Vascular Complications at Femoral Access Site Following PCI
Vascular Complications at Femoral Access Site Following PCI
There were 2,063,515 PCI procedures included in the registry from the first quarter of 2005 through the second quarter of 2009. Of these, 201,949 procedures (9.8%) were excluded from analysis for one of the above-noted considerations. That left 1,861,566 PCI procedures that were included in the study. Of these, there were 1,819,611 PCI procedures with femoral access (97.7%), 27,402 with radial access (1.5%), 6878 with brachial access (0.4%), and 7675 procedures with other access, missing values or with no arterial catheter (0.4%).
Use of the different types of hemostasis strategy varied substantially in the studied population: MC: 723,859 (38.9%); mechanical compression devices (MCD): 185,039 (9.9%); Angio-Seal: 534,556 (28.7%); Perclose: 155,279 (8.3%); StarClose: 81,242 (4.4%); Mynx: 23,690 (1.3%); Boomerang Closure Wire: 10,950 (0.6%); and patches: 146,951 (7.9%).
Table 1 shows complication rates in univariate analysis for every outcome among different strategy groups. Every VCD was associated with lower complication rates than MC for every clinical outcome except for retroperitoneal bleed. Hemostasis patches demonstrated complication rates that were higher than the VCDs but lower than MC or MCD.
Table 2 shows the trend analysis by quarter (beginning with the first quarter in which there were 10 or more PCIs using that hemostasis strategy) for "bleeding or vascular complication" rates over time, for each of the 8 hemostasis strategy groups.
All 8 types of hemostasis were associated with decreasing rates over time, as demonstrated by correlation coefficients between the corresponding rates and time period ranging from −0.51 to −0.92. All trends were statistically significant at the P<.02 level, except for Mynx, which was not statistically significant at the P<.05 level.
Multivariate analyses involved only PCIs with femoral artery access sites, except for the analysis that compared rates by access site. Table 3 shows the adjusted ORs (with MC as the reference group) for each of the other 7 hemostasis strategy groups for the 3 major outcomes ("bleeding complications," "vascular complications," and "bleeding or vascular complications").
All of the hemostasis strategies performed better compared to MC, except for mechanical compression devices and Mynx. The other hemostasis strategy groups all demonstrated significantly low odds of "bleeding or vascular complications" compared to MC, including Angio-Seal (OR, 0.68; CI, 0.65–0.70; P<.001), Perclose (OR, 0.54; CI, 0.51–0.57; P<.001), StarClose (OR, 0.77; CI, 0.72–0.82; P<.001), Boomerang Closure Wire (OR, 0.63; CI, 0.53–0.75; P<.001), and patches (OR, 0.70; CI, 0.67–0.74; P<.001). Mechanical compression demonstrated significantly higher odds of "bleeding or vascular complications" than MC (OR, 1.15; CI, 1.10–1.20; P<.001), and there was no significant difference in "bleeding or vascular complications" between MC and Mynx.
All hemostasis strategy groups demonstrated significantly lower odds of vascular complications than MC, except for mechanical compression devices, which demonstrated a significantly higher rate. Perclose, Angio-Seal, and patches also demonstrated significantly lower odds of bleeding complications than MC. There were no significant differences in bleeding complications compared to MC for StarClose and Boomerang. Mechanical compression and Mynx demonstrated significantly higher odds of bleeding complications than MC.
Within the Perclose device group, both specific devices (A-T and ProGlide) were associated with significantly lower odds of "bleeding or vascular complications" than MC. However, when compared to MC, Perclose ProGlide (OR, 0.51; CI, 0.48–0.55) was associated with a lower OR than Perclose A-T (OR, 0.64; CI, 0.58–0.71). Within the StarClose group, both devices were associated with significantly lower odds of "bleeding or vascular complications" than MC. However, StarClose SE (OR, 0.57; CI, 0.44–0.73) was associated with a lower OR than StarClose Vascular Closure System (OR, 0.79; CI, 0.74–0.84) when compared to MC. Within the Angio-Seal group, all the specific devices were associated with significantly lower odds of "bleeding or vascular complications" than MC. However, Angio-Seal VIP (OR, 0.63; CI, 0.60–0.66) and Angio-Seal STS Plus (OR, 0.61; CI, 0.57–0.65) were associated with significantly lower odds than the other two (Angio-Seal STS and plain Angio-Seal). Although the hemostasis patches, as a group, were associated with significantly lower odds of "bleeding or vascular complications" than MC, two patches were not: D-stat (Vascular Solutions) demonstrated by far the lowest odds of "bleeding or vascular complications" (OR, 0.43; CI, 0.39–0.48). Clo-Sur Pad (Scion Cardio-Vascular; OR, 1.04; CI, 0.87–1.26) and Neptune Patch (TZ Medical, Inc; OR, 0.91; CI, 0.79–1.04) were not associated with lower complication odds than MC.
