Invasive physiologic assessment with fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) guides coronary revascularization and supports deferral of nonischemic lesions; however, sex-specific outcomes after physiology-guided deferral remain incompletely characterized. We performed a retrospective cohort study using the TriNetX Global Collaborative Network to identify adults undergoing invasive physiologic assessment with FFR or iFR in whom revascularization was deferred. The primary endpoint was a composite of percutaneous coronary intervention (PCI), myocardial infarction (MI), or all-cause mortality. Secondary outcomes included individual components of the composite and acute heart failure. Women and men were matched 1:1 using propensity scores. Odds ratios (OR) and hazard ratios (HR) with 95% confidence intervals (CI) were calculated. Among 140,262 eligible patients, 47,413 matched pairs were identified after propensity score matching. Over 2 years of follow-up, women had lower odds of the composite endpoint compared with men (4192 vs 4569 events; OR 0.85, 95% CI 0.81-0.89; P < 0.001). Repeat PCI was less frequent in women (OR 0.82, 95% CI 0.78-0.86; P < 0.001), and all-cause mortality was modestly lower (OR 0.93, 95% CI 0.88-0.98; P = 0.032). MI rates were comparable (OR 1.03, 95% CI 0.97-1.09; P = 0.338). Acute heart failure occurred more frequently in women (OR 1.05, 95% CI 1.01-1.09; P = 0.046). Female sex was independently associated with lower revascularization risk (HR 0.83, 95% CI 0.79-0.87; P = 0.001). Women had lower rates of repeat revascularization and mortality over 2 years after physiology-guided deferral, with similar MI rates but a slightly higher rate of acute heart failure compared with men.
Type II myocardial infarction (MI), caused by myocardial oxygen supply-demand imbalance rather than acute plaque rupture, represents a growing clinical challenge with high mortality but limited evidence-based management strategies. It requires a rise and/or fall in cardiac troponins with objective evidence of ischemia and should be distinguished from acute myocardial injury without ischemic features. Current guidelines provide limited, but largely diagnostic and principle-based guidance and do not provide trial-validated pathways for coronary evaluation or revascularization in type II MI with coexisting coronary artery disease. Observational studies suggest potential benefit of revascularization and secondary prevention, yet selection bias and procedural risks complicate decision-making. Emerging strategies, including the use of drug-coated balloon (DCB) angioplasty, may offer a balance between invasive therapy and bleeding risk in this high-risk population. This article highlights the diagnostic complexities, therapeutic dilemmas, and the urgent need for randomized trials to define optimal management pathways. A pragmatic framework is proposed, integrating systemic trigger correction, coronary evaluation, physiology-based testing, and individualized revascularization strategies, with emphasis on underutilized guideline-directed medical therapy. The proposed diagnostic and management framework is pragmatic and expert-opinion-based, reflecting current evidence gaps rather than validated trial data.
Scarce evidence exists comparing clinical outcomes of novel lipid-lowering monotherapy with standard statin therapy for primary prevention. We compared clinical outcomes among primary prevention patients treated with novel lipid-lowering monotherapy versus statin monotherapy. We performed a retrospective matched cohort study using the TriNetX network comprising 107 predominantly U.S. healthcare organizations. Adults with LDL-C > 100 mg/dL, between 2015 and 2024, and no prior ischemic heart disease, heart failure, cerebral infarction, or peripheral vascular disease were included. Exposure was treatment with evolocumab, alirocumab, or inclisiran without concomitant statins within 1 year of the qualifying LDL-C, compared with initiation of statin monotherapy. Propensity score matching was performed 1:1 across 28 covariates. Follow-up began 7 days after treatment initiation and extended to 2 years. Primary outcomes were all-cause mortality and acute myocardial infarction (AMI). Secondary outcomes included hospitalization, acute heart failure, ventricular tachycardia, atrial fibrillation, cerebral infarction, and MACE. After matching, 5844 patients remained in each cohort. Median follow-up was 675 days. All-cause mortality (0.8% vs 1.1%; HR 0.79, 95% CI 0.54-1.15) and AMI (0.3% vs 0.3%; HR 1.31, 95% CI 0.65-2.62) were similar between novel therapy and statin cohorts. Hospitalizations, stroke, atrial fibrillation, ventricular tachycardia, and MACE did not differ significantly. Novel therapies were associated with lower acute heart failure events (0.7% vs 1.2%; HR 0.63, 95% CI 0.42-0.93). Among patients without prior ASCVD, novel lipid-lowering monotherapy achieved comparable short-term outcomes to statin monotherapy, with fewer acute heart failure events, complementing the VESALIUS trial.
