Cardiac troponin T estimation post elective stent implantation and prediction of early and late outcomes

Background: Coronary artery disease (CAD) is a major cause of mortality and morbidity. Per Cutaneous Interventions (PCI) is emerging as the mainstay of treatment for CAD. Periprocedural myocardial necrosis, which can range from a low-level elevation of cardiac biomarkers to a large myocardial infarction, is an important complication of PCI. There are conflicting reports regarding peri-procedural biomarker elevation and adverse outcome. It is in this context we have undertaken this study to assess the prognostic significance of cardiac troponin T elevation after elective stent implantation.Methods: The study population included 100 consecutive patients who underwent elective PCI with stent implantation in cardiology unit of Medical College, Trivandrum. Serial cardiac enzyme levels were measured in all patients undergoing the procedure. CPK was measured at 8 hrs, 16 hrs and 24 hrs and Troponin T was measured at 8hrs and 24 hrs. post PCI. In hospital events were documented and patients were on follow up for a period of 1 year. Primary endpoints of death, myocardial infarction, recurrent ischemia leading to revascularization were noted.Results: In our study population of 100 patients there were 87 males and 13 females. Among them 50% had unstable angina, 18% had exertional angina and 32% were post myocardial infarction patients. In this group of hundred patients 79% had single vessel disease, 18% had two vessels and 3% had triple vessel disease. A total of 103 stents were deployed. Mean CPK levels were CPK-1 (80.11+36.19), mean CPK-2 (83.91± 34.8) and mean CPK-3 (86.32+57.80). Mean Troponin T-1 was 0.04+0.1 and mean Troponin-2 was 0.06+0.145. In this study, we compared late onset angina with Troponin and CPK positivity and found that both Troponin-1 & Troponin-2 had significant correlation with late onset angina.Conclusions: Periprocedural Troponin T is more sensitive than CPK in predicting late events. Thrombus containing lesions and bifurcation lesions were significantly associated with elevation in Troponin T. No significant Troponin T elevations were noted in patients with diabetes mellitus and those containing calcified lesions. Drug eluting stents were associated with a relatively lesser Troponin T elevations but not statistically significant

Effect of a Quality Improvement Intervention on Clinical Outcomes in Patients in India With Acute Myocardial Infarction: The ACS QUIK Randomized Clinical Trial.

Importance: Wide heterogeneity exists in acute myocardial infarction treatment and outcomes in India. Objective: To evaluate the effect of a locally adapted quality improvement tool kit on clinical outcomes and process measures in Kerala, a southern Indian state. Design, Setting, and Participants: Cluster randomized, stepped-wedge clinical trial conducted between November 10, 2014, and November 9, 2016, in 63 hospitals in Kerala, India, with a last date of follow-up of December 31, 2016. During 5 predefined steps over the study period, hospitals were randomly selected to move in a 1-way crossover from the control group to the intervention group. Consecutively presenting patients with acute myocardial infarction were offered participation. Interventions: Hospitals provided either usual care (control group; n = 10 066 participants [step 0: n = 2915; step 1: n = 2649; step 2: n = 2251; step 3: n = 1422; step 4; n = 829; step 5: n = 0]) or care using a quality improvement tool kit (intervention group; n = 11 308 participants [step 0: n = 0; step 1: n = 662; step 2: n = 1265; step 3: n = 2432; step 4: n = 3214; step 5: n = 3735]) that consisted of audit and feedback, checklists, patient education materials, and linkage to emergency cardiovascular care and quality improvement training. Main Outcomes and Measures: The primary outcome was the composite of all-cause death, reinfarction, stroke, or major bleeding using standardized definitions at 30 days. Secondary outcomes included the primary outcome's individual components, 30-day cardiovascular death, medication use, and tobacco cessation counseling. Mixed-effects logistic regression models were used to account for clustering and temporal trends. Results: Among 21 374 eligible randomized participants (mean age, 60.6 [SD, 12.0] years; n = 16 183 men [76%] ; n = 13 689 [64%] with ST-segment elevation myocardial infarction), 21 079 (99%) completed the trial. The primary composite outcome was observed in 5.3% of the intervention participants and 6.4% of the control participants. The observed difference in 30-day major adverse cardiovascular event rates between the groups was not statistically significant after adjustment (adjusted risk difference, -0.09% [95% CI, -1.32% to 1.14%]; adjusted odds ratio, 0.98 [95% CI, 0.80-1.21]). The intervention group had a higher rate of medication use including reperfusion but no effect on tobacco cessation counseling. There were no unexpected adverse events reported. Conclusions and Relevance: Among patients with acute myocardial infarction in Kerala, India, use of a quality improvement intervention compared with usual care did not decrease a composite of 30-day major adverse cardiovascular events. Further research is needed to understand the lack of efficacy. Trial Registration: clinicaltrials.gov Identifier: NCT02256657

