Duration of dual antiplatelet therapy after myocardial infarction: Insights from a pooled database of the SMART-DATE and DAPT-STEMI trials.

BACKGROUND AND AIMS: The optimal duration of dual antiplatelet therapy (DAPT) after myocardial infarction (MI) in patients treated with second-generation drug-eluting stent (DES) is unclear, therefore, we aim to evaluate the ischemic and bleeding risk according to DAPT duration using a pooled-analysis of two randomized trials. METHODS: MI patients treated with durable-polymer second-generation DES from two randomized trials, SMART-DATE and DAPT-STEMI, were pooled. The primary endpoint was a composite of net adverse clinical events (NACEs) defined by all-cause mortality, any MI, stroke and BARC 3-5 bleeding, between 6 and 18 months after index percutaneous coronary intervention. RESULTS: A total of 2016 patients were analyzed, 1014 were treated with 6-month DAPT versus 1002 patients with ≥12-month DAPT duration. The primary endpoint occurred in 2.7% vs 2.5% (HR 1.07; 95%CI 0.62-1.85, p = 0.80) of cases, in 6 vs ≥ 12-month DAPT, respectively. The composite of cardiac death, MI and stroke was similar (2% vs 1.6%, HR 1.24, 95%CI 0.65-2.4, p = 0.52). BARC 3-5 bleeding occurred more frequently in the ≥12-month DAPT (0.2% vs 0.9%, HR 0.22, 95%CI 0.05-1.02 p = 0.05, log rank p = 0.03). MI occurred more frequently in the 6-month DAPT (1.6% vs 0.6%, HR 2.66, 95%CI 1.04-6.79, p = 0.04). Stent thrombosis was similar in both arms (0.7% vs 0.5%, p = 0.26). CONCLUSIONS: Six vs ≥ 12-month DAPT, followed by aspirin alone, resulted in comparable NACEs in patients with event-free MI at six months after durable-polymer DES implantation. However, single therapy with aspirin beyond the 6 months reduced bleeding rates but was associated with a higher rate of MI compared to ≥12-month DAPT.

Evaluation of left ventricular function three years after percutaneous recanalization of chronic total coronary occlusions.

We investigated early and late effects of percutaneous revascularization for chronic total coronary occlusion on left ventricular (LV) function and volumes. Magnetic resonance imaging was performed in 21 patients before and 5 months and 3 years after recanalization. Global LV function and volumes and segmental wall thickening (SWT) were quantified on cine images. The 2 viability indexes used were the transmural extent of infarction (TEI) on delayed contrast enhancement images and end-diastolic wall thickness at baseline. Significant decreases in mean end-diastolic (86 +/- 14 to 78 +/- 15 ml/m2; p = 0.02) and mean end-systolic volume indexes (35 +/- 13 to 30 +/- 13 ml/m2; p = 0.03) were observed 3 years after recanalization. Mean ejection fraction tended to improve (60 +/- 9% to 63 +/- 11%; p = 0.11). SWT significantly increased at 5-months' follow-up (p <0.001), and an additional improvement was found at 3 years' (p = 0.04) follow-up in segments with TEI <25%. In segments with TEI of 25% to 75%, SWT was unchanged at 5-month follow-up (p = 0.89), but improved at 3 years (p = 0.04). SWT was unchanged in segments with transmural scars. For segmental functional recovery, TEI was a better predictor than end-diastolic wall thickness at baseline (odds ratio 5.6, 95% confidence interval 1.5 to 21.1, p = 0.01 vs odds ratio 2.5, 95% confidence interval 0.7 to 8.3, p = 0.14). In conclusion, a positive effect on LV remodeling and ejection fraction was observed up to 3 years after recanalization. Both early and late improvements in regional LV function were observed in the perfusion territory of chronic total coronary occlusion and were related to the transmural extent of infarction on pretreatment magnetic resonance imaging.

The TandemHeart, percutaneous transseptal left ventricular assist device: a safeguard in high-risk percutaneous coronary interventions. The six-year Rotterdam experience.

AIMS: Percutaneous coronary interventions (PCI) in high-risk cardiac patients are preferentially referred to specialised myocardial intervention centres (MIC). Included in this group are patients with a haemodynamic collapse or high likelihood of haemodynamic collapse, either during balloon inflation or with acute vessel closure. The TandemHeart, a percutaneous transseptal left ventricular assist (PTVA) that can be introduced using standard catheterisation laboratory techniques, offers interesting perspectives to reduce procedural risks. METHODS AND RESULTS: Between September 2000 to July 2006, The TandemHeart, supported the circulation of 23 patients (age: range 46-74, mean 59) admitted to our centre for high risk, either emergency or elective, PCI. Successful implantation was achieved in 100% of patients. The mean time for implementation of circulatory support was 35 minutes (range 16-62). The index PCI was successful in all patients except two. A pump flow up to 4L/min was achieved with significant reduction of left ventricular filling pressures, pulmonary capillary wedge pressure and with significant increase of systemic arterial pressures. Duration of support ranged from 1-222 hours (mean 31+/-49.8 hours). Five patients died with the TandemHeart in place, four of whom were in irreversible cardiogenic shock at admission. Mild to moderate access site bleeding was seen in 27% of patients. One patient experienced a loge syndrome of the leg. Core temperature (Ct) decreased to <36.5 degrees C in six patients, profound hypothermia (Ct <35 degrees C) was observed in two patients. There was no technical device failure. CONCLUSIONS: The TandemHeart - PTVA provides effective, total left ventricular support in very high risk PCI settings. The rate of device related cardiac and vascular complications was acceptable.