Clinical Outcomes of Biodegradable Polymer Drug‐Eluting Stents for Percutaneous Coronary Intervention: An Updated Meta‐analysis of Randomized Controlled Trials

Biodegradable polymer drug‐eluting stents (DES) are innovative concepts in the era of percutaneous coronary intervention. We systematically reviewed the latest randomized evidence on the efficacy and safety of biodegradable polymer DES as compared to durable polymer DES. MEDLINE, Embase, and the Cochrane database were searched in August 2013 for eligible randomized controlled trials (RCTs) comparing biodegradable polymer DES with durable polymer DES. Clinical outcomes of interest were mortality, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis. A total of 20 RCTs randomizing 20 021 participants were included, of whom 11 045 were allocated to biodegradable polymer DES and 8976 to durable polymer DES. Treatment of biodegradable polymer DES was not associated with a significant reduction of any of the clinical outcomes (all‐cause mortality, odds ratio [OR]: 0.94, 95% confidence interval [CI]: 0.80 to 1.10, P = 0.42; cardiovascular mortality, OR: 0.97, 95% CI: 0.79 to 1.19, P = 0.74; MI, OR: 1.07, 95% CI: 0.91 to 1.26, P = 0.41; TLR, OR: 0.87, 95% CI: 0.69 to 1.08, P = 0.20; TVR, OR: 1.05, 95% CI: 0.85 to 1.28, P = 0.67; definite/probable stent thrombosis, OR: 0.80, 95% CI: 0.59 to 1.07, P = 0.14). Current randomized data indicate that clinical efficacy and safety profiles of biodegradable polymer DES are comparable to those of durable polymer DES. Findings from large‐scale studies with rigorous methodology and long follow‐up duration are needed.     

Current Status of Drug‐Eluting Stents

First‐generation drug‐eluting stents (DES) with controlled release of sirolimus or paclitaxel from durable polymers compared with bare‐metal stents have been consistently shown to reduce the risk of repeat revascularization procedures due to restenosis. The superior efficacy was found across a wide range of patients and lesion subsets and persisted up to 5 years whereas similar outcomes have been observed in terms of death and myocardial infarction. Newer generation DES have been developed with the goal to further improve upon the safety profile of first‐generation DES while maintaining efficacy. These platforms include DES with improved and more biocompatible durable polymers, DES using bioabsorbable polymers for drug release, DES with polymer‐free drug release, and fully bioabsorbable DES. Newer generation DES with durable polymers such as zotarolimus‐eluting or everolimus‐eluting XIENCE V stents have been directly compared with first‐generation DES. Most recent results of large scale clinical trials are encouraging in terms of similar or increased efficacy while improving safety by reducing the rates of myocardial infarctions and stent thrombosis. DES using biodegradable polymers for drug release represent the next technological modification and preliminary results are favorable and demonstrate similar angiographic and clinical efficacy as first‐generation DES, but only longer term follow‐up and investigation in larger patient cohorts will determine whether their use is associated with improved long‐term safety. Fully bioabsorbable stents represent another innovative approach. Whether this innovative concept will enter into clinical routine remains yet to be determined.     

Everolimus‐Eluting Stents Versus Sirolimus‐ or Paclitaxel‐Eluting Stents: Two‐Year Results from the Guthrie Health Off‐Label Stent (GHOST) Registry

Objectives

We sought to compare the safety and effectiveness of everolimus‐eluting stents (EES) versus first generation drug‐eluting stents (FG‐DES; sirolimus‐eluting stent [SES] or paclitaxel‐eluting stent [PES]).

Methods

In 2,126 patients undergoing percutaneous coronary intervention (PCI), we compared the 2‐year incidence of stent thrombosis (ST) and target vessel revascularization (TVR) between the EES versus FG‐DES groups. Secondary end‐points included all‐cause death, myocardial infarction (MI), death or MI, and major adverse cardiovascular events (MACE, including death, MI, ST, or TVR). Further, we evaluated these end‐points in 2 propensity‐matched subgroups: EES versus SES; EES versus PES.

