Intravascular Imaging-Guided or Angiography-Guided Complex PCI.

BACKGROUND: Data regarding clinical outcomes after intravascular imaging-guided percutaneous coronary intervention (PCI) for complex coronary-artery lesions, as compared with outcomes after angiography-guided PCI, are limited. METHODS: In this prospective, multicenter, open-label trial in South Korea, we randomly assigned patients with complex coronary-artery lesions in a 2:1 ratio to undergo either intravascular imaging-guided PCI or angiography-guided PCI. In the intravascular imaging group, the choice between intravascular ultrasonography and optical coherence tomography was at the operators' discretion. The primary end point was a composite of death from cardiac causes, target-vessel-related myocardial infarction, or clinically driven target-vessel revascularization. Safety was also assessed. RESULTS: A total of 1639 patients underwent randomization, with 1092 assigned to undergo intravascular imaging-guided PCI and 547 assigned to undergo angiography-guided PCI. At a median follow-up of 2.1 years (interquartile range, 1.4 to 3.0), a primary end-point event had occurred in 76 patients (cumulative incidence, 7.7%) in the intravascular imaging group and in 60 patients (cumulative incidence, 12.3%) in the angiography group (hazard ratio, 0.64; 95% confidence interval, 0.45 to 0.89; P = 0.008). Death from cardiac causes occurred in 16 patients (cumulative incidence, 1.7%) in the intravascular imaging group and in 17 patients (cumulative incidence, 3.8%) in the angiography group; target-vessel-related myocardial infarction occurred in 38 (cumulative incidence, 3.7%) and 30 (cumulative incidence, 5.6%), respectively; and clinically driven target-vessel revascularization in 32 (cumulative incidence, 3.4%) and 25 (cumulative incidence, 5.5%), respectively. There were no apparent between-group differences in the incidence of procedure-related safety events. CONCLUSIONS: Among patients with complex coronary-artery lesions, intravascular imaging-guided PCI led to a lower risk of a composite of death from cardiac causes, target-vessel-related myocardial infarction, or clinically driven target-vessel revascularization than angiography-guided PCI. (Supported by Abbott Vascular and Boston Scientific; RENOVATE-COMPLEX-PCI ClinicalTrials.gov number, NCT03381872).

Heart failure with mid-range ejection fraction and the effect of ß-blockers after acute myocardial infarction.

There is currently an ongoing debate about the 'grey area' of heart failure with mid-range ejection fraction (HFmrEF). We evaluated characteristics, prognosis, and the effect of ß-blockers on clinical outcomes in patients with HFmrEF after acute myocardial infarction (AMI). We included a total of 10,785 patients and divided them into three groups: EF 40-49% (HFmrEF; n = 2717; reference); EF < 40% (reduced EF [HFrEF]; n = 1194); and EF ≥ 50% (preserved EF [HFpEF]; n = 6874). The primary outcome was 2-year all-cause mortality. HFmrEF was intermediate between HFrEF and HFpEF for baseline characteristics. The risk of all-cause mortality was lower for HFmrEF patients compared to HFrEF patients (adjusted hazard ratio [HR] 0.710; 95% confidence interval [CI] 0.544-0.927; P = 0.012). However, HFmrEF patients tended to be at higher risk for 2-year all-cause mortality than HFpEF patients (adjusted HR 1.235; 95% CI 0.989-1.511; P = 0.090). ß-blockers were associated with reductions in all-cause mortality for the entire cohort (adjusted HR 0.760; 95% CI 0.592-0.975; P = 0.031). ß-blockers were effective in patients with HFrEF (adjusted HR 0.667; 95% CI 0.471-0.944; P = 0.022), tended to be effective in patients with HFmrEF (adjusted HR 0.665; 95% CI 0.426-1.038; P = 0.072), but not effective in patients with HFpEF (adjusted HR 0.852; 95% CI 0.548-1.326; P = 0.478; interaction P = 0.026). In conclusion, clinical profiles and prognosis of patients with post-AMI HFmrEF are largely intermediate between HFrEF and HFpEF. ß-blockers reduced or tended to reduce 2-year all-cause mortality in patients with HFrEF or HFmrEF, respectively, but not those with HFpEF after AMI.

Comparing the performance of artificial intelligence and conventional diagnosis criteria for detecting left ventricular hypertrophy using electrocardiography.

