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Background: Data on concomitant mitral regurgitation (MR) in patients with severe aortic stenosis (AS) are scarce.Methods and Results: We investigated the risk of concomitant MR in patients with severe AS in the CURRENT AS Registry-2 according to initial treatment strategy (transcatheter aortic valve implantation [TAVI], surgical aortic valve replacement [SAVR], or conservative). Among 3,365 patients with severe AS, 384 (11.4%) had moderate/severe MR (TAVI: n=126/1,148; SAVR: n=68/591; conservative: n=190/1,626). The cumulative 3-year incidence for death or heart failure (HF) hospitalization was significantly higher in the moderate/severe than no/mild MR group in the entire population (54.6% vs. 34.3%, respectively; P<0.001) and for each treatment strategy (TAVI: 45.0% vs. 31.8% [P=0.006]; SAVR: 31.9% vs. 18.7% [P<0.001]; conservative: 67.8% vs. 41.6% [P<0.001]). The higher adjusted risk of moderate/severe MR relative to no/mild MR for death or HF hospitalization was not significant in the entire population (hazard ratio [HR] 1.15; 95% confidence interval [CI] 0.95-1.39; P=0.15); however, the risk was significant in the SAVR (HR 1.92; 95% CI 1.04-3.56; P=0.04) and conservative (HR 1.30; 95% CI 1.02-1.67; P=0.04) groups, but not in the TAVI group (HR 1.03; 95% CI 0.70-1.52; P=0.86), despite no significant interaction (P interaction =0.37)., Conclusions: Moderate/severe MR was associated with a higher risk for death or HF hospitalization in the initial SAVR and conservative strategies, while the association was less pronounced in the initial TAVI strategy.

Background: There is a paucity of data on the effect of optimal intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) compared with standard PCI or coronary artery bypass grafting (CABG) in patients with multivessel disease., Methods and results: The OPTIVUS-Complex PCI study multivessel cohort was a prospective multicenter single-arm study enrolling 1,021 patients undergoing multivessel PCI including the left anterior descending coronary artery using IVUS aiming to meet the prespecified criteria for optimal stent expansion. We conducted propensity score matching analyses between the OPTIVUS group and historical PCI or CABG control groups from the CREDO-Kyoto registry cohort-3 (1,565 and 899 patients) fulfilling the inclusion criteria for this study. The primary endpoint was a composite of death, myocardial infarction, stroke, or any coronary revascularization. In the propensity score-matched cohort (OPTIVUS vs. historical PCI control: 926 patients in each group; OPTIVUS vs. historical CABG control: 436 patients in each group), the cumulative 1-year incidence of the primary endpoint was significantly lower in the OPTIVUS group than in the historical PCI control group (10.4% vs. 23.3%; log-rank P<0.001) or the historical CABG control group (11.8% vs. 16.5%; log-rank P=0.02)., Conclusions: IVUS-guided PCI targeting the OPTIVUS criteria combined with contemporary clinical practice was associated with superior clinical outcomes at 1 year compared with not only the historical PCI control, but also the historical CABG control.

Background: There is a scarcity of studies comparing the clinical outcomes after percutaneous coronary intervention (PCI) for women and men stratified by the presentation of acute coronary syndromes (ACS) or stable coronary artery disease (CAD)., Methods and results: The study population included 26,316 patients who underwent PCI (ACS: n=11,119, stable CAD: n=15,197) from the CREDO-Kyoto PCI/CABG registry Cohort-2 and Cohort-3. The primary outcome was all-cause death. Among patients with ACS, women as compared with men were much older. Among patients with stable CAD, women were also older than men, but with smaller difference. The cumulative 5-year incidence of all-cause death was significantly higher in women than in men in the ACS group (26.2% and 17.9%, log rank P<0.001). In contrast, it was significantly lower in women than in men in the stable CAD group (14.2% and 15.8%, log rank P=0.005). After adjusting confounders, women as compared with men were associated with significantly lower long-term mortality risk with stable CAD but not with ACS (hazard ratio [HR]: 0.75, 95% confidence interval [CI]: 0.69-0.82, P<0.001, and HR: 0.92, 95% CI: 0.84-1.01, P=0.07, respectively). There was a significant interaction between the clinical presentation and the mortality risk of women relative to men (interaction P=0.002)., Conclusions: Compared with men, women had significantly lower adjusted mortality risk after PCI among patients with stable CAD, but not among those with ACS.

