2.1

Patients’ selection

Patients over 80 years old who underwent primary or rescue PCI between January 2002 and September 2007 were considered eligible for this study. Patients with persistent (more than 20 minutes) ST segment elevation >2 mm in two or more contiguous leads, with new left bundle-branch block or true posterior myocardial infarction, were enrolled. Patients with previous bypass operation or cardiogenic shock on presentation were excluded from the study since the transfemoral procedure was preferred in these patients and they represent a higher-risk population. Patients in whom a conversion of the access site was performed during the procedure were also excluded from the data analysis, but the conversion rate was recorded. All operators were familiar with the transradial procedure and performed more than 100 PCIs per year.

The decision for the approach was on the operator’s discretion.

2.2

Antiplatelet and anticoagulation treatment

All patients received a bolus dose of aspirin (320 mg) and clopidogrel (300 or 600 mg) if not already on these medications, followed by a 75-mg daily aspirin dose and 75-mg clopidogrel dose for a period from 1 to 6 months.

The three following main treatment strategies were anticipated during PCI: heparin only, heparin plus a platelet glycoprotein IIb/IIIa receptor inhibitor, and only bivalirudin. The heparin-only patient group received a 100 U/kg bolus intravenous dose, followed by additional doses during PCI in order to maintain ACT more than 250 s. The heparin plus glycoprotein IIb/IIIa receptor inhibitor received 60 U/kg heparin and abciximad or eptifibatide (abciximab group, 0.25 mg/kg bolus dose intravenously followed by 0.125 μg/kg per minute intravenous infusion for 12 h; eptifibatide group, 180 μg/kg bolus dose followed by a second bolus dose intravenously after 10 min and by a 10 μg/kg per minute intravenous infusion for 18 h). Additional doses of heparin were administered in order to maintain ACT over 200 s. The bivalirudin patient group received a 0.75 mg/kg bolus dose followed by a 1.75-mg/kg per hour intravenous infusion, which was terminated immediately after the end of the procedure. Antiplatelet and anticoagulation treatment was on operator’s discretion.

2.3

Vascular access and hemostasis

An Allen test indicating a well-functioning ulnar artery was necessary in order to consider a patient eligible for the transradial approach. The arm and forearm were extended and, after local anesthesia with 2% lidocaine, the radial artery was cannulated with a 19-gauge needle, through which a 0.022″ guidewire was advanced and a 6F radial sheath (Terumo, Japan) was introduced over it. The use of vasodilating medical cocktail containing 20 mg lidocaine, 2.5 mg verapamil, and 0.25 mg nitroglycerin was an option in patients with excessive spasm in the radial artery. Hemostasis was achieved with external compression either with TR band (Terumo, Japan) or with Radistop (Radi Medical Systems Inc, Uppsala, Sweden).

For the transfemoral approach, after local anesthesia with 2% lidocaine, a 6F sheath (Cordis Corp, Warren, NJ) was advanced over a 0.035″ guidewire, using the Seldinger technique. The use of closure devices was on the operator’s discretion. The following closure devices were used under the study period: Angioseal (St Jude Medical Inc., Minnetonka, MN), Starclose (Abbott Vascular Devices, Redwook City, CA), and Perclose (Abbott Vascular Devices, Redwook City, CA). Alternatively, the femoral sheath was removed 3–6 h after the intervention, and external compression was applied with Femostop (Radi Medical Systems Inc, Uppsala, Sweden).

The patients were allowed to ambulate 1 h after intervention in the transradial group and after 12–24 h in the femoral group, unless indicated otherwise by their clinical condition.

2.4

Intervention

All interventions were performed for both approaches using 6F guiding catheters (Boston Scientific, Natick, MA), according to the medical standards and the routine use of bare metal stents. The use of drug-eluting stents in patients with ST-elevation myocardial infarction was not a clinical routine in our institution during the study period.

2.5

End points

Major adverse cardiac and cerebral events were recorded during hospitalization, as well as 30- and 365-day mortality. Access site bleeding complications, divided as major and minor, were also recorded. Major access site bleeding was defined as those leading to hemoglobin drop >2 mmol/l, those leading to administration of blood transfusions, requiring vascular repair or prolonging hospital stay. Minor access site bleeding was defined as those leading to hematoma formation not needing a specific treatment. Procedural times (needle to balloon time, total procedure time, fluoroscopy time), contrast volume, and the conversion rate for both the radial and the femoral approach were recorded.

