Lower Rates Of Target Vessel Revascularization Research Articles

Very long-term efficacy and safety of paclitaxel-eluting balloon after a bare-metal stent for the treatment of ST-elevation myocardial infarction: 8-year results of a randomized clinical trial (PEBSI study).

Drug-eluting stents (DES) are considered the therapy of choice in ST-segment elevation myocardial infarction (STEMI); however, a low persistent rate of revascularizations and stent thrombosis exist over the time. We have previously shown that a paclitaxel (PTX)-drug-coated balloon (DCB) after a bare-metal stent (BMS) implantation (DCB-combined strategy) yields superior angiographic and clinical results compared to BMS in the short term. However, the long-term safety and efficacy of this approach remain uncertain. An 8-year clinical follow-up was conducted on patients enrolled in the randomized PEBSI-1 trial (NCT01839890). The original trial included patients who suffered a STEMI, patients were randomly assigned to receive a DCB-combined strategy or BMS only and the primary endpoint was in-stent late luminal loss (LLL) at 9-month follow-up. After the completion of this study, death, myocardial re-infarction, ischemia-driven repeated revascularizations included target lesion revascularization (TLR) and target vessel revascularization (TVR), and stent thrombosis, were assessed by yearly contact by a clinical visit, telephone or by electronic records. These outcomes were adhered to ARC-2 criteria. The rate of incomplete follow-up was very low, with only 3 out of 111 patients (2.7%) in the DCB-combined strategy group and 1 out of 112 patients (0.9%) in the BMS group. At 8 years there were a lower rate of TVR [3.7% vs. 14.3%; hazard ratio (HR): 0.243; 95% confidence interval (CI): 0.081-0.727; P=0.006], and a trend towards lower TLR (2.8% vs. 8.9%; HR: 0.300; 95% CI: 0.083-1.090; P=0.052) in the DCB-combined strategy group. No statistical difference between the DCB-combined strategy and BMS groups were found for all causes of death, deaths from cardiovascular disease, reinfarctions or stent thrombosis. Notably in the DCB-combined strategy group, no episode of stent thrombosis occurred after the first year. Similarly, there were no cardiovascular deaths, TVR and TLR in the DCB-combined strategy group after 5 years. In contrast, during the period from year 5 to 8, the BMS group experienced an additional cardiovascular death, as well as one case of TVR, one case of TLR, and one case of stent thrombosis. In STEMI patients, the DCB-combined strategy maintains its safety and clinical efficacy over time. Our rates of TVR, TLR, and very late stent thrombosis (VLST) at very long-term are the lowest ever found in a STEMI trial. Further studies are warranted to assess the potential superiority of this novel strategy as compared with new-generation DES to prevent very late events in these patients. ClinicalTrials.gov; identifier: NCT01839890.

Outcome of percutaneous coronary intervention using ultrathin-strut biodegradable polymer sirolimus-eluting versus thin-strut durable polymer zotarolimus-eluting stents in patients with comorbid peripheral arterial disease: a post-hoc analysis from two randomized trials.

In patients with peripheral arterial disease (PADs), who underwent percutaneous coronary intervention (PCI), little is known about the potential impact of using different new-generation drug-eluting stents (DES) on outcome. In PCI all-comers, the results of most between-stent comparisons-stratified by strut thickness-suggested some advantage of coronary stents with ultrathin-struts. The current post-hoc analysis aimed to assess outcomes of PCI with ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) vs. thin-strut durable polymer zotarolimus-eluting stents (DP-ZES) in patients with PADs. We pooled 3-year patient-level data from two large-scale randomized all-comer trials to compare Orsiro ultrathin-strut BP-SES vs. Resolute-type thin-strut DP-ZES in trial participants with concomitant PADs. BIO-RESORT (December 2012 to August 2015) and BIONYX (October 2015 to December 2016) included all-comer patients who were aged 18 years or older, capable of providing informed consent, and required a PCI. The trials had web-based randomization, with block sizes of 4 and 8, performed in a 1:1:1 or 1:1 fashion. Assessors, research staff, and patients were blinded to the type of stent used. We assessed the composite main clinical endpoint target vessel failure [TVF: cardiac death, target vessel related myocardial infarction (MI), or clinically indicated target vessel revascularization (TVR)], its components, and stent thrombosis. Of 4,830 trial participants, 360 had PADs: 177 (49.2%) were treated with BP-SES and 183 (50.8%) with DP-ZES. Baseline characteristics were similar. For BP-SES, the 3-year TVF rate was 11.0% and for DP-ZES 17.9% [hazard ratio (HR): 0.59, 95% CI: 0.33-1.04; P=0.07]. For BP-SES, the TVR rate was lower than for DP-ZES (4.1% vs. 11.0%; HR: 0.36, 95% CI: 0.15-0.86; P=0.016), but this did not translate into between-group differences in cardiac death or MI. In small vessels (<2.75 mm), the TVR rate was also lower in BP-SES (5.6% vs. 13.9%; HR: 0.32, 95% CI: 0.11-0.91; P=0.024). Definite-or-probable stent thrombosis rates were 1.2% and 2.3% (P=0.43). In PCI patients with PADs, the 3-year TVF incidence was numerically lower in the ultrathin-strut BP-SES vs. the thin-strut DP-ZES group. Furthermore, TVR risk was significantly lower in ultrathin-strut BP-SES, mainly driven by a lower TVR rate in small vessels. BIO-RESORT trial: clinicaltrials.gov (NCT01674803); BIONYX trial: clinicaltrials.gov (NCT02508714).

