Reply Waksman, Ron; Baker, Nevin C; Lhermusier, Thibault
The American journal of cardiology,
08/2015, Volume:
116, Issue:
3
Journal Article
Peer reviewed
In the case of cangrelor, further discussions between the Sponsor and the FDA led to a second panel on April 2015, which included the presentation of new data and additional sensitivity analyses from ...the Sponsor.3 In the April 2015 meeting, the FDA reviewers gave a favorable review and said that the agent could now be considered for approval "in patients in whom treatment with an oral P2Y12 platelet inhibitor before PCI is not feasible and when glycoprotein IIb/IIIa receptor antagonists are not anticipated to be used."
The aim of this network meta-analysis is to assess the impact of strut thickness on clinical outcomes in patients who underwent percutaneous coronary intervention. We searched Medline/PubMed and ...performed a Bayesian network meta-analysis to compare outcomes of patients who underwent percutaneous coronary intervention with drug-eluting stents (DES) of different strut thicknesses (ultrathin 60 to 80 μm; thin 81 to 100 μm; intermediate 101 to 120 μm; thick ≥120 μm). Studies comparing DES with similar strut thickness, bare metal stents, and fully bioresorbable scaffolds were excluded. Odds ratios with credible intervals (OR CrIs) were generated with random-effects models to compare outcomes. Our primary end point was stent thrombosis (ST). We identified 69 RCTs including 80,885 patients (ultrathin group = 10,219; thin group = 36,575; intermediate group = 11,399; thick group = 22,692). Mean age was 64 ± 11 years and 75% were male gender. When compared with thick-strut DES, ultrathin struts had significant less ST and myocardial infarction (OR 0.43 CrI 0.27 to 0.68; and OR 0.73 CrI 0.62 to 0.92, respectively). Sensitivity analysis including only studies with permanent polymer DES gave similar results. Improvement in DES technology with thinner struts is associated with significant reduction in ST and myocardial infarction compared with thicker struts.
The self-expanding CoreValve Evolut PRO/PRO+ transcatheter aortic valve was designed to overcome the limitations of its forerunner, Evolut R. Evolut PRO/PRO+ offers the lowest delivery profile for ...23–29 mm valves, with an external tissue wrap on all valve sizes. We compared safety and efficacy of Evolut PRO/PRO+ and Evolut R.
We analyzed 300 patients enrolled in the EPROMPT Registry against a historical control cohort of 242 patients who received Evolut R. The two arms were matched (1:1) via propensity-score methodology by accounting for differences in Society of Thoracic Surgeons Predicted Risk of Mortality scores, yielding 440 patients. The endpoints included in-hospital safety clinical outcomes, all-cause mortality, and echocardiographic parameters at 30 days and 1 year.
After propensity-score matching, cardiac death (0.5% vs. 0.5%, p = 0.995), stroke (1.6% vs. 2.8%, p = 0.410), life-threatening bleeding (1.1% vs. 3.3%, p = 0.139), major vascular complications (0.5% vs. 0.9%, p = 0.653), and pacemaker implantation (16.9% vs. 13.6%, p = 0.345) were comparable between the Evolut PRO/PRO+ and Evolut R groups. Likewise, the rates of all-cause mortality were similar both at 30 days (0.5% vs. 1.4%, p = 0.315) and 1 year (1.8% vs. 4.1%, p = 0.159). The rates of moderate paravalvular leak (5.7% vs. 2.6%, p = 0.402), and mean gradient (7.27 ± 3.25 mmHg vs. 8.84 ± 4.36 mmHg, p = 0.105) were also comparable between groups at 1 year.
Our largest-to-date observational study suggests that the Evolut PRO/PRO+ system is safe and effective in treating severe aortic stenosis, with commensurate 30-day and 1-year mortality and similar 1-year echocardiographic hemodynamic outcomes in comparison to Evolut R.
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•Evolut PRO/PRO+ valve was designed to improve upon Evolut R.•We compared safety and efficacy of the two valves.•Our study suggests Evolut PRO/PRO+ is safe and effective in treating severe AS.•Evolut PRO/PRO+ showed similar survival and hemodynamics compared to Evolut R.
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