Stents In Large Coronary Arteries Research Articles

One-Year clinical outcomes of drug-eluting stents versus bare-metal stents in large coronary arteries

Background: Drug-eluting stents (DESs) have been shown to reduce the risk of restenosis and other adverse cardiac events after percutaneous coronary intervention (PCI) as compared with bare-metal stents (BMSs). However, the superiority of DES over BMS has been questioned in large vessels. We evaluated the risks and benefits of the use of DES versus BMS in patients who undergo stenting of large coronary arteries (≥3.5 mm) up to 1-year follow-up. Materials and Methods: This was a prospective study carried out in all-comer patients enrolled between January 2015 and December 2015. The patients with the variable indication for PCI, multivessel involvement, prior revascularization, and adjuvant drugs such as GP IIb–IIIa inhibitors were included in the study. However, patients who did not provide written informed consent and received both DES and BMS were excluded from the study. The clinical outcomes were evaluated at 1 year. Results: A total of 266 lesions (240 patients) in the large coronary arteries were stented, of which 130 lesions were treated with BMS and 136 lesions were treated with DES. At 1-year follow-up, target lesion revascularization/target vessel revascularization (P = 0.6492) and all-cause death (P = 0.7098) did not differ significantly between the two groups. In addition, no significant difference was found in patients requiring medical management (P = 0.3937) as well as number of asymptomatic patients (P = 0.2027). Conclusions: At 1-year follow-up, BMSs and DESs showed similar clinical outcomes in large coronary arteries. Hence, the use of BMS in large coronary arteries (≥3.5 mm) should not be discouraged unless clinically indicated.

Do ultrathin strut bare-metal stents with passive coating improve efficacy in large coronary arteries? Insights from the randomized, multicenter BASKET-PROVE trials

BackgroundThe new generation thinner-strut silicon carbide (SiC) coated cobalt chromium (CoCr) bare-metal stents (BMS) are designed to accelerate rapid endothelialisation and reduce thrombogenicity when implanted in coronary arteries. However, smaller studies suggest higher rates of symptomatic restenosis in patients receiving the newer generation BMS.We investigated the efficacy of a newer generation ultrathin strut silicon-carbide coated cobalt-chromium (CoCr) BMS (SCC-BMS) as compared to an older thin-strut uncoated CoCr BMS (UC-BMS) in patients presenting with coronary artery disease requiring stenting of large vessels (≥3.0 mm).MethodsAll patients randomized to SCC- (n = 761) or UC-BMS (n = 765) in the two BASKET-PROVE trials were included. Design, patients, interventions and follow-up were similar between trials except differing regimens of dual antiplatelet therapy. The primary endpoint was clinically driven target-vessel revascularization within 24 months. Safety endpoints of cardiac death, non-fatal myocardial infarction (MI), and definite/probable stent thrombosis (ST) were also assessed. We used inverse probability weighted proportional hazards Cox regressions adjusting for known confounders.ResultsDemographics, clinical presentation, and risk factors were comparable between the groups, but patients receiving SCC-BMS underwent less complex procedures. The risk for clinically driven TVR was increased om the SCC-BMS group compared to the UC-BMS group (cumulative incidence, 10.6% vs. 8.4%; adjusted relative hazard [HR], 1.49 [95% CI, 1.05–2.10]). No differences in safety endpoints were detected, cardiac death (1.6% vs. 2.8%; HR, 0.62 [CI, 0.30–1.27]), non-fatal MI (3.2% vs. 2.5%; HR, 1.56 [CI, 0.83–2.91]), and definite/probable ST (0.8% vs. 1.1%; HR, 1.17 [CI, 0.39–3.50]). Differences in strut thickness between the two stents did not explain the association between stent type and clinically driven TVR.ConclusionsIn patients requiring stenting of large coronary arteries, use of the newer generation SCC-BMS was associated with a higher risk of clinically driven repeat revascularization compared to the UC-BMS with no signs of an offsetting safety benefit.

