Testing P2Y12 platelet inhibitors generics beyond bioequivalence: a parallel single-blinded randomized trial.

Cardiovascular diseases are the leading cause of death worldwide. Ticagrelor is an oral antiplatelet drug used in acute coronary syndrome. Although generic drugs are approved for their bioequivalence to the original product, they are not necessarily to be therapeutically equivalent. This study was conducted to prove the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers. A loading dose of 180 mg ticagrelor named Brilique® or Ticaloguard® followed by a 90 mg twice daily regimen as maintenance dose was given to 14 and 15 volunteers in Tica and Brili groups, respectively. The platelet aggregation on the ADP agonist was assessed at baseline and repeated 1 h and 3 h after the loading dose, on day 4 (after reaching steady-state), 12 and 24 h after discontinuation of the antiplatelet drug. Adverse effects from trial medications were noted by direct questions. It was shown that generic Ticaloguard® provides a similar therapeutic effect and safety as its branded Brilique® (p > 0.05). This will permit safe and trusted use of the generic Ticaloguard® when treating it in the same manner as Brilique®. Testing generic drug effects rather than simple bioequivalency, especially for drugs that are used in critical life-threatening situations, is crucial. We advocate applying this form of a clinical trial to test surrogate clinical efficacy for generics used in critical indications before having real-world data whenever possible.

Intravascular ultrasound-guided percutaneous coronary intervention for patients with unprotected left main coronary artery lesions.

BACKGROUND: In percutaneous coronary intervention (PCI) procedures for patients with unprotected left main coronary artery (ULMCA) lesions, intravascular ultrasonography (IVUS) guidance has shown potential for enhancing clinical outcomes. However, studies confirming its superiority to conventional angiographic-guided PCI remain few. This study aimed to assess if IVUS-guided PCI for patients with unprotected LMCA stenosis improves clinical outcomes compared to angiographic-guided PCI. METHODS: This randomized clinical study enrolled 181 patients with ULMCA lesions scheduled for drug-eluting stent implantation. Patients were split into 90 in the IVUS-guided group and 91 in the conventional group. Procedural characteristics, clinical outcomes, and the incidence of major adverse cardiovascular event (MACE) were evaluated for all patients. The risk reduction associated with IVUS-guided PCI was evaluated using a multivariate Cox regression analysis. RESULTS: Patients who underwent IVUS demonstrated significantly higher pre-dilatation before stenting (88.9% vs. 72.5%, P  = 0.005), post-dilatation balloon diameter (4.46 ±â€…0.48 vs. 4.21 ±â€…0.49, P  < 0.001), stent diameter (3.9 ±â€…0.4 vs. 3.7 ±â€…0.3, P  = 0.002), and pressure for post dilatation (18 ±â€…3 vs. 16 ±â€…2, P  = 0.001). Regarding 12-month outcomes, patients who underwent IVUS demonstrated significantly lower MACE (3.3% vs. 18.7%, P  < 0.001) than those who underwent the conventional method. Multivariate Cox regression analysis revealed that IVUS was related to 84.4% risk reduction of 1-year MACE (HR = 0.156, 95% CI = 0.044-0.556, P  = 0.004). CONCLUSION: Compared to angiographic-guided PCI, IVUS-guided PCI resulted in improved clinical results and a markedly reduced risk of MACE in patients with ULMCA lesions.

Impact of dapagliflozin on cardiac function following anterior myocardial infarction in non-diabetic patients - DACAMI (a randomized controlled clinical trial).

BACKGROUND: The role of Sodium-glucose co-transporter 2 inhibitors (SGLT2i) in heart failure is established. Early data also suggests their favorable role in patients with acute coronary syndromes, but more evidence is still needed. METHODS: In this dual center, double-blinded randomized controlled trial, non-diabetic patients (N = 100) who presented with anterior ST- elevation myocardial infarction (STEMI) & had undergone successful primary percutaneous coronary intervention, but their left ventricular ejection fraction was below 50%, were randomized to dapagliflozin 10 mg or a placebo once daily. The primary endpoint was a change in cardiac function assessed by N-terminal pro-Brain Natriuretic Peptide - NT-proBNP measured at baseline & 12 weeks post the cardiac event &/or echocardiographic parameters (left ventricular ejection fraction, left ventricular diastolic dimension & left ventricular mass index) assessed at baseline, 4-weeks & 12-weeks post the cardiac event. RESULTS: From October 2021 to April 2022, 100 patients were randomized. The mean drop of NT- proBNP in the study group was more significant compared to the control group by 10.17% (95% CI: -3.28-19.67, p-value 0.034). In addition, the decrease in the left ventricular mass index (LV mass index) was also significant in the study group compared to the control group by 11.46% (95% CI: -19.37 to -3.56, p-value 0.029). CONCLUSIONS: Dapagliflozin seems to have a role in preventing left ventricular dysfunction & maintaining cardiac function following anterior ST-elevation myocardial infarction. More Large-scale trials need to be done to confirm these findings further. This trial is locally registered at the National Heart Institute, Cairo - Egypt, and Faculty of Medicine, Ain Shams University, with reference numbers CTN1012021 & MS-07/2022, respectively. It is also registered retrospectively at the US National Institutes of Health (ClinicalTrial.gov) with identifier number: NCT05424315 - June 16th,2022.

Boosting protection for patients with non-acute cardiovascular disease: a focus on antithrombotic regimen (a consensus expert opinion from the Egyptian Society of Cardiology working group of thrombosis and prevention).

BACKGROUND: Till the moment of this document writing, no Egyptian consensus is there to guide selection of additional antithrombotic in stable patients with established CVD. Despite use of lifestyle measures and statins, those patients with established CVD still face a considerable burden of residual risk. MAIN BODY: With the evolvement of evidence-based medicine, there have been a lot of recommendations to use additional antithrombotic medications to maximize protection for those patients. Accordingly, the Egyptian Society of Cardiology working group of thrombosis and prevention took the responsibility of providing an expert consensus on the current recommendations for using antithrombotic medications to maximize protection in stable patients with established CVD. For stable patients with established CVD, in addition to proper lifestyle measures and appropriate dose statins, we recommend long-term aspirin therapy. In patients who are unable to take aspirin and in those with a history of gastrointestinal bleeding, clopidogrel is a reasonable alternative. CONCLUSIONS: For some stable atherosclerotic CVD patients who are at high risk of cardiovascular events and at low risk for bleeding, a regimen of rivaroxaban and aspirin might be taken into consideration.

The five keys for a successful implementation of a cardiac telerehabilitation: a step-by-step effective digitalization of rehabilitation health services in Egypt.

BACKGROUND: Telerehabilitation enables patients to communicate with physicians through the Internet and may be utilized to evaluate patients' conditions and offer treatment plans. This method became necessary as a result of the COVID-19 pandemic and its influence on face-to-face rehabilitation choices. Many rehabilitation professionals throughout the world have turned to the 'online' approach, relying on smartphone and smartwatch services such as WhatsApp, Facebook, and various mobile applications that comply with the ESC requirements. MAIN BODY: Throughout this editorial, we examine the function of cardiac telerehabilitation in light of the journalistic '5 W,' taking into consideration the rising interest in this topic during the 'COVID era.' CONCLUSIONS: Telerehabilitation is the future of rehabilitation, particularly in the COVID age. Additionally, telerehabilitation has proved to be successful in the cardiac profession when compared to face-to-face treatments, implying that this type of rehabilitation may continue after the world is COVID-free, and forecasting that it would be the preferable choice in the future.