Radial vs Femoral Approach in PCI With IABP Support
Between 2007 and 2011, a total of 321 patients undergoing urgent or emergent PCI received periprocedural IABP support. Each center provided data on a minimum of 50 patients, and the recruitment was competitive among the hospital involved. Counterpulsation was normally started at the beginning of the procedure, but in 29% of cases, bailout IABP use was conditioned by an acute clinical status worsening or a procedure-related complication.
The main clinical and procedural characteristics are reported in Table I, Table II. Median patient age was 70 (60–79) years, with 73% males. Patients were admitted for ACS in most of cases, with acute STEMI as predominant diagnosis (76%). The median left ventricular ejection fraction was 30% (25%-40%), and the median additive EuroSCORE was 11, with 69% of patients presenting with cardiogenic shock. The prevalence of comorbidities was 29.3% for diabetes mellitus, 12.5% for chronic lung disease, 31.2% for peripheral vascular disease, and 47.0% for chronic kidney disease.
Transfemoral access was the preferred approach for revascularization procedure in these patients (65%), but temporal trend analysis showed a constant and significant increase of transradial access: from 20% in 2007 to 69% in 2011 (P < .001). There was no difference in transradial access use between patients receiving elective versus bailout IABP support (32% vs 37%, P = .472). Anticoagulant and antithrombotic therapies were similar in the 2 subgroups: 2.8% of patients had received unsuccessful thrombolysis, median heparin dose was 83 U/kg (68–100), and glycoprotein IIb/IIIa inhibitors were used in 45.2% of cases.
Patients undergoing transfemoral or transradial approach for PCI showed comparable baseline characteristics (eg, comorbidities, ACS diagnosis) and cardiac risk profile (eg, coronary artery disease severity), but those undergoing transfemoral approach generally presented a more severe hemodynamic impairment indicated by a lower systolic blood pressure (88 vs 90 mm Hg, P = .006) and a more frequent need for inotropic support (68% vs 58%, P = .077) and/or mechanical ventilation (37% vs 27%, P = .068). Notwithstanding these differences, both groups showed a comparable preprocedural risk score, as assessed by EuroSCORE (Table I).
Finally, there were no differences between the 2 study groups in term of procedural strategy, complication rate and angiographic failure (17.2% vs 13.4%, P = .372), but patients undergoing transradial approach had an increased probability to receive a ≤6 French sheath (98.2% vs 76.1%, P < .001) and a higher dose of contrast dye (240 vs 200 mL, P = .011) (Table II).
Unadjusted analyses showed that 30-day NACE occurred in 161 patients (50.2%) and were significantly more frequent in the transfemoral group when compared with transradial group (57.4% vs 36.6%, 95% CI 9.4–31.4, P = .001) ( Table III). Analysis of individual NACE components revealed significantly more bleedings (33.5% vs 16.1%, 95% CI 7.5–26.1, P = .001) and cardiac deaths (34.9% vs 19.6%, 95% CI 5.0–24.5, P = .004) in transfemoral patients when compared with transradial patients. On the contrary, MI (6.7% vs 7.1%, 95% CI −7.7 to 3.0, P = .881), TLR (3.8% vs 5.4%, 95% CI −7.7 to 3.0, P = .523), and stroke (1.9% vs 3.6%, 95% CI −7.0 to 2.0, P = .364) incidences were comparable in the 2 groups. No significant outcome difference was found among the participating centers.
At multivariable propensity score adjusted Cox hazard analysis based on difference in the 2 groups at bivariate analyses (Table IV), transradial approach was confirmed as an independent predictor of 30-day NACE (HR 0.57, 95% CI 0.4–0.9, P = .007), together with the need for inotropic support (HR 1.67, 95% CI 1.1–2.5, P = .018). Propensity-matched analyses confirmed in magnitude of effect and statistical significance results based on multivariable propensity-adjusted analyses. Figure 1 shows the 30-day NACE Kaplan-Meier curves.
(Enlarge Image)
Figure 1.
Time-to-event curves for NACE. *NACE, composite of cardiac death, MI, TLR, stroke, and bleeding.
The net difference in clinical relevant hemorrhagic (BARC ≥2 bleeding) complications was mainly related to a significant reduction of access site bleeding in the transradial group when compared with transfemoral group (6.3% vs 18.7%, 95% CI 4.7–19.1, P = .002), whereas non–access site bleedings, accounting for 47% of bleeding events, were similar (9.8% vs 14.8%, 95% CI −3.1 to 11.9, P = .204). Thus, patients in the transradial group showed a less severe postprocedural decrease of hemoglobin level with ensuing reduced need for blood transfusion (6.3% vs 14.8%, 95% CI 1.2–14.9, P = .028). No difference in terms of bleeding was observed in patients receiving elective or bailout IABP. Notably, patients without bleeding showed comparable outcomes (20.5% vs 23.9%, 95% CI −12.3 to 6.5, P = .582) regardless of the arterial approach adopted (Figure 2).
(Enlarge Image)
Figure 2.
Bleeding and major cardiac and cerebrovascular adverse events (MACCE) distribution according to arterial access in patients with clinical events. *NACE, net adverse clinical event; MACCE, composite of cardiac death, MI, TLR, and stroke.
Median hospital stay length was 9 days and was similar in 2 study subgroups, but patients undergoing transradial approach showed a trend toward a shorter intensive coronary care stay (4 vs 6 days, P = .078). In particular, transradial patients exhibited a shorter intensive care unit stay in the absence of vascular complications (4 vs 5 days, P = .063) when compared with transfemoral patients, whereas no difference was observed in case of bleeding (7 vs 6 days, P = .719).