AIMS: Although left ventricular hypertrophy (LVH) has a high incidence and clinical importance, the conventional diagnosis criteria for detecting LVH using electrocardiography (ECG) has not been satisfied. We aimed to develop an artificial intelligence (AI) algorithm for detecting LVH. METHODS AND RESULTS: This retrospective cohort study involved the review of 21 286 patients who were admitted to two hospitals between October 2016 and July 2018 and underwent 12-lead ECG and echocardiography within 4 weeks. The patients in one hospital were divided into a derivation and internal validation dataset, while the patients in the other hospital were included in only an external validation dataset. An AI algorithm based on an ensemble neural network (ENN) combining convolutional and deep neural network was developed using the derivation dataset. And we visualized the ECG area that the AI algorithm used to make the decision. The area under the receiver operating characteristic curve of the AI algorithm based on ENN was 0.880 (95% confidence interval 0.877-0.883) and 0.868 (0.865-0.871) during the internal and external validations. These results significantly outperformed the cardiologist's clinical assessment with Romhilt-Estes point system and Cornell voltage criteria, Sokolov-Lyon criteria, and interpretation of ECG machine. At the same specificity, the AI algorithm based on ENN achieved 159.9%, 177.7%, and 143.8% higher sensitivities than those of the cardiologist's assessment, Sokolov-Lyon criteria, and interpretation of ECG machine. CONCLUSION: An AI algorithm based on ENN was highly able to detect LVH and outperformed cardiologists, conventional methods, and other machine learning techniques.

Extension of catheter ablation and outcome for ventricular tachycardia or premature ventricular contractions from the right ventricular outflow tract.

Objective We aimed to determine whether the extension of ablation could influence the ablation outcome for ventricular tachycardia (VT)/premature ventricular contractions (PVCs) from the right ventricular outflow tract (RVOT). Methods and results The radiofrequency catheter ablation results of 33 VT/6 frequent PVCs from the RVOT were analysed. The ablation extension was divided into 3 categories from the final successful ablation point with the earliest activation: (I) focal ablation (15 cases); ablation at 1 or 2 points; (II) focal with extended ablation (12 cases); focal and surrounding area ablation (maximum ≤1 cm) after elimination of clinical VT/PVCs; and (III) broad ablation (12 cases); continued broad ablation (maximum >1 cm) after elimination of clinical VT/PVCs. Acute termination was defined as the complete elimination and non-inducibility of clinical VT/PVCs during the procedure. For the mean follow-up of 12.8 months, the recurrence rate was not significantly different among the groups (P = 0.49). The mean procedure time was longer in group II, but ablation times and complication rates were not different among the groups. When acute termination was achieved, the overall recurrence rate was 7.6%. However, when confirming absence of the clinical VT/PVCs using 24-hour Holter monitoring immediately after the procedure, the recurrence rate was 2.7%. Conclusions Ablation extension did not affect ablation outcome of VT/PVCs from the RVOT. Confirmation of absence of clinical VT/PVCs using 24-hour Holter monitoring immediately after the procedure could guarantee long-term success.

Initial Total Bilirubin and Clinical Outcome in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention With Drug-Eluting Stents.

BACKGROUND: Total bilirubin (TB) concentration is inversely associated with stable coronary artery disease, but there have been few studies on initial TB in patients with ST-segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: A total of 1,111 consecutive patients with STEMI undergoing primary percutaneous coronary intervention (PCI) with drug-eluting stents (DES) were divided into a high TB group (n=295) and a low TB group (n=816) according to the optimal cut-off 0.79 mg/dl. The high TB group had a higher rate of in-hospital major adverse cardiac events (MACE), a composite of cardiac death, non-fatal MI, and definite/probable stent thrombosis (14.2% vs. 4.2%, P<0.001) and cardiac death (13.9% vs. 3.9%, P<0.001) compared with the low TB group. The 30-day MACE-free survival rate was also significantly different between the groups (P<0.001, log-rank test). On multivariate Cox regression, initial high TB was a significant predictor of in-hospital MACE (HR, 2.69; 95% CI: 1.67-4.34, P=0.010) and of cardiac death (HR 2.72, 95% CI: 1.67-4.44, P=0.012). Adding initial TB to TIMI risk score significantly improved prediction for in-hospital MACE according to net reclassification improvement (NRI=5.2%, P=0.040) and integrated discrimination improvement (IDI=0.027, P=0.006). CONCLUSIONS: Initial TB is a powerful prognostic marker, and inclusion of this can improve prediction of in-hospital MACE in patients with STEMI undergoing primary PCI with DES. (Circ J 2016; 80: 1437-1444).

