Impact of Kissing Balloon in Patients Treated With Ultrathin Stents for Left Main Lesions and Bifurcations

Author:

Gaido Luca1,D’Ascenzo Fabrizio2,Imori Yoichi3,Wojakowski Wojciech4,Saglietto Andrea2,Figini Filippo2,Mattesini Alessio5,Trabattoni Daniela6,Rognoni Andrea7,Tomassini Francesco89,Bernardi Alessandro10,Ryan Nicola11,Muscoli Saverio12,Helft Gerard13,De Filippo Ovidio,Parma Radoslaw14,De Luca Leonardo15,Ugo Fabrizio10,Cerrato Enrico89,Montefusco Antonio2,Pennacchi Mauro15,Wańha Wojciech4,Smolka Grzegorz4,de Lio Giulia2,Bruno Francesco2,Huczek Zenon14,Boccuzzi Giacomo10,Cortese Bernardo16,Capodanno Davide17,Omedè Pierluigi2,Mancone Massimo18,Nuñez-Gil Ivan11,Romeo Francesco12,Varbella Ferdiando89,Rinaldi Mauro2,Escaned Javier11,Conrotto Federico2,Burzotta Francesco19,Chieffo Alaide20,Perl Leor21,D’Amico Maurizio2,di Mario Carlo5,Sheiban Imad22,Gagnor Andrea1,Giammaria Massimo1,De Ferrari Gaetano Maria2

Affiliation:

1. Division of Cardiology, Ospedale Maria Vittoria, Turin (L.G., A.G., M.G.).

2. Division of Cardiology, Department of Medical Science, Città della Salute e della Scienza, Turin (F.D., A.S., F.F., A. Montefusco, G.d.L., F.B., P.O., M.R., F.C., M.D., G.M.D.F.).

3. Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan (Y.I.).

4. Department of Cardiology, Medical University of Silesia, Katowice, Poland (W. Wojakowski, W. Wańha, G.S.).

5. Structural Interventional Cardiology, Careggi University Hospital, Florence, Italy (A. Mattesini, C.d.M.).

6. Department of Cardiovascular Sciences, IRCCS Centro Cardiologico Monzino, University of Milan, Italy (D.T.).

7. Coronary Care Unit and Catheterization laboratory, A.O.U. Maggiore della Carità, Novara, Italy (A.R.).

8. Department of Cardiology, Infermi Hospital, Rivoli, Italy (F.T., E.C., F.V.).

9. Department of Cardiology, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy (F.T., E.C., F.V.).

10. Dipartimento di Cardiologia, Ospedale San Giovanni Bosco, Italy (A.B., F.U., G.B.).

11. Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain (N.R., I.N.-G., J.E.).

12. Department of Medicine, Università degli Studi di Roma ‘Tor Vergata’, Rome, Italy (S.M., F.R.).

13. Pierre and Marie Curie University, Paris, France (G.H.).

14. University Clinical Hospital, Warsaw, Poland (R.P., Z.H.).

15. Division of Cardiology, S. Giovanni Evangelista Hospital, Tivoli, Rome, Italy (L.D.L., M.P.).

16. San Carlo Clinic, Milano, Italy (B.C.).

17. Division of Cardiology, Cardio-Thoracic-Vascular Department, Azienda Ospedaliero Universitaria “Policlinico-Vittorio Emanuele,” Catania, Italy (D.C.).

18. Università degli Studi di ROMA “La Sapienza” (M.M.), Lazio, Italia.

19. Università Cattolica del Sacro Cuore Roma (F.B.), Lazio, Italia.

20. San Raffaele Scientific Institute, Milan, Italy (A.C.).

21. Rabin Medical Center, Department of Cardiology, Tel Aviv, Israel (L.P.).

22. Pederzoli Hospital, Peschiera del Garda, Italy (I.S.).

Abstract

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

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