BACKGROUND:Recent trials support the superior efficacy of clopidogrel compared to aspirin monotherapy after completion of dual antiplatelet therapy (DAPT) in patients who have undergone percutaneous coronary intervention (PCI). However, limited evidence is available in patients with diabetes mellitus (DM). OBJECTIVES:The current study sought to evaluate the comparative efficacy and safety of clopidogrel vs aspirin monotherapy according to the presence of DM. METHODS:This was a prespecified analysis of the SMART-CHOICE 3 trial, which was a multicenter, open-label, randomized controlled trial comparing clopidogrel vs aspirin monotherapy in patients with complex coronary lesions or high-risk clinical characteristics. From August 2020 to July 2023, a total of 5,506 patients who underwent PCI and standard DAPT duration and had complex coronary lesions, DM, or previous myocardial infarction, were randomized to clopidogrel or aspirin monotherapy groups. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), which was defined as a composite of death from any cause, myocardial infarction, or stroke. RESULTS:Of 5,506 patients, 2,089 had DM (1,039 in the clopidogrel group and 1,050 in the aspirin group). At a median follow-up of 2.3 years (IQR: 1.6-3.0 years), DM patients had a higher risk of MACCE compared to non-DM patients (6.8% vs 4.7%; HR: 1.44, 95% CI: 1.10-1.87, P = 0.008). Clopidogrel showed a significantly lower risk of MACCE than aspirin in DM patients (4.5% vs 9.1%; HR: 0.57, 95% CI: 0.38-0.86, P = 0.008). There was no significant interaction between DM and antiplatelet monotherapy regarding MACCE (P for interaction = 0.124). The risk of bleeding was comparable between the 2 groups in DM patients (2.9% vs 2.9%; HR: 1.06, 95% CI: 0.57-1.95, P = 0.855). CONCLUSIONS:Among DM patients who completed the standard duration of DAPT after PCI, clopidogrel monotherapy was associated with a lower risk of a composite of death from any cause, myocardial infarction, and stroke compared with aspirin monotherapy, without increased rates of bleeding. There was no significant interaction between DM and antiplatelet monotherapy with respect to MACCE. (SMART-CHOICE 3 [SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3]; NCT04418479).

ABSTRACT Low‐dose single‐pill combinations (SPCs) are gaining recognition as an efficient therapeutic strategy for mild hypertension. However, evidence from randomized controlled trials regarding the efficacy and safety of half‐dose telmisartan/amlodipine SPCs remains limited. In this randomized, double‐blind, active‐controlled phase III trial, patients with essential hypertension [mean sitting systolic blood pressure (MSSBP) ≥ 140 and < 180 mmHg] were allocated to four treatment arms to receive either telmisartan/amlodipine 20/2.5 mg SPC (TEL/AML 20/2.5), or monotherapy with telmisartan 20 mg (TEL 20), amlodipine 2.5 mg (AML 2.5), or telmisartan 40 mg (TEL 40) once daily for 8 weeks. The primary endpoint was the change in MSSBP from baseline to week 8. A gatekeeping approach was used to test the superiority of TEL/AML 20/2.5 over TEL 20 and AML 2.5, followed by non‐inferiority versus TEL 40. At week 8, TEL/AML 20/2.5 showed significantly greater MSSBP reductions compared with TEL 20 [least squares mean (LSM) differences: −5.79 mmHg; p = 0.0003] and AML 2.5 (−8.57 mmHg; p < 0.0001). Non‐inferiority to TEL 40 was established, with an LSM difference of −3.88 mmHg (95% Confidence Interval: −6.67 to −1.09), which met the pre‐specified 3 mmHg margin. The overall incidence of adverse events was 8.05%, with no statistically significant differences between groups. Overall, TEL/AML 20/2.5 SPC provided superior BP‐lowering efficacy compared with TEL 20 and AML 2.5 monotherapies and was non‐inferior to TEL 40. With a comparable safety profile across treatment groups, these findings suggest that TEL/AML 20/2.5 is a practical and effective option for hypertension management. Trial Registration: ClinicalTrials.gov, NCT06052748

