Daily risk of adverse outcomes in patients undergoing complex lesions revascularization: A subgroup analysis from the RAIN-CARDIOGROUP VII study (veRy thin stents for patients with left mAIn or bifurcatioN in real life)
Carloalberto Biolè
(1)
,
Zenon Huczek
(2)
,
Ivan Nuñez-Gil
(3)
,
Giacomo Boccuzzi
(4)
,
Michele Autelli
(1)
,
Antonio Montefusco
(1)
,
Daniela Trabattoni
(5)
,
Nicola Ryan
(3)
,
Giuseppe Venuti
(6)
,
Yoichi Imori
(7)
,
Hitoshi Takano
(7)
,
Junya Matsuda
(7)
,
Wataru Shimizu
(7)
,
Saverio Muscoli
(8)
,
Andrea Montabone
(9)
,
Wojciech Wojakowski
(10)
,
Andrea Rognoni
(11)
,
Gerard Helft
(12, 13)
,
Diego Gallo
(14)
,
Radoslaw Parma
(2)
,
Leonardo de Luca
(15)
,
Filippo Figini
(16)
,
Satoru Mitomo
(17)
,
Mauro Pennone
(1)
,
Alessio Mattesini
(9)
,
Christian Templin
(18)
,
Giorgio Quadri
(19)
,
Wojciech Wańha
(10)
,
Enrico Cerrato
(19)
,
Grzegorz Smolka
(10)
,
Marcin Protasiewicz
(20)
,
Wiktor Kuliczkowski
(20)
,
Cristina Rolfo
(19)
,
Bernardo Cortese
(21)
,
Davide Capodanno
(6)
,
Alaide Chieffo
(22)
,
Umberto Morbiducci
(14)
,
Mario Iannaccone
(1)
,
Sebastiano Gili
(18)
,
Carlo Di Mario
(9)
,
Maurizio d'Amico
(1)
,
Francesco Romeo
(8)
,
Thomas Lüscher
(18)
,
Imad Sheiban
(16)
,
Javier Escaned
(3)
,
Ferdinando Varbella
(19)
,
Fabrizio d'Ascenzo
(1)
1
Azienda Ospedalerio - Universitaria Città della Salute e della Scienza di Torino = University Hospital Città della Salute e della Scienza di Torino
2 Medical University of Warsaw - Poland
3 IdISSC - Instituto de Investigación Sanitaria del Hospital Clínico San Carlos [Madrid, Spain]
4 OSGB - Ospedale San Giovanni Bosco [Turin, Italy]
5 Centro Cardiologico Monzino, IRCCS
6 AOU Policlinico Vittorio-Emanuele [Catania, Italia]
7 Nippon Medical School [Tokyo, Japon]
8 Università degli Studi di Roma Tor Vergata [Roma] = University of Rome Tor Vergata
9 AOUC - Azienda Ospedaliero Universitaria Careggi [Firenze] = Careggi University Hospital [Florence, Italy]
10 SUM - Medical University of Silesia
11 Ospedale Maggiore della Carità
12 ICAN - Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases
13 UPMC - Université Pierre et Marie Curie - Paris 6 - UFR de Médecine Pierre et Marie Curie
14 Polito - Politecnico di Torino = Polytechnic of Turin
15 OSGE - Ospedale San Giovanni Evangelista [Rome, Italy]
16 CP - Clinica Pederzoli [Peschiera del Garda, Italy]
17 Ospedale San Raffaele Scientific Institute [Milan, Italy]
18 University hospital of Zurich [Zurich]
19 SLGUH Orbassano - San Luigi Gonzaga University Hospital [Turin, Italy]
20 Wrocław Medical University
21 ASST Fatebenefratelli-Sacco [Milan, Italy]
22 IRCCS San Raffaele Scientific Institute [Milan, Italie]
2 Medical University of Warsaw - Poland
3 IdISSC - Instituto de Investigación Sanitaria del Hospital Clínico San Carlos [Madrid, Spain]
4 OSGB - Ospedale San Giovanni Bosco [Turin, Italy]
5 Centro Cardiologico Monzino, IRCCS
6 AOU Policlinico Vittorio-Emanuele [Catania, Italia]
7 Nippon Medical School [Tokyo, Japon]
8 Università degli Studi di Roma Tor Vergata [Roma] = University of Rome Tor Vergata
9 AOUC - Azienda Ospedaliero Universitaria Careggi [Firenze] = Careggi University Hospital [Florence, Italy]
10 SUM - Medical University of Silesia
11 Ospedale Maggiore della Carità
12 ICAN - Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases
13 UPMC - Université Pierre et Marie Curie - Paris 6 - UFR de Médecine Pierre et Marie Curie
14 Polito - Politecnico di Torino = Polytechnic of Turin
15 OSGE - Ospedale San Giovanni Evangelista [Rome, Italy]
16 CP - Clinica Pederzoli [Peschiera del Garda, Italy]
17 Ospedale San Raffaele Scientific Institute [Milan, Italy]
18 University hospital of Zurich [Zurich]
19 SLGUH Orbassano - San Luigi Gonzaga University Hospital [Turin, Italy]
20 Wrocław Medical University
21 ASST Fatebenefratelli-Sacco [Milan, Italy]
22 IRCCS San Raffaele Scientific Institute [Milan, Italie]
Carloalberto Biolè
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Michele Autelli
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Daniela Trabattoni
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Nicola Ryan
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Giuseppe Venuti
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Yoichi Imori
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Hitoshi Takano
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Diego Gallo
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Giorgio Quadri
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Bernardo Cortese
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Mario Iannaccone
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Sebastiano Gili
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Francesco Romeo
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Résumé
Introduction: Percutaneous coronary intervention (PCI) for complex lesions, including unprotected left main (ULM) and bifurcations, is gaining a relevant role in treating coronary artery disease with good outcomes, also thanks to new generation stents. The daily risk of adverse cardiovascular events and their temporal distribution after these procedures is not known.
Methods: All consecutive patients presenting with a critical lesion of ULM or bifurcation treated with very thin struts stents, enrolled in the RAIN-Cardiogroup VII study, were analyzed. The daily risk of major acute cardiovascular events (MACE), target lesion revascularization (TLR) and stent thrombosis (ST) and their temporal distribution in the first year of follow-up was the primary endpoint. Differences among subgroups (ULM, patient presentation, kind of stent polymer) were the secondary endpoint.
Results: 2745 patients were included, mean age 68 ± 11 years, 33.3% diabetics, 54.5% had an acute coronary syndrome (ACS); 88.5% of treated lesions were bifurcations, 27.2% ULM. Average daily risk was 0.022% for MACE, 0.005% for TLR and 0.004% for ST, in the first year. Bimodal distribution of adverse events, especially TLR, with an early peak in the first 50 days and a late one after 150 days, was observed. Patients with ULM presented a significantly higher daily risk of events, and ACS patients presented higher MACE risk. No difference emerged according to the type of stent polymer.
Conclusions: The daily risk of adverse events in the first year after complex PCI in our study is acceptably low. PCI on ULM carries a higher risk of complications.