Drug-eluting stents in large coronary vessels improve both safety and efficacy compared with bare-metal stents in women: a pooled analysis of the BASKET-PROVE I and II trials

BackgroundDrug-eluting stents (DES) have proven superior to bare-metal stents (BMS) in terms of safety and efficacy. However, inference to the female subgroup has been limited by low enrolment rates of...

Predictors of major adverse cardiac events following elective stenting of large coronary arteries

ObjectiveDiameter of the affected coronary artery is an important predictor of restenosis and need for revascularization. In the present study, we investigated the frequency and potential risk factors for major adverse cardiac events following elective percutaneous coronary intervention (PCI) and stenting of large coronary arteries. MethodsWe reviewed the data of elective candidates of PCI on a large coronary artery who presented to our center. Demographic, clinical, angiographic and follow-up data of the eligible patients were retrieved from our databank. The study characteristics were then compared between the patients with and without MACE in order to find out the probable risk factors for MACE in patients with large stent diameter. ResultsData of 3043 patients who underwent single vessel elective PCI with a stent diameter of ≥3.5mm was reviewed. During a median follow up period of 14 months, 64 (2.1%) patients had MACE. TVR was the most common type of MACE that was observed in 29 patients, while 5 patients had cardiac death. Higher serum levels of creatinine, history of cerebrovascular accident (CVA), and use of a drug eluting stent (DES) were significantly associated with MACE. In the multivariate model, history of CVA (odds ratio=5.23, P=0.030) and use of DES (odds ratio=0.048, P=0.011) were the independent predictors of MACE in patients underwent large coronary artery stenting. ConclusionThis study showed that prior CVA and the use of BMS were the potential risk factors for MACE in patients who were stented on their large coronary arteries.

0234: Drug-eluting stents versus bare-metal stent in large coronary arteries

Although drug-eluting stents (DES) have been shown to dramatically reduce restenosis and improve the rate of event-free survival, the benefit of DES appears to be limited to restenosis. In this retrospective, single-center study we aimed to compare the long-term outcomes of DES versus bare-metal stent (BMS) in large coronary arteries (diameter ≥3.5mm). A total of 164 consecutive patients (mean age 60 years) required percutaneous coronary intervention with stents ≥3.5mm in diameter, 84 were BMS and 80 DES. The primary endpoint was major adverse cardiac events (MACE) defined as angiographically defined in-stent restenosis (ISR), stent thrombosis and death from any cause. A mean clinical follow up of 28 months was obtained. The DES group had higher rates of diabetes (63% vs 37%, p=0.001), previous CAD (74% vs 25%, p=0.001) and previous PCI (69% vs 31%, p=<0.04). There was no significant difference between the two groups regarding the rate of hyper-tension, dyslipidemia, smokers and the mean left ventricular ejection fraction. There was a higher average stent length in the DES group (18.7 vs 16.3, p=0.011) as well as a lower average stent diameter (3.54 vs 3.63, p=0.003). There was a significant difference in MACE between the two groups in favour of DES (11.3% DES vs 23.8% BMS group, p=0.04) at 28 months. The rate of in-stent restenosis (ISR) was significantly reduced among patients receiving DES with ISR rates of 15.8% among patients receiving DES compared to 41.7% among those receiving BMS (p=0.025). There were no significant differences in the rate of death or stent thrombosis. In patients requiring stenting of large coronary arteries, there was reduced MACE in patients treated with DES. This benefit was primarily driven by decreased in-stent restenosis rate.

Abstract 16776: Drug-eluting Stents in Large Coronary Vessels Improve Both Safety and Efficacy in Women Compared to Bare-metal Stents