Long term clinical outcome after success re-attempt percutaneous coronary intervention of chronic total occlusion

BackgroundTo evaluate the long-term outcome after re-attempt CTO-PCI.MethodsThis is a retrospective cohort study that included 113 re-attempt CTO-PCI patients who were consecutively registered from January 2019 to December 2020 at Beijing Anzhen Hospital's Center of Coronary Artery Disease. All patients were divided into two groups based on procedural success or failure. The primary endpoint was major adverse cardiac events (MACE), a composite of all-cause mortality, myocardial infarction and target vessel revascularization (TVR). The secondary endpoint was angina after PCI.ResultsOverall, the successful re-attempt CTO-PCI was archived in 77 patients, the failed CTO-PCI was performed in 36 patients. After a median follow-up of 21.7 months (interquartile range: 10.9–26.0), the incidence of the primary outcome was significantly lower in the success group [14.2% vs. 38.9%, adjusted hazard ratio (HR) 0.351, 95% CI 0.134–0.917, P = 0.033], mainly driven by the reduction of TVR (9.1% vs. 30.6%, adjusted HR 0.238, 95% CI: 0.078–0.72, P = 0.011). Furthermore, patients who had successful re-attempt CTO-PCI had a lower risk of angina after PCI (27.3% vs.61.1%, adjusted HR 0.357, 95% CI 0.167–0.76, P = 0.008). The risk factors of TVR in the patients with successful re-attempt CTO-PCI were stent length > 100 mm (adjusted HR 21.805, 95% CI 1.765–269.368, P = 0.016) and J-CTO score > 3(adjusted HR: 9.733, 95% CI:1.533–61.797, P = 0.016).ConclusionsFor the patients with previous CTO-PCI failure, a successful re-attempt CTO-PCI was associated with significantly lower MACE, which was primarily driven by a lower TVR rate. More complex CTO lesions and longer stents were the independent predictors of TVR after successful CTO-PCI.

Invasive versus conservative management in spontaneous coronary artery dissection: a meta-analysis and meta-regression study

Abstract Background There is a paucity of data regarding the best treatment for spontaneous coronary artery dissection (SCAD). Purpose To compare the prognostic impact of conservative versus invasive treatment in patients with SCAD. Methods We systematically searched the literature for studies evaluating the comparative efficacy and safety of invasive revascularization versus medical therapy for the treatment of SCAD from 1990 to 2019. Random-effect meta-analysis was performed comparing clinical outcomes between the two groups. Results 24 observational studies with 1720 patients were included. After 28±14 months, a conservative approach reduced target vessel revascularization rate compared with invasive treatment (OR=0.50; 95% CI 0.28–0.90; P=0.02). No difference was found regarding all-cause mortality (OR=0.81; 95% CI 0.31–2.08; P=0.66), cardiovascular mortality (OR=0.89; 95% CI 0.15–5.40; P=0.89), myocardial infarction (OR=0.95; 95% CI 0.50–1.81; P=0.87), heart failure (OR 0.96; 95% CI 0.41–2.22; P=0.92) and SCAD recurrence (OR=0.94; 95% CI 0.52–1.72; P=0.85). The meta-regression analysis suggested that male gender, diabetes mellitus, smoking habit, prior coronary artery disease, left main coronary artery involvement and lower ejection fraction at admission are related with higher overall mortality, whereas SCAD recurrence was higher among patients with fibromuscular dysplasia. Conclusion A conservative approach provides similar clinical outcomes and lower target vessel revascularization rates compared to an invasive strategy in the setting of SCAD; therefore, when feasible, it should be preferred in this scenario. Forest plots on the study outcomes Funding Acknowledgement Type of funding source: None

