Combination Therapy With Nicardipine and Isosorbide Dinitrate to Prevent Spasm in Transradial Percutaneous Coronary Intervention (from the NISTRA Multicenter Double-Blind Randomized Controlled Trial).

Verapamil and nitroglycerin are widely used to prevent radial artery spasm (RAS) during percutaneous cardiovascular procedures. However, these agents are not typically available in most African countries and consequently, isosorbide dinitrate is often the only spasmolytic treatment. Our aim was to compare the efficacy of isosorbide dinitrate alone versus isosorbide dinitrate used together with nicardipine to prevent RAS during transradial coronary procedures. This was a randomized controlled double-blind multicenter trial. Patients (n = 1,523) were randomized to receive either a sole therapy of isosorbide dinitrate (n = 760) or the combination of isosorbide dinitrate and nicardipine (n = 763). Our primary end point was the occurrence of RAS; defined as considerable perceived hindrance of catheter advancement. Our secondary end points were severe RAS; defined as (1) severe arm pain, (2) the need for either morphine or midazolam treatment, and (3) necessity for crossover to the contralateral radial or femoral artery. RAS incidence was reduced with the combination therapy versus isosorbide dinitrate alone (15% vs 25%, p <0.001), with a number needed to treat of 10 patients. There was also a significant reduction in the incidence of the secondary end points with combination therapy (3.6% vs 8.2%, p <0.001), with a number needed to treat of 22 patients. This result was driven by reductions in both femoral crossover (0.5% vs 2.4%, p = 0.003) and the use of morphine or midazolam injections (1.6% vs 3.5%, p = 0.02) with combination therapy. In conclusion, we demonstrated the superiority of the combination therapy of isosorbide dinitrate and nicardipine over isosorbide dinitrate alone in reducing the incidence of RAS.

The impact of right bundle branch block and SIQIII-type patterns in determining risk levels in acute pulmonary embolism.

Background: Electrocardiography (ECG) findings in acute pulmonary embolism (PE) are known to be related to various right ventricular (RV) alterations. These abnormalities are not included in risk stratification algorithms despite emerging evidence of their association with patient outcomes. We aimed to analyze the impact of right bundle branch block (RBBB) and/or SIQIII patterns as indicators for determining the level of risk in patients with PE. Methods: We performed a retrospective cohort study including all patients with confirmed acute PE hospitalized from January 2008 to December 2019 in two tertiary care cardiology departments. The first ECG taken at admission was selected and the analysis focused on the presence of a complete or an incomplete RBBB and SIQIII-type patterns. Results: A total of 255 patients were divided into two groups: Group I (47.8%, n=122) included patients with PE without RBBB nor SIQIII patterns, and Group II (52.2%, n=133) included patients with RBBB and/or SIQIII patterns. Patients in group II presented significantly more frequently with acute right heart symptoms (45.1% vs. 18%, p<0.001) and cardiogenic shock at admission (31.6 vs. 4.1%, p<0.001). Echocardiographic parameters indicating right heart injury also occurred more significantly in group II patients (p<0.001). By univariate analysis, patients in group II were found to be significantly associated with in-hospital mortality (22.6 vs. 6.1%, p=0.002) and major cardiovascular events (MACEs) during hospitalization (43.3 vs. 13.7%, p<0.001). Multivariate logistic regression analysis identified five independent factors predictive of MACEs: SIQIII and/or RBBB, renal failure, positive troponin levels, RV dysfunction and right heart failure symptoms during initial presentation. Kaplan-Meier survival analysis identified the inclusion in Group II and the presence of SIQIII pattern as predictors of overall mortality (p<0.001). Conclusions: Our study suggests an important and independent prognostic value of RBBB and SIQIII patterns and their usefulness in determining the outcome of PE patients.

Design and Rationale of the National Tunisian Registry of Percutaneous Coronary Intervention: Protocol for a Prospective Multicenter Observational Study.

BACKGROUND: Coronary artery diseases remain the leading cause of death in the world. The management of this condition has improved remarkably in the recent years owing to the development of new technical tools and multicentric registries. OBJECTIVE: The aim of this study is to investigate the in-hospital and 1-year clinical outcomes of patients treated with percutaneous coronary intervention (PCI) in Tunisia. METHODS: We will conduct a prospective multicentric observational study with patients older than 18 years who underwent PCI between January 31, 2020 and June 30, 2020. The primary end point is the occurrence of a major adverse cardiovascular event, defined as cardiovascular death, myocardial infarction, cerebrovascular accident, or target vessel revascularization with either repeat PCI or coronary artery bypass grafting (CABG). The secondary end points are procedural success rate, stent thrombosis, and the rate of redo PCI/CABG for in-stent restenosis. RESULTS: In this study, the demographic profile and the general risk profile of Tunisian patients who underwent PCI and their end points will be analyzed. The complexity level of the procedures and the left main occlusion, bifurcation occlusion, and chronic total occlusion PCI will be analyzed, and immediate as well as long-term results will be determined. The National Tunisian Registry of PCI (NATURE-PCI) will be the first national multicentric registry of angioplasty in Africa. For this study, the institutional ethical committee approval was obtained (0223/2020). This trial consists of 97 cardiologists and 2498 patients who have undergone PCI with a 1-year follow-up period. Twenty-eight catheterization laboratories from both public (15 laboratories) and private (13 laboratories) sectors will enroll patients after receiving informed consent. Of the 2498 patients, 1897 (75.9%) are managed in the public sector and 601 (24.1%) are managed in the private sector. The COVID-19 pandemic started in Tunisia in March 2020; 719 patients (31.9%) were included before the COVID-19 pandemic and 1779 (60.1%) during the pandemic. The inclusion of patients has been finished, and we expect to publish the results by the end of 2022. CONCLUSIONS: This study would add data and provide a valuable opportunity for real-world clinical epidemiology and practice in the field of interventional cardiology in Tunisia with insights into the uptake of PCI in this limited-income region. TRIAL REGISTRATION: Clinicaltrials.gov NCT04219761; https://clinicaltrials.gov/ct2/show/NCT04219761. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/24595.