Objectives: Drug-eluting stents (DES) are associated with lower rates of target vessel revascularization (TVR) compared with bare-metal stents (BMS), possibly with a particular benefit in women. Inferences on efficacy and safety of DES compared to BMS have been difficult to study in female subgroups as clinical trials often enroll a low proportion of women. Therefore we investigated the safety and efficacy of DES vs. BMS in women and men in a pooled analysis of two randomized stent trials. Methods: BASKET PROVE and BASKET PROVE II were all-comers trials including patients with coronary artery disease requiring at least one stent ≥ 3.0 mm. 4605 patients were randomized to DES vs. BMS and followed for 2 years with a primary endpoint of major adverse cardiac events (MACE: cardiac death, non-fatal myocardial infarction, TVR). The safety (cardiac death and myocardial infarction) and efficacy (non-myocardial infarction TVR) of DES vs. BMS in men and women with large coronary vessels were examined with adjusted Cox proportional hazard models. Results: At baseline, women presented with higher age and more hypertension and heart failure than did men. Risk factors such as smoking, prior myocardial infarction or revascularization were more frequent in men. DES reduced MACE rates at 2 years compared to BMS in both women (6.8 vs. 14.9 %, hazard ratio (HR) 0.40 (0.27-0.60)) and men (7.8 vs. 12.3 %, HR 0.61 (0.49-0.76)), although the reduction in MACE rates was more pronounced in women (p-value for interaction, 0.05). DES significantly reduced the overall rates of non-fatal myocardial infarction and cardiac death compared to BMS in women (HR 0.52 (0.28-0.99)) but not in men (HR 0.75 (0.53-1.05)). The stent-dependent difference in MACE was mainly driven by a difference in non-myocardial infarction TVR in women (2.7 vs. 8.9 %, HR 0.25 (0.14-0.44)) and men (3.8 vs. 7.6 %, HR 0.48 (0.36-0.65)). Conclusions: In patients requiring stenting of large coronary arteries we found that DES, as compared to BMS, were associated with improved safety in women, but not in men. Although, DES demonstrated superior efficacy over BMS in both genders, women benefited more than men. Our findings suggest that DES should always be the stent of choice in women - even in patients at low risk of restenosis.

Abstract 16775: Efficacy and Safety of a Thinner-strut Silicon Carbide-coated Cobalt Chromium Bare-metal Stent Compared to a Thin-strut Uncoated Cobalt Chromium Bare-metal Stent in Large Vessel Stenting: Insights From Two Prospective Randomised All-comers Trials

Introduction: The new generation thinner-strut silicon carbide (SiC) coated cobalt chromium (CoCr) bare-metal stents (BMS) are designed to accelerate rapid endothelialisation and reduce thrombogenicity when implanted in coronary arteries. However, smaller studies suggest reduced efficacy with higher rates of symptomatic restenosis in patients receiving the newer generation BMS. Objective: We investigated the efficacy and safety of a new generation thinner-strut SiC coated CoCr BMS (SCC-BMS) as compared to an older thin-strut uncoated CoCr BMS (UC-BMS) in patients presenting with coronary artery disease requiring stenting of large vessels (≥3.0mm) and thus at low risk of restenosis. Methods: We included all patients randomized to SCC- (n=761) or UC-BMS (n=765) in the BASKET-PROVE II and I trials, respectively. Design, patients, interventions and follow-up were similar between trials except differing regimens of dual antiplatelet therapy. The primary endpoint was clinically driven target-vessel revascularization within 24 months. Safety endpoints of cardiac death, non-fatal myocardial infarction (MI), and definite/probable stent thrombosis were also assessed. We used Cox proportional hazards regressions to estimate relative hazards adjusting for known confounders. Results: Demographics, clinical presentation, and risk factors were comparable between the groups, but patients receiving SCC-BMS underwent less complex procedures. Rates of the primary endpoint were 10.4% in the SCC-BMS group and 8.4% among patients receiving UC-BMS yielding an adjusted relative hazard (HR) of 1.46 ([1.03-2.07], p=0.032). Estimates for the safety endpoints were: cardiac death (1.8% vs. 2.4% ; HR 0.77 [0.36-1.59], p=0.46), non-fatal MI (3.2% vs. 2.5% ; HR 1.68 [0.88-3.21], p=0.11), and definite/probable stent thrombosis (0.8% vs. 1.0% ; HR 0.97 [0.32-3.00], p=0.96). We detected no particular subgroups driving the increased risk of target-vessel revascularization in the SCC-BMS group. Conclusions: In patients requiring stenting of large coronary arteries, use of the newer generation SCC-BMS was associated with a higher risk of symptomatic restenosis despite less complex procedures compared to the UC-BMS with no signs of an offsetting safety benefit.