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Hertz Contact Intravascular Lithotripsy (HC-IVL) is the first mechanical IVL platform designed to fragment coronary calcium, while minimizing injury to adjacent non-calcified vessel tissue and eliminating the need for external energy source or capital equipment. The PINNACLE-I clinical trial has demonstrated the safety and effectiveness of HC-IVL in treating moderate to severe calcific coronary lesions. In the MY-IVL Study, we aim to evaluate the safety and performance of HC-IVL in a real-world population including patients with multivessel disease, left main disease, chronic total occlusions, and in-stent restenosis. This study includes consecutive patients undergoing HC-IVL between April and September 2025 at a single center with an estimated sample size of 100 subjects. All subjects undergo angiographic and intravascular imaging (OCT / IVUS) at baseline, post-HC-IVL, and post-PCI. Primary safety endpoint was 30-day freedom from MACE (cardiovascular death, MI, target vessel revascularization). Co-primary effectiveness endpoints were residual stenosis <30% without intraprocedural MACE and minimum stent area ≥ 4.9 mm2 by intravascular imaging. All imaging analyses are performed by an independent core laboratory. A total of 102 patients with 130 calcified lesions were treated with HC-IVL, with successful device delivery in all cases and a median of one IVL catheter used per procedure. The primary safety endpoint was achieved in 96.1%, with 96.3% of stented lesions demonstrating residual stenosis <30% without intraprocedural MACE. The 30-day MACE rate was 3.9%, with no myocardial infarction, no target vessel revascularization, and no device-related complications. By intravascular imaging, the mean minimum stent area was 6.89 mm2 and the lower bound of the 95% confidence interval was 6.50 mm2, which exceeded the PG of 4.9 mm2 (p < 0.0001). Mean stent expansion was 113.7% across a wide spectrum of calcium morphologies including concentric, eccentric, and circumferential arcs up to 360°. Acute angiographic gain averaged 1.75 ± 0.58 mm with a final in-lesion diameter stenosis of 10.7%. MY-IVL study demonstrates that the LithiX HC-IVL system provides safe, effective, and efficient calcium modification across diverse calcified lesion morphologies in a high-risk, real-world Asian PCI population, facilitating optimal coronary stent implantation with favorable early clinical outcomes.
Aortic stenosis leads to adverse left ventricular remodeling; aortic valve replacement (AVR) remains the cornerstone of management. We evaluated clinical and echocardiographic outcomes with renin-angiotensin system inhibitor (RASi) use in patients undergoing AVR. Five electronic databases were systematically queried for studies comparing outcomes with and without RASi post-AVR. Outcomes were pooled using random-effects models to calculate risk ratios (RRs), mean differences, and standardized mean differences with 95% confidence intervals. Outcomes of interest included all-cause and cardiovascular mortality, heart failure, myocardial infarction, stroke/TIA, arrhythmias, pacemaker requirement, acute kidney injury, and echocardiographic parameters. Seventeen studies (16 observational, 1 RCT) including 44,935 patients [RASi: 20,723; no RASi: 24,212] were included. RASi use was associated with significantly reduced all-cause mortality (RR: 0.74; 95% CI: 0.65-0.83; p < 0.0001) and cardiovascular mortality (RR: 0.65; 95% CI: 0.49-0.85; p = 0.002), consistent across TAVR and SAVR subgroups. No significant differences were observed for heart failure, myocardial infarction, stroke, or pacemaker requirement. RASi did not increase acute kidney injury (p = 0.08) or major bleeding (p = 0.67). Echocardiographic outcomes, including peak aortic valve velocity and LV mass index, showed no significant differences between groups. In predominantly observational studies, RASi use following AVR is associated with lower all-cause and cardiovascular mortality without increasing major adverse clinical events. Survival benefits were not accompanied by consistent echocardiographic improvements. Given substantial heterogeneity and residual confounding inherent to observational data, prospective randomized trials are needed to confirm these associations. Meta-analysis of 17 studies shows survival benefit with ACEI/ARB in the patients undergoing TAVR/SAVR, with no significant differences in HF, MI, stroke/TIA, AF, pacemaker, or echo outcomes.
