Hiroki Shiomi

1) Page 1661, abstract Incorrect: Methods and Results: In the OPTIVUS-Complex PCI study multivessel cohort enrolling 982 patients undergoing multivessel PCI, including left anterior descending coronary artery using intravascular ultrasound (IVUS), we conducted 90-day landmark analyses to compare shorter and longer DAPT. DAPT discontinuation was defined as withdrawal of P2Y12 inhibitors or aspirin for at least 2 months. The prevalence of acute coronary syndrome and high bleeding risk by the Bleeding Academic Research Consortium were 14.2% and 52.5%, respectively. The cumulative incidence of DAPT discontinuation was 22.6% at 90 days, and 68.8% at 1 year. In the 90-day landmark analyses, there were no differences in the incidences of a composite of death, myocardial infarction, stroke, or any coronary revascularization (5.9% vs. 9.2%, log-rank P = 0.12 adjusted hazard ratio, 0.59; 95% confidence interval, 0.32-1.08; P = 0.09 ) and BARC type 3 or 5 bleeding (1.4% vs. 1.9%, log-rank P = 0.62 ) between the off- and on-DAPT groups at 90 days. Correct: Methods and Results: In the OPTIVUS-Complex PCI study multivessel cohort enrolling 978 patients undergoing multivessel PCI, including left anterior descending coronary artery using intravascular ultrasound (IVUS), we conducted 90-day landmark analyses to compare shorter and longer DAPT. DAPT discontinuation was defined as withdrawal of P2Y 12 inhibitors or aspirin for at least 2 months. The prevalence of acute coronary syndrome and high bleeding risk by the Bleeding Academic Research Consortium were 14.1% and 52.5%, respectively. The cumulative incidence of DAPT discontinuation was 22.6% at 90 days, and 68.9% at 1 year. In the 90-day landmark analyses, there were no differences in the incidences of a composite of death, myocardial infarction, stroke, or any coronary revascularization (5.9% vs. 9.1%, log-rank P = 0.13 adjusted hazard ratio, 0.60; 95% confidence interval, 0.35-1.15; P = 0.1 ) and BARC type 3 or 5 bleeding (1.4% vs. 1.9%, log-rank P = 0.62 ) between the off- and on-DAPT groups at 90 days.

Background: The prognostic significance of the 6-minute walk distance (6MWD) in patients with severe aortic stenosis (AS) has not been thoroughly investigated. Results: This study evaluated 998 patients with severe AS who underwent a 6-min walk test as part of a large multicenter prospective cohort. Patients were categorized as either fast walkers (6MWD ≥300 m; n=515) or slow walkers (6MWD <300 m; n=483). During a median follow-up of 2.3 years, 861 (86.3%) patients underwent surgical or transcatheter aortic valve replacement (AVR; 87.0% of fast walkers vs. 85.5% of slow walkers). The cumulative 3-year incidence of death was significantly lower among fast walkers than slow walkers (10.9% vs. 31.7%; P<0.001). After adjusting for confounders, slow walkers had a significantly higher risk of all-cause mortality than fast walkers (hazard ratio 2.36; 95% confidence interval 1.55-3.58; P<0.001). Stratified analysis by initial treatment strategy revealed that the cumulative 3-year incidence of all-cause death was consistently lower among fast walkers than slow walkers (initial AVR strategy: 10.1% vs. 28.1% [P<0.001]; conservative strategy: 13.4% vs. 46.7% [P<0.001]). Among asymptomatic patients managed conservatively, fast walkers demonstrated a remarkably low cumulative 3-year incidence of all-cause death (8.1%). Conclusions: The 6MWD is a reliable prognostic marker for patients with severe AS, regardless of initial treatment strategy.

