1-year Target Vessel Revascularization Research Articles

Predictive value of post-percutaneous coronary intervention fractional flow reserve: a systematic review and meta-analysis.

We aimed to investigate the relationship between post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) and clinical outcome using a systematic review with a study-level meta-analysis. MEDLINE, Embase, and CENTRAL were systematically searched for articles with clinical follow-up reporting mean or median final post-PCI FFR. The main outcome was a composite of major adverse cardiac events (MACE) including all-cause death, myocardial infarction (MI), and target vessel revascularization (TVR). Meta-regression analyses were performed on mean post-PCI FFR values. A total of 62 studies with 12340 patients and 12923 stented vessels were included, with follow-ups ranging from 1 to 89 months. Post-PCI FFR was not continuously associated with the rate of 1-year MACE or 1-year TVR using meta-regression models accounting for heterogeneous follow-up lengths. For studies comparing high vs. low post-PCI FFR, low post-PCI FFR was associated with high risk ratio for MACE {1.97 [95% confidence interval (CI):1.45-2.67]}, all-cause death [1.59 (95% CI: 1.08-2.34)], MI [3.18 (95% CI: 1.84-5.50)], TVR [2.08 (95% CI: 1.63-2.65)] and angina status [2.50 (95% CI: 1.53-4.06)] using different optimal cut-off values spanning from 0.80 to 0.95. We found no clear continuous association between post-PCI FFR and clinical outcomes in this systematic study-level meta-analysis. In a subset of studies investigating binary classification, high post-PCI FFR was associated with a better clinical outcome than low post-PCI FFR.We investigated the relationship between post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) and rate of major adverse cardiac events (MACE), including all-cause death, myocardial infarction (MI), and target vessel revascularization (TVR), using a systematic review and study-level meta-analysis, pooling 12340 patients from 62 studies. Mean post-PCI FFR was not continuously associated with a 1-year MACE rate accounting for heterogenous follow-up lengths. Still, the risk ratio favoured high post-PCI FFR for reduced MACE, all-cause death, MI, TVR, and better angina status using different cut-offs.

Temporal Trends in Complex Percutaneous Coronary Interventions.

BackgroundAccumulated experience combined with technological advancements in percutaneous coronary interventions (PCI) over the past four decades, has led to a gradual increase in PCI utilization and complexity. We aimed to investigate the temporal trends in PCI complexity and the outcomes of complex PCI (C-PCI) in our institution.MethodsWe analyzed 20,301 consecutive PCI procedures performed over a 12-year period. C-PCI was defined as a procedure involving at least one of the following: Chronic total occlusion (CTO), left main (LM), bifurcation or saphenous vein graft (SVG) PCI. Four periods of 3-year time intervals were defined (2008–10, 2011–2013, 2014–2016, 2017–2019), and temporal trends in the rate and outcomes of C-PCI within these intervals were studied. Endpoints included mortality and major adverse cardiac events [MACE: death, acute myocardial infarction (MI), and target vessel revascularization (TVR)] at 1 year.ResultsA total of 5,647 (27.8%) C-PCI procedures were performed. The rate of C-PCI has risen significantly since 2,017 (31.2%, p < 0.01), driven mainly by bifurcation and LM interventions (p < 0.01). At 1-year, rates of death, acute MI, TVR and MACE, were all significantly higher in the C-PCI group (8.8 vs. 5.1%, 5.6 vs. 4.5%, 5.5 vs. 4.0%, 17.2 vs. 12.2%, p < 0.001 for all, respectively), as compared to the non-complex group. C-PCI preformed in the latter half of the study period (2014–2019) were associated with improved 1-year TVR (4.4% and 4.8% vs. 6.7% and 7.1%, p = 0.01, respectively) and MACE (13.8% and 13.5% vs. 17.3% and 18.2%, p = 0.001, respectively) rates compared to the earlier period (2007–2013). Death rate had not significantly declined with time.ConclusionIn the current cohort, we have detected a temporal increase in PCI complexity coupled with improved 1-year clinical outcomes in C-PCI.