Transcatheter aortic valve replacement (TAVR) is an established treatment for severe aortic stenosis. Although TAVR has improved clinical outcomes, data on racial and ethnic differences in in-hospital clinical outcomes and their temporal trends, particularly within urban hospital settings, remain limited. Accordingly, we examined racial and ethnic differences in in-hospital outcomes and their temporal trends among patients undergoing TAVR in urban hospitals. We utilized the National Inpatient Sample from 2016 through 2022 and identified TAVR-related hospitalizations in urban hospitals. Patients were classified by race and ethnicity, with White patients serving as the reference group. Primary endpoints included in-hospital mortality and major adverse cardiovascular events. Secondary endpoints included acute myocardial infarction, stroke, cardiac arrest, acute kidney injury, need for transfusion, mechanical ventilation, and other in-hospital complications. Survey-weighted multivariable analyses were performed. We identified a weighted total of 469,175 hospitalizations for TAVR in urban hospitals. Overall, 87.1% of patients were White, and 12.9% were racial and ethnic minority patients. Compared with White patients, Black and Hispanic patients had higher adjusted odds of major adverse cardiovascular events, driven in part by acute myocardial infarction, while Hispanic patients also had higher in-hospital mortality. Rates of ischemic and hemorrhagic stroke did not differ significantly across groups. Significant race-by-year interactions were observed for in-hospital mortality and blood transfusion. Our findings highlight persistent racial and ethnic disparities in in-hospital outcomes following TAVR, emphasizing the need for targeted efforts to address inequities in care delivery.
Surgical ventricular reconstruction (SVR) is not always feasible in patients with ischaemic cardiomyopathy and left ventricular (LV) aneurysm, due to high surgical risk. The Revivent-TC Transcatheter Ventricular Enhancement System is a less invasive alternative option. We conducted a systematic literature search using PubMed, Ovid Medline and Google Scholar between January 2013 up to May 2025 to assess the effectiveness and safety of Revivent-TC System. Inclusion criteria included symptomatic patients with ischaemic left ventricular (LV) systolic impairment and anterior or anteroseptal scar, with appropriate anatomy confirmed by cardiac magnetic resonance (CMR), who were treated with the device. Outcomes included echocardiographic parameters, procedural data, adverse events and survival. Eight studies (276 patients) were included: seven observational and the prospective non-randomised dual-arm ALIVE trial. Mean age was 61.8 years; 73% were male with LV ejection fraction (EF) ranging from 22.8% to 35.6%. Procedural success ranged from 96 to 100%, with procedure-related mortality of 2.5%. Conversion to full median sternotomy was required in 1.4% due to complications such as right ventricular (RV) perforation, acute mitral regurgitation and right ventricular (RV) failure. Surgical re-intervention was required in 4.3% of patients. Overall mortality during follow-up was 6.5%. Statistically significant improvement in LVEF and LV volumes was observed across observational studies, persisting up to 5 years post-operatively. Improvements in exercise tolerance, NYHA functional class and quality of life were also observed. However, the ALIVE trial did not demonstrate a significant clinical benefit over guideline-directed medical therapy (win ratio 1.13; p = 0.32), with cardiovascular mortality and HF hospitalisation numerically favouring the control group. The Revivent-TC system is associated with LV volume reduction and functional improvements in selected patients, offering a less invasive alternative to surgical ventricular reconstruction. However, the evidence base consists predominantly of small observational studies, and the only controlled trial did not demonstrate significant benefit on hard clinical endpoints. Longer-term randomised data, including a guideline-directed medical therapy comparator arm, are needed before definitive conclusions about efficacy can be drawn.
