Methods

We included all patients with a diagnosis of AF or atrial flutter who had undergone percutaneous coronary intervention with stenting examined by the cardiology department of our institution from 2000 through 2010. The Centre Hospitalier Régional et Universitaire at Tours serves approximately 400,000 inhabitants and is the only public institution in an area of around 4,000 km ² . AF was defined on electrocardiogram by the replacement of consistent P waves by rapid oscillations or fibrillatory waves that varied in amplitude, shape, and timing, associated with an irregular, often rapid ventricular response with atrioventricular conduction intact. Individual patient management decisions such as type of revascularization performed, type of stent implanted, and regimen of oral anticoagulation and/or antiplatelet drugs at discharge were decided by the interventional cardiologist and/or responsible clinical cardiologist based on type of AF, stroke/thromboembolic risk factors, co-morbidities, and revascularization procedure. Treatment at discharge was obtained by screening hospitalization reports. Patients’ characteristics were obtained from records of our institution’s computerized codification system for each patient hospitalized in the cardiology department and by screening hospitalization reports. The score for cardiac failure, hypertension, age ≥75 years (2 times), diabetes, stroke (2 times), vascular disease, age 65 to 74 years, and female gender could be calculated as previously described. We also calculated the score for bleeding risk factors, namely hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, age >65 years, and drugs/alcohol (HAS-BLED), concomitantly to assess bleeding risk, where a score ≥3 indicates high risk.

Since May 2002 DESs were routinely used in our hospital. Of patients discharged with dual-antiplatelet therapy, 1 antiplatelet agent was usually stopped at 1 month after percutaneous coronary intervention when a BMS was used and 3 to 12 months when a DES was used. During patient follow-up, death, acute myocardial infarction, target lesion revascularization, bleeding complications, and stroke were recorded whenever documented within our institution. The primary end point was defined as the occurrence of major adverse cardiovascular events (MACEs) including death, acute myocardial infarction, and target lesion revascularization. A secondary end point was major adverse events that included the occurrence of any MACE, major bleeding complications, and/or stroke during the follow-up period. Nonfatal myocardial infarction was defined as ischemic symptoms and an increase of creatine kinase-MB >2 times the upper limit of normal with or without ST-segment elevation or development of Q waves. Major bleeding was defined as a decrease in blood hemoglobin level of >5.0 g/dl (including the period around the coronary interventional procedure), need for transfusion of ≥1 U blood, need for corrective surgery, or occurrence of intracranial or retroperitoneal hemorrhage. The definition of target lesion revascularization was based on the consensus of the Academic Research Consortium.

Characteristics of patients were presented as percentage and mean ± SD. Comparisons between groups were made using chi-square tests to compare categorical variables and Student’s t test for continuous variables. A logistic regression model was used to identify characteristics associated with the occurrence of an event during follow-up. Potential confounding factors were entered into the model for adjustment. This model was then used for associating implantation of a DES or BMS with an event during follow-up. Results were expressed as relative risk and 95% confidence interval. A p value <0.05 was considered statistically significant. Statistical analysis was carried out with StatView 5.0 (Abacus Concepts, Berkeley, California).

Results

Of 8,962 unselected patients with AF from 2000 through 2010, 2,709 (30%) had coronary artery disease and 833 (9%) had undergone percutaneous coronary intervention with stent implantation. Of these 833 patients, 678 patients (81%) received only BMSs and 155 (19%) received ≥1 DES. HAS-BLED score was ≥3 in 301 patients treated by a BMS (44%) and in 68 patients treated by DESs (44%; Table 1 ).

Patients treated by DESs were younger and more frequently had a history of diabetes. They were less likely to have heart failure and permanent AF. Bleeding risk estimated with the HAS-BLED score was similar in the 2 groups. In our series, a BMS was used more frequently in ST-segment elevation myocardial infarction. Concerning procedural characteristics, a DES was not used in smaller arteries and total stent length was not significantly different in the 2 groups.

Of drugs used at discharge ( Figure 1 ), aspirin was prescribed to 92% of patients treated by BMSs and 94% of patients treated by DESs. Furthermore, clopidogrel was more frequently prescribed to patients receiving DESs than to patients receiving BMSs. A vitamin K antagonist was prescribed at discharge to only 23% of patients receiving a BMS and 18% of patients receiving a DES, although the vast majority of patients in the 2 groups had a score ≥2 for cardiac failure, hypertension, age ≥75 years (2 times), diabetes, stroke (2 times), vascular disease, age 65 to 74 years, and female gender ( Table 1 ). Triple therapy (vitamin K antagonist, aspirin, and clopidogrel) was used in 95 patients (14%) receiving BMSs and in 20 patients receiving DESs (13%). Only 28 patients receiving DESs (18%) and 156 patients receiving BMSs (23%) were taking a vitamin K antagonist ( Table 1 ). Prasugrel was used in a very small number of patients since 2010 but more likely in patients receiving DESs (4% vs 1%, p = 0.02). Patients in the 2 groups were similar in the remaining characteristics.

Antithrombotic treatment in patients with atrial fibrillation and stent implantation.

During a follow-up of 1,048 ± 1,114 days (median 688, interquartile range 1,755), there were 107 deaths. During follow-up, 133 acute coronary syndromes, 32 procedures of target lesion revascularization, 69 strokes or systemic embolism (47 ischemic strokes, 12 hemorrhagic strokes, 10 systemic embolisms), and 80 major bleedings were recorded in 278 patients. Incidence of MACE was 13.4% per year with an incidence of major bleeding of 3.6% per year and a high overall incidence of major adverse events (19.3% per year). Incidence of all-cause mortality was 4.5% per year during follow-up.

