Routine Functional Testing or Standard Care in High-Risk Patients after PCI.

BACKGROUND: There are limited data from randomized trials to guide a specific follow-up surveillance approach after myocardial revascularization. Whether a follow-up strategy that includes routine functional testing improves clinical outcomes among high-risk patients who have undergone percutaneous coronary intervention (PCI) is uncertain. METHODS: We randomly assigned 1706 patients with high-risk anatomical or clinical characteristics who had undergone PCI to a follow-up strategy of routine functional testing (nuclear stress testing, exercise electrocardiography, or stress echocardiography) at 1 year after PCI or to standard care alone. The primary outcome was a composite of death from any cause, myocardial infarction, or hospitalization for unstable angina at 2 years. Key secondary outcomes included invasive coronary angiography and repeat revascularization. RESULTS: The mean age of the patients was 64.7 years, 21.0% had left main disease, 43.5% had bifurcation disease, 69.8% had multivessel disease, 70.1% had diffuse long lesions, 38.7% had diabetes, and 96.4% had been treated with drug-eluting stents. At 2 years, a primary-outcome event had occurred in 46 of 849 patients (Kaplan-Meier estimate, 5.5%) in the functional-testing group and in 51 of 857 (Kaplan-Meier estimate, 6.0%) in the standard-care group (hazard ratio, 0.90; 95% confidence interval [CI], 0.61 to 1.35; P = 0.62). There were no between-group differences with respect to the components of the primary outcome. At 2 years, 12.3% of the patients in the functional-testing group and 9.3% in the standard-care group had undergone invasive coronary angiography (difference, 2.99 percentage points; 95% CI, -0.01 to 5.99), and 8.1% and 5.8% of patients, respectively, had undergone repeat revascularization (difference, 2.23 percentage points; 95% CI, -0.22 to 4.68). CONCLUSIONS: Among high-risk patients who had undergone PCI, a follow-up strategy of routine functional testing, as compared with standard care alone, did not improve clinical outcomes at 2 years. (Funded by the CardioVascular Research Foundation and Daewoong Pharmaceutical; POST-PCI ClinicalTrials.gov number, NCT03217877.).

Routine stress testing in diabetic patients after percutaneous coronary intervention: the POST-PCI trial.

BACKGROUND AND AIMS: The optimal follow-up surveillance strategy for high-risk diabetic patients with had undergone percutaneous coronary intervention (PCI) remains unknown. METHODS: The POST-PCI (Pragmatic Trial Comparing Symptom-Oriented versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention) study was a randomized trial comparing a follow-up strategy of routine functional testing at 1 year vs. standard care alone after high-risk PCI. Randomization was stratified according to diabetes status. The primary outcome was a composite of death from any cause, myocardial infarction, or hospitalization for unstable angina at 2 years. RESULTS: Among 1706 randomized patients, participants with diabetes (n = 660, 38.7%) had more frequent comorbidities and a higher prevalence of complex anatomical or procedural characteristics than those without diabetes (n = 1046, 61.3%). Patients with diabetes had a 52% greater risk of primary composite events [hazard ratio (HR) 1.52; 95% confidence interval (CI) 1.02-2.27; P = .039]. The 2-year incidences of the primary composite outcome were similar between strategies of routine functional testing or standard care alone in diabetic patients (7.1% vs. 7.5%; HR 0.94; 95% CI 0.53-1.66; P = .82) and non-diabetic patients (4.6% vs. 5.1%; HR 0.89; 95% CI 0.51-1.55; P = .68) (interaction term for diabetes: P = .91). The incidences of invasive coronary angiography and repeat revascularization after 1 year were higher in the routine functional-testing group than the standard-care group irrespective of diabetes status. CONCLUSIONS: Despite being at higher risk for adverse clinical events, patients with diabetes who had undergone high-risk PCI did not derive incremental benefit from routine surveillance stress testing compared with standard care alone during follow-up.

Optical Coherence Tomography-Guided or Intravascular Ultrasound-Guided Percutaneous Coronary Intervention: The OCTIVUS Randomized Clinical Trial.

