before initiating TRT.
What VTE history actually means at baseline
Most TRT prescribers in 2026 elicit four pieces of information at the initial visit relevant to VTE risk:
- Prior unprovoked DVT or PE. This is the strongest individual contraindication or relative contraindication, depending on framework.
- Prior provoked DVT or PE in a high-risk setting. Post-surgical or immobilization-associated events carry different implications than unprovoked events.
- Family history of unprovoked VTE in a first-degree relative. Raises suspicion of thrombophilia and may trigger screening for factor V Leiden, prothrombin G20210A, or other inherited conditions.
- Active VTE risk factors. Smoking, severe obesity, certain hormonal medications, malignancy, recent major surgery, prolonged immobilization.
The European Panel does not categorically exclude TRT in men with provoked prior VTE who are no longer in a high-risk window, but it raises the threshold for shared decision-making and recommends tighter hematocrit monitoring throughout therapy.
The hematocrit-VTE mechanistic link
Rising hematocrit increases blood viscosity, which is a recognized risk factor for venous thromboembolism in both the cardiology and andrology literature. Testosterone is a known stimulator of erythropoiesis, and intramuscular injection protocols typically produce larger hematocrit increases than transdermal gel. This is the most concrete mechanistic link between TRT and the TRAVERSE PE signal, and it is the reason hematocrit monitoring is the central operational lever in 2026 cardiovascular risk management. Our hematocrit on TRT deep dive walks through phlebotomy, dose reduction, and frequency-split protocols.
Hematocrit thresholds and erythrocytosis amplification
The Endocrine Society 2018 clinical practice guideline (Bhasin et al., JCEM, DOI 10.1210/jc.2018-00229) set 54% as the hematocrit threshold for therapeutic action — pause or reduce testosterone, address modifiable contributors, consider phlebotomy if clinically indicated. The European Expert Panel position statement reaffirms 54% as the operational threshold for 2026.
Why 54%
The 54% number is not arbitrary. It derives from blood donor and observational cohort studies showing inflection points in viscosity-related events at and above that range. It is a guideline-codified threshold, not a randomized trial endpoint. Some clinicians operate at stricter thresholds in high-risk men:
- 52% threshold in men with established cardiovascular disease, prior MI, or high baseline stroke risk.
- 50% threshold in men with prior AFib, prior VTE, or strong family history of unprovoked thromboembolism.
- Standard 54% threshold in men with no individual risk-amplifying history.
These stricter operating numbers are not codified in any single guideline document; they reflect risk-stratified clinical practice as discussed in the European Panel framework and post-TRAVERSE commentary in cardiology journals.
What to do when hematocrit climbs
Four operational levers exist in 2026, used in roughly this order:
- Address modifiable contributors. Treat or document OSA, reduce smoking, optimize hydration, review iron supplementation and androgen co-administration.
- Split the dose / change frequency. Moving from once-weekly to twice-weekly or three-times-weekly intramuscular dosing reduces peak-to-trough variation and often reduces erythrocytosis. Transdermal gel typically raises hematocrit less than injections.
- Reduce the dose. Lowering weekly total testosterone almost always lowers hematocrit, though it may sacrifice some symptom benefit.
- Therapeutic phlebotomy. Performed by a clinician for documented erythrocytosis at or above threshold. Distinct from voluntary Red Cross blood donation in the U.S., which has eligibility requirements unrelated to TRT.
What changed since 2018: The 54% threshold has not moved, but the framing has. In 2018, hematocrit was treated as a polycythemia management issue. Post-TRAVERSE and post-European-Panel, hematocrit is increasingly framed as a downstream amplifier of the AFib and VTE risks identified in the trial. The threshold is the same; the clinical urgency around enforcing it has tightened.
TRAVERSE subgroup analyses published since 2023
Three substantive secondary analyses have come out of the TRAVERSE dataset since the primary publication. Each refines a specific question the 2023 paper raised but did not resolve.
Older-men subgroup
Subgroup analyses comparing men 65 and older to men 45–64 in TRAVERSE indicate the absolute event rates for AFib, VTE, and acute kidney injury were higher in the older group on both arms, with the relative testosterone-versus-placebo differences broadly preserved. The MACE non-inferiority result held across age strata. The clinical takeaway: TRT cardiovascular safety in men over 65 is not categorically worse than in younger men by the MACE measure, but absolute risk of secondary events is meaningfully higher because baseline risk is higher. Our TRT for older men after 65 article covers this subgroup in detail.
