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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

To the Editor Drs Ridker and Wilson 1 proposed that statin guidelines formulate treatment recommendations through consideration of “… patient populations for whom clinical trials have demonstrated benefit.” They failed to provide a clear definition of benefit. The authors cited approximately 20 randomized clinical trials; however, the measures of benefit varied widely between some of these trials. In addition, the vascular events terminology is insufficiently specific. Efficacy measures in randomized clinical trials of statins often include outcomes that differ in their clinical importance, ranging from death to clinician-driven end points such as revascularization procedures and hospitalizations. For example, in the Scandinavian Simvastatin Survival Study (4S), 2 in which participants with a history of coronary heart disease were enrolled, the primary efficacy measure was total mortality. In the Subcutaneous Heparin and Angioplasty Restenosis Prevention (SHARP) trial, 3 in which participants with chronic kidney disease were enrolled, the modified efficacy outcome was a broad composite of events (ie, nonfatal myocardial infarction, coronary death, nonhemorrhagic stroke, or any arterial revascularization procedure). In fact, a reduction in revascularization procedures contributed most to the statistically significant result in SHARP. 4 Even though total mortality was reduced in the 4S trial (relative risk, 0.70 [95% CI, 0.58-0.85]; P < .001), this was not the case in SHARP (rate ratio, 1.02 [95% CI, 0.941.11]; P =. 63). Despite the qualitative differences in the benefit demonstrated in these 2 clinical settings, Ridker and Wilson 1 endorsed statin therapy equally for patients with chronic kidney disease as for patients with a history of coronary heart disease. The authors suggested incorporation of the number needed to treat metric into clinical decision making, but the number needed to treat for which outcome? Guidelines that use oversimplified and ambiguous references to benefit or lack of benefit (without specification of the efficacy measures tested in the relevant trials) are unlikely to be usable by clinicians and patients. In our view, before guideline panels engage in interpretation and application of evidence, they should first specify for guideline users a hierar

Clinical Question Is fixed-dose combination therapy (polypill) that combines antiplatelet, blood pressure–lowering, and cholesterol-lowering medications into a single pill associated with improved cardiovascular disease (CVD) risk factors or reduced all-cause mortality or fatal and nonfatal CVD events? Is the polypill associated with an increase in adverse events? Bottom Line Polypills are associated with greater reductions in systolic blood pressure and total cholesterol compared with usual care, placebo, or active comparators, but also with a 19% higher risk of any adverse event. Due to limited power from available evidence, the association of polypills with all-cause mortality or fatal and nonfatal CVD events is uncertain.