Search

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

IMPORTANCE: In patients with acute myocardial infarction (AMI) who have high ischemic risk, data on the efficacy and safety of the de-escalation strategy of switching from ticagrelor to clopidogrel are lacking. OBJECTIVE: To evaluate the outcomes of the de-escalation strategy compared with dual antiplatelet therapy (DAPT) with ticagrelor in stabilized patients with AMI and high ischemic risk following percutaneous coronary intervention (PCI). DESIGN, SETTING, AND PARTICIPANTS: This was a post hoc analysis of the Ticagrelor vs Clopidogrel in Stabilized Patients With Acute Myocardial Infarction (TALOS-AMI) trial, an open-label, assessor-blinded, multicenter, randomized clinical trial. Patients with AMI who had no event during 1 month of ticagrelor-based DAPT after PCI were included. High ischemic risk was defined as having a history of diabetes or chronic kidney disease, multivessel PCI, at least 3 lesions treated, total stent length greater than 60 mm, at least 3 stents implanted, left main PCI, or bifurcation PCI with at least 2 stents. Data were collected from February 14, 2014, to January 21, 2021, and analyzed from December 1, 2021, to June 30, 2022. INTERVENTION: Patients were randomly assigned to either de-escalation from ticagrelor to clopidogrel or ticagrelor-based DAPT. MAIN OUTCOMES AND MEASURES: Ischemic outcomes (composite of cardiovascular death, myocardial infarction, ischemic stroke, ischemia-driven revascularization, or stent thrombosis) and bleeding outcomes (Bleeding Academic Research Consortium type 2, 3, or 5 bleeding) were evaluated. RESULTS: Of 2697 patients with AMI (mean [SD] age, 60.0 [11.4] years; 454 [16.8%] female), 1371 (50.8%; 684 assigned to de-escalation and 687 assigned to ticagrelor-based DAPT) had high ischemic risk features and a significantly higher risk of ischemic outcomes than those without high ischemic risk (1326 patients [49.2%], including 665 assigned to de-escalation and 661 assigned to ticagrelor-based DAPT) (hazard ratio [HR], 1.74; 95% CI, 1.15-2.63; P = .01). De-escalation to clopidogrel, compared with ticagrelor-based DAPT, showed no significant difference in ischemic risk across the high ischemic risk group (HR, 0.88; 95% CI, 0.54-1.45; P = .62) and the non–high ischemic risk group (HR, 0.65; 95% CI, 0.33-1.28; P = .21), without heterogeneity (P for interaction = .47). The bleeding risk of the de-escalation group was consistent in both the high ischemic risk group (HR, 0.64; 95% CI, 0.37-1.11; P = .11) and the non–high ischemic risk group (HR, 0.42; 95% CI, 0.24-0.75; P = .003), without heterogeneity (P for interaction = .32). CONCLUSIONS AND RELEVANCE: In stabilized patients with AMI, the ischemic and bleeding outcomes of an unguided de-escalation strategy with clopidogrel compared with a ticagrelor-based DAPT strategy were consistent without significant interaction, regardless of the presence of high ischemic risk.

The relationship between visit-to-visit blood pressure variability (BPV) and cardiovascular outcomes remains unclear. Our study assessed the prognostic implications of visit-to-visit BPV in patients after acute myocardial infarction (AMI). The present study enrolled 7,375 patients who underwent percutaneous coronary intervention for AMI and at least five measurements of blood pressure after hospital discharge. Visit-to-visit BPV was estimated as variability independent of mean. The primary endpoint was all-cause mortality. The secondary endpoints were major cardiovascular events (the composite of cardiovascular death, myocardial infarction, and ischemic stroke) and hospitalization for heart failure. During a median follow-up of 5.8 years, adjusted risks of all-cause mortality, major cardiovascular events, and hospitalization for heart failure continuously increased as systolic BPV and diastolic BPV increased. Patients in the highest quartile of systolic BPV (versus lowest) had increased risk of all-cause mortality (adjusted hazard ratio (aHR) 1.51 [95% confidence interval (CI) 1.23–1.85]), major cardiovascular events (aHR 1.31 [95% CI 1.1–1.55]), and hospitalization for heart failure (aHR 2.15 [95% CI 1.49–3.1]). Patients in the highest quartile of diastolic BPV was also associated with all-cause mortality (aHR 1.39 [95% CI 1.14–1.7]), major cardiovascular events (aHR 1.29 [95% CI 1.08–1.53]), and hospitalization for heart failure (aHR 2.01[95% CI 1.4–2.87]). Both systolic and diastolic BPV improved the predictive ability of the GRACE (Global Registry of Acute Coronary Events) risk score for both all-cause mortality and major cardiovascular events. Higher visit-to-visit BPV was associated with increased risks of mortality and cardiovascular events in patients after AMI.

In patients with acute myocardial infarction receiving potent antiplatelet therapy, the bleeding risk remains high during the maintenance phase. We sought data on a uniform unguided de-escalation strategy of dual antiplatelet therapy (DAPT) from ticagrelor to clopidogrel after acute myocardial infarction.