Results

Complete 2‐year follow‐up was available in 1,911 (90%) patients. Compared to FG‐DES, implantation of EES was associated with trends towards lower ST (0.9% vs. 2.8%, P = 0.068) and TVR (3.8% vs. 7.2%, P = 0.052), which persisted after adjustment for baseline differences (for ST, adjusted hazard ratio, HR 0.32; 95% confidence interval, 95% CI 0.10–1.02, P = 0.053; for TVR, HR 0.40; 95% CI 0.22–0.75, P = 0.004). Compared to SES, EES implantation was associated with lower TVR and a trend towards lower ST. Compared to PES, EES implantation was associated with less ST and TVR and trends towards lower death/MI and MACE. In the EES group, no ST was seen after the first 3 months.

Conclusions

The use of EES compared to FG‐DES appears to be associated with reductions in ST and TVR at 2‐year follow‐up. Improved outcomes with EES are observed in comparison with SES as well as PES. (J Interven Cardiol 2013;26:153–162)

     

Second‐Generation Everolimus‐Eluting Stents Compared to First‐Generation Drug‐Eluting Stents in Patients Treated for Multivessel Disease

Objective

This study aimed to compare the safety and efficacy of everolimus‐eluting stents (EES) to first‐generation drug‐eluting stents (DES) in multivessel disease (MVD).

Background

Second‐generation EES have demonstrated superiority over first‐generation DES for single‐vessel disease, although the merits of EES in MVD are less established.

Methods

A cohort of 1,285 patients (3,124 lesions) with ≥2 diseased vessels were treated with either first‐generation DES (n = 1,002) or EES (n = 283). The rates of death, myocardial infarction, target lesion revascularization, target vessel revascularization, definite stent thrombosis, and major adverse cardiac events (MACE), defined as the combined incidence of target vessel revascularization, death, and non‐fatal myocardial infarction, were compared at 1 year.

Results

Baseline characteristics were similar except for a lower left ventricular ejection fraction and a lower incidence of stable angina pectoris in the first‐generation DES group (P = 0.001 and 0.013, respectively). At 1 year, the MACE rate was lower in the EES group (9.5P% vs. 15.7%; P = 0.01). Multivariable analysis demonstrated that EES use predicted a higher chance of freedom from MACE at 1 year (hazard ratio 0.58 [0.38–0.87]; P = 0.009; 95% confidence interval).

Conclusions

The use of EES in patients with MVD is safe with signals for improved effectiveness compared to first‐generation DES. Randomized trials comparing new‐generation DES to coronary artery bypass grafting surgery are warranted.

     

New‐Generation Drug‐Eluting Stents: Focus on Xience V® Everolimus‐Eluting Stent and Resolute® Zotarolimus‐Eluting Stent

Compared to bare metal stent angioplasty, first‐generation drug‐eluting stents (DES) have markedly reduced the incidence of in‐stent restenosis. However, given the increased concerns over late and very late stent thrombosis, newer‐generation DES were developed. To date, these DES have virtually replaced the use of first‐generation DES worldwide. In this review article, we carefully consider the pre‐clinical and clinical trials that have been performed with currently available, european conformity‐marked and Food and Drug Administration–approved new‐generation Resolute^® and Xience V^® DES. (J Interven Cardiol 2013;26:278–286)

     

Sustained clinical safety and efficacy of a biodegradable‐polymer coated sirolimus‐eluting stent in “real‐world” practice: Three‐year outcomes of the CREATE (multi‐center registry of EXCEL biodegradable polymer drug eluting stents) study

Background: The CREATE is a post‐marketing surveillance multicenter registry that demonstrated satisfactory angiographic and clinical (at 18 months) outcomes of a biodegradable polymer based sirolimus‐eluting stent (EXCEL, JW Medical System, Weihai, China) for the treatment of patients in routine clinical practice. Objectives: To evaluate the three‐year clinical safety and efficacy outcomes in patients enrolled in the CREATE study. Methods: A total of 2077 all comers have been enrolled in the CREATE study at 59 centers from four countries. Recommended antiplatelet regimen was clopidogrel and aspirin for six months followed by chronic aspirin therapy. The prespecified primary outcome was the rate of major adverse cardiac events (MACE) at 12, 18, and 36 months. Results: Clinical follow‐up was completed in 2025 (97.5%) patients at three years. The average duration of clopidogrel treatment was 199.8 ± 52.7 days and 80.5% of discharged patients discontinued clopidogrel at six months. The cumulative rate of MACE was 4.5% and the rate of stent thrombosis was 1.53% at three years. At six months to three years, prolonged clopidogrel therapy (>6 months) was not beneficial in reducing cumulative hazards of MACE (3.4% vs. 3.1%, log rank P = 0.725) or stent thrombosis (1.5% vs. 0.6%, log rank P = 0.053). Conclusions: This study demonstrates sustained three‐year clinical safety and efficacy of biodegradable polymer‐based sirolimus‐eluting stents when used with six months of dual antiplatelet therapy in a “real‐world” setting. © 2011 Wiley Periodicals, Inc.     

