Mark Rosenberg1, Matthias Waliszewski2,3, Kenneth Chin4, Wan Azman Wan Ahmad5, Giuseppe Caramanno6, Diego Milazzo6, Amin Ariff Nuruddin7, Houng Bang Liew8, Oteh Maskon9, Pierre Aubry10, Raphael Poyet11, Norbert Frey1. 1. Innere Medizin III, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Germany. 2. Medical Scientific Affairs, B.Braun Melsungen AG, Berlin, Germany. 3. Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin Campus Virchow, Berlin, Germany. 4. Pantai Hospital, Kuala Lumpur, Malaysia. 5. Pusat Perubatan Universiti, Kuala Lumpur, Malaysia. 6. Ospedale San Giovanni di Dio, Agrigento, Italy. 7. The National Heart Institute of Malaysia, Kuala Lumpur, Malaysia. 8. Hospital Queen Elizabeth II, Sabah, Malaysia. 9. Pusat Perubatan Universiti Kebangsaan, Kuala Lumpur, Malaysia. 10. Centre Hospitalier Gonesse, Gonesse, France. 11. HIA Toulon, Toulon, France.
Abstract
OBJECTIVES: This prospective, observational all-comers registry assessed the safety and efficacy of a Drug Coated Balloon-only strategy (DCB-only) in patients with coronary lesions. BACKGROUND: Data regarding the performance of a DCB-only approach, especially in patients with previously untreated de-novo coronary artery disease (CAD), are still limited. METHODS: This study was conducted as an international, multicenter registry primarily enrolling patients with de-novo CAD. However, it was also possible to include patients with in-stent restenosis (ISR). The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) after 9 months. RESULTS: A total of 1,025 patients with a mean age of 64.0 ± 11.2 years were enrolled. The majority of treated lesions were de-novo (66.9%), followed by drug-eluting-stent ISR (DES-ISR; 22.6%) and bare-metal-stent ISR (BMS-ISR; 10.5%). The TLR rate was lower in the de-novo group (2.3%) when compared to BMS- (2.9%) and DES-ISR (5.8%) (P = 0.049). Regarding MACE, there was a trend toward fewer events in the de-novo group (5.6%) than in the BMS- (7.8%) and DES-ISR cohort (9.6%) (P = 0.131). Subgroup analyses revealed that lesion type (95% CI 1.127-6.587); P = 0.026) and additional stent implantation (95% CI 0.054-0.464; P = 0.001) were associated with higher TLR rates. CONCLUSIONS: Our results show that DCB-only angioplasty of de-novo coronary lesions is associated with low MACE and TLR rates. Thus, DCBs appear to be an attractive alternative for the interventional, stentless treatment of suitable de-novo coronary lesions.
OBJECTIVES: This prospective, observational all-comers registry assessed the safety and efficacy of a Drug Coated Balloon-only strategy (DCB-only) in patients with coronary lesions. BACKGROUND: Data regarding the performance of a DCB-only approach, especially in patients with previously untreated de-novo coronary artery disease (CAD), are still limited. METHODS: This study was conducted as an international, multicenter registry primarily enrolling patients with de-novo CAD. However, it was also possible to include patients with in-stent restenosis (ISR). The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) after 9 months. RESULTS: A total of 1,025 patients with a mean age of 64.0 ± 11.2 years were enrolled. The majority of treated lesions were de-novo (66.9%), followed by drug-eluting-stent ISR (DES-ISR; 22.6%) and bare-metal-stent ISR (BMS-ISR; 10.5%). The TLR rate was lower in the de-novo group (2.3%) when compared to BMS- (2.9%) and DES-ISR (5.8%) (P = 0.049). Regarding MACE, there was a trend toward fewer events in the de-novo group (5.6%) than in the BMS- (7.8%) and DES-ISR cohort (9.6%) (P = 0.131). Subgroup analyses revealed that lesion type (95% CI 1.127-6.587); P = 0.026) and additional stent implantation (95% CI 0.054-0.464; P = 0.001) were associated with higher TLR rates. CONCLUSIONS: Our results show that DCB-only angioplasty of de-novo coronary lesions is associated with low MACE and TLR rates. Thus, DCBs appear to be an attractive alternative for the interventional, stentless treatment of suitable de-novo coronary lesions.
Authors: Gal Sella; Gera Gandelman; Nicholay Teodorovich; Ortal Tuvali; Omar Ayyad; Haitham Abu Khadija; Dan Haberman; Lion Poles; Michael Jonas; Igor Volodarsky; Jacob George; Alex Blatt Journal: J Clin Med Date: 2022-03-27 Impact factor: 4.241