Triple versus dual antiplatelet therapy after percutaneous coronary intervention for coronary bifurcation lesions: results from the COBIS (COronary BIfurcation Stent) II Registry.

The efficacy and safety of adding cilostazol to aspirin plus clopidogrel (triple antiplatelet therapy, TAPT) have not been fully evaluated in complex percutaneous coronary intervention (PCI). We sought to investigate whether TAPT after PCI for bifurcation lesions improves long-term clinical outcomes. Consecutive patients undergoing PCI for bifurcation lesions were enrolled from 18 centers in Korea between 2003 and 2009. We compared target vessel failure (TVF), defined as a composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR), among 675 patients who received TAPT and 2081 who received dual antiplatelet therapy (DAPT: aspirin plus clopidogrel). Patients who received TAPT had more cardiovascular co-morbidities with regard to clinical, angiographic, and procedural characteristics. During the follow-up (median 36 months), 346 (12.6%) TVFs occurred. The incidence of TVF was significantly higher in the TAPT group, mainly driven by a higher TVR rate. In the TAPT group, however, the risk of TVF was not significantly different from the DAPT group after adjusting for the confounders of TVFs (adjusted hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.53-1.39, p = 0.53). And also, there were no significant differences between the 2 groups in terms of the risks for death, cardiac death, MI, TVR, stent thrombosis, or cerebrovascular accident. These results were consistent after propensity score-matched analysis, and were also constant among the high-risk subgroups. TAPT after bifurcation PCI had no beneficial effect on the risk of long-term clinical outcomes in real-world clinical practice. Further studies are needed to confirm these findings.

Acquired Large Calcified Unruptured Sinus of Valsalva Aneurysm.

Acquired aneurysms of the sinus of Valsalva are rare. They are caused by infections such as tuberculosis, syphilis and endocarditis, as well as atherosclerosis and traumatic injury. They may be asymptomatic and incidentally discovered. We present a rare case of a large acquired calcified unruptured aneurysm of the right coronary sinus of Valsalva that was compressing the right ventricular outflow tract.

Spironolactone lowers the rate of repeat revascularization in acute myocardial infarction patients treated with percutaneous coronary intervention.

BACKGROUND: We sought to assess the effect of the aldosterone receptor blocker, spironolactone, on 1-year clinical outcomes in all-comers with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention. METHODS: A total of 10,309 AMI patients were recruited between November 2005 and April 2008 from a nationwide AMI registry in Korea. Patients were divided into 2 groups: those treated with spironolactone (n = 720; 7.0%) and those who had not been treated at discharge. The primary end point was major adverse cardiac events (MACEs), defined as the composite of death from any cause, recurrent AMI, or repeat revascularization at 1 year after admission. RESULTS: The spironolactone group had a greater number of comorbidities than the nonspironolactone group. There was no significant association between the spironolactone treatment and MACE at 1 year (adjusted hazard ratio [HR] 0.95, 95% confidence interval 0.72-1.24, P = .69) in the overall population. The risks of death from any cause, cardiac death, and recurrent AMI were also similar between the groups. However, patients who received spironolactone had a lower risk of repeat revascularization than did those who did not receive spironolactone (adjusted HR 0.58, 95% CI 0.39-0.86, P = .007). Of guideline-eligible patients (n = 821/10,309; 8.0%), 170 (20.7%) of 821 patients received a spironolactone at hospital discharge. When limited to the guideline-eligible patients' population, a statistical trend toward lower MACE was observed in patients treated with spironolactone (14.3% vs 13.7%, adjusted HR 0.63, 95% CI 0.37-1.10, P = .10). CONCLUSIONS: All-comer AMI patients undergoing percutaneous coronary intervention who received spironolactone had a lower risk of repeat revascularization. Randomized trials are needed.

Percutaneous coronary intervention for nonculprit vessels in cardiogenic shock complicating ST-segment elevation acute myocardial infarction.

