Drug-Eluting Versus Bare-Metal Stents in Older Patients: A Meta-Analysis of Randomized Controlled Trials

BackgroundDespite the high prevalence of ischemic heart disease in older patients, there is a substantial lack of evidence to guide clinical decision-making in this population. Hence, we performed a meta-analysis to determine the safety and efficacy of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) versus bare-metal stents (BMS).MethodsElectronic databases were searched for randomized trials comparing DES with BMS in patients ≥70 years-old. The primary outcome was major adverse cardiovascular events (MACE). Secondary outcomes included different ischemic and bleeding events. Subgroup analyses for dual-antiplatelet therapy (DAPT) duration were conducted.ResultsWe included 7 trials with a total of 5449 patients. The use of DES compared with BMS was associated with a significant reduction in MACE (odds ratio [OR]:0.76; 95% confidence interval [CI]:0.62–0.93; P = 0.007) with no increased risk of bleeding events (OR: 1.07; 95% CI: 0.89–1.27; P = 0.48). However, longer duration of DAPT (>6 months) for the DES group increased bleeding events (OR: 1.52; 95% CI: 1.05–2.20; P = 0.03). In contrast, shorter DAPT showed persistent efficacy in reducing MACE in DES-treated patients with no increased bleeding events (OR: 0.72; 95% CI: 0.60–0.87; P < 0.01 and OR: 1.01; 95% CI: 0.84–1.22; P = 0.89, respectively).ConclusionsIn older patients who had undergone PCI, DES showed superior efficacy in reducing MACE with no increased risk of bleeding compared with BMS. Persistent MACE reduction was evident with shorter DAPT durations in DES-treated patients.SummaryThis meta-analysis of randomized clinical trials demonstrated that drug-eluting stents were associated with a significant reduction in major adverse cardiovascular events with no increased risk of bleeding compared with bare-metal stents. The risk of bleeding was high with longer dual antiplatelet therapy duration for patients who underwent DES placement. However, short duration of dual antiplatelet therapy substantially reduced major adverse cardiovascular events with no increased bleeding risk.     

Drug-Eluting Stents Versus Bare-Metal Stents in Patients With End-Stage Renal Disease

Background

The clinical outcomes of drug-eluting stents versus bare-metal stents in end-stage renal disease patients remains controversial.

Biodegradable Polymer Drug-Eluting Stents Versus Second-Generation Drug-Eluting Stents for Patients With Coronary Artery Disease: An Update Meta-Analysis

Objective

Permanent polymer drug-eluting stents (DES) are associated with a higher risk of late and very late stent thrombosis (ST); biodegradable polymer drug-eluting stents (BP-DES) were designed to reduce these risks. However, their benefits are not completely clear.

Method

We undertook a meta-analysis of randomized studies identified in systematic searches of MEDLINE, EMBASE, and the Cochrane Database. Eligible studies were those that compared BP-DES with second-generation permanent polymer DES in patients undergoing percutaneous coronary intervention.

Results

Five studies (8,740 patients) with a mean follow-up of 19.2 months were included. Overall, BP-DES were associated with a broadly equivalent risk of definite and probable ST (odds ratio [OR], 1.07; 95 % confidence interval [CI], 0.67 to 1.71; P?=?0.76; I ²?=?5.0 %), target vessel revascularization (OR, 1.04; 95 % CI, 0.87 to 1.24; P?=?0.68; I ²?=?38.0 %), all-cause mortality (OR, 1.10; 95 % CI, 0.87 to 1.41; P?=?0.42; I ²?=?0.0 %), and major adverse cardiac events (OR, 1.03; 95 % CI, 0.88 to 1.20; P?=?0.74; I ²?=?0.0 %) when compared with second-generation DES. However, BP-DES significantly decreased in-stent late luminal loss (standard mean difference [SMD], ?0.01; 95 % CI, ?0.12 to 0.11; P?=?0.93; I ²?=?0.0 %) and in-segment late luminal loss (SMD, ?0.06; 95 % CI, ?0.17 to 0.05; P?=?0.27; I ²?=?0.0 %) compared with second-generation DES.

Conclusions

Compared with second-generation permanent polymer DES, biodegradable stents appear to have equivalent short- to medium-term clinical benefits, and it remains unclear whether they reduce the incidence of very late ST.     

