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Background: Patients at high-bleeding risk (HBR) undergoing percutaneous coronary intervention represent a challenging patient population. The use of drug-coated balloon (DCB) allows shorter duration of dual antiplatelet therapy compared with drug-eluting stents (DES) and reduces thrombotic risk due to the absence of a permanent implant. The present analysis aimed to investigate if the effect of DCB versus DES differed between patients with and without HBR treated with percutaneous coronary intervention in small coronary arteries. Methods: This prespecified subgroup analysis of a multicenter, randomized, noninferiority trial included 758 patients with de novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention, randomized to DCB (n=382) or second-generation DES (n=376). Patients were followed over 3 years for major adverse cardiac events. Results: Of the 758 patients randomized, 155 (20%) had HBR; these patients had higher mortality at 3 years (hazard ratio [95% CI], 3.09 [1.78-5.36]; P <0.001).> P =0.064), were similar in patients with HBR (4.5% versus 3.4%) but less frequent in DCB-versus DES-treated patients without HBR (0.9% versus 3.8%). There was no difference in major adverse cardiac events between DCB and DES regardless of bleeding risk (HBR, hazard ratio: 1.16 [0.51-2.62]; P =0.719 versus non-HBR, 0.96 [0.62-1.49]; P =0.863). Conclusions: DCBs were similarly safe and effective as current-generation DES in the treatment of coronary arteries <3 mm, regardless of bleeding risk. In patients treated with DCB, there was a trend towards a reduction of severe bleeding events at 3 years. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01574534. * Patients at high-bleeding risk undergoing percutaneous coronary intervention represent a challenging patient population. * The use of drug-coated balloon allows shorter duration of dual antiplatelet therapy compared with drug-eluting stents and may reduce thrombotic risk due to the absence of a permanent implant. * The present analysis investigated the effect of drug-coated balloon versus drug-eluting stent in patients with and without high-bleeding risk in small coronary arteries. * Rates of major bleeding events were overall low but tended to be lower after drug-coated balloon versus drug-eluting stent. * There was no difference in major adverse cardiac events between drug-coated balloon and drug-eluting stent regardless of bleeding risk. [ABSTRACT FROM AUTHOR]

The diagnosis of atrial fibrillation (AF) significantly increases the risk of having cardio embolic events. Cerebrovascular events are still a leading cause of death and disability worldwide. Current guidelines recommend an antithrombotic regimen to prevent thromboembolism in medium and high risk patients with AF. However, a substantial number of patients are not eligible for this therapy. Therefore, an exclusion of the left atrial appendage (LAA) from circulation seems to be an alternative strategy for stroke prevention in AF. This review focuses on the different strategies for LAA exclusion with a special focus on the WATCHMAN®-device. Two devices are currently in use for percutaneous transcatheter occlusion of the LAA: the WATCHMAN®-device and the AMPLATZER®-Cardiac plug. Only for the WATCHMAN®-device safety, feasibility and non inferiority data compared to standard therapy data are currently available. Additionally, about 200 patients at high risk for thromboembolic stroke and contraindications for oral anticoagulation therapy received the PLAATO® -device which is currently off the market. The WATCHMAN®-device was implanted in 800 patients that were eligible for long-term anticoagulation therapy with a moderate risk for thromboembolic stroke due to non-valvular AF. Current evidence indicates an equivalent risk of stroke compared to oral anticoagulation with a reduced rate of bleeing complications at least for the WATCHMAN®-device. Hence, another therapeutic option now is available to prevent thrombembolic events in patients with atrial fibrillation not suitable for medical anticoagulation therapy. [ABSTRACT FROM AUTHOR]

Background: Drug-coated balloons (DCBs) are an established treatment strategy for coronary artery disease. Randomized data on the application of DCBs in patients with an acute coronary syndrome (ACS) are limited. We evaluated the impact of clinical presentation (ACS versus chronic coronary syndrome) on clinical outcomes in patients undergoing DCB or drug-eluting stent (DES) treatment in a prespecified analysis of the BASKET-SMALL 2 trial (Basel Kosten Effektivitats Trial-Drug-Coated Balloons Versus Drug-Eluting Stents in Small Vessel Interventions). Methods: BASKET-SMALL 2 randomized 758 patients with small vessel coronary artery disease to DCB or DES treatment and followed them for 3 years regarding major adverse cardiac events (cardiac death, nonfatal myocardial infarction, and target vessel revascularization). Results: Among 758 patients, 214 patients (28.2%) presented with an ACS (15 patients [7%], ST-segment-elevation myocardial infarction; 109 patients [50.9%], non-ST-segment-elevation myocardial infarction; 90 patients [42.1%], unstable angina pectoris). At 1-year follow-up, there was no significant difference in the incidence of the primary end point by randomized treatment in patients with ACS (hazard ratio, 0.50 [95% CI, 0.19-1.26] for DCB versus DES) or chronic coronary syndrome (hazard ratio, 1.29 [95% CI, 0.67-2.47] for DCB versus DES). There was no significant interaction between clinical presentation and treatment effect (P for interaction, 0.088). For cardiac death (P for interaction, 0.049) and nonfatal myocardial infarction (P for interaction, 0.010), a significant interaction between clinical presentation and treatment was seen at 1 year with lower rates of these secondary end points in patients with ACS treated by DCB. At 3 years, there were similar major adverse cardiac event rates throughout groups without significant interaction between clinical presentation and treatment (P for interaction, 0.301). All-cause mortality was higher in ACS compared with chronic coronary syndrome; however, there was no difference between DCB and DES irrespective of clinical presentation. Conclusions: In this subgroup analysis of the BASKET-SMALL 2 trial, there was no interaction between indication for percutaneous coronary intervention (acute versus chronic coronary syndrome) and treatment effect of DCB versus DES in patients with small vessel coronary artery disease. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01574534. * A drug-coated balloon treatment strategy compared with drug-eluting stent implantation resulted in similar major adverse cardiac event rates at 1- and 3-year follow-up in patients presenting with acute coronary syndromes. * Major adverse cardiac event rates in drug-coated balloon-treated patients with an acute coronary syndrome were low and similar to the rates of those receiving drug-coated balloon treatment for chronic coronary syndrome. * The drug-coated balloon treatment strategy has evolved for patients presenting with in-stent restenosis, de novo small vessel coronary artery disease, and for patients at high bleeding risk. * Our results expand the knowledge of this approach to patients presenting with an acute coronary syndrome supporting the concept of leaving nothing behind without compromising safety. [ABSTRACT FROM AUTHOR]