The PRAGMATIC Study:A Prospective Randomized Clinical Trial Comparing Radial Artery Intimal Hyperplasia Resulting From a 7F Sheathless Guide (Mach 1TM) vs. a 6F Transradial Sheath/Guide Combination in Coronary Intervention

The purpose of the PRAGMATIC study (A Prospective Randomized Trial comparing Radial Artery Intimal Hyperplasia resulting from a 7F Transradial Sheathless Guide [Mach 1] vs. a 6F Transradial Sheath/Guide Combination in Coronary Intervention) is 3 fold: (1) to determine if the routine use of a simple inexpensive "home-made" 7F sheathless guide catheter approach for TRA-PCI was associated with comparable degrees of radial artery access site injury and intimal-medial thickening (IMT) as the routine use of a 6F standard sheath/guide catheter combination; (2) to determine if the 7F sheathless approach was associated with comparable procedural success rates, procedure times, number of guides and crossover rates to a femoral approach compared to a 6F sheath/guide combination; and (3) to use ultrahigh resolution ultrasound to characterize the degree of RA injury and intimal-medial hyperplasia (IMT) that routinely occurs following transradial percutaneous coronary intervention.

Materials and Methods

Subjects and Study Design The study enrolled 41 consecutive patients undergoing elective non-emergent TRA-PCI at Tallahassee Memorial Hospital (TMH) from June 2016 to December 2016. The study protocol was approved by the TMH institutional review board. Informed consent was obtained prior to diagnostic coronary arteriography. Patients aged 21 years and over who were undergoing planned non-emergent PCI and willing to undergo a 24 hour and 90day post PCI RA ultrasound were eligible. Patients were excluded if they had undergone a prior ipsilateral TRA heart catheterization or PCI. There were no angiographic exclusions. Baseline clinical, demographic and angiographic characteristics were collected prospectively. Patients were randomly assigned to undergo TRA-PCI using a 7F sheathless Mach 1TM (Boston Scientific, Marlborough, MA) guide catheter or using our catheterization lab's standard 6F CordisTM (Johnson and Johnson, Inc.) sheath/6F Mach1TM guide combination. In order to minimize radial artery size bias, randomization was stratified according to patient sex. PCI with a drug-eluting stent was performed according to routine local practice and physician discretion. Patients were preferentially treated with a SYNERGYTM (Boston Scientific, Marlborough, MA) drug-eluting stent as the primary stent choice, however, other stents were allowed according to physician discretion.

All patients received dual antiplatelet therapy (DAPT) prior to TRA-PCI with an oral aspirin (325 mg) and a p2Y12 platelet inhibitor (either 600mg clopidogrel or 180mg ticagrelor) bolus. Intravenous heparin was administered to achieve an activated clotting time (ACT) of at least 300 seconds. Immediately following TRA-PCI, the sheath and/or guide was removed and RA hemostasis was achieved using a standardized and previously validated patent hemostasis protocol that incorporates the Terumo TR Band Radial Compression DeviceTM.

The technique used for the sheathless introduction of the 7F guide catheter was as follows: following diagnostic coronary angiography, a 6F 100 cm length multipurpose catheter (MP) was telescoped through the inner lumen of a 90 cm 7F Mach 1TM guide catheter. The MP was then used as an obturator to facilitate insertion of the 7F guide through the skin and into the RA arteriotomy site over a 0.035 J wire. Only after the 7F guide/6F MP combination was introduced into the RA and advanced together back to the aortic root, were the inner 6F MP catheter and 0.035 wire removed and the 7F guide engaged into the coronary ostium for TRA-PCI.