Methods

Management of patients with AF undergoing coronary artery stenting is an observational, multicenter, prospective registry including patients with AF who are referred for PCI ( Clinicaltrials.gov identifier NCT00596570 ). Inclusion criteria were elective or acute PCI and (1) history of AF (paroxysmal, persistent, or permanent) or (2) ongoing AF during the index hospital stay. Because of the observational design, the only exclusion criterion was unwillingness/inability to participate in the study or to give written informed consent. At each of the 17 centers, patients were treated according to local policies and were followed up for 12 months (phone call or outpatient clinic visit at 3, 6, and 12 months). The accuracy of the events and medications were checked using hospital and outpatient clinic records and mortality registries where appropriate. Patients were included from October 2008 to August 2010. Ethic committees of participating centers approved the study protocol, and written informed consent was obtained from every patient. The study complied with the Declaration of Helsinki. Coronary angiography and PCI were performed using either radial or femoral approach for arterial access, and hemostasis was obtained according to the local practice. Lesions were treated according to the contemporary interventional techniques. Low-molecular weight heparin (LMWH), unfractionated heparin, bivalirudin, and glycoprotein IIb/IIIa inhibitors were administered at the operator’s discretion. Moreover, the choice of the combination of antithrombotic treatment after the procedure was at the treating physician’s discretion.

HAS-BLED, ATRIA, mOBRI, and REACH bleeding risk scores were calculated for each patient based on the definitions used in their validation cohorts. In HAS-BLED score, each risk factor (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile INR, elderly, and drugs/alcohol) is calculated as 1 point, and patients with scores ≥3 are considered to be at intermediate/high bleeding risk. In the HAS-BLED score, labile INR and impaired liver function could not be assessed, and these were therefore omitted so that a maximum of 7 points was used for a “modified HAS-BLED” analysis. For the ATRIA score, anemia (hemoglobin <13 g/dl in men and <12 g/dl in women) and renal impairment (estimated glomerular filtration rate [eGFR] <30 or dialysis treatment) yield 3 point each; age ≥75 years 2 points; and hypertension and previous bleeding episode 1 point each. Patients with scores ≥4 are considered to be at intermediate/high bleeding risk. For mOBRI, age ≥65 years, previous stroke or gastrointestinal tract bleeding within 2 weeks are assigned 1 point each; and any of the following maximum of 1 point (recent myocardial infarction, diabetes, hematocrit <0.30, creatinine >1.5 mg/dl, or 133 μmol/L). Patients with ≥1 mOBRI points are at intermediate/high bleeding risk. For REACH score, age groups 45 to 54, 55 to 64, 65 to 74, and ≥75 yield 0, 2, 4, and 6 points, respectively. Peripheral arterial disease, diabetes, and hypercholesterolemia yield 1 point each; congestive heart failure and hypertension 2 points each; oral anticoagulant 4 points; aspirin 1 point, other antiplatelet 2, and combination of 2 antiplatelet drugs 4 points; former smoking 1; and current smoking 2 points. REACH scores >10 are considered intermediate/high for the risk of bleeding.

The primary end points were bleeding complications defined according to the bleeding academic research consortium (BARC) criteria as any (BARC 2, 3a, 3b, 3c, and 5) or major (BARC 3a, 3b, 3c, and 5) and all-cause mortality.

Data are presented as mean ± SD, median (interquartile range) and frequencies (%), where appropriate. Continuous variables were analyzed using independent samples t test. Categorical variables were analyzed using chi-square tests. Independent determinants of any bleeding complication were assessed using univariate modeling and those associated with any bleeding event at p level <0.10 were entered into a stepwise backward logistic regression analysis. Bleeding risk scores were analyzed in 3 ways: (1) as continuous variables and (2) as dichotomous variables (low vs intermediate/high risk); and (3) Cox proportional hazard analysis was used with each score assessed separately. Receiver operating characteristic curves and c-indexes were constructed for any bleeding and major bleeding end points. Significance was set at p value <0.05. Analysis was performed with SPSS version 16.0 (SPSS Inc., Chicago, Illinois).

