Jorge Sanz Sánchez

Background: Frailty is common in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation and portends worse outcomes. Whether the benefit of posttranscatheter aortic valve implantation dapagliflozin differs by frailty is uncertain. Methods: In this post hoc analysis, we investigated the efficacy of dapagliflozin according to frailty status in the DapaTAVI (Dapagliflozin in Patients Undergoing Transcatheter Aortic Valve Implantation) trial. Frailty was assessed through the Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight scale (robust=0, prefrail=1–2, frail=3–5). The primary outcome was the composite of all‐cause death or worsening heart failure at 1 year. Results: Among 1222 patients with baseline frailty assessment, 47.2% were frail, 40.3% prefrail, and 12.4% robust. Over 12 months, 215 patients (17.6%) experienced the primary end point. Patients who were prefrail and frail had higher risk than robust patients (adjusted hazard ratios [HRs], 1.88 [95% CI, 1.05–3.38] and 2.29 [1.29–4.07], respectively; P =0.004). Dapagliflozin was associated with a lower risk of the primary end point in patients who were frail (HR, 0.53 [95% CI, 0.36–0.77]) but not in those who were prefrail (HR, 1.01 [95% CI, 0.66–1.55]) or robust patients (HR, 1.26 [95% CI, 0.42–3.75]); P for interaction=0.021. There was no evidence that frailty modified the safety profile of dapagliflozin. Conclusions: Frailty was common and independently associated with worse outcomes after transcatheter aortic valve implantation. Dapagliflozin appeared to confer greater relative benefit in patients with frailty.

Background: The optimal revascularisation strategy for patients undergoing percutaneous coronary intervention (PCI) after transcatheter aortic valve implantation (TAVI) remains undefined. In particular, the prognostic impact of complete revascularisation (CR) versus incomplete revascularisation (ICR) in this setting is unknown. Aims: To evaluate the long-term clinical outcomes of CR versus ICR in patients undergoing PCI after TAVI. Methods: We analysed 447 patients from the multicentre, international Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL) registry who underwent PCI after TAVI between 2008 and 2023. Patients were classified as CR or ICR according to the presence of residual significant stenosis following PCI. The primary endpoint was the 4-year incidence of major adverse cardiovascular events (MACE), a composite of cardiovascular death, myocardial infarction or stroke. The Kaplan-Meier method was used to estimate cumulative event rates, and a weighted Cox regression model employing an entropy balance approach was used to adjust for possible confounders. Results: ICR was achieved in 132 patients (29.5%) and CR in 315 patients (70.5%). The mean follow-up after PCI was 1065±904 days (1213±938 in the ICR group; 1002±883 in the CR group). The crude 4-year incidence of MACE was 35.0% with ICR and 34.7% with CR (HR 0.93, 95% CI 0.62 to 1.39, p=0.710). Adjusted analysis confirmed no significant difference (32.5% vs 34.1%; HR 1.01, 95% CI 0.62 to 1.64, p=0.971). Conclusion: In this registry, CR after TAVI was common but not associated with improved outcomes compared with ICR. These results support a selective rather than systematic pursuit of CR in elderly, high-risk post-TAVI patients.

Background: Transcatheter aortic valve replacement (TAVR) has evolved significantly, expanding its indication to lower surgical risk patients. However, challenges remain, including conduction disorders or paravalvular leak (PVL). The ALLEGRA TAVI system (Biosensors International) is a supra‐annular self‐expanding prosthesis designed to optimize implantation and hemodynamic performance. Aims: The objective of this study was to analyze short‐term outcomes following the implantation of the Allegra valve in real‐world practice. Methods: This multicenter retrospective study included 500 patients who underwent TAVR with the Allegra valve across 11 Spanish centers between 2017 and 2024. Success rates, complications, and 30‐day clinical outcomes were analyzed. Results: The median age was 82.1 ± 5.5 years. The overall success rate was 96.8% (95% CI 94.8%−98.0%), with complications in 11.6% (95% CI 8.0%−13.0%) of cases. The need for permanent pacemaker implantation (PPI) was 19.2% (95% CI 16.0%−22.9%), while moderate‐to‐severe PVL occurred in 4.1% (95% CI 2.7%−6.3%). The in‐hospital mortality rate was 1.0% (95% CI 0.5%−2.6%). Hemodynamic performance was favorable, with post‐implant mean gradients of 4.0 mmHg (IQR 2.0−5.0 mmHg) in native aortic stenosis and 7.0 mmHg (IQR 5.0−10.0 mmHg) in valve‐in‐valve procedures. A reduction in complications was observed, but not significantly, with increased experience (15.2% vs. 10.4%, p 0.147), though without impact on success rates. Conclusions: This study confirms that the Allegra valve is a safe and effective TAVR option, with outcomes comparable to other self‐expanding prostheses. Further design optimization could reduce PVL and PPI rates. Long‐term studies are needed to assess durability.