Modern coronary physiology in the cardiac catheterization laboratory has evolved from a solely wire-based approach to a broader portfolio that now includes coronary computed tomography angiography, angiography-derived physiology, and microcatheter-derived physiology. Limited data exists on real-world practice patterns and perspectives among interventional cardiologists. A web-based 76-item international survey was distributed to attending interventional cardiologists via email and social media from April to July 2024. In total, 206 interventional cardiologists completed the survey. Respondents represented diverse global regions, with 55% based in the United States. Most operators performed both percutaneous coronary intervention (PCI) and structural interventions (34%) or only PCI (25%). Nearly all respondents (98%) had access to invasive coronary physiology tools, with non-hyperemic pressure ratios (NHPR) usage being favored over fractional flow reserve (FFR) by operators (60% vs. 40%), particularly in US centers. Pressure-wire pullback was routinely performed by 44% of operators. Angiography-derived FFR was used by 33%, with lack of access being the primary barrier to adoption. Coronary microvascular dysfunction (CMD) evaluation was performed or referred by 39%, primarily using bolus thermodilution (78%) followed by continuous thermodilution in 22%. This multinational survey demonstrates substantial heterogeneity and marked geographic variation in the use of modern coronary physiology tools. Although important advances have broadened the coronary physiology toolkit, their routine use remains limited and inconsistent. These findings provide valuable insights into how novel modalities are being integrated into practice, including notable geographic differences.
Non-obstructive coronary artery disease (NOCA) is characterized by coronary ischemia/angina without significant epicardial coronary stenosis. This study explored sex-related differences in clinical characteristics, endotypes, and angina outcomes in NOCA patients. We conducted a retrospective, multicenter, observational study including all consecutive atients diagnosed with a NOCA syndrome between January 2020 and March 2025 at three different tertiary hospitals. NOCA patients were classified into microvascular angina, vasospastic angina or mixed angina, according to standardized criteria. The Seattle Angina Questionnaire 7 (SAQ-7) was evaluated at baseline and at 6-month follow-up. A total of 287 patients (65.1% women) were included. Men had higher rate of positive ischemia tests (49.2% vs. 67.0%; p = 0.004) and lower prevalence of anxiety/depression (37.93% vs. 19.0%; p < 0.001); as compared with women. No significant differences were observed between groups regarding NOCA endotype and treatment. SAQ-7 scores were significantly lower in women than in men either at baseline or 6-month follow-up (56.00 [47.00-66.00] vs. 63.00 [51.75-73.00]; p = 0.002 and 67.00 [56.00-80.00] vs. 80.00 [65.00-92.25]; p < 0.001, respectively). There was a significant improvement in both groups (women: + 9.00 [2.00-22.00]; p < 0.001; men: + 17.00 [2.00-27.75]; p < 0.001) between baseline and follow-up, without any statistically significant difference between men and women (p = 0.062). Women with NOCA syndrome exhibit a higher prevalence of psychological comorbidities and lower positive ischemia test. They had worse angina symptoms compared with men. These findings may highlight the need for sex-specific therapeutic strategies in NOCA syndrome.
Since their creation in 2002, drug-eluting stents (DES) have proven their superiority over their bare-metal counterparts and significantly evolved. Efforts are now concentrated on improving the DES platform, particularly by integrating thinner stent design. We aimed to compare outcomes between a broad range of current generation DES to evaluate the impact of thinner strut design in a real-world setting. We analysed data from 3092 patients who underwent percutaneous coronary intervention (PCI) with thin (≤80 μm) or thick (>80 μm) DES in the Cardio-FR database. Of these, 2551 (1567 thick DES and 984 thin DES) met the inclusion and exclusion criteria and completed a two-year follow-up: The primary outcome was the device-oriented composite endpoint (DOCE) of cardiac death, non-fatal target vessel myocardial infarction (TVMI) and target lesion revascularization (TLR). The mean age was 67 years, and 75% were male. After multivariable adjustment, thick-strut DES were associated with higher 2-year DOCE compared with thin-strut DES (adjusted OR for thick vs thin: 1.298; 95% CI: 1.006-1.674; p = 0.045). In contrast, stroke was less frequent with thick-strut DES (2.0% vs 3.4%; p = 0.041). All other event rates were similar between the groups. Clinical follow-up up to two years shows treatment with thin strut DES significantly lowers DOCE rates compared with thick strut DES. More research is needed to assess the impact of thinner strut design on performance.
