Hot Line 8: SENIOR-RITA, EARTH-STEMI and SCOFF
01 Sep 2024
Hot Line 8 session described trials designed to inform various aspects of the interventional treatment of myocardial infarction (MI) and cath lab procedures.
As presented by Professor Vijay Kunadian (Newcastle University - Newcastle-Upon-Tyne, UK), the open-label SENIOR-RITA trial compared CV outcomes with an invasive strategy (angiography and, if deemed necessary, coronary revascularisation) on top of optimal medical therapy vs. optimal medical therapy alone in 1,518 patients aged ≥75 years admitted with a non-ST-elevation MI (NSTEMI). After median follow-up of 4.1 years, there was no difference in the primary endpoint of CV death or non-fatal MI between the invasive strategy group (25.6%) and the conservative strategy group (26.3%; hazard ratio [HR] 0.94, 95% CI 0.77 to 1.14; p=0.53). No differences were observed for CV death, but there was a significant reduction in non-fatal MI (11.7% with invasive vs. 15.0% with conservative; HR 0.75; 95% CI 0.57 to 0.99). Patients in the invasive strategy group also required fewer subsequent revascularisation procedures vs. the conservative strategy group (3.9% vs. 13.7%; HR 0.26; 95% CI 0.17 to 0.39). The rate of procedural complications was less than 1%. Prof. Kunadian concluded: “An invasive strategy did not reduce the primary endpoint, but we did see some benefits. Importantly, the invasive strategy appeared to be safe overall in our older patients. Including older patients in trials enables us to challenge current practice and highlights that age should not be a barrier to individualised care, including access to angiography and percutaneous coronary intervention.”
As presented by Professor Gianluca Campo (University Hospital of Ferrara - Ferrara, Italy), the EARTH-STEMI meta-analysis assessed data from 1,733 older patients (aged ≥75 years) included in 7 trials comparing complete revascularisation vs. culprit-lesion only revascularisation for the treatment of STEMI and multivessel disease. Follow-up ranged from 6 months to 6.2 years (median 2.5 years), with 20% of patients having follow-up data at 4 years. The primary endpoint – death, MI and ischaemia-driven revascularisation – was significantly reduced with complete revascularisation vs. culprit-only revascularisation at 4 years (adjusted HR [aHR] 0.78; 95% CI 0.63 to 0.96; p=0.005). At the longest follow-up, the difference between the groups was not significant (aHR 0.83; 95% CI 0.69 to 1.01; p=0.063). At the longest follow-up, there was a 24% reduction in CV death or MI with complete vs. culprit-only revascularisation (aHR 0.76; 95% CI 0.58 to 0.99; p=0.046), but no difference for all-cause mortality, CV death or non-CV death. Ischaemia-driven revascularisation was significantly reduced with complete vs. culprit-only revascularisation (HR 0.52; 95% CI 0.34 to 0.85; p=0.002). There were no significant differences between the groups for safety endpoints. “At least in the first 4 years, complete revascularisation improved outcomes in older patients with STEMI and multivessel disease. A limitation is the lack of patients followed up beyond 4 years and we await additional data to provide further information on longer-term outcomes,” concluded Prof. Campo.
Doctor David Ferreira (John Hunter Hospital - Newcastle, Australia) ended the session by revealing results from the SCOFF trial, which investigated complications in 716 patients who did or did not fast before cardiac cath lab procedures requiring conscious sedation. The primary endpoint of hypotension, aspiration pneumonia, hyperglycaemia and hypoglycaemia occurred in 19.1% in the fasting group and 12.0% in the no-fasting group (the estimate of the mean posterior difference was −5.2% [95% CI −9.6 to −0.9] and within the prespecified non-inferiority margin). Patient satisfaction was significantly better without fasting vs. with fasting. “There is now a strong case that fasting is not needed in patients undergoing these types of procedures. Removing fasting has been consistently shown to be safe, patients often prefer not to fast and there are logistical benefits to the healthcare system if patients can eat and drink normally. With this new evidence, I think it is now time to reconsider fasting requirements in clinical guidelines,” concluded Dr. Ferreira.