Open-labeled randomized controlled trial to evaluate the 1-year clinical outcomes of polymer-free sirolimus-eluting coronary stents as compared with biodegradable polymer-based sirolimus-eluting coronary stents

Background: Head to head trials of clinical outcomes of sirolimus eluting polymer free vs. biodegradable polymer stents are lacking. Methods: Single centre prospective open labeled randomised controlled clinical trial. Basis for sample size calculation was the rate of MACE from the ISAR TEST 3 trial in which the absolute difference was 10.25% with a standard deviation of 0.24. Assuming null hypothesis, 80% power and 5% alpha error, to detect a 10% difference, adjusting for 10% loss of follow up, sample size was 204. Inclusion criteria: Patients with stable coronary artery disease or recent acute coronary syndrome ( >1 week from the date of STEMI), being taken up for elective angioplasty. End points: Primary end point was MACE at 1 year and secondary end points at the end of 1 year were cardiac death, urgent target lesion revascularization, acute coronary syndrome, stroke and in-stent re-stenosis. Results: 204 patients were enrolled between January 2013 to July 2014, 91 in the polymer-free group and 113 in the biodegradable polymer group. Baseline characteristics were comparable between both groups. 21 patients (10.29%), were lost to follow up. MACE at 1 year were comparable in both the groups 3 of 85(3.52%) in the polymer-free group and 3 of 98(3.06%) in the biodegradable polymer group, p = 0.859. The secondary end points were also comparable between the two groups- Death- 1 of 85(1.17%) vs. 2 of 98(2.04%), p = 0.646, Stroke 0 of 85 vs. 2 of 98(2.04%), p = 0.185 and acute coronary syndrome – 2 of 85(2.35%) vs. 1 of 98(1.02%), p = 0.204. There were no instances of urgent target lesion re-vascularisation or definite stent thrombosis in either groups. In stent re-stenosis was found in 7 of 85(8.2%) in the polymer-free group vs. 6 of 98(6.12%) in the biodegradable polymer group. Conclusion: The 1 year MACE rates are comparable in patients who underwent elective coronary revascularization using sirolimus eluting polymer-free and biodegradable polymer stents. Keywords: Polymer-free, Biodegradable polymer, Stent thrombosis, Sirolimus, Randomised controlled tria

Rheumatic Heart Disease in Kerala: A Vanishing Entity? An Echo Doppler Study in 5–15-Years-Old School Children

Background. Early detection of subclinical rheumatic heart disease by use of echocardiography warrants timely implementation of secondary antibiotic prophylaxis and thereby prevents or retards its related complications. Objectives. The objective of this epidemiological study was to determine prevalence of RHD by echocardiography using World Heart Federation criteria in randomly selected school children of Trivandrum. Methods. This was a population-based cross-sectional screening study carried out in Trivandrum. A total of 2060 school children, 5–15 years, were randomly selected from five government and two private (aided) schools. All enrolled children were screened for RHD according to standard clinical and WHF criteria of echocardiography. Results. Echocardiographic examinations confirmed RHD in 5 children out of 146 clinically suspected cases. Thus, clinical prevalence was found to be 2.4 per 1000. According to WHF criteria of echocardiography, 12 children (12/2060) were diagnosed with RHD corresponding to echocardiographic prevalence of 5.83 cases per 1000. As per criteria, 6 children were diagnosed with definite RHD and 6 with borderline RHD. Conclusions. The results of the current study demonstrate that echocardiography is more sensitive and feasible in detecting clinically silent RHD. Our study, the largest school survey of south India till date, points towards declining prevalence of RHD (5.83/1000 cases) using WHF criteria in Kerala