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Aspirin for the primary prevention of cardiovascular events in women and men: a sex-specific meta-analysis of randomized controlled trials

Berger, Jeffrey S; Roncaglioni, Maria C; Avanzini, Fausto; Pangrazzi, Ierta; Tognoni, Gianni; Brown, David L
CONTEXT: Aspirin therapy reduces the risk of cardiovascular disease in adults who are at increased risk. However, it is unclear if women derive the same benefit as men. OBJECTIVE: To determine if the benefits and risks of aspirin treatment in the primary prevention of cardiovascular disease vary by sex. DATA SOURCES AND STUDY SELECTION: MEDLINE and the Cochrane Central Register of Controlled Trials databases (1966 to March 2005), bibliographies of retrieved trials, and reports presented at major scientific meetings. Eligible studies were prospective, randomized controlled trials of aspirin therapy in participants without cardiovascular disease that reported data on myocardial infarction (MI), stroke, and cardiovascular mortality. Six trials with a total of 95 456 individuals were identified; 3 trials included only men, 1 included only women, and 2 included both sexes. DATA EXTRACTION: Studies were reviewed to determine the number of patients randomized, mean duration of follow-up, and end points (a composite of cardiovascular events [nonfatal MI, nonfatal stroke, and cardiovascular mortality], each of these individual components separately, and major bleeding). DATA SYNTHESIS: Among 51,342 women, there were 1285 major cardiovascular events: 625 strokes, 469 MIs, and 364 cardiovascular deaths. Aspirin therapy was associated with a significant 12% reduction in cardiovascular events (odds ratio [OR], 0.88; 95% confidence interval [CI], 0.79-0.99; P = .03) and a 17% reduction in stroke (OR, 0.83; 95% CI, 0.70-0.97; P = .02), which was a reflection of reduced rates of ischemic stroke (OR, 0.76; 95% CI, 0.63-0.93; P = .008). There was no significant effect on MI or cardiovascular mortality. Among 44,114 men, there were 2047 major cardiovascular events: 597 strokes, 1023 MIs, and 776 cardiovascular deaths. Aspirin therapy was associated with a significant 14% reduction in cardiovascular events (OR, 0.86; 95% CI, 0.78-0.94; P = .01) and a 32% reduction in MI (OR, 0.68; 95% CI, 0.54-0.86; P = .001). There was no significant effect on stroke or cardiovascular mortality. Aspirin treatment increased the risk of bleeding in women (OR, 1.68; 95% CI, 1.13-2.52; P = .01) and in men (OR, 1.72; 95% CI, 1.35-2.20; P<.001). CONCLUSIONS: For women and men, aspirin therapy reduced the risk of a composite of cardiovascular events due to its effect on reducing the risk of ischemic stroke in women and MI in men. Aspirin significantly increased the risk of bleeding to a similar degree among women and men
PMID: 16418466
ISSN: 1538-3598
CID: 101151

Mechanical complications of central venous catheters

Eisen, Lewis A; Narasimhan, Mangala; Berger, Jeffrey S; Mayo, Paul H; Rosen, Mark J; Schneider, Roslyn F
We analyzed 385 consecutive central venous catheter (CVC) attempts over a 6-month period. All critically ill patients 18 years of age or older requiring a CVC were included. The rate of mechanical complications not including failure to place was 14%. Complications included failure to place the CVC (n = 86), arterial puncture (n = 18), improper position (n = 14), pneumothorax (n = 5 in 258 subclavian and internal jugular attempts), hematoma (n = 3), hemothorax (n = 1), and asystolic cardiac arrest of unknown etiology (n = 1). Male patients had a significantly higher complication rate than female patients (37% vs 27%, P = .04). The subclavian approach had a higher complication rate than the internal jugular or the femoral approach (39% vs 33% vs. 24%, P = .02). The complication rate increased with the number of percutaneous punctures, with a rate of 54% when more than 2 punctures were required
PMID: 16698743
ISSN: 0885-0666
CID: 101146

Retrograde cerebral perfusion: report of a fatal complication from a subarachnoid venous hemorrhage during thoracoabdominal aortic surgery [Case Report]

Berger, Jeffrey S; Ryjikov, Natalia; Girardi, Leonard N; Fontes, Manuel L
PMID: 16202902
ISSN: 1053-0770
CID: 101152

Effects of antibiotic therapy on outcomes of patients with coronary artery disease: a meta-analysis of randomized controlled trials

