Key result
Among 13,223 SIHD patients undergoing PCI, 77.3% with moderate-to-severe ischemia were eligible for the ISCHEMIA trial and had comparable outcomes to the RCT participants.
Why the study?
The applicability and potential influence of the ISCHEMIA trial findings in daily clinical practice remained unclear.
Are the results of the ISCHEMIA trial applicable to real-world stable ischemic heart disease patients undergoing PCI?
Cohort (n=13,223)
Yes
Are the results of the ISCHEMIA trial applicable to real-world stable ischemic heart disease patients undergoing PCI?
The ISCHEMIA trial results are highly applicable to real-world practice, as over three-quarters of SIHD patients undergoing PCI would have been eligible for the trial and share similar characteristics and outcomes.
Supports applicability of ISCHEMIA findings to most real-world SIHD PCI patients; extends RCT evidence via observational cohort data.
In the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial, an early invasive strategy did not decrease mortality compared to a conservative strategy for stable ischemic heart disease (SIHD) patients with moderate-to-severe ischemia, and the role of revascularization would be revised. However, the applicability and potential influence of this trial in daily practice remains unclear. Our objective was to assess the eligibility and representativeness of the ISCHEMIA trial on the patients with percutaneous coronary intervention (PCI). From a multicenter registry, we extracted a consecutive 13,223 SIHD patients with PCI (baseline cohort). We applied ISCHEMIA eligibility criteria and compared the baseline characteristics between the eligible patients and the actual study participants (randomized controlled trial (RCT) patients). In 3463 patients with follow-up information (follow-up cohort), the 2 year composite of major adverse cardiac events was evaluated between the eligible patients and RCT patients, as well as eligible and non-eligible patients in the registry. In the baseline cohort, 77.3% of SIHD patients with moderate-to-severe ischemia were eligible for the ISCHEMIA. They were comparable with RCT patients for baseline characteristics and outcomes unlike the non-eligible patients. In conclusion, the trial results seem applicable for the majority of PCI patients with moderate-to-severe ischemia except for the non-eligible patients.
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Niimi et al. (2020) conducted a cohort in Stable ischemic heart disease (SIHD) with moderate-to-severe ischemia (n=13,223). ISCHEMIA trial eligibility vs. ISCHEMIA trial non-eligibility and actual ISCHEMIA RCT participants was evaluated on 2-year composite of major adverse cardiac events. Among 13,223 SIHD patients undergoing PCI, 77.3% with moderate-to-severe ischemia were eligible for the ISCHEMIA trial and had comparable outcomes to the RCT participants.
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