Outcomes following percutaneous coronary revascularization among South Asian and Chinese Canadians

BackgroundPrevious data suggest significant ethnic differences in outcomes following percutaneous coronary revascularization (PCI), though previous studies have focused on subgroups of PCI patients or used administrative data only. We sought to compare outcomes in a population-based cohort of men and women of South Asian (SA), Chinese and “Other” ethnicity.MethodsUsing a population-based registry, we identified 41,792 patients who underwent first revascularization via PCI in British Columbia, Canada, between 2001 and 2010. We defined three ethnic groups (SA, 3904 [9.3%]; Chinese, 1345 [3.2%]; and all “Others” 36,543 [87.4%]). Differences in mortality, repeat revascularization (RRV) and target vessel revascularization (TVR), at 30 days and from 31 days to 2 years were examined.ResultsAdjusted mortality from 31 days to 2 years was lower in Chinese patients than in “Others” (hazard ratio [HR] 0.72; 95% confidence interval [CI] 0.53-0.97), but not different between SAs and “Others”. SA patients had higher RRV at 30 days (adjusted odds ratio [OR] 1.30; 95% CI: 1.12-1.51) and from 31 days to 2 years (adjusted hazard ratio [HR] 1.17; 95% CI: 1.06-1.30) compared to “Others”. In contrast, Chinese patients had a lower rate of RRV from 31 days to 2 years (adjusted HR 0.79; 95% CI: 0.64-0.96) versus “Others”. SA patients also had higher rates of TVR at 30 days (adjusted OR 1.35; 95% CI: 1.10-1.66) and from 31 days to 2 years (adjusted HR 1.19; 95% CI: 1.06-1.34) compared to “Others”. Chinese patients had a lower rate of TVR from 31 days to 2 years (adjusted HR 0.76; 95% CI: 0.60-0.96).ConclusionsSA had higher RRV and TVR rates while Chinese Canadians had lower rates of long-term RRV, compared to those of “Other” ethnicity. Further research to elucidate the reasons for these differences could inform targeted strategies to improve outcomes.

Long-Term Safety of Drug-Eluting and Bare-Metal Stents: Evidence From a Comprehensive Network Meta-Analysis

BackgroundPrevious meta-analyses have investigated the relative safety and efficacy profiles of different types of drug-eluting stents (DES) and bare-metal stents (BMS); however, most prior trials in these meta-analyses reported follow-up to only 1 year, and as such, the relative long-term safety and efficacy of these devices are unknown. Many recent studies have now reported extended follow-up data. ObjectivesThis study sought to investigate the long-term safety and efficacy of durable polymer-based DES, bioabsorbable polymer-based biolimus-eluting stents (BES), and BMS by means of network meta-analysis. MethodsRandomized controlled trials comparing DES to each other or to BMS were searched through MEDLINE, EMBASE, and Cochrane databases and proceedings of international meetings. Information on study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. ResultsFifty-one trials that included a total of 52,158 randomized patients with follow-up duration ≥3 years were analyzed. At a median follow-up of 3.8 years, cobalt-chromium everolimus-eluting stents (EES) were associated with lower rates of mortality, definite stent thrombosis (ST), and myocardial infarction than BMS, paclitaxel-eluting stents (PES), and sirolimus-eluting stents (SES) and less ST than BES. Phosphorylcholine-based zotarolimus-eluting stents had lower rates of definite ST than SES and lower rates of myocardial infarction than BMS and PES. The late rates of target-vessel revascularization were reduced with all DES compared with BMS, with cobalt-chromium EES, platinum chromium-EES, SES, and BES also having lower target-vessel revascularization rates than PES. ConclusionsAfter a median follow-up of 3.8 years, all DES demonstrated superior efficacy compared with BMS. Among DES, second-generation devices have substantially improved long-term safety and efficacy outcomes compared with first-generation devices.