Impact of high-density lipoprotein levels in males and females undergoing percutaneous coronary intervention with drug eluting stents

Abstract Background/Introduction Low levels of high-density lipoprotein (HDL) have been associated with adverse cardiovascular events in multiple epidemiological studies. Evidence regarding the role of HDL in males and females with established coronary artery disease undergoing percutaneous coronary intervention (PCI) with drug eluting stents (DES) is scarce. Purpose We sought to investigate the impact of low HDL levels on 1-year cardiovascular outcomes in males and females undergoing PCI with DES. Methods We screened all patients undergoing PCI in our center from 2012 to 2017. Exclusion criteria were: unavailable baseline HDL measurement, age &amp;lt;18 years, presentation with ST-segment elevation myocardial infarction (MI) or shock, coexisting neoplastic disease and treatment without a stent or with a bare metal stent. The final population was divided by gender and further stratified to the high or low HDL group according to baseline HDL levels. Cut-offs were 40mg/dL in males and 50mg/dL in females, per the most recent ACC/AHA guideline recommendations. The primary endpoint of the analysis was major adverse cardiovascular events (MACE) at 1 year, defined as death, MI or target vessel revascularization (TVR). To account for potential clinical and anatomical confounders the outcomes were also adjusted for age, Caucasian ethnicity, hypertension, diabetes mellitus (DM), body mass index, smoking, prior MI, multi-vessel disease and type B2/C lesions. Results Out of the 10,843 patients included, 7,718 (71.2%) were male and 3,125 (28.8%) were female. Low HDL was noted in 58.5% of males and 63.8% of females. Patients with low HDL were younger and had a higher prevalence of DM, prior MI, smoking and multi-vessel disease. When comparing low to high HDL groups in terms of 1-year MACE a borderline significant difference was shown in males (7.4% vs. 6.0%; p-value=0.08) but not in females (7.7% vs 8.1%; p-value=0.90) [Panel A]. The numerically higher incidence of MACE in males with low HDL was primarily driven by TVR (5.4% vs 3.7%; p-value=0.005) while the rates of Death (1.4% vs. 1.3%; p=0.96) and MI (2.0% vs. 1.8%; p-value=0.89) were similar between the two groups. After adjustment the male low HDL subgroup remained at a higher risk for 1-year TVR but not 1-year MACE compared to the male high HDL subgroup [Panel B]. No difference for any individual component of MACE was shown between low and high HDL subgroups in females [Panel C]. Conclusion(s) High HDL levels were associated with a lower incidence of TVR and borderline reduction of MACE in male but not female patients undergoing PCI with DES. No difference was demonstrated in terms of death or MI between the high and low HDL subgroups at 1-year follow-up. Impact of HDL levels according to gender Funding Acknowledgement Type of funding source: None

Comparative Outcomes of Supera Interwoven Nitinol vs Bare Nitinol Stents for the Treatment of Femoropopliteal Disease: Insights From the XLPAD Registry

Purpose: To report a propensity score analysis comparing outcomes of the Supera interwoven nitinol stent to bare nitinol stents (BNS) in the femoropopliteal segment. Materials and Methods: A retrospective study was conducted utilizing data extracted from the Excellence in Peripheral Artery Disease (XLPAD) registry (ClinicalTrials.gov identifier NCT01904851) on 871 patients (mean age 65.1 years; 713 men) who underwent femoropopliteal balloon angioplasty with either Supera stent implantation in 118 limbs or other contemporary BNS in 753 limbs between January 2006 and December 2016. All patients in both groups were matched for baseline demographic and clinical characteristics in a 1:1 propensity score matching using the nearest neighbor method to create the 118-patient matched BNS cohort. One-year outcomes included all-cause mortality, target vessel revascularization (TVR), and target limb revascularization (TLR). An additional core laboratory analysis was conducted to measure the deployed length of Supera stents. Results: In unmatched data, the Supera stent group had a numerically lower rate of TVR (7.6% vs 13.4%, p=0.08) and a significantly lower 1-year TLR rate (7.6% vs 16.2%, p=0.02) compared to the BNS group. Both groups had similar 1-year mortality (2.5% vs 2.7%, p=0.9). Kaplan-Meier analysis demonstrated that the Supera group had a significantly lower risk of TVR (p=0.02) and TLR (p=0.002) than the BNS group. After propensity matching, the 1-year TVR estimate was lower for Supera stents (7.6% vs 12.7%, p=0.08) and significantly lower for TLR (7.6% vs 13.6%, p=0.04) than the BNS group. There was no statistically significant association between Supera stent elongation (>10% of the labeled stent length) and 1-year risk of TLR (p=0.6). Conclusion: Supera stent usage in femoropopliteal intervention was associated with reduced risk of 1-year repeat target limb revascularization compared with BNS treatment in both unmatched and matched cohorts.

