Retrograde coronary chronic total occlusion revascularization: procedural and in-hospital outcomes from a multicenter registry in the United States.

OBJECTIVES: This study sought to examine the contemporary outcomes of retrograde chronic total occlusion (CTO) interventions among 3 experienced U.S. centers. BACKGROUND: The retrograde approach, pioneered and developed in Japan, has revolutionized the treatment of coronary CTO, yet limited information exists on procedural efficacy, safety, and reproducibility of outcomes in other settings. METHODS: Between 2006 and 2011, 462 consecutive retrograde CTO interventions were performed at 3 U.S. institutions. Patient characteristics, procedural outcomes, and in-hospital clinical events were ascertained. RESULTS: Mean patient age was 65 ± 9.7 years, 84% were men, and 50% had prior coronary artery bypass surgery. The CTO target vessel was the right coronary artery (66%), circumflex (18%), left anterior descending artery (15.5%), and left main artery or bypass graft (0.5%). The retrograde approach was used as the primary method in 46% of cases and after failed antegrade recanalization in 54%. Retrograde collateral vessels were septal (68%), epicardial (24%), and bypass grafts (8%). Technical and procedural success was 81.4% (n = 376) and 79.4% (n = 367), respectively. The mean contrast volume and fluoroscopy time were 345 ± 177 ml and 61 ± 40 min, respectively. A major complication occurred in 12 patients (2.6%). In multivariable analysis, years since initiation of retrograde CTO percutaneous coronary intervention (PCI) at each center, female sex, and ejection fraction ≥40% were associated with higher technical success. CONCLUSIONS: Among selected U.S. programs, retrograde CTO PCI is often performed in patients with prior coronary bypass graft surgery and is associated with favorably high success and low complication rates.

Pilot trial of cryoplasty or conventional balloon post-dilation of nitinol stents for revascularization of peripheral arterial segments: the COBRA trial.

OBJECTIVES: The purpose of this study is to compare post-dilation strategies of nitinol self-expanding stents implanted in the superficial femoral artery of diabetic patients with peripheral arterial disease. BACKGROUND: Endovascular treatment of superficial femoral artery disease with nitinol self-expanding stents is associated with high rates of in-stent restenosis in patients with diabetes mellitus. METHODS: We conducted a prospective, multicenter, randomized, controlled clinical trial of diabetic patients to investigate whether post-dilation of superficial femoral artery nitinol self-expanding stents using a cryoplasty balloon reduces restenosis compared to a conventional balloon. Inclusion criteria included diabetes mellitus, symptomatic peripheral arterial disease, and superficial femoral artery lesions requiring implantation of stents>5 mm in diameter and >60 mm in length. Primary endpoint was binary restenosis at 12 months, defined as ≥2.5-fold increase in peak systolic velocity by duplex ultrasonography. RESULTS: Seventy-four patients, with 90 stented superficial femoral artery lesions, were randomly assigned to post-dilation using cryoplasty (n=45 lesions) or conventional balloons (n=45 lesions). Mean lesion length was 148±98 mm, mean stented length was 190±116 mm, mean stent diameter was 6.1±0.4 mm, and 50% of the lesions were total occlusions. Post-dilation balloon diameters were 5.23±0.51 mm versus 5.51±0.72 mm in the cryoplasty and conventional balloon angioplasty groups, respectively (p=0.02). At 12 months, binary restenosis was significantly lower in the cryoplasty group (29.3% vs. 55.8%, p=0.01; odds ratio: 0.36, 95% confidence interval: 0.15 to 0.89). CONCLUSIONS: Among diabetic patients undergoing implantation of nitinol self-expanding stents in the superficial femoral artery, post-dilation with cryoplasty balloon reduced binary restenosis compared to conventional balloon angioplasty. (Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease [COBRA]; NCT00827853).