Stent Thrombosis in Drug-Eluting or Bare-Metal Stents in Patients Receiving Dual Antiplatelet Therapy

ObjectivesThis study sought to compare rates of stent thrombosis and major adverse cardiac and cerebrovascular events (MACCE) (composite of death, myocardial infarction, or stroke) after coronary stenting with drug-eluting stents (DES) versus bare-metal stents (BMS) in patients who participated in the DAPT (Dual Antiplatelet Therapy) study, an international multicenter randomized trial comparing 30 versus 12 months of dual antiplatelet therapy in subjects undergoing coronary stenting with either DES or BMS.BackgroundDespite antirestenotic efficacy of coronary DES compared with BMS, the relative risk of stent thrombosis and adverse cardiovascular events is unclear. Many clinicians perceive BMS to be associated with fewer adverse ischemic events and to require shorter-duration dual antiplatelet therapy than DES.MethodsProspective propensity-matched analysis of subjects enrolled into a randomized trial of dual antiplatelet therapy duration was performed. DES- and BMS-treated subjects were propensity-score matched in a many-to-one fashion. The study design was observational for all subjects 0 to 12 months following stenting. A subset of eligible subjects without major ischemic or bleeding events were randomized at 12 months to continued thienopyridine versus placebo; all subjects were followed through 33 months.ResultsAmong 10,026 propensity-matched subjects, DES-treated subjects (n = 8,308) had a lower rate of stent thrombosis through 33 months compared with BMS-treated subjects (n = 1,718, 1.7% vs. 2.6%; weighted risk difference −1.1%, p = 0.01) and a noninferior rate of MACCE (11.4% vs. 13.2%, respectively, weighted risk difference −1.8%, p = 0.053, noninferiority p < 0.001).ConclusionsDES-treated subjects have long-term rates of stent thrombosis that are lower than BMS-treated subjects. (The Dual Antiplatelet Therapy Study [DAPT study]; NCT00977938)     

Drug-Eluting Stents in the Elderly

The introduction of drug-eluting stents (DES) in 2003 has had a great impact on the management of coronary artery disease in the United States. The application of DES to older adults, the population with the highest prevalence of and worst prognosis for coronary artery disease, remains relatively more controversial. Dual-antiplatelet therapy, which is recommended for at least 12 months after DES placement, is particularly problematic for older patients because of greater age-related bleeding risks. Unfortunately, few current data are available to gauge the balance of risk and benefit in elderly community-dwelling DES patients. Although trial data show a benefit for DES among elderly patients, many older adults typically are excluded from randomized trials because of comorbidities, making generalizability of DES safety based on trial data less certain. New, more potent thienopyridines may place the elderly at a particularly elevated bleeding risk. There is a fine balance between efficacy and safety for older DES patients that still needs to be clarified. As the population ages, these issues become more pervasive and of widespread concern. This review summarizes the current literature on DES therapy in the elderly, with a focus on effectiveness and safety profiles of DES versus bare metal stents.     

Complications and Survival After Surgery for Rectal Cancer in Patients Younger Than and Aged 75 Years or Older

PURPOSE: An increasing number of rectal cancer patients are elderly and have comorbid medical diseases. This study was designed to compare perioperative morbidity, mortality, and survival after surgery for rectal cancer in patients younger than and aged 75 years or older.METHODS: Between 1980 and 1997, 294 patients with rectal cancer were admitted to the Fourth Department of Surgery, Helsinki University Central Hospital. Of these, 95 (32 percent) were aged 75 or older and comprise the elderly group.RESULTS: Major curative operation was possible in 59 of 95 patients in the elderly group and in 147 of 199 patients in the younger age group. Among those operated on with curative intent, 20 of 59 patients (34 percent) in the older age group and 39 of 147 patients (27 percent) in the younger age group had complications (P = 0.31). Thirty-day mortality was 2 percent (n = 1) and 0, respectively. Although five-year crude survival was significantly lower in the older age group (43 vs. 65 percent, P = 0.01), five-year cancer-specific survival (60 vs.70 percent, P = 0.6) and disease-free, five-year survival (60 vs. 69 percent, P = 0.4) were similar in both groups. Patients (n = 17) treated with local excision had a cancer-specific survival of 81 and 83 percent in younger and older age groups, respectively. After palliative resection, the two-year survival was similar (20 vs. 24 percent) in both age groups. Ten elderly patients (11 percent) were not operated on at all in contrast to two patients (1 percent) younger than aged 75 years (P = 0.003).CONCLUSIONS: Major, curative, rectal cancer surgery in selected elderly patients can be performed with similar indications, perioperative morbidity, and mortality, as well as five-year, cancer-specific and disease-free survival as in younger patients.Presented at the meeting of the Finnish Surgical Society, Helsinki, Finland, December 20 to 22, 2002.Reprints are not available.     