BACKGROUND: Intravascular imaging-guided percutaneous coronary intervention (PCI) with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) showed superior clinical outcomes compared with angiography-guided PCI. However, the comparative effectiveness of OCT-guided and IVUS-guided PCI regarding clinical outcomes is unknown. METHODS: In this prospective, multicenter, open-label, pragmatic trial, we randomly assigned 2008 patients with significant coronary artery lesions undergoing PCI in a 1:1 ratio to undergo either an OCT-guided or IVUS-guided PCI. The primary end point was a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year, which was powered for noninferiority of the OCT group compared with the IVUS group. Safety outcomes were also assessed. RESULTS: At 1 year, primary end point events occurred in 25 of 1005 patients (Kaplan-Meier estimate, 2.5%) in the OCT group and in 31 of 1003 patients (Kaplan-Meier estimate, 3.1%) in the IVUS group (absolute difference, -0.6 percentage points; upper boundary of one-sided 97.5% CI, 0.97 percentage points; P<0.001 for noninferiority). The incidence of contrast-induced nephropathy was similar (14 patients [1.4%] in the OCT group versus 15 patients [1.5%] in the IVUS group; P=0.85). The incidence of major procedural complications was lower in the OCT group than in the IVUS group (22 [2.2%] versus 37 [3.7%]; P=0.047), although imaging procedure-related complications were not observed. CONCLUSIONS: In patients with significant coronary artery lesions, OCT-guided PCI was noninferior to IVUS-guided PCI with respect to the incidence of a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year. The selected study population and lower-than-expected event rates should be considered in interpreting the trial. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique number: NCT03394079.

Primary versus rescue retrograde approach for chronic total coronary occlusion.

OBJECTIVES: We aimed to assess the advantages of using the retrograde approach as an initial strategy rather than as a rescue strategy for complex chronic total occlusions (CTOs). BACKGROUND: Even for complex CTOs where a retrograde approach is deemed necessary, an antegrade approach is frequently used as an initial strategy in real-world practice. METHODS: We evaluated 352 retrograde procedures for CTO conducted at our high-volume center between January 2007 and January 2019. Procedural efficiency and safety was assessed based on the guidewire manipulation time (GWMT) and the occurrence of procedure-related adverse events for the primary retrograde approach (PRA) and the rescue retrograde approach (RRA). RESULTS: PRA and RRA were used in 191 (54.3%) and 161 (45.7%) of the CTO procedures, respectively. The complexity of the CTO lesion was significantly higher in the PRA group than in the RRA group (Japanese-CTO score, 2.62 ± 1.07 vs. 2.38 ± 1.06, p = 0.037). The technical success rate of two groups was similar (p = 0.47). The median GWMT required for PRA was significantly shorter than that for RRA (85 [interquartile range, 55-126] vs. 120 [85-157] min, p < 0.001). The total duration of the procedure and fluoroscopic time were shorter, and the number of guidewires and amount of contrast used during the index procedure were smaller in the PRA group. The incidence of procedure-related adverse events was not significantly different between the two groups. CONCLUSIONS: PRA showed higher procedural efficiency than RRA with comparable safety. Opting for PRA for complex CTOs might be a rational decision to enhance the procedural efficiency.

Radial Plus Ipsilateral Femoral Approach is Feasible in Percutaneous Interventions for Iliac Artery Chronic Total Occlusion.

BACKGROUND: Compared with conventional bilateral femoral (BF) approach, radial plus ipsilateral femoral (RF) approach may be feasible in the percutaneous intervention for iliac artery chronic total occlusion (CTO). METHODS: We included patients who underwent iliac CTO intervention between August 2009 and July 2018 in a tertiary referral center in Korea. RESULTS: A total of 83 patients were enrolled in this study. Of them, 51 and 32 patients were categorized into RF and BF initial access groups, respectively. The overall success rates were 98.0% and 96.7% in RF and BF group, respectively, and the techniques were also similar including use of bilateral wiring, stent type and profile, and post balloon but longer procedure time in the BF group. Additional contralateral femoral access was needed in 6 patients for the treatment of contralateral lesions, distal embolization, and due to tortuous right subclavian artery. Periprocedural complications including vascular injury, iliac perforation, and distal embolization occurred similarly in both groups with numerically lower rate of periprocedural bleeding in the RF group (9.8%) than in the BF group (21.9%). Clinical follow-up at 6 months showed there were no difference in the rates of death, cardiovascular death, target-limb reintervention, and unplanned target limb amputation in both groups. CONCLUSIONS: RF approach for iliac CTO intervention was related to similar technical success rate with acceptable periprocedural safety outcomes compared with conventional BF approach.

Pragmatic trial comparing routine versus no routine functional testing in high-risk patients who underwent percutaneous coronary intervention: Rationale and design of POST-PCI trial.

