Comparison of Effectiveness of Sirolimus-Eluting Stents Versus Bare Metal Stents for Percutaneous Coronary Intervention in Patients at High Risk for Coronary Restenosis or Clinical Adverse Events

doi:10.1016/j.amjcard.2005.01.096

The American Journal of Cardiology

Volume 95, Issue 12, 15 June 2005, Pages 1409-1414

https://doi.org/10.1016/j.amjcard.2005.01.096 Get rights and content

We evaluated the clinical effect of selective use of sirolimus-eluting stents (SESs) in real-world, high-risk patients. A total of 4,237 consecutive patients who underwent percutaneous coronary intervention (SES, n = 872, bare metal stents [BMSs], n = 3,365) was enrolled in a prospective regional survey. A prespecified high-risk subset of patients was selected on the basis of clinical and angiographic characteristics. A propensity score analysis was performed to compare patients who received SESs with those who received BMSs. Patients in the SES group more often had diabetes and more frequently had previous myocardial infarction or coronary revascularization, type C lesions, and multivessel procedures. Patients who presented with acute myocardial infarction were treated more often with BMSs. At 9 months, the use of SESs was associated with fewer major adverse cardiac events (death, myocardial infarction, or target lesion revascularization; hazard ratio 0.56, 95% confidence interval 0.37 to 0.85) and target lesion revascularizations (hazard ratio 0.43, 95% confidence interval 0.20 to 0.91). This decrease was more evident in a prespecified high-risk subgroup of patients (major adverse cardiac events, 8.0% SES vs 15.6% BMS, hazard ratio 0.45, 95% confidence interval 0.29 to 0.72). We conclude that selective SES use in real-world patients who have high-risk clinical and angiographic characteristics is associated with significant decreases in major adverse cardiac events and repeat revascularizations compared with BMS use.

Section snippets

Study design and patient population

Shortly after the marketing of the Cypher SES (Johnson & Johnson, Cordis Unit, Cordis Europa NV, Roden, The Netherlands) in Europe, the health care agency of Emilia-Romagna, an Italian region with 4 million residents, launched a Web-based registry named Registro Regionale Angioplastiche (REAL). Twelve public and private centers of interventional cardiology were asked to prospectively enter clinical and angiographic data of all procedures performed in the region. The REAL was launched on July 1,

Baseline and procedural characteristics

Baseline and procedural characteristics of the 4,237 patients who were eligible for the study are listed in TABLE 1, TABLE 2. Patients who received ≥1 SES were younger than patients in the BMS group. They more frequently had diabetes mellitus (25% vs 20%, p = 0.001), previous myocardial infarction, PCI, and coronary artery bypass surgery, and unstable angina at hospital admission (48% vs 41%, p = 0.0001). Conversely, acute myocardial infarction was more common in the BMS group (19% vs 9%, p

Discussion

In this study, we demonstrated that selective SES use in a real-world setting decreased the incidence of major adverse cardiac events by 44% and the need for further revascularization procedures by 57%. Thus, our study confirmed an association of SES use with a decrease in repeat interventions, although this effect seems less pronounced than the association observed in randomized, controlled trials.5, 6, 7 This difference could be explained by a number of factors, including the high-risk

