[Long-term clinical outcomes after percutaneous coronary intervention for ST-segment elevation myocardial infarction due to late and very late stent thrombosis].

Li X ，Yang Y ，Gao M ，Li C ，Wu X ，Liu Y ，Gao J ... -  《-》

Comparison of newer-generation drug-eluting with bare-metal stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) and COMFO

This study sought to study the efficacy and safety of newer-generation drug-eluting stents (DES) compared with bare-metal stents (BMS) in an appropriately powered population of patients with ST-segment elevation myocardial infarction (STEMI). Among patients with STEMI, early generation DES improved efficacy but not safety compared with BMS. Newer-generation DES, everolimus-eluting stents, and biolimus A9-eluting stents, have been shown to improve clinical outcomes compared with early generation DES. Individual patient data for 2,665 STEMI patients enrolled in 2 large-scale randomized clinical trials comparing newer-generation DES with BMS were pooled: 1,326 patients received a newer-generation DES (everolimus-eluting stent or biolimus A9-eluting stent), whereas the remaining 1,329 patients received a BMS. Random-effects models were used to assess differences between the 2 groups for the device-oriented composite endpoint of cardiac death, target-vessel reinfarction, and target-lesion revascularization and the patient-oriented composite endpoint of all-cause death, any infarction, and any revascularization at 1 year. Newer-generation DES substantially reduce the risk of the device-oriented composite endpoint compared with BMS at 1 year (relative risk [RR]: 0.58; 95% confidence interval [CI]: 0.43 to 0.79; p = 0.0004). Similarly, the risk of the patient-oriented composite endpoint was lower with newer-generation DES than BMS (RR: 0.78; 95% CI: 0.63 to 0.96; p = 0.02). Differences in favor of newer-generation DES were driven by both a lower risk of repeat revascularization of the target lesion (RR: 0.33; 95% CI: 0.20 to 0.52; p < 0.0001) and a lower risk of target-vessel infarction (RR: 0.36; 95% CI: 0.14 to 0.92; p = 0.03). Newer-generation DES also reduced the risk of definite stent thrombosis (RR: 0.35; 95% CI: 0.16 to 0.75; p = 0.006) compared with BMS. Among patients with STEMI, newer-generation DES improve safety and efficacy compared with BMS throughout 1 year. It remains to be determined whether the differences in favor of newer-generation DES are sustained during long-term follow-up.

Sabaté M ，Räber L ，Heg D ，Brugaletta S ，Kelbaek H ，Cequier A ，Ostojic M ，Iñiguez A ，Tüller D ，Serra A ，Baumbach A ，von Birgelen C ，Hernandez-Antolin R ，Roffi M ，Mainar V ，Valgimigli M ，Serruys PW ，Jüni P ，Windecker S ... -  《-》

Impact of lesion length and vessel size on clinical outcomes after percutaneous coronary intervention with everolimus- versus paclitaxel-eluting stents pooled analysis from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent

The aim of this study was to investigate the impact of reference vessel diameter (RVD) and lesion length (LL) on the relative safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES). Lesion length and RVD are well-known predictors of adverse events after percutaneous coronary intervention. Patient-level data were pooled from the randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) trials. Quantitative angiographic core laboratory data were available for 6,183 patients randomized to EES (n = 3,944) or PES (n = 2,239). Long lesions and small vessels were defined as LL >median (13.4 mm) and RVD ≤median (2.65 mm), respectively. Major adverse cardiac events (MACE) (consisting of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) were assessed at 2 years, according to stent type in 3 groups: short lesions in large vessels (group A, n = 1,297); long lesions or small vessels but not both (group B, n = 2,981); and long lesions in small vessels (group C, n = 1,905). The pooled 2-year MACE rates were 5.6%, 8.2%, and 10.4% in Groups A, B, and C, respectively (p < 0.0001). There was no significant interaction between lesion group and stent type (p = 0.64), indicating lower MACE with EES compared with PES regardless of LL and RVD. However, the absolute difference was largest in Groups B and C. In Group A, 2-year MACE rates were not significantly different between EES and PES (4.8% vs. 7.0%, respectively, p = 0.11). In contrast, EES was associated with lower 2-year rates of MACE in Group B (6.6% vs. 11.2%, p < 0.01) and in Group C (9.1% vs. 12.7%, p = 0.008) as well as lower rates of myocardial infarction, target lesion revascularization, and stent thrombosis. Multivariable analysis confirmed EES versus PES as an independent predictor of freedom from MACE in Groups B and C. Patients with short lesions in large vessels have low rates of MACE at 2 years after treatment with either EES or PES. In higher-risk patients with long lesions and/or small vessels, EES results in significant improvements in both clinical safety and efficacy outcomes. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00180479; SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00307047; A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial; NCT01016041).

Claessen BE ，Smits PC ，Kereiakes DJ ，Parise H ，Fahy M ，Kedhi E ，Serruys PW ，Lansky AJ ，Cristea E ，Sudhir K ，Sood P ，Simonton CA ，Stone GW ... -  《-》

Effect of Chronic Kidney Disease in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents: A Patient-Level Pooled Analysis of Randomized Controlled Trials.