Bone substudy (Snyder et al., NEJM 2024)
The TRAVERSE bone substudy (Snyder et al., NEJM 2024, DOI 10.1056/NEJMoa2308836) reported more clinical fractures on testosterone (3.50% vs 2.46%, HR 1.43, 95% CI 1.04–1.97) despite reassuring imaging-based BMD data from the older Testosterone Trials. The fracture signal is not strictly a cardiovascular outcome, but it factors into the overall risk-benefit conversation and is covered in the dedicated TRAVERSE fracture risk article.
Sexual function and quality-of-life endpoints
Secondary analyses of sexual function, libido, mood, and physical function from the TRAVERSE participants — building on the framework first established by the Testosterone Trials (Snyder et al., NEJM 2016, PMID 26886521) — generally support symptomatic benefit in men with confirmed hypogonadism. These are positive findings for the overall risk-benefit calculus but do not change the cardiovascular monitoring framework.
Delivery route and the open question on injections
TRAVERSE tested 1.62% transdermal testosterone gel. It did not test intramuscular cypionate or enanthate, subcutaneous injection protocols, oral testosterone undecanoate (Jatenzo, Kyzatrex, Tlando), or pellet therapy. The European Expert Panel position statement explicitly identifies route extrapolation as an unresolved question.
Why route matters mechanistically
Intramuscular cypionate or enanthate produces serum testosterone profiles with significantly higher peaks 24–72 hours post-injection than transdermal gel at equivalent weekly doses. Higher peaks correlate with larger hematocrit rises in the published comparative pharmacokinetic literature. Because the most plausible mechanistic link from TRAVERSE to the AFib and VTE signals is the hematocrit pathway, the same dose-equivalent of intramuscular testosterone may carry a different cardiovascular risk profile than gel.
What the data do and do not show
No randomized cardiovascular safety trial of intramuscular testosterone at the scale of TRAVERSE has been completed or published. Observational and registry data on injection users are confounded by the selection issues that contaminated the original Vigen and Finkle analyses. The European Panel framework treats injection users with route-specific caution — closer hematocrit surveillance, more aggressive dose-frequency optimization, and stricter operating thresholds in men with baseline cardiovascular risk — but does not categorically discourage injections.
Oral testosterone undecanoate
The newer oral testosterone undecanoate products — Jatenzo, Kyzatrex, and Tlando — were not part of TRAVERSE either, but their pivotal FDA trials documented a blood pressure signal of approximately 4–5 mmHg ambulatory systolic that is now part of their product labels. The cardiovascular signal for oral TU is therefore route-specific and BP-mediated rather than VTE-mediated, and is covered in the dedicated oral TRT comparison article.
Older men, pre-existing CV disease, and OSA overlap
The 2026 European Panel framework gives more attention to overlapping comorbidities than the original Endocrine Society 2018 guideline did. Three populations get specific framing.
Men over 65
Older men carry baseline AFib and VTE risk that climbs steeply with each decade. TRAVERSE subgroup data support TRT cardiovascular safety on the MACE composite in this group, but the absolute number of AFib and VTE events is higher. The Panel recommends explicit AFib screening at baseline (resting ECG, possibly extended Holter monitoring in higher-risk men), VTE history review, and tighter hematocrit thresholds. Our TRT after 65 pillar covers the full subgroup analysis.
Men with pre-existing cardiovascular disease
TRAVERSE explicitly enrolled men with established CVD or high CV risk. The MACE non-inferiority result therefore directly addresses this population — which is the population most clinicians historically worried about most. Pre-TRAVERSE, many cardiologists counseled against TRT on principle in men with a prior stent, prior MI, or stable angina. Post-TRAVERSE, the conversation has shifted toward individualized risk-benefit, with tighter monitoring rather than categorical avoidance. Recent MI within 3–6 months remains a near-universal contraindication.
Men with obstructive sleep apnea
OSA independently raises AFib and erythrocytosis risk, and testosterone can worsen OSA in susceptible men. The European Panel recommends STOP-BANG screening at baseline and consideration of polysomnography in men with high screening scores or symptoms. CPAP compliance is increasingly viewed as part of cardiovascular risk management on TRT rather than a separate pulmonary issue. Our TRT and sleep apnea article covers screening and CPAP overlap in detail.