OBJECTIVES: We investigated the clinical impact of multivessel percutaneous coronary intervention in ST-segment elevation myocardial infarction complicated by cardiogenic shock with multivessel disease. DESIGN: A prospective, multicenter, observational study. SETTING: Cardiac ICU of a university hospital. PATIENTS: Between November 2005 and September 2010, 338 patients were selected. Inclusion criteria were as follows: 1) ST-segment elevation myocardial infarction with cardiogenic shock and 2) multivessel disease with successful primary percutaneous coronary intervention for the infarct-related artery. Patients were divided into multivessel percutaneous coronary intervention and culprit-only percutaneous coronary intervention. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Primary outcome was all-cause mortality. Median follow-up duration was 224 days (interquartile range, 46-383 d). Multivessel percutaneous coronary intervention was performed during the primary percutaneous coronary intervention in 60 patients (17.8%). In-hospital mortality was similar in both groups (multivessel percutaneous coronary intervention vs culprit-only percutaneous coronary intervention, 31.7% vs 24.5%; p = 0.247). All-cause mortality during follow-up was not significantly different between the two groups after adjusting for patient, angiographic, and procedural characteristics as well as propensity scores for receiving multivessel percutaneous coronary intervention (35.0% vs 30.6%; adjusted hazard ratio, 1.06; 95% CI, 0.61-1.86; p = 0.831). There were no significant differences between the groups in rates of major adverse cardiac events (41.7% vs 37.1%; adjusted hazard ratio, 1.03; 95% CI, 0.62-1.71; p = 0.908) and any revascularization (6.7% vs 4.7%; adjusted hazard ratio, 1.88; 95% CI, 0.51-6.89; p = 0.344). CONCLUSIONS: Multivessel percutaneous coronary intervention could not reduce the prevalence of mortality in patients with cardiogenic shock complicating ST-segment elevation myocardial infarction and multivessel disease during primary percutaneous coronary intervention.

Valve prosthesis distortion after cardiac compression in a patient who underwent transcatheter aortic valve implantation (TAVI).

Transcatheter aortic valve implantation (TAVI) has been developed as an alternative to conventional aortic valve replacement for the treatment of symptomatic severe aortic stenosis in high-risk patients. Nevertheless, TAVI has been associated with serious complications such as stroke, vascular injury, renal failure, and arrhythmia. Herein we describe a case of distortion of the Edward-Sapien prosthesis (Edwards Lifesciences, USA), which was mounted on a balloon-expandable stent, after chest compression for cardiac resuscitation in a patient who underwent TAVI for severe aortic stenosis.

Comparison of the axillary venous approach and subclavian venous approach for efficacy of permanent pacemaker implantation. 8-Year follow-up results.

BACKGROUND: Long-term data on lead complication rates are limited for both the axillary and subclavian venous approaches for permanent pacemaker implantation. METHODS AND RESULTS: We conducted a single-center, retrospective, nonrandomized comparison. We reviewed the patients who had consented to receiving a permanent pacemaker implant. A superficial landmark or radiographic contrast guiding was used for the axillary venous approach, whereas conventional landmarks were used for the subclavian venous approach. From January 1992 to December 2005, we analyzed 1,161 permanent pacemaker leads in 655 patients [subclavian venous approach (group I: 338 patients, 542 leads) and axillary venous approach (group II: 317 patients, 619 leads)]. Baseline characteristics of the patients did not differ. However, DDD-pacemakers and atrial leads were used more often in group II than in group I (94% vs. 62% and 49% vs. 40%, P<0.01). During the 8-year follow-up, lead complication rates were lower in group II (17 leads, 3%) than in group I (31 leads, 6%) (P=0.03), and group II had a better complication-free survival curve than group I with a 49% relative risk reduction in lead complication rates (hazard ratio =0.51; 95% confidence interval, 0.27-0.94; P=0.03). CONCLUSIONS: The axillary venous approach for permanent pacemaker implantation has better long-term efficacy and lower lead complication rates than the subclavian venous approach.

Congenital partial defect of the left pericardium presenting as chest pain.

Congenital pericardial defect is a rare cardiac defect with variable clinical presentations. It is usually an unexpected finding during cardiac surgery or autopsy. The clinical detection of congenital absence of pericardium is important because of its life-threatening complications such as fatal myocardial strangulation, myocardial ischaemia and sudden death. We present a patient with the incidental finding of left-sided partial defect of the pericardium during evaluation of chest pain.

A large pericardial cyst compressing the left atrium presenting as a pericardiopleural efussion.

