BACKGROUND: The RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention) demonstrated that intravascular imaging–guided percutaneous coronary intervention (PCI) improved clinical outcome compared with angiography-guided PCI for patients with complex coronary artery lesions. This study aims to assess whether the prognostic benefit of intravascular imaging–guided procedural optimization persists in patients undergoing PCI for left main coronary artery disease. METHODS: Of 1639 patients enrolled in the RENOVATE-COMPLEX-PCI, 192 patients with left main coronary artery disease were selected for the current prespecified substudy. Selected patients were randomly assigned to either the intravascular imaging–guided PCI group (n=138) or the angiography-guided PCI group (n=54). The primary end point was target vessel failure defined as a composite of cardiac death, target vessel–related myocardial infarction, or clinically driven target vessel revascularization. RESULTS: At a median follow-up of 2.1 years (interquartile range 1.1 to 3.0 years), intravascular imaging–guided PCI was associated with lower incidence of primary end point compared with angiography-guided PCI (6.8% versus 25.1%; hazard ratio, 0.31 [95% CI, 0.13–0.76]; P =0.010). This significant reduction in primary end point was mainly driven by a lower risk of cardiac death or spontaneous target vessel–related myocardial infarction (1.6% versus 12.7%; hazard ratio, 0.16 [95% CI, 0.03–0.82]; P =0.028). Intravascular imaging–guided PCI was independently associated with a lower risk of primary end point, even after adjusting for various clinical factors (hazard ratio, 0.29 [95% CI, 0.12–0.72]; P =0.007). CONCLUSIONS: Intravascular imaging–guided PCI showed clinical benefit over angiography-guided PCI for left main coronary artery disease in reducing the risk of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03381872.

BACKGROUND: Although clinical benefits of intravascular imaging-guided percutaneous coronary intervention (PCI) in patients with complex coronary artery lesions have been observed in previous trials, the cost-effectiveness of this strategy is uncertain. METHODS: RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance vs Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention) was conducted in Korea between May 2018 and May 2021. This prespecified cost-effectiveness substudy was conducted using Markov model that simulated 3 states: (1) post-PCI, (2) spontaneous myocardial infarction, and (3) death. A simulated cohort was derived from the intention-to-treat population, and input parameters were extracted from either the trial data or previous publications. Cost-effectiveness was evaluated using time horizon of 3 years (within trial) and lifetime. The primary outcome was incremental cost-effectiveness ratio (ICER), an indicator of incremental cost on additional quality-adjusted life years (QALYs) gained, in intravascular imaging-guided PCI compared with angiography-guided PCI. The current analysis was performed using the Korean health care sector perspective with reporting the results in US dollar (1200 Korean Won, ₩=1 dollar, $). Willingness to pay threshold was $35 000 per QALY gained. RESULTS: A total of 1639 patients were included in the trial. During 3-year follow-up, medical costs ($8661 versus $7236; incremental cost, $1426) and QALY (2.34 versus 2.31; incremental QALY, 0.025) were both higher in intravascular imaging-guided PCI than angiography-guided PCI, resulting incremental cost-effectiveness ratio of $57 040 per QALY gained within trial data. Conversely, lifetime simulation showed total cumulative medical cost was reversed between the 2 groups ($40 455 versus $49 519; incremental cost, −$9063) with consistently higher QALY (8.24 versus 7.89; incremental QALY, 0.910) in intravascular imaging-guided PCI than angiography-guided PCI, resulting in a dominant incremental cost-effectiveness ratio. Consistently, 70% of probabilistic iterations showed cost-effectiveness of intravascular imaging-guided PCI in probabilistic sensitivity analysis. CONCLUSIONS: The current cost-effectiveness analysis suggests that imaging-guided PCI is more cost-effective than angiography-guided PCI by reducing medical cost and increasing quality-of-life in complex coronary artery lesions in long-term follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03381872.

BACKGROUND: Intravascular imaging-guided percutaneous coronary intervention (PCI) has been shown to improve clinical outcomes in patients with complex coronary artery lesions compared with angiography-guided PCI. However, the prognostic impact of suboptimal findings on intravascular imaging such as stent underexpansion, malapposition, or dissection is unclear in the era of contemporary drug-eluting stents. METHODS: From RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention) which compared imaging-guided PCI with angiography-guided PCI in patients with complex lesions, post-PCI intravascular imaging findings, including minimum stent area (MSA), relative stent underexpansion (MSA≤80% of the average reference lumen area), malapposition, or dissection, were assessed in nonleft main target lesions. The primary end point was target lesion failure (TLF), a composite of cardiac death, target lesion–related myocardial infarction, target lesion revascularization, or definite stent thrombosis. RESULTS: A total of 897 nonleft main lesions from 714 patients undergoing imaging-guided PCI were included. During a median follow-up duration of 2.1 years, the optimal cutoff value of MSA to predict the occurrence of TLF was 5.5 mm ² , and MSA<5.5 mm ² was associated with a significantly higher risk of TLF than MSA≥5.5 mm ² (2.2% versus 4.8%; adjusted hazard ratio, 3.09 [95% CI, 1.01–9.50]; P =0.048). Compared with the reference group (MSA≥5.5 mm ² and no suboptimal findings), the subgroup of patients with MSA≥5.5 mm ² and post-PCI intravascular imaging findings of relative stent underexpansion, major malapposition, or major dissection was associated with a numerically increased risk of TLF (0.0% versus 3.2%; P =0.057). Compared with the same reference group, the subgroup of patients with MSA<5.5 mm ² and suboptimal post-PCI intravascular imaging findings was associated with a significantly increased risk of TLF (0.0% versus 4.7%; P =0.017). CONCLUSIONS: After intravascular imaging–guided PCI with contemporary drug-eluting stents for nonleft main complex lesions, inadequate absolute stent expansion was independently associated with a higher risk of TLF. Suboptimal post-PCI intravascular imaging findings of relative stent underexpansion, major malapposition, and major dissection seem to contribute to the risk of TLF. REGISTRATION: https://www.clinicaltrials.gov ; Unique identifier: NCT03381872.

Accumulating evidence shows that sodium-glucose cotransporter 2 inhibitors (SGLT2is) reduce adverse cardiovascular outcomes. However, whether SGLT2i, compared with other antidiabetic drugs, reduce the new development of atrial fibrillation (AF) is unclear. In this study, we compared SGLT2i with dipeptidyl peptidase-4 inhibitors (DPP-4is) in terms of reduction in the risk of AF in individuals with type 2 diabetes. We included 42,786 propensity score-matched pairs of SGLT2i and DPP-4i users without previous AF diagnosis using the Korean National Health Insurance Service database between May 1, 2016, and December 31, 2018. During a median follow-up of 1.3 years, SGLT2i users had a lower incidence of AF than DPP-4i users (1.95 vs. 2.65 per 1,000 person-years; hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.55-0.97; p=0.028]). In individuals without heart failure, SGLT2i users was associated with a decreased risk of AF incidence (HR, 0.70; 95% CI 0.52-0.94; p=0.019) compared to DPP-4i users. However, individuals with heart failure, SGLT2i users was not significantly associated with a change in risk (HR, 1.04; 95% CI, 0.44-2.44; p=0.936). In this nationwide cohort study of individuals with type 2 diabetes, treatment with SGLT2i was associated with a lower risk of AF compared with treatment with DPP-4i.

Yeon MH, et al. Korean Circ J. 2013 May;43(5):356-359. https://doi.org/10.4070/kcj.2013.43.5.356