Table 4 shows the ORs, with CIs and P-values for each of the co-variables that demonstrated significant ORs in patients with femoral artery access sites.
Co-variates that were associated with an increased risk of "bleeding or vascular complications" included, age, female sex, body mass index, renal failure, peripheral vascular disease, hypertension, congestive heart failure, New York Heart Association (NYHA) class IV, acute myocardial infarction, recent PCI, history of congestive heart failure, use of IABP during the procedure, PCI status of emergency, urgent or salvage, and use of IIb/IIIa inhibitors, thrombolytics, low molecular weight heparin or unfractionated heparin during the procedure. Co-variables that were associated with a decreased risk of "bleeding or vascular complications" included black race, diabetes, cardiogenic shock, left main coronary artery disease, and the use of aspirin or thrombin inhibitors (which included bivalirudin, argatroban, or lepirudin-rDNA) during the procedure.
In multivariate analysis, a radial artery access site was associated with far lower odds of "bleeding or vascular complications" compared to femoral access site (OR, 0.33; CI, 0.29–0.39; P<.001). Both bleeding and vascular complications were substantially lower for radial access site patients than for femoral access site patients. A brachial access site was associated with far higher odds of "bleeding or vascular complications" compared to femoral access site (OR, 2.41; CI, 2.15–2.69; P<.001).
Missing values for variables used in the multivariate regression equations were very low. The highest rate was for race, for which there were only 2872 missing values (0.15% of the total sample). The highest number of missing values for a co-morbid condition was NYHA class, for which there were only 415 missing values (only 0.02% of the total sample).
Results
Sample Sizes
There were 2,063,515 PCI procedures included in the registry from the first quarter of 2005 through the second quarter of 2009. Of these, 201,949 procedures (9.8%) were excluded from analysis for one of the above-noted considerations. That left 1,861,566 PCI procedures that were included in the study. Of these, there were 1,819,611 PCI procedures with femoral access (97.7%), 27,402 with radial access (1.5%), 6878 with brachial access (0.4%), and 7675 procedures with other access, missing values or with no arterial catheter (0.4%).
Use of the different types of hemostasis strategy varied substantially in the studied population: MC: 723,859 (38.9%); mechanical compression devices (MCD): 185,039 (9.9%); Angio-Seal: 534,556 (28.7%); Perclose: 155,279 (8.3%); StarClose: 81,242 (4.4%); Mynx: 23,690 (1.3%); Boomerang Closure Wire: 10,950 (0.6%); and patches: 146,951 (7.9%).
Univariate Analysis
Table 1 shows complication rates in univariate analysis for every outcome among different strategy groups. Every VCD was associated with lower complication rates than MC for every clinical outcome except for retroperitoneal bleed. Hemostasis patches demonstrated complication rates that were higher than the VCDs but lower than MC or MCD.
Trend Analysis
Table 2 shows the trend analysis by quarter (beginning with the first quarter in which there were 10 or more PCIs using that hemostasis strategy) for "bleeding or vascular complication" rates over time, for each of the 8 hemostasis strategy groups.
All 8 types of hemostasis were associated with decreasing rates over time, as demonstrated by correlation coefficients between the corresponding rates and time period ranging from −0.51 to −0.92. All trends were statistically significant at the P<.02 level, except for Mynx, which was not statistically significant at the P<.05 level.
Multivariate Analysis
Multivariate analyses involved only PCIs with femoral artery access sites, except for the analysis that compared rates by access site. Table 3 shows the adjusted ORs (with MC as the reference group) for each of the other 7 hemostasis strategy groups for the 3 major outcomes ("bleeding complications," "vascular complications," and "bleeding or vascular complications").
