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. 2020 Sep 7;9(9):2889.
doi: 10.3390/jcm9092889.

Applicability and Eligibility of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) for Patients who Underwent Revascularization with Percutaneous Coronary Intervention

Nozomi Niimi  1 , Mitsuaki Sawano  2 , Nobuhiro Ikemura  1 , Toshiyuki Nagai  3 , Shintaro Nakano  4 , Satoshi Shoji  1 , Yasuyuki Shiraishi  1 , Ikuko Ueda  1 , Yohei Numasawa  5 , Masahiro Suzuki  6 , Shigetaka Noma  7 , Keiichi Fukuda  1 , Shun Kohsaka  1
Affiliations

Applicability and Eligibility of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) for Patients who Underwent Revascularization with Percutaneous Coronary Intervention

Nozomi Niimi et al. J Clin Med. .

Abstract

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.

Keywords: ISCHEMIA; percutaneous coronary intervention; registry; stable ischemic heart disease.

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Conflict of interest statement

S.K. received an unrestricted research grant from the Department of Cardiology, Keio University School of Medicine from Bayer Pharmaceutical and Pfizer Japan. The other authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Study flow chart. Abbreviations: SIHD, stable ischemic heart disease; PCI, percutaneous coronary intervention; JCD–KiCS, The Japan Cardiovascular Database–Keio Interhospital Cardiovascular Studies.
Figure 2
Figure 2
The frequency of observed exclusion criteria of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial in JCD–KiCS. Abbreviations: LMT, left main coronary trunk artery; CKD G5, chronic kidney disease grade 5; HD, hemodialysis; HF, heart failure; EF, ejection fraction; CCS, Canadian Cardiovascular Society functional classification.
Figure 3
Figure 3
The periprocedural complications in JCD–KiCS. Abbreviations: AKI, acute kidney disease; HF, heart failure.
Figure 4
Figure 4
The association between long-term outcomes and eligibility: (A) the cumulative incidence of the composite outcome of death from cardiovascular causes and new-onset acute coronary syndrome in the eligible group and the non-eligible group; (B) the cumulative incidence of all-cause death in the eligible group and the non-eligible group.
Figure 5
Figure 5
Univariate Cox regression analysis in ISCHEMIA-eligible Patients. Primary outcome was a composite of death from cardiovascular cause and the new onset acute coronary syndrome. Optimal medical therapy was defined as a prescription of aspirin, P2Y12 inhibitors, and statins after PCI. Abbreviations: BMI, body mass index; OMT, optimal medical therapy; MI, myocardial infarction; HR, hazard ratio.
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