Background: There is scarce data evaluating the current practice pattern and clinical outcomes for patients with severe aortic stenosis (AS), including both those who underwent surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) and those who were managed conservatively in the TAVI era., Methods and results: The Contemporary outcomes after sURgery and medical tREatmeNT in patients with severe Aortic Stenosis (CURRENT AS) Registry-2 is a prospective, physician-initiated, multicenter registry enrolling consecutive patients who were diagnosed with severe AS between April 2018 and December 2020 among 21 centers in Japan. The rationale for the prospective enrollment was to standardize the assessment of symptomatic status, echocardiographic evaluation, and other recommended diagnostic examinations such as computed tomography and measurement of B-type natriuretic peptide. Moreover, the schedule of clinical and echocardiographic follow up was prospectively defined and strongly recommended for patients who were managed conservatively. The entire study population consisted of 3,394 patients (mean age: 81.6 years and women: 60%). Etiology of AS was degenerative in 90% of patients. AS-related symptoms were present in 60% of patients; these were most often heart failure symptoms. The prevalence of high- and low-gradient AS was 58% and 42%, respectively, with classical and paradoxical low-flow low-gradient AS in 4.6% and 6.7%, respectively., Conclusions: The CURRENT AS Registry-2 might be large and meticulous enough to determine the appropriate timing of intervention for patients with severe AS in contemporary clinical practice.

Background: The comparative efficacy of second-generation (G2) vs. first-generation (G1) drug-eluting stents (DES) for calcified coronary lesions is unknown.Methods and Results:We compared the 3-year clinical outcomes of patients with G1- or G2-DES according to the presence or absence of calcified coronary lesions as assessed in an angiographic core laboratory using data from 2 large-scale prospective multicenter randomized trials, RESET and NEXT. G1-DES and G2-DES were implanted in 299 and 1,033 patients, respectively, in the Calc stratum (≥1 lesion with moderate/severe calcification), and 1,208 and 3,550 patients, respectively, in the Non-calc stratum (no/mild calcification). The patients in the Calc stratum had a significantly higher adjusted risk for the primary outcome measure (any target-lesion revascularization (TLR)) than those in the Non-calc stratum (HR: 1.38, 95% CI: 1.11-1.71, P=0.004). The cumulative 3-year incidence of any TLR was not significantly different between the G1-DES and G2-DES groups in both the Calc and Non-calc strata (12.1% vs. 9.7%, P=0.22, and 6.8% vs. 6.1%, P=0.44, respectively). After adjusting for confounders, the effect of G2DES relative to G1-DES for any TLR remained insignificant in both the Calc and Non-calc strata (HR: 0.78, 95% CI: 0.48-1.25, P=0.3, and HR: 0.84, 95% CI: 0.61-1.17, P=0.31, respectively, P interaction=0.55)., Conclusions: The effect of G2-DES relative to G1-DES for TLR was not significantly different regardless of the presence or absence of lesion calcification.

Background: In ST-segment elevation myocardial infarction (STEMI), QRS score at presentation ECG may reflect the progression of infarction and facilitate prediction of the degree of myocardial salvage achieved by reperfusion therapy.Methods and Results:Admission electrocardiogram (ECG) was studied in 2,607 patients with STEMI undergoing primary percutaneous coronary intervention (PCI) within 24 h of symptom onset. Patients were classified into 3 groups according to QRS score: low (0-3, n=1,227), intermediate (4-7, n=810), and high (≥8, n=570). An increase of infarct size estimated by median peak creatine phosphokinase was observed as QRS score increased (low score, 1,836 IU/L; inter-quartile range (IQR), 979-3,190 IU/L; intermediate score, 2,488 IU/L; IQR, 1,126-4,640 IU/L; high score, 3,454 IU/L; IQR, 1,759-5,639 IU/L; P<0.001). Higher QRS score was associated with higher long-term mortality (low, intermediate, and high score, 15.6%, 19.7%, and 23.7% at 5 years, respectively; log-rank P<0.001). The positive relationship of QRS score with mortality was consistently seen when stratified by infarct location. The association of high QRS score with increased mortality was most remarkably seen in patients with early (≤2 h) presentation (low, intermediate, and high score: 16.7%, 16.6%, and 28.1% at 5 years, respectively; log-rank P<0.001)., Conclusions: Higher QRS score at presentation ECG was associated with larger infarct size, and higher long-term mortality in patients with STEMI undergoing primary PCI. QRS score appears to be important in the early risk stratification for STEMI.

