Significantly Improved Vascular Complications Among Women Undergoing Percutaneous Coronary Intervention

Abstract

Background-Women are at a higher risk for bleeding/vascular complications (VC) related to cardiovascular procedures.Although the overall incidence of percutaneous coronary intervention (PCI)-related bleeding/VC has declined, the impact of this decline, specifically in women, is unknown. Methods and Results-We studied 13 653 female and 32 334 male consecutive cases, from 2002 to 2007, in the Northern New England PCI Registry. We sought to (1) compare absolute rates of bleeding/VC in women and men over time, (2) define predictors of bleeding/VC in women and men undergoing PCI, and (3) trend the impact of female gender in predicting bleeding/VC over time. Bleeding/VC was defined as any access-site vessel injury requiring surgical intervention or bleeding requiring transfusion. The overall risk of bleeding/VC was significantly higher in women versus men (4.5Ϯ1.3% versus 1.6Ϯ0.5%; PϽ0.004). Over time, there was a significant (PϽ0.001) 50% decrease in absolute bleeding/VC rates in both women and men. After adjustment for baseline differences, female gender remained a significant predictor of increased risk in 2007 (odds ratio, 2.6; 95% CI, 1.74 to 3.91). Independent predictors of increased risk of bleeding/VC in women included older age, shock, renal failure, presentation with non-ST-elevation myocardial infraction and larger sheath sizes, whereas the use of fluoroscopy-guided access, closure devices, history of dyslipidemia or prior PCI, and use of bivalirudin were protective. Conclusion-Women undergoing PCI have had a significant decline in bleeding/VC rates during the last 6 years. Despite the improvement in procedural safety, female gender continues to be associated with a Ͼ2-fold risk of bleeding/VC compared with men. (Circ Cardiovasc Intervent. 2009;2:423-429.)

Women, Bleeding, and Coronary Intervention

“…Despite improvement in bleeding events over time, female sex remained a strong independent predictor of bleeding and vascular complications over a 6-year period (Figures 3 and 4). 17 Similarly, the CathPCI Registry examined 570 777 patients between 2008 and 2011 and found that women had a near 2-fold increased risk of bleeding compared with men (7.8% versus 3.7%; odds ratio, 1.95 [95% CI, 1.91-2.02]) despite adjusting for baseline clinical and procedural variables. 26 Thus, although bleeding complications have improved for men and women, female sex remains a potent predictor of increased risk for bleeding.…”

“…13 Increased focus on the morbidity and mortality associated with PCI-related bleeding has led to pharmacological, procedural, and technological advances, 14 which have resulted in improvement in post-PCI bleeding rates over the past decade ( Figure 1). [15][16][17][18] The 2011 American College of CardiologyAmerican Heart Association PCI Guidelines formally recognize the quality improvement goal of reducing bleeding complications: "All patients should be evaluated for risk of bleeding complications before PCI" (class I, level of evidence C). 19 Absolute event rates for bleeding have improved over time for both men and women undergoing PCI and, as reviewed below, major bleeding occurs in <3% of both sexes.…”

Early Treadmill ECG Stress Testing After Percutaneous Coronary Intervention Following Hemostasis with the Angioseal™ Vascular Closure Device: A Prospective Single-Center Cohort Study

“…Third, duration of follow-up was only 14 days and as a result we might have missed some late complications. Fourth, most patients were male and this may have biased the results, because women have a more than twofold risk of bleeding and/or vascular complications compared with men [16].…”

Nonlinear Mathematics of Death and Vascular Access

“…Second, bleeding complications have been reduced over the past decade, even in regions that have very limited radial access adoption; thus, the relationship between radial access-induced bleeding reduction and mortality trends may be confounded. 8,9 Third, the curve of lives saved appears steeper than the exponential function that defines radial access growth (Figure) This discordance between the temporal trends in odds of death and the projected lives saved with radial access growth may be a result of nonrandom heterogeneity in practice: specifically, the effect of the learning curve. When interventional cardiologists first adopt radial access, they are most likely to avoid time-pressured situations (primary PCI) and patients with smaller radial arteries (elderly, women).…”