BACKGROUND: Although the need to detect restenosis has diminished in the contemporary practice of percutaneous coronary intervention (PCI) with drug-eluting stents (DES), the surveillance of ischemia owing to restenosis or disease progression deserves attention in high-risk PCI settings. It is unknown whether follow-up strategy of routine noninvasive functional testing potentially reduces the risk of major cardiovascular events in high-risk PCI patients. METHODS: The POST-PCI study is an investigator-initiated, multicenter, prospective randomized trial comparing the effectiveness of two follow-up strategies in patients with high-risk anatomic or clinical characteristics who underwent PCI. Study participants were randomly assigned to either (1) the routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing. In the routine stress testing group, depending on the testing results, all clinical decisions regarding subsequent diagnostic or therapeutic procedures were at the treating physician's discretion. The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI. RESULTS: More than 1700 high-risk PCI patients have been randomized over 2.0 years at 11 major cardiac centers in Korea. CONCLUSION: This pragmatic POST-PCI trial will provide valuable clinical evidence on the effectiveness of follow-up strategy of routine noninvasive stress testing in high-risk PCI patients.

Association between non-alcoholic fatty liver disease and risk of new-onset atrial fibrillation in healthy adults.

BACKGROUND & AIMS: Previous studies demonstrated conflicting results regarding the association between non-alcoholic fatty liver disease (NAFLD) and atrial fibrillation (AF). The statistical power was not sufficient because of modest sample sizes of these studies. We analysed a large population-based cohort to evaluate the association between NAFLD and AF. METHODS: We evaluated 334 280 healthy individuals without comorbidities who underwent National Health check-ups in South Korea from 2009 to 2014. NAFLD was defined by a surrogate marker, the fatty liver index (FLI). The association between FLI and AF incidence was analysed using multivariate Cox proportional hazards regression models. RESULTS: During a median follow-up of 5.3 years, 1415 subjects (0.4%) were newly diagnosed with AF. Subjects were categorized into quartile groups according to FLI (range: Q1, 0-4.9; Q2, 5.0-12.5; Q3, 12.6-31.0; Q4, >31.0). The cumulative incidence of AF was significantly higher in subjects with higher FLIs than in those with lower FLIs (Q1, 167 [0.2%]; Q2, 281 [0.3%]; Q3, 470 [0.6%]; Q4, 497 [0.6%]; P < .001). Adjusted hazard ratios (HRs) indicated that a higher FLI was independently associated with an increased risk for AF (HR between Q4 and Q1, 1.35; 95% confidence interval [CI], 1.11-1.63; P = .002). After further adjustment for the interim events (diabetes, hypertension, heart failure and myocardial infarction), this association remained statistically significant (HR between Q4 and Q1, 1.55; 95% CI, 1.19-2.03; P = .001). CONCLUSIONS: NAFLD, assessed by FLI, was independently associated with increased risk for AF in healthy Korean population. Moreover, NAFLD itself predisposes to AF independently of the interim events.

Higher fatty liver index is associated with increased risk of new onset heart failure in healthy adults: a nationwide population-based study in Korea.

BACKGROUND: Heart failure (HF) is relatively common cardiovascular disease with high mortality and morbidity. Although it is associated with many cardiovascular risk factors, the association between nonalcoholic fatty liver disease (NAFLD), the most common chronic liver disease, and HF has not been evaluated in a large-scale cohort study. Thus, we evaluated the ability of the fatty liver Index (FLI), a surrogate marker of NAFLD, to predict the development of HF in healthy individuals. METHODS: We analyzed the association between the FLI and new-onset HF with multivariate Cox proportional-hazards models in 308,578 healthy persons without comorbidities who underwent the National Health check-ups in the republic of Korea from 2009 to 2014. RESULTS: A total of 2532 subjects (0.8%) were newly diagnosed with HF during the study period (a median of 5.4 years). We categorized our subjects into quartile groups according to FLI (Q1, 0-4.9; Q2, 5.0-12.5; Q3, 12.6-31.0; and Q4, > 31.0). The cumulative incidence of HF was significantly higher in the highest FLI group than in the lowest FLI group (Q1, 307 [0.4%] and Q4, 890 [1.2%]; P < 0.001). Adjusted hazard ratio (HRs) indicated that the highest FLI group was independently associated with an increased risk for HF (HR between Q4 and Q1, 2.709; 95% confidence interval = 2.380-3.085; P < 0.001). FLI was significantly associated with an increased risk of new-onset HF regardless of their baseline characteristics. CONCLUSIONS: Higher FLI was independently associated with increased risk of HF in a healthy Korean population.

Long-term (10-year) outcomes of stenting or bypass surgery for acute coronary syndromes and stable ischemic heart disease with unprotected left main coronary artery disease.