Pericardial cysts are rare congenital abnormalities with a reported incidence rate of 1:100,000, accounting for about 7.6% of all mediastinal masses. These cysts frequently occur in the right cardiophrenic angle and their diagnosis is usually suspected after an abnormal chest X-ray is obtained. Herein, we present a case of pericardial cyst compressing the left atrium complicated by a pericardial effusion and pleural effusion in a 62 year-old man with chest discomfort and dyspnoea. After the pericardial cyst was surgically removed, the histopathological examination revealed an inflamed pericardial cyst lined with mesothelial cells.

The Association of CHADS-P2A2RC Risk Score With Clinical Outcomes in Patients Taking P2Y12 Inhibitor Monotherapy After 3 Months of Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention.

BACKGROUND AND OBJECTIVES: Concerns remain that early aspirin cessation may be associated with potential harm in subsets at high risk of ischemic events. This study aimed to assess the effects of P2Y12 inhibitor monotherapy after 3-month dual antiplatelet therapy (DAPT) vs. prolonged DAPT (12-month or longer) based on the ischemic risk stratification, the CHADS-P2A2RC, after percutaneous coronary intervention (PCI). METHODS: This was a sub-study of the SMART-CHOICE trial. The effect of the randomized antiplatelet strategies was assessed across 3 CHADS-P2A2RC risk score categories. The primary outcome was a major adverse cardiac and cerebral event (MACCE), a composite of all-cause death, myocardial infarction, or stroke. RESULTS: Up to 3 years, the high CHADS-P2A2RC risk score group had the highest incidence of MACCE (105 [12.1%], adjusted hazard ratio [HR], 2.927; 95% confidence interval [CI], 1.358-6.309; p=0.006) followed by moderate-risk (40 [1.4%], adjusted HR, 1.786; 95% CI, 0.868-3.674; p=0.115) and low-risk (9 [0.5%], reference). In secondary analyses, P2Y12 inhibitor monotherapy reduced the Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding without increasing the risk of MACCE as compared with prolonged DAPT across the 3 CHADS-P2A2RC risk strata without significant interaction term (interaction p for MACCE=0.705 and interaction p for BARC types 2, 3, or 5 bleeding=0.055). CONCLUSIONS: The CHADS-P2A2RC risk score is valuable in discriminating high-ischemic-risk patients. Even in such patients with a high risk of ischemic events, P2Y12 inhibitor monotherapy was associated with a lower incidence of bleeding without increased risk of ischemic events compared with prolonged DAPT. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02079194.

Optimal timing of revascularization for patients with non-ST segment elevation myocardial infarction and severe left ventricular dysfunction.

Optimal timing of revascularization for patients who presented with non-ST segment elevation myocardial infarction (NSTEMI) and severe left ventricular (LV) dysfunction is unclear. A total of 386 NSTEMI patients with severe LV dysfunction from the nationwide, multicenter, and prospective Korea Acute Myocardial Infarction Registry V (KAMIR-V) were enrolled. Severe LV dysfunction was defined as LV ejection fraction ≤ 35%. Patients with cardiogenic shock were excluded. Patients were stratified into two groups: PCI within 24 hours (early invasive group) and PCI over 24 hours (selective invasive group). Primary endpoint was major adverse cardiac and cerebrovascular events (MACCE) including all-cause death, non-fatal MI, repeat revascularization, and stroke at 12 months after index procedure. Early invasive group showed higher incidence of in-hospital death (9.4% vs 3.3%, P = .036) and cardiogenic shock (11.5% vs 4.6%, P = .030) after PCI. Early invasive group also showed higher maximum troponin I level during admission (27.7 ±â€…44.8 ng/mL vs 14.9 ±â€…24.6 ng/mL, P = .001), compared with the selective invasive group. Early invasive group had an increased risk of 12-month MACCE, compared with selective invasive group (25.6% vs 17.1%; adjusted HR = 2.10, 95% CI 1.17-3.77, P = .006). Among NSTEMI patients with severe LV dysfunction, the early invasive strategy did not improve the clinical outcomes. This data supports that an individualized approach may benefit high-risk NSTEMI patients rather than a routine invasive approach.

Clinical Impact of Self-Recognition of Recurrent Acute Myocardial Infarction: From KRMI-RCC.