Lessons from the Unrestricted Use of Drug-Eluting Stents: Insights from the RESEARCH and T-SEARCH Registry

Drug-eluting stents have raised the current interventional practice to a new and higher level. With the commercializa-tion of sirolimus-and paclitaxel-eluting stents in 2002 and 2003 respectively, the range of applications for coronarystenting expanded. The growing confidence in these drug-eluting devices is based on their capability to reducerestenosis when compared to bare metal stents. We performed two prospective cohort studies, namely the RESEARCH and T-SEARCH registries, to evaluate the safety and efficacy of both the types of drug-eluting stents in a "real world," unselected patient population, in which they were used in almost every type of coronary lesion. In specifichigh-risk subsets, the use of sirolimus eluting stent was associated with a better outcome in terms of major adversecardiac events compared to bare metal stents. The T-SEARCH registry did not show a difference in clinical outcomebetween both devices up to two years. It is still a topic of debate in some countries whether this new technology shouldbecome a standard treatment because of the associated higher costs.     

Long-term clinical outcomes of the Drug-Eluting Stents in the Real World (DESIRE) Registry

Background: Recently, cardiologists have treated more complex patients and lesions with drug-eluting stents (DES). However, long-term efficacy and safety of the off-label use of these new devices is yet to be demonstrated.
Methods: The Drug-Eluting Stents in the Real World (DESIRE) registry is a prospective, nonrandomized single-center registry with consecutive patients treated solely with DES between May 2002 and May 2007. The primary end-point was long-term occurrence of major adverse cardiac events (MACE). Patients were clinically evaluated at 1, 3, and 6 months and then annually up to 5 years.
Results: A total of 2,084 patients (2,864 lesions and 3,120 DES) were included. The mean age was 63.8 ± 11.5 years. Diabetes was detected in 28.9% and 40.7% presented with acute coronary syndrome. Cypher™ was the predominant DES in this registry (83.5%). Mean follow-up time was 2.6 ± 1.2 years and was obtained in 96.5% of the eligible patients. Target lesion revascularization (TLR) was performed in 3.3% of the patients. Q wave myocardial infarction (MI) occurred in only 0.7% of these patients and total stent thrombosis rate was 1.6% (n = 33). Independent predictors of thrombosis were PCI in the setting of MI (HR 11.2; 95% CI, 9.6–12.4, P = 0.001), lesion length (HR 4.6; 95% CI, 3.2–5.3, P = 0.031), moderate to severe calcification at lesion site (HR 13.1; 95% CI, 12.1–16.7, P < 0.001), and in-stent residual stenosis (HR 14.5; 95% CI, 10.2–17.6, P < 0.001).
Conclusion: The use of DES in unselected population is associated with long-term safety and effectiveness with acceptable low rates of adverse clinical events.     

Bare-Metal Stents Versus Drug-Eluting Stents for Primary Angioplasty: Long-Term Outcome

Percutaneous transluminal coronary intervention (PCI) is the most used myocardial revascularization technique for patients with coronary artery disease. Primary PCI with stent implantation is widely considered the gold standard for the treatment of ST-elevation myocardial infarction patients. Coronary stents, compared with balloon angioplasty, have reduced focal lesion restenosis. To reduce in-stent restenosis, drug-eluting stents (DES) were designed to locally release drugs inhibiting neointimal growth. Recent concerns have emerged on the potential higher risk of stent thrombosis with DES that might be even more pronounced among myocardial infarction patients. For these reasons, DES for primary PCI remains an “off-label” use. In the last several years, a number of randomized trials and registries have tested the safety and efficacy of DES in primary PCI. Data from these studies were analyzed in several meta-analyses, reasonably consistently demonstrating that the use of DES significantly decreased the need for revascularization without an increase in the incidence of death, recurrent infarction, or stent thrombosis at long-term follow-up.