Kaplan–Meier survival curves showed that incidence of MACE was similar in the 2 groups (relative risk 1.24, 95% confidence interval 0.86 to 1.78 p = 0.23 for patients with DESs compared to those treated with BMSs; Figure 2 ). Rate of target lesion revascularization was similar in the DES and BMS groups (2.7% vs 1.3%/year of exposure, p = 0.15). The AF population had a similar prognosis for all-cause mortality irrespective of stent type ( Figure 3 ). Eleven severe bleeding complications were recorded in patients treated with DESs (7%) versus 69 (10%) in those not treated with BMSs, and no significant difference was found according to type of stent or bleeding risk according to HAS-BLED score ( Figure 4 ). Incidence of major adverse events was similar in the BMS and DES groups but was significantly higher for patients with a HAS-BLED score >3 ( Figure 5 ).

Major adverse cardiovascular events (death, acute myocardial infarction, and/or target lesion revascularization) in patients (n = 833) with atrial fibrillation and bare-metal (top curve) or drug-eluting (bottom curve) stent implantation (follow-up 703 ± 949 days, 215 events). CI = confidence interval; RR = relative risk.

All-cause death in patients (n = 833) with atrial fibrillation and bare-metal (top curve) or drug-eluting (bottom curve) stent implantation (follow-up 1,049 ± 1,114 days, 107 events). Abbreviations as in Figure 2 .

Bleeding events in patients (n = 833) with atrial fibrillation and low (n = 379) (lower solid curve) and high (n = 299) (upper dotted curve) hemorrhagic risk from bare-metal implantation or low (n = 88) (upper solid curve) and high (n = 67) (lower dotted curve) hemorrhagic risk from drug-eluting stent implantation (follow-up 969 ± 1,080 days, 80 events). Abbreviations as in Figure 2 .

Major adverse events (major bleeding complications, and/or stroke) in patients (n = 833) with atrial fibrillation and low (n = 379) (upper solid curve) and high (n = 299) (upper dotted curve) hemorrhagic risk from bare-metal implantation or low (n = 88) (lower solid curve) and high (n = 67) (lower dotted curve) hemorrhagic risk from drug-eluting stent implantation (follow-up 631 ± 903 days, 278 events). Abbreviations as in Figure 2 .

Factors independently associated with an increased risk of MACE were older age, implantation of stent during acute ST-segment elevation myocardial infarction, and stent diameter. Factors independently associated with an increased risk of mortality were older age and renal failure ( Table 2 ). The only factor independently associated with an increased risk of a major bleeding event was renal failure. Factors independently associated with an increased risk of major adverse events were older age, heart failure, and renal failure ( Table 3 ).

Table 2

Cox regression analysis for prediction of events: major adverse cardiovascular events and all-cause death

	Multivariate Analysis
	HR (95% CI)	p Value
Analysis for end point of major adverse cardiovascular events ⁎
Age	1.024 (1.004–1.044)	0.02
Male gender	0.83 (0.56–1.25)	0.37
Diabetes mellitus	1.01 (0.76–1.64)	0.58
Hypertension	0.92 (0.65–1.32)	0.65
Permanent atrial fibrillation	0.86 (0.60–1.25)	0.44
Heart failure	1.32 (0.91–1.89)	0.14
Left ventricular ejection fraction <45%	1.16 (0.69–1.96)	0.58
Renal failure	1.37 (0.88–2.17)	0.17
CHADS 2 score	1.23 (0.83–1.82)	0.31
HAS-BLED score	1.38 (0.92–2.07)	0.12
Acute coronary syndrome	1.35 (0.85–2.04)	0.15
Acute ST-segment elevation myocardial infarction	1.81 (1.10–2.99)	0.02
Stent diameter	1.09 (1.01–1.18)	0.03
Total stent length	1.01 (0.99–1.04)	0.26
Clopidogrel at discharge	0.98 (0.61–1.56)	0.93
Vitamin K antagonist at discharge	0.68 (0.33–1.39)	0.30
Triple therapy	1.09 (0.44–2.70)	0.85
Use of drug-eluting stent	1.41 (0.92–2.17)	0.12
Analysis for end point of all-cause death
Age	1.080 (1.040–1.120)	<0.0001
Male gender	0.97 (0.53–1.75)	0.93
Diabetes mellitus	0.74 (0.39–1.43)	0.37
Hypertension	1.01 (0.58–1.79)	0.96
Permanent atrial fibrillation	1.03 (0.60–1.79)	0.90
Heart failure	1.67 (0.92–3.03)	0.10
Left ventricular ejection fraction <45%	1.14 (0.54–2.38)	0.74
Renal failure	3.25 (1.84–5.75)	<0.0001
CHADS 2 score	1.02 (0.60–1.76)	0.93
HAS-BLED score	1.24 (0.76–2.04)	0.39
Acute coronary syndrome	1.14 (0.61–2.08)	0.68
Acute ST-segment elevation myocardial infarction	1.28 (0.68–2.44)	0.43
Stent diameter	0.99 (0.73–1.36)	0.96
Total stent length	1.01 (0.98–1.05)	0.51
Clopidogrel at discharge	1.30 (0.59–2.86)	0.52
Vitamin K antagonist at discharge	0.45 (0.22–0.93)	0.03
Triple therapy	1.02 (0.23–4.55)	0.98
Use of drug-eluting stent	1.45 (0.75–2.86)	0.27

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