Long‐Term Clinical Outcomes of a Biodegradable Polymer‐Based Biolimus‐Eluting Stent

Objectives

To investigate the long‐term clinical outcomes of biolimus‐eluting stents with biodegradable polymers in real‐world clinical practice.

Background

Long‐term clinical outcomes of biolimus‐eluting stents have not been clearly established.

Methods

A total of 824 all‐comer patients (971 lesions) treated with unrestricted implantation of a biolimus‐eluting stent with a biodegradable polymer were prospectively enrolled. Patients were divided into complex (413 patients) versus noncomplex (411 patients) groups according to the complexity of coronary lesions. Long‐term clinical outcomes for stent efficacy (target lesion revascularization) and safety (composite of cardiac death, target lesion‐related myocardial infarction, and definite or probable stent thrombosis) were compared between the two groups during 5 years of follow‐up.

Results

The complex group showed higher rates of decreased left ventricular ejection fraction, impaired renal function, previous history of myocardial infarction, and diabetes mellitus compared to the noncomplex group. In the overall population, the 5‐year cumulative rate of target lesion revascularization was 4.8% (8.3% in the complex group vs 1.6% in the noncomplex group, P < 0.001). For stent safety, the 5‐year cumulative rate for a composite of cardiac death, target lesion‐related myocardial infarction, and stent thrombosis was 2.5% overall (3.9% in the complex group vs 1.1% in the noncomplex group, P = 0.010). Overall 5‐year cumulative rate of stent thrombosis was 0.4% (0.5% in the complex vs 0.2% in the noncomplex group, P = 0.561) with no very late stent thrombosis (VLST).

Conclusions

Biodegradable polymer‐based biolimus‐eluting stents showed favorable efficacy and safety in all‐comer patients during 5 years of follow‐up. (J Interven Cardiol 2016;29:162–167)

     

Same or Different Drug‐Eluting Stent Re‐Implantation for Drug‐Eluting Stent Restenosis: An Assessment Including Second‐Generation Drug‐Eluting Stents

Objectives

We examined the long‐term outcomes of implanting a different type of drug‐eluting stent (DES), including second‐generation DES, for treatment of DES‐in stent restenosis (ISR).

Background

Treatment for DES‐ISR has not been standardized.

Methods

The subjects were 80 patients with 89 lesions underwent DES implantation for DES‐ISR. The patients were divided into the group of patients receiving the same DES for DES‐ISR (Homo‐stent: 24 patients, 25 lesions) and a different DES for DES‐ISR (Hetero‐stent: 56 patients, 64 lesions). The primary endpoint was survival free of major adverse cardiovascular events (MACE), including cardiac death, myocardial infarction, and target vessel revascularization (TVR). The secondary endpoint was late loss at 8–12 months follow‐up. In the subgroup of patients who were treated with second‐generation DES for DES‐ISR, we also assessed the survival free of MACE.

Results

During a mean follow‐up of 45.1 ± 21.2 months, 26 patients experienced MACE. There was no significant difference in the survival free of MACE (Log rank P = 0.17). In the sub‐analysis of second generation DES, MACE was significantly higher in the Homo‐stent group compared to the Hetero‐stent group (Log rank P = 0.04). Late loss was significantly higher in the Homo‐stent group than in the Hetero‐stent group (0.86 ± 1.03 vs. 0.38 ± 0.74 mm, P = 0.03). This trend was prominent in the first‐generation DES group.