Improved outcomes of elderly patients treated with drug-eluting versus bare metal stents in large coronary arteries: Results from the BAsel Stent Kosten-Effektivitäts Trial PROspective Validation Examination randomized trial

Drug-eluting stents (DES) improve outcomes in elderly patients with small coronary artery disease compared with bare-metal stents (BMS), but randomized data in elderly patients in need of large coronary stents are not available. Planned secondary analysis of patients ≥75 years recruited to the "BASKET-PROVE" trial, in which 2,314 patients undergoing percutaneous coronary intervention for large (≥3.0 mm) native vessel disease were randomized 2:1 to DES (everolimus- vs sirolimus-eluting stents 1:1) versus BMS. All patients received 12 months of dual antiplatelet therapy. The primary end point was a composite of cardiac death or nonfatal myocardial infarction at 2 years. Comparison of DES versus BMS among 405 patients ≥75 years showed significantly lower rates of the primary end point for DES (5.0% vs 11.6%; hazard ration (HR) 0.64 [0.44-0.91]; P = .014). Rates of nonfatal myocardial infarction (1.2% vs 5.5%, hazard ration (HR) 0.44 [0.21-0.83]; P = .009), all-cause death (7.4% vs 14.4%; HR 0.7 [0.51-0.95]; P = .02), and target vessel revascularization (TVR) (2.3% vs 6.2%; HR 0.59 [0.34-0.99]; P = .046) were also lower, whereas stent thrombosis and bleeding rates were similar. In contrast, among patients <75 years (n = 1,909), the only significant benefit of DES was a reduced rate of TVR (4.0% vs 8.7%, HR 0.66 [0.55-0.80]; P < .0001). In patients ≥75 years requiring large (≥3.0 mm) coronary stents, use of DES was beneficial compared with BMS and reduced the rate of ischemic events, mortality, and TVR. These data suggest that DES should be preferred over BMS in elderly patients.

Drug-eluting versus bare-metal stents in large coronary arteries of patients with ST-segment elevation myocardial infarction: Findings from the ICAS registry

Background and purposeThere are a few retrospective subgroup analyses or registries of large-vessel (≥3.5mm) stenting. We investigated clinical outcomes of patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and bare-metal stents (BMS) in large coronary vessels. Methods and subjectsOf 1100 STEMI patients registered in the Ibaraki Cardiovascular Assessment Study (ICAS) multicenter registry from April 2007 to June 2012 who underwent PCI, we enrolled 454 patients (65.8±12.7 years old, 81% male) with ≥3.5-mm stents. We excluded 53 patients with cardiogenic shock or left main trunk lesions. The remaining 401 patients were divided into Group-D, PCI with DES (n=184), and Group-B, PCI with BMS (n=217). Propensity score analysis matched 1:1 according to treatment with DES (n=101) or with BMS (n=101). We evaluated major adverse cardiac and cerebrovascular events (MACCE) and incidence of stent thrombosis (ST). MACCE was defined as all-cause death, myocardial infarction (MI), target-vessel revascularization (TVR), or cerebrovascular accident (CVA). Essential resultsDuring a mean follow-up period of 526 days, all-cause death, MI, CVA, MACCE, and ST were not significantly different in Group-D versus Group-B (all-cause death: 4.35% vs. 4.61%, p=0.90; MI: 0% vs. 0%; CVA: 2.72% vs. 3.23%, p=0.76; MACCE: 15.2% vs. 20.3%, p=0.19; and ST: 0.0% vs. 1.38%, p=0.11). After adjusting for age, insulin use, multivessel disease, intra-aortic balloon pump use, culprit lesions, and estimated glomerular filtration rate <60ml/min/1.73m2, MACCE was not significantly different between the groups (odds ratio: 0.69; 95% CI: 0.40–1.23; p=0.21). However, TVR was significantly lower in Group-D than Group-B in Kaplan–Meier analysis (p=0.048) after propensity score matching. Principal conclusionThere was no advantage to using a DES in large vessels for preventing a hard endpoint, whereas DES use resulted in a significant reduction in TVR in the patients with STEMI in this registry.

