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PCI-Clarity trial
Early use of clopidogrel, started prior to rather than at the time of angioplasty, reduces the risk of death, MI, or stroke by nearly half, reported Marc S. Sabatine, MD, MPH, lead investigator of PCI-CLARITY (Clopidogrel as Adjunctive Reperfusion Therapy).
Early use of clopidogrel, started prior to rather than at the time of angioplasty, reduces the risk of death, MI, or stroke by nearly half, reported Marc S. Sabatine, MD, MPH, lead investigator of PCI-CLARITY (Clopidogrel as Adjunctive Reperfusion Therapy). The results from PCI-CLARITY were presented at the European Society of Cardiology Congress 2005 in Stockholm, Sweden.
"For every 100 patients undergoing percutaneous coronary intervention (PCI), clopidogrel pretreatment prevented 4 major cardiovascular events," he said.
PCI-CLARITY is an offshoot of its parent trial, CLARITY, which was conducted in patients with ST-segment-elevation MI who received a fibrinolytic and were randomized on presentation to clopidogrel initiated with a 300-mg loading dose followed by 75 mg/d, or placebo for an average of 4 days, until coronary angiography. In CLARITY, significantly fewer patients assigned to clopidogrel had an occluded culprit artery or a recurrent MI or died compared with the control group (15.0% vs 21.7%; P=.00000036). The 30-day rate of cardiovascular death, MI, or reinfarction requiring urgent revascularization was reduced by 20% in the clopidogrel group (11.6% vs 14.1%, P=.026).
This primary outcome occurred in 3.6% of the clopidogrel recipients compared with 6.2% of the placebo recipients-a 46% relative reduction with early clopidogrel (P=.008). "The benefit of clopidogrel was consistent across all events constituting the primary end point," said Dr Sabatine, an associate physician in the cardiovascular division at Brigham and Women's Hospital, Boston, Mass.
The benefit of clopidogrel pretreatment was consistent regardless of the patient's age or gender and whether PCI was urgent or elective, whether GP IIb/IIIa blockers were administered, whether a loading dose was used at the time of PCI, or whether there was a delay until the procedure. There was no excess in minor or major bleeding with clopidogrel pretreatment.
Pretreatment reduced the risk of recurrent MI or stroke while awaiting PCI by 38% (P=.028).
FDA Approves Combination Therapy for Pulmonary Arterial Hypertension
March 25th 2024J&J’s Opsynvi is single-tablet combination of macitentan, an endothelin receptor antagonist, and tadalafil, a PDE5 inhibitor. It will be priced on parity with Opsumit, which is also a J&J product to treat patients with PAH.
FDA Issues Complete Response Letter for Onpattro in Heart Failure Indication
October 9th 2023Alnylam Pharmaceuticals will no longer pursue this indication of Onpattro and will instead on focus on a label expansion for Amvuttra, which is in phase 3 development to treat patients with cardiomyopathy of ATTR amyloidosis.
