Angiographic Control vs. Ischemia-driven Management of Patients Treated With PCI on Left Main With Drug-eluting Stents (PULSE)

October 31, 2019 updated by: Fabrizio D'Ascenzo, Azienda Ospedaliera Città della Salute e della Scienza di Torino

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

550

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ferrara, Italy, 44124
        • Active, not recruiting
        • Azienda Ospedaliero-Universitaria di Ferrara
      • Orbassano, Italy, 10043
        • Active, not recruiting
        • Ospedale San Luigi Gonzaga, Orbassano
      • Torino, Italy, 10126
        • Recruiting
        • AOU Città della Salute e della Scienza di Torino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with ULM disease treated by PCI with DES-II with the following inclusion criteria:

  • Age 18-85.
  • Glomerular filtration rate > 30 ml/min Indication to percutaneous revascularization of ULM according to Syntax score (< 33) or, in dubious cases, after Heart Team evaluation

Exclusion Criteria:

  • Cardiogenic shock
  • Refusal or inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: coronary computed tomography
Diagnostic test: coronary computed tomography
patients randomized in this arm will perform computed coronary tomography 6 months after the index percutaneous revascularization on unprotected left main artery
No Intervention: conservative (ischemia-guided) management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events (MACE)
Time Frame: 18 months after the index revascularization
composite and mutual exclusive end point including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina (UA), stent thrombosis
18 months after the index revascularization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target lesion revascularization (TLR)
Time Frame: 18 months after the index revascularization
target lesion revascularization including any TLR, any unplanned TLR and TLR driven by PAC
18 months after the index revascularization
All cause death
Time Frame: within 18 months from the index revascularization
death from any cause occurring during follow up
within 18 months from the index revascularization
stent thrombosis
Time Frame: within 18 months from the index revascularization
Any stent thrombosis (definite, probable or possible)
within 18 months from the index revascularization
CV death
Time Frame: within 18 months from the index revascularization
death from cardiovascular causes
within 18 months from the index revascularization
Myocardial infarction
Time Frame: within 18 months from the index revascularization
Myocardial infarction defined as non ST elevation acute coronary syndrome (NST-ACS) or ST elevation myocardial infarction (STEMI)
within 18 months from the index revascularization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
AKI
Time Frame: 2 days after CCT in the experimental arm
Acute kidney injury (AKI) following CCT will constitute safety end-point
2 days after CCT in the experimental arm
Renal function impairment
Time Frame: 18 months after the index revascularization
reduction of glomerular filtration rate of >24% or end-stage chronic kidney disease
18 months after the index revascularization
Overall bleedings
Time Frame: 18 months after the index revascularization
Any bleeding regardless of severity, defined according to Bleeding Academic Research Consortium (BARC) criteria
18 months after the index revascularization
Major bleedings
Time Frame: 18 months after the index revascularization
BARC bleedings type III-IV-V
18 months after the index revascularization
procedural complications
Time Frame: Index hospitalization
Procedural complications following each percutaneous coronary intervention (PCI): periprocedural MI defined, arterial access site complications, acute kidney injury
Index hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Collaborators

Università degli Studi di Ferrara
Arcispedale Santa Maria Nuova-IRCCS
AUSL Romagna Rimini
Ospedale Santa Croce-Carle Cuneo
Ospedale San Luigi Gonzaga, Orbassano

Investigators

  • Principal Investigator: Fabrizio D'Ascenzo, MD, AOU Città della Salute e della Scienza di Torino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2019

Primary Completion (Anticipated)

December 15, 2020

Study Completion (Anticipated)

October 15, 2022

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

November 4, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PULSE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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