Rationale and design of the TUXEDO-2 India study: Ultra-Thin strUt Supraflex Cruz versus XiencE in a Diabetic pOpulation with multi-vessel disease-2.

BACKGROUND: The role of percutaneous coronary interventions (PCI) in patients with diabetes mellitus and multi-vessel disease has been questioned by the results of the FREEDOM trial, which showed superiority of coronary artery bypass graft(CABG) over first generation drug-eluting stents (DES) including a reduction in mortality. In the light of safer and more efficacious stents and significantly better medical management, those results that date back to 2012 need to be revisited. TUXEDO-2 is a study designed to compare two contemporary stents in Indian diabetic patients with multi-vessel disease. AIMS: The primary objective of the TUXEDO-2 study is to compare the clinical outcomes of PCI with ultra-thin Supraflex Cruz vs Xience when combined with contemporary optimal medical therapy (OMT) in diabetic patients with multi-vessel disease. The secondary objective is to compare clinical outcomes between a pooled cohort from both arms of the study (Supraflex Cruz + Xience; PCI arm) vs CABG based on a performance goal derived from the CABG arm of the FREEDOM trial (historical cohort). The tertiary objective is a randomized comparison of ticagrelor vs prasugrel in addition to aspirin for the composite of ischemic and bleeding events. METHODS: In this prospective, open-label, multi-centre, 2 × 2 factorial, randomized, controlled study, 1,800 patients with diabetes mellitus and multi-vessel disease (inclusion criteria similar to FREEDOM trial) with indication for coronary revascularization will be randomly assigned to Supraflex Cruz or Xience stents and also to ticagrelor- or prasugrel- based antiplatelet strategies. All patients will receive guideline directed OMT and optimal PCI including image- and physiology-guided complete revascularization where feasible. The patients will be followed through five years to assess their clinical status and major clinical events. The primary endpoint is a non-inferiority comparison of target lesion failure at one-year for Supraflex Cruz vs Xience (primary objective) with an expected event rate of 11% and a non-inferiority margin of 4.5%. For PCI vs CABG (secondary objective), the primary endpoint is major adverse cardiac events (MACE), defined as a composite of all cause death, nonfatal myocardial infarction, or stroke at one-year and yearly up to five years, with a performance goal of 21.6%. For ticagrelor vs prasugrel (tertiary objective), the primary endpoint is composite of death, myocardial infarction, stroke, and major bleeding as per the Bleeding Academic Research Consortium (BARC) at one-year with expected event rate of 15% and a non-inferiority margin of 5%. CONCLUSIONS: The TUXEDO-2 study is a contemporary study involving state-of-the-art PCI combined with guideline directed OMT in a complex subset of patients with diabetes mellitus and multi-vessel disease. The trial will answer the question as to whether a biodegradable polymer coated ultra-thin Supraflex Cruz stent is an attractive option for PCI in diabetic patients with multi-vessel disease. It will also help address the question whether the results of FREEDOM trial would have been different in the current era of safer and more efficacious stents and modern medical therapy. In addition, the comparative efficacy and safety of ticagrelor vs prasugrel in addition to aspirin will be evaluated. (CTRI/2019/11/022088).

Influence of SGLT2 Inhibitors in Remodeling, Substrate and Ion Metabolism of Myocardium to Prevent Cardiovascular Risks: Recent Work and Advancement.

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a new class of drugs that lower blood glucose levels while decreasing blood pressure, volume loss, and weight loss. SGLT2 inhibitors were studied to determine their effectiveness in treating cardiovascular disease and their side effects. Study outcomes related to cardiovascular and metabolic outcomes were examined in patients on SGLT2 inhibitors by searching PubMed, Embase, Cochrane, and SCOPUS. Articles related to clinical trials, reviews, and meta-analyses were considered. A review of SGLT2 inhibitors' mechanisms of action in preventing cardiovascular (CVS) disease progression was described. We then reviewed the possible effects of SGLT2 inhibitors on CVS dysfunction development, composition, and stability. In the following, we discussed the impact of SGLT2 inhibitors on CVD events, such as ischemic strokes and myocardial infarctions, and their role in treating congestive heart failure and cardiovascular mortality.

Stellate ganglion block as rescue therapy in drug-resistant electrical storm.

Electrical storm or incessant ventricular tachycardia is a life-threatening condition and is associated with high morbidity and mortality. Often patients respond to traditional anti-arrhythmia treatment. However, some patients are resistant to the drug therapy and thus, pose huge challenges in effective management. Though stellate ganglion block has been found to be effective in treating patients with electrical storm, it is still under-utilized. In this case report, we successfully managed to revert the drug-resistant arrhythmia to sinus rhythm after ultrasound-guided stellate ganglion block. Earlier utilization of the block can possibly provide effective treatment in drug-resistant ventricular arrhythmias and prevent morbidity and mortality.

Thrombocytapheresis: managing essential thrombocythemia in a surgical patient.

A 73-year-old man presented with acute chest pain and shortness of breath suggestive of unstable angina. A detailed investigation revealed essential thrombocythemia and coronary artery pathology. With a baseline platelet count of 2,650×10(3)/µL, coronary artery bypass grafting became nearly impossible. Three therapeutic plateletpheresis procedures successfully lowered the platelet count to 367×10(3)/µL. Thereafter, surgery was performed with no complications. Although a drop and rise in platelet counts were observed postoperatively, the patient could be discharged in stable condition after 14 days. Thus, therapeutic plateletpheresis reduces platelet count rapidly in essential thrombocythemia and relieves patients of acute symptoms.

Myocardial Bridge in association with fixed atherosclerotic lesions treated with drug-eluting stents: a follow-up report with quantitative coronary analysis.

Stenting of muscle bridge is still a controversial issue with concerns regarding high restenosis rates, plaque prolapse and stent fracture. We report a case with significant atherosclerotic disease of right coronary artery and left anterior descending artery associated with a muscle bridge, proximal to the diseased segment which became more prominent after stenting the fixed lesion. This was managed by implanting another drug eluting stent, covering the bridge. Angiographic follow-up at 9 months revealed no difference in quantitative coronary angiography parameters in the stented segment of the bridge, as compared to other stented segments.