Background: Inter-facility transfer for primary percutaneous coronary intervention (PCI) from referring facilities to PCI centers causes a significant delay in treatment of ST-segment elevation acute myocardial infarction (STEMI) patients undergoing primary PCI. However, little is known about the clinical outcomes of STEMI patients undergoing inter-facility transfer in Japan., Methods and results: In the CREDO-Kyoto acute myocardial infarction (AMI) registry that enrolled 5,429 consecutive AMI patients in 26 centers in Japan, the current study population consisted of 3,820 STEMI patients who underwent primary PCI within 24 h of symptom onset. We compared long-term clinical outcomes between inter-facility transfer patients and those directly admitted to PCI centers. The primary outcome measure was a composite of all-cause death or heart failure (HF) hospitalization. There were 1,725 (45.2%) inter-facility transfer patients, and 2,095 patients (54.8%) with direct admission to PCI centers. The cumulative 5-year incidence of death/HF hospitalization was significantly higher in the inter-facility transfer patients than in those with direct admission (26.9% vs. 22.2%; log-rank P<0.001). After adjusting for potential confounders, the risk for death/HF hospitalization was significantly higher (adjusted hazard ratio: 1.22, 95% confidence interval: 1.07-1.40, P<0.001) in the inter-facility transfer patients than in those directly admitted., Conclusions: Inter-facility transfer was associated with significantly worse long-term clinical outcomes for patients with STEMI undergoing primary PCI. (Circ J 2016; 80: 1764-1772).

Background: In the setting of elective percutaneous coronary intervention (PCI), intravascular ultrasound (IVUS)-guided PCI is associated with a reduction in the incidence of target vessel revascularization (TVR), but the impact of IVUS on long-term clinical outcome in the setting of emergency PCI for ST-segment elevation acute myocardial infarction (STEMI) is still unclear., Methods and results: The subjects consisted of 3,028 STEMI patients who underwent primary PCI within 24 h of symptom onset in the CREDO-Kyoto acute myocardial infarction registry. Of these, 932 patients (31%) underwent IVUS-guided PCI. Compared with the angiography-guided PCI without IVUS, IVUS-guided PCI was associated with significantly lower incidences of TVR (primary outcome measure; 22% vs. 27%, log-rank P<0.001) and definite stent thrombosis (ST; 1.2% vs. 3.1%, log-rank P=0.003). The cumulative incidence of all-cause death was not significantly different between the 2 groups. After adjusting for confounders, however, there were no significant differences between the 2 groups in risk for TVR (adjusted HR, 1.14; 95% CI: 0.86-1.51, P=0.38) and definite ST (adjusted HR, 0.58; 95% CI: 0.19-1.72, P=0.33)., Conclusions: IVUS-guided PCI was not associated with a lower risk for TVR or ST in STEMI patients undergoing primary PCI.

Background: ST-segment elevation (STE) in leads V1-2 is often observed in patients with severe aortic stenosis (AS), but its significance remains unknown., Methods and results: We retrospectively evaluated baseline ECGs and 5-year clinical outcomes in 211 consecutive patients with severe AS, defined as peak aortic jet velocity (Aortic Vmax) >4.0 m/s, or mean aortic pressure gradient >40 mmHg, or aortic valve area (AVA) <1.0 cm(2). The primary outcome measure was a composite of death or surgical aortic valve replacement (AVR). Patients with STE in leads V1-2(≥0.15 mV) had greater Aortic Vmax and smaller AVA than patients without. With a median follow-up of 4.9 years, the cumulative 5-year incidence of death or AVR was significantly higher in patients with STE in leads V1-2 than in patients without (91.4% vs. 77.1%; P=0.003). After adjusting for confounders, STE in leads V1-2 was independently associated with higher risk for death or AVR (hazard ratio, 1.53; 95% confidence interval, 1.06-2.22; P=0.02). In 64 asymptomatic patients without any indication for AVR at initial diagnosis of severe AS, the cumulative incidence of AVR was significantly higher in patients with STE in leads V1-2 than in patients without (57.6% vs. 30.5%; P<0.001)., Conclusions: STE in leads V1-2 independently predicted poorer prognosis and more frequent need for AVR in patients with severe AS.