TCT-400 2-Year Clinical Follow-up of the TRYTON IDE Randomized Trial Comparing a Dedicated Bifurcation Stent to Provisional Stenting in the Treatment of Coronary Bifurcations

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Elevated Fasting Glucose and C-Reactive Protein Levels Predict Increased All-Cause Mortality after Elective Transcatheter Aortic Valve Implantation

Surgical aortic valve replacement in the elderly is now being supplanted by transcatheter aortic valve implantation (TAVI). Scoring systems to predict survival after catheter-based procedures are understudied. Both diabetes (DM) and underlying inflammatory conditions are common in patients undergoing TAVI, but their impact remains understudied in this patient group. We examined 560 consecutive TAVI procedures and identified eight pre-procedural factors: age, body mass index (BMI), DM, fasting blood glucose (BG), left-ventricular ejection fraction (EF), aortic valve (AV) mean gradient, C-reactive protein levels, and serum creatinine levels and studied their impact on survival. The overall mortality rate at 30 days, 1 year and 2 years were 5.2%, 16.6%, and 34.3%, respectively. All-cause mortality was higher in patients with DM (at 30 days: 8.9% vs. 3.1%, p = 0.008; at 1 year: 19.7% vs. 14.9%, p = 0.323; at 2 years: 37.9% vs. 32.2%, p = 0.304). The presence of DM was independently associated with increased 30-day mortality (hazard ratio [HR] 5.38, 95% confidence interval [CI], 1.24–23.25, p = 0.024). BG levels within 7–11, 1 mmol/L portended an increased risk for 30-day and 2-year mortality compared to normal BG (p = 0.001 and p = 0.027). For each 1 mmol/L increase in BG 30-day mortality increased (HR 1.21, 95% CI, 1.04–1.41, p = 0.015). Reduced EF and elevated CRP were each associated with increased 2-year mortality (p = 0.042 and p = 0.003). DM, elevated BG, reduced EF, and elevated baseline CRP levels each are independent predictors of short- and long-term mortality following TAVI. These easily accessible screening parameters should be integrated into risk-assessment tools for catheter-based aortic valve replacement candidates

Short- and Medium-Term Outcomes Comparison of Native- and Valve-in-Valve TAVI Procedures

Background: In high-risk patients with degenerated aortic bioprostheses, valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) has emerged as a less invasive alternative to surgical valve replacement. To compare outcomes of ViV and native valve (NV) TAVI procedures. Methods: 34 aortic ViV-TAVI performed between 2012 and 2022 using self-expanding valves, were included in this retrospective analysis. Propensity score matching (1:2 ratio, 19 criteria) was used to select a comparison NV-TAVI group from a database of 1206 TAVI procedures. Clinical and echocardiographic endpoints, short- and long-term all-cause mortality (ACM) and cardiovascular mortality (CVM) data were obtained. Subgroup analyses were completed according to the true internal diameter, dividing patients into a small (≤19 mm) valve group (SVG) and a large (>19 mm) valve group (LVG). Results: Clinical outcomes of ViV- and NV-TAVI were comparable, including device success [88.2% vs. 91.1%, p = 0.727], major adverse cardiovascular and cerebrovascular events [5.8% vs. 5.8%, p = 1.000], hemodialysis need [5.8% vs. 2.9%, p = 0.599], pacemaker need [2.9% vs. 11.7%, p = 0.265], major vascular complications [2.9% vs. 1.4%, p = 1.000], life-threatening or major bleeding [2.9% vs. 1.4%, p = 1.000] and in-hospital mortality [8.8% vs. 5.9%, p = 0.556]. There was a significant difference in the immediate post-intervention mean residual aortic valve gradient (MAVG) [14.6 ± 8.5 mm Hg vs. 6.4 ± 4.5 mm Hg, p < 0.0001], which persisted at 1 year [p = 0.0002]. There were no differences in 12- or 30-month ACM [11.8% vs. 8.8%, p = 0.588; 23.5% vs. 27.9%, p = 0.948], and CVM [11.8% vs. 7.3%, p = 0.441; 23.5% vs. 16.2%, p = 0.239]. Lastly, there was no difference in CVM at 1 year and 30 months [11.1% vs. 12.5%, p = 0.889; 22.2% vs. 25.0%, p = 0.742]. Conclusions: Analyzing a limited group (n = 34) of ViV-TAVI procedures out of 1206 TAVIs done at a single institution, ViV-TAVI appeared to be an acceptable approach in patients not deemed appropriate candidates for redo valve replacement surgery. Clinical outcomes of ViV-TAVI were comparable to TAVI for native valve stenosis

Remote ischaemic postconditioning protects the heart during acute myocardial infarction in pigs