All of the hemostasis strategies performed better compared to MC, except for mechanical compression devices and Mynx. The other hemostasis strategy groups all demonstrated significantly low odds of "bleeding or vascular complications" compared to MC, including Angio-Seal (OR, 0.68; CI, 0.65–0.70; P<.001), Perclose (OR, 0.54; CI, 0.51–0.57; P<.001), StarClose (OR, 0.77; CI, 0.72–0.82; P<.001), Boomerang Closure Wire (OR, 0.63; CI, 0.53–0.75; P<.001), and patches (OR, 0.70; CI, 0.67–0.74; P<.001). Mechanical compression demonstrated significantly higher odds of "bleeding or vascular complications" than MC (OR, 1.15; CI, 1.10–1.20; P<.001), and there was no significant difference in "bleeding or vascular complications" between MC and Mynx.
All hemostasis strategy groups demonstrated significantly lower odds of vascular complications than MC, except for mechanical compression devices, which demonstrated a significantly higher rate. Perclose, Angio-Seal, and patches also demonstrated significantly lower odds of bleeding complications than MC. There were no significant differences in bleeding complications compared to MC for StarClose and Boomerang. Mechanical compression and Mynx demonstrated significantly higher odds of bleeding complications than MC.
Within the Perclose device group, both specific devices (A-T and ProGlide) were associated with significantly lower odds of "bleeding or vascular complications" than MC. However, when compared to MC, Perclose ProGlide (OR, 0.51; CI, 0.48–0.55) was associated with a lower OR than Perclose A-T (OR, 0.64; CI, 0.58–0.71). Within the StarClose group, both devices were associated with significantly lower odds of "bleeding or vascular complications" than MC. However, StarClose SE (OR, 0.57; CI, 0.44–0.73) was associated with a lower OR than StarClose Vascular Closure System (OR, 0.79; CI, 0.74–0.84) when compared to MC. Within the Angio-Seal group, all the specific devices were associated with significantly lower odds of "bleeding or vascular complications" than MC. However, Angio-Seal VIP (OR, 0.63; CI, 0.60–0.66) and Angio-Seal STS Plus (OR, 0.61; CI, 0.57–0.65) were associated with significantly lower odds than the other two (Angio-Seal STS and plain Angio-Seal). Although the hemostasis patches, as a group, were associated with significantly lower odds of "bleeding or vascular complications" than MC, two patches were not: D-stat (Vascular Solutions) demonstrated by far the lowest odds of "bleeding or vascular complications" (OR, 0.43; CI, 0.39–0.48). Clo-Sur Pad (Scion Cardio-Vascular; OR, 1.04; CI, 0.87–1.26) and Neptune Patch (TZ Medical, Inc; OR, 0.91; CI, 0.79–1.04) were not associated with lower complication odds than MC.
Table 4 shows the ORs, with CIs and P-values for each of the co-variables that demonstrated significant ORs in patients with femoral artery access sites.
Co-variates that were associated with an increased risk of "bleeding or vascular complications" included, age, female sex, body mass index, renal failure, peripheral vascular disease, hypertension, congestive heart failure, New York Heart Association (NYHA) class IV, acute myocardial infarction, recent PCI, history of congestive heart failure, use of IABP during the procedure, PCI status of emergency, urgent or salvage, and use of IIb/IIIa inhibitors, thrombolytics, low molecular weight heparin or unfractionated heparin during the procedure. Co-variables that were associated with a decreased risk of "bleeding or vascular complications" included black race, diabetes, cardiogenic shock, left main coronary artery disease, and the use of aspirin or thrombin inhibitors (which included bivalirudin, argatroban, or lepirudin-rDNA) during the procedure.
In multivariate analysis, a radial artery access site was associated with far lower odds of "bleeding or vascular complications" compared to femoral access site (OR, 0.33; CI, 0.29–0.39; P<.001). Both bleeding and vascular complications were substantially lower for radial access site patients than for femoral access site patients. A brachial access site was associated with far higher odds of "bleeding or vascular complications" compared to femoral access site (OR, 2.41; CI, 2.15–2.69; P<.001).
Missing values for variables used in the multivariate regression equations were very low. The highest rate was for race, for which there were only 2872 missing values (0.15% of the total sample). The highest number of missing values for a co-morbid condition was NYHA class, for which there were only 415 missing values (only 0.02% of the total sample).