Comparison of drug‐eluting and bare metal stents in large coronary arteries

This study sought to evaluate the safety and effectiveness of drug-eluting stents (DES) compared to bare-metal stents (BMS) for patients with large coronary vessels. Randomized trials have demonstrated that DES reduce the risk of target vessel revascularization (TVR) compared to BMS. This benefit is less pronounced as artery diameter increases. Whether DES are superior to BMS for larger coronary arteries in the setting of routine clinical practice is unknown. We analyzed data from 869 patients undergoing de novo lesion PCI with reference vessel diameter greater than or equal to 3.5 mm in the NHLBI Dynamic Registry according to whether they were treated with DES or BMS. Patients were followed for 3 years for the occurrence of cardiovascular events. At 3-year follow-up, rates of TVR at 3 years were similar and low in both groups (4.4% vs. 3.7%, P = 0.62). After adjustment for differences in baseline characteristics, the adjusted hazard ratio for 3-year MI for DES was 1.85 (95% CI 0.93-3.7, P = 0.08), for TVR at 3 years 1.14 (95% CI 0.52-2.49, P = 0.75) and for mortality 0.89 (95%CI 0.49-1.62, P = 0.71). In our study of the unrestricted use of DES for patients with lesions in larger diameter coronary arteries, first generation DES did not reduce 3-year risk of TVR. Our findings do not support the preferred use of DES over BMS for patients with lesions located in arteries >3.5 mm. It is unknown whether secondary generation DES can offer better outcome compared to BMS in large coronary vessels. Further study on this issue is warranted.

Clinical value of drug-eluting stent over bare-metal stents in large coronary arteries in the patients with ST-segment elevation myocardial infarction

Clinical value of drug-eluting stent over bare-metal stents in large coronary arteries in the patients with ST-segment elevation myocardial infarction

Impact of stent diameter and length on in-stent restenosis after drug eluting stent versus bare metal stent implantation in patients needing large coronary stents

Introduction: The advantage of drug eluting stents (DES) compared to bare metal stents (BMS) is small for the the risk of in-stent-restenosis (ISR) in short lesions of large coronary arteries. Therefore, the British National Institutes of Clinical Excellence (NICE) guidelines recommend to use BMS instead of DES in lesions 3mm diameter. However, no dedicated trial has tested this question. We analysed the impact of stent length and stent diameter on ISR in the BASKET-PROVE study population. Methods: In the multicentre randomized BASKET-PROVE study we compared BMS vs. DES regarding target vessel revascularization (TVR) rates in large coronary arteries (needing ≥3mm stents) resulting in significantly lower 2-year TVR rates in the DES group. For this retrospective subgroup analysis two experienced interventionalists blinded to stent type reviewed all angiographic films for the presence of ISR. We used a mixed-effects Cox survival model to analyse the impact of stent length and stent diameter on ISR on a basis, with ISR being defined as luminal narrowing >50% by visual assessment. Results: 2312 patients with a total of 3278 stented segments were included in the analysis (mean age 63.7±10.9 years; 24.4% female). 123 patients had at least one re-angiography during the two years follow-up due to recurrent ischemia. A total of 75 ISR in 63 patients were observed (mean age 61.9±11.1 years). ISR was significantly more frequent in segments with a BMS (5.3%) compared to segments with a DES (0.74%; HR = 6.18, p<0.001). Based on the Cox analysis, the strongest predictor of ISR was the use of a BMS (hazard ratio (HR)) 6.74; p<0.001). There was a decreased risk of ISR per 1mm increase in stent diameter (HR of 0.30, p=0.003). The HR for stent length per segment was 1.02 (p=0.02; CI= 1.0-1.04) indicating a 2% increased risk of ISR per 1mm increase in stent length. Co-factors like renal failure or diabetes mellitus had no significant effect on ISR. The HR for ISR in patients with stent diameter >3mm and stent length <15mm was not significantly different between the DES and the BMS group although the event rate in this subgroup was low (2.0% with BMS, 1.4% with DES, p=NS). Conclusion: The risk of ISR in patients receiving stents in large coronary arteries is low. Nevertheless, even in patients in need of stents ≥3.0mm, the strongest predictor of ISR was the use of a BMS. Other co-factors like renal failure or DM are not associated with ISR in this population. Alltogether, these findings challenge the restriction of NICE to use BMS instead of DES in vessels >3.0mm.