Conclusions

Although there was no significant difference in MACE between the Hetero‐stent and the Homo‐stent groups including both first and second‐generation DES, the sub‐analysis demonstrated different DES implantation for DES‐ISR significantly improved the MACE rate among patients treated with second‐generation DES. (J Interven Cardiol 2016;29:311–318)

     

Two‐Year Clinical Registry Follow‐up of Endothelial Progenitor Cell Capture Stent Versus Sirolimus‐Eluting Bioabsorbable Polymer‐Coated Stent Versus Bare Metal Stents in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Elevation Myocardial Infarction

Background: Endothelial progenitor cell (EPC) capture stent is designed to promote rapid endothelization and healing and is potentially useful in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). We studied the intermediate‐term efficacy and safety of EPC stent and compared that with sirolimus‐eluting bioabsorbable polymer stent (CURA) and bare metal stent (BMS) in AMI patients. Methodology: Patients presenting with AMI who underwent primary PCI with the respective stents between January 2004 and June 2006 were enrolled in the single‐center clinical registry. The study end‐points were major adverse cardiac events (MACE) and stent thrombosis. Results: A total of 366 patients (EPC = 95, CURA = 53, BMS 218) were enrolled. Baseline demographics including age, gender, diabetes, renal impairment, predischarge left ventricular ejection fraction, and creatinine kinase level were comparable among the groups. Procedural success rate was 99.5%. Post‐procedural thrombolysis in myocardial infarction (TIMI) 3 flow was achieved in EPC 91.6%, CURA 96.2%, and BMS 88.5% (P = 0.209). At 2 years, the MACE rate was EPC 13.7%, CURA 15.1%, and BMS 19.7% (P = 0.383). Target vessel revascularizations (TVR) were EPC 4.2%, CURA 9.4%, and BMS 6.0% (P = 0.439). Nonfatal myocardial infarctions were EPC 1.1%, CURA 3.8%, and BMS 4.1% (P = 0.364). One patient in the EPC group had acute stent thrombosis. There was no late stent thrombosis in the EPC group. Conclusion: EPC stent appeared to be safe and had comparable clinical efficacy with a BMS when used in the AMI setting. At 2‐year follow‐up, the EPC group showed favorable, single‐digit TVR rate and stent thrombosis remained a low‐event occurrence. (J Interven Cardiol 2010;23:101‐108)     

Long‐term clinical,angiographic, and intravascular ultrasound outcomes of biodegradable polymer‐coated sirolimus‐eluting stents

Background: The residual drug carriers on drug‐eluting stents (DES) surfaces are considered to be one of the most significant reasons causing late thrombosis. There is no documented data currently available on the safety/benefit profile beyond 6 months of EXCEL stent, a novel sirolimus‐eluting stent with biodegradable polymer coating, in treating patients with coronary artery disease (CHD). Objective: To evaluate the long‐term efficacy and safety of EXCEL stent on treating CHD patients. Methods: Between February and March 2006, a consecutive cohort of complex patients treated with the EXCEL stent was prospectively enrolled in this single‐center registry. Antiplatelet protocol was 6‐month dual antiplatelet therapy with clopidogrel and aspirin followed by aspirin alone indefinitely. The primary outcome was major adverse cardiac events (MACE) at 12 months. Secondary outcomes included in‐segment and in‐stent late lumen loss and binary restenosis rate measured by quantitative coronary angiography (QCA) analysis at 8 months postindex PCI procedure. Results: A total of 100 patients with 153 lesions were included in this analysis. Most lesions (83.0%) were classified as complex (B2/C). At 12 months, four patients (4.0%) experienced MACE, which were four target‐lesion revascularizations due to in‐stent restenosis (ISR). All patients received follow‐up up to 24 ± 0.4 months and no cardiac death, MI, and in‐stent thrombosis occurred during the 6 months of dual antiplatelet therapy or the subsequent 15 months of aspirin treatment alone. QCA analysis of 112 lesions from 75 patients showed 3.6% (4/112) in‐stent lesion restenosis, 5.4% (6/112) in‐segment lesion restenosis, 0.12 ± 0.34 mm in‐stent late lumen loss, and 0.08 ± 0.35 mm in‐segment late lumen loss. Conclusions: In this single‐center experience with complex patients and lesions, the EXCEL^TM stent implantation with 6‐month dual antiplatelet treatment proved to markedly reduce the incidence of 24‐month ISR and MACE. These preliminary findings require further validation by large scale, randomized trials. © 2008 Wiley‐Liss, Inc.     

国产无聚合物紫杉醇涂层支架和可降解聚合物雷帕霉素涂层支架治疗冠心病疗效评价

目的:探讨国产无聚合物紫杉醇涂层支架(YINYI)和可降解聚合物雷帕霉素涂层支架(EXCEL)治疗冠心病,预防心血管事件的有效性和安全性.方法:167例符合冠状动脉介入手术指征的冠状动脉病变患者被随机分为YINYI组和EXCEL组,分别接受YINYI和EXCEL治疗.12个月临床随访,观察2组支架内血栓形成事件、MAC...     