Background/Objectives: Self-recognition of recurrent myocardial infarction (re-MI) may be essential for reducing prehospital time contrast to awareness of re-MI symptoms. However, data on the current status and clinical impact of self-recognition of re-MI are limited in the contemporary period. Thus, this study aimed to increase this body of knowledge. Methods: We enrolled 1018 patients with re-MI using data from the Korean Registry of Acute Myocardial Infarction for Regional Cardiocerebrovascular Centres. The patients were classified into self-recognised MI and unrecognised MI groups, and the differences between them were compared. Results: The rate of self-recognition among the patients with previous experience of MI was only 52.4%. Among the patients with re-MI, factors associated with self-recognition included recent first MI within 3 years, prior dyslipidaemia, two or more MI symptoms, and the male gender (p < 0.05). Factors associated with a lack of recognition were older age (≥70 years), prior stroke, and cancer history (p < 0.05). The proportion of symptoms-to-emergency room arrival time within 90 min among the patients with ST-elevation MI was significantly higher in the self-recognised group than in the unrecognised group (52.6% vs. 31.6%, p < 0.001). The self-recognised group showed a lower in-hospital mortality rate (1.5% vs. 6.2%, p < 0.001), and this benefit was maintained even after 1 year (hazard ratio: 0.53; p < 0.001). Conclusions: Only half of the patients who previously experienced a MI recognised a re-MI when it occurred. This recognition reduced prehospital delay and led to higher survival rates, which highlights the importance of patient education as well as objective monitoring devices, irrespective of individual recognition ability for immediate response.

Intravascular Imaging and Angiography Guidance in Complex Percutaneous Coronary Intervention Among Patients With Diabetes: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Data are limited regarding the effects of intravascular imaging guidance during complex percutaneous coronary intervention (PCI) in patients with diabetes. Objective: To compare the clinical outcomes of intravascular imaging-guided vs angiography-guided complex PCI in patients with or without diabetes. Design, Setting, and Participants: This prespecified secondary analysis of a subgroup of patients in RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention), an investigator-initiated, open-label multicenter trial, analyzed enrolled patients who underwent complex PCI at 20 sites in Korea from May 2018 through May 2021. Eligible patients were randomly assigned in a 2:1 ratio to undergo either the intravascular imaging-guided PCI or angiography-guided PCI. Data analyses were performed from June 2023 to April 2024. Interventions: Percutaneous coronary intervention was performed either under the guidance of intravascular imaging or angiography alone. Main Outcomes and Measures: The primary end point was target vessel failure (TVF), defined as a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization. Results: Among the 1639 patients included in the analysis (mean [SD] age, 65.6 [10.2] years; 1300 males [79.3%]), 617 (37.6%) had diabetes. The incidence of TVF was significantly higher in patients with diabetes than patients without diabetes (hazard ratio [HR], 1.86; 95% CI, 1.33-2.60; P < .001). Among patients without diabetes, the intravascular imaging-guided PCI group had a significantly lower incidence of TVF compared with the angiography-guided PCI group (4.7% vs 12.2%; HR, 0.41 [95% CI, 0.25-0.67]; P < .001). Conversely, in patients with diabetes, the risk of TVF was not significantly different between the 2 groups (12.9% vs 12.3%; HR, 0.97 [95% CI, 0.60-1.57]; P = .90). There was a significant interaction between the use of intravascular imaging and diabetes for the risk of TVF (P for interaction = .02). Among patients with diabetes, only those with good glycemic control (hemoglobin A1c level ≤7.5%) and who achieved stent optimization by intravascular imaging showed a lower risk of future ischemic events (HR, 0.31; 95% CI, 0.12-0.82; P = .02). Conclusions and Relevance: In this secondary analysis of a subgroup of patients in the RENOVATE-COMPLEX-PCI trial, intravascular imaging guidance reduced the risk of TVF compared with angiography guidance in patients without diabetes (but not in patients with diabetes) during complex PCI. In patients with diabetes undergoing complex PCI, attention should be paid to stent optimization using intravascular imaging and glycemic control to improve outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT03381872.

Impact of Intravascular Imaging-Guided Stent Optimization According to Clinical Presentation in Patients Undergoing Complex PCI.

