We aim to validate NT-proBNP nonresponse score (NNRS) previously derived from the PROTECT and BATTLESCARRED studies in comparison with standard health status measures in predicting natriuretic peptide responses in patients with heart failure with reduced ejection fraction. Data on the GUIDE-IT trial were used to derive the NNRS based on 4 predictors including baseline NT-proBNP, heart rate, NYHA functional class, and history of atrial fibrillation. The discriminative capacity of the NNRS and health status measures for having NT-proBNP >1,000 pg/mL at 12 months was assessed and compared with baseline or follow-up health status measures including Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS), Duke Activity Status Index (DASI), and 6-minute walk distance. Multivariable logistic regression analysis was used to determine the predictive value of the score and health status measures greater than the median values for NT-proBNP response with adjustment for age, sex, body mass index, comorbidities, baseline creatinine and NT-proBNP levels. Among 877 patients, 252 (28.7%) patients had NT-proBNP >1,000 pg/mL at 12 months. The discriminative capacity of the NT-proBNP nonresponse score was 0.72 (95% CI, 0.67-0.77). After adjusting for covariates, only NNRS (P = .044) and KCCQ-OSS (P = .002) remained predictive for NT-proBNP nonresponse at 12 months. NT-proBNP nonresponse score and KCCQ-OSS was associated with persistently elevated NT-proBNP 12 months independently of baseline NT-proBNP levels.

Percutaneous coronary intervention of severely calcified lesions is limited by inadequate stent expansion and poor clinical outcomes. Over the past decade, several devices and techniques have been developed for calcium modification and lesion preparation. Intravascular lithotripsy (IVL) is a novel tool in this context. Although numerous observational studies have been reported on this technique, randomized trials powered for clinical outcomes on the relative merits of IVL in patients with severely calcified lesions are lacking. The ISAR-WAVE trial is a multicenter, prospective, randomized, single-blind controlled trial. The aim is to test whether IVL is superior to other calcium-modifying techniques (modified or super high-pressure balloon and atheroablative devices) in de novo severely calcified coronary lesions. The study is planned to enroll 666 patients. The primary endpoint is the composite of major cardiac and cerebrovascular adverse events defined as death, nonfatal myocardial infarction, nonfatal stroke and clinically indicated target vessel revascularization at 12 months. In addition to the individual components of the primary endpoint, secondary endpoints include also safety, quality of life and cost-effectiveness measures. ISAR-WAVE is a multicenter, randomized trial designed to test the hypothesis that a strategy of IVL confers superior clinical performance compared to other calcium-modifying techniques in patients undergoing percutaneous intervention for a de novo severely calcified coronary artery lesion. ClilicalTrial.gov, NCT06369142.