Meta-analysis of minimally invasive coronary artery bypass versus drug-eluting stents for isolated left anterior descending coronary artery disease

To compare the outcomes between minimally invasive coronary artery bypass (MINI-CAB) and drug-eluting stent (DES) implantation for isolated left anterior descending artery disease. Randomized and observational comparative publications were identified using MEDLINE and Google Scholar databases (January 2003 to December 2013). Studies without outcomes data, without DES use, or using conventional bypass surgery were excluded. The outcomes of interest were cardiac death, myocardial infarction, target vessel revascularization, and periprocedural stroke. Data were compared using the Mantel-Haenszel methods and are presented as odds ratios (ORs), 95% confidence intervals (CIs), and number needed to treat. From 230 publications, we identified 4 studies (2 randomized and 2 observational) with 941 patients (478 had undergone MINI-CAB and 463 DES implantation). The incidence of target vessel revascularization at maximum follow-up (range, 6-60 months) was significantly lower in the MINI-CAB group (OR, 0.16; 95% CI, 0.08-0.30; P<.0001; number needed to treat, 13). The incidence of cardiac mortality and MI was similar between the MINI-CAB and DES groups during follow-up (OR, 1.05; 95% CI, 0.44-2.47; and OR, 0.83; 95% CI, 0.43-1.58, respectively). In addition, a similar incidence of periprocedural death (OR, 0.85; 95% CI, 0.21-3.47; P=.82), myocardial infarction (OR, 0.98; 95% CI, 0.38-2.58; P=.97), and stroke (OR, 1.36; 95% CI, 0.28-6.70; P=.70) was observed between the 2 treatment modalities. Given the available evidence, MINI-CAB will result in lower target vessel revascularization rates but otherwise similar clinical outcomes compared with DESs in patients with left anterior descending artery disease.

Clinical Outcomes With Bioabsorbable Polymer- Versus Durable Polymer-Based Drug-Eluting and Bare-Metal Stents: Evidence From a Comprehensive Network Meta-Analysis

This study sought to investigate the relative safety and efficacy of bioabsorbable polymer (BP)-based biolimus-eluting stents (BES) versus durable-polymer (DP)-drug-eluting stents (DES) and bare-metal stents (BMS) by means ofa network meta-analysis. Studies have suggested that BP-BES might reduce the risk of stent thrombosis (ST) and late adverse outcomes compared with first-generation DES. However, the relative safety and efficacy of BP-BES versus newer-generation DES coated with more biocompatible DP have not been investigated in depth. Randomized controlled trials comparing BP-BES versus currently U.S.-approved DES or BMS were searched through MEDLINE, EMBASE, and Cochrane databases. Information on study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. Data from 89 trials including 85,490 patients were analyzed. At 1-year follow-up, BP-BES were associated with lower rates of cardiac death/myocardial infarction (MI), MI, and target vessel revascularization (TVR) than BMS and lower rates of TVR than fast-release zotarolimus-eluting stents. The BP-BES had similar rates of cardiac death/MI, MI, and TVR compared with other second-generation DP-DES but higher rates of 1-year ST than cobalt-chromium everolimus-eluting stents (CoCr-EES). The BP-BES were associated with improved late outcomes compared with BMS and paclitaxel-eluting stents, considering the latest follow-up data available, with nonsignificantly different outcomes compared with other DP-DES although higher rates of definite ST compared with CoCr-EES. In this large-scale network meta-analysis, BP-BES were associated with superior clinical outcomes compared with BMS and first-generation DES and similar rates of cardiac death/MI, MI, and TVR compared with second-generation DP-DES but higher rates of definite ST than CoCr-EES.

