Coronary Artery Disease Clinical Trial
Official title:
Angiographic Control vs. Ischemia-driven Management of Patients Undergoing Percutaneous Revascularization of the Unprotected Left Main Coronary Artery With Second-generation Drug Eluting Stents: the PULSE Trial
The present study aims to compare a planned angiographic control (PAC) follow-up strategy vs. conservative management for patients treated with drug-eluting stents on unprotected left main artery in a prospective, randomized setting. PAC will be performed by coronary computed tomography (CCT), to avoid the limitations of the invasive coronary angiography which is usually employed to perform PAC. The superiority of a PAC-based approach will be tested on a hard clinical end-point such as the incidence of major adverse cardiovascular events. The investigators will also assess the performance of CCT as a tool to perform PAC.
Given the undefined picture surrounding the appropriateness of planned angiographic control
(PAC) following percutaneous coronary intervention (PCI) of the unprotected left main (ULM)
with drug-eluting stents (DES), our aim is to evaluate, in a prospective, randomized,
setting, the potential benefits of a PAC-based strategy vs. ischemia and symptoms driven
conservative management. The disease of the native ULM is associated with an unfavorable
prognostic outcome, which can be at least partially reversed by revascularization.
Significant stenosis of the stented ULM caused by in-stent restenosis (ISR), however,
presents some peculiar pathophysiological, flow-related and shear-stress features, which
partly makes it a distinct disease as compared to native vessel atherosclerosis. Treatment of
ISR, moreover, is a scarcely standardized and often complex procedure; some uncertainties
still persist regarding the best strategy to treat ISR (stent-in-stent, drug-eluting
balloons, dilation with conventional balloons). Computed coronary tomography (CCT) can
precisely and not-invasively assess the presence of ISR in the stented ULM, without exposing
the patients to the risks of invasive catheterization. CCT may provide an accurate
reconstruction of the stented vessels, exposing the patients to a limited amount of contrast
dye (approximately, 80-100 cc) and of radiation dose (approximately, 92 mGy). CCT has a very
high negative predictive value for ISR, thus limiting the negative impact of the
indiscriminate execution of invasive angiography on all patients treated by PCI of the ULM.
Only patients with relevant ISR of ULM at CCT will undergo coronary angiography to confirm
the presence of critical stenosis, and fractional flow reserve (FFR) and/or intravascular
ultrasound (IVUS) will be performed in dubious cases.
An increased rate of PCI has to be taken in to account with a PAC-based approach. However,
with the accurate, stepwise selection of the patients and the lesions amenable to PCI of our
study protocol, based on CCT, coronary angiography and, where necessary, FFR/IVUS, the
increased rate of PCI is not expected to bear a negative prognostic impact. Based on these
premises, our hypothesis is that early, appropriate, detection of ULM ISR and its subsequent
treatment may positively impact patients' survival and reduce the incidence of adverse
cardiovascular events.
Specific aim 1:
Evaluation of the effectiveness and safety of a PAC-based approach to follow-up patients
treated by PCI of the ULM with DES-II
Specific aim 2:
Assessment of the incidence of ISR in patients undergoing PCI of the ULM with DES-II and
evaluation of the diagnostic accuracy of CCT in the evaluation of ISR in the stented ULM
Specific Aim 3:
Assessment of the prognostic implications and safety of the PCI of ISR of the ULM detected by
PAC as compared to conservative management with revascularization driven by symptoms and
ischemia.
For this purpose in this prospective, randomized controlled trial (RCT), patients will be
enrolled following the index percutaneous revascularization of ULM with DES. Patients will be
randomized in a 1:1 fashion to PAC-based management with CCT vs.
symptoms and ischemia driven conservative management.
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