Systematic Review and Meta-Analysis of Balloon Angioplasty Versus Primary Stenting in the Infrapopliteal Disease

We performed a systematic review and meta-analysis of comparing balloon angioplasty and primary stenting for symptomatic infrapopliteal disease to evaluate the clinical value of primary stenting in treating infrapopliteal diseases. Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines were followed. PubMed (1984-present), ScienceDirect (1980-present), Embase (1990-present), and CBM (1988-present) databases were searched for relevant articles. Finally, 16 studies (published between 2001 and 2013) satisfying the inclusion criteria were identified. The outcome parameters were immediate technical success, 1-year primary patency rate, 1-year limb salvage rate, and 1-year target vessel revascularization (TVR)-free rate. Comparisons were made with balloon angioplasty and primary stenting, and based on the different types of stents, we divided the primary stent group into the bare metal stent (BMS) group and drug-eluting stent (DES) group. A total of 3789 patients and 4339 limbs constituted our final study population. The technical success rate of balloon angioplasty was 92.29% (95% confidence interval [CI] 88.75%-94.78%). Only 2 study reported the technical failure rates as 4% and 5.2% in the primary stent group. The pooled estimates of 1-year primary patency and TVR-free rate were similarly low in the balloon angioplasty group and BMS group (primary patency: 57.65%, 95% CI 53.54%-61.67% vs 60.95%, 95% CI 48.31%-72.28%, P = .38; TVR-free rate: 73.41%, 95% CI 66.51%-80.08% vs 73.66%, 95% CI 63.58%-81.75%, P = .91). The pooled estimates of 1-year primary patency and TVR-free rate in DES group were 81.10% (95% CI 75.48%-85.67%) and 90.30% (95% CI 85.30%-93.73%), respectively, which were better than those of the BMS and balloon angioplasty groups (P < .001 for both). The pooled estimate of 1-year limb salvage in the balloon angioplasty, BMS, and DES groups was 88.61% (95% CI 85.01%-91.43%), 94.41% (95% CI 89.52%-97.1%), and 95.20% (95% CI 86.97%-98.33%), respectively (P < .001). The BMS and DES groups had higher limb salvage rates than the balloon angioplasty group (P < .001 for both comparisons). The rates of severe complications were low both in the balloon angioplasty and in the primary stent groups. Primary BMS implantation had no advantage over balloon angioplasty in reducing restenosis or revascularization for infrapopliteal disease. Primary DES implantation seems to be a promising treatment for focal infrapopliteal lesions. Publication bias could not be ruled out, and the results should be treated with caution.

Clinical Outcomes With Drug-Eluting and Bare-Metal Stents in Patients With ST-Segment Elevation Myocardial Infarction: Evidence From a Comprehensive Network Meta-Analysis

The authors investigated the relative safety and efficacy of different drug-eluting stents (DES) and bare metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) using a network meta-analysis. The relative safety of DES and BMS in patients with STEMI continues to be debated, and whether advances have been made in this regard with second-generation DES is unknown. Randomized controlled trials comparing currently U.S. approved DES or DES with BMS in patients with STEMI were searched using MEDLINE, EMBASE, and Cochrane databases. Information on study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. Twenty-two trials including 12,453 randomized patients were analyzed. At 1-year follow-up, cobalt-chromium everolimus eluting stents (CoCr-EES) were associated with significantly lower rates of cardiac death or myocardial infarction (MI) and stent thrombosis (ST) than BMS. Differences in ST were apparent as early as 30 days and were maintained for 2 years. CoCr-EES were also associated with significantly lower rates of 1-year ST than paclitaxel-eluting stents (PES). Sirolimus-eluting stents (SES) were also associated with significantly lower rates of 1-year cardiac death/myocardial infarction than BMS. CoCr-EES, PES, and SES, but not zotarolimus-eluting stents, had significantly lower rates of 1-year target vessel revascularization (TVR) than BMS, with SES also showing lower rates of TVR than PES. In patients with STEMI, steady improvements in outcomes have been realized with the evolution from BMS to first-generation and now second-generation DES, with the most favorable safety and efficacy profile thus far demonstrated with CoCr-EES.