What the AUA, Endocrine Society, and FDA added since 2024
The major U.S. bodies and the FDA itself have moved post-TRAVERSE. None has reversed any pre-existing caution. Each has refined the framework.
AUA 2024 amendment
The American Urological Association amended its 2018 testosterone deficiency guideline in 2024 (Mulhall et al.) to incorporate TRAVERSE as supportive evidence for cardiovascular safety in selected hypogonadal men with pre-existing cardiovascular risk. The amendment retained baseline cardiovascular risk assessment and ongoing hematocrit monitoring. It did not lift the recent-MI exclusion or modify the decompensated heart failure contraindication.
Endocrine Society practice updates
The Endocrine Society's 2018 clinical practice guideline (Bhasin JCEM 2018, DOI 10.1210/jc.2018-00229) predates TRAVERSE. Subsequent practice updates and society commentaries treat TRAVERSE as MACE-reassuring while retaining the 54% hematocrit threshold and adding explicit framing around AFib screening and VTE history. The Society has not yet released a fully revised guideline integrating TRAVERSE, but its practice positions are consistent with the European Panel framework.
FDA label updates (2024)
In early 2024, the FDA updated U.S. testosterone product labeling to reflect the TRAVERSE findings. The revised labels temper the 2015 cardiovascular warning language regarding MACE while retaining specific warnings about venous thromboembolism. This is a measured, evidence-aligned label evolution. The label change does not eliminate the requirement for prescribers to evaluate cardiovascular risk before initiating therapy.
European bodies and international convergence
The European Association of Urology (EAU) has issued commentaries broadly consistent with the European Expert Panel position statement. The Endocrine Society of Australia and several national andrology societies have published parallel synthesis documents. The 2026 international picture is convergence on a single framework: MACE-reassuring within studied population and route, AFib and VTE as active monitoring targets, hematocrit as operational lever, and risk stratification rather than population-level prescribing decisions.
Practical CV monitoring framework for 2026
Synthesizing the European Panel position statement, the AUA 2024 amendment, the Endocrine Society 2018 guideline with practice updates, and the post-TRAVERSE commentary literature, a working 2026 cardiovascular monitoring framework for TRT looks like the following. This is a synthesis of guideline content, not a prescription — every protocol is individualized by the prescriber.
Baseline (before initiating TRT)
- Cardiovascular history: prior MI, stroke, AFib, VTE, heart failure, peripheral artery disease.
- Family history: unprovoked VTE in first-degree relatives, premature CAD, AFib.
- Risk factor inventory: hypertension, diabetes, hyperlipidemia, smoking, obesity, OSA symptoms.
- Baseline labs: CBC including hematocrit, lipid panel, comprehensive metabolic panel including renal function.
- Cardiac evaluation: resting ECG; STOP-BANG sleep apnea screen; consider polysomnography in high-risk men.
- Blood pressure: documented control before initiation.
3-month and 6-month follow-up
- Hematocrit recheck — the single most important lab on the CV monitoring panel. Target <54%; stricter in high-risk men.
- Total and free testosterone — for dose titration and to confirm therapeutic range. Our TRT blood work schedule covers timing by ester.
- Blood pressure check at the same visit cadence.
- Symptom inventory for new palpitations, dyspnea, chest pain, calf swelling (DVT screening).
- Estradiol if symptomatic — covered in our estradiol on TRT article.
- PSA at 6 months for men over 40, per AUA guidance — see our PSA on TRT deep dive.
Annual surveillance (year 2 and beyond)
- Hematocrit, lipid panel, metabolic panel, PSA, total/free testosterone.
- Cardiovascular symptom review.
- Blood pressure documentation.
- Reassessment of OSA status if previously flagged.
- Reassessment of indication and benefit — does the patient still derive symptomatic benefit warranting continued therapy?
Pause or evaluate immediately if
- New-onset atrial fibrillation.
- Confirmed deep vein thrombosis or pulmonary embolism.
- Hematocrit at or above 54% without a reversible cause.
- Hospitalization for decompensated heart failure.
- Acute MI or stroke (typical pause of 3–6 months minimum).
- Uncontrolled hypertension that does not respond to standard management.