This study sought to evaluate: 1) the effect of impaired renal function on long-term clinical outcomes in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES); and 2) the safety and efficacy of new-generation compared with early-generation DES in women with chronic kidney disease (CKD). The prevalence and effect of CKD in women undergoing PCI with DES is unclear. We pooled patient-level data for women enrolled in 26 randomized trials. The study population was categorized by creatinine clearance (CrCl) <45 ml/min, 45 to 59 ml/min, and ≥60 ml/min. The primary endpoint was the 3-year rate of major adverse cardiovascular events (MACE). Participants for whom baseline creatinine was missing were excluded from the analysis. Of 4,217 women included in the pooled cohort treated with DES and for whom serum creatinine was available, 603 (14%) had a CrCl <45 ml/min, 811 (19%) had a CrCl 45 to 59 ml/min, and 2,803 (66%) had a CrCl ≥60 ml/min. A significant stepwise gradient in risk for MACE was observed with worsening renal function (26.6% vs. 15.8% vs. 12.9%; p < 0.01). Following multivariable adjustment, CrCl <45 ml/min was independently associated with a higher risk of MACE (adjusted hazard ratio: 1.56; 95% confidence interval: 1.23 to 1.98) and all-cause mortality (adjusted hazard ratio: 2.67; 95% confidence interval: 1.85 to 3.85). Compared with older-generation DES, the use of newer-generation DES was associated with a reduction in the risk of cardiac death, myocardial infarction, or stent thrombosis in women with CKD. The effect of new-generation DES on outcomes was uniform, between women with or without CKD, without evidence of interaction. Among women undergoing PCI with DES, CKD is a common comorbidity associated with a strong and independent risk for MACE that is durable over 3 years. The benefits of newer-generation DES are uniform in women with or without CKD.

Baber U ，Giustino G ，Sartori S ，Aquino M ，Stefanini GG ，Steg PG ，Windecker S ，Leon MB ，Wijns W ，Serruys PW ，Valgimigli M ，Stone GW ，Dangas GD ，Morice MC ，Camenzind E ，Weisz G ，Smits PC ，Kandzari D ，Von Birgelen C ，Mastoris I ，Galatius S ，Jeger RV ，Kimura T ，Mikhail GW ，Itchhaporia D ，Mehta L ，Ortega R ，Kim HS ，Kastrati A ，Chieffo A ，Mehran R ... -  《-》

The influence between plaque rupture and non-plaque rupture on clinical outcomes in patients with ST-segment elevation myocardial infarction after primary percutaneous coronary intervention: a prospective cohort study.

Coronary atherosclerosis can lead to acute clinical events upon atherosclerotic plaque rupture (PR) or erosion and arterial thrombus formation. Identifying the effect of distinct plaque characteristics on clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) is critical for clinical therapy. Our goal was to ascertain the correlation between clinical outcome, long-term prognosis, and morphological plaque characteristics in STEMI. The data used in this prospective cohort research came from a prior multicenter prospective cohort study (ChiCTR1800019923). One hundred and thirteen consecutive STEMI patients were involved in our cohort study. Patients with STEMI who received primary percutaneous coronary intervention (pPCI) within 24 hours of symptom onset were included in the study and divided into two groups according to plaque characteristics derived from intravascular ultrasound (IVUS): a PR group and a non-PR group. The primary outcome was the incidence of no reflow or slow flow, the secondary outcome was major adverse cardiac events (MACEs) at 1-year follow-up. This study enrolled 113 consecutive patients with STEMI [mean age 56 (range, 49-65.5) years; males 90.27%]. Of the 113 patients, PR was found in 93 (82.3%), while non-PR was found in 20 (17.7%). The PR group had a higher rates of plaque eccentricity index (64.28%±22.69% vs. 60.08%±15.54%; P=0.045), higher rates of lipid pool-like images (62.37% vs. 30.00%; P=0.008), and higher rates of tissue prolapse (22.95% vs. 13.33%; P=0.01). Compared with that in the non-PR group, the incidence of no reflow or slow flow was higher in the PR group after pPCI (26.88% vs. 5.00%; P=0.04). Multivariable logistic regression showed that PR [odds ratio (OR) =8.188; 95% confidence interval (CI): 1.020-65.734; P=0.048] was an independent predictor of no reflow or slow flow. Survival analysis revealed no significant differences in MACE incidence between the two groups at 1-year follow-up (7.61% vs. 10.00%; P=0.66). Furthermore, 29 patients with PR were treated without stenting, most of them were free of MACEs (27/29). MACE between subgroups of stenting and non-stenting had no significant differences (7.94% vs. 6.90%; P=0.86) in the PR group. In comparison to patients with non-PR, PR were not associated with the risk of recurrent myocardial infarction (MI), revascularization, heart failure, or cardiac death at 1-year follow-up, while associated with an increased incidence of no reflow or slow flow during pPCI. This observation would be considered while risk stratification and dealing with patients who have STEMI. Most patients with PR who were treated without stenting were MACE free. Further research should be conducted to determine whether interventional treatment without stenting is feasible for patients with STEMI and PR.

Yang X ，Yang J ，Kashima Y ，Hachinohe D ，Sugie T ，Xu S ，Guo X ，Li X ，Hu X ，Sun B ，Nagraj S ，Lymperopoulos A ，Kim YH ，Tu S ，Dong H ... -  《-》