Coronary chronic total occlusions (CTOs) are among the most challenging coronary artery lesions to treat percutaneously. In the last decade, great strides have been made to develop techniques to improve success rates. While success rates among high-volume operators are >90 %, non-CTO operators still continue to struggle with this lesion subset. Thus, efforts have been made to develop algorithms to help operators achieve successful recanalisation consistently and improve patient outcomes. The North American Total Occlusion (NATO) algorithm emphasises dual coronary injection using two guide catheters, which allows for switching from an antegrade to retrograde approach or vice versa should the initial strategy fail - the so-called 'hybrid' approach. Special attention is paid to four angiographic characteristics: 1) location of the proximal cap, 2) lesion length, 3) presence and suitability of collateral vessels for retrograde crossing and 4) location and quality of target vessel distal cap. The ultimate goal of this algorithm is to provide a strategy to achieve successful CTO revascularisation while using the least amount of fluoroscopy, contrast and equipment possible.
This study sought to evaluate the safety and effectiveness of the Ranger drug-coated balloon (DCB) (paclitaxel dose density 2 μg/mm2) for treating superficial femoral artery or proximal popliteal artery lesions.Paclitaxel-coated balloon treatment prevents reinterventions, but dose and coating characteristics differ among balloons and necessitate discrete confirmation of safety and effectiveness.Patients with symptomatic lower limb ischemia (Rutherford classification 2 to 4) were randomized 3:1 to treatment with the Ranger DCB or standard percutaneous transluminal angioplasty (PTA). Twelve-month primary target lesion patency, freedom from major adverse events (i.e., target lesion revascularization, major amputations, death within 1 month of the index procedure), and patient outcomes were analyzed.Mean lesion length was 82.5 ± 48.9 mm for the Ranger DCB group (n = 278) and 79.9 ± 49.3 mm for the control group (n = 98). Ranger DCB was superior to PTA (82.9% [n = 194 of 234] vs. 66.3% [n = 57 of 86]) with observed 12-month primary patency rates yielding a difference of 16.6% (95% confidence interval: 5.5% to 27.7%; p = 0.0013). Noninferior freedom from major adverse events (94.1% [n = 241 of 256] vs. 83.5% [n = 76 of 91]) was demonstrated with a difference of 10.6% (95% confidence interval: 2.5% to 18.8%; noninferiority p < 0.0001). Primary patency rate curves showed significant separation by Kaplan-Meier analysis (log-rank p = 0.0005), with rates of 89.8% and 74.0% estimated at day 365 for the Ranger DCB and PTA cohorts, respectively.The low-dose Ranger DCB demonstrated significantly better effectiveness than standard PTA through 1 year and a good safety profile. (Ranger™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty [RANGER II SFA]; NCT03064126).