Obesity is increasingly recognized as a critical modifier of outcomes following transcatheter aortic valve replacement (TAVR), predisposing patients to subclinical leaflet thrombosis (SLT), hypo-attenuated leaflet thickening (HALT), and paravalvular leak (PVL). Metabolic inflammation, endothelial dysfunction, and pro-thrombotic states associated with obesity contribute to impaired bioprosthetic valve healing. Tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, has demonstrated robust metabolic, anti-inflammatory, and vascular protective effects. However, its impact on post-TAVR valve performance has not been previously evaluated. To determine whether tirzepatide therapy initiated before TAVR and continued post-procedure reduces the incidence of HALT and PVL in obese patients undergoing TAVR. TAVR-MET was a prospective, randomized, open-label, multicenter trial enrolling obese patients (BMI ≥ 30 kg/m2) undergoing transfemoral TAVR. Patients were randomized to tirzepatide therapy or standard care. The primary endpoint was HALT incidence at 6 months assessed by 4D-CT or transesophageal echocardiography (TEE). Secondary endpoints included PVL severity, major adverse valve events (MAVE), inflammatory biomarker changes, weight reduction, and bleeding outcomes. Among 260 randomized patients, tirzepatide therapy significantly reduced HALT incidence (8.4% vs 21.6%, p = 0.002) and ≥ mild PVL (10.7% vs 25.3%, p = 0.006) at 6 months. Tirzepatide was associated with marked reductions in CRP and body weight without an increase in major bleeding. Multivariable analysis identified tirzepatide use, CRP reduction >30%, and BMI <32 kg/m2 at follow-up as independent predictors of HALT absence. Metabolic modulation with tirzepatide significantly improves post-TAVR valve healing and hemodynamics in obese patients. These findings introduce a novel cardio-metabolic strategy to reduce structural valve complications following TAVR. TAVR-MET STUDY: The TAVR-MET trial was a prospective, randomized, multicenter study designed to evaluate whether metabolic modulation with tirzepatide, a dual GIP/GLP-1 receptor agonist, could improve bioprosthetic valve outcomes following transcatheter aortic valve replacement (TAVR) in obese patients. Obesity is increasingly recognized as a key determinant of post-TAVR complications, particularly subclinical leaflet thrombosis (HALT) and paravalvular leak (PVL), driven by chronic inflammation, endothelial dysfunction, and a prothrombotic state. Tirzepatide has demonstrated potent weight-reducing, anti-inflammatory, and vascular protective effects, but its role in structural valve outcomes had not previously been explored. The trial enrolled 260 obese patients (BMI ≥ 30 kg/m2) undergoing transfemoral TAVR across eight high-volume centers. Participants were randomized to receive tirzepatide initiated four weeks before TAVR and continued for 12 months, or standard care alone. All patients received guideline-directed antithrombotic therapy. The primary endpoint was the incidence of HALT at six months assessed by advanced imaging. Secondary endpoints included PVL severity, major adverse valve events, inflammatory biomarker changes, weight reduction, and bleeding outcomes. At six months, tirzepatide therapy was associated with a significant reduction in HALT compared with standard care, as well as a marked decrease in ≥ mild paravalvular leak. These structural valve improvements were accompanied by substantial weight loss and significant reductions in systemic inflammatory markers, without an increase in major bleeding or adverse safety signals. Multivariable analysis confirmed tirzepatide use and inflammation reduction as independent predictors of improved valve outcomes. In conclusion, the TAVR-MET trial provides the first clinical evidence that targeted metabolic therapy can favorably influence bioprosthetic valve healing after TAVR. These findings support a novel cardio-metabolic strategy for improving post-TAVR outcomes in obese patients and highlight the importance of addressing metabolic inflammation alongside procedural excellence in contemporary structural heart interventions.