2.1

Patients’ selection

Patients over 80 years old who underwent primary or rescue PCI between January 2002 and September 2007 were considered eligible for this study. Patients with persistent (more than 20 minutes) ST segment elevation >2 mm in two or more contiguous leads, with new left bundle-branch block or true posterior myocardial infarction, were enrolled. Patients with previous bypass operation or cardiogenic shock on presentation were excluded from the study since the transfemoral procedure was preferred in these patients and they represent a higher-risk population. Patients in whom a conversion of the access site was performed during the procedure were also excluded from the data analysis, but the conversion rate was recorded. All operators were familiar with the transradial procedure and performed more than 100 PCIs per year.

The decision for the approach was on the operator’s discretion.

2.2

Antiplatelet and anticoagulation treatment

All patients received a bolus dose of aspirin (320 mg) and clopidogrel (300 or 600 mg) if not already on these medications, followed by a 75-mg daily aspirin dose and 75-mg clopidogrel dose for a period from 1 to 6 months.

The three following main treatment strategies were anticipated during PCI: heparin only, heparin plus a platelet glycoprotein IIb/IIIa receptor inhibitor, and only bivalirudin. The heparin-only patient group received a 100 U/kg bolus intravenous dose, followed by additional doses during PCI in order to maintain ACT more than 250 s. The heparin plus glycoprotein IIb/IIIa receptor inhibitor received 60 U/kg heparin and abciximad or eptifibatide (abciximab group, 0.25 mg/kg bolus dose intravenously followed by 0.125 μg/kg per minute intravenous infusion for 12 h; eptifibatide group, 180 μg/kg bolus dose followed by a second bolus dose intravenously after 10 min and by a 10 μg/kg per minute intravenous infusion for 18 h). Additional doses of heparin were administered in order to maintain ACT over 200 s. The bivalirudin patient group received a 0.75 mg/kg bolus dose followed by a 1.75-mg/kg per hour intravenous infusion, which was terminated immediately after the end of the procedure. Antiplatelet and anticoagulation treatment was on operator’s discretion.

2.3

Vascular access and hemostasis

An Allen test indicating a well-functioning ulnar artery was necessary in order to consider a patient eligible for the transradial approach. The arm and forearm were extended and, after local anesthesia with 2% lidocaine, the radial artery was cannulated with a 19-gauge needle, through which a 0.022″ guidewire was advanced and a 6F radial sheath (Terumo, Japan) was introduced over it. The use of vasodilating medical cocktail containing 20 mg lidocaine, 2.5 mg verapamil, and 0.25 mg nitroglycerin was an option in patients with excessive spasm in the radial artery. Hemostasis was achieved with external compression either with TR band (Terumo, Japan) or with Radistop (Radi Medical Systems Inc, Uppsala, Sweden).

For the transfemoral approach, after local anesthesia with 2% lidocaine, a 6F sheath (Cordis Corp, Warren, NJ) was advanced over a 0.035″ guidewire, using the Seldinger technique. The use of closure devices was on the operator’s discretion. The following closure devices were used under the study period: Angioseal (St Jude Medical Inc., Minnetonka, MN), Starclose (Abbott Vascular Devices, Redwook City, CA), and Perclose (Abbott Vascular Devices, Redwook City, CA). Alternatively, the femoral sheath was removed 3–6 h after the intervention, and external compression was applied with Femostop (Radi Medical Systems Inc, Uppsala, Sweden).

The patients were allowed to ambulate 1 h after intervention in the transradial group and after 12–24 h in the femoral group, unless indicated otherwise by their clinical condition.

2.4

Intervention

All interventions were performed for both approaches using 6F guiding catheters (Boston Scientific, Natick, MA), according to the medical standards and the routine use of bare metal stents. The use of drug-eluting stents in patients with ST-elevation myocardial infarction was not a clinical routine in our institution during the study period.

2.5

End points

Major adverse cardiac and cerebral events were recorded during hospitalization, as well as 30- and 365-day mortality. Access site bleeding complications, divided as major and minor, were also recorded. Major access site bleeding was defined as those leading to hemoglobin drop >2 mmol/l, those leading to administration of blood transfusions, requiring vascular repair or prolonging hospital stay. Minor access site bleeding was defined as those leading to hematoma formation not needing a specific treatment. Procedural times (needle to balloon time, total procedure time, fluoroscopy time), contrast volume, and the conversion rate for both the radial and the femoral approach were recorded.