Long-term outcomes of drug-eluting stents versus bare-metal stents in large coronary arteries

Long-term (>3 years) outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in large coronary arteries were not conclusive. In addition, large coronary vessels were defined using a wide size range (≥3.0 mm) in previous studies. The aim of this study was to assess the long-term efficacy of DES versus BMS in subgroups of different vessel sizes. A total of 1096 patients (1342 lesions) who underwent either DES or BMS implantation in large coronary vessels was followed for a mean duration of 4.5 years. Patients were divided into 4 subgroups by the reference vessel diameters (Q1: 3.0-3.25 mm, Q2: 3.26-3.50 mm, Q3: 3.51-3.75 mm, and Q4: 3.76-4.50 mm). The primary endpoint was major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, target vessel revascularization, and stent thrombosis. The propensity score-adjusted Cox regression method was applied. In the 3 subgroups with smaller vessel sizes, the adjusted risk of MACE in DES recipients was reduced by 82% in Q1 (hazard ratio [HR]: 0.18, 95% confidence interval [CI]: 0.09-0.38), 49% in Q2 (HR: 0.51, 95% CI: 0.26-0.98), and 67% in Q3 (HR: 0.33, 95% CI: 0.15-0.73). However, in the largest vessel subgroup (>3.75 mm), all clinical outcomes were not significantly different irrespective of the stent type used. The incidence of MACE in 3.0-3.75 mm vessels was significantly reduced by the use of DES than by the use of BMS during a long-term follow-up. However, DES lost its benefit in >3.75 mm vessels.

Bare-metal stenting of large coronary arteries in ST-elevation myocardial infarction is associated with low rates of target vessel revascularization

During percutaneous coronary intervention (PCI) performed in the emergent setting of ST-segment elevation myocardial infarction (STEMI), uncertainty about patients' ability to comply with 12 months dual antiplatelet therapy after drug-eluting stenting is common, and thus, selective bare-metal stent (BMS) deployment could be an attractive strategy if this achieved low target vessel revascularization (TVR) rates in large infarct-related arteries (IRAs) (≥3.5 mm). To evaluate this hypothesis, among 1,282 patients with STEMI who underwent PCI during their initial hospitalization, we studied 1,059 patients (83%) who received BMS, of whom 512 (48%) had large IRAs ≥3.5 mm in diameter, 333 (31%) had IRAs 3 to 3.49 mm, and 214 (20%) had IRAs <3 mm. At 1 year, TVR rate in patients with BMS was 5.8% (2.2% with large BMS [≥3.5 mm], 9.2% with BMS 3-3.49 mm [intermediate], and 9.0% with BMS <3.0 mm [small], P < .001). The rates of death/reinfarction among patients with large BMS compared with intermediate BMS or small BMS were lower (6.6% vs 11.7% vs 9.0%, P = .042). Among patients who received BMS, the independent predictors of TVR at 1 year were the following: vessel diameter <3.5 mm (odds ratio [OR] 4.39 [95% CI 2.24-8.60], P < .001), proximal left anterior descending coronary artery lesions (OR 1.89 [95% CI 1.08-3.31], P = .027), hypertension (OR 2.01 [95% CI 1.17-3.438], P = .011), and prior PCI (OR 3.46 [95% CI 1.21-9.85], P = .02). The predictors of death/myocardial infarction at 1 year were pre-PCI cardiogenic shock (OR 8.16 [95% CI 4.16-16.01], P < .001), age ≥65 years (OR 2.63 [95% CI 1.58-4.39], P < .001), left anterior descending coronary artery culprit lesions (OR 1.95 [95% CI 1.19-3.21], P = .008), female gender (OR 1.93 [95% CI 1.12-3.32], P = .019), and American College of Cardiology/American Heart Association lesion classes B2 and C (OR 2.17 [95% CI 1.10-4.27], P = .026). Bare-metal stent deployment in STEMI patients with IRAs ≥3.5 mm was associated with low rates of TVR. Their use in this setting warrants comparison with second-generation drug-eluting stenting deployment in future randomized clinical trials.

