Safety and Efficacy of Minimally Interrupted Dabigatran vs Uninterrupted Warfarin Therapy in Adults Undergoing Atrial Fibrillation Catheter Ablation: A Randomized Clinical Trial.

Importance: Uninterrupted dabigatran therapy reduces stroke risk in patients with nonvalvular atrial fibrillation (NVAF) undergoing ablation and is associated with a lower bleeding risk than uninterrupted warfarin therapy. Minimally interrupted direct oral anticoagulant therapy is widely used, but data from controlled studies are insufficient. Objective: To compare the safety and efficacy of minimally interrupted dabigatran vs uninterrupted warfarin therapy in patients undergoing catheter ablation for NVAF. Design, Setting, and Participants: The ABRIDGE-J (ABlation peRIoperative DabiGatran in use Envisioning in Japan) trial is a open-label, randomized clinical trial performed in 28 Japanese treatment centers. A total of 504 patients scheduled for NVAF ablation were enrolled; 500 were randomized to the study treatments; 499 received at least 1 dose of dabigatran etexilate (n = 248) or warfarin potassium (n = 251); and 442 underwent ablation (220 in the dabigatran group and 222 in the warfarin group). Data were collected from May 1, 2014, through September 14, 2015, and analyzed from March 7, 2017, through January 28, 2019. Interventions: Appropriate dose anticoagulation was administered 4 weeks before and at least 3 months after ablation in all patients. Dabigatran therapy was interrupted before catheter ablation (holding of 1-2 doses) and resumed after ablation. Main Outcomes and Measures: Primary end points were the incidence of embolism during the perioperative period and atrial thrombus just before the ablation. The main secondary end point was the incidence of major bleeding events until 3 months after ablation. Results: Of the 442 patients who underwent ablation, 74.9% were men and the median age was 66 years (interquartile range, 59-71 years). Before ablation, 1 cerebral infarction and 1 thrombus in the left atrium occurred in the warfarin group, but no events occurred in the interrupted dabigatran group. After ablation, the mean (SD) incidence of major bleeding events was significantly lower with dabigatran (3 patients [1.4% {0.8%}; 95% CI, 0.4%-4.2%]) vs warfarin (11 patients [5.0% {1.5%}; 95% CI, 2.8%-8.8%]; P = .03). No thromboembolic events occurred after ablation in the dabigatran group; 1 (0.5%) occurred in the warfarin group. Conclusions and Relevance: In patients undergoing ablation for NVAF, anticoagulation with minimally interrupted dabigatran therapy did not increase thromboembolic events and was associated with fewer bleeding complications than uninterrupted warfarin therapy. Trial Registration: umin.ac.jp Identifier: UMIN000013129.

Early prediction of myocardial salvage after primary coronary angioplasty: comparative study of coronary flow velocity pattern immediately after primary coronary angioplasty and perfusion-metabolism mismatch.

OBJECTIVES: Perfusion-metabolism mismatch in the subacute phase using thallium-201/radio iodinated beta-methyl-p-iodophenyl pentadecanoic acid (T1/BMIPP) dual scintigraphy is an indicator of viable myocardium in acute myocardial infarction. This study investigated early prediction of myocardial salvage from the T1/BMIPP mismatch and coronary flow velocity (CFV) patterns in patients with acute myocardial infarction. METHODS: Thirty three patients with first anterior wall myocardial infarction underwent primary coronary angioplasty and achieved reflow within 8 hr of onset. By using a Doppler guide wire, CFV patterns were assessed immediately after primary coronary angioplasty. T1/BMIPP dual scintigraphy was performed within 3 days after reperfusion. The extent of discordance in severity score was defined as the T1/BMIPP mismatch score. RESULTS: Regression analysis showed dual scintigraphy mismatch score correlated well with deceleration time of diastolic flow velocity (r = 0.54, p < 0.01). Mismatch score was greater in the non-early systolic reversal flow group than in the early systolic reversal flow group (5.5 +/- 3.3 vs 1.9 +/- 2.1, respectively, p < 0.01). CONCLUSIONS: Changes in CFV patterns correlated well with T1/BMIPP mismatch score. CFV pattern immediately after reperfusion is useful for early prediction of myocardial salvage.

Efficacy of stenting after rotational atherectomy for ostial LAD and ostial LCX stenosis in patients with diabetes.

OBJECTIVE: The goal of this study was to investigate the efficacy of stenting after rotational atherectomy (rotastent) for ostial LAD and ostial LCX stenosis in patients with diabetes. BACKGROUND: Previous studies have demonstrated that rotastent for non-aorto ostial stenoses can be performed safely with high clinical success rate. However, in diabetic patients, long-term results of rotastent for ostial stenoses are still unknown. METHODS: A series of 70 patients with de novo non-aorto ostial stenosis who underwent successful elective stenting after rotational atherectomy were the subject of this study. Clinical, angiographic, and procedural characteristics, as well as acute and chronic results were obtained for all patients. RESULTS: There were no significant differences between diabetic versus non-diabetic patients in terms of baseline clinical characteristics, lesion characteristics, and procedural factors. The restenosis rate of diabetic patients was significantly higher than that of non-diabetic patients as assessed by the follow-up angiogram (53% versus 28%, respectively; p < 0.05). The rate of lesion progression which meant the development of new left main or non-treated artery-ostial narrowing was significantly higher in diabetic patients at follow-up angiography (23% versus 5%; p < 0.05 compared to non-diabetic patients). By use of multiple regression analysis, diabetes mellitus was identified as an independent predictor of restenosis and lesion progression. CONCLUSIONS: These results suggest that diabetic patients are more likely to have not only higher rates of restenosis but also development of new left main narrowing or non-treated artery ostial narrowing compared to non-diabetic patients.

Predictors of recurrent restenosis after coronary stenting: an analysis of 197 patients.

One of the major limitations in coronary stenting is in-stent restenosis. This study was aimed to identify clinical, angiographic, and procedural factors that may be related to recurrent in-stent restenosis. We analyzed consecutive 197 patients who underwent coronary stenting. Follow-up angiography was available in 170 patients and repeat balloon angioplasty was performed for in-stent restenosis. These patients were subdivided into 3 groups: group A consisted of 100 patients that were never restenosed, group B had 49 patients restenosed once, and in group C were 21 patients restenosed more than twice. Group C was more often female (48%) and included diabetes mellitus patients (52%). Lesion location, reference vessel size and diameter stenosis were similar for all groups. However, the incidence of calcified lesions tended to be higher (50% vs. 29%; p = 0.07), and lesion length was longer in group C than in group A (11.9+/- 5.4 mm vs. 9.0+/- 3.9 mm; p < 0.01). Diameter stenosis after predilation as well as after stenting was significantly higher in group C than in group A (50+/- 10% vs 39+/- 10%; p < 0.01, 32+/- 8% vs. 19+/- 10%; p < 0.01). The incidence of diffuse type of in-stent restenosis was significantly higher in group C than in group B (62% vs. 14%; p < 0.01). Multivariate logistic regression analysis identified diameter stenosis after stenting (p = 0.0022), female (p = 0.0135), and diameter stenosis after predilatation (p = 0.0233) as the significant correlate of recurrent in-stent restenosis. In conclusion, the major recurrent in-stent restenosis predictors identified included female gender, final diameter stenosis, and diameter stenosis after predilatation.