BACKGROUND: Acuity of clinical presentation may influence decision making of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery (LMCA) disease. However, it is undetermined whether clinical indication for myocardial revascularization may affect the relative long-term effect after PCI and CABG. METHODS: In the MAIN-COMPARE study including 2,240 patients with LMCA disease treated with PCI (n = 1102) or CABG (n = 1138), we examined interaction between acuity of clinical presentation (acute coronary syndromes [ACS] or non-ACS) and revascularization strategy on 10-year outcomes. Primary outcome was a composite of all-cause death, Q-wave myocardial infarction, or stroke. Secondary outcomes were all-cause death or target vessel revascularization. RESULTS: In overall patients, 1,603 patients (71.6%) presented with ACS and 637 patients (28.4%) presented with non-ACS. The 10-year adjusted risks for primary composite outcome were similar after PCI and CABG among patients who presented with non-ACS (hazard ratio [HR] 1.07; 95% CI 0.71-1.61) and those who presented with ACS (HR 1.00; 95% CI 0.81-1.24) (P for interaction = .29). The adjusted risks of death were also similar between 2 groups in non-ACS (HR 0.98; 95% CI 0.63-1.51) and ACS (HR 1.02; 95% CI 0.81-1.28) patients (P for interaction = .62). The adjusted risks of target vessel revascularization were consistently higher after PCI in non-ACS (HR 6.38; 95% CI 3.14-12.96) and ACS (HR 3.96; 95% CI 2.80-5.60) patients (P for interaction = .39). CONCLUSIONS: In patients with LMCA disease, we have identified no significant interaction between the acuity of clinical indication and the relative treatment effect of PCI versus CABG on 10-year clinical outcomes.

Long-term trends of treatment effect of stenting or bypass surgery in patients with ostial or shaft left main coronary artery disease.

BACKGROUND: Little is known about how the relative treatment effect of percutaneous coronary intervention (PCI) and coronary-artery bypass grafting (CABG) on clinical outcomes in ostial or shaft left main coronary artery (LMCA) disease has evolved over time. METHODS: This study included 2,112 patients with ostial or shaft LMCA disease from IRIS-MAIN registry who underwent PCI (n = 1,329) or CABG (n = 783). Patients were stratified by time period based on stent type availability: wave 1 (1995-2002, bare-metal stent [BMS] era); wave 2 (2003-2006, first-generation drug-eluting stent [DES] era); and wave 3 (2007-2014, second-generation DES era). RESULTS: Compared to CABG, PCI has been used more frequently from wave 1 to wave 3. PCI showed substantial improvements over time with respect to death (P for trend = 0.012); the composite of death, myocardial infarction (MI), or stroke (P for trend = 0.047); repeat revascularization (P for trend < 0.001); and major adverse cardiac and cerebrovascular events (MACCE; a composite of death, MI, stroke, or repeat revascularization) (P for trend < 0.001). By contrast, outcomes of CABG remained relatively stable over time. The gap between the treatment effects of CABG vs PCI for MACCE has narrowed over time; the adjusted hazard ratios for CABG compared to PCI during wave 1, 2, and 3 were 0.41 (95% confidence interval [CI]: 0.22-0.76), 0.47 (95% CI: 0.31-0.71), and 0.78 (95% CI: 0.50-1.20), respectively. CONCLUSIONS: In patients with ostial or shaft LMCA disease, significant improvements in PCI outcomes resulted in a progressive decline in the gap between the outcomes of CABG and PCI.

Impact of in-hospital bleeding according to the Bleeding Academic Research Consortium classification on the long-term adverse outcomes in patients undergoing percutaneous coronary intervention.

OBJECTIVES: The aim of this study was to assess the impact of bleeding after percutaneous coronary intervention (PCI) with drug-eluting stents on long-term clinical events according to the newly proposed Bleeding Academic Research Consortium (BARC) classification. BACKGROUND: Current evidence about the impact of the BARC classification is limited. METHODS: Out of a total of 6,166 patients who underwent PCI in a prospective IRIS-DES registry, the impact of in-hospital bleeding defined as the BARC classification on major adverse cardiovascular events (MACE) comprising death, myocardial infarction (MI), or stroke was analyzed. RESULTS: In-hospital bleeding occurred in 235 patients (3.8%) according to BARC classification. During the 2-year follow-up, MACE occurred in 599 patients (9.7%). The 2-year incidence of MACE was significantly higher in patients with bleeding (16.7% vs. 8.3%; adjusted hazard ratio [HR], 1.6; 95% confidence interval [CI], 1.2-2.3; P = 0.002) than in those without bleeding. We observed a higher risk of MI (12.4% vs. 6.4%; adjusted HR, 1.7; 95% CI, 1.2-2.6, P = 0.005), stroke (3.0% vs. 0.6%; adjusted HR, 2.9; 95% CI, 1.4-6.2, P = 0.005) in patients with bleeding. Death (3.8% vs. 1.6%; adjusted HR, 1.6; 95% CI, 0.9-3.0, P = 0.120) and target vessel revascularization (4.3% vs. 1.9%; adjusted HR, 1.6; 95% CI, 0.9-2.9, P = 0.108) were statistically insignificant. Incidence, adjusted HR and P-value were similar between BARC and TIMI classification. CONCLUSIONS: In-hospital bleeding events according to the newly proposed BARC definition were significantly associated with an increased risk of adverse long-term events in patients undergoing PCI with drug-eluting stents. © 2014 Wiley Periodicals, Inc.

