Abstract Background The benefits and risks of prolonged dual antiplatelet therapy may be different for patients with acute myocardial infarction (MI) compared with more stable presentations. ...Objectives This study sought to assess the benefits and risks of 30 versus 12 months of dual antiplatelet therapy among patients undergoing coronary stent implantation with and without MI. Methods The Dual Antiplatelet Therapy Study, a randomized double-blind, placebo-controlled trial, compared 30 versus 12 months of dual antiplatelet therapy after coronary stenting. The effect of continued thienopyridine on ischemic and bleeding events among patients initially presenting with versus without MI was assessed. The coprimary endpoints were definite or probable stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE). The primary safety endpoint was GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries) moderate or severe bleeding. Results Of 11,648 randomized patients (9,961 treated with drug-eluting stents, 1,687 with bare-metal stents), 30.7% presented with MI. Between 12 and 30 months, continued thienopyridine reduced stent thrombosis compared with placebo in patients with and without MI at presentation (MI group, 0.5% vs. 1.9%, p < 0.001; no MI group, 0.4% vs. 1.1%, p < 0.001; interaction p = 0.69). The reduction in MACCE for continued thienopyridine was greater for patients with MI (3.9% vs. 6.8%; p < 0.001) compared with those with no MI (4.4% vs. 5.3%; p = 0.08; interaction p = 0.03). In both groups, continued thienopyridine reduced MI (2.2% vs. 5.2%, p < 0.001 for MI; 2.1% vs. 3.5%, p < 0.001 for no MI; interaction p = 0.15) but increased bleeding (1.9% vs. 0.8%, p = 0.005 for MI; 2.6% vs. 1.7%, p = 0.007 for no MI; interaction p = 0.21). Conclusions Compared with 12 months of therapy, 30 months of dual antiplatelet therapy reduced the risk of stent thrombosis and MI in patients with and without MI, and increased bleeding. (The Dual Antiplatelet Therapy Study The DAPT Study; NCT00977938 )
Longest Available Clinical Outcomes After Drug-Eluting Stent Implantation for Unprotected Left Main Coronary Artery Disease: The DELFT (Drug Eluting stent for LeFT main) Registry Emanuele Meliga, ...Hector Manuel Garcia-Garcia, Marco Valgimigli, Alaide Chieffo, Giuseppe Biondi-Zoccai, Andrew O. Maree, Stephen Cook, Lindsay Reardon, Claudio Moretti, Stefano De Servi, Igor F. Palacios, Stephen Windecker, Antonio Colombo, Ron van Domburg, Imad Sheiban, Patrick W. Serruys We investigated the long-term safety and efficacy of percutaneous coronary intervention with drug-eluting stent (DES) implantation for unprotected left main coronary artery (ULMCA) disease in a population of 358 consecutive patients analyzed in 7 European and U.S. tertiary care centers. After 3 years, major adverse cardiovascular event-free survival in the whole population was 73.5%. Cardiac death occurred in 9.2% of patients and reinfarction, target lesion revascularization, and target vessel revascularization occurred in 8.6%, 5.8%, and 14.2% of patients, respectively. Routine DES implantation in ULMCA disease seems encouraging, with favorable long-term clinical results.
Abstract Objectives This study sought to assess the safety and effectiveness of the drug-filled stent (DFS) (Medtronic, Santa Rosa, California) in the treatment of patients with coronary artery ...disease. Background Polymer-free drug-eluting stents have the potential to improve clinical outcomes and facilitate shorter durations of dual antiplatelet therapy. The polymer-free DFS is made from a trilayered continuous wire with an outer cobalt chromium layer, a middle tantalum layer, and an inner lumen coated with sirolimus. Small laser-drilled holes on the abluminal stent surface control drug elution. Methods The RevElution trial enrolled 100 patients with de novo coronary lesions 2.25 to 3.50 mm in diameter and length ≤27 mm in 2 cohorts of 50 patients for angiographic, intravascular ultrasound, and clinical assessment at 9 or 24 months, with optical coherence tomography performed in a subset of 30 patients at each time period. The primary endpoint was angiographic in-stent late lumen loss at 9 months compared with Resolute zotarolimus-eluting stent (Medtronic) historical control data. Results Fifty patients with 56 lesions were treated with DFS in the 9-month cohort. In-stent late lumen loss was 0.26 ± 0.28 mm for DFS and 0.36 ± 0.52 mm for Resolute (pnoninferiority <0.001). The binary angiographic restenosis rate was 0%. Median stent strut coverage by optical coherence tomography was 91.4%, 95.6%, and 99.1% at 1, 3, and 9 months, respectively. One non–Q-wave myocardial infarction occurred, with a 9-month target lesion failure rate of 2.1%. No stent thrombosis occurred. Conclusions At 9 months, the polymer-free DFS was safe and effective with high rates of early strut coverage and noninferior late lumen loss compared to Resolute. (Medtronic RevElution Trial RevElution; NCT02480348 )
Thrombosis and Drug-Eluting Stents Holmes, David R., MD; Kereiakes, Dean J., MD; Laskey, Warren K., MD ...
Journal of the American College of Cardiology,
07/2007, Letnik:
50, Številka:
2
Journal Article
Recenzirano
Odprti dostop
Thrombosis and Drug-Eluting Stents: An Objective Appraisal David R. Holmes, MD, Dean J. Kereiakes, MD, Warren K. Laskey, MD, Antonio Colombo, MD, Stephen G. Ellis, MD, Timothy D. Henry, MD, Jeffrey ...J. Popma, MD, Patrick W. J. C. Serruys, MD, Takeshi Kimura, MD, David O. Williams, MD, Stephan Windecker, MD, Mitchell W. Krucoff, MD Stent thrombosis is an infrequent but severe complication of both bare-metal stents (BMS) and drug-eluting stents (DES). In randomized controlled trials, during 4-year follow-up there is no apparent difference in overall stent thrombosis frequency although the time course for occurrence appears to differ, with a relative numeric excess of thrombosis late after DES. Despite this imbalance, there are no differences in death or death and infarction between DES and BMS. Longer-term follow-up with these patients as well as larger angiographic and clinical subsets of patients who receive DES outside of randomized trials are required to fully study this issue.
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