Stephane Noble1, Elena Tessitore2, Baris Gencer2, Marc Righini3, Helia Robert-Ebadi3, Marco Roffi2, Robert F Bonvini4. 1. Cardiology Division, University Hospital of Geneva, Geneva, Switzerland. Electronic address: Stephane.noble@hcuge.ch. 2. Cardiology Division, University Hospital of Geneva, Geneva, Switzerland. 3. Angiology and Hemostasis Division, University Hospital of Geneva, Geneva, Switzerland. 4. Cardiology Division, University Hospital of Geneva, Geneva, Switzerland; Angiology and Hemostasis Division, University Hospital of Geneva, Geneva, Switzerland.
Abstract
BACKGROUND: The small diameter of radial arteries remains a major limitation of the transradial approach for percutaneous coronary intervention (PCI). Sheathless guiding catheters (GCs) might offer an advantage over standard GCs. METHODS: Between 2011 and 2013, we randomized 233 transradial PCIs performed in men with ostial or bifurcation lesions and in all women between standard GC (Medtronic Launcher; Minneapolis, MN) and the SheathLess Eaucath GC (Asahi Intecc, Aichi, Japan). RESULTS: Successful PCI using the transradial approach was not different between the groups (P = 0.74), however the rate of successful transradial PCI with the designated GC (ie, without crossover to the opposing GC) was superior in the SheathLess group compared with the standard GC group (96.5% vs 89.9%; P = 0.047). Safety end point (ie, absence of PCI complication, radial artery occlusion, perforation, pseudoaneurysm, and Early Discharge after Transradial Stenting of Coronary Arteries [EASY] hematoma grade ≥ 2) did not differ between the groups (60.5% in both groups). Mean PCI duration (45.1 minutes vs 45.9 minutes), fluoroscopy (20.1 minutes and 19.9 minutes), and cannulation times (3.6 minutes vs 3.7 minutes), contrast media volume (196 mL vs 187 mL) and conversion to transfemoral approach (1.8% vs 0.8%) were not different between the groups. Patients' subjective assessment revealed less arm pain during navigation of the SheathLess GC (1.9 ± 1.9 vs 4.8 ± 3.6; P < 0.001). Operators graded arm crossability as easier with the SheathLess GC (8.7 ± 1.5 vs 5.1 ± 3.5; P < 0.001). CONCLUSIONS: In selected coronary lesions requiring large-bore catheters in men and in all lesions in women, the SheathLess GC was superior to the standard GC for successful transradial PCI with the designated GC. The SheathLess GC was also associated with easier arm navigation and less patient discomfort. Copyright Â
RCT Entities:
BACKGROUND: The small diameter of radial arteries remains a major limitation of the transradial approach for percutaneous coronary intervention (PCI). Sheathless guiding catheters (GCs) might offer an advantage over standard GCs. METHODS: Between 2011 and 2013, we randomized 233 transradial PCIs performed in men with ostial or bifurcation lesions and in all women between standard GC (Medtronic Launcher; Minneapolis, MN) and the SheathLess Eaucath GC (Asahi Intecc, Aichi, Japan). RESULTS: Successful PCI using the transradial approach was not different between the groups (P = 0.74), however the rate of successful transradial PCI with the designated GC (ie, without crossover to the opposing GC) was superior in the SheathLess group compared with the standard GC group (96.5% vs 89.9%; P = 0.047). Safety end point (ie, absence of PCI complication, radial artery occlusion, perforation, pseudoaneurysm, and Early Discharge after Transradial Stenting of Coronary Arteries [EASY] hematoma grade ≥ 2) did not differ between the groups (60.5% in both groups). Mean PCI duration (45.1 minutes vs 45.9 minutes), fluoroscopy (20.1 minutes and 19.9 minutes), and cannulation times (3.6 minutes vs 3.7 minutes), contrast media volume (196 mL vs 187 mL) and conversion to transfemoral approach (1.8% vs 0.8%) were not different between the groups. Patients' subjective assessment revealed less arm pain during navigation of the SheathLess GC (1.9 ± 1.9 vs 4.8 ± 3.6; P < 0.001). Operators graded arm crossability as easier with the SheathLess GC (8.7 ± 1.5 vs 5.1 ± 3.5; P < 0.001). CONCLUSIONS: In selected coronary lesions requiring large-bore catheters in men and in all lesions in women, the SheathLess GC was superior to the standard GC for successful transradial PCI with the designated GC. The SheathLess GC was also associated with easier arm navigation and less patient discomfort. Copyright Â