Impact of Kissing Balloon in Patients Treated With Ultrathin Stents for Left Main Lesions and Bifurcations
Luca Gaido
(1)
,
Fabrizio D’ascenzo
(2)
,
Yoichi Imori
(3)
,
Wojciech Wojakowski
(4)
,
Andrea Saglietto
(2)
,
Filippo Figini
(2)
,
Alessio Mattesini
(5)
,
Daniela Trabattoni
(6)
,
Andrea Rognoni
(7)
,
Francesco Tomassini
(8, 9)
,
Alessandro Bernardi
(10)
,
Nicola Ryan
(11)
,
Saverio Muscoli
(12)
,
Gerard Helft
(13)
,
Ovidio de Filippo
(14)
,
Radoslaw Parma
(15)
,
Leonardo de Luca
(16)
,
Fabrizio Ugo
(10)
,
Enrico Cerrato
(8, 9)
,
Antonio Montefusco
(2)
,
Mauro Pennacchi
(16)
,
Wojciech Wańha
(4)
,
Grzegorz Smolka
(4)
,
Giulia de Lio
(2)
,
Francesco Bruno
(2)
,
Zenon Huczek
(15)
,
Giacomo Boccuzzi
(10)
,
Bernardo Cortese
(17)
,
Davide Capodanno
(18)
,
Pierluigi Omedè
(2)
,
Massimo Mancone
(19)
,
Ivan Nuñez-Gil
(11)
,
Francesco Romeo
(12)
,
Ferdiando Varbella
(8, 9)
,
Mauro Rinaldi
(2)
,
Javier Escaned
(11)
,
Federico Conrotto
(2)
,
Francesco Burzotta
(20)
,
Alaide Chieffo
(21)
,
Leor Perl
(22)
,
Maurizio D’amico
(2)
,
Carlo Di Mario
(5)
,
Imad Sheiban
(23)
,
Andrea Gagnor
(1)
,
Massimo Giammaria
(1)
,
Gaetano Maria de Ferrari
(2)
1
Maria Vittoria Hospital [Turin]
2 Azienda Ospedalerio - Universitaria Città della Salute e della Scienza di Torino = University Hospital Città della Salute e della Scienza di Torino
3 Nippon Medical School [Tokyo, Japon]
4 SUM - Medical University of Silesia
5 AOUC - Azienda Ospedaliero Universitaria Careggi [Firenze] = Careggi University Hospital [Florence, Italy]
6 UNIMI - Università degli Studi di Milano = University of Milan
7 University Hospital “Maggiore della Carità” [Novara, Italy]
8 OR - Ospedale di Rivoli [Rivoli, Italy]
9 SLGUH Orbassano - San Luigi Gonzaga University Hospital [Turin, Italy]
10 OSGB - Ospedale San Giovanni Bosco [Turin, Italy]
11 IdISSC - Instituto de Investigación Sanitaria del Hospital Clínico San Carlos [Madrid, Spain]
12 Università degli Studi di Roma Tor Vergata [Roma] = University of Rome Tor Vergata
13 UPMC - Université Pierre et Marie Curie - Paris 6 - UFR de Médecine Pierre et Marie Curie
14 UNITO - Università degli studi di Torino = University of Turin
15 Medical University of Warsaw - Poland
16 OSGE - Ospedale San Giovanni Evangelista [Rome, Italy]
17 CSC - Clinica San Carlo [Milan, Italy]
18 AOU Policlinico Vittorio-Emanuele [Catania, Italia]
19 UNIROMA - Università degli Studi di Roma "La Sapienza" = Sapienza University [Rome]
20 Unicatt - Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma]
21 IRCCS San Raffaele Scientific Institute [Milan, Italie]
22 Rabin Medical Center [Tel Aviv, Israël]
23 CP - Clinica Pederzoli [Peschiera del Garda, Italy]
2 Azienda Ospedalerio - Universitaria Città della Salute e della Scienza di Torino = University Hospital Città della Salute e della Scienza di Torino
3 Nippon Medical School [Tokyo, Japon]
4 SUM - Medical University of Silesia
5 AOUC - Azienda Ospedaliero Universitaria Careggi [Firenze] = Careggi University Hospital [Florence, Italy]
6 UNIMI - Università degli Studi di Milano = University of Milan
7 University Hospital “Maggiore della Carità” [Novara, Italy]
8 OR - Ospedale di Rivoli [Rivoli, Italy]
9 SLGUH Orbassano - San Luigi Gonzaga University Hospital [Turin, Italy]
10 OSGB - Ospedale San Giovanni Bosco [Turin, Italy]
11 IdISSC - Instituto de Investigación Sanitaria del Hospital Clínico San Carlos [Madrid, Spain]
12 Università degli Studi di Roma Tor Vergata [Roma] = University of Rome Tor Vergata
13 UPMC - Université Pierre et Marie Curie - Paris 6 - UFR de Médecine Pierre et Marie Curie
14 UNITO - Università degli studi di Torino = University of Turin
15 Medical University of Warsaw - Poland
16 OSGE - Ospedale San Giovanni Evangelista [Rome, Italy]
17 CSC - Clinica San Carlo [Milan, Italy]
18 AOU Policlinico Vittorio-Emanuele [Catania, Italia]
19 UNIROMA - Università degli Studi di Roma "La Sapienza" = Sapienza University [Rome]
20 Unicatt - Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma]
21 IRCCS San Raffaele Scientific Institute [Milan, Italie]
22 Rabin Medical Center [Tel Aviv, Israël]
23 CP - Clinica Pederzoli [Peschiera del Garda, Italy]
Résumé
Background: There are limited data regarding the impact of final kissing balloon (FKI) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. Methods: All patients undergoing left main or bifurcations percutaneous coronary intervention enrolled in the RAIN registry (Very Thin Stents for Patients With MAIN or BiF in Real Life: The RAIN, a Multicenter Study) evaluating ultrathin stents were included. Major adverse cardiac event (a composite of all-cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) was the primary end point, while its components, along with target vessel revascularization, were the secondary end points. The main analysis was performed comparing patients with and without FKI after adjustment with inverse probability of treatment weighting. Subgroup analyses were performed according to FKI (short [<3 mm] versus long overlap), strategy (provisional versus 2-stent), routine versus bail-out FKI, and the use of imaging and proximal optimization technique. Results: Two thousand seven hundred forty-two patients were included. At 16 months (8–20) follow-up, inverse probability of treatment weighting adjusted rates of major adverse cardiac event were similar between FKI and no-FKI group (15.1% versus 15.5%; P =0.967), this result did not change with use of imaging, proximal optimization technique, or routine versus bail-out FKI. In the 2-stent subgroup, FKI was associated with lower rates of target vessel revascularization (7.8% versus 15.9%; P =0.030) and target lesion revascularization (7.3% versus 15.2%; P =0.032). Short overlap FKI was associated with a lower rate of target lesion revascularization compared with no FKI (2.6% versus 5.4%; P =0.034), while long overlap was not (6.8% versus 5.4%; P =0.567). Conclusions: In patients with bifurcations or unprotected left main treated with ultrathin stents, short overlap FKI is associated with less restenosis. In a 2-stent strategy, FKI was associated with less target vessel revascularization and restenosis. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03544294.