Comparison of a polymer‐free rapamycin‐eluting stent (YUKON) with a polymer‐based paclitaxel‐eluting stent (TAXUS) in real‐world coronary artery lesions

Background : In selected patient cohorts the polymer‐free rapamycin‐eluting YUKON stent (A) has demonstrated noninferiority compared with the polymer‐based paclitaxel‐eluting TAXUS stent (B). To test for equivalency in unselected real‐world patients with coronary lesions of various complexities, we retrospectively compared both stent designs. Methods : A total of 410 patients with symptomatic CAD were successfully treated with A (n = 205) or with B (n = 205). Baseline clinical characteristics, coronary lesion location, lesion length, and the number of stents implanted per lesion were equally distributed between the treatment groups. All patients underwent QCA‐analysis at baseline. Clinical follow‐up with assessment of MACE and noncardiac deaths was obtained at 30 days and 6 months. Results : Nominal stent diameter was 2.96 ± 0.38 mm in Group A vs. 3.05 ± 0.42 mm in Group B (P = 0.2); nominal length of stented segmentwas 22.97 ±13.0 mm vs. 23.63 ± 10.0 (P = 0.56). Analysis of MACE after 6 months resulted in one angiographically documented stent thrombosis causing MI in B (0.2%) vs. none in A. No other MI or cardiac deaths occurred in either group, while two noncardiac deaths in A (1.0%) were reported. Fifteen target lesion revascularizations (7.3%) were performed in A vs. 7 (3.4%) in B. Differences in study endpoints at 6 months did not reach statistical significance (P > 0.05). Conclusions : Up to 6 months after PCI of real‐world coronary lesions, there were no statistically significant differences in MACE between patients treated with the polymer‐free rapamycin‐eluting YUKON stent and the polymer‐based paclitaxel‐eluting TAXUS stent. © 2008 Wiley‐Liss, Inc.     

Polymer‐free drug‐eluting stents for coronary artery disease

Polymer‐free drug‐eluting stents (PF‐DES) were designed with the expectation of avoiding late restenosis and thrombosis related to the polymer used in traditional DES platforms. Furthermore, due to similarities with bare metal stents after drug elution, PF‐DES has been considered as particularly suitable for patients at high bleeding risk. A variety of PF‐DES platforms have been clinically tested. Despite their theoretical advantages, PF platforms showed comparable clinical outcomes with modern permanent‐ or biodegradable polymer‐based DES up to 5 years after implantation. Use of more biocompatible polymers on the modern DES platforms is one of the reasons therefore. Their improved safety profile allows already less intensive antithrombotic regimes after DES. Hence, nowadays PF‐DES platforms can be considered as one of many DES options for percutaneous treatment of coronary artery disease.

     

Comparison between sirolimus‐ and paclitaxel‐eluting stents in complex patient and lesions subsets

Background : Sirolimus‐eluting stents (SES) and paclitaxel‐eluting stents (PES) both significantly reduce the need for repeat intervention compared to bare metal stents. Studies comparing the clinical outcomes of these stents in noncomplex subsets of patients and lesions demonstrate a similar safety and efficacy profile. The data for more complex subsets of patients and lesions remains conflicting. This study aimed to compare SES with PES in a selected population with a broad range of complex features. Methods and Results : The patient population consisted of 1,591 consecutive patients with complex features undergoing drug‐eluting stent (DES) implantation. In the SES group there were 1,095 patients (1,653 lesions) and in the PES group 496 patients (802 lesions). In‐hospital, 30‐day, and 12‐month clinical outcomes were compared between groups. No discernable difference in major adverse cardiac events (MACE) between SES and PES was detected at intermediate and longer‐term follow‐up (SES 22.4% vs. PES 20.5% at 12 months; P = 0.407). A trend toward increased angiographically documented stent thrombosis was observed in the SES group at both 3 and 12 months (SES 2.2% vs. PES 0.8% at 12 months; P = 0.051). When adopting the more inclusive definition of probable stent thrombosis, this trend was no longer seen. After adjusting for baseline differences between the two groups, there still remained no difference in MACE between SES and PES (HR 1.051 [CI 0.826–1.339] P = 0.685). The trend toward increased angiographically documented stent thrombosis in the SES group remained after adjustment for baseline differences (HR 2.836 [CI 0.968–8.311] P = 0.057). Conclusions : In a selected population with complex disease the rate of MACE was comparable between SES and PES, with higher overall rates of thrombosis and MACE compared to a noncomplex population. Thus, the focus should be directed to prevent late complications in this complex subset regardless of stent type selection. © 2007 Wiley‐Liss, Inc.     

