A Meta-analysis of Clinical Trials Evaluating the Impact of Bivalirudin-based Anticoagulation for Primary Percutaneous Coronary on Long-Term Mortality.

ABSTRACT: Bivalirudin and heparin are the principal anticoagulants used during primary percutaneous coronary intervention (PCI) for patients experiencing ST-elevation myocardial infarctions. Based on previous meta-analyses, bivalirudin improves 30-day mortality rates compared with heparin, especially when vascular access is predominantly femoral. However, no meta-analysis has yet reported whether this mortality benefit with bivalirudin persists beyond 30 days. Scientific databases and websites were searched to find randomized controlled trials, and risk ratios (RRs) were calculated using random effect models. Data from 4 trials were analyzed. Compared with heparin ± glycoprotein IIb/IIIa inhibitors, bivalirudin decreased all-cause mortality [RR, 0.81; 95% confidence interval (CI), 0.69-0.94; P = 0.008], cardiac mortality (RR, 0.72; 95% CI, 0.60-0.88; P = 0.001), and net adverse clinical events (RR, 0.83; 95% CI, 0.72-0.97; P = 0.016) at 1 year. In conclusion, a bivalirudin-based anticoagulation strategy during primary percutaneous coronary intervention significantly decreases the 1-year risks for all-cause mortality, cardiac mortality, and net adverse clinical events compared with heparin ± glycoprotein IIb/IIIa inhibitor.

A meta-analysis of optimal medical therapy with or without percutaneous coronary intervention in patients with stable coronary artery disease.

BACKGROUND: Whether percutaneous coronary intervention (PCI) improves clinical outcomes in patients with chronic angina and stable coronary artery disease (CAD) has been a continuing area of investigation for more than two decades. The recently reported results of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches, the largest prospective trial of optimal medical therapy (OMT) with or without myocardial revascularization, provides a unique opportunity to determine whether there is an incremental benefit of revascularization in stable CAD patients. METHODS: Scientific databases and websites were searched to find randomized clinical trials (RCTs). Pooled risk ratios were calculated using the random-effects model. RESULTS: Data from 10 RCTs comprising 12 125 patients showed that PCI, when added to OMT, were not associated with lower all-cause mortality (risk ratios, 0.96; 95% CI, 0.87-1.08), cardiovascular mortality (risk ratios, 0.91; 95% CI, 0.79-1.05) or myocardial infarction (MI) (risk ratios, 0.90; 95% CI, 0.78-1.04) as compared with OMT alone. However, OMT+PCI was associated with improved anginal symptoms and a lower risk for revascularization (risk ratios, 0.52; 95% CI, 0.37-0.75). CONCLUSIONS: In patient with chronic stable CAD (without left main disease or reduced ejection fraction), PCI in addition to OMT did not improve mortality or MI compared to OMT alone. However, this strategy is associated with a lower rate of revascularization and improved anginal symptoms.

Meta-Analysis of Optimal Revascularization Strategy for Patients With ST-Segment Elevation Myocardial Infarction and Multi-Vessel Coronary Artery Disease.

Several clinical trials have shown that complete revascularization (CR) lowers the risks of revascularization and nonfatal myocardial infarction (MI) in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease compared with infarct-related artery-only revascularization (IRA-OR). However, individual trials have been underpowered for hard outcomes such as cardiovascular (CV) mortality. Therefore, we conducted an updated meta-analysis representing the largest sample size to date inclusive of contemporary studies comparing CR versus IRA-OR. Pooled risk ratios (RRs) were calculated using random effects model. Data from 11 RCTs involving 7,343 patients showed that compared with IRA-OR, CR was associated with lower CV mortality (RR 0.75; 95% confidence interval [CI] 0.57 to 0.99; p = 0.04), MI (RR 0.70; 95% CI 0.53 to 0.93), and recurrent revascularization (RR 0.38; 95% CI 0.27 to 0.54), but similar all-cause mortality (RR 0.85; 95% CI 0.70 to 1.05). In conclusion, in patients with STEMI and multivessel coronary artery disease, compared with IRA-OR, CR was associated with lower risk for CV mortality, MI, and recurrent revascularization, suggesting that CR should be the standard of care for STEMI patients.