Results
Population and Procedural Characteristics
Between 2007 and 2011, a total of 321 patients undergoing urgent or emergent PCI received periprocedural IABP support. Each center provided data on a minimum of 50 patients, and the recruitment was competitive among the hospital involved. Counterpulsation was normally started at the beginning of the procedure, but in 29% of cases, bailout IABP use was conditioned by an acute clinical status worsening or a procedure-related complication.
The main clinical and procedural characteristics are reported in Table I, Table II. Median patient age was 70 (60–79) years, with 73% males. Patients were admitted for ACS in most of cases, with acute STEMI as predominant diagnosis (76%). The median left ventricular ejection fraction was 30% (25%-40%), and the median additive EuroSCORE was 11, with 69% of patients presenting with cardiogenic shock. The prevalence of comorbidities was 29.3% for diabetes mellitus, 12.5% for chronic lung disease, 31.2% for peripheral vascular disease, and 47.0% for chronic kidney disease.
Transfemoral access was the preferred approach for revascularization procedure in these patients (65%), but temporal trend analysis showed a constant and significant increase of transradial access: from 20% in 2007 to 69% in 2011 (P < .001). There was no difference in transradial access use between patients receiving elective versus bailout IABP support (32% vs 37%, P = .472). Anticoagulant and antithrombotic therapies were similar in the 2 subgroups: 2.8% of patients had received unsuccessful thrombolysis, median heparin dose was 83 U/kg (68–100), and glycoprotein IIb/IIIa inhibitors were used in 45.2% of cases.
Patients undergoing transfemoral or transradial approach for PCI showed comparable baseline characteristics (eg, comorbidities, ACS diagnosis) and cardiac risk profile (eg, coronary artery disease severity), but those undergoing transfemoral approach generally presented a more severe hemodynamic impairment indicated by a lower systolic blood pressure (88 vs 90 mm Hg, P = .006) and a more frequent need for inotropic support (68% vs 58%, P = .077) and/or mechanical ventilation (37% vs 27%, P = .068). Notwithstanding these differences, both groups showed a comparable preprocedural risk score, as assessed by EuroSCORE (Table I).
Finally, there were no differences between the 2 study groups in term of procedural strategy, complication rate and angiographic failure (17.2% vs 13.4%, P = .372), but patients undergoing transradial approach had an increased probability to receive a ≤6 French sheath (98.2% vs 76.1%, P < .001) and a higher dose of contrast dye (240 vs 200 mL, P = .011) (Table II).
Clinical Outcome and NACE Predictors
Unadjusted analyses showed that 30-day NACE occurred in 161 patients (50.2%) and were significantly more frequent in the transfemoral group when compared with transradial group (57.4% vs 36.6%, 95% CI 9.4–31.4, P = .001) ( Table III). Analysis of individual NACE components revealed significantly more bleedings (33.5% vs 16.1%, 95% CI 7.5–26.1, P = .001) and cardiac deaths (34.9% vs 19.6%, 95% CI 5.0–24.5, P = .004) in transfemoral patients when compared with transradial patients. On the contrary, MI (6.7% vs 7.1%, 95% CI −7.7 to 3.0, P = .881), TLR (3.8% vs 5.4%, 95% CI −7.7 to 3.0, P = .523), and stroke (1.9% vs 3.6%, 95% CI −7.0 to 2.0, P = .364) incidences were comparable in the 2 groups. No significant outcome difference was found among the participating centers.
At multivariable propensity score adjusted Cox hazard analysis based on difference in the 2 groups at bivariate analyses (Table IV), transradial approach was confirmed as an independent predictor of 30-day NACE (HR 0.57, 95% CI 0.4–0.9, P = .007), together with the need for inotropic support (HR 1.67, 95% CI 1.1–2.5, P = .018). Propensity-matched analyses confirmed in magnitude of effect and statistical significance results based on multivariable propensity-adjusted analyses. Figure 1 shows the 30-day NACE Kaplan-Meier curves.
(Enlarge Image)
Figure 1.
Time-to-event curves for NACE. *NACE, composite of cardiac death, MI, TLR, stroke, and bleeding.
The net difference in clinical relevant hemorrhagic (BARC ≥2 bleeding) complications was mainly related to a significant reduction of access site bleeding in the transradial group when compared with transfemoral group (6.3% vs 18.7%, 95% CI 4.7–19.1, P = .002), whereas non–access site bleedings, accounting for 47% of bleeding events, were similar (9.8% vs 14.8%, 95% CI −3.1 to 11.9, P = .204). Thus, patients in the transradial group showed a less severe postprocedural decrease of hemoglobin level with ensuing reduced need for blood transfusion (6.3% vs 14.8%, 95% CI 1.2–14.9, P = .028). No difference in terms of bleeding was observed in patients receiving elective or bailout IABP. Notably, patients without bleeding showed comparable outcomes (20.5% vs 23.9%, 95% CI −12.3 to 6.5, P = .582) regardless of the arterial approach adopted (Figure 2).
(Enlarge Image)
Figure 2.
Bleeding and major cardiac and cerebrovascular adverse events (MACCE) distribution according to arterial access in patients with clinical events. *NACE, net adverse clinical event; MACCE, composite of cardiac death, MI, TLR, and stroke.
Median hospital stay length was 9 days and was similar in 2 study subgroups, but patients undergoing transradial approach showed a trend toward a shorter intensive coronary care stay (4 vs 6 days, P = .078). In particular, transradial patients exhibited a shorter intensive care unit stay in the absence of vascular complications (4 vs 5 days, P = .063) when compared with transfemoral patients, whereas no difference was observed in case of bleeding (7 vs 6 days, P = .719).
SHARE