Fenofibrate may offer cardiovascular benefit in statin-treated individuals with elevated triglyceride-rich lipoprotein cholesterol (TRL-C), a measure reflecting cholesterol carried in triglyceride-rich lipoproteins, yet its role remains uncertain. We investigated whether fenofibrate added to statin therapy is associated with lower risk of atherosclerotic cardiovascular disease (ASCVD), particularly in individuals with high TRL-C. We analyzed 67,662 statin-treated adults without baseline ASCVD from the Korean National Health Insurance Service cohort. Participants were stratified by median TRL-C (26mg/dL), and propensity score matching was performed for fenofibrate users and non-users within each stratum. The primary outcome was incident ASCVD, defined as a composite of coronary artery disease, ischemic stroke, and cardiovascular death. Over a mean follow-up of 87 months, fenofibrate use was associated with lower ASCVD risk in individuals with TRL-C ≥median (adjusted hazard ratio [HRadj] 0.76; 95% confidence interval [CI] 0.59–0.99), but not in those with TRL-C <median after matching. The association remained consistent in multiple sensitivity analyses and was most pronounced in individuals with the highest TRL-C quartile (Pinteraction=0.04). A significant benefit was also observed in individuals with non–high density lipoprotein cholesterol (Non-HDL-C) ≥140 mg/dL, with HRadj of 0.68 (95% CI 0.49–0.94) for non–HDL-C 140–172 mg/dL and 0.68 (95% CI 0.46–0.99) for non–HDL-C 172–199 mg/dL. In this nationwide cohort, fenofibrate use was associated with 24% lower ASCVD risk with elevated TRL-C despite statin therapy. These findings suggest that TRL-C may help identify individuals who derive greater benefit from fenofibrate therapy.

BACKGROUND:Although low-dose triple single-pill combination therapies show promising efficacy and safety, studies comparing them to standard-dose monotherapies remain limited. This phase III, randomized, double-blind trial evaluated the efficacy and safety of a low-dose single-pill combination of telmisartan, amlodipine, and chlorthalidone versus standard-dose telmisartan monotherapy in patients with essential hypertension. METHODS:After a 4-week placebo run-in period, 314 eligible subjects were randomized to either receive telmisartan/amlodipine/chlorthalidone 20/2.5/6.25 mg or telmisartan 40 mg for 8 weeks. The primary efficacy end point was the change in mean sitting systolic blood pressure from baseline to week 8, with noninferiority assessed in the per-protocol set (PPS), followed by superiority testing in the full analysis set using a gatekeeping approach to control for type I error. RESULTS:At week 8, the combination group demonstrated significant mean sitting systolic blood pressure reduction compared with monotherapy in the per-protocol set analysis (least squares mean difference, -3.8 mm Hg [95% CI: -6.7 to -0.9]; P=0.01), establishing its noninferiority. Furthermore, the superiority of the combination therapy was confirmed in the full analysis set (LS mean difference, -4.0 mm Hg [95% CI, -6.8 to -1.3]; P<0.01). Mean sitting diastolic BP, BP normalization rates, and response rates also favored the combination group at weeks 4 and 8 (all P<0.01). Subgroup analyses showed consistent efficacy across clinical strata, including age and prior antihypertensive treatment. The incidence of adverse events was comparable between groups, with no serious drug-related events reported. CONCLUSIONS:Low-dose triple single-pill combination of telmisartan/amlodipine/chlorthalidone demonstrated superior BP-lowering efficacy with well-tolerated and comparable safety to standard-dose telmisartan monotherapy. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT06348576.

