Feasibility and safety of minimal-contrast IVUS-guided rotational atherectomy for complex calcified coronary artery disease.

OBJECTIVES: To assess the feasibility and safety of minimal-contrast percutaneous coronary intervention (PCI) using rotational atherectomy (RA) in patients with severe coronary calcification at high-risk of contrast-associated acute kidney injury (AKI). METHODS: Twenty-six patients with advanced chronic kidney disease undergoing PCI with RA at three high-volume centres were included. Baseline intravascular ultrasound (IVUS) was performed to assess lesion morphology, and to guide burr-, balloon-, and stent-selection. Final result was assessed by IVUS and angiographically. Feasibility and safety were determined by procedural and in-hospital complications, and efficacy was assessed by freedom from contrast-associated AKI after PCI. Procedural and in-hospital outcome was compared to a propensity-matched population of standard RA PCI. RESULTS: Mean glomerular filtration rate was 32 ± 17 ml/min/1.73 m2. In seven cases PCI was performed in the setting of acute coronary syndrome. The left main coronary artery was treated in 27.8% and a two-stent bifurcation technique in 44.4%. RA was more often performed electively compared to the standard RA cohort (92.3 vs. 50%; p = 0.0016). Angiographic success was achieved in 100% and documented with a median contrast amount of 12.5 ml [Range 4-43]. No in-hospital death or myocardial infarction was reported. Contrast-associated AKI occurred in one patient versus five patients in standard RA group (p = 0.19). Shorter fluoroscopy time and lower radiation dose were achieved as compared to standard RA. CONCLUSION: A minimal-contrast RA approach with IVUS-guidance for treatment of complex calcified coronary lesions is feasible and safe with high success rate.

Polymer-free drug-coated vs. bare-metal coronary stents in patients undergoing non-cardiac surgery: a subgroup analysis of the LEADERS FREE trial.

AIMS: To compare the outcomes of patients undergoing non-cardiac surgery (NCS) after PCI with either a drug-coated stent (DCS) or a bare-metal stent (BMS), followed by 1-month dual antiplatelet therapy and to explore the impact of the timing of NCS. METHODS: This is a subgroup analysis of the LEADERS FREE trial. The primary safety end point was a composite of cardiac death, myocardial infarction, or stent thrombosis, and the primary efficacy end point was clinically driven target lesion revascularization (TLR). RESULTS: Out of 2432 patients included in the LEADERS FREE trial, 278 (11.4%) underwent NCS within 1 year after PCI. Among NCS patients, the 1-year safety end point was numerically lower with DCS; however, this difference was not significant as compared to BMS (4.7% vs. 10.1%, HR: 0.459 [0.178-1.183], p = 0.099), clinically driven TLR was significantly lower after DCS (2.4% vs. 8.3%, HR: 0.281 [0.079-0.996], p = 0.036), and BARC 3-5 bleeding was similar with DCS vs. BMS (10.2% vs. 7.5%, p = 0.438). In patients treated with BMS, NCS within 3 months after PCI was associated with higher incidence of the safety end point than NCSs performed later: 14.9% vs. 4.4%, HR: 3.586 [1.012-12.709], p = 0.034. The timing of surgery had no impact on patients treated with DCS (4.7% vs. 4.7%, p = 0.947). CONCLUSIONS: Among patients undergoing NCS after PCI, DCS-treated patients had a lower probability of clinically driven TLR compared with BMS. However, there was no significant difference in the occurrence of the primary composite safety end point or bleeding complications. Early NCS after BMS-PCI was associated with impaired safety, while the timing of NCS had no such influence after DCS implantation.

Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes.

