ABSTRACT
OBJECTIVE: Supraflex (Sahajanand Medical Technologies Pvt. Ltd, Surat, India) is the latest generation of biodegradable polymer-coated sirolimus-eluting coronary stent designed on ultra-thin (60 µm) cobalt-chromium platform with flexible 'S-link.' The present study was designed to establish the safety and clinical performance of Supraflex in real-world Indian patients with coronary artery disease. METHODS: The study included 839 consecutive patients with coronary artery disease who were implanted with Supraflex from January 2014 to August 2017 at six different tertiary care centers in India. Follow-up was performed at 30 days, 6 months, and 12 months after the index procedure. The primary end-point of the study was the incidence of major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) at the 12-month follow-up. The occurrence of stent thrombosis was analyzed as safety end-point. RESULTS: A total of 1025 lesions were treated by implantation of 1098 Supraflex stents. At the 12-month follow-up, MACE was 4.92%, including 7 (0.86%) cardiac deaths, 16 (1.97%) MI, and 17 (2.09%) TLR. Only three incidences of stent thrombosis were found at the 12-month follow-up. CONCLUSION: The study results showed excellent safety and clinical effectiveness of Supraflex in a high proportion of high-risk real-world Indian patients with coronary artery disease.
Subject(s)
Coronary Stenosis/surgery , Drug-Eluting Stents , Immunosuppressive Agents , Sirolimus , Coronary Stenosis/mortality , Female , Humans , India , Male , Middle Aged , Percutaneous Coronary Intervention , Survival Analysis , Tertiary Care Centers , Treatment OutcomeABSTRACT
OBJECTIVES: In a randomized double-blind crossover trial, we compared the efficacy of phosphodiesterase-5 (PDE-5) inhibitor tadalafil with placebo in patients of Eisenmenger Syndrome (ES). The primary end point was the change in 6-minute walk test distance (6 MWD). Secondary end points were the effect of the drug on systemic oxygen saturation (SO(2) ), pulmonary vascular resistance (PVR), systemic vascular resistance (SVR), effective pulmonary blood flow (EPBF), and World Health Organization (WHO) functional class. BACKGROUND: ES is a disorder with limited treatment options. Uncontrolled studies have shown PDE-5 inhibitors to be beneficial in patients of ES. METHODS: Twenty-eight symptomatic adult patients of ES with weight ≥30 kg in WHO class II and III were enrolled. Patients were given 40 mg of tadalafil or matching placebo for 6 weeks followed by crossover to the other drug after a washout period of 2 weeks. Assessment of WHO class, exercise capacity by 6 MWD, and various hemodynamic parameters by cardiac catheterization was done at baseline, after 6 weeks and at the end of the study. RESULTS: All patients completed the study. There was significant increase in 6 MWD following drug administration compared with baseline (404.18 ± 69.54 m vs. 357.75 ± 73.25 m, P < .001). Compared with placebo, tadalafil produced significant decrease in PVR (-7.32 ± 1.58, P < .001), resulting in significant increase in EPBF (0.12 ± 0.05, P= .03), SO(2) % (1.72 ± 0.58, P= .007), and WHO functional class (1.96 ± 0.18 vs. 2.14 ± 0.44, P= .025), with no significant change in SVR (P= NS). CONCLUSION: In this first short-term placebo-controlled trial of tadalafil in patients of ES, the drug was well tolerated and significantly improved exercise capacity, functional class, SO(2) , and pulmonary hemodynamics.
Subject(s)
Carbolines/therapeutic use , Eisenmenger Complex/drug therapy , Phosphodiesterase 5 Inhibitors/therapeutic use , Vasodilator Agents/therapeutic use , Adolescent , Adult , Carbolines/adverse effects , Cardiac Catheterization , Cross-Over Studies , Double-Blind Method , Eisenmenger Complex/blood , Eisenmenger Complex/diagnosis , Eisenmenger Complex/enzymology , Eisenmenger Complex/physiopathology , Exercise Test , Exercise Tolerance/drug effects , Female , Hemodynamics/drug effects , Humans , India , Male , Oxygen/blood , Phosphodiesterase 5 Inhibitors/adverse effects , Placebo Effect , Tadalafil , Time Factors , Treatment Outcome , Vasodilator Agents/adverse effects , Young AdultSubject(s)
Coronary Disease/diagnosis , Coronary Sinus/pathology , Adult , Coronary Disease/etiology , Coronary Disease/pathology , Coronary Sinus/diagnostic imaging , Dilatation, Pathologic , Echocardiography, Doppler, Color , Female , Humans , Mitral Valve Stenosis/complications , Predictive Value of Tests , Tricuspid Valve Insufficiency/complications , Vascular Malformations/complications , Vena Cava, Inferior/abnormalitiesABSTRACT
Reversal of anticoagulant effect of heparin to treat coronary perforation after bare metal stent implantation is an accepted practice. However this practice may not be safe following drug eluting stent implantation. We report a case of acute stent thrombosis following protamine administration for coronary perforation after drug eluting stent implantation.
Subject(s)
Coronary Stenosis/drug therapy , Drug-Eluting Stents , Graft Occlusion, Vascular/chemically induced , Heparin Antagonists/adverse effects , Heparin/administration & dosage , Protamines/adverse effects , Sirolimus/administration & dosage , Acute Disease , Aged , Coronary Angiography , Echocardiography , Electrocardiography , Female , HumansABSTRACT
We report a rare case of a 25-year-old asymptomatic female who was referred for evaluation of a cardiac murmur. She had recent history of treatment for pulmonary tuberculosis. On investigation, she was diagnosed with left ventricular pseudoaneurysm (PSA) likely secondary to rupture of myocardial tubercular abscess. She was operated successfully for the left ventricular PSA and was discharged from the hospital in a good condition.