ACEF score in the risk stratification of patients undergoing percutaneous coronary interventions of chronic coronary total occlusion

Purpose: The Age, Creatinine, and Ejection Fraction (ACEF) score can reliably predict clinical outcomes in patients undergoing elective coronary artery bypass surgery. However, its utility in patients undergoing percutaneous coronary intervention of a chronic total occlusion is not known. Methods: ACEF score was calculated in 308 consecutive patients treated with PCI of CTO between January 2008 and June 2012. Patients with successful recanalization of CTO were divided according to the ACEF score tertiles: ACEFlow ≤ 0.89 (n=80, 26%), ACEFmid 0.90-1.10 (n=68, 22%), and ACEFhigh > 1.10 (n=73, 24%). Patients with failed recanalization were excluded from the analysis (n=87 [28%]). Follow up was available in 206 patients (93%) with a median of 25 months (10-37). Clinical endpoints assessed at the follow-up were major adverse cardiovascular events (MACE), overall death, non-fatal myocardial infarction (MI) and target vessel revascularization (TVR). Results: The 3 groups did not differ significantly with respect to the angiographic characteristics. At the follow-up, MACE rate was significantly lower in the lowest ACEF score tertile (ACEFlow = 7%, ACEFmid = 14%, ACEFhigh = 21%, HR: 0.46 (0.26-0.81), p<0.01). At Kaplan-Mayer analysis, MACE-free survival was significantly higher in the lowest ACEF score tertiles (Log-Rank: 5.36, p<0.01). This difference in outcome was mainly driven by lower TVR rate in the ACEFlow group (ACEFlow = 3%, ACEFmid = 9%, ACEFhigh = 15%, HR: 0.47 (0.25-0.87), p=0.02). No significant difference was found both in death and non-fatal MI. Conclusions: ACEF score represents a simple tool in the prognostication of patients treated with PCI of CTO. In addition, it provides the evidence about the benefit of revascularization of a CTO in patients with the lowest ACEF score.

Two-Year Follow-Up of Outcomes of Second-Generation Everolimus-Eluting Stents Versus First-Generation Drug-Eluting Stents for Stenosis of Saphenous Vein Grafts Used as Aortocoronary Conduits

Second-generation everolimus-eluting stents (EESs) have demonstrated superiority in efficacy and safety compared with first-generation drug-eluting stents (DESs) in the treatment of native coronary artery lesions. The present study evaluated and compared the safety and efficacy of EESs and first-generation DESs in saphenous vein graft lesions. The EES group consisted of 88 patients with 96 lesions, and the first-generation DES group consisted of 243 patients with 317 lesions (sirolimus-eluting stents, n = 212; paclitaxel-eluting stents, n = 105). The end points included target lesion revascularization, target vessel revascularization, major adverse cardiovascular events (composite of all-cause death, myocardial infarction, and target vessel revascularization), and definite stent thrombosis at 2 years. The groups had similar baseline characteristics and graft ages (128.1 ± 77.5 vs 132.4 ± 90.8 months, p = 0.686). The EES group had more type C lesions and less embolic protection device use. The peak postprocedure values of creatinine kinase-MB and troponin I were similar between the 2 groups. Overall, major adverse cardiovascular events occurred in 18.2% of EES patients and 35.0% of first-generation DES patients (p = 0.003), mainly driven by a lower target vessel revascularization rate (6.8% vs 24.5%, p <0.001). The target lesion revascularization rate was lower in the EES group (1.1% vs 11.6%, p = 0.005). Stent thrombosis was low and similar between the 2 groups (0% vs 0.8%, p = 1.000). On multivariate analysis, the type of DES implanted and graft age were the only independent predictors of major adverse cardiovascular events. In conclusion, the superiority of EESs compared with first-generation DESs shown in native artery lesions has been extended to saphenous vein graft lesions and should be considered as the DES of choice for this lesion type.

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.

A comparative analysis of major clinical outcomes using drug‐eluting stents versus bare metal stents in diabetic versus nondiabetic patients

We aim to explore the clinical outcome of drug-eluting stents (DES) versus bare-metal stents (BMS) implantation in diabetics versus nondiabetic patients. Diabetic patients sustain worse long-term clinical outcomes after percutaneous coronary interventions (PCI) when compared with nondiabetics. The use of DES decreases the rate of repeat revascularization in this population but data concerning long-term clinical benefits, such as myocardial infarction (MI) or mortality is scant. We analyzed data from a comprehensive registry of 6,583 consecutive patients undergoing PCI at our center. A propensity score was used for analysis of outcomes and for matching (DES vs. BMS). Outcome parameters were total mortality, MI, repeat target vessel revascularization (TVR) rates, and risk-adjusted event-free survival. Within this cohort, we identified 2,571 nondiabetic patients and these were compared with 1,826 diabetic coronary patients. Mean and median follow up time was 3 and 3.25 years, respectively. Overall, diabetics had higher rates of major-adverse cardiovascular events (MACE) at 4 years compared with nondiabetics (23.03 vs. 31.96 P > 0.001). DES use was associated with lower rates of TVR in both groups [diabetics hazard ratio (HR) = 0.56, 95% confidence interval (CI): 0.42-0.76, P < 0.001, nondiabetics HR = 0.73, 95% CI: 0.55-0.97, P = 0.03] while sustained decreased rates of both mortality and MI were evident solely among diabetics (HR = 0.71, 95% CI: 0.56-0.89, P = 0.004 in diabetic vs. HR = 0.88, 95% CI: 0.69-1.13, P = 0.3). In a "real-world," unselected population and extended clinical use, DES in diabetics was associated with sustained decreased rates of MI, death, TVR, and MACE while this benefit was attenuated in the nondiabetic population.