Drug-eluting or bare-metal stents in large coronary arteries.

Drug-eluting or bare-metal stents in large coronary arteries.

Drug-Eluting or Bare-Metal Stents in Large Coronary Arteries

Drug-Eluting or Bare-Metal Stents in Large Coronary Arteries

Drug-eluting or bare-metal stents in large coronary arteries.

Drug-eluting or bare-metal stents in large coronary arteries.

Effectiveness of Drug-Eluting Stents versus Bare-Metal Stents in Large Coronary Arteries in Patients with Acute Myocardial Infarction

This study compared clinical outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in large coronary arteries in patients with acute myocardial infarction (MI). A total of 985 patients who underwent single-vessel percutaneous coronary intervention (PCI) in large coronary arteries (≥ 3.5 mm) in lesions < 25 mm were divided into DES group (n = 841) and BMS group (n = 144). Clinical outcomes during 12 months were compared. In-hospital outcome was similar between the groups. At six months, death/MI rate was not different. However, DES group had significantly lower rates of target-lesion revascularization (TLR) (1.7% vs 5.6%, P = 0.021), target-vessel revascularization (TVR) (2.2% vs 5.6%, P = 0.032), and total major adverse cardiac events (MACE) (3.4% vs 11.9%, P = 0.025). At 12 months, the rates of TLR and TVR remained lower in the DES group (2.5% vs 5.9%, P = 0.032 and 5.9% vs 3.1%, P = 0.041), but the rates of death/MI and total MACE were not statistically different. The use of DES in large vessels in the setting of acute MI is associated with lower need for repeat revascularization compared to BMS without compromising the overall safety over the course of one-year follow-up.

BASKET-PROVE: DES Just as Safe as BMS in Large Coronary Vessels

Drug-eluting stents confer no additional late cardiovascular risk in patients with stenting of large coronary arteries when compared with bare-metal stents according to the results of the 24-month Basel Stent Cost-effectiveness Trial-PROspective Evaluation Examination [BASKET-PROVE; ISRCTN72444640].

Drug-Eluting versus Bare-Metal Stents in Large Coronary Arteries

Recent data have suggested that patients with coronary disease in large arteries are at increased risk for late cardiac events after percutaneous intervention with first-generation drug-eluting stents, as compared with bare-metal stents. We sought to confirm this observation and to assess whether this increase in risk was also seen with second-generation drug-eluting stents. We randomly assigned 2314 patients needing stents that were 3.0 mm or more in diameter to receive sirolimus-eluting, everolimus-eluting, or bare-metal stents. The primary end point was the composite of death from cardiac causes or nonfatal myocardial infarction at 2 years. Late events (occurring during months 7 to 24) and target-vessel revascularization were the main secondary end points. The rates of the primary end point were 2.6% among patients receiving sirolimus-eluting stents, 3.2% among those receiving everolimus-eluting stents, and 4.8% among those receiving bare-metal stents, with no significant differences between patients receiving either drug-eluting stent and those receiving bare-metal stents. There were also no significant between-group differences in the rate of late events or in the rate of death, myocardial infarction, or stent thrombosis. Rates of target-vessel revascularization for reasons unrelated to myocardial infarction were 3.7% among patients receiving sirolimus-eluting stents, 3.1% among those receiving everolimus-eluting stents, and 8.9% among those receiving bare-metal stents. The rate of target-vessel revascularization was significantly reduced among patients receiving either drug-eluting stent, as compared with a bare-metal stent, with no significant difference between the two types of drug-eluting stents. In patients requiring stenting of large coronary arteries, no significant differences were found among sirolimus-eluting, everolimus-eluting, and bare-metal stents with respect to the rate of death or myocardial infarction. With the two drug-eluting stents, similar reductions in rates of target-vessel revascularization were seen. (Funded by the Basel Cardiovascular Research Foundation and the Swiss National Foundation for Research; Current Controlled Trials number, ISRCTN72444640.).