Recent evidence questioned the overall safety and efficacy of colchicine in patients with coronary artery disease (CAD), as novel evidence focusing on acute coronary syndromes (ACSs) gave neutral results, while trials focusing on chronic coronary syndrome supported colchicine administration to improve long‐term outcomes. However, no study has ever explored whether there is a true therapeutic difference across the populations or these discrepancies are due to additional confounders. Against this background, we performed a systematic review and meta‐analysis of randomized trials of colchicine in patients with CAD. The primary endpoints were trial‐defined major adverse cardiovascular events (MACE) and serious adverse events (SAEs). Secondary endpoints included all‐cause death, measures of ischemia (cardiovascular death, myocardial infarction [MI], any revascularization, stroke) and measures of safety (serious infections or sepsis and gastrointestinal adverse events). All analyses included an interaction term for the clinical presentation. Sensitivity analyses were performed to explore sources of heterogeneity. After literature search, 20 trials encompassing a total of 21,486 patients (65.4% ACS) were included. Colchicine significantly reduced MACE (incidence rate ratio [IRR]: 0.70; 95% CI 0.55–0.87) without increasing risk for SAEs. Colchicine also reduced MI (IRR 0.81; 95% CI 0.70–0.94) and any revascularization (IRR 0.71; 95% CI 0.51–0.99), while increasing the risk of gastrointestinal adverse events (IRR 1.68; 95% CI 1.23–2.28). No statistically significant interaction was noted for clinical presentation for any endpoint, but a significant interaction for the drug dosage administered and the relationship with the COVID‐19 pandemic was noted. In conclusion, the use of colchicine in patients with CAD reduces MACE without significantly increasing SAEs compared to control, although increasing gastrointestinal adverse events, without interaction by clinical presentation.

To compare the effects of drug-coated balloon (DCB) vs drug-eluting stent (DES) in patients presenting with de novo large vessel coronary artery disease (CAD). We conducted a systematic research of randomized controlled trials comparing DCB vs DES in patients with de novo large vessel CAD. Data were pooled by meta-analysis using a random-effects model. The prespecified primary endpoint was target lesion revascularization (TLR). A total of 7 trials enrolling 2961 patients were included. The use of DCB vs DES was associated with a similar risk of TLR (OR, 1.21; 95%CI, 0.44-3.30; I² = 48%), all-cause mortality (OR, 1.56; 95%CI, 0.942.57; I² = 0%), cardiac death (OR, 1.65; 95%CI, 0.90-3.05; I² = 0%), myocardial infarction (OR, 0.97; 95%CI, 0.58-1.61; I² = 0%), major adverse cardiovascular adverse (OR, 1.19; 95%CI, 0.74-1.90; I² = 13.5%) and late lumen loss (standardized mean difference [SMD], −0.35; 95%CI, −0.74 to 0.04; I² = 81.4%). However, the DCB was associated with a higher risk of target vessel revascularization (OR, 2.47; 95%CI, 1.52-4.03; I² = 0%) and smaller minimal lumen diameter during late follow-up (SMD, −0.36; 95%CI, −0.56 to −0.15; I² = 34.5%). Nevertheless, prediction intervals included the value of no difference for both outcomes. In patients with de novo large vessel CAD the use of DCB vs DES is associated with a similar risk of TLR. However, the DES achieves better late angiographic results.