BACKGROUND:Provisional stenting has become the default treatment strategy for most coronary bifurcation lesions However, in some clinical and anatomical settings, final two-stent implantation may yield better cardiovascular outcomes. This study aimed to identify preprocedural clinical and angiographic predictors associated with greater benefit from final two-stent implantation in coronary artery bifurcation lesions and to guide patient selection for this strategy. METHODS:We analyzed 5333 patients with coronary bifurcation lesions (mean age 66.2 years; 76% male) from the BIFURCAT registry, an international merged dataset combining the COBIS III and RAIN registries. All patients received second-generation drug-eluting stents; 82% underwent final single-stent and 18% final two-stent implantation. The primary endpoint was major adverse cardiac events (MACE)-a composite of all-cause death, myocardial infarction, and target lesion revascularization-at 2 years. Multivariable Cox regression with interaction testing was used to identify preprocedural clinical and angiographic predictors of differential benefit from two-stent implantation. RESULTS:Six predictors demonstrated a statistically significant interaction with final one stent and two stent implantation groups: diabetes mellitus, main vessel reference diameter > 3.0 mm, main vessel lesion length < 20 mm, side branch lesion length ≥ 20 mm, non-left main lesion, and severe coronary artery calcification. Each variable was assigned one point to construct the Bifurcation Two-Stent (BTS) score. In patients with a BTS score < 4 (80% of the cohort), final two-stent implantation was associated with significantly higher MACE rates compared with single-stent implantation (HR: 2.04; 95% CI: 1.64-2.56; P < 0.001). Conversely, patients with a BTS score ≥ 4 (approximately 20% of the cohort) demonstrated significantly lower MACE with two-stent implantation (HR: 0.56; 95% CI: 0.35-0.89; P = 0.014), driven primarily by a reduction in hard endpoints including death and myocardial infarction. These findings remained consistent after adjustment for procedural variables and antiplatelet therapy. CONCLUSION:The BTS score may help identify patients with coronary bifurcation lesions who are most likely to benefit from final two-stent implantation. In patients with BTS score ≥ 4, final two-stent implantation was associated with lower MACE and hard clinical endpoints, supporting a selective rather than routine two-stent strategy in bifurcation PCI.

BACKGROUND:The optimal strategy for long-term antiplatelet maintenance for patients who underwent percutaneous coronary intervention (PCI) remains uncertain. This study aimed to compare the efficacy and safety of clopidogrel versus aspirin monotherapy in patients who completed a standard duration of dual antiplatelet therapy (DAPT) following PCI with drug-eluting stents. METHODS:In this multicentre, randomised, open-label trial, patients aged 19 years or older at high risk of recurrent ischaemic events (previous myocardial infarction at any time before enrolment, medication-treated diabetes, or complex coronary lesions) who completed a standard duration of DAPT after PCI were randomly assigned (1:1) to receive clopidogrel (75 mg once a day) or aspirin (100 mg once a day) oral monotherapy at 26 sites in South Korea. The primary endpoint was the cumulative incidence of a composite of death from any cause, myocardial infarction, or stroke, assessed in the intention-to-treat population. Adverse events were captured as part of the secondary endpoints. This trial is registered with ClinicalTrials.gov (NCT04418479). It is closed to accrual and extended follow-up is ongoing. FINDINGS:Between Aug 10, 2020, and July 31, 2023, 5542 patients were assessed for eligibility and 5506 were randomly assigned (2752 to clopidogrel monotherapy and 2754 to aspirin monotherapy). The median time between PCI and randomisation was 17·5 months (IQR 12·6-36·1 months). During a median follow-up period of 2·3 years (IQR 1·6-3·0), the primary endpoint occurred in 92 patients in the clopidogrel group and 128 patients in the aspirin group (Kaplan-Meier estimated 3-year incidence 4·4% [95% CI 3·4-5·4] vs 6·6% [5·4-7·8]; hazard ratio 0·71 [95% CI 0·54-0·93]; p=0·013). Death from any cause occurred in 50 patients in the clopidogrel group and 70 in the aspirin group (2·4% [1·6-3·1] vs 4·0% [2·9-5·0] at 3 years; 0·71 [0·49-1·02]); myocardial infarction in 23 patients in the clopidogrel group and 42 in the aspirin group (1·0% [0·6-1·4] vs 2·2% [1·4-2·9] at 3 years; 0·54 [0·33-0·90]); and stroke in 23 in the clopidogrel group and 29 in the aspirin group (1·3% [0·7-2·0] vs 1·3% [0·8-1·7] at 3 years; 0·79 [0·46-1·36]). There was no difference in the risk of bleeding between the clopidogrel and aspirin groups (3·0% [2·0-3·9] vs 3·0% [2·2-3·9] at 3 years; 0·97 [0·67-1·42]). Clopidogrel was not associated with a higher incidence of any adverse event compared with aspirin. INTERPRETATION:Among patients who were at high risk of recurrent ischaemic events and who completed the standard duration of DAPT following PCI, clopidogrel monotherapy, compared with aspirin monotherapy, significantly reduced the cumulative incidence of a composite of death from any cause, myocardial infarction, and stroke, without an apparent increase in the risk of bleeding. FUNDING:Dong-A ST.