The optimal timing for aortic valve replacement (AVR) in asymptomatic patients with severe aortic stenosis (AS) remains debatable. This study aimed to compare the clinical outcomes of early AVR and clinical surveillance in asymptomatic patients with high-gradient severe AS. Among 3369 patients enrolled in the CURRENT AS Registry-2, which included consecutive patients with severe AS, we identified 596 asymptomatic patients with high-gradient severe AS (initial AVR strategy: 285 patients; clinical surveillance strategy: 311 patients). A propensity score-matched cohort was constructed, comprising 206 patients each in the initial AVR and clinical surveillance groups. The primary outcome measure was a composite of all-cause death, stroke, or hospitalization for heart failure (HF). In the propensity score-matched cohort, the mean age was 79.6 years, and the median Society of Thoracic Surgeons-predicted risk of mortality was 3.2%. In the initial AVR group, surgical and transcatheter AVR were performed in 83 and 123 patients, respectively, whereas in the clinical surveillance group, conversion to AVR occurred in 11.1%, 32.9%, and 69.0% patients at 6 months, 1 year, and 3 years. The cumulative 3-year incidence of the primary outcome was not significantly different between the initial AVR and clinical surveillance groups (26.4% vs. 28.4%; log-rank P = 0.46; hazard ratio [HR]: 0.85, 95% confidence interval [CI]: 0.56-1.29). In conclusion, in asymptomatic patients with high-gradient severe AS, the initial AVR strategy compared to clinical surveillance was not associated with a lower risk for a composite of all-cause death, stroke or hospitalization for HF. UMINID: UMIN000034169.

Background: Drug-coated balloons (DCBs) have emerged as an alternative to drug-eluting stents (DESs) for percutaneous coronary intervention (PCI) in de novo coronary artery diseases (CADs). However, the optimal predilatation strategy prior to DCB dilatation has yet to be validated. Methods: The NATURE (Non-stent PCI with an appropriate dilatation by means of cutting balloon and drug-coated balloon in de novo lesion) study is a prospective, multi-center, randomized controlled trial designed to evaluate the safety and efficacy of a cutting balloon compared to standard balloons (semi-compliant or non-compliant balloons) for lesion preparation prior to DCB treatment in normal-sized vessels. The DCB treatment is performed with the guidance of intravascular ultrasound (IVUS) and fractional flow reserve (FFR). The study will enroll 200 patients with a single de novo coronary lesion (reference vessel diameter: 2.5-4.0 mm) at 18 sites. Patients are randomized 1:1 to undergo predilatation with either a cutting or standard balloons, followed by DCB dilatation. The primary endpoint is the success rate of optimal predilatation, as defined by the International DCB Consensus Group: no flow-limiting dissections, residual stenosis ≤30 %, and FFR >0.80. Secondary endpoints include in-segment late lumen loss (LLL) at 9 months, the incidence of bailout stenting, and clinical outcomes at 6 and 12 months. Conclusions: The NATURE study aims to address the critical gap in evidence regarding optimal predilatation for DCBs in de novo CADs. By utilizing state-of-the-art DCB treatment strategies, including cutting balloons, intravascular imaging, and physiological tools, this study is expected to provide meaningful insights for refining DCB-based PCI strategies. Background: https://jrct.niph.go.jp/. Unique Identifier: jRCTs032230543.

Data on clinical outcomes after intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) in patients with multivessel disease and left ventricular (LV) dysfunction are scarce. The OPTIVUS-Complex PCI study multivessel cohort was a prospective multicenter single-arm trial enrolling 1,010 patients undergoing multivessel IVUS-guided PCI including left anterior descending coronary artery target with an intention to meet the prespecified OPTIVUS criteria for optimal stent expansion. We compared clinical outcomes between patients with and without LV dysfunction. The primary endpoint was a composite of death, myocardial infarction, stroke, any coronary revascularization, or hospitalization for heart failure. There were 763 patients (75.5%) with preserved LV function (LV ejection fraction [LVEF] >50%), 176 patients (17.4%) with moderate LV dysfunction (35