Guiding Intervention for Complex Coronary Lesions by Optical Coherence Tomography or Intravascular Ultrasound.

BACKGROUND: Optical coherence tomography (OCT) and intravascular ultrasound (IVUS) have shown comparable outcomes in guiding percutaneous coronary intervention (PCI). However, their comparative effectiveness in complex coronary artery lesions remains unclear. OBJECTIVES: This study compared the effectiveness and safety of OCT-guided vs IVUS-guided PCI for complex coronary artery lesions. METHODS: This was a prespecified, main subgroup analysis of complex coronary artery lesions in the OCTIVUS (Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention) trial, which included unprotected left main disease, bifurcation disease, an aorto-ostial lesion, a chronic total occlusion, a severely calcified lesion, an in-stent restenotic lesion, a diffuse long lesion, or multivessel PCI. The primary endpoint was a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target vessel revascularization. RESULTS: In 2,008 randomized patients, 1,475 (73.5%) underwent imaging-guided PCI for complex coronary artery lesions; 719 (48.7%) received OCT-guided and 756 (51.3%) IVUS-guided PCI. At a median follow-up of 2.0 years, primary endpoint event had occurred in 47 patients (6.5%) in the OCT-guided group and in 56 patients (7.4%) in the IVUS-guided group (HR: 0.87; 95% CI: 0.59-1.29; P = 0.50). These findings were consistent in adjusted analyses. The incidence of contrast-induced nephropathy was similar between the 2 groups (1.9% vs 1.5%; P = 0.46). The incidence of major procedural complications was lower in the OCT-guided group than in the IVUS-guided group (1.7% vs 3.4%; P = 0.03). CONCLUSIONS: Among patients with complex coronary artery lesions, OCT-guided PCI showed a similar risk of primary composite event of death from cardiac causes, target vessel-related myocardial infarction, or target vessel revascularization as compared with IVUS-guided PCI. (Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention [OCTIVUS]; NCT03394079).

Routine Stress Testing After PCI in Patients With and Without Acute Coronary Syndrome: A Secondary Analysis of the POST-PCI Randomized Clinical Trial.

Importance: The appropriate follow-up surveillance strategy for patients with acute coronary syndrome (ACS) who have undergone percutaneous coronary intervention (PCI) remains unknown. Objective: To assess clinical outcomes in patients with and without ACS who have undergone high-risk PCI according to a follow-up strategy of routine stress testing at 12 months after PCI vs standard care alone. Design, Setting, and Participants: The POST-PCI (Pragmatic Trial Comparing Symptom-Oriented vs Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention) trial was a randomized clinical trial that compared follow-up strategies of routine functional testing vs standard care alone 12 months after high-risk PCI. Patients were categorized as presenting with or without ACS. Patients were enrolled in the trial from November 2017 through September 2019, and patients were randomized from 11 sites in South Korea; data analysis was performed in 2022. Intervention: Patients categorized as presenting with or without ACS were randomized to either a routine functional testing or standard care alone follow-up strategy 12 months after high-risk PCI. Main Outcomes and Measures: The primary outcome was a composite of death from any cause, myocardial infarction, or hospitalization for unstable angina at 2 years following randomization. Kaplan-Meier event rates through 2 years and Cox model hazard ratios (HRs) were generated, and interactions were tested. Results: Of 1706 included patients, 350 patients (20.5%) were female, and the mean (SD) patient age was 64.7 (10.3) years. In total, 526 patients (30.8%) presented with ACS. Compared with those without ACS, patients with ACS had a 55% greater risk of the primary outcome (HR, 1.55; 95% CI, 1.03-2.33; P = .03) due to higher event rates in the first year. The 2-year incidences of the primary outcome were similar between strategies of routine functional testing or standard care alone in patients with ACS (functional testing: 16 of 251 [6.6%]; standard care: 23 of 275 [8.5%]; HR, 0.76; 95% CI, 0.40-1.44; P = .39) and in patients without ACS (functional testing: 30 of 598 [5.1%]; standard care: 28 of 582 [4.9%]; HR, 1.04; 95% CI, 0.62-1.74; P = .88) (P for interaction for ACS = .45). Although a landmark analysis suggested that the rates of invasive angiography and repeat revascularization were higher after 1 year in the routine functional testing group, the formal interactions between ACS status and either invasive angiography or repeat revascularization were not significant. Conclusion and Relevance: Despite being at higher risk for adverse clinical events in the first year after PCI than patients without ACS, patients with ACS who had undergone high-risk PCI did not derive incremental benefit from routine surveillance stress testing at 12 months compared with standard care alone during follow-up. Trial Registration: ClinicalTrials.gov Identifier: NCT03217877.