BACKGROUND:The efficacy and safety of a 1-month prasugrel-based dual antiplatelet therapy (DAPT) strategy followed by reduced-dose prasugrel monotherapy in acute coronary syndrome (ACS) patients treated with drug-coated stents (DCS) have not been studied. AIMS:We aimed to evaluate the safety and efficacy of a 1-month prasugrel-based DAPT regimen followed by reduced-dose monotherapy in ACS patients receiving a DCS. METHODS:In the multicentre, randomised, open-label trial, 656 ACS patients (age: 60.9±9.7 years; 82.6% male) receiving DCS were randomised to either 1-month DAPT with aspirin 100 mg and prasugrel 10 mg (or 5 mg in patients aged ≥75 years or body weight <60 kg) followed by prasugrel 5 mg monotherapy (1M-DAPT) or 12-month DAPT with aspirin and prasugrel 5 mg (12M-DAPT). The primary endpoint was 12-month net adverse clinical events (NACE), a composite of death, non-fatal myocardial infarction, stroke, ischaemia-driven target vessel revascularisation, and Bleeding Academic Research Consortium Type 2-5 bleeding. RESULTS:NACE occurred in 4.9% of the 1M-DAPT group and 8.8% of the 12M-DAPT group, meeting the criteria for both non-inferiority (non-inferiority margin: 2.0%; absolute difference: -3.9%; 95% confidence interval [CI] for absolute difference: -6.7% to -0.2%; p=0.014) and superiority (hazard ratio [HR] 0.51; 95% CI: 0.27-0.95; p=0.034). Any bleeding occurred in 1.2% vs 5.2% (HR 0.23; p=0.009), and major bleeding occurred in 0.6% vs 4.6% (HR 0.13; p=0.007) in the 1M-DAPT versus 12M-DAPT group, respectively. Ischaemic outcomes were similar. CONCLUSIONS:In ACS patients treated with DCS, a 1-month prasugrel-based DAPT strategy followed by prasugrel 5 mg monotherapy reduced NACE by 49%, mainly driven by a 77% reduction of bleeding events without compromising ischaemic safety.

