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| Name | Class |
|---|---|
| Università degli Studi di Ferrara | OTHER |
| Ospedale San Luigi Gonzaga, Orbassano | UNKNOWN |
| Ospedale Santa Croce-Carle Cuneo | OTHER |
| Azienda USL Reggio Emilia - IRCCS |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| coronary computed tomography | Experimental |
| |
| conservative (ischemia-guided) management | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coronary computed tomography | Diagnostic Test | patients randomized in this arm will perform computed coronary tomography 6 months after the index percutaneous revascularization on unprotected left main artery |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular events (MACE) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion revascularization (TLR) | target lesion revascularization including any TLR, any unplanned TLR and TLR driven by PAC | 18 months after the index revascularization |
| All cause death | death from any cause occurring during follow up |
| Measure | Description | Time Frame |
|---|---|---|
| AKI | Acute kidney injury (AKI) following CCT will constitute safety end-point | 2 days after CCT in the experimental arm |
| Renal function impairment | reduction of glomerular filtration rate of >24% or end-stage chronic kidney disease |
Inclusion Criteria:
Patients with ULM disease treated by PCI with DES-II with the following inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabrizio D'Ascenzo, MD | A.O.U. Città della Salute e della Scienza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Città della Salute e della Scienza di Torino | Torino | Italy | 10126 | Italy | ||
| Azienda Ospedaliero-Universitaria di Ferrara |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25173339 | Background | Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available. | |
| 27209125 |
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| OTHER_GOV |
| AUSL Romagna Rimini | OTHER |
| University of Ferrara Department of Life Sciences and Biotechnology | UNKNOWN |
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| within 18 months from the index revascularization |
| stent thrombosis | Any stent thrombosis (definite, probable or possible) | within 18 months from the index revascularization |
| CV death | death from cardiovascular causes | within 18 months from the index revascularization |
| Myocardial infarction | 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 |
| 18 months after the index revascularization |
| Overall bleedings | Any bleeding regardless of severity, defined according to Bleeding Academic Research Consortium (BARC) criteria | 18 months after the index revascularization |
| Major bleedings | BARC bleedings type III-IV-V | 18 months after the index revascularization |
| procedural complications | Procedural complications following each percutaneous coronary intervention (PCI): periprocedural MI defined, arterial access site complications, acute kidney injury | Index hospitalization |
| Ferrara |
| 44124 |
| Italy |
| Ospedale San Luigi Gonzaga, Orbassano | Orbassano | 10043 | Italy |
| Background |
| Sheiban I, Moretti C, D'Ascenzo F, Chieffo A, Taha S, Connor SO, Chandran S, de la Torre Hernandez JM, Chen S, Varbella F, Omede P, Iannaccone M, Meliga E, Kawamoto H, Montefusco A, Mervyn C, Garot P, Sin L, Gasparetto V, Abdirashid M, Cerrato E, Biondi Zoccai G, Gaita F, Escaned J, Hiddick Smith D, Lefevre T, Colombo A. Long-Term (>/=10 Years) Safety of Percutaneous Treatment of Unprotected Left Main Stenosis With Drug-Eluting Stents. Am J Cardiol. 2016 Jul 1;118(1):32-9. doi: 10.1016/j.amjcard.2016.04.007. Epub 2016 Apr 26. |
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| 19755282 | Background | Valgimigli M, Chieffo A, Lefevre T, Colombo A, Morice MC, Serruys PW. Revisiting the incidence and temporal distribution of cardiac and sudden death in patients undergoing elective intervention for unprotected left main coronary artery stenosis in the drug eluting stent era. EuroIntervention. 2007 Feb;2(4):435-43. |