Ischaemic preconditioning results in a reduction in ischaemic-reperfusion injury to the heart. This beneficial effect is seen both with direct local preconditioning of the myocardium and with remote preconditioning of easily accessible distant non-vital limb tissue. Ischaemic postconditioning with a comparable sequence of brief periods of local ischaemia, when applied immediately after the ischaemic insult, confers benefits similar to preconditioning

Comparative Methodological Assessment of the Randomized GLOBAL LEADERS Trial Using Total Ischemic and Bleeding Events

BACKGROUND Time-to-first-event analysis considers only the first event irrespective of its severity. There are several methods to assess trial outcomes beyond time-to-first-event analysis, such as analyzing total events and ranking outcomes. In the GLOBAL LEADERS study, time-to-first-event analysis did not show superiority of ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention to conventional 12-month DAPT followed by aspirin monotherapy in the reduction of the primary composite end point of all-cause mortality or new Q-wave myocardial infarction. This study sought to explore various analytical approaches in assessing total ischemic and bleeding events after percutaneous coronary intervention in the GLOBAL LEADERS study. METHODS AND RESULTS Total ischemic and bleeding events were defined as all-cause mortality, any stroke, any myocardial infarction, any revascularization, or Bleeding Academic Research Consortium grade 2 or 3 bleeding. We used various analytical approaches to analyze the benefit of ticagrelor monotherapy over conventional DAPT. For ischemic and bleeding events at 2 years after percutaneous coronary intervention, ticagrelor monotherapy demonstrated a 6% risk reduction, compared with conventional 12-month DAPT in time-to-first-event analysis (hazard ratio, 0.94 [95% CI, 0.88-1.01]; log-rank P=0.10). In win ratio analysis, win ratio was 1.05 (95% CI, 0.97-1.13; P=0.20). Negative binomial regression and Andersen-Gill analyses which include repeated events showed statistically significant advantage for ticagrelor monotherapy (rate ratio, 0.92 [95% CI, 0.85-0.99; P=0.020] and hazard ratio, 0.92 [95% CI, 0.85-0.99; P=0.028], respectively), although in weighted composite end point analysis, the hazard ratio was 0.93 (95% CI, 0.84-1.04; log-rank P=0.22). CONCLUSIONS Statistical analyses considering repeated events or event severity showed that ticagrelor monotherapy consistently reduced ischemic and bleeding events by 5% to 8%, compared with conventional 1-year DAPT. Applying multiple statistical methods could emphasize the multiple facets of a trial and result in accurate and more appropriate analyses. Considering the recurrence of ischemic and bleeding events, ticagrelor monotherapy appeared to be beneficial after percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435

Comparative Methodological Assessment of the Randomized GLOBAL LEADERS Trial Using Total Ischemic and Bleeding Events

BACKGROUND Time-to-first-event analysis considers only the first event irrespective of its severity. There are several methods to assess trial outcomes beyond time-to-first-event analysis, such as analyzing total events and ranking outcomes. In the GLOBAL LEADERS study, time-to-first-event analysis did not show superiority of ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention to conventional 12-month DAPT followed by aspirin monotherapy in the reduction of the primary composite end point of all-cause mortality or new Q-wave myocardial infarction. This study sought to explore various analytical approaches in assessing total ischemic and bleeding events after percutaneous coronary intervention in the GLOBAL LEADERS study. METHODS AND RESULTS Total ischemic and bleeding events were defined as all-cause mortality, any stroke, any myocardial infarction, any revascularization, or Bleeding Academic Research Consortium grade 2 or 3 bleeding. We used various analytical approaches to analyze the benefit of ticagrelor monotherapy over conventional DAPT. For ischemic and bleeding events at 2 years after percutaneous coronary intervention, ticagrelor monotherapy demonstrated a 6% risk reduction, compared with conventional 12-month DAPT in time-to-first-event analysis (hazard ratio, 0.94 [95% CI, 0.88-1.01]; log-rank P=0.10). In win ratio analysis, win ratio was 1.05 (95% CI, 0.97-1.13; P=0.20). Negative binomial regression and Andersen-Gill analyses which include repeated events showed statistically significant advantage for ticagrelor monotherapy (rate ratio, 0.92 [95% CI, 0.85-0.99; P=0.020] and hazard ratio, 0.92 [95% CI, 0.85-0.99; P=0.028], respectively), although in weighted composite end point analysis, the hazard ratio was 0.93 (95% CI, 0.84-1.04; log-rank P=0.22). CONCLUSIONS Statistical analyses considering repeated events or event severity showed that ticagrelor monotherapy consistently reduced ischemic and bleeding events by 5% to 8%, compared with conventional 1-year DAPT. Applying multiple statistical methods could emphasize the multiple facets of a trial and result in accurate and more appropriate analyses. Considering the recurrence of ischemic and bleeding events, ticagrelor monotherapy appeared to be beneficial after percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435