raderie and esprit-de-corps.
On the other hand, he said, there are reasons
NOT to have a TAVR team: most patient decisions
have become straightforward; logistics are still an
issue; reimbursement for team services remains an
issue; and TAVR procedures are becoming singleoperator procedures.
Another recent article asked whether the emphasis
Bleeding Related to CABG – In TRITON-TIMI 38, 437 patients who received a thienopyridine
underwent CABG during the course of the study. The rate of CABG-related TIMI Major or
Minor bleeding was 14.1% for the Effient group and 4.5% in the clopidogrel group (see
Table 3). The higher risk for bleeding adverse reactions in patients treated with Effient
persisted up to 7 days from the most recent dose of study drug.
Table 3: CABG-Related Bleedinga (TRITON-TIMI 38)
Effient (%)
Clopidogrel (%)
(N=213)
(N=224)
TIMI Major or Minor bleeding
14.1
4.5
TIMI Major bleeding
11.3
3.6
Fatal
0.9
0
Reoperation
3.8
0.5
Transfusion of ≥5 units
6.6
2.2
Intracranial hemorrhage
0
0
TIMI Minor bleeding
2.8
0.9
a
Patients may be counted in more than one row.
Bleeding Reported as Adverse Reactions – Hemorrhagic events reported as adverse
reactions in TRITON-TIMI 38 were, for Effient and clopidogrel, respectively: epistaxis (6.2%,
3.3%), gastrointestinal hemorrhage (1.5%, 1.0%), hemoptysis (0.6%, 0.5%), subcutaneous
hematoma (0.5%, 0.2%), post-procedural hemorrhage (0.5%, 0.2%), retroperitoneal
hemorrhage (0.3%, 0.2%), pericardial effusion/hemorrhage/tamponade (0.3%, 0.2%), and
retinal hemorrhage (0.0%, 0.1%).
Malignancies: During TRITON-TIMI 38, newly-diagnosed malignancies were reported
in 1.6% and 1.2% of patients treated with prasugrel and clopidogrel, respectively. The
sites contributing to the differences were primarily colon and lung. In another Phase 3
clinical study of ACS patients not undergoing PCI, in which data for malignancies were
prospectively collected, newly-diagnosed malignancies were reported in 1.8% and 1.7% of
patients treated with prasugrel and clopidogrel, respectively. The site of malignancies
was balanced between treatment groups except for colorectal malignancies. The rates
of colorectal malignancies were 0.3% prasugrel, 0.1% clopidogrel and most were
detected during investigation of GI bleed or anemia. It is unclear if these observations
are causally-related, are the result of increased detection because of bleeding, or are
random occurrences.
Other Adverse Events: In TRITON-TIMI 38, common and other important non-hemorrhagic
adverse events were, for Effient and clopidogrel, respectively: severe thrombocytopenia
(0.06%, 0.04%), anemia (2.2%, 2.0%), abnormal hepatic function (0.22%, 0.27%), allergic
reactions (0.36%, 0.36%), and angioedema (0.06%, 0.04%). Table 4 summarizes the
adverse events reported by at least 2.5% of patients.
Table 4: Non-Hemorrhagic Treatment-Emergent Adverse Events Reported by at
Least 2.5% of Patients in Either Group
Hypertension
Hypercholesterolemia/Hyperlipidemia
Headache
Back pain
Dyspnea
Nausea
Dizziness
Cough
Hypotension
Fatigue
Non-cardiac chest pain
Atrial fibrillation
Bradycardia
Leukopenia (<4 x 109 WBC/L)
Rash
Pyrexia
Peripheral edema
Pain in extremity
Diarrhea
Effient (%)
(N=6741)
7.5
7.0
5.5
5.0
4.9
4.6
4.1
3.9
3.9
3.7
3.1
2.9
2.9
2.8
2.8
2.7
2.7
2.6
2.3
Clopidogrel (%)
(N=6716)
7.1
7.4
5.3
4.5
4.5
4.3
4.6
4.1
3.8
4.8
3.5
3.1
2.4
3.5
2.4
2.2
3.0
2.6
2.6
6.2 Postmarketing Experience: The following adverse reactions have been identified
during post approval use of Effient. Because these reactions are reported voluntarily from a
population of uncertain size, it is not a