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Inhaled corticosteroid/long-acting bronchodilator treatment mitigates STEMI clinical presentation in COPD patients
2018, European Journal of Internal Medicine
Citation Excerpt :
Here, we focused on 2032 patients with a COPD diagnosis before hospital admission for STEMI [6]. The REAL registry was previously described [19]. Briefly, it is a large prospective World Wide Web–based registry launched in July 2002 and designed to collect clinical and angiographic data on all consecutive PCIs performed in a 4-million-resident region of Italy.
Patients with myocardial infarction and concomitant COPD are at increased risk of poor clinical outcomes, including death, as compared to patients without COPD.
To investigate and compare the severity of the clinical presentation of ST-segment elevation myocardial infarction (STEMI) and of the short-(7 days) and long-term-(end of follow up) mortality in COPD patients treated with inhaled corticosteroids (ICS)/long-acting bronchodilator (LABD) - either long-acting beta2 agonist (LABA) or long-acting muscarinic antagonist (LAMA) - vs. any other inhaled treatments.
Data from the REAL (Registro Angioplastiche dell'Emilia-Romagna) Registry were obtained from a large prospective study population of 11,118 patients admitted to hospital for STEMI.
From January 2003 to June 2009 we identified 2032 COPD patients admitted to hospital for STEMI. Eight hundred and twenty (40%) COPD patients were on ICS/LABD treatment (of which 55% on ICS/LABA) prior to admission. After adjustment for potential confounding factors, ICS/LABD treatment before STEMI was an independent predictor of reduced risk of pulmonary oedema and cardiogenic shock (OR 0.5, 95%CI 0.3–0.72, p < 0.01; OR 0.7, 95%CI 0.4–0.9, p = 0.03, respectively). ICS/LABD treatment was associated to reduced 7-days mortality (OR 0.54, 95%CI 0.29–0.98, p = 0.045) compared to other inhaled regimens. ICS/LABD-treated did not affect long-term (median 4 years) mortality. After hospital discharge, the proportion of ICS/LABD treated patients decreased significantly at 6 months and afterwards after the STEMI episode.
Our data provide preliminary evidence that in COPD patients ICS/LABD treatment reduces the severity of STEMI acute-phase clinical manifestations compared to other inhaled treatments.
Review: The outcomes of different vessel diameter in patients receiving coronary artery stenting
2016, International Journal of Cardiology
Compared to bare metal stent (BMS) implantation, drug-eluting stents (DES) is significantly better in attenuating intimal hyperplasia and reducing the rate of revascularization. However, the requirement of prolonged dual antiplatelet therapy (DAPT) and the economic cost have been the major disadvantages of DES. Studies have shown that the use of DES in small vessels decrease revascularization rate, but the results in large vessels vary. Previous studies have shown that the extent of late loss is unrelated to vessel diameter, and that late loss is easily accommodated in large vessels, thus resulting in decreased clinical benefit of DES in this setting. No definite cut-off point value of the vessel size has yet been demonstrated. Series studies aimed at evaluating the clinical outcomes of DES versus BMS in large vessels, but their results have been controversial. In this review, we evaluate the latest studies on clinical outcomes for different vessel sizes and clinical conditions. Nonetheless, further large clinical trials are warranted to address the clinical results of newer stents in different size vessels, especially in large vessels.
Antithrombotic management and 1-year outcome of patients on oral anticoagulation undergoing coronary stent implantation (from the registro regionale angioplastiche Emilia-Romagna registry)
2012, American Journal of Cardiology
Citation Excerpt :
REAL is a large, dynamic, multicenter, regional registry of percutaneous coronary intervention, in which the clinical and procedural data of all consecutive patients who undergo percutaneous coronary intervention at 13 hospitals in the Italian region of Emilia-Romagna are continuously conveyed through an on-line database.10 REAL is based on current practice at each institution, and only written informed consent to percutaneous coronary intervention and continuous data collection are requested for inclusion.10 The study conformed to the principles outlined in the Declaration of Helsinki, and written informed consent was obtained from all participants.
Current recommendations for the antithrombotic management of patients receiving oral anticoagulation (OAC) who undergo percutaneous coronary intervention with stent implantation (PCI-S) are based on limited and relatively weak data. To broaden and strengthen available evidence, the management and 1-year outcomes of OAC patients who underwent PCI-S and were included in a prospective, multicenter registry from 2003 to 2007 were evaluated. Among the 632 patients receiving OAC, mostly because of atrial fibrillation (58%), who underwent PCI-S, mostly because of acute coronary syndromes (63%), dual-antiplatelet therapy with aspirin and clopidogrel was the most frequently prescribed at discharge (48%), followed by triple therapy with OAC, aspirin, and clopidogrel (32%) and OAC plus aspirin (18%). The choice of antithrombotic therapy largely matched the thromboembolic risk profiles of patients, with the prescription of regimens including OAC predicted by the presence of non-low-risk features. The cumulative 1-year occurrence of major adverse cardiovascular events was as high as 27% and was not significantly different among the 3 treatment groups. Stroke and stent thrombosis were limited to 2% and 3%, respectively, and although no significant differences were found among the 3 groups, stroke was 4 times less frequent when OAC, with either 1 or 2 antiplatelet agents, was administered. Major bleeding was also limited to 3%, with no significant differences among the 3 groups. In conclusion, these findings suggest overall real-world management of OAC patients who undergo PCI-S that is in accordance with their clinical risk profiles and give further support to the reported efficacy and safety of triple therapy for the optimal treatment of these patients.
