Delays in ST-Elevation Myocardial Infarction Care During the COVID-19 Lockdown: An Observational Study.

BACKGROUND: Management of ST-elevated myocardial infarction (STEMI) necessitates rapid reperfusion. Delays prolong myocardial ischemia and increase the risk of complications, including death. The COVID-19 pandemic may have impacted STEMI management. We evaluated the relative volume of hospitalizations and clinical time intervals within a regional STEMI system. METHODS: 494 patients with STEMI were grouped into pre-lockdown, lockdown and re-opening cohorts. Clinical, temporal and outcome data were collected and compared between groups for both urban and rural patients, receiving primary percutaneous coronary intervention (PCI) and pharmacoinvasive revascularization, respectively. Data was compared to a 10-year historical comparator. RESULTS: During pre-lockdown there was 238 cases versus 193 in lockdown; a 19.0% reduction in volume. When lockdown was compared to the median caseload from a 10-year historical cohort, a 19.8% reduction was observed. For patients treated with primary PCI during lockdown, median symptom-to-balloon time increased by 44-minutes [217 (IQR 157-387) vs. 261 (160-659) minutes; p=0.03]; driven by an increase in median symptom-to-door time of 41-minutes [136 (IQR 80-267) vs. 177 (IQR 90-569) minutes; p<0.01]. Only patients transferred from non-PCI facilities demonstrated an increase in door-to-reperfusion time [116 (IQR 93-150) vs. 139 (IQR 100-199) minutes; p<0.01]. More patients had left ventricular dysfunction during the lockdown [35% vs. 44%; p=0.04], but there was no difference in mortality. CONCLUSION: During the COVID-19 lockdown, fewer patients presented with STEMI. Time-to-reperfusion was significantly prolonged and appeared driven predominantly by patient-level and transfer delays. Public education and systems-level changes will be integral to STEMI care during the second wave of COVID-19.

Rationale and design of the TAILOR-PCI digital study: Transitioning a randomized controlled trial to a digital registry.

BACKGROUND: Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI) is the largest cardiovascular genotype-based randomized pragmatic trial (NCT#01742117) to evaluate the role of genotype-guided selection of oral P2Y12 inhibitor therapy in improving ischemic outcomes after PCI. The trial has been extended from the original 12- to 24-month follow-up, using study coordinator-initiated telephone visits. TAILOR-PCI Digital Study tests the feasibility of extending the trial follow-up in a subset of patients for up to 24 months using state-of-the-art digital solutions. The rationale, design, and approach of extended digital study of patients recruited into a large, international, multi-center clinical trial has not been previously described. METHODS: A total of 930 patients from U.S. and Canadian sites previously enrolled in the 5,302 patient TAILOR-PCI trial within 23 months of randomization are invited by mail to the Digital Study website (http://tailorpci.eurekaplatform.org) and by up to 2 recruiting telephone calls. Eureka, a direct-to-participant digital research platform, is used to consent and collect prospective data on patients for the digital study. Patients are asked to answer health-related surveys at fixed intervals using the Eureka mobile app and or desktop platform. The likelihood of patients enrolled in a randomized clinical trial transitioning to a registry using digital technology, the reasons for nonparticipation and engagement rates are evaluated. To capture hospitalizations, patients may optionally enable geofencing, a process that allows background location tracking and triggering of surveys if a hospital visit greater than 4 hours is detected. In addition, patients answer digital hospitalization surveys every month. Hospitalization data received from the Digital Study will be compared to data collected from study coordinator telephone visits during the same time frame. CONCLUSIONS: The TAILOR-PCI Digital Study evaluates the feasibility of transitioning a large multicenter randomized clinical trial to a digital registry. The study could provide evidence for the ability of digital technology to follow clinical trial patients and to ascertain trial-related events thus also building the foundation for conducting digital clinical trials. Such a digital approach may be especially pertinent in the era of COVID-19.