Andraws, Richard; Berger, Jeffrey S; Brown, David L
CONTEXT: Although Chlamydia pneumoniae infection has been associated with the initiation and progression of atherosclerosis, results of clinical trials investigating antichlamydial antibiotics as adjuncts to standard therapy in patients with coronary artery disease (CAD) have been inconsistent. OBJECTIVE: To conduct a meta-analysis of clinical trials of antichlamydial antibiotic therapy in patients with CAD. DATA SOURCES: The MEDLINE and Cochrane Central Register of Controlled Trials databases were searched from 1966 to April 2005 for English-language trials of antibiotic therapy in patients with CAD. Bibliographies of retrieved articles were searched for further studies. Presentations at major scientific meetings (2003-2004) were also reviewed. Search terms included antibacterial agents, myocardial infarction, unstable angina, and coronary arteriosclerosis. STUDY SELECTION: Eligible studies were prospective, randomized, placebo-controlled trials of antichlamydial antibiotic therapy in patients with CAD that reported all-cause mortality, myocardial infarction, or unstable angina. Of the 110 potentially relevant articles identified, 11 reports enrolling 19,217 patients were included. DATA EXTRACTION: Included studies were reviewed to determine the number of patients randomized, mean duration of follow-up, and end points. End points of interest included all-cause mortality, myocardial infarction (MI), and a combined end point of MI and unstable angina. DATA SYNTHESIS: Event rates were combined using a random-effects model. Antibiotic therapy had no impact on all-cause mortality among treated vs untreated patients (4.7% vs 4.6%; odds ratio [OR], 1.02; 95% confidence interval [CI], 0.89-1.16; P = .83), on the rates of MI (5.0% vs 5.4%; OR, 0.92; 95% CI, 0.81-1.04; P = .19), or on the combined end point of MI and unstable angina (9.2% vs 9.6%; OR, 0.91; 95% CI, 0.76-1.07; P = .25). CONCLUSION: Evidence available to date does not demonstrate an overall benefit of antibiotic therapy in reducing mortality or cardiovascular events in patients with CAD
PMID: 15928286
ISSN: 1538-3598
CID: 101153

Impact of platelet glycoprotein IIb/IIIa inhibitor therapy on in-hospital outcomes and long-term survival following percutaneous coronary rotational atherectomy

Berger, Jeffrey S; Slater, James N; Sherman, Warren; Green, Stephen J; Sanborn, Timothy A; Brown, David L
BACKGROUND: Percutaneous coronary rotational atherectomy (PCRA) is a potent stimulus of platelet activation and aggregation in vivo. For this reason, many patients undergoing PCRA are treated with platelet glycoprotein (GP) IIb/IIIa inhibitors. However, there is limited data regarding the ability of GP IIb/IIIa inhibitors to reduce ischemic complications of PCRA and no data regarding their effect on long-term survival. METHODS: Data on 1138 consecutive patients undergoing PCRA in 5 hospitals in 1998-1999 were pooled and analyzed. Long-term survival was available for all 530 patients treated in 3 of the hospitals. RESULTS AND CONCLUSIONS: GP IIb/IIIa inhibitors were administered to 315 of 1138 (28%) PCRA patients. There was no difference in age, gender or race among patients treated with and without GP IIb/IIIa antagonists. The prevalence of hypertension, diabetes, renal insufficiency and peripheral vascular disease did not differ between groups. Unstable angina was more common among patients treated with GP IIb/IIIa inhibitors (45% vs. 38%, P = 0.036) Patients treated with GP IIb/IIIa inhibitors had lower ejection fractions (50% vs. 55%, P < 0.001) and more 3-vessel coronary disease (24% vs. 16%, P = 0.002). Angiographic success was over 99% in both groups (P = NS). The frequency of major adverse cardiovascular events (MACE) was slightly greater in GP IIb/IIIa inhibitor treated patients (3.8% vs. 2.2%, P = 0.126). At a mean follow-up of 3 years, mortality was 13.3% in the GP IIb/IIIa treated patients and 12% in the untreated patients (P = 0.224). On Cox proportional hazards analysis, treatment with a GP IIb/IIIa inhibitor was not significantly associated with increased survival (Hazard Ratio, 0.81, 95% Confidence Interval, 0.631-1.039, P = 0.098). These data do not indicate a significant association between GP IIb/IIIa inhibitor treatment during PCRA and MACE or survival. CONDENSED ABSTRACT: There is limited data regarding the ability of GP IIb/IIIa inhibitors to reduce ischemic complications of percutaneous coronary rotational atherectomy (PCRA) and no data regarding their effect on long-term survival. These data do not indicate a significant association between GP IIb/IIIa inhibitor treatment during PCRA and MACE or survival
PMID: 15976967
ISSN: 0929-5305
CID: 94800

Effect of chronic obstructive pulmonary disease on survival of patients with coronary heart disease having percutaneous coronary intervention

Berger, Jeffrey S; Sanborn, Timothy A; Sherman, Warren; Brown, David L
There are limited data regarding the effect of chronic obstructive pulmonary disease (COPD) on the survival of patients with coronary artery disease. Prospectively developed and collected data elements on 4,284 consecutive patients who underwent percutaneous coronary intervention in 3 hospitals in 1998 and 1999 were pooled and analyzed. In-hospital major adverse cardiac outcomes were not different between groups. At 3-year follow-up, mortality for patients with COPD was 21% versus 9% for patients without COPD (log-rank p < 0.001). COPD was independently associated with a 2-fold increase in the hazard of long-term mortality (hazard ratio 2.146, 95% confidence interval 1.525 to 3.021, p < 0.001)
PMID: 15342301
ISSN: 0002-9149
CID: 101154

Comparison of three-year outcomes in blacks versus whites with coronary heart disease following percutaneous coronary intervention

Berger, Jeffrey S; Sanborn, Timothy A; Sherman, Warren; Brown, David L
There are limited data regarding the effect of race on survival after percutaneous coronary intervention (PCI) in the modern era. The investigators analyzed the impact of race on 3-year survival in 3,783 consecutive patients who underwent PCI in 1998 and 1999
PMID: 15342300
ISSN: 0002-9149
CID: 101155

Impact of gender on mortality following primary angioplasty for acute myocardial infarction

Berger, Jeffrey S; Brown, David L
PMID: 14961453
ISSN: 0033-0620
CID: 101156