Off-hour primary percutaneous coronary angioplasty does not affect outcome of patients with ST-segment elevation acute myocardial infarction treated within a regional network for reperfusion: The REAL (Registro Regionale Angioplastiche dell'Emilia-Romagna) registry
2011, JACC: Cardiovascular Interventions
Citation Excerpt :
This is a retrospective cohort study based on a prospective assembled Internet-based database, the REAL (Registro Regionale Angioplastiche dell'Emilia-Romagna) registry (13), as previously described (14).
This study aims to evaluate whether results of “off-hours” and “regular-hours” primary angioplasty (primary percutaneous coronary intervention [pPCI]) are comparable in an unselected population of patients with ST-segment elevation acute myocardial infarction treated within a regional network organization.
Conflicting results exist on the outcome of off-hours pPCI.
We analyzed in-hospital and 1-year cardiac mortality among 3,072 consecutive ST-segment elevation myocardial infarction (STEMI) patients treated with pPCI between January 1, 2004, and June 30, 2006, during regular-hours (weekdays 8:00 am to 8:00 pm) and off-hours (weekdays 8:01 pm to 7:59 am, weekends, and holidays) within the STEMI Network of the Italian Region Emilia-Romagna (28 hospitals: 19 spoke and 9 hub interventional centers).
Fifty-three percent of patients were treated off-hours. Baseline findings were comparable, although regular-hours patients were older and had more incidences of multivessel disease. Median pain-to-balloon (195 min, interquartile range [IQR]: 140 to 285 vs. 186 min, IQR: 130 to 280 min; p = 0.03) and door-to-balloon time (88 min, IQR: 60 to 122 vs. 77 min, IQR: 48 to 116 min; p < 0.0001) were longer for off-hours pPCI. However, unadjusted in-hospital (5.8% off-hours vs. 7.2% regular-hours, p = 0.11) and 1-year cardiac mortality (8.4% off-hours vs. 10.3% regular-hours, p = 0.08) were comparable. At multivariate analysis, off-hours pPCI did not predict an adverse outcome either for the overall population (odds ratio [OR]: 0.70, 95% confidence interval [CI]: 0.49 to 1.01) or for patients directly admitted to the interventional center (OR: 0.79, 95% CI: 0.52 to 1.20).
When pPCI is performed within an efficient STEMI network focused on reperfusion, the clinical effectiveness of either off-hours or regular-hours pPCI is comparable.
Long-term outcome after drug eluting stenting in patients with ST-segment Elevation Myocardial Infarction. Data from the REAL Registry
2010, International Journal of Cardiology
Citation Excerpt :
To elucidated both long-term safety and efficacy of DES during pPCI we used the data from the REAL (Registro Angioplastiche dell’Emilia-Romagna) registry, a large, real-world multicenter registry. The REAL registry has been described previously [7,10,11]. In this analysis, all consecutive patients with STEMI undergoing mechanical reperfusion have been considered.
The long-term safety and efficacy of drug eluting stents (DES) implanted during primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) is unclear. The purpose of this study was to compare the long-term outcome of STEMI patients undergoing primary PCI with DES vs. bare metal stent (BMS) implantation.
In the present analysis 4764 patients were enrolled (706, 15%, received DES). We assessed the cumulative incidence of major adverse cardiac events (MACE) and stent thrombosis (ST).
Overall, no significant difference emerged for the rates of death and reinfarction. DES implantation was associated to a reduction of target vessel revascularization (TVR) (HR 0.65, 95%CI 0.47–0.91; p = 0.01), leading to a MACE reduction (HR 0.7, 95%CI 0.56–0.86; p < 0.01). In particular, during the first 2 years we observed less adverse events in the DES group, mainly because of a lower TVR rate (TVR: HR 0.56, 95%CI 0.37–0.83, p < 0.01; MACE: HR 0.71, 95%CI 0.54–0.94, p = 0.01). On the contrary, during the third year, adverse events tended to be higher in the DES group. ST did not differ between DES and BMS groups (p = 0.6). No differences were observed between sirolimus eluting stents and paclitaxel eluting stents.
DES implantation during primary PCI is safe and associated with a significant TVR and MACE reduction in the first two years, whereas a trend to have more adverse events in the third year is observed. More data about long-term follow-up are needed to better evaluate both safety and efficacy of DES in the setting of STEMI.
Future outlook for drug eluting stents
2009, Drug-Device Combination Products: Delivery Technologies and Applications
This chapter provides an overview of drug eluting stents (DESs), discussing their evolution from bare metal stents. The chapter begins by addressing mechanisms of restenosis and various platforms for DES that has been developed before to overcome these complications. Also, the shortcoming of DES with respect to thrombosis has been critically reviewed, while providing an insight about the future of DES. The chapter also includes two sections discussing the biodegradable stent platform, and the prohealing approach that can improve the drug eluting stent technology.

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: This study was supported by the Agenzia Sanitaria Regionale of Emilia-Romagna, Bologna, Italy.

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Coronary artery diseaseComparison of Effectiveness of Sirolimus-Eluting Stents Versus Bare Metal Stents for Percutaneous Coronary Intervention in Patients at High Risk for Coronary Restenosis or Clinical Adverse Events

Section snippets

Study design and patient population

Baseline and procedural characteristics

Discussion

J Thorac Cardiovasc Surg

J Chron Dis

J Clin Epidemiol

Lancet

Coronary artery disease
Comparison of Effectiveness of Sirolimus-Eluting Stents Versus Bare Metal Stents for Percutaneous Coronary Intervention in Patients at High Risk for Coronary Restenosis or Clinical Adverse Events