Synthesized from Endocrine Society 2018 (Bhasin JCEM, DOI 10.1210/jc.2018-00229), AUA 2018/2024 amendment (Mulhall), the European Expert Panel position statement, and TRAVERSE (Lincoff NEJM 2023). Specific cadence should be individualized by the prescriber.
What the 2026 evidence still does not settle
TRAVERSE plus the European Expert Panel position statement and the post-TRAVERSE commentary literature represent the most coherent cardiovascular safety framework available to date. The picture is still incomplete in five specific ways.
1. Long-term safety beyond five years
Mean follow-up in TRAVERSE was approximately 33 months. TRT is typically lifelong. Cardiovascular outcomes at 10, 15, or 20 years of continuous testosterone exposure are not characterized by any randomized data. Observational registry studies are accumulating but carry the usual confounders.
2. Cardiovascular safety in men under 45
TRAVERSE enrolled men aged 45–80. A growing clinical population of men in their 20s, 30s, and early 40s on TRT is not represented in any large randomized cardiovascular safety dataset. Extrapolation from the older cohort is not straightforward.
3. Cardiovascular safety in low-risk men
TRAVERSE required either pre-existing CVD or high CV risk. The trial is silent on whether TRT alters the cardiovascular trajectory of a 50-year-old with normal blood pressure, normal lipids, normal weight, and no family history of heart disease.
4. Injection-specific cardiovascular safety
No equivalent of TRAVERSE has been conducted for intramuscular cypionate or enanthate. The European Panel flags this as an open question. Whether route changes the cardiovascular risk profile in a clinically meaningful way is mechanistically plausible but unresolved.
5. Supraphysiological dosing
TRAVERSE titrated to mid-normal physiological range. Higher-dose protocols — 200 mg per week and above — were not tested and may carry different risk profiles. Our 200mg testosterone per week article covers where physiological replacement ends and supraphysiological territory begins.
How to read the 2026 evidence: The cardiovascular safety story for TRT is far more refined than it was three years ago, and substantially more reassuring on the MACE composite. The active questions have moved to AFib and VTE management, hematocrit thresholds, route-specific differences, and long-term exposure. Anyone making a personal decision about starting or continuing TRT should be talking with a prescriber who is familiar with TRAVERSE, the European Expert Panel framework, and the AUA 2024 amendment — and who is comfortable with structured cardiovascular monitoring.
Where this fits in the broader TRT conversation
Cardiovascular safety is one branch of the full TRT risk-benefit tree. For the original headline trial, see our TRAVERSE trial explained article. For the bone signal that emerged from the same parent trial, see TRT and fracture risk. For the lab side of monitoring, see TRT blood work schedule, hematocrit on TRT, estradiol on TRT, and PSA on TRT. For older men specifically, see TRT for older men after 65. For OSA overlap, see TRT and sleep apnea. The overall side effects pillar guide integrates these threads.
A brief scenario
Consider a 62-year-old man with controlled hypertension, a prior stent placed seven years ago, two morning total testosterone readings of 225 ng/dL, persistent symptomatic hypogonadism on a verified symptom inventory, no personal or family VTE history, no AFib on baseline ECG, STOP-BANG score of 2, and a hematocrit of 47% at baseline. Pre-TRAVERSE, his cardiologist might have counseled against TRT on principle. In a 2026 European Panel-aligned framework, his prescriber would document the absence of major contraindications, initiate transdermal gel at a conservative dose, recheck hematocrit and ECG at 3 months, recheck the full panel at 6 months, and treat any rise in hematocrit aggressively. He would not be casually prescribed TRT, but he would also not be categorically refused. The shift from "TRT is dangerous in CV disease" to "TRT in CV disease requires structured monitoring" is the change the 2026 evidence has driven.
Next steps if you want to go deeper: The primary TRAVERSE paper (Lincoff et al., NEJM 2023, DOI 10.1056/NEJMoa2215025) is freely accessible and is the foundational reference. The European Expert Panel position statement is published through the European Academy of Andrology and the European Society of Endocrinology channels. Companion deep dives on this site cover hematocrit, the blood work schedule, OSA overlap, and older-men subgroup data. For the broader side effects integration, the side effects pillar is the entry point.
Sources referenced in this article
- Lincoff AM, Bhasin S, Flevaris P, et al. "Cardiovascular Safety of Testosterone-Replacement Therapy" (TRAVERSE trial). New England Journal of Medicine. 2023;389(2):107–117. DOI 10.1056/NEJMoa2215025.