PURPOSE:This study aimed to evaluate the efficacy and safety of triple combination of ezetimibe (Eze)/atorvastatin (Ato) 10/40 mg + amlodipine (Aml) 10 mg therapy for lowering the low-density lipoprotein cholesterol (LDL-C) and blood pressure compared with either Eze/Ato 10/40 mg or Aml 10 mg therapies in patients with comorbid primary hypercholesterolemia and essential hypertension. METHODS:This was a randomized, multicenter, double-blind, active-controlled, Phase III clinical trial. Participants underwent a wash-out period (2 weeks for nonfibrate medications, 6 weeks for fibrates) followed by 4 weeks of therapeutic lifestyle changes. Subsequently, 109 participants were randomly assigned to 3 groups: (1) Eze/Ato 10/40 mg + Aml 10 mg, (2) Eze/Ato 10/40 mg, and (3) Aml 10 mg. The coprimary end points were percentage change in LDL-C and change in mean sitting systolic blood pressure (SBP) compared with baseline at week 8. FINDINGS:A total of 109 participants were enrolled in the study, and there were no statistically significant differences in the baseline characteristics of participants across the 3 groups. After 8 weeks of treatment, the least-square (LS) mean (SE) of percent change from baseline in LDL-C was -57.95% (3.52%) for the Eze/Ato 10/40 mg + Aml 10 mg group and 8.93% (3.54%) for the Aml 10 mg group. The LS mean difference (SE) between these 2 groups was statistically significant at -66.88 (4.95) (95% CI, -76.77% to -56.99%) (P < 0.0001). Furthermore, at week 8, the LS mean (SE) change in mean sitting SBP between the Eze/Ato 10/40 mg + Aml 10 mg group and the Eze/Ato 10/40 mg group was -19.24 (2.42) mm Hg and -4.43 (2.56) mm Hg, respectively. The LS mean difference (SE) between the 2 groups was statistically significant -14.81 (3.53) (95% CI, -21.87 to -7.74) mm Hg (P < 0.0001). No serious adverse drug reactions occurred in any of the study groups. IMPLICATIONS:Triple combination therapy with Eze/Ato + Aml has effectively reduced the LDL-C and SBP independently, compared with either Eze/Ato or Aml therapies over 8 weeks of treatment period. In terms of safety, there were no significant differences among the 3 treatment groups. This research lays the groundwork for the development of a triple fixed-dose combination in the future, which could improve patient convenience and adherence by reducing pill burden. Clinical Research Information Service (CRIS), Republic of Korea: KCT0006283.

BACKGROUND:Bifurcation lesions are associated with higher rates of major adverse cardiac events (MACE). AIM:To investigate the impact of imaging-guided percutaneous coronary intervention (PCI) in a real-world population with coronary bifurcation lesions. METHODS AND RESULTS:From the ULTRA-BIFURCAT registry, we compared intravascular ultrasound (IVUS) vs. angiographic guidance in a cohort of 3486 propensity matched patients. MACE, a composite of all-cause death, myocardial infarction (MI), target-lesion revascularization, and stent thrombosis was the primary endpoint. Subgroup analyses were performed for unprotected left main (ULM) and non-ULM disease. PSM generated 1743 pairs. MACE occurred in 154 (9%) patients in the IVUS-guided group and in 199 (11%) patients in the angio-guided group (P = 0.09). IVUS guidance was associated with lower MACE in the ULM population [hazard ratio (HR) 0.62, 95% confidence internal (CI) 0.46-0.83], but had no impact in the non-ULM population (HR 1.12, 95% CI 0.83-1.51), P for interaction = 0.006. IVUS was associated with a reduction in all-MI (HR 0.32, 95% CI 0.16-0.64) in the ULM population and with lower stent thrombosis (ST) in the non-ULM population (HR 0.24, 95% CI 0.08-0.71). Provisional stenting was associated with lower MACE in the ULM population (HR 0.67, 95% CI 0.45-0.98), whereas kissing balloon (HR 0.75, 95% CI 0.56-0.99) and ultra-thin stents (HR 0.44, 95% CI 0.29-0.67) were protective factors in the non-ULM population. CONCLUSION:In a real-world scenario, IVUS guidance during drug eluting stent (DES) implantation is associated with a lower rate of MACE in patients with ULM coronary bifurcation lesions. In non-ULM bifurcations, no difference was observed on MACE, while IVUS guidance was associated with a lower rate of ST.

