STREAM-2: Half-Dose Tenecteplase or Primary Percutaneous Coronary Intervention in Older Patients With ST-Segment-Elevation Myocardial Infarction: A Randomized, Open-Label Trial.

BACKGROUND: ST-segment-elevation myocardial infarction (STEMI) guidelines recommend pharmaco-invasive treatment if timely primary percutaneous coronary intervention (PCI) is unavailable. Full-dose tenecteplase is associated with an increased risk of intracranial hemorrhage in older patients. Whether pharmaco-invasive treatment with half-dose tenecteplase is effective and safe in older patients with STEMI is unknown. METHODS: STREAM-2 (Strategic Reperfusion in Elderly Patients Early After Myocardial Infarction) was an investigator-initiated, open-label, randomized, multicenter study. Patients ≥60 years of age with ≥2 mm ST-segment elevation in 2 contiguous leads, unable to undergo primary PCI within 1 hour, were randomly assigned (2:1) to half-dose tenecteplase followed by coronary angiography and PCI (if indicated) 6 to 24 hours after randomization, or to primary PCI. Efficacy end points of primary interest were ST resolution and the 30-day composite of death, shock, heart failure, or reinfarction. Safety assessments included stroke and nonintracranial bleeding. RESULTS: Patients were assigned to pharmaco-invasive treatment (n=401) or primary PCI (n=203). Median times from randomization to tenecteplase or sheath insertion were 10 and 81 minutes, respectively. After last angiography, 85.2% of patients undergoing pharmaco-invasive treatment and 78.4% of patients undergoing primary PCI had ≥50% resolution of ST-segment elevation; their residual median sums of ST deviations were 4.5 versus 5.5 mm, respectively. Thrombolysis In Myocardial Infarction flow grade 3 at last angiography was ≈87% in both groups. The composite clinical end point occurred in 12.8% (51/400) of patients undergoing pharmaco-invasive treatment and 13.3% (27/203) of patients undergoing primary PCI (relative risk, 0.96 [95% CI, 0.62-1.48]). Six intracranial hemorrhages occurred in the pharmaco-invasive arm (1.5%): 3 were protocol violations (excess anticoagulation in 2 and uncontrolled hypertension in 1). No intracranial bleeding occurred in the primary PCI arm. The incidence of major nonintracranial bleeding was low in both groups (<1.5%). CONCLUSIONS: Halving the dose of tenecteplase in a pharmaco-invasive strategy in this early-presenting, older STEMI population was associated with electrocardiographic changes that were at least comparable to those after primary PCI. Similar clinical efficacy and angiographic end points occurred in both treatment groups. The risk of intracranial hemorrhage was higher with half-dose tenecteplase than with primary PCI. If timely PCI is unavailable, this pharmaco-invasive strategy is a reasonable alternative, provided that contraindications to fibrinolysis are observed and excess anticoagulation is avoided. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02777580.

Observational study of left ventricular global longitudinal strain in ST-segment elevation myocardial infarction patients with extended pharmaco-invasive strategy: A six months follow-up study.

AIMS AND OBJECTIVES: To evaluate left ventricular (LV) function by assessment of LV global longitudinal strain (GLS) in ST-segment elevation myocardial infarction (STEMI) patients who underwent delayed fibrinolysis and coronary intervention (extended pharmaco-invasive strategy), since LV function is one of the determinants of both immediate and long-term outcomes. METHODS: Prospective study of consecutive STEMI patients who underwent extended pharmaco-invasive strategy. The LV function was estimated using LV GLS at baseline and at 6 months. RESULTS: The study included eighty-seven STEMI patients who received delayed pharmaco-invasive therapy and coronary intervention. The primary aim of the study was to evaluate a change in LV function by assessment of GLS at 6 months as compared to baseline. Prior to PCI, LV ejection fraction was 48.08 ± 6.23% and GLS was -11.11 ± 2.99%. Procedural success was achieved in all patients. LV ejection fraction after 6 months of follow-up increased to 53.12 ± 5.61% and the GLS improved to -13.03 ± 3.06% In comparison to baseline, there was a significant improvement in both LV ejection fraction and GLS at 6 months of follow-up (P < .001).The cardiac mortality was 1.1% at 6 months. CONCLUSION: There is a significant improvement of LV function as assessed by GLS and ejection fraction at short-term follow-up. In a stable cohort of STEMI patients, extended pharmaco-invasive strategy is also a reasonable option if PCI cannot be performed within the first 24 hours, due to logistic and infrastructural constraints.

