Aims : Owing to new evidence from randomized controlled trials (RCTs) in low-risk patients with severe aortic stenosis, we compared the collective safety and efficacy of transcatheter aortic valve implantation (TAVI) vs. surgical aortic valve replacement (SAVR) across the entire spectrum of surgical risk patients. Methods and results : The meta-analysis is registered with PROSPERO (CRD42016037273). We identified RCTs comparing TAVI with SAVR in patients with severe aortic stenosis reporting at different follow-up periods. We extracted trial, patient, intervention, and outcome characteristics following predefined criteria. The primary outcome was all-cause mortality up to 2 years for the main analysis. Seven trials that randomly assigned 8020 participants to TAVI (4014 patients) and SAVR (4006 patients) were included. The combined mean STS score in the TAVI arm was 9.4%, 5.1%, and 2.0% for high-, intermediate-, and low surgical risk trials, respectively. Transcatheter aortic valve implantation was associated with a significant reduction of all-cause mortality compared to SAVR {hazard ratio [HR] 0.88 [95% confidence interval (CI) 0.78–0.99], P = 0.030}; an effect that was consistent across the entire spectrum of surgical risk (P-for-interaction = 0.410) and irrespective of type of transcatheter heart valve (THV) system (P-for-interaction = 0.674). Transcatheter aortic valve implantation resulted in lower risk of strokes [HR 0.81 (95% CI 0.68–0.98), P = 0.028]. Surgical aortic valve replacement was associated with a lower risk of major vascular complications [HR 1.99 (95% CI 1.34–2.93), P = 0.001] and permanent pacemaker implantations [HR 2.27 (95% CI 1.47–3.64), P < 0.001] compared to TAVI. Conclusion : Compared with SAVR, TAVI is associated with reduction in all-cause mortality and stroke up to 2 years irrespective of baseline surgical risk and type of THV system.
1 January 2019 in International Journal of Cardiology
The impact of ECG presentations of acute myocardial infarction (AMI) in cardiogenic shock is unknown. In myocardial infarction with cardiogenic shock, is there a difference in the outcomes and effect of revascularization strategies between non-ST-segment elevation myocardial infarction (NSTE-MI) and left bundle branch block (LBBB-MI) versus STEMI? Cardiogenic shock patients from the CULPRIT-SHOCK trial presenting with NSTE-MI or LBBB-MI were compared with STE-MI patients for 30-day and 1-year all-cause mortality. The interaction between ECG presentation and the effect of revascularization strategies on outcomes was evaluated. Of 665 cardiogenic shock patients analyzed, 55.9% presented with STE-MI, 29.3% with NSTE-MI and 14.7% with LBBB-MI. Patients differed in age (68.0 years in STE-MI, 71.0 years in NSTE-MI and 73.5 years in LBBB-MI, p=0.015), cardiovascular risk factors and angiographic severity. There was no difference in the 30-day risk of death between NSTE-MI and STE-MI (48.7 % vs. 43.0%, aOR 1.05, 95%CI, 0.66 - 1.67, p=0.85), nor between LBBB-MI and STE-MI (59.2% vs. 43.0%, aOR 1.31, 95%CI 0.73 - 2.34, p=0.36). While the univariate risk of 1-year death was higher in NSTE-MI and LBBB-MI patients compared with STE-MI, ECG presentation was not an independent risk factor of mortality after adjustment (NSTE-MI vs. STE-MI : 56.4 % vs 46.8 % aOR 1.21, 95%CI 0.76 - 1.92, p=0.42 ; LBBB-MI vs. STEMI : 69.4% vs. 46.8% : aOR : 1.59, 95%CI 0.89 - 2.84, p=0.12) . ECG presentation did not modify the effect of the revascularization strategy on 30-day and 1-year mortality (p interaction =0.91 and 0.97). In patients with cardiogenic shock, NSTE-MI and LBBB-MI presentations reflect higher risk profiles than STE-MI but are not independent risk factors of mortality. ECG presentations did not modify the treatment effect, supporting culprit-lesion-only PCI as the preferred strategy across the AMI spectrum.