Clinical impact of gastrointestinal bleeding in patients undergoing percutaneous coronary interventions.

The risk factors and clinical sequelae of gastrointestinal bleeding (GIB) in the current era of drug-eluting stents, prolonged dual antiplatelet therapy, and potent P2Y12 inhibitors are not well established. We determined the frequency, predictors, and clinical impact of GIB after percutaneous coronary interventions (PCIs) in a contemporary cohort of consecutive patients treated with unrestricted use of drug-eluting stents. Between 2009 and 2012, all consecutive patients undergoing PCI were prospectively included in the Bern PCI Registry. Bleeding Academic Research Consortium (BARC) GIB and cardiovascular outcomes were recorded within 1 year of follow-up. Among 6212 patients, 84.1% received new-generation drug-eluting stents and 19.5% received prasugrel. At 1 year, GIB had occurred in 65 patients (1.04%); 70.8% of all events and 84.4% of BARC ≥ 3B events were recorded > 30 days after PCI. The majority of events (64.4%) were related to upper GIB with a more delayed time course compared with lower GIB. Increasing age, previous GIB, history of malignancy, smoking, and triple antithrombotic therapy (ie, oral anticoagulation plus dual antiplatelet therapy) were independent predictors of GIB in multivariable analysis. GIB was associated with increased all-cause mortality (adjusted hazard ratio, 3.40; 95% confidence interval, 1.67-6.92; P = 0.001) and the composite of death, myocardial infarction, or stroke (adjusted hazard ratio, 3.75; 95% confidence interval, 1.99-7.07; P < 0.001) and was an independent predictor of all-cause mortality during 1 year. Among unselected patients undergoing PCI, GIB has a profound effect on prognosis. Triple antithrombotic therapy emerged as the single drug-related predictor of GIB in addition to patient-related risk factors within 1 year of PCI. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02241291.

Koskinas KC ，Räber L ，Zanchin T ，Wenaweser P ，Stortecky S ，Moschovitis A ，Khattab AA ，Pilgrim T ，Blöchlinger S ，Moro C ，Jüni P ，Meier B ，Heg D ，Windecker S ... -  《-》

Duration of Triple Antithrombotic Therapy and Outcomes Among Patients Undergoing Percutaneous Coronary Intervention.

The aim of this study was to compare clinical outcomes in relation to the duration of triple antithrombotic therapy (TAT) among patients with indications for oral anticoagulation undergoing percutaneous coronary intervention (PCI). TAT is recommended for patients undergoing PCI with a firm indication for oral anticoagulation. Duration of TAT may influence outcomes, but the optimal period of TAT remains uncertain. Between 2009 and 2013, 8,772 consecutive patients undergoing PCI for stable coronary artery disease or acute coronary syndrome were prospectively included in the Bern PCI Registry (NCT02241291). Of 568 patients with indications for oral anticoagulation, 245 (43%) were discharged on a regimen of 1-month TAT and 323 (57%) on a regimen >1-month TAT (mean 5.1 ± 3.3 months, median 3 months). The primary endpoint was a composite of cardiac death, myocardial infarction, stroke, definite stent thrombosis, or TIMI (Thrombolysis in Myocardial Infarction) major bleeding within 1 year. Patients on 1-month compared with >1-month TAT were more commonly women, with stable coronary artery disease, had higher HAS-BLED scores, and less frequently received drug-eluting stents. In multivariate analyses, the primary endpoint did not differ between groups (adjusted hazard ratio: 1.07; 95% confidence interval: 0.56 to 2.06; p = 0.84). Results were consistent in stratified analyses in relation to clinical presentation with acute coronary syndrome (38%) and PCI with drug-eluting stents (79%) (p for interaction = 0.18 and 0.95, respectively). There were no differences in the secondary bleeding endpoint, Bleeding Academic Research Consortium ≥3 bleeding (adjusted hazard ratio: 0.62; 95% confidence interval: 0.21 to 1.80; p = 0.37) and the secondary composite ischemic endpoint (cardiac death, myocardial infarction, stroke, or definite stent thrombosis) (adjusted hazard ratio: 1.12; 95% confidence interval: 0.55 to 2.29; p = 0.76). One-month TAT, used preferentially in patients with higher estimated bleeding risk in this observational study, was associated with similar net clinical outcomes compared with longer TAT durations throughout 1 year following PCI.

Koskinas KC ，Räber L ，Zanchin T ，Pilgrim T ，Stortecky S ，Hunziker L ，Blöchlinger S ，Billinger M ，Gartwyl F ，Moro C ，Moschovitis A ，Jüni P ，Heg D ，Windecker S ... -  《-》

Adjunctive cilostazol versus double-dose clopidogrel after drug-eluting stent implantation: the HOST-ASSURE randomized trial (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Safety & Effectiveness of Drug-Eluting Stents & Anti-plate

This study sought to test the noninferiority of triple antiplatelet therapy (TAT) versus double-dose clopidogrel dual antiplatelet therapy (DDAT) in patients undergoing percutaneous coronary intervention (PCI). Antiplatelet regimen is an integral component of medical therapy after PCI. A 1-week duration of doubling the dose of clopidogrel was shown to improve outcome at 1 month compared with the conventional dose in patients with acute coronary syndrome undergoing PCI. Yet in Asia, the addition of cilostazol is used more commonly than DDAT in high-risk patients. We randomly assigned 3,755 all-comers undergoing PCI to either TAT or DDAT, which was continued for 1 month, to test the noninferiority of TAT versus DDAT. The primary outcome was the cumulative incidence of net clinical outcome at 1 month post-PCI defined as the composite of cardiac death, nonfatal myocardial infarction, stent thrombosis, stroke, and PLATO (Platelet Inhibition and Patient Outcomes) major bleeding. TAT was noninferior to DDAT with respect to the primary outcome, which occurred in 1.2% and 1.4% of patients, respectively (-0.22% absolute difference, 0.34% 1-sided 97.5% confidence interval, p = 0.0007 for noninferiority; hazard ratio: 0.85; 95% confidence interval: 0.49 to 1.48; p = 0.558 for superiority). The individual risks of cardiac death, nonfatal myocardial infarction, stent thrombosis, stroke, and PLATO major bleeding did not differ significantly between the 2 groups. There were no significant between-group differences in the treatment effect with regard to the rate of the primary outcome. The adjunctive use of cilostazol was noninferior to doubling the dose of clopidogrel for 1 month in all-comers undergoing PCI with exclusively drug-eluting stents. (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen [HOST-ASSURE]; NCT01267734).

Park KW ，Kang SH ，Park JJ ，Yang HM ，Kang HJ ，Koo BK ，Park BE ，Cha KS ，Rhew JY ，Jeon HK ，Shin ES ，Oh JH ，Jeong MH ，Kim S ，Hwang KK ，Yoon JH ，Lee SY ，Park TH ，Moon KW ，Kwon HM ，Chae IH ，Kim HS ... -  《-》

Comparative incidence and risk factors for gastrointestinal bleeding following percutaneous coronary intervention for coronary artery disease: Insights from the Keio Cardiovascular Registry in Japan.

Ueda I ，Kohsaka S ，Numasawa Y ，Takemura R ，Hosoe N ，Ieda M ... -  《-》

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.

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. Current evidence about the impact of the BARC classification is limited. 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. 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. 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.

Yoon YH ，Kim YH ，Kim SO ，Lee JY ，Park DW ，Kang SJ ，Lee SW ，Lee CW ，Park SW ，Park SJ ... -  《-》