Drug-Eluting Stents vs. Bare Metal Stents in Saphenous Vein Graft Disease - Insights From a Meta-Analysis of 7,090 Patients -

Evidence supporting the use of drug-eluting stents (DES) in saphenous vein graft (SVG) disease is uncertain. Previous studies have suggested that DES might reduce the re-intervention rate in SVG disease, with conflicting data on mortality. Thus, a meta-analysis was performed to compare outcomes of DES vs. bare metal stent (BMS) in SVG disease. Medline and Web databases were searched for studies comparing DES and BMS for SVG disease, reporting rates of overall mortality, target vessel revascularization (TVR) and myocardial infarction (MI) with a follow-up of ≥6 months. The meta-analysis included 23 studies (7,090 patients). Compared with BMS, DES-treated patients had lower rates of TVR (odds ratio (OR), 0.53; confidence interval (CI), 0.39-0.72; P<0.0001) and overall mortality (OR, 0.63; CI, 0.40-0.99; P=0.05), but similar rates of MI (OR, 0.92; CI, 0.64-1.33; P=0.7). Subgroup analysis highlighted differences between non-randomized studies, in which DES improved mortality rates, and randomized trials, in which benefit from DES was not evident. Meta-regression analysis showed that DES were more effective in the presence of older grafts and type 2 diabetes. The present meta-analysis showed that, in SVG disease, DES significantly reduced TVR, but did not provide clear benefits on mortality and MI, with an opposite direction of results in mortality observed from randomized and observational data.

THE USE OF BARE-METALS STENTS IN PRIMARY PERCUTANEOUS CORONARY INTERVENTION FOR ACUTE MYOCARDIAL INFARCTION: IS THERE A DIFFERENCE IN CLINICAL OUTCOME BETWEEN COBALT CHROMIUM VERSUS STAINLESS STEEL STENTS?

Background: The use of DES results in lower risk of target vessel revascularization (TVR) compared to bare metal stents (BMS) following primary PCI for patients with acute ST-elevation myocardial infarction (STEMI). However, BMS are more commonly implanted compared to DES due to concerns of poor compliance to dual antiplatelet therapy, risk of late stent thrombosis and increased cost. Newer generation BMS based on cobalt chromium alloy have thinner stent struts, better deliverability and potentially lower rates of TVR compared with conventional stainless steel BMS. Therefore we aim to determine the clinical outcome and rates of TVR in patients undergoing primary PCI for STEMI who were treated with cobaltchromium stents compared to stainless steel stents.

Stent choice in primary percutaneous coronary intervention: drug-eluting stents or bare metal stents?

The controversial choice between bare metal stents and drug-eluting stents (DES) in primary percutaneous coronary intervention (PCI) seems to be driven by a growing body of evidence. Although evidence supporting the use of DES in the setting of ST-segment elevation myocardial infarction (STEMI) has been demonstrated, including a lower target vessel revascularization (TVR) rate without increased mortality, at present the proportion of DES implants in STEMI patients is low. This may be due to higher costs of DES, cultural issues, lack of concerns about restenosis in STEMI, lack of information on patient bleeding risk and the need for surgery within a limited time. In addition, initial enthusiasm about the efficacy of DES in reducing restenosis is now decreasing as a result of the safety concerns regarding in-stent thrombosis. Moreover, DES requires long-term dual antiplatelet therapy (DAT), which may pose problems in patients prone to bleeding or in candidates for elective surgery. Nevertheless, benefits associated with use of DES include significantly lower TVR rates without remarkable adverse effects in terms of death and myocardial infarction. Data about the efficacy of DES are still limited to 1-year follow-up in most trials. Uncoated stents permit early arterial wall healing, requiring a shorter duration of DAT and are potentially associated with a reduced risk of thrombus formation at long-term follow-up. Importantly, however, this potential late threat has not been confirmed in recent data from the limited number of studies with longer than 2-years follow-up. Anatomical features and individual risk profiles can sometimes help in the choice of the most suitable type of stent. In conclusion, stent choice in primary PCI cannot be standardized for all patients and appears to be influenced by various factors that need to be considered to provide better revascularization in terms of both efficacy and safety.

