The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System.

BACKGROUND: A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has issued multiple advisories regarding paclitaxel use. We analyzed how this controversy impacted device purchasing and related utilization patterns in the period immediately following publication of the meta-analysis. METHODS AND RESULTS: Ascension Healthcare System purchase data over a 14-month period were synthesized across centers for both paclitaxel and non-paclitaxel devices. A fixed-effects regression model and a binary regression model with facility-level controls were used to compare purchasing patterns before and after the meta-analysis. Purchase volumes of each paclitaxel device fell. Pooled purchase volumes of all paclitaxel devices decreased from a 14-month peak of 631 devices in October 2018 to a 14-month nadir of 359 devices in February 2019. An F-test comparing the pooled-month specific fixed effects for the months before vs after the publication of the meta-analysis has an F-statistic of 11.64, suggesting that average purchasing levels in the two periods are statistically different (P<.001). Utilization of non-paclitaxel devices did not decline. CONCLUSIONS: Purchase volumes of paclitaxel devices decreased immediately during the months following publication of the related meta-analysis. Total Ascension-wide paclitaxel device purchase volume in February 2019 demonstrated a 43.1% reduction from peak monthly purchase volume during the assessed period and a 32.5% reduction compared with November 2019, the last month preceding publication of the meta-analysis.

Presentation and therapy of spontaneous coronary artery dissection and comparisons of postpartum versus nonpostpartum cases.

Predisposing risk factors, clinical course, and prognosis of spontaneous coronary artery dissection (SCAD) remain poorly understood. We reviewed medical records and coronary angiograms of patients admitted to our institution with the diagnosis of SCAD from 1999 through 2010. A definite diagnosis of SCAD required the agreement of 2 blinded board-certified interventional cardiologists who reviewed all images separately. Baseline characteristics of patients (n = 23) included mean age 45 ± 11 years, female gender in all (100%), history of hypertension in 13 (57%), and postpartum in 7 (30%). Eleven (48%) had ST-segment elevation on initial electrocardiogram. SCAD involved the left main in 5 patients (21.7%), left anterior descending coronary artery in 16 (70%), left circumflex coronary artery in 8 (35%), and right coronary artery in 6 (26%). Four patients (17%) underwent coronary stenting and 6 (26%) required urgent bypass surgery. Comparison between postpartum and nonpostpartum patients revealed significant differences in mean peak troponin levels: 50 ± 34 ng/ml vs 21 ± 23, p = 0.04, mean left ventricular ejection fraction: 34 ± 6% vs 49 ± 9, p <0.01, proximal coronary segment distribution: 6 (86%) vs 3 (19%), p = 0.004, and left anterior descending coronary artery distribution: 7 (100%) vs 9 (56%), p = 0.04, respectively. Repeat coronary angiographies were performed in 11 patients (46%) during a mean follow-up of 39 ± 38 months and 10 (91%) were found to have healed SCAD, including those who had undergone bypass surgery. In conclusion, our patients with SCAD were characterized by female gender, absence of coronary risk factors, and a high rate of vascular healing without residual stenosis. Larger infarct was found in postpartum patients.

The pharmacodynamics of enoxaparin in percutaneous coronary intervention with precise rapid enoxaparin loading (PEPCI-PRE study).

OBJECTIVE: We evaluated the early pharmacodynamic profile of the combined 30 mg intravenous and 1 mg/kg subcutaneous enoxaparin loading utilized in the TIMI 11B and ExTRACT TIMI 25 trials. BACKGROUND: It has not been reported whether anti-Xa levels appropriate for percutaneous coronary intervention (PCI) can be reliably achieved within 2 h utilizing this regimen. METHODS: Twenty-six patients with acute coronary syndrome (ACS) treated with this regimen had anti-Xa levels measured at 5 min, 2, 4, 6 and 8 h. RESULTS: Seventy-six percent of patients had anti-Xa levels above 0.5 IU/ml at 5 min. Dose-response curves showed all patients to have anti-Xa levels above 0.5 IU/ml within 1 h. Anti-Xa remained in the targeted range for PCI (0.5 to 1.8 IU/ml) at 2, 4, 6 and 8 h in all patients. CONCLUSION: This regimen is well suited for ACS treatment with an invasive strategy, including the rapid transition to early and rescue PCI.