Reperfusion Strategy of ST-Elevation Myocardial Infarction: A Meta-Analysis of Primary Percutaneous Coronary Intervention and Pharmaco-Invasive Therapy.

Background: Pharmaco-invasive therapy (PIT), combining thrombolysis and percutaneous coronary intervention, was a potential complement for primary percutaneous coronary intervention (pPCI), while bleeding risk was still a concern. Objectives: This study aims to compare the efficacy and safety outcomes of PIT and pPCI. Methods: A systematic search for randomized controlled trials (RCTs) and observational studies were conducted on Pubmed, Embase, Cochrane library, and Scopus. RCTs and observational studies were all collected and respectively analyzed, and combined pooled analysis was also presented. The primary efficacy outcome was short-term all-cause mortality within 30 days, including in-hospital period. The primary safety outcome was 30-day trial-defined major bleeding events. Results: A total of 26,597 patients from 5 RCTs and 12 observational studies were included. There was no significant difference in short-term mortality [RCTs: risk ratio (RR): 1.14, 95% CI: 0.67-1.93, I 2 = 0%, p = 0.64; combined results: odds ratio (OR): 1.09, 95% CI: 0.93-1.29, I 2 = 0%, p = 0.30] and 30-day major bleeding events (RCTs: RR: 0.44, 95% CI: 0.07-2.93, I 2 = 0%, p = 0.39; combined results: OR: 1.01, 95% CI: 0.53-1.92, I 2 = 0%, p = 0.98). However, pPCI reduced risk of in-hospital major bleeding events, stroke and intracranial bleeding, but increased risk of in-hospital heart failure and 30-day heart failure in combined analysis of RCTs and observational studies, despite no significant difference in analysis of RCTs. Conclusion: Pharmaco-invasive therapy could be an important complement for pPCI in real-world clinical practice under specific conditions, but studies aiming at optimizing thrombolysis and its combination of mandatory coronary angiography are also warranted.

Delay in Seeking Medical Treatment Among Patients With Acute Coronary Syndrome.

Background Various Indian registries have documented a delay of more than five hours for acute coronary syndrome patients from onset of symptoms to reaching thrombolysis-enabled centres. We conducted this study to evaluate the factors responsible for pre-hospital delay in acute coronary syndrome patients. Methods This was a descriptive cross-sectional study conducted in consecutive acute coronary syndrome patients who reported to the tertiary care medical centre in North India. A standardized tool was used to record the demographic data, socioeconomic status and clinical presentation of patients. All factors which led to pre-hospital delay were noted and the appropriate statistical tests were used for analysis. Results A total of 130 patients (males=93, females=37) were included in the study. The median time at which the acute coronary syndrome patients presented to the thrombolysis and percutaneous coronary intervention enabled centre was 490 minutes (range: 20 - 810 minutes) and 710 minutes (range: 45 - 940 minutes) respectively. The various factors responsible for prehospital delay were rural residence (p-value <0.0001), visit to local dispensary (p-value=0.0023), delay in getting transport (p-value=0.03) and misinterpretation of cardiac symptoms (p-value=0.0004). A significant but weak negative correlation was found between per capita income, decision making time and time taken to receive thrombolytic therapy. Out of a total of 83 ST-elevation myocardial infarction patients, only 46 (51.80%) were thrombolysed. Though 69/83 (83.13%) ST-elevation myocardial infarction patients reached thrombolysis enabled centre directly, only nine (10.84%) were thrombolysed at first medical contact; the rest were transferred to the percutaneous coronary intervention-enabled centre without any prior information.  Conclusion Our study concludes that besides socioeconomic and demographic variables, lack of public awareness, well established public transport & health insurance system lead to significant pre-hospital delays and increase the time to revascularization. Besides, judgemental error on the part of medical practitioners in the peripheries also significantly delays thrombolysis in ST-elevation myocardial infarction patients.