Outcome Differences With the Use of Drug-Eluting Stents for the Treatment of In-Stent Restenosis of Bare-Metal Stents Versus Drug-Eluting Stents

Drug-eluting stent (DES) implantation is the standard treatment for patients with bare-metal stent (BMS) in-stent restenosis (ISR) and is associated with low rates of target-vessel revascularization. Outcomes in patients with DES ISR treated using repeated DES placement are less certain. A total of 119 patients who presented with BMS ISR and 119 patients with DES ISR matched for baseline characteristics were evaluated. Both groups of patients were treated using DESs and compared with regard to major adverse cardiac events, including death, myocardial infarction, and target-vessel revascularization, at 1 year. Baseline characteristics were similar between groups. Compared with patients with BMS ISR, those with DES ISR had similar 1-year rates of death (5.1% BMS ISR vs 3.5% DES ISR; p = 0.75) and myocardial infarction (2.6% BMS ISR vs 3.5% DES ISR; p = 0.72) when treated using DESs. However, at 1 year, patients with DES ISR experienced significantly higher rates of target-vessel revascularization (10.3% BMS ISR vs 22.2% DES ISR; p = 0.01), with a trend toward increased overall major adverse cardiac events, including death, myocardial infarction, and target-vessel revascularization (16.0% BMS ISR vs 25.2% DES ISR; p = 0.08). Stent thrombosis occurred with similar frequency in both groups (2.5% BMS ISR vs 0.8% DES ISR; p = 0.62). In conclusion, DES ISR continues to be a therapeutic challenge because patients with DES ISR treated using DESs experience higher rates of recurrence compared with patients with BMS ISR treated using DESs. The optimal treatment of patients with DES restenosis remains to be defined.

Long-term Clinical Outcomes Following Coronary Stenting

Clinical trials of drug-eluting stents (DES) vs bare metal stents (BMS) report a reduced need for target lesion revascularization with no difference in death or myocardial infarction. However, these trials selectively enrolled patients with lower risk, single-vessel coronary artery disease (CAD) and limited the follow-up period to 1 year or less. Thus, it is not known how these short-term results apply to patients with higher risk, multivessel CAD seen in community practice settings. The objective of this study was to compare the long-term clinical outcomes of patients receiving DES vs BMS in a clinical practice setting. Patients from the Duke Databank for Cardiovascular Disease undergoing their initial revascularization with DES or BMS from January 1, 2000, through July 31, 2005, were included in the study population. Propensity scores and inverse probability weighted estimators were used to adjust for treatment group imbalances. The study population included 1501 patients who received DES and 3165 who received BMS. After adjustment, DES reduced target vessel revascularization (TVR) rates at 6, 12, and 24 months compared with BMS (24-month rates: DES, 6.6%; BMS, 16.3%; difference, -9.7%; 95% confidence interval [CI], -11.7% to -7.7%; P < .001). The TVR benefit for DES increased among patients with multivessel CAD (1-vessel CAD: -8.3%; 95% CI, -10.9% to -5.8%; P < .001; 2-vessel CAD: -9.7%; 95% CI, -3.6% to -5.8%; P < .001; 3-vessel CAD: -16.2%; 95% CI, -25.2% to -7.2%; P < .001). However, in the overall cohort there were no statistically significant differences in the composite of death or myocardial infarction. Patients receiving DES vs BMS in a clinical practice setting have lower TVR rates, albeit with less absolute benefit than those observed in clinical trials. Patients with multivessel vs single-vessel disease experience a greater reduction in TVR.

TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions

Drug-eluting stents (DESs) have shown to be effective in reducing in-stent restenosis, although data relating to long-term experience in treating more complex lesion subsets are limited. In order to assess the long-term safety and clinical efficacy of the polymer-based moderate release (MR) paclitaxel-eluting TAXUS MR stent in treatment of complex lesion subsets, we evaluated the 2-year follow-up of TAXUS VI. TAXUS VI was a randomized multi-centre study enrolling 446 patients with complex lesions, including small vessels in 28% of patients and a mean lesion length of 20.6 mm. At 9-month follow-up, the use of the TAXUS MR stent was highly effective, resulting in a significant 53% reduction of the target vessel revascularization (TVR) rate (primary endpoint) from 19.4% in the control group to 9.1% in the TAXUS group (P = 0.0027). Clinical follow-up at 2 years post-stenting was available in 98.6% of the TAXUS group and 95.6% of the control group. The incidence of major adverse cardiac event at 1- and 2-year follow-up was 16.4% and 21.3% in the TAXUS group when compared with 22.5 and 25.1% in the control group, respectively. A significant difference in TVR was maintained at 2-year follow-up (TAXUS 13.9%; control 21.9%; P = 0.0335). The cumulative 1- and 2-year survival rates free from TVR were, respectively, 91.7 and 90.3% in the TAXUS group vs. 80.0 and 79.0% in the control group (log-rank P < 0.001). The number of patients required to be treated with a TAXUS stent to prevent one re-percutaneous coronary intervention at 2 years was 12.5. Treatment of complex coronary lesions with the polymer-based MR paclitaxel-eluting TAXUS MR stent is associated with a sustained clinical benefit and low rates of TVR up to 2 years after device implantation.

Safety and efficacy with drug‐eluting stent in st‐segment elevation and non‐ST‐segment elevation myocardial infarction

Drug-eluting stents (DES) have been shown to reduce the need for repeat revascularization compared with bare metal stents (BMS). However, there is little information regarding the safety and long-term efficacy of DES in patients with acute myocardial infarction (AMI). The aim of this study was to evaluate the safety and efficacy of DES in patients with AMI. Data from 211 consecutive patients with AMI treated with DES were compared with those from 228 consecutive patients with AMI treated with BMS. All patients were treated within 7 days of symptom onset. The incidence of major adverse cardiovascular events ([MACE]: death, reinfarction, and target vessel revascularization) was evaluated at 30 days and 1 year. Baseline clinical and angiographic characteristics were similar for both stent groups. However, patients who received DES had longer lesion lengths (23.0 +/- 12.7 vs. 18.8 +/- 10.6 mm, respectively; p < 0.001) and smaller reference diameters (2.97 +/- 0.52 vs. 3.19 +/- 0.63 mm, respectively, p < 0.001). At 30 days, the incidence rates of MACE (DES vs. BMS: 2.2 vs. 1.9%, p = 1.000) and stent thrombosis (BMS vs. DES: 0.9 vs. 1.7%; p = 0.434) did not differ significantly between the groups. At 1 year, patients with DES had a lower rate of MACE (BMS vs. DES: 14.0 vs. 6.6%; p = 0.011) primarily due to a lower target vessel revascularization rate (BMS vs. DES: 9.6 vs. 4.8%; p = 0.028). The DES appear to be superior to the BMS in reducing the risk of MACE in patients with AMI.

Adjunctive Balloon Postdilatation after Stent Deployment: Is It Still Necessary with Drug‐Eluting Stents?

Deployment of bare metal stents (BMS) with current stent delivery systems is often associated with suboptimal stent expansion. Adjunctive postdilatation with noncompliant balloons has improved stent expansion with BMS and has been associated with less need for target vessel revascularization (TVR). Drug-eluting stents (DES) have proven highly effective in reducing restenosis and TVR and are now being used in the great majority of percutaneous coronary interventions. Because of the very low rates of TVR with DES, many operators have felt that postdilatation may no longer be necessary. In this review, we present data showing that stent expansion of DES (like BMS) using current stent delivery systems is frequently suboptimal. Furthermore, smaller mimimal stent area (MSA) and stent underexpansion following deployment of DES are strong predictors of stent thrombosis and TVR. Adjunctive postdilatation with noncompliant balloons can increase MSA and decrease the frequency of suboptimal stent deployment and potentially can reduce the frequency of stent thrombosis and TVR. Despite the lack of evidence from randomized clinical trials, we believe the observational data support the use of adjunctive balloon postdilatation following deployment of DES in the great majority of patients.