BACKGROUND: The relative merits of ticagrelor as compared with prasugrel in patients with acute coronary syndromes for whom invasive evaluation is planned are uncertain. METHODS: In this multicenter, randomized, open-label trial, we randomly assigned patients who presented with acute coronary syndromes and for whom invasive evaluation was planned to receive either ticagrelor or prasugrel. The primary end point was the composite of death, myocardial infarction, or stroke at 1 year. A major secondary end point (the safety end point) was bleeding. RESULTS: A total of 4018 patients underwent randomization. A primary end-point event occurred in 184 of 2012 patients (9.3%) in the ticagrelor group and in 137 of 2006 patients (6.9%) in the prasugrel group (hazard ratio, 1.36; 95% confidence interval [CI], 1.09 to 1.70; P = 0.006). The respective incidences of the individual components of the primary end point in the ticagrelor group and the prasugrel group were as follows: death, 4.5% and 3.7%; myocardial infarction, 4.8% and 3.0%; and stroke, 1.1% and 1.0%. Definite or probable stent thrombosis occurred in 1.3% of patients assigned to ticagrelor and 1.0% of patients assigned to prasugrel, and definite stent thrombosis occurred in 1.1% and 0.6%, respectively. Major bleeding (as defined by the Bleeding Academic Research Consortium scale) was observed in 5.4% of patients in the ticagrelor group and in 4.8% of patients in the prasugrel group (hazard ratio, 1.12; 95% CI, 0.83 to 1.51; P = 0.46). CONCLUSIONS: Among patients who presented with acute coronary syndromes with or without ST-segment elevation, the incidence of death, myocardial infarction, or stroke was significantly lower among those who received prasugrel than among those who received ticagrelor, and the incidence of major bleeding was not significantly different between the two groups. (Funded by the German Center for Cardiovascular Research and Deutsches Herzzentrum München; ISAR-REACT 5 ClinicalTrials.gov number, NCT01944800.).

Long-term durability and haemodynamic performance of a self-expanding transcatheter heart valve beyond five years after implantation: a prospective observational study applying the standardised definitions of structural deterioration and valve failure.

AIMS: Long-term results of transcatheter aortic valve implantation (TAVI), in particular the incidence of bioprosthetic valve failure (BVF), are uncertain. This study presents data derived from a long-term, structured follow-up programme of the self-expanding CoreValve device utilising standardised definitions and core lab adjudication of valve performance. METHODS AND RESULTS: The study prospectively included all 152 patients who had undergone TAVI with the self-expanding CoreValve up to December 2011 at the Heart Center, Bad Segeberg, Germany. Late BVF (>30 days) was defined as either: 1) severe structural valve deterioration (transprosthetic mean pressure gradient ≥40 mmHg and/or ≥20 mmHg rise from baseline OR severe intraprosthetic aortic regurgitation), OR 2) bioprosthetic valve dysfunction leading to death or reintervention. Echocardiographic follow-up at 6.3±1.0 years (range: 5.0-8.9 years) was 88% complete (60 out of 68 survivors beyond five years) and all echocardiograms were analysed by an independent core laboratory. The all-cause mortality rate at 1, 2, 5, 6, 7 and 8 years was 14%, 20%, 50%, 60%, 65%, and 73%, respectively. Among survivors beyond five years, effective orifice area was 1.60±0.46 cm2, and transvalvular mean pressure gradient was 6.7±3.1 mmHg; no cases showed evidence of structural valve deterioration. Five patients (3.3%) had undergone redo TAVI (n=4) or surgery (n=1) 0.6 to 5.2 years after the index procedure, all due to paravalvular leakage. The estimated rate of BVF at eight years was 7.9% for the actuarial and 4.5% for the actual analysis. CONCLUSIONS: Long-term follow-up up to 8.9 years after TAVI documents favourable performance of the self-expanding CoreValve with low rates of BVF.

Redo TAVI: initial experience at two German centres.

AIMS: The aim of this study was to assess the feasibility and early outcomes of transcatheter aortic valve implantation (TAVI) in dysfunctional TAVI prostheses (redo TAVI). METHODS AND RESULTS: Nineteen redo TAVI procedures were performed between October 2011 and November 2015 at two German centres. Mean age was 78 years, 13 (68%) were male, and the mean logistic EuroSCORE was 32%. Median time elapsed since index TAVI was 644 days (interquartile range 191-1,831). Failure mode of the index TAVI prosthesis was regurgitation (AR) in 16 patients (n=12 paravalvular AR, n=3 combined paravalvular/valvular AR, n=1 valvular AR) and stenosis in three patients. Device success was achieved in 89% (17/19). Median invasive post-interventional transprosthetic gradient was 3.0 mmHg. No severe prosthesis-patient mismatch (PPM) was observed. At one year, mean pressure gradient was 9±1.2 mmHg and no relevant PPM was documented in 90% of the cases. All-cause mortality at 30 days and one year was 11% and 33% (6/18, five non-cardiac deaths), respectively. Mean follow-up time was 404 days. CONCLUSIONS: Redo TAVI appears to be feasible. Paravalvular regurgitation was the most common indication for a redo procedure. Rates of device success were high with low post-interventional gradients and no severe PPM. Good functional status of the prosthesis was maintained after 12 months, but mortality rates were high in this small comorbid patient population.