Coronary calcification negatively affects the safety and effectiveness of percutaneous coronary intervention. There is a lack of randomized comparisons among different plaque modification techniques. The aim of this study was to compare rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), and intravascular lithotripsy (IVL) for the treatment of patients with calcified coronary stenosis. Patients with moderate to severe calcified coronary lesions were randomly assigned to percutaneous coronary intervention with RA, IVL, or ELCA. The primary endpoint was the percentage of stent expansion by optical coherence tomography. An intention-to-treat, noninferiority analysis was conducted. A total of 171 patients (77.2% men [n = 132], mean age 70.9 ± 8.2 years) were enrolled, 57 in each treatment arm. Clinical presentation was chronic coronary syndrome in 64.3% of patients (n = 110) and acute coronary syndrome in 35.7% (n = 61). Severe angiographic calcification was observed in 82.5% of lesions (n = 141). Procedural success rate and final minimum stent area (RA, 5.5 ± 2.1 mm2; IVL, 5.4 ± 1.8 mm2; ELCA, 5.1 ± 1.8 mm2) were similar among the 3 arms. IVL proved to be noninferior to RA, with no differences in stent expansion (RA, 86.4% ± 14.1%; IVL, 85.6% ± 13.3%; P = 0.77). ELCA did not reach noninferiority in the intention-to-treat analysis. The rate of complications was low, with no significant differences in the 3 arms but numerically lower with IVL. In the first randomized trial comparing RA, IVL, and ELCA for the treatment of patients with calcified coronary lesions, IVL was noninferior to RA in terms of stent expansion. ELCA did not reach this noninferiority margin compared with RA. No significant differences were observed among the 3 arms regarding minimum stent area, procedural success rate, and complications, which were numerically lower with IVL.
Baseline cardiovascular toxicity risk stratification is critical in cardio-oncology. The Heart Failure Association (HFA) and International Cardio-Oncology Society (ICOS) score aims to assess this risk but lacks real-life validation. This study validates the HFA-ICOS score for anthracycline-induced cardiovascular toxicity. Anthracycline-treated patients in the CARDIOTOX registry (NCT02039622) were stratified by the HFA-ICOS score. The primary endpoint was symptomatic or moderate to severe asymptomatic cancer therapy-related cardiac dysfunction (CTRCD), with all-cause mortality and cardiovascular mortality as secondary endpoints. The analysis included 1066 patients (mean age 54 ± 14 years; 81.9% women; 24.5% ≥65 years). According to the HFA-ICOS criteria, 571 patients (53.6%) were classified as low risk, 333 (31.2%) as moderate risk, 152 (14.3%) as high risk, and 10 (0.9%) as very high risk. Median follow-up was 54.8 months (interquartile range 24.6–81.8). A total of 197 patients (18.4%) died, and 718 (67.3%) developed CTRCD (symptomatic: n = 45; moderate to severe asymptomatic: n = 24; and mild asymptomatic: n = 649). Incidence rates of symptomatic or moderate to severe symptomatic CTRCD and all-cause mortality significantly increased with HFA-ICOS score [hazard ratio 28.74, 95% confidence interval (CI) 9.33–88.5; P < .001, and hazard ratio 7.43, 95% CI 3.21–17.2; P < .001) for very high-risk patients. The predictive model demonstrated good calibration (Brier score 0.04, 95% CI 0.03–0.05) and discrimination (area under the curve 0.78, 95% CI 0.70–0.82; Uno’s C-statistic 0.78, 95% CI 0.71–0.84) for predicting symptomatic or severe/moderate asymptomatic CTRCD at 12 months. The HFA-ICOS score effectively categorizes patients by cardiovascular toxicity risk and demonstrates strong predictive ability for high-risk anthracycline-related cardiovascular toxicity and all-cause mortality. This study aimed to validate the Heart Failure Association and International Cardio-Oncology Society score for anthracycline-induced cardiovascular toxicity in a real-world cohort, the CARDIOTOX registry (NCT02039622). The Heart Failure Association and International Cardio-Oncology Society score effectively categorized patients based on their cardiovascular toxicity risk, demonstrating strong predictive capabilities for high-risk anthracycline-related cardiovascular toxicity and all-cause mortality.
Background: The usefulness of drug-eluting balloons (DEBs) has not been fully elucidated in calcified coronary lesions (CCLs). This meta-analysis aimed to evaluate the efficacy of DEBs compared to a drug-eluting stent (DES) in this setting. Methods: PubMed, EMBASE and Cochrane were searched through December 2023. The primary endpoint was 12 months major adverse cardiac events (MACE). Secondary endpoints included clinical outcomes and angiographic results after PCI and at a 12-month follow-up. Results: Five studies and a total of 1141 patients with 1176 coronary lesions were included. Overall, the DEB was comparable to DES in MACE (RR = 0.86, 95% CI: 0.62–1.19, p = 0.36), cardiac death (RR = 0.59, 95% CI: 0.23–1.53, p = 0.28), myocardial infarction (RR = 0.89, 95% CI: 0.25–3.24, p = 0.87) and target lesion revascularization (RR = 1.1, 95% CI: 0.68–1.77, p = 0.70). Although the DEB was associated with worse acute angiographic outcomes (acute gain; MD = −0.65, 95% CI: −0.73, −0.56 and minimal lumen diameter; MD = −0.75, 95% CI: −0.89, −0.61), it showed better results at 12 months follow-up (late lumen loss; MD = −0.34, 95% CI: −0.62, −0.07). Conclusions: This meta-analysis showed that the DEB strategy is comparable to DES in the treatment of CCLs in terms of clinical outcomes. Although the DEB strategy had inferior acute angiographic results, it may offer better angiographic results at follow-up.
20 May 2025 in Catheterization and Cardiovascular Interventions
BACKGROUND: Stent underexpansion is a significant challenge in percutaneous coronary intervention, critically impacting patient outcomes. While excimer laser coronary angioplasty (ELCA) and intravascular lithotripsy (IVL) are increasingly used to address this issue, their full impact on the integrity of drug-eluting stents remains unclear, raising concerns about their safety and efficacy. METHODS: This in vitro study assessed the effects of ELCA and IVL on the structural integrity of drug-eluting stents using scanning electron microscopy. Nine stents, 5 Onyx Frontier (with durable circumferential polymer coating) and 4 Cre8 (polymer-free), were implanted in a 3-dimensional coronary artery simulator following standardized protocols. After implantation, treatments with saline-ELCA, contrast-ELCA, IVL, and high-pressure balloon dilatation were applied. A comprehensive evaluation of the stent surface was performed at 60-fold magnification. RESULTS: Scanning electron microscopy analysis revealed significant differences in polymer damage between the techniques. High-pressure balloon dilatation and contrast-ELCA exhibited substantial polymer fragmentation and detachment compared with IVL, saline-ELCA, and conventional dilatation. High-pressure balloon dilatation demonstrated the highest incidence of polymer shaving and overcoating. No significant alterations were observed in polymer-free stents, regardless of the technique used. CONCLUSIONS: IVL and saline-ELCA applied immediately after stent implantation produce minimal polymer damage, whereas high-pressure balloon dilatation and contrast-ELCA cause significant damage to the polymer coating. The integrity of polymer-free drug-eluting stent appears stable regardless of the technique used. Further research is needed to validate these findings and explore their clinical implications.