| 23723447 | Background | Roura G, Gomez-Lara J, Ferreiro JL, Gomez-Hospital JA, Romaguera R, Teruel LM, Carreno E, Esplugas E, Alfonso F, Cequier A. Multislice CT for assessing in-stent dimensions after left main coronary artery stenting: a comparison with three dimensional intravascular ultrasound. Heart. 2013 Aug;99(15):1106-12. doi: 10.1136/heartjnl-2013-303679. Epub 2013 May 30. |
| 19228612 | Background | Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18. |
| 24280157 | Background | Buchanan GL, Chieffo A, Bernelli C, Montorfano M, Carlino M, Latib A, Figini F, Giannini F, Durante A, Ielasi A, Castelli A, Colombo A. Two-year outcomes following unprotected left main stenting with first vs. new-generation drug-eluting stents: the FINE registry. EuroIntervention. 2013 Nov;9(7):809-16. doi: 10.4244/EIJV9I7A134. |
| 19144937 | Background | Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611. |
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| 25553722 | Background | Hicks KA, Tcheng JE, Bozkurt B, Chaitman BR, Cutlip DE, Farb A, Fonarow GC, Jacobs JP, Jaff MR, Lichtman JH, Limacher MC, Mahaffey KW, Mehran R, Nissen SE, Smith EE, Targum SL. 2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards). J Am Coll Cardiol. 2015 Jul 28;66(4):403-69. doi: 10.1016/j.jacc.2014.12.018. Epub 2014 Dec 29. No abstract available. |
| 17331245 | Background | Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713. |
| 21670242 | Background | Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available. |
| 22922414 | Background | Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available. |
| 10545431 | Background | Mehran R, Dangas G, Abizaid AS, Mintz GS, Lansky AJ, Satler LF, Pichard AD, Kent KM, Stone GW, Leon MB. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation. 1999 Nov 2;100(18):1872-8. doi: 10.1161/01.cir.100.18.1872. |
| 26970964 | Background | D'Ascenzo F, Iannaccone M, Giordana F, Chieffo A, Connor SO, Napp LC, Chandran S, de la Torre Hernandez JM, Chen SL, Varbella F, Omede P, Taha S, Meliga E, Kawamoto H, Montefusco A, Chong M, Garot P, Sin L, Gasparetto V, Abdirashid M, Cerrato E, Biondi-Zoccai G, Gaita F, Escaned J, Hiddick Smith D, Lefevre T, Colombo A, Sheiban I, Moretti C. Provisional vs. two-stent technique for unprotected left main coronary artery disease after ten years follow up: A propensity matched analysis. Int J Cardiol. 2016 May 15;211:37-42. doi: 10.1016/j.ijcard.2016.02.136. Epub 2016 Mar 3. |
| 40886174 | Derived | D'Ascenzo F, Cerrato E, De Filippo O, Gaido L, Franze A, Iannaccone M, Wanha W, Santarelli A, Guiducci V, Barbero U, Fernandez Pereira C, Gatti M, Tebaldi M, Giammaria M, Boccuzzi G, Wojakowski W, di Pietro G, Placido R, Gili S, Depaoli A, Biondi Zoccai G, Tomassini F, Bruno F, Zugna D, Faletti R, Biscaglia S, Caglioni S, Varbella F, de Ferrari GM, Campo G. Computed Tomography Angiography or Standard Care After Left Main PCI? J Am Coll Cardiol. 2025 Nov 11;86(19):1724-1734. doi: 10.1016/j.jacc.2025.07.060. Epub 2025 Aug 31. |
| 33122421 | Derived | De Filippo O, Bianco M, Tebaldi M, Iannaccone M, Gaido L, Guiducci V, Santarelli A, Zaccaro L, Depaoli A, Vaudano P, Quadri G, Gagnor A, Boccuzzi G, Solitro F, Cortese G, Guarnaccia C, Tore D, Veltri A, Franchin L, Angelini F, Garbo R, Giammaria M, Varbella F, Marchisio F, Fonio P, De Ferrari GM, Cerrato E, Campo G, D'Ascenzo F. Angiographic control versus ischaemia-driven management of patients undergoing percutaneous revascularisation of the unprotected left main coronary artery with second-generation drug-eluting stents: rationale and design of the PULSE trial. Open Heart. 2020 Oct;7(2):e001253. doi: 10.1136/openhrt-2020-001253. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D060050 | Angina, Stable |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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