Marie-Claude Morice1, Suneel Talwar2, Oliver Gaemperli3, Gert Richardt4, Franz Eberli5, Ian Meredith6, Azfar Zaman7, Jean Fajadet8, Samuel Copt9, Samantha Greene9, Philip Urban10. 1. Ramsay Générale de Santé - ICPS, Massy, France. Electronic address: mc.morice@icps.com.fr. 2. Royal Bournemouth Hospital, Bournemouth, UK. 3. University Hospital Zurich, Zurich, Switzerland. 4. Herzzentrum Segeberger Kliniken, Bad Segeberg, Germany. 5. Triemli Hospital, Zurich, Switzerland. 6. Monash Heart and Monash University Melbourne, Australia. 7. Freeman Hospital and Newcastle University, Newcastle-upon-Tyne, UK. 8. Clinique Pasteur, Toulouse, France. 9. Biosensors Europe, Morges, Switzerland. 10. Hôpital de La Tour, Geneva, Switzerland.
Abstract
BACKGROUND: The randomized, LEADERS FREE trial showed superior safety and efficacy of a polymer-free DCS vs. a bare metal stent in high-bleeding risk patients with only one month dual antiplatelet treatment. We report characteristics and outcomes of the pre-specified group of elderly patients (aged ≥75). METHODS: Age >75 was one of the trial's inclusion criteria. The main additional criteria were: need for oral anticoagulants, recent bleeding, anemia, chronic renal failure and cancer. All patients received 1month DAPT only. Both primary endpoints (efficacy: clinically driven TLR and safety: composite of cardiac death, MI and stent thrombosis) as well as bleeding were recorded up to 390days. RESULTS:1564 elderly patients (63.4% of the population) were enrolled with a mean of 2 inclusion criteria/patient. The primary safety endpoint was reached less frequently in DCS than BMS patients (10.7 vs. 14.3%, p=0.03), as was the primary efficacy endpoint (5.8 vs. 10.8% p=0.0003). Major bleeding rates were high and similar in both groups (7.3 vs. 8.2%, p=0.55). For the 562 (23.4%) patients with age as sole entry criterion, trends were similar for DCS and BMS patients respectively: safety endpoint (7.3%vs.11.4% p=0.10) and Cd TLR (4.7 vs. 13.2% p=0.0003), but for both groups, major bleeding occurred less frequently than for elderly patients with more comorbid conditions (3.6%vs. 2.8%). CONCLUSION: Compared to a BMS, use of a DCS together with a short one-month DAPT course was associated with significant safety and efficacy benefits for the elderly patients enrolled in LEADERS FREE.
RCT Entities:
BACKGROUND: The randomized, LEADERS FREE trial showed superior safety and efficacy of a polymer-free DCS vs. a bare metal stent in high-bleeding risk patients with only one month dual antiplatelet treatment. We report characteristics and outcomes of the pre-specified group of elderly patients (aged ≥75). METHODS: Age >75 was one of the trial's inclusion criteria. The main additional criteria were: need for oral anticoagulants, recent bleeding, anemia, chronic renal failure and cancer. All patients received 1month DAPT only. Both primary endpoints (efficacy: clinically driven TLR and safety: composite of cardiac death, MI and stent thrombosis) as well as bleeding were recorded up to 390days. RESULTS: 1564 elderly patients (63.4% of the population) were enrolled with a mean of 2 inclusion criteria/patient. The primary safety endpoint was reached less frequently in DCS than BMS patients (10.7 vs. 14.3%, p=0.03), as was the primary efficacy endpoint (5.8 vs. 10.8% p=0.0003). Major bleeding rates were high and similar in both groups (7.3 vs. 8.2%, p=0.55). For the 562 (23.4%) patients with age as sole entry criterion, trends were similar for DCS and BMS patients respectively: safety endpoint (7.3%vs.11.4% p=0.10) and Cd TLR (4.7 vs. 13.2% p=0.0003), but for both groups, major bleeding occurred less frequently than for elderly patients with more comorbid conditions (3.6%vs. 2.8%). CONCLUSION: Compared to a BMS, use of a DCS together with a short one-month DAPT course was associated with significant safety and efficacy benefits for the elderly patients enrolled in LEADERS FREE.
Authors: Jose M de la Torre Hernandez; Ramon Lopez Palop; Jesus M Jimenez Mazuecos; Pilar Carrillo Sáez; Alejandro Gutierez-Barrios; Eduardo Pinar; Belen Cid; Luis Fernandez; Tamara Garcia Camarero; Cristóbal Urbano-Carrillo; Juan F Oteo Dominguez; Victor A Jimenez Diaz; Antonio E Gomez Menchero; Eladio Galindo Fernández; Juan G Córdoba Soriano; Raymundo Ocaranza; Eduardo Arroyo Úcar; Koldobika Garcia San Roman; Silvio Leal; Ginés Martínez Cáceres; Jose A Linares Vicente; Georgina Fuertes Ferre; Xavier Carrillo; Juan C Rama Merchán; Catia Costa; Juan Sanchis; Renato Fernandes; Alberto Rodrigues; Jose M Vegas Valle; Hélder Pereira; Armando Perez de Prado Journal: J Geriatr Cardiol Date: 2022-05-28 Impact factor: 3.189
Authors: Philip Urban; Roxana Mehran; Roisin Colleran; Dominick J Angiolillo; Robert A Byrne; Davide Capodanno; Thomas Cuisset; Donald Cutlip; Pedro Eerdmans; John Eikelboom; Andrew Farb; C Michael Gibson; John Gregson; Michael Haude; Stefan K James; Hyo-Soo Kim; Takeshi Kimura; Akihide Konishi; John Laschinger; Martin B Leon; P F Adrian Magee; Yoshiaki Mitsutake; Darren Mylotte; Stuart Pocock; Matthew J Price; Sunil V Rao; Ernest Spitzer; Norman Stockbridge; Marco Valgimigli; Olivier Varenne; Ute Windhoevel; Robert W Yeh; Mitchell W Krucoff; Marie-Claude Morice Journal: Eur Heart J Date: 2019-08-14 Impact factor: 29.983
Authors: Philip Urban; Roxana Mehran; Roisin Colleran; Dominick J Angiolillo; Robert A Byrne; Davide Capodanno; Thomas Cuisset; Donald Cutlip; Pedro Eerdmans; John Eikelboom; Andrew Farb; C Michael Gibson; John Gregson; Michael Haude; Stefan K James; Hyo-Soo Kim; Takeshi Kimura; Akihide Konishi; John Laschinger; Martin B Leon; P F Adrian Magee; Yoshiaki Mitsutake; Darren Mylotte; Stuart Pocock; Matthew J Price; Sunil V Rao; Ernest Spitzer; Norman Stockbridge; Marco Valgimigli; Olivier Varenne; Ute Windhoevel; Robert W Yeh; Mitchell W Krucoff; Marie-Claude Morice Journal: Circulation Date: 2019-05-22 Impact factor: 29.690