Percutaneous coronary intervention (PCI) for bifurcation lesions presents several difficulties and often results in suboptimal procedural, post-procedural clinical outcomes. While the provisional 1-stent strategy is generally favored for its simplicity and favorable outcomes, a few studies suggest no significant difference between 1-stent and 2-stent techniques for true bifurcation lesions. Drug-eluting balloons (DEBs) have demonstrated potential in small vessel disease, including bifurcation side branches. However, no studies have compared the 2-stent strategy with the provisional 1-stent plus DEB strategy in non-LM true bifurcation lesions. Our study aims to address this gap by comparing these strategies, with a focus on real-world practice and detailed endpoint analysis. The PROVISION-DEB study is an open-label, randomized, multi-center clinical trial designed to investigate noninferiority and compare a 1-stent strategy with a drug-eluting balloon and a planned 2-stent strategy at non-LM coronary true-bifurcation lesions. A total of 750 patients with de novo non-LM coronary bifurcation lesions undergoing coronary interventions will be randomized 1:1 to either a provisional 1-stent plus DEB strategy or a 2-stent strategy with stratified Diabetes. The primary endpoint is a target lesion failure, composite outcome of cardiac death, target vessel myocardial infarction, or target lesion revascularization at the anticipated 3 years follow-up (6, 12, and 36 months). In conclusion, PROVISION-DEB study is a randomized, multi-center, non-inferior clinical trial and will compare a 1-setnt strategy with a drug-eluting balloon and a planned 2-stent strategy at non-LM coronary true-bifurcation.

Background Although true bifurcation lesions are associated with a high risk of procedural complications, the differential prognostic implications of percutaneous coronary intervention for true bifurcations according to lesion location are unclear. This study aimed to identify whether clinical outcomes of true bifurcation lesions differed between left main coronary artery (LM) and non‐LM bifurcations and to determine the optimal treatment strategy for subtypes of bifurcation lesions in the current‐generation drug‐eluting stent era. Methods The ULTRA‐BIFURCAT (Combined Insights From the Unified COBIS III, RAIN, and ULTRA Registries) was created by merging 3 bifurcation‐dedicated registries from Korea and Italy. For this, 6548 patients treated with bifurcation lesions were stratified by lesion location and subtype. The primary end point was major adverse cardiac events (MACEs; composite of all‐cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) at 800 days. Results In patients with an LM bifurcation, those with a true bifurcation had a significantly higher risk of a MACE than those with a nontrue bifurcation (20.2% versus 13.4%, adjusted hazard ratio [HR], 1.44 [95% CI, 1.11–1.86]; P=0.006). Conversely, there was no significant difference in the risk of a MACE according to true versus nontrue bifurcation in patients with non‐LM bifurcation lesions (9.0% versus 8.8%; adjusted HR, 1.02 [95% CI, 0.82–1.27]; P=0.849). For LM true bifurcations, MACE rates were comparable between 1‐stent and 2‐stent strategies, whereas for LM nontrue bifurcations, the 2‐stent strategy was associated with a significantly higher risk of MACEs than the 1‐stent strategy. No significant differences in the risk of MACEs were observed in non‐LM bifurcation lesions according to lesion subtype or treatment strategy. Conclusions Clinical outcomes were worse for LM true bifurcation lesions than non‐LM true bifurcation lesions. A provisional 1‐stent strategy should be the preferred approach for treating LM nontrue bifurcation lesions. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03068494, NCT03544294, and NCT05205148.