Treatment extent of femoropopliteal disease and clinical outcomes following endovascular therapy.

BACKGROUND: Endovascular therapy (EVT) has become the preferred treatment modality for femoropopliteal disease. However, there is limited evidence regarding its procedural and clinical outcomes according to the affected area. AIMS: The aim of this study is to investigate clinical outcomes and device effectiveness according to treatment extent in the superficial femoral artery (SFA), popliteal artery (PA), or both. METHODS: In this study, we analysed EVT for SFA (2,404 limbs), PA (155 limbs), SFA/PA (383 limbs) using the population in the K-VIS ELLA (Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases) registry. The primary endpoint was target lesion revascularisation (TLR) at 2 years. RESULTS: The SFA/PA group exhibited a higher prevalence of anatomical complexity, characterised by long lesions, moderate to severe calcification, and total occlusion. The procedures were successful in 97.2% of SFA, 92.9% of PA, and 95.6% of SFA/PA EVTs. The 2-year TLR rates were 21.1%, 18.6%, and 32.7% in the SFA, PA, and SFA/PA groups, respectively. SFA/PA EVT was associated with a significantly increased risk for TLR compared to the SFA group (adjusted hazard ratio [HR] 1.48 [1.09-2.00]; p=0.008) and a trend towards an increased risk compared to the PA group (adjusted HR 1.80 [1.00-3.27]; p=0.052). After overlap weighting, the use of a drug-coated balloon (DCB) was shown to be beneficial, with the lowest TLR rate after SFA and SFA/PA EVT. CONCLUSIONS: In this large real-world registry, SFA/PA EVT was associated with an increased risk for TLR at 2 years compared to the SFA or PA EVT groups, with favourable outcomes when using a DCB or drug-eluting stent in the SFA/PA EVT group.

Surveillance Stress Testing After Percutaneous Intervention for Patients With Multivessel or Left Main Coronary Disease.

BACKGROUND: The optimal surveillance strategy after percutaneous coronary intervention (PCI) for high-risk patients with multivessel or left main coronary artery disease (CAD) remains uncertain. OBJECTIVES: This study aims to determine the prognostic role of routine functional testing in patients with multivessel or left main CAD who underwent PCI. METHODS: The POST-PCI (Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention) trial randomized high-risk PCI patients to routine functional testing at 1 year or standard care alone during follow-up. This analysis focused on participants with multivessel or left main CAD. The primary outcome was a composite of death from any cause, myocardial infarction, or hospitalization for unstable angina at 2 years. RESULTS: Among 1,706 initially randomized patients, 1,192 patients with multivessel (n = 833) or left main (n = 359) were identified, with 589 in the functional testing group and 603 in the standard care group. Two-year incidences of primary outcome were similar between the functional testing group and the standard care group (6.2% vs 5.7%, respectively; HR: 1.09; 95% CI: 0.68-1.74; P = 0.73). This trend persisted in both groups of multivessel (6.2% vs 5.7%; HR: 1.09; 95% CI: 0.62-1.89; P = 0.78) and left main disease (6.2% vs 5.7%; HR: 1.09; 95% CI: 0.46-2.56; P = 0.85) (P for interaction = 0.90). Routine surveillance functional testing was associated with increased rates of invasive angiography and repeat revascularization beyond 1 year. CONCLUSIONS: In high-risk patients with multivessel or left main CAD who underwent PCI, there was no incremental clinical benefit from routine surveillance functional-testing compared with standard care alone during follow-up. (Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention [POST-PCI]; NCT03217877).

Aspirin Monotherapy vs No Antiplatelet Therapy in Stable Patients With Coronary Stents Undergoing Low-to-Intermediate Risk Noncardiac Surgery.

