- Email: [email protected]
NEW GENERATION DRUG-ELUTING STENT SUPERIOR TO BENCHMARK XIENCE DRUG-ELUTING STENT
427 JACC April 5, 2016 Volume 67, Issue 13
ACC.i2 Interventional Cardiology NEW GENERATION DRUG-ELUTING STENT SUPERIOR TO BENCHMARK XIENCE DRUG-ELUTING STENT Poster Contributions Poster Area, South Hall A1 Monday, April 04, 2016, 9:45 a.m.-10:30 a.m. Session Title: Devices: Coronary Stents Abstract Category: 7. ACC.i2 Interventional Cardiology: Coronary Intervention: Devices Presentation Number: 1256-180 Authors: Masato Nakamura, Satoru Otsuji, Yoshihisa Nakagawa, Yuji Oikawa, Nobuo Shiode, Masatoshi Miyahara, Gaku Nakazawa, Hiroyoshi Yokoi, Associations for Establishment of Evidence in Interventions, Minatoku, Tokyo, Japan
Background: The Resolute IntegrityTM drug eluting stent (DES; Medtronic) utilizes the Continuous Sinusoidal Technology. The PROPEL study is the first large, real world study to assess the safety, efficacy and deliverability of Resolute Integrity DES compared with a historical control, Xience VTM DES (Abbott Laboratories). Methods: PROPEL is a prospective, single arm, open label study that enrolled 1,204 subjects with coronary artery disease treated with Resolute Integrity DES at 76 sites in a Japanese all comers population. Angiographic follow-up was planned in 299 subjects at 10 months. The primary endpoint was target lesion failure (TLF) at 1 year compared with Xience V DES from the RESOLUTE All Comers study in subjects in the clinical follow-up only cohorts in both arms.
Results: In PROPEL, 41.3% of the subjects had diabetes mellitus, 22.1% prior myocardial infarction, and over 60% were complex subjects, and similar to Xience V controls. Procedure success was 99.3%. At 1 year in the clinical only cohort, TLF was 4.3% (34/800) with Resolute Integrity compared with 8.5% (97/1142) from Xience V historical controls, propensity adjusted p<0.001 for non-inferiority and p<0.001 for superiority. At 1 year with Resolute Integrity in all subjects (n=1055), TLF was 4.5% and comprised of 0.8% cardiac death, 0.2% target vessel myocardial infarction, and 3.7% clinically-driven target lesion revascularization. ARC definite/probable stent thrombosis was 0.3% at 1 year. In the angiographic follow-up group, in-segment and in stent late lumen loss was 0.16±0.37 and 0.26±0.39 mm, respectively.
Conclusions: The PROPEL study is the first large, prospective, multicenter study to investigate long-term clinical outcomes of the Resolute Integrity DES in a real-world patient population, and the first study to demonstrate superiority of a new generation DES to the benchmark Xience V DES used as historical comparator.
ACC.i2 Interventional Cardiology NEW GENERATION DRUG-ELUTING STENT SUPERIOR TO BENCHMARK XIENCE DRUG-ELUTING STENT Poster Contributions Poster Area, South Hall A1 Monday, April 04, 2016, 9:45 a.m.-10:30 a.m. Session Title: Devices: Coronary Stents Abstract Category: 7. ACC.i2 Interventional Cardiology: Coronary Intervention: Devices Presentation Number: 1256-180 Authors: Masato Nakamura, Satoru Otsuji, Yoshihisa Nakagawa, Yuji Oikawa, Nobuo Shiode, Masatoshi Miyahara, Gaku Nakazawa, Hiroyoshi Yokoi, Associations for Establishment of Evidence in Interventions, Minatoku, Tokyo, Japan
Background: The Resolute IntegrityTM drug eluting stent (DES; Medtronic) utilizes the Continuous Sinusoidal Technology. The PROPEL study is the first large, real world study to assess the safety, efficacy and deliverability of Resolute Integrity DES compared with a historical control, Xience VTM DES (Abbott Laboratories). Methods: PROPEL is a prospective, single arm, open label study that enrolled 1,204 subjects with coronary artery disease treated with Resolute Integrity DES at 76 sites in a Japanese all comers population. Angiographic follow-up was planned in 299 subjects at 10 months. The primary endpoint was target lesion failure (TLF) at 1 year compared with Xience V DES from the RESOLUTE All Comers study in subjects in the clinical follow-up only cohorts in both arms.
Results: In PROPEL, 41.3% of the subjects had diabetes mellitus, 22.1% prior myocardial infarction, and over 60% were complex subjects, and similar to Xience V controls. Procedure success was 99.3%. At 1 year in the clinical only cohort, TLF was 4.3% (34/800) with Resolute Integrity compared with 8.5% (97/1142) from Xience V historical controls, propensity adjusted p<0.001 for non-inferiority and p<0.001 for superiority. At 1 year with Resolute Integrity in all subjects (n=1055), TLF was 4.5% and comprised of 0.8% cardiac death, 0.2% target vessel myocardial infarction, and 3.7% clinically-driven target lesion revascularization. ARC definite/probable stent thrombosis was 0.3% at 1 year. In the angiographic follow-up group, in-segment and in stent late lumen loss was 0.16±0.37 and 0.26±0.39 mm, respectively.
Conclusions: The PROPEL study is the first large, prospective, multicenter study to investigate long-term clinical outcomes of the Resolute Integrity DES in a real-world patient population, and the first study to demonstrate superiority of a new generation DES to the benchmark Xience V DES used as historical comparator.