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Background Cangrelor, an intravenous, reversible P2Y12 antagonist, is approved for use in patients undergoing percutaneous coronary intervention (PCI). Objectives This study sought to evaluate the efficacy and safety of cangrelor compared with clopidogrel in subgroups that did and did not receive glycoprotein IIb/IIIa inhibitors (GPIs). Methods This pooled, patient-level analysis of the 3 CHAMPION (Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition) trials analyzed all randomized patients who underwent PCI and received the study drug (n = 24,902). Only bailout/rescue GPI use was permitted, except in CHAMPION PCI, in which routine or bailout/rescue GPI use was at the site investigator’s discretion. The primary efficacy endpoint was the composite of all-cause mortality, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 h after randomization. Results Overall, 3,173 patients (12.7%) received a GPI, most commonly eptifibatide (69.4%). Despite variation in indications for GPIs, baseline characteristics were well balanced between the cangrelor and clopidogrel arms in subsets receiving and not receiving GPIs. Rates of the primary composite endpoint were lower with cangrelor compared with clopidogrel in patients who did (4.9% vs. 6.5%; odds ratio [OR]: 0.74; 95% confidence interval [CI]: 0.55 to 1.01) or did not receive a GPI (3.6% vs. 4.4%; OR: 0.82; 95% CI: 0.72 to 0.94; Pint = 0.55). Cangrelor did not increase the primary safety endpoint, GUSTO-defined severe/life-threatening bleeding, in patients who did (0.4% vs. 0.5%; OR: 0.71; 95% CI: 0.25 to 1.99) or did not receive GPIs (0.2% vs. 0.1%; OR: 1.56; 95% CI: 0.80 to 3.04; Pint = 0.21). GPI use was associated with increased risk of bleeding in both treatment arms. Conclusions Cangrelor’s efficacy in reducing ischemic complications in patients undergoing PCI was maintained irrespective of GPI administration. GPI use was associated with substantially higher bleeding rates, regardless of the randomization to cangrelor or clopidogrel. (A Clinical Trial to Demonstrate the Efficacy of Cangrelor [PCI]: NCT00305162 ; Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition [PLATFORM]: NCT00385138 ; A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI] [CHAMPION PHOENIX] [CHAMPION]: NCT01156571 )

The choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention (PCI) has been debated. Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) have produced contradictory results, ranging from equivalence between stent types to superiority of everolimus-eluting stents.We randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95% confidence interval of the risk difference. The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at the 1-year follow-up.At 1 year, paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point (rate of target-vessel failure, 5.6% vs. 2.9%; risk difference, 2.7 percentage points [95% confidence interval, 0.8 to 4.5]; relative risk, 1.89 [95% confidence interval, 1.20 to 2.99]; P=0.38 for noninferiority). There was a significantly higher 1-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure (P=0.005), spontaneous myocardial infarction (3.2% vs. 1.2%, P=0.004), stent thrombosis (2.1% vs. 0.4%, P=0.002), target-vessel revascularization (3.4% vs. 1.2%, P=0.002), and target-lesion revascularization (3.4% vs. 1.2%, P=0.002).In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. (Funded by Boston Scientific; TUXEDO-India Clinical Trials Registry-India number, CTRI/2011/06/001830).

Objectives: This study was conducted to assess the systemic drug release and distribution of sirolimus-eluting coronary stents. Methods: Twenty patients with coronary artery disease (CAD) were treated with 1, 2, or 3 a newly designed metallic stents. Blood samples were drawn at 14 time points to determine the pharmacokinetic of sirolimus. Whole blood concentrations of sirolimus were determined by using a sensitive validated high-performance liquid chromatography mass spectrometry/mass spectrometry method. Results: Minimal measurable blood levels were detectable at 7 days. Across all dose levels, individual Tmax values ranged from 1.00 hour and 12.00 hours; individual Cmax ranged from 0.73 ng/mL and 4.13 ng/mL. Conclusion: This study confirms the limited exposure of the systemic circulation of the eluted drug with the use of the Supralimus-Core® Sirolimus-Eluting Coronary Stent System (Sahajanand Medical Technologies Pvt. Ltd., Surat, India). In this study, sirolimus concentration in systemic circulation is to be safe, well-tolerated and short-lived.

The main aim of the CORE Registry was to evaluate clinical performance of the Supralimus-Core® biodegradable polymer-coated sirolimus-eluting cobalt-chromium stent (Sahajanand Medical technologies Pvt. Ltd., Surat, India) in unselected real-world patients.This was a multicenter, retrospective, non-randomized, single-arm study. A total of 376 consecutive patients treated with the Supralimus-Core® between April 2010 and June 2014 were enrolled. The primary-end point of the registry was major adverse cardiac events (MACE), which is a composite of cardiac death, target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI) and stent thrombosis (ST). Clinical follow-up were scheduled at 30-day and 6-month.The mean age of enrolled patients was 54.6±10.3 years. A total of 444 lesions were treated successfully with 457 stents (1.0±0.2 per lesion). The average stent length and diameter was 24.0±8.0 mm and 3.0±0.33 mm, respectively. Out of total patients, 300 (79.8%) were male. Diabetes, hypertension and chronic totally occluded lesions were found in 95 (25.3%), 102 (27.1%) and 125 (28.2%) patients, respectively, reflecting high-risk patients involvement. The incidence of MACE at 30-day and 6-month was found to be in 4 (1.1 %) and 4 (1.1%) patients, respectively. The TLR and ST was found in 1 (0.3 %) and 1 (0.3 %) patient respectively at 6-month follow-up.The lower incidence of MACE, TLR and ST clearly delineates safety and efficacy of Supralimus-Core sirolimus-eluting stent in "real-world" patients with complex coronary lesions.