BACKGROUND: Current guidelines recommend the perioperative continuation of aspirin in patients with coronary drug-eluting stents (DES) undergoing noncardiac surgery. However, supporting evidence is limited. OBJECTIVES: This study aimed to compare continuing aspirin monotherapy vs temporarily holding all antiplatelet therapy before noncardiac surgery in patients with previous DES implantation. METHODS: We randomly assigned patients who had received a DES >1 year previously and were undergoing elective noncardiac surgery either to continue aspirin or to discontinue all antiplatelet agents 5 days before noncardiac surgery. Antiplatelet therapy was recommended to be resumed no later than 48 hours after surgery, unless contraindicated. The primary outcome was a composite of death from any cause, myocardial infarction, stent thrombosis, or stroke between 5 days before and 30 days after noncardiac surgery. RESULTS: A total of 1,010 patients underwent randomization. Among 926 patients in the modified intention-to-treat population (462 patients in aspirin monotherapy group and 464 patients in the no-antiplatelet therapy group), the primary composite outcome occurred in 3 patients (0.6%) in the aspirin monotherapy group and 4 patients (0.9%) in the no antiplatelet group (difference, -0.2 percentage points; 95% CI: -1.3 to 0.9; P > 0.99). There was no stent thrombosis in either group. The incidence of major bleeding did not differ significantly between groups (6.5% vs 5.2%; P = 0.39), whereas minor bleeding was significantly more frequent in the aspirin group (14.9% vs 10.1%; P = 0.027). CONCLUSIONS: Among patients undergoing low-to-intermediate risk noncardiac surgery >1 year after stent implantation primarily with a DES, in the setting of lower-than-expected event rates, we failed to identify a significant difference between perioperative aspirin monotherapy and no antiplatelet therapy with respect to ischemic outcomes or major bleeding. (Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery [ASSURE-DES]; NCT02797548).

Blood Pressure Measurement Based on the Camera and Inertial Measurement Unit of a Smartphone: Instrument Validation Study.

Background: Even though several mobile apps that can measure blood pressure have been developed, the data about the accuracy of these apps are limited. Objective: We assessed the accuracy of AlwaysBP (test) in blood pressure measurement compared with the standard, cuff-based, manual method of brachial blood pressure measurement (reference). Methods: AlwaysBP is a smartphone software that estimates systolic blood pressure (SBP) and diastolic blood pressure (DBP) based on pulse transit time (PTT). PTT was calculated with a finger photoplethysmogram and seismocardiogram using, respectively, the camera and inertial measurement unit sensor of a commercially available smartphone. After calculating PTT, SBP and DBP were estimated via the Bramwell-Hill and Moens-Korteweg equations. A calibration process was carried out 3 times for each participant to determine the input parameters of the equations. This study was conducted from March to August 2021 at Chungnam National University Sejong Hospital with 87 participants aged between 19 and 70 years who met specific conditions. The primary analysis aimed to evaluate the accuracy of the test method compared with the reference method for the entire study population. The secondary analysis was performed to confirm the stability of the test method for up to 4 weeks in 15 participants. At enrollment, gender, arm circumference, and blood pressure distribution were considered according to current guidelines. Results: Among the 87 study participants, 45 (52%) individuals were male, and the average age was 35.6 (SD 10.4) years. Hypertension was diagnosed in 14 (16%) participants before this study. The mean test and reference SBPs were 120.0 (SD 18.8) and 118.7 (SD 20.2) mm Hg, respectively (difference: mean 1.2, SD 7.1 mm Hg). The absolute differences between the test and reference SBPs were <5, <10, and <15 mm Hg in 57.5% (150/261), 84.3% (220/261 ), and 94.6% (247/261) of measurements. The mean test and reference DBPs were 80.1 (SD 12.6) and 81.1 (SD 14.4) mm Hg, respectively (difference: mean -1.0, SD 6.0 mm Hg). The absolute differences between the test and reference DBPs were <5, <10, and <15 mm Hg in 75.5% (197/261), 93.9% (245/261), and 97.3% (254/261) of measurements, respectively. The secondary analysis showed that after 4 weeks, the differences between SBP and DBP were 0.1 (SD 8.8) and -2.4 (SD 7.6) mm Hg, respectively. Conclusions: AlwaysBP exhibited acceptable accuracy in SBP and DBP measurement compared with the standard measurement method, according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization protocol criteria. However, further validation studies with a specific validation protocol designed for cuffless blood pressure measuring devices are required to assess clinical accuracy. This technology can be easily applied in everyday life and may improve the general population's awareness of hypertension, thus helping to control it.

Relationship between sexual differences and cardiovascular risk factors in the prevalence of asymptomatic coronary disease.

