The DAPT score is a recently-proposed decision tool for guiding optimal duration of dual antiplatelet therapy (DAPT). It showed modest accuracy in prior derivation and validation cohorts of patients with ≥12 months DAPT. This study was aimed to evaluate the validity of the DAPT score in a cohort of patients with 6 or 12 months DAPT after implantation of predominantly second-generation drug-eluting stents. We analyzed data of patients enrolled in the ISAR-SAFE trial. Patients were classified into low (<2) or high (≥2) DAPT score groups. Primary ischaemic (all-cause death, myocardial infarction, definite stent thrombosis or stroke) and bleeding (TIMI major or minor) outcomes were analyzed in the low and high DAPT score groups. Data of 3976 patients were available for DAPT score calculation. 2407 patients (60.5%) were classified in the low DAPT score group and 1569 patients (39.5%) in the high DAPT score group. In the low DAPT score group there were no significant differences between 6 and 12 months DAPT regarding ischaemic (1.0% vs. 1.4%, HR=0.74, 95% CI, 0.35–1.57; p=0.43) or bleeding outcomes (0.3% vs. 0.8%, HR=0.44, 95% CI, 0.13–1.42; p=0.17). In the high DAPT score group there were also no significant differences between 6 and 12 months DAPT regarding ischaemic (1.9% vs. 1.8%, HR=1.02, 95% CI, 0.49–2.14; p=0.96) or bleeding (0.3% vs. 0.5%, HR=0.51, 95% CI, 0.09–2.78; p=0.44) outcomes. In conclusion, the DAPT score failed to show a differential treatment effect in patients receiving 6 or 12 months DAPT after contemporary drug-eluting stent implantation.

Background: Coronary microvascular dysfunction (CMD) has been proposed as a crucial factor in the pathophysiology of Takotsubo syndrome (TTS). The angiography-derived index of microcirculatory resistance (caIMR) offers an alternative to conventional hyperemic wire-based IMR to assess CMD. We aimed to evaluate CMD’s prevalence, transience, and impact on in-hospital outcomes in TTS. Methods: All three coronary arteries of 96 patients with TTS were assessed for their coronary angiography derived Index of microcirculatory Resistance (caIMR) and compared to non-obstructed vessels of matched patients with ST-elevation myocardial infarction. Further, the association between caIMR and the TTS-specific combined in-hospital endpoint of death, cardiac arrest, ventricular arrhythmogenic events and cardiogenic shock was investigated. Results: Elevated IMR was present in all TTS patients, with significantly elevated caIMR values in all coronary arteries compared to controls. CaIMR did not differ between apical and midventricular TTS types. CaIMR normalized in TTS patients with follow-up angiographies performed at a median of 28 months (median caIMR at event vs follow-up: LAD 34.8 [29.9–41.1] vs 20.3 [16.0–25.3], p < 0.001; LCX: 38.7 [32.9–50.1] vs 23.7 [19.4–30.5], p < 0.001; RCA: 31.7 [25.0–39.1] vs 19.6 [17.1–24.0], p < 0.001). The extent of caIMR elevation significantly correlated with the combined in-hospital endpoint (p = 0.036). Conclusion: TTS patients had evidence of elevated caIMR in at least one coronary artery with a trend towards higher LAD caIMR in apical type TTS and normalization after recovery. Furthermore, extent of caIMR elevation was associated with increased risk of in-hospital MACE of TTS patients. Graphical

In patients presenting with acute coronary syndrome (ACS) the optimal duration of dual-antiplatelet therapy after drug-eluting stent (DES) implantation remains unclear. At 6 months after intervention, patients receiving clopidogrel were randomly assigned to either a further 6-month period of placebo or clopidogrel. The primary composite endpoint was death, myocardial infarction, stent thrombosis, stroke, or major bleeding 9 months after randomization. The ISAR-SAFE trial was terminated early due to low event rates and slow recruitment. 1601/4000 (40.0%) patients presented with ACS and were randomized to 6 (n = 794) or 12 months (n = 807) clopidogrel. The primary endpoint occurred in 14 patients (1.8%) receiving 6 months of clopidogrel and 17 patients (2.2%) receiving 12 months; hazard ratio (HR) 0.83, 95% confidence interval (CI) 0.41–1.68, P = 0.60. There were 2 (0.3%) cases of stent thrombosis in each group; HR 1.00, 95% CI 0.14–7.09, P = >0.99. Major bleeding occurred in 3 patients (0.4%) receiving 6 months clopidogrel and 5 (0.6%) receiving 12 months; HR 0.60, 95% CI 0.15–2.49, P = 0.49. There was no significant difference in net clinical outcomes after DES implantation in ACS patients treated with 6 versus 12 months clopidogrel. Ischaemic and bleeding events were low beyond 6-months.

BACKGROUND: Differences between balloon- and self-expandable transcatheter heart valves (BE-THVs and SE-THVs, respectively) may influence the outcomes of transcatheter aortic valve replacement for bicuspid aortic valve (BAV) stenosis. METHODS: Consecutive patients undergoing transcatheter aortic valve replacement with BE-THV or SE-THV for computed tomography–diagnosed bicuspid aortic valve stenosis at 29 centers were included. The primary outcome was death or stroke. After propensity score matching in 10 data sets generated by multiple imputation, outcomes from transcatheter aortic valve replacement to 3-year follow-up were computed by multivariable binomial logistic mixed-effects models, multivariable linear mixed-effects models, or multivariable frailty models accounting for center-related influences and residual confounding effects (doubly robust adjustment). The results were replicated by inverse probability of treatment weighting and multivariable adjustment. RESULTS: A total of 1443 consecutive patients with bicuspid aortic valve stenosis undergoing BE-THV (n=860) or SE-THV (n=583) implantation were included. In-hospital and 30-day death or stroke did not significantly differ between BE-THV and SE-THV groups (5.1% versus 6.1%; hazard ratio after propensity score matching, 1.02 [95% CI, 0.51–2.02]). BE-THV implantation was associated with higher annulus rupture and mean transvalvular gradient compared with SE-THV implantation. In contrast, SE-THV implantation was associated with higher additional valve implantation and paravalvular regurgitation compared with BE-THV implantation. The results were consistent across the statistical methods used and between early- and new-generation THVs. At 30 days, pacemaker implantation was lower in the BE-THV group compared with the SE-THV group (11.9% versus 18.6%; hazard ratio after propensity score matching, 0.58 [95% CI, 0.36–0.93]). This result did not depend on the statistical method used. At 3 years, consistent with the 1- and 2-year analyses, death or stroke was not significantly different between the BE-THV and SE-THV groups (23.7% versus 26.2%; hazard ratio after propensity score matching, 0.99 [95% CI, 0.65–1.51]). Death or stroke across major clinical, anatomical, functional, and procedural conditions was consistent with the main analysis. After inverse probability of treatment weighting and multivariable adjustment, these conclusions remained unchanged. CONCLUSIONS: In patients undergoing transcatheter aortic valve replacement for bicuspid aortic valve stenosis, death or stroke does not significantly differ between those receiving a BE-THV and those receiving an SE-THV over a follow-up of 3 years. BE-THV is associated with higher transvalvular mean gradient and more frequent annulus rupture, whereas SE-THV is associated with more frequent moderate to severe aortic regurgitation, additional THV implantation, and permanent pacemaker implantation.