BACKGROUND: It is unclear whether the beneficial effects of intravascular imaging-guided stent optimization vary by clinical presentation during complex percutaneous coronary intervention (PCI). OBJECTIVES: In this prespecified, stratified subgroup analysis from RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance versus Angiography-Guidance on Clinical Outcomes After Complex PCI), we sought to compare the outcomes between intravascular imaging vs angiography guidance according to clinical presentation. METHODS: Patients with complex coronary artery lesions were randomly assigned to undergo either intravascular imaging-guided PCI or angiography-guided PCI in a 2:1 ratio. The primary endpoint was target vessel failure (TVF), which is a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. RESULTS: Of 1,639 patients, 832 (50.8%) presented with acute coronary syndrome (ACS) and 807 (49.2%) with chronic coronary syndrome. During a median follow-up of 2.1 years (Q1-Q3: 1.4-3.0 years), there was no significant interaction between the treatment effect of intravascular imaging and clinical presentation (P for interaction = 0.19). Among patients with ACS, the incidences of TVF were 10.4% in the intravascular imaging group and 14.6% in the angiography group (HR: 0.74; 95% CI: 0.48-1.15; P = 0.18). Among patients with CCS, the incidences of TVF were 5.0% in the intravascular imaging group and 10.4% in the angiography group (HR: 0.46; 95% CI: 0.27-0.80; P = 0.006). Achieving stent optimization by intravascular imaging resulted in a reduced risk of TVF among patients with ACS who were randomly assigned to intravascular imaging-guided PCI for complex coronary lesions (optimized vs unoptimized, 6.5% vs 14.1%; HR: 0.49; 95% CI: 0.27-0.87; P = 0.02) but not those with CCS (5.4% vs 4.7%, HR: 1.18; 95% CI: 0.53-2.59; P = 0.69). CONCLUSIONS: No significant interaction was observed between the benefits of intravascular imaging and clinical presentation in the risk of TVF. Stent optimization by intravascular imaging was particularly important for ACS patients. (Intravascular Imaging- Versus Angiography-Guided Percutaneous Coronary Intervention For Complex Coronary Artery Disease [RENOVATE]; NCT03381872).

Intravascular Imaging-Guided Optimization of Complex Percutaneous Coronary Intervention by Sex: A Subgroup Analysis of the RENOVATE-COMPLEX-PCI Trial.

Importance: There have been heterogeneous results related to sex differences in prognosis after percutaneous coronary artery intervention (PCI) for complex coronary artery lesions. Objective: To evaluate potential differences in outcomes with intravascular imaging-guided PCI of complex coronary artery lesions between women and men. Design, Setting, and Participants: This prespecified substudy evaluates the interaction of sex in the investigator-initiated, open-label, multicenter RENOVATE-COMPLEX-PCI randomized clinical trial, which demonstrated the superiority of intravascular imaging-guided PCI compared with angiography-guided PCI in patients with complex coronary artery lesions. The trial was conducted at 20 sites in Korea. Patients with complex coronary artery lesions undergoing PCI were enrolled between May 2018 and May 2021, and the median (IQR) follow-up period was 2.1 (1.4-3.0) years. Data were analyzed from December 2022 to December 2023. Interventions: After diagnostic coronary angiography, eligible patients were randomly assigned in a 2:1 ratio to receive intravascular imaging-guided PCI or angiography-guided PCI. The choice and timing of the intravascular imaging device were left to the operators' discretion. Main Outcomes and Measures: 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. Secondary end points included individual components of the primary end point. Results: Of 1639 included patients, 339 (20.7%) were women, and the mean (SD) age was 65.6 (10.2) years. There was no difference in the risk of the primary end point between women and men (9.4% vs 8.3%; adjusted hazard ratio [HR], 1.39; 95% CI, 0.89-2.18; P = .15). Intravascular imaging-guided PCI tended to have lower incidence of the primary end point than angiography-guided PCI in both women (5.2% vs 14.5%; adjusted HR, 0.34; 95% CI, 0.15-0.78; P = .01) and men (8.3% vs 11.7%; adjusted HR, 0.72; 95% CI, 0.49-1.05; P = .09) without significant interaction (P for interaction = .86). Conclusions and Relevance: In patients undergoing complex PCI, compared with angiographic guidance, intravascular imaging guidance was associated with similar reduction in the risk of target vessel failure among women and men. The treatment benefit of intravascular imaging-guided PCI showed no significant interaction between treatment strategy and sex. Trial Registration: ClinicalTrials.gov Identifier: NCT03381872.