BACKGROUND: The impact of final kissing balloon inflation (FKB) in patients treated with an upfront provisional strategy for coronary bifurcation lesions is controversial. AIMS: We aimed to assess the impact of FKB on patient-and lesion-oriented outcomes in a large real-world cohort. METHODS: The ULTRA-BIFURCAT registry was obtained by patient-level merging the BIFURCAT and ULTRA registries. Pairs of patients were generated with propensity score matching (PSM). The primary outcome of interest was major adverse cardiac events (MACE) - a composite of all-cause death, myocardial infarction (MI), target lesion revascularisation (TLR) or stent thrombosis. A lesion-oriented composite outcome (LOCO) - a composite of target vessel MI (TVMI) or TLR - along with each single component of MACE represented the secondary outcomes. Subgroup analyses included the site of bifurcation (unprotected left main [ULM] vs non-ULM), side branch involvement (true bifurcation vs non-true bifurcation), side branch diameter and lesion length. Follow-up was censored at 800 days. RESULTS: A total of 5,607 patients undergoing a provisional stenting technique were selected for the present analysis. PSM generated 1,784 pairs. Between the matched patients with FKB versus no FKB, no significant difference in MACE was observed (9.0% vs 8.6%; p=0.68). FKB was associated with a lower rate of the LOCO (1.9% vs 2.9%; p=0.04) compared to the no FKB group, driven by lower rates of TVMI (0.2% vs 0.5%; p=0.03) and TLR (1.8% vs 2.6%; p=0.14). These results were confirmed in the subgroups of patients treated for bifurcations with side branches with a diameter >2.5 mm and for true coronary bifurcation lesions. CONCLUSIONS: Among patients treated for coronary bifurcation lesions with provisional stenting, FKB had no significant impact on MACE but was associated with a mild reduction in the incidence of the LOCO.

BACKGROUND:The optimal duration of dual antiplatelet therapy (DAPT) after complex percutaneous coronary intervention (PCI) remains unclear. We aim to investigate the efficacy and safety of 3 to 6 months of DAPT over 12 months after complex PCI. METHODS:A post hoc analysis of the HOST-IDEA (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Coronary Intervention With Next-Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy) randomized trial which enrolled patients undergoing PCI with third-generation drug-eluting stents was performed. Complex PCI was defined by any of the following: ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with 2-stenting, total stent length ≥60 mm, left main PCI, or heavy calcification. The major end points were target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization for ischemic outcomes, and major bleeding, defined as BARC (Bleeding Academic Research Consortium) type 3 or 5, for bleeding outcomes at 12 months. RESULTS:Among 1992 patients, 624 underwent complex PCI. The complex PCI group had clinical features associated with high bleeding risk. A shortened DAPT duration did not increase the risk of target lesion failure, with hazard ratios of 0.818 (95% CI, 0.403-1.659) for the complex PCI group and 1.282 (95% CI, 0.506-3.249) for the noncomplex PCI group (Pinteraction=0.451). Conversely, it decreased the risk of major bleeding in the complex PCI group (hazard ratio, 0.269 [95% CI, 0.075-0.965]), but not in the noncomplex PCI group (hazard ratio, 1.534 [95% CI, 0.627-3.754], showing a significant interaction; Pinteraction=0.029). CONCLUSIONS:In patients undergoing complex PCI with a third-generation drug-eluting stent, a 3- to 6-month duration of DAPT was associated with a reduced risk of bleeding without an increased risk of ischemic events compared with 12-month DAPT. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique Identifier: NCT02601157.

Background/Aims The coronavirus disease 2019 (COVID-19) pandemic has significantly impacted global health, exacerbated metabolic health issues, and altered lifestyle behaviors. This study examined the sex-specific impact of the COVID-19 outbreak on the incidence of metabolic syndrome using data from the Korea National Health and Nutrition Examination Survey (KNHANES). Methods Data from the KNHANES VII (2018) and VIII (2019–2021), including 15,499 participants, were analyzed. The study population was stratified by sex, and further subdivisions were conducted based on the timeframe relative to the COVID-19 outbreak. Variables such as age, education level, household income, smoking status, and high-risk drinking were analyzed to assess their influence on the prevalence of metabolic syndrome. Results The overall prevalence of metabolic syndrome significantly increased from 28.11% before the outbreak to 29.69% after the outbreak. Both males and females reported significant increases in waist circumference and fasting glucose levels. Age and education level differentially influenced the prevalence of metabolic syndrome between the sex. Smoking was significantly associated with increased prevalence in males, whereas high-risk drinking was associated with increased prevalence in males and decreased prevalence in females. Conclusions The COVID-19 pandemic has significantly increased the prevalence of metabolic syndrome with notable sex-specific differences. These findings highlight the need for sex-specific public health interventions to mitigate the impact of the pandemic on metabolic health.