Safety and efficacy of second‐generation drug‐eluting stents compared with bare‐metal stents: An updated meta‐analysis and regression of 9 randomized clinical trials

The efficacy of second‐generation drug‐eluting stents (DES; eg, everolimus and zotarolimus) compared with bare‐metal stents (BMS) in patients undergoing percutaneous coronary intervention was challenged recently by new evidence from large clinical trials. Thus, we aimed to conduct an updated systematic review and meta‐analysis of randomized clinical trials (RCTs) evaluating the efficacy and safety of second‐generation DES compared with BMS . Electronic databases were systematically searched for all RCTs comparing second‐generation DES with BMS and reporting clinical outcomes. The primary efficacy outcome was major adverse cardiac events (MACE); the primary safety outcome was definite stent thrombosis. The DerSimonian and Laird method was used for estimation of summary risk ratios (RR). A total of 9 trials involving 17 682 patients were included in the final analysis. Compared with BMS, second‐generation DES were associated with decreased incidence of MACE (RR: 0.78, 95% confidence interval [CI]: 0.69‐0.88), driven by the decreased incidence of myocardial infarction (MI) (RR: 0.67, 95% CI: 0.48‐0.95), target‐lesion revascularization (RR: 0.47, 95% CI: 0.42‐0.53), definite stent thrombosis (RR: 0.57, 95% CI: 0.41‐0.78), and definite/probable stent thrombosis (RR: 0.54, 95% CI: 0.38‐0.80). The incidence of all‐cause mortality was similar between groups (RR: 0.94, 95% CI: 0.79‐1.10). Meta‐regression showed lower incidences of MI with DES implantation in elderly and diabetic patients (P = 0.026 and P < 0.0001, respectively). Compared with BMS, second‐generation DES appear to be associated with a lower incidence of MACE, mainly driven by lower rates of target‐lesion revascularization, MI, and stent thrombosis. However, all‐cause mortality appears similar between groups.     

The short‐ and long‐term outcomes of percutaneous intervention with drug‐eluting stent vs bare‐metal stent in saphenous vein graft disease: An updated meta‐analysis of all randomized clinical trials

The use of drug‐eluting stents (DES) vs bare‐metal stents (BMS) in saphenous vein graft (SVG) lesions remains controversial. We conducted a meta‐analysis of all randomized clinical trials comparing the outcomes of DES with BMS in SVG percutaneous coronary interventions. A search of PubMed, Embase, the Cochrane Register of Controlled Trials, and Clinicaltrials.gov was performed for all randomized clinical trials. We evaluated the short‐ and long‐term clinical outcomes of the following: all‐cause mortality, major adverse cardiovascular events (MACE), definite/probable stent thrombosis, target lesion revascularization (TLR), and target‐vessel revascularization (TVR). From a total of 1582 patients in 6 randomized clinical trials, 797 had DES and 785 had BMS. Patients with DES had lower short‐term MACE, TLR, and TVR in comparison with BMS (odds ratio [OR]: 0.56, 95% confidence interval [CI]: 0.35–0.91, P = 0.02; OR: 0.43, 95% CI: 0.19–0.99, P = 0.05; and OR: 0.45, 95% CI: 0.22–0.95, P = 0.04, respectively). However, there were no different outcomes for all‐cause mortality (P = 0.63) or stent thrombosis (P = 0.21). With long‐term follow‐up, there were no significant reductions of MACE (P = 0.20), TLR (P = 0.57), TVR (P = 0.07), all‐cause mortality (P = 0.29), and stent thrombosis (P = 0.76). The use of DES in SVG lesions was associated with lower short‐term MACE, TLR, and TVR in comparison with BMS. However, there were no significant differences with long‐term follow‐up.     