Use of Drug-Eluting Stents as a Function of Predicted Benefit

Benefits of drug-eluting stents (DES) in percutaneous coronary intervention (PCI) are greatest in those at the highest risk of target-vessel revascularization (TVR). Drug-eluting stents cost more than bare-metal stents (BMS) and necessitate prolonged dual antiplatelet therapy (DAPT), which increases costs, bleeding risk, and risk of complications if DAPT is prematurely discontinued. Our objective was to assess whether DES are preferentially used in patients with higher predicted TVR risk and to estimate if lower use of DES in low-TVR-risk patients would be more cost-effective than the existing DES use pattern. We analyzed more than 1.5 million PCI procedures in the National Cardiovascular Data Registry (NCDR) CathPCI registry from 2004 through 2010 and estimated 1-year TVR risk with BMS using a validated model. We examined the association between TVR risk and DES use and the cost-effectiveness of lower DES use in low-TVR-risk patients (50% less DES use among patients with <10% TVR risk) compared with existing DES use. There was marked variation in physicians' use of DES (range 2%-100%). Use of DES was high across all predicted TVR risk categories (73.9% in TVR risk <10%; 78.0% in TVR risk 10%-20%; and 83.2% in TVR risk >20%), with a modest relationship between TVR risk and DES use (relative risk, 1.005 per 1% increase in TVR risk [95% CI, 1.005-1.006]). Reducing DES use by 50% in low-TVR-risk patients was projected to lower US health care costs by $205 million per year while increasing the overall TVR event rate by 0.5% (95% CI, 0.49%-0.51%) in absolute terms. Use of DES in the United States varies widely among physicians, with only a modest correlation to patients' risk of restenosis. Less DES use among patients with low risk of restenosis has the potential for significant cost savings for the US health care system while minimally increasing restenosis events.

Abstract P350: Predicting the Restenosis Benefit of Drug-Eluting vs. Bare Metal Stenting Prior to Angiography: A Tool for Patients and Clinicians

Background: While drug-eluting stents (DES) are associated with lower restenosis rates compared with bare metal stents (BMS), they require prolonged thienopyridine use and may be associated with higher rates of stent thrombosis. Recent work has demonstrated that the absolute risk reductions of DES (i.e. the restenosis benefits) vary by clinical and angiographic features. However, to engage patients in the decision-making surrounding stent type, the benefits of alternative stents must be shared prior to angiography so that they can participate in a non-sedated state. To address this challenge, we created multivariable models based on clinical characteristics available prior to PCI to predict restenosis one-year after DES or BMS. Methods: Patients undergoing PCI in Massachusetts between 4/03 and 9/06 were identified and 1-year target vessel revascularization (TVR) outcomes determined. Parsimonious multivariable logistic regression models were constructed, using pre-angiographic data from NCDR versions 2 and 3, to identify clinical factors associated with TVR. The final models for DES and BMS consisted of 12 and 10 sociodemographic and clinical variables, respectively, chosen by backwards elimination while maintaining 95% of the predictive ability of the full models. We simulated random combinations of risk factors to determine the range of predicted restenosis benefit for DES vs. BMS. Results: A total of 19577 DES and 5255 BMS admissions were included in the development cohort and 9809 DES and 2597 BMS admissions were used in a validation cohort. The c-statistics for the models for predicting TVR after BMS and DES were 0.60 and 0.61 in the derivation cohorts, and 0.615 and 0.62 in the validation cohorts. Good calibration was observed in all models. Depending on the simulated clinical profile, the relative risk of TVR after BMS vs. DES ranged from &lt; 1.0 to &gt; 10. Conclusions: We generated multivariable models to predict TVR with DES or BMS based on clinical variables available prior to PCI that are comparable to previously published models that