- Snyder PJ, Bhasin S, Cunningham GR, et al. "Lessons From the Testosterone Trials." Endocrine Reviews and primary NEJM 2016 publication, PMID 26886521.
- Snyder PJ, Kopperdahl DL, Stephens-Shields AJ, et al. "Effect of Testosterone Treatment on Volumetric Bone Density and Strength in Older Men With Low Testosterone" (Testosterone Trials bone substudy). JAMA Internal Medicine. 2017;177(4):471–479. PMID 28241248.
- Snyder PJ, et al. TRAVERSE bone substudy on clinical fractures. New England Journal of Medicine. 2024. DOI 10.1056/NEJMoa2308836.
- Bhasin S, Brito JP, Cunningham GR, et al. "Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline." Journal of Clinical Endocrinology & Metabolism. 2018;103(5):1715–1744. DOI 10.1210/jc.2018-00229. PMID 29562364.
- Mulhall JP, Trost LW, Brannigan RE, et al. "Evaluation and Management of Testosterone Deficiency: AUA Guideline." Originally 2018, amended 2024.
- Corona G, Maggi M, and colleagues. European Expert Panel position statement on testosterone therapy and cardiovascular safety, developed under the European Academy of Andrology and the European Society of Endocrinology (post-TRAVERSE synthesis).
- Basaria S, Coviello AD, Travison TG, et al. "Adverse Events Associated With Testosterone Administration" (TOM trial). New England Journal of Medicine. 2010;363(2):109–122. PMID 20592293.
- Basaria S, Harman SM, Travison TG, et al. "Effects of Testosterone Administration for 3 Years on Subclinical Atherosclerosis Progression in Older Men With Low or Low-Normal Testosterone Levels" (TEAAM). JAMA. 2015;314(6):570–581. PMID 26284720.
- Vigen R, O'Donnell CI, Barón AE, et al. "Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels." JAMA. 2013;310(17):1829–1836.
- Finkle WD, Greenland S, Ridgeway GK, et al. "Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men." PLOS ONE. 2014;9(1):e85805.
- U.S. Food and Drug Administration. Drug Safety Communications: Testosterone product labeling — original 2015 cardiovascular warning and 2024 post-TRAVERSE label updates.
- Gami AS, Hodge DO, Herges RM, et al. "Obstructive Sleep Apnea, Obesity, and the Risk of Incident Atrial Fibrillation." Journal of the American College of Cardiology. 2007;49(5):565–571 — referenced for the OSA–AFib mechanistic link.
This article was written by the TRT FAQ Editorial Team and reviewed against the published TRAVERSE primary paper, the TRAVERSE bone substudy, the AUA 2024 amendment, the Endocrine Society 2018 clinical practice guideline, and the European Expert Panel position statement on testosterone therapy and cardiovascular safety. It is educational content, not medical advice. Last content review: May 2026.
Frequently Asked Questions
Is TRT safe for the heart in 2026?
For middle-aged and older hypogonadal men with pre-existing cardiovascular risk who receive transdermal testosterone titrated to mid-normal serum levels, the cumulative randomized evidence through 2026 supports non-inferiority versus placebo for the composite endpoint of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. That conclusion comes from the TRAVERSE trial (Lincoff et al., New England Journal of Medicine, 2023, DOI 10.1056/NEJMoa2215025), follow-up subgroup analyses published in 2024 and 2025, and the European Expert Panel position statement issued under the European Academy of Andrology and the European Society of Endocrinology. The same body of evidence has, however, sharpened the signal on three narrower outcomes — atrial fibrillation, venous thromboembolism, and erythrocytosis — and modern guidance treats those as the active monitoring targets rather than MACE in 2026.
Does testosterone cause arrhythmia?
TRAVERSE (Lincoff NEJM 2023) reported new-onset atrial fibrillation in 3.5% of men randomized to transdermal testosterone versus 2.4% of men on placebo over a mean follow-up of approximately 33 months — roughly one additional case of AFib per 100 men treated over three years. Subgroup analyses presented after the primary publication and reviewed in the European Expert Panel position statement reinforce that the AFib signal is most pronounced in older men, men with sleep apnea, and men with prior atrial enlargement on echocardiography. The mechanism is not settled. Candidate explanations include direct androgen effects on atrial electrical remodeling, worsened obstructive sleep apnea (covered in our trt and sleep apnea article), and indirect effects via blood pressure and hematocrit. The European Panel recommends explicit AFib screening at baseline and on follow-up, especially in men over 65 or with risk factors.