Objectives. The present study was performed to determine the outcome of emergent balloon mitral valvotomy (BMV) in patients with cardiac arrest, pulmonary edema or cardiogenic shock.Background. In India, many patients with mitral stenosis present in critical condition. They have high mortality despite surgical relief. The role of BMV in such patients is ill-defined.Methods. Of 558 patients undergoing BMV between January 1993 and December 1994, 40 presented with cardiogenic shock, cardiac arrest or pulmonary edema refractory to medical treatment and underwent emergent BMV (group I). Elective BMV was performed in the remaining 518 patients (group II).Results. Age ([mean ± SD] 40 ± 13 vs. 31 ± 9 years, p < 0.05), incidence of atrial fibrillation (35% vs. 11%, p < 0.05), pulmonary artery systolic pressure (PAsP) (64 ± 14 vs. 51 ± 12 mm Hg, p < 0.001) and mitral valve (MV) score (7.4 ± 1.2 vs. 6.4 ± 1, p < 0.001) were higher and MV area lower (0.74 ± 0.17 vs. 0.86 ± 0.14 cm2, p < 0.001) in group I patients. After emergent BMV in group I, mitral regurgitation occurred in 15%, and the mortality rate was 35%. Stepwise logistic regression analysis identified MV score ≥8 (p = 0.008), PAsP ≥65 mm Hg (p = 0.023) and cardiac output ≤3.151 liters/min (p = 0.001) as significant predictors of a fatal outcome. Follow-up of 1 to 16 months (median 8) was available in 20 of 26 survivors in group I, of whom 15 were asymptomatic. The gain in MV area and the decrease in transmitral gradient and PAsP obtained immediately after BMV persisted during the follow-up period.Conclusions. Emergent BMV is feasible in critically ill patients. In-hospital survivors have excellent clinical and hemodynamic status at intermediate follow-up.

Catalytic iron (CI) mediates vascular injury by generating reactive oxygen species. We evaluated role of CI in predicting mortality in patients with acute coronary syndrome (ACS) and studied association of contrast nephropathy with CI levels.We investigated 806 patients with ACS undergoing contrast exposure for a cardiac procedure who were followed up for 30 days.Overall mortality was 1.6% at 30 days. Catalytic iron at baseline predicted mortality with CI levels significantly higher in those who died, 0.45 μmol/L (0.37, 0.68) compared with survivors 0.31 μmol/L (0.21, 0.40); P = .004. Catalytic iron was associated with increased risk of death in the highest quartile compared with lower 3 quartiles (hazard ratio 7.88, P = .001) after adjustment for age, diabetes, ST deviation, Killip class, ejection fraction, baseline creatinine, hemoglobin level, and troponin. Fifty-five patients (6.8%) developed contrast nephropathy. Patients with contrast nephropathy had a 27% increase in median CI levels from baseline up to 48 hours compared with a marginal 2.9% increase in those without contrast nephropathy (0.37, 0.14 μmol/L to 0.47, 0.20 μmol/L versus 0.35, 0.12 μmol/L to 0.36, 0.14 μmol/L, P.0001). Patients with contrast nephropathy had significantly higher mortality compared with those without contrast nephropathy (9.1% vs 1.1%, P = .001).High baseline CI levels predicted mortality in patients with ACS. Occurrence of contrast nephropathy was associated with rise in CI levels and higher mortality. Therapeutic options to buffer or chelate CI may have beneficial effects on mortality in this setting.

Objectives The aim of the merit-3 study was to determine the safety and performance of the BioMime Sirolimus-Eluting Coronary Stent System (SES) in all-comer patients with coronary artery disease (CAD) in one-year clinical follow-up period. Methods The meriT-3 was a multi-centre, observational, post-marketing study conducted in 1161 patients with CAD who were implanted with BioMime SES at 15 sites in India. The primary endpoint was major adverse cardiac event (MACE) at one year defined as the composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR). Clinical follow-up was performed at 1, 6, and 12 months. Major adverse cardiac event occurred at 30 days and subsequently at 6 months and at long-term follow-up of 1 year was analyzed. Results MACE observed at 1 and 6 months follow-up was 16 (1.38%) and 21 (1.83%) respectively. Cumulative 1 year MACE was 26 (2.35%) with 16 (1.39%) all cause death, 4 (0.35%) MI and 6 (0.52%) TLR. In addition, ST was observed in 1 (0.09%) patient. Conclusions The present study suggests that the BioMime SES is safe and effective in a “real-world”, all-comers CAD patients, indicating low rates of MACE. CTRI Acknowledgement No REF/2016/07/011808.