Angina with non-obstructive coronary arteries (ANOCA) and myocardial infarction with non-obstructive coronary arteries (MINOCA) are increasingly recognized as manifestations of coronary vasomotor dysfunction. Intracoronary acetylcholine (ACh) testing remains the gold standard for diagnosing endothelial-dependent coronary dysfunction, epicardial spasm, and microvascular spasm; however, variability in protocols and safety concerns has limited broader adoption. To provide a contemporary, practice-oriented review of the indications, mechanisms, protocols, safety profile, and clinical utility of ACh provocation testing, integrating emerging multicenter registry data and recent mechanistic insights. We review standardized ACh dosing strategies (bolus and continuous infusion), diagnostic endotypes, and integration with wire-based hemodynamic assessment. Building upon prior state-of-the-art reviews, this article incorporates new data from abstracts presented in 2025 from the DISCOVER-INOCA registry and recent prospective multicenter endotype studies demonstrating (1) high diagnostic yield, (2) quantitative differentiation of epicardial spasm, microvascular spasm, isolated endothelial dysfunction, and enhanced nociception, and (3) a very low incidence of major complications (<1%). Contemporary meta-analysis further clarifies the safety profile of ACh relative to ergonovine. We also provide updated contraindications aligned with 2024 ESC chronic coronary syndrome guidance and MINOCA recommendations. Importantly, emerging data support a shift from purely qualitative spasm provocation toward mechanism-guided, endotype-specific therapy. This review advances the field by integrating prospective North American registry validation, contemporary safety meta-analyses, and quantitative endotype phenotyping frameworks. ACh testing is repositioned not only as a diagnostic tool but as a platform for precision medicine in ANOCA and MINOCA, enabling tailored therapy and improved patient-centered outcomes.
Coronary stent length has been considered an important predictor of adverse events in stable patients undergoing percutaneous coronary intervention (PCI). However, data regarding on the impact of long drug-eluting stent (DES) length on the clinical outcomes in acute myocardial infarction (AMI) patients are limited. The study analyzed a total of 9021 AMI patients who underwent PCI with 2nd generation DESs from Korea AMI registry-National Institutes of Health. The patients were categorized into three groups according to the stent length (SL) in a treated coronary artery: <38 mm, n = 6821, 38-59 mm, n = 1735 and ≥60 mm, n = 465 and compared using the inverse probability of treatment-weighted (IPTW) method. The primary endpoint was the incidence of major adverse cardiac events up to 3 years. After adjustment for differences in the baseline risk factors, SL was significantly associated with higher cumulative rates of MACE [Odds ratio (OR) 1.15 for 38-59mm group, 95% confidence interval (CI): 1.06-1.26, p = 0.001, and OR 1.23 for ≥60mm group, 95% CI:1.13-1.34, p < 0.001], especially, non target vessel revascularization (TVR), not TVR. Stent thrombosis (ST) showed a significant association with long DESs after IPTW. Patients with very long DESs ≥60 mm showed a markedly higher risk (HR: 1.798, 95% CI: 1.149-2.814, P = 0.010). DES length reflecting diffuse coronary atherosclerosis was associated with adverse long-term clinical outcomes in AMI patients treated with 2nd generation DESs. Long stent implantation did not affect TVF but was associated with increased non-TVR. Although the incidence of ST is low, patients with SL ≥60 mm had an increased risk of ST, underscoring an important consideration during PCI.
Drug-coated balloon with paclitaxel was established as a standard of care for the treatment of in-stent restenosis (ISR). The efficacy and safety of sirolimus-eluting balloons compared to paclitaxel-coated is unknown. The authors performed an interstudy comparison of long-term clinical outcomes of the AGENT IDE and SELUTION4ISR randomized pivotal control trials comparing the efficacy of paclitaxel-coated vs. sirolimus-eluting balloons for the treatment of in-stent restenosis. Data from the pivotal studies of these devices was compared between the paclitaxel-coated vs. sirolimus-eluting arms for their primary endpoint the 1-year target-vessel failure (defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target vessel revascularization). This analysis included 615 patients, 406 in AGENT and 210 in SELUTION. There were no differences in the one-year TVF rate between the paclitaxel DCB vs. sirolimus DEB arms, 17.9% vs. 16.2%, respectively (log-rank p = 0.3). There was also no difference in the secondary endpoint of the individual components of TVF: CV death (2.9% vs. 2.0%, p = 0.45), TV-MI (7.5% vs. 7.0%, p = 0.38), or TLR (13% vs. 13%, p = 0.64). Both devices paclitaxel-coated balloon and sirolimus-eluting balloons have similar performance for the treatment of ISR at one year. Longer follow-up to determine if the results are sustained and similar at longer follow-up are warranted.
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