Drug treatment before angioplasty or stent placement not beneficial for heart attack patients
EMBARGO: 00:01H (London time) Tuesday February 14, 2006. In North America the embargo lifts at 18:30H ET Monday February 13, 2006.A common practice for improving outcomes in patients with sudden heart attack actually offers no benefit and could cause harm, according to a review of randomised trials published online today (Tuesday February 14, 2006) by The Lancet.
Despite the lack of evidence for its safety and effectiveness, many doctors believe the practice of giving patients with sudden ST-elevation* heart attack drugs before undergoing emergency revascularisation procedures (angioplasty or stent placement**) improves outcome. However, preliminary studies have suggested this practice confers no benefit.
To investigate the effect of pre-intervention drug treatment, Ellen Keeley (University of Texas Southwestern Medical Center, Dallas, TX, USA) and colleagues reviewed data from 17 trials comparing the outcomes for ST-elevation heart attack patients assigned the drug based procedure before angioplasty/stent placement (2237) and those assigned angioplasty/stent placement alone (2267). The investigators found that more of the patients who received drugs prior to their intervention died than those who did not receive medication (106 versus 78). Pre-intervention drugs also increased the risk of non-fatal heart attack, bleeding, stroke, and the need for repeat revascularisation treatment. These increased rates were mainly seen when the pharmacological treatment was a drug that dissolved clots (thrombolytic therapy).
Dr Keeley states: "Drug facilitated angioplasty or stent placement offers no benefit over primary intervention in ST-elevation heart attack and should not be used outside the context of randomised controlled trials. Furthermore facilitated interventions with thrombolytic-based regimens should be avoided." (Quote by e-mail; not in paper)
In an accompanying Comment Drs. Gregg Stone (Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY, USA) and Bernard Gersh (Mayo Clinic, Rochester, MN, USA) state: "The results of this quantitative review are unequivocal and surprising: facilitated angioplasty compared with primary angioplasty alone, rather than saving lives as expected, results in an increase in mortality, along with greater rates of reinfarction, urgent repeat revascularisation, major bleeding, haemorrhagic stroke, and total stroke."
In a different trial (ASSENT-4), also published online today by The Lancet, FransVan de Werf (Gasthuisberg University Hospital, Leuven, Belgium) and colleagues looked at whether giving patients with ST-elevation heart attack the drug tenecteplase (TNKase) before a delayed angioplasty/stent placement would result in a better outcome than those receiving the delayed procedure alone. They found that a strategy of full-dose tenecteplase was associated with major adverse events when compared with angioplasty/stent placement alone and cannot be recommended.
Contact: Dr Ellen C Keeley, University of Texas Southwestern Medical Center, Division of Cardiology, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA. T) 214 590 8617 Ellen.Keeley@UTSouthwestern.edu
Professor Frans Van de Werf, Department of Cardiology, Gasthuisberg University Hospital, Herestaat 49. B-3000 Leuven, Belgium. T) +32 16 34 34 71 firstname.lastname@example.org
Comment: Dr Gregg W Stone, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY 10021, USA. T) 1-212-851-9304 email@example.com
Notes to editors:
*ST-elevation refers to elevated readings in an electrocardiogram.
**Angioplasty and stent placement are techniques that unblock narrowed coronary arteries without surgery.
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