Results

Overall, 929 patients were followed up for 1 year. Baseline characteristics according to any bleeding event versus no bleeding event at 1-year follow-up are listed in Table 1 . The use of drug-eluting stents was 25%. The median (interquartile range) duration of clopidogrel use in the whole cohort was 3 (5) months.

At 12 months, the rates of any (BARC 2, 3a, 3b, 3c, and 5), BARC 3, and major (BARC 3a, 3b, 3c, and 5) bleeding events were 18.1%, 9.1%, and 10.4%, respectively. Most bleeding events occurred early within the first month after the index PCI. INR level at the time of the first bleeding event was 1.8 ± 0.6 (range 1.0 to 3.0). Acute coronary syndrome (ACS) as an indication for PCI appeared to increase the rate of any bleeding and major bleeding events compared with stable angina (21.4% vs 13.8%, p = 0.003, and 12.9% vs 7.3%, p = 0.007, respectively). Compared with patients receiving bare metal stents, the rates of any bleeding and major bleeding events were similar in patients receiving drug-eluting stents (19.1% vs 15.4%, p = 0.23, and 10.9% vs 9.3%, p = 0.53, respectively). Increasing age (odds ratio 1.03, 95% confidence interval 1.01 to 1.06, p = 0.009), previous peptic ulcer (odds ratio 2.32, 95% confidence interval 1.12 to 4.84, p = 0.024), and femoral access site (1.86, 95% confidence interval 1.17 to 2.97, p = 0.009) remained independent predictors of any bleeding event in a multivariate logistic regression model including also renal impairment (eGFR <60), gender, body mass index, acute coronary syndromes versus stable angina as an indication for PCI, previous transient ischemic attack/stroke and the use of glycoprotein IIb/IIIa blockers during the index procedure in the model.

HAS-BLED, mOBRI, and REACH scores were available in all the 929 patients and ATRIA score in 748 patients because of the lack of eGFR values in the rest of the cohort. C indexes and Cox proportional hazard ratios of the scores for the outcomes of any bleeding and major bleeding are listed in Tables 2 and 3 , respectively. Figure 1 shows receiver operating characteristic curves for the outcomes of any bleeding and major bleeding. Low bleeding risk scores as determined by HAS-BLED 0 to 2, ATRIA 0 to3, mOBRI 0, and REACH 0 to 10 were detected in 23.7%, 73.0%, 7.8%, and 5.7% of patients of the cohort, respectively.

Table 3

C-indexes for HAS-BLED, ATRIA, mOBRI, and REACH scores

	Any Bleeding			Major Bleeding			All-Cause Mortality
	AUC	95% CI	SE	AUC	95% CI	SE	AUC	95% CI	SE
HAS-BLED
Score	0.51	0.45-0.56	0.03	0.52	0.45-0.59	0.04	0.54	0.47-0.61	0.04
Low <3 vs high ≥3	0.50	0.45-0.55	0.03	0.51	0.44-0.58	0.04	0.53	0.46-0.60	0.04
ATRIA
Score	0.54	0.49-0.59	0.03	0.55	0.48-0.62	0.04	0.62	0.55-0.69	0.04
Low <4 vs high ≥4	0.52	0.47-0.58	0.03	0.55	0.48-0.62	0.04	0.58	0.51-0.65	0.04
mOBRI
Score	0.53	0.48-0.59	0.03	0.55	0.49-0.62	0.03	0.61	0.55-0.68	0.03
Low 0 vs high ≥1	0.50	0.46-0.55	0.03	0.51	0.45-0.57	0.04	0.53	0.47-0.58	0.04
REACH
Score	0.52	0.47-0.58	0.03	0.50	0.43-0.57	0.04	0.58	0.51-0.65	0.03
Low <11 vs high ≥11	0.49	0.44-0.54	0.03	0.49	0.43-0.55	0.04	0.51	0.45-0.57	0.04

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