Title : Improve upper extremity function following transradial PCI; Slender PCI and its potential benefits improve study
Transradial percutaneous coronary intervention (TRPCI) is rapidly becoming the gold standard especially in primary percutaneous coronary intervention (PCI). Results of the ARCUS trial (Effects of trAnsRadial perCUtaneouS Coronary Intervention on Upper Extremity Function) showed upper extremity dysfunction (UED) after TRPCI.
In the IMPROVE study UED following slender TRPCI using small bore catheters (5F) will be compared to standard TRPCI using regular size guiding catheters (6F) and conventional stent techniques on two-weeks, one month and 6-months clinical outcomes.
A total of 100 patients undergoing radial PCI using small bore guiding catheters (≤5F) and slender PCI will be included in the slender TRPCI group. Patent hemostasis of the radial artery will be obtained by means of an inflatable wrist band, and a pulse oximeter and will be maintained for a maximum of 4 hours.
The historical control group consists of 500 patients that underwent standard TRPCI using regular size 6F radial sheath and 6F guiding catheters and conventional stent techniques, following non-oxygen saturation guided hemostasis.
The main study parameter is a binary score of UED after two weeks as compared to baseline. This score for UED consists of questionnaires regarding functional status of the upper extremity as well as physical examination of the upper extremity. For the primary endpoint, the slender TRPCI group will be compared to the historical control group (ARCUS trial) at two weeks of follow-up.
The current binary primary endpoint will be compared to the similar primary endpoint variable of the historical control group using the Pearson’s chi-square test.
To this day, 50% of all inclusions and follow-up have been completed and results of the data will be presented.
We expect that with the suggested procedural changes and adjusted features that are known to have very high risk of radial artery occlusion (disparity in sheath-to-artery ratio along with non-patent hemostasis and elongated duration of compression), approximately 5% of patients will develop new significant symptoms of UED after slender TRPCI vs. 20% of patients who underwent standard TRPCI (previous interim results of the ARCUS trial).
Interim analysis of UED after slender TRPCI will be presented at the CWC 2019.