Randomized evaluation of two drug‐eluting stents with identical metallic platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1‐Year results of the PAINT trial

Objectives: We tested two novel drug‐eluting stents (DES), covered with a biodegradable‐polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti‐restenosis effects of sirolimus versus paclitaxel (secondary objective). Background: The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel. Methods: Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow‐up was obtained at 9 months and major cardiac adverse events up to 12 months. Results: Both paclitaxel and sirolimus stents reduced the 9‐month in‐stent late loss (0.54–0.44 mm, 0.32–0.43 mm, vs. 0.90–0.45 mm respectively), and 1‐year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1‐year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups. Conclusion: Both novel DES were effective in reducing neointimal hyperplasia and 1‐year re‐intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.© 2009 Wiley‐Liss, Inc.     

Long‐term risk of clinical events from stenting side branches of coronary bifurcation lesions with drug‐eluting and bare‐metal stents: An observational meta‐analysis

Objectives : To compare the long‐term risks of coronary bifurcation lesions treated with side‐branch stenting using drug‐eluting versus bare‐metal stents. Background : Side‐branch stenting is an off‐label practice, but when needed, the incidence of late adverse events may differ between drug‐eluting and bare‐metal stents. Methods : We systematically searched PubMed, and the National Institutes of Health and Cochrane Registries for studies of coronary bifurcation stenting reporting clinical outcomes over at least 5 months. Data were extracted and cross checked independently by two investigators for inclusion in an observational meta‐analysis. Clinical outcomes included major adverse clinical events (MACE), death, myocardial infarction, target vessel revascularization (TVR), and definite stent thrombosis. We used random‐effects models and meta‐regression in 6,825 subjects from 42 studies. Results : Most (79%) of the heterogeneity in MACE between treatment groups was explained by differences in stent type, side‐branch stenting, and length of follow‐up. Compared with drug‐eluting stents without side‐branch stenting, drug‐eluting stents with side‐branch stenting had a 3% higher incidence of myocardial infarction [95% confidence interval (CI) = 0.3%, 5%, P < 0.05], but no significant increase in MACE, death, TVR, or stent thrombosis. Bare‐metal stenting without side‐branch stenting had 10% (95% CI = 3%, 16%, P < 0.01) higher MACE, and 10% (95% CI = 4%, 17%, P < 0.01) higher TVR, whereas bare‐metal side‐branch stenting had 31% (95% CI = 23%, 39%, P < 0.001) higher MACE, and 19% (95% CI = 10%, 28%, P < 0.001) higher TVR. Conclusions : Side‐branch stenting has a much smaller impact on long‐term MACE with drug‐eluting stents compared with bare‐metal stents. Although this study does not support routine side‐branch stenting, when side‐branch stenting is required, drug‐eluting stents are associated with less adverse outcomes.© 2011 Wiley‐Liss, Inc.     

Aggressive Plaque Modification with Rotational Atherectomy and/or Cutting Balloon before Drug‐Eluting Stent Implantation for the Treatment of Calcified Coronary Lesions

Introduction: Calcified coronary lesions may be associated with stent underexpansion, malapposition, and high rates of restenosis. The use of drug‐eluting stents (DES) in such lesions has not been fully addressed in the major trials. We sought to examine the outcomes of patients who were treated with plaque modification (PM) to facilitate DES implantation. Methods: We analyzed 164 calcified coronary lesions in 145 consecutive patients who underwent aggressive PM with either rotational atherectomy (RA) and/or cutting balloon (CB) before DES implantation. CB was used in moderate calcified lesions and RA alone or followed by CB in severe calcified lesions. Results: Patients were 68.7 ± 10.1 years old, 47% were diabetic, 34% had left ventricular ejection fraction (LVEF) ≤50%, and 39% had 3‐vessel disease. Ninety‐five percent of lesions were classified as B2/C, 100% as moderately/severely calcified. PM was achieved by using CB in 57% and by RA alone or followed by CB in 43%. In 100%, a DES was implanted. There was no failure to deliver a stent. At 15 ± 11 months follow‐up, the overall major adverse cardiac events (MACE) rate was 9.6% (3.4% cardiac death, 2.3% myocardial infarction, and 3.4% target lesion revascularization [TLR]). The only independent predictor of MACE was LVEF ≤50% (odds ratio 3.88; 95% confidence interval: 1.15–13.1; P = 0.03). The incidence of stent thrombosis (ST) was 2.1%. There were no significant differences in MACE and TLR based on the type of PM used. Conclusions: In this population at high risk of restenosis, aggressive PM by CB and/or RA before DES implantation provides excellent mid‐term outcomes with only 3.4% TLR and 2.1% ST. (J Interven Cardiol 2010;23:240–248)