Little is known about the association between serial high-sensitivity C-reactive protein (hsCRP) measurements and long-term outcomes in post–myocardial infarction (MI) patients. We aimed to investigate the usefulness of serial hsCRP measurements for risk stratification in stabilised post-MI patients after percutaneous coronary intervention (PCI).

Introduction:Potent antiplatelet therapy has a high bleeding risk after acute myocardial infarction, so de-escalation from ticagrelor to clopidogrel has recently been introduced. But, optimal de-escalation strategy according to BMI is unclear.MethodIn TALOS-AMI trial, patients with acute myocardial infarction receiving aspirin and ticagrelor after index percutaneous coronary intervention (PCI) were investigated. This post hoc study determined the efficacy and safety of de-escalation (clopidogrel plus aspirin) compared with active control (ticagrelor plus aspirin) across a range of patient BMIs.ResultsAmong 2,686 randomized patients, 1,558 (58.0%) had 18.5 ≤BMI <25 kg/m2, 935 (34.8%) had 25 ≤ BMI < 30 kg/m2, and 154 (5.7%) had BMI ≥ 30 kg/m2. The combination of clopidogrel plus aspirin compared with ticagrelor plus aspirin reduced in the primary outcome led by bleeding events reduction, in 18.5 ≤BMI <25 kg/m2. For 18.5 ≤BMI <25 kg/m2: 4.3% vs. 7.9%; hazard ratio (HR): 0.516 (95% confidential interval [CI]: 0.334 to 0.797); 25 ≤ BMI <30 kg/m2: 4.9% vs. 7.1%; HR: 0.674 (95% CI: 0.389 to 1.166); BMI ≥30 kg/m2: 1.2% vs. 4.2%; HR: 0.284 (95% CI: 0.029 to 2.792).ConclusionIn conclusion, our results suggest that in the patients of 18.5 kg/m2 ≤BMI <25 kg/m2, with acute myocardial infarction after index PCI, de-escalation strategy is better net clinical outcome, mainly by reducing the bleeding events. But, there are no differences between two groups BMI ≥25 kg/m2.

Purpose:We evaluated the incremental prognostic value of combining the CYP2C19 poor metabolizer (PM) and ABCB1 3435 TT for adverse clinical outcomes over conventional risk factors in a percutaneous coronary intervention (PCI) cohort.Methods:We enrolled 2,188 patients. The primary end point was a composite of death from any cause, nonfatal myocardial infarction (MI), and stroke during 1-year follow-up. The population was stratified into the following four groups: CYP2C19 EM/IM+ABCB1 3435 CC/CT, CYP2C19 EM/IM+ABCB1 3435 TT, CYP2C19 PM+ABCB1 3435 CC/CT, and CYP2C19 PM+ABCB1 3435 TT.Results:A total of 87 (3.97%) primary end-point events occurred (64 deaths, 8 non-fatal MIs and 15 strokes). Multivariate Cox analysis indicated that CYP2C19 PM+ABCB1 3435 TT status was a significant predictor of the primary end point (hazard ratio = 4.51, 95% confidence interval (CI) = 1.92–10.58). However, addition of combined genetic status to the clinical risk model did not improve the model discrimination (C-statistic = 0.786 (95% CI = 0.734–0.837) to 0.785 (95% CI = 0.733–0.838)) or risk reclassification (categorical net reclassification improvement (0.040, P = 0.32), integrated discrimination improvement (0.021, P = 0.026)).Conclusions:In a real-world East Asian PCI population taking clopidogrel, although the concurrent presence of CYP2C19 PM and ABCB1 TT is a strong independent predictor of adverse outcomes, the combined status of two at-risk variants does not have an incremental prognostic value beyond that of the conventional clinical risk factors.Genet Med 18 8, 833–841.

We evaluated the incremental prognostic value of combining the CYP2C19poor metabolizer (PM) and ABCB13435 TT for adverse clinical outcomes over conventional risk factors in a percutaneous coronary intervention (PCI) cohort.

The impact of the CYP2C1917 polymorphism on the clinical outcome in Asians undergoing percutaneous coronary intervention (PCI) is unknown. We sought to assess the long-term impact of CYP2C1917 on the risk for adverse clinical events in 2188 Korean patients taking clopidogrel after PCI. The prevalence of the CYP2C1917 allele wt17: 2.4 (n=53), 1717: 0 was very low. The 2-year cumulative event rates for bleeding wt17 vs. wtwt: 2 vs. 2.3; adjusted hazard ratio (HR), 1.23; 95 confidence interval (CI), 0.16–9.45, stent thrombosis (2 vs. 1.1; HR, 3.98; 95 CI, 0.49–31.6) or composite of any death, and myocardial infarction or stroke (5.4 vs. 7.1; HR, 1.37; 95 CI, 0.32–5.73) did not differ on the basis of the presence of CYP2C1917. In conclusion, in our study population of Asian patients, the CYP2C1917 polymorphism was not associated with adverse clinical outcomes after PCI because of its low prevalence, the rarity of homozygotes, and the relatively low rate of adverse clinical events.

Anemia is associated with an increased risk of mortality in patients who underwent percutaneous coronary intervention (PCI) in the bare-metal stent era. However, there have been no data concerning the clinical importance of anemia improvement during the follow-up period after discharge from the hospital during the drug-eluting stent era.