BACKGROUND: This study investigated the sexual differences of coronary artery disease (CAD) prevalence and its association with cardiovascular risk factors in the asymptomatic population. METHODS: In total 6434 asymptomatic participants without known CAD (1740 women and 4694 men) underwent coronary computed tomography angiography (CCTA). The prevalence of significant CAD (diameter stenosis ≥50%) and other CCTA findings were compared by sex, and its influence on CAD was investigated in groups stratified by the number of cardiovascular risk factors, including age (>55 years), hypertension, diabetes, dyslipidemia, and current smoking. RESULTS: The prevalence of current smokers, hypertension, and diabetes were higher in men than women. The mean coronary artery calcium score was 13.1 ± 58.4 for women and 51.1 ± 158.2 for men; the coronary atherosclerosis burden indices were significantly higher in men than women. Significant CAD was identified in 65 women (3.7%) and 429 men (9.1%), showing a significant association (adjusted odds ratio [OR] 2.38, P < 0.001). The relatively higher risk for significant CAD in men was observed in patients with fewer risk factors, and the risk difference was not significant in patients with many risk factors (adjusted ORs: 7.69, 3.37, 1.71, 1.31, and 0.88 in patients with 0, 1, 2, 3, and 4-5 risk factors, respectively). The association between sex and risk factor groups was significant (P < 0.001). CONCLUSIONS: In the asymptomatic population, a significantly higher CAD prevalence was noted in men than women. However, women with a high number of cardiovascular risk factors showed a CAD prevalence similar to that of men.

Prognostic Impact of Left Atrial Strain After Mitral Valve Repair Surgery in Patients With Severe Mitral Regurgitation.

BACKGROUND AND OBJECTIVES: The prognostic value of left atrial (LA) function in terms of long-term clinical outcomes after mitral regurgitation (MR) surgery remains unclear. Therefore, we investigated the impact of preoperative LA global longitudinal strain (LAGLS) on the long-term postoperative clinical outcomes in chronic severe MR patients who underwent mitral valve (MV) repair surgery. METHODS: From January 2012 to December 2017, we analyzed 338 patients (mean age, 51.9±12.5 years; 218 males [64.5%]) treated with MV repair surgery for severe MR. The primary outcome was cardiovascular events, defined as the composite of all-cause death, newly developed atrial fibrillation (AF), and re-hospitalization for cardiovascular causes. RESULTS: During a median follow-up of 45 months (interquartile range, 26-65), 30 (8.9%) cardiovascular events, 5 (1.5%) all-cause death, 8 (2.4%) newly developed AF, and 26 (7.7%) re-hospitalizations occurred. On multivariable analysis, baseline LAGLS was an independent predictor of cardiovascular events (adjusted hazard ratio [HR], 0.91; 95% confidential interval [CI], 0.85-0.97; p=0.004) and re-hospitalization (adjusted HR, 0.93; 95% CI, 0.86-1.00; p=0.037). According to the optimal cutoff value of LAGLS, patients with low LAGLS (<23.6%) had a significantly higher risk of cardiovascular events (adjusted HR, 2.70; 95% CI, 1.04-7.00; p=0.041) than those with high LAGLS (≥23.6%). In a subgroup analysis, patients with high LAGLS had better clinical outcomes regardless of whether the patient had a LA volume index <60 mL/m². CONCLUSIONS: In patients with chronic severe MR who received successful MV repair surgery, preoperative LAGLS is an independent predictor of long-term postoperative outcomes.

Time-Dependent Impact of Sex on the Long-Term Outcomes After Left Main Revascularization.

Background There are still limited data about the differential effect of sex on long-term outcomes after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for left main coronary artery disease. This extended follow-up study of the MAIN-COMPARE (Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease) registry evaluated clinical outcomes beyond 10 years. Methods and Results Of 2240 patients with unprotected left main coronary artery disease (PCI=1102 and CABG=1138), all-cause mortality, the composite of death, Q-wave myocardial infarction, or stroke, and target vessel revascularization were separately evaluated in both sexes. Of 2240 patients, 631 (28.2%) were women and 1609 (71.8%) were men. Women had lower 10-year incidences of death and serious composite outcomes than men. The adjusted 10-year risks of adverse outcomes were similar in men. However, the adjusted 10-year risks were different according to a prespecified period in women. In the short-term (0-1 year) period, PCI had a significantly lower risk for serious composite outcomes (adjusted hazard ratio [HR], 0.41; 95% CI, 0.19-0.91; P=0.03) compared with CABG. The adjusted risks for death and serious composite outcomes were significantly higher after PCI than after CABG, during the midterm (1-5 years) period (death; adjusted HR, 3.99; 95% CI, 2.01-7.92; P<0.001 and composite outcome; adjusted HR, 2.93; 95% CI, 1.59-5.39; P=0.001). Beyond 5 years, adjusted risks were similar after PCI and CABG in women. Conclusions In this 10-year extended follow-up study of patients undergoing left main coronary artery revascularization, we observed a time-dependent impact of sex on the long-term outcomes after PCI and CABG, especially in women, with significant interactions. However, these results warrant confirmation on larger series of studies. Registration URl: https://www.clinicaltrials.gov; Unique identifier: NCT02791412.