Clinical end points in coronary stent trials: a case for standardized definitions.
ABSTRACT Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation.
The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in Washington, DC, in January 2006 and in Dublin, Ireland, in June 2006, sponsored by the Academic Research Consortium and including representatives of the US Food and Drug Administration and all device manufacturers who were working with the Food and Drug Administration on drug-eluting stent clinical trial programs, were focused on consensus end point definitions for drug-eluting stent evaluations. The effort was pursued with the objective to establish consistency among end point definitions and provide consensus recommendations. On the basis of considerations from historical legacy to key pathophysiological mechanisms and relevance to clinical interpretability, criteria for assessment of death, myocardial infarction, repeat revascularization, and stent thrombosis were developed. The broadly based consensus end point definitions in this document may be usefully applied or recognized for regulatory and clinical trial purposes.
Although consensus criteria will inevitably include certain arbitrary features, consensus criteria for clinical end points provide consistency across studies that can facilitate the evaluation of safety and effectiveness of these devices.
Article: Efficacy and safety of 12 versus 48 months of dual antiplatelet therapy after implantation of a drug-eluting stent: the OPTImal DUAL antiplatelet therapy (OPTIDUAL) trial: study protocol for a randomized controlled trial.[show abstract] [hide abstract]
ABSTRACT: BACKGROUND: Dual antiplatelet therapy with aspirin and thienopyridine is required after placement of coronary drug-eluting stents (DES) to prevent thrombotic complications. Current clinical guidelines recommend at least 6 to 12 months of treatment after a DES implantation, but it may be beneficial to apply dual antiplatelet therapy for a longer duration.Methods/design: The optimal dual antiplatelet therapy (OPTIDUAL) study aims to compare the benefits and risks of dual antiplatelet therapy applied for either 12 or 48 months. We will examine the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) in patients undergoing percutaneous coronary intervention with DES for the treatment of coronary lesions. The OPTIDUAL study is an open-label multicenter, randomized, national trial that will include 1,966 patients treated with DES. All patients will be treated with dual antiplatelet therapy for 12 months (+/- 3). Then, patients with no MACCE or major bleeding will be randomized to receive either 36 additional months of clopidogrel plus aspirin or aspirin only. The primary end-point is the combination of death from all causes, myocardial infarction, stroke and major bleeding. The secondary end points include the individual components of the primary end-point, stent thrombosis, repeat revascularization of the treated vessel and minor bleeding. DISCUSSION: This randomized trial is designed to assess the benefits and safety of 12 versus 48 months of dual antiplatelet therapy in patients that receive a DES. We aim to determine whether substantial prolongation of clopidogrel (a thienopyridine) after DES implantation offers an advantage over its discontinuation.Trial registration: ClinicalTrials.gov Identifier: NCT00822536.Trials 02/2013; 14(1):56. · 2.02 Impact Factor
Article: Trans-Radial versus Trans-Femoral Intervention for the Treatment of Coronary Bifurcations: Results from Coronary Bifurcation Stenting Registry.[show abstract] [hide abstract]
ABSTRACT: Trans-radial (TR) approach is increasingly recognized as an alternative to the routine use of trans-femoral (TF) approach. However, there are limited data comparing the outcomes of these two approaches for the treatment of coronary bifurcation lesions. We evaluated outcomes of TR and TF percutaneous coronary interventions (PCI) in this complex lesion. Procedural outcomes and clinical events were compared in 1,668 patients who underwent PCI for non-left main bifurcation lesions, according to the vascular approach, either TR (n = 503) or TF (n = 1,165). The primary outcome was major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) in all patients and in 424 propensity-score matched pairs of patients. There were no significant differences between TR and TF approaches for procedural success in the main vessel (99.6% vs 98.6%, P = 0.08) and side branches (62.6% vs 66.7%, P = 0.11). Over a mean follow-up of 22 months, cardiac death or MI (1.8% vs 2.2%, P = 0.45), TLR (4.0% vs 5.2%, P = 0.22), and MACE (5.2% vs 7.0%, P = 0.11) did not significantly differ between TR and TF groups, respectively. These results were consistent after propensity score-matched analysis. In conclusion, TR PCI is a feasible alternative approach to conventional TF approaches for bifurcation PCI (clinicaltrials.gov number: NCT00851526).Journal of Korean medical science 03/2013; 28(3):388-95. · 0.84 Impact Factor
Article: Seven-year clinical outcomes of sirolimus-eluting stent versus bare-metal stent: a matched analysis from a real world, single center registry.[show abstract] [hide abstract]
ABSTRACT: The aim of this study is to compare clinical outcomes for seven years, between sirolimus-eluting stent (SES) and bare metal stent (BMS). During the BMS and drug-eluting stent (DES) transition period (from April 2002 to April 2004), 434 consecutive patients with 482 lesions underwent percutaneous coronary intervention, using BMS or SES. Using propensity score matching, 186 patients with BMS and 166 patients with SES were selected. Seven year clinical outcomes of major adverse cardiac events (MACE), such as cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization (TVR), and angiographic definite stent thrombosis (ST) were compared. At one-year follow up, patients with SES showed significantly lower MACE (9.1% in BMS vs 3.0% in SES, P = 0.024). However, cumulative MACE for 7 yr was not significantly different between two groups (24.7% in BMS vs 17.4% in SES, P = 0.155). There was no significant difference in MI, TVR, death and ST. The TVR were gradually increased from 1 to 7 yr in SES, on the contrary to that of BMS. In conclusion, although SES showed better clinical outcomes in the early period after implantation, it did not show significant benefits in the long-term follow up, compared with that of BMS.Journal of Korean medical science 03/2013; 28(3):396-401. · 0.84 Impact Factor