Does TRT increase blood clot risk?
Pulmonary embolism occurred in 0.9% of men on testosterone versus 0.5% on placebo in TRAVERSE. The absolute difference is small but the relative difference roughly doubles, and U.S. and European prescribing information now carry explicit warnings about venous thromboembolism (VTE) on testosterone therapy. The European Expert Panel position statement (Corona, Maggi, and colleagues, under the European Academy of Andrology and the European Society of Endocrinology) treats the VTE signal as biologically plausible — testosterone raises hematocrit and blood viscosity, and androgens influence procoagulant pathways — and recommends caution in men with a personal or family history of unprovoked deep vein thrombosis, pulmonary embolism, factor V Leiden, prothrombin mutation, or other thrombophilia. Men with a documented prior unprovoked VTE event are generally counseled toward alternatives or, at minimum, a documented risk-benefit conversation before initiating TRT.
What are the new TRT heart guidelines after TRAVERSE?
Through 2024 to 2026, three changes matter most. First, the AUA amended its testosterone deficiency guideline in 2024 to incorporate TRAVERSE as supportive evidence on MACE while retaining baseline cardiovascular assessment and hematocrit monitoring. Second, the Endocrine Society practice updates have reaffirmed the 54% hematocrit threshold and added more explicit framing around AFib screening, OSA assessment, and VTE history. Third, the European Expert Panel position statement — the most detailed post-TRAVERSE synthesis to date — codifies a risk-stratified monitoring framework: baseline AFib screen, baseline VTE risk assessment, baseline blood pressure and hematocrit, and structured follow-up at 3 months, 6 months, and annually. No major society treats TRAVERSE as a green light to prescribe without evaluation. Every guideline body retains individualized risk-benefit assessment as the standard.
Does the TRAVERSE MACE result apply to testosterone injections?
TRAVERSE used 1.62% transdermal testosterone gel exclusively. The European Expert Panel position statement explicitly flags route extrapolation as an open question. Intramuscular testosterone cypionate or enanthate produces higher peak serum testosterone and larger week-over-week hematocrit increases than gel at equivalent weekly doses, and high-peak injection protocols may amplify the erythrocytosis pathway that drives the VTE and AFib mechanistic concerns. Most clinicians and the European Panel treat TRAVERSE as reassuring on MACE within the population and route studied, and route-specific caution remains warranted — particularly for once-weekly or every-two-week intramuscular regimens at the upper end of the dose range. Our trt gel vs injections article compares delivery methods in depth.
What hematocrit threshold should trigger a dose change on TRT in 2026?
The 54% hematocrit threshold from the 2018 Endocrine Society clinical practice guideline (Bhasin et al., JCEM, DOI 10.1210/jc.2018-00229) remains the most widely cited cutoff and was reaffirmed in the European Expert Panel position statement. At hematocrit greater than or equal to 54%, prescribers typically pause or reduce testosterone, address modifiable contributors (sleep apnea, dehydration, smoking, supplemental androgens), and consider therapeutic phlebotomy if symptoms warrant. Some clinicians use stricter operating thresholds — 52% in men with high baseline VTE or stroke risk, or 50% in men with prior atrial fibrillation — but those are not codified guideline numbers. The 2026 framework treats erythrocytosis not as a standalone lab finding but as a risk amplifier for the AFib and VTE signals identified in TRAVERSE. Our hematocrit on TRT article walks through the management options in depth.
When should men pause TRT for a cardiovascular reason in 2026?
Clinical pause is not a one-rule decision, but the European Expert Panel position statement and current AUA and Endocrine Society guidance converge on several scenarios. A new diagnosis of atrial fibrillation, a confirmed deep vein thrombosis or pulmonary embolism, a hematocrit at or above 54% without a reversible cause, a hospitalization for decompensated heart failure, an acute myocardial infarction within the prior 3 to 6 months, or a poorly controlled blood pressure crisis are the most common triggers cited in published commentary. Decompensated heart failure remains an absolute contraindication in most frameworks. Pause is typically temporary and accompanied by workup and risk-stratified reintroduction with closer monitoring. The decision is individualized to the patient and is not an automatic discontinuation.