Effectiveness of statin-gemfibrozil combination therapy in patients with mixed hyperlipidemia: experience of a community lipid clinic and safety review from the literature.

This retrospective study was carried out to assess the effectiveness of statin-gemfibrozil combination therapy in a community practice lipid clinic and to review safety data from published literature. Forty-six consecutive patients received a statin and gemfibrozil combination for resistant hyperlipidemia to either agent therapy. Fasting total cholesterol (mg/dL), high-density lipoprotein cholesterol (mg/dL), and triglycerides (mg/dL) were measured. Low-density lipoprotein cholesterol (mg/dL) was calculated using the Friedewald formula if triglycerides were <400 mg/dL. Combination therapy reduced total cholesterol, low-density lipoprotein cholesterol, and triglycerides by 11% (p=0.02), 22% (p=0.049), and 39% (p=0.0002), respectively, and raised high-density lipoprotein cholesterol by 5% (p=0.3). A pooled analysis of 838 patients from the literature on statin-gemfibrozil combination therapy revealed an incidence of myositis and severe myopathy of 0.7% and 0.6%, respectively (excluding cerivastatin). We conclude that statin-gemfibrozil combination therapy is effective in significantly reducing total cholesterol, low-density lipoprotein cholesterol, and triglycerides with a trend toward raising high-density lipoprotein cholesterol in patients with hyperlipidemia resistant to either agent alone. Myositis and severe myopathy are infrequent, but not rare side effects which may be statin-specific regarding the incidence of occurrence.

Randomized comparison of Vasoseal and Angioseal closure devices in patients undergoing coronary angiography and angioplasty.

AngioSeal (AS) and VasoSeal (VS) are collagen-based arterial closure devices utilized to achieve earlier hemostasis and ambulation in diagnostic and interventional percutaneous procedures. To our knowledge, there has been no randomized studies comparing these two devices as approved for use in the United States. One hundred fifty-seven patients were randomized to receive either the 8 Fr AS (n = 79) or VS (n = 78) closure device. Data on 95 patients who had coronary angiography (49 AS, 46 VS) and 55 patients who underwent angioplasty (28 AS, 27 VS) were completed. Heparin was not administered during the coronary angiogram procedure. The activated clotting time was kept at approximately 300 sec during angioplasty. Patients on coumadin or GP IIb/IIIa platelet inhibitors were not included in this study. The time unit interval to achieve hemostasis in this study was based on the time the AS tension spring was left over the common femoral artery following collagen deployment as per the manufacturer's instructions (20 min). Time to hemostasis, time to ambulation, and major and minor complications were prospectively recorded. Two-tailed t-test and chi-square analysis were performed on continuous and dichotomous variables, respectively. For the angiogram-only subgroup, time (min) to hemostasis (20.51 +/- 4.36 vs. 18.59 +/- 11.77; P = 0.30) and ambulation (145.71 +/- 124 vs. 109.89 +/- 60.37; P = 0.075) were not statistically different for the AS and VS, respectively. Similarly, for the angioplasty subgroup, time (min) to hemostasis (24.23 +/- 12.70 vs. 19.57 +/- 2.27; P = 0.077) and ambulation (607.32 +/- 344.22 vs. 486.48 +/- 200.37; P = 0.12) were not statistically different for both AS and VS, respectively. Furthermore, there were no statistical differences in deployment failure, major, minor, or total complication rates between the two devices. In the absence of GP IIb/IIIa inhibitors, VS and the 8 Fr AS devices have statistically similar time to hemostasis and ambulation as well as device failures and complication rates following coronary angiography and angioplasty.