Long-Term Safety and Efficacy of Drug-Eluting Stents

Marzocchi, Antonío; Saia, Francesco; Piovaccari, Giancarlo; Manari, Antonio; Aurier, E; Benassi, Alberto; Cremonesi, Alberto; Percoco, Gianfranco; Varani, Elisabetta; Magnavacchi, Paolo; Guastaroba, Paolo; Grilli, Roberto; Maresta, A

doi:10.1161/circulationaha.106.667592

Cited by 136 publications

(22 citation statements)

References 39 publications

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“…11,12,34 Our findings build on the results of more recent studies, some of which included patients in usual-care settings or had longer follow-up, or both. 5,21,[23][24][25][26]35 Despite recent concerns about the safety of drug-eluting stents, we did not detect an overwhelming increase in the risk of death among patients who received this type of stent. Also, we did not observe any notable survival drops or clusters of deaths, particularly when the survival of patients with drug-eluting stents was juxtaposed with that of patients with bare-metal stents.…”

Section: Discussionmentioning

confidence: 77%

Long-term outcomes of patients receiving drug-eluting stents

Philpott¹,

Southern²,

Clement³

et al. 2009

Canadian Medical Association Journal

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D rug-eluting stents now comprise at least 85% of stents used in the United States and up to 40% or more of stents elsewhere. The overwhelming worldwide use of drug-eluting stents has, however, been tempered by the cost differential to bare-metal stents, the lack of data on long-term outcomes in large patient populations and, more recently, emerging concerns about safety because of reports of late thrombosis. [1][2][3][4][5][6][7][8] The use of stents has been shown to reduce the rates of repeat revascularization and restenosis after angioplasty compared with angioplasty alone. 9 Despite this, the long-term efficacy of stent use has been limited by the need for repeat revascularization owing to restenosis.10 Drug-eluting stents were developed to address this problem. Both clinical trials [11][12][13][14][15][16][17][18][19][20] and registry data [21][22][23][24][25] have shown reduced rates of restenosis with drug-eluting stents up to 4 years after implantation. This advantage appears to extend to patients with acute coronary syndromes: a recent 2-year follow-up study involving 7217 patients with acute coronary syndromes suggested that rates of death were lower among patients with drugeluting stents than among those with bare-metal stents. 26 The possibility of late thrombosis associated with drug-eluting stents is, however, a concern. Rates of late thrombosis have been reported to be 3.6-5.9 events per 1000 patients receiving drug-eluting stents. 27 This adverse event has been the subject of a review by the US Food and Drug Administration and has captured the attention of authoritative bodies around the world.Because of concerns about the long-term safety of drugeluting stents, we compared the rates of death and of death or repeat revascularization over 3 years among patients who received either bare-metal or drug-eluting stents during angioplasty. Methods Study design and patient populationWe assembled a prospective cohort of all patients undergoing percutaneous coronary intervention with either bare-metal or Long-term outcomes of patients receiving drug-eluting stentsFrom the Department of Medicine (Philpott, Galbraith, Traboulsi, Knudtson, Ghali) and the Department of Community Health Sciences, Centre for Health and Policy Studies (Southern, Clement, Ghali), University of Calgary, Calgary, Alta. CMAJ ResearchBackground: We sought to establish the long-term safety of drug-eluting stents compared with bare-metal stents in a usual care setting. Methods:Using data from a prospective multicentre registry, we compared rates of death and of death or repeat revascularization during 3 years of follow-up of 6440 consecutive patients who underwent angioplasty with either drug-eluting or bare-metal stents between Apr. 1, 2003, and Mar. 31, 2006.Results: Drug-eluting stents were inserted in 1120 patients and bare-metal stents in 5320. The drug-eluting stents were selected for patients who had a greater burden of comorbid illness, including diabetes mellitus (32.8% v. 20.8% in the bare-metal group, p < 0.001) and rena...

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Section: Discussionmentioning

confidence: 77%

Long-term outcomes of patients receiving drug-eluting stents

Philpott¹,

Southern²,

Clement³

et al. 2009

Canadian Medical Association Journal

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“…Interestingly after an additional year of follow-up, providing a total of 13,786 DES and 21,480 BMS patients, there was no significant difference in mortality between the two groups (RR 1.03, 95% CI 0.94 to 1.14) 18 . Other large scale 'real-world' registries have similarly reported comparable or lower mortality between the two groups [19][20][21][22] . These 'real world' registries have also suggested that use of DES in more complex situations is not associated with adverse outcomes.…”

Section: The Real Risk Of Stent Thrombosis With Desmentioning

confidence: 77%

Os stents farmacológicos são seguros e eficazes em longo prazo?

Sastry¹,

Morice²

2010

Arq. Bras. Cardiol.

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“…[14][15][16] The presence of poor clinical conditions and shorter life expectancy might have impacted the choice of stent type, favoring the use of the fully reimbursed CCS rather than DES. The recommendations of longer use of clopidogrel for patients treated with DES, 17,18) and the possible higher bleeding risk in patients with renal failure or renal impairment, and other comorbidity associated with bleeding tendency might have influenced the physicians' choice of stent, again favoring CCS in such clinically worse patients.…”

Section: Discussionmentioning

confidence: 99%

Cobalt Chromium Coronary Stents and Drug-Eluting Stents in Real Practice

Youssef

Hussein²,

Hsueh

et al. 2010

Int. Heart J.

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SummaryCobalt chromium stents (CCS) are seldom compared to drug-eluting stents (DES) for coronary intervention in published clinical trials. We evaluated the daily usage patterns of CCS in comparison to DES unconstrained by eligibility criteria. We compared consecutive patients (n = 303) with de novo lesions treated exclusively with a CCS to 432 patients treated exclusively with a DES. Patients in the CCS group were older, frequently had heart failure, renal failure, prior coronary balloon angioplasty, prior stroke, more comorbidities, and more multivessel disease than the DES group. The DES group had longer and more type C and left anterior descending (LAD) coronary artery lesions. The in-hospital major adverse cardiac events (MACE; death, myocardial infarction, stroke and target lesion revascularization (TLR)) were similar. At 6 months, the cumulative rate of MACE was 12.9% in the CCS group and 5.6% in the DES group (P < 0.001), and this was driven by TLR. The rates of stent thrombosis were similar in CCS (0.9%) and DES (1.0%) patients.In conclusion, the CCS were used in clinically higher risk patients, while DES were used in more severely diseased coronary arteries. Drug-eluting stent use resulted in lower rates of clinically driven repeat revascularization with similar rates of death, MI, stroke, and stent thrombosis. (Int Heart J 2010; 51: 231-237) Key words: Stents, Cobalt chromium, Drug-eluting, Restenosis T he rates of restenosis and major adverse cardiac events (MACE) have both been demonstrated to be significantly reduced with the use of drug-eluting stents (DES) compared with bare-metal stents (BMS) in a broad variety of studies and trials.1-6) The same trials could not demonstrate any differences in mortality or acute myocardial infarction (AMI) rates. Therefore, the reported clinical benefit of DES is entirely due to the highly significant reduction in the need for repeated interventions. However, concerns about late events associated with DES have come to light, suggesting that the indiscriminate use of DES is actually not advisable. [7][8][9] Moreover, there is controversy regarding the advantage of using DES over BMS in terms of clinical outcome for short lesions and relatively large vessels (≥ 3.0 mm). 6) Also, exploring how physicians decide which stent category to use for different uncontrolled clinical and angiographic varieties, and how this impacts clinical outcome in real practice represents is important. And finally, in the majority of the randomized DES trials, the BMS used were not the most up-to-date in terms of stent design and technology. A study involving last-generation BMS, essentially cobalt chromium stents (CCS), showed lower revascularization rates. This famous randomized trial showed that the use of DES compared to CCS in all patients has no clinical benefit, including no significant difference in restenosis related target vessel revascularization. 10) However, data regarding such comparisons and the usage patterns in clinical settings are limited in the literature. . Subjects...

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Long-Term Safety and Efficacy of Drug-Eluting Stents

Cited by 136 publications

References 39 publications

Long-term outcomes of patients receiving drug-eluting stents

Long-term outcomes of patients receiving drug-eluting stents

Os stents farmacológicos são seguros e eficazes em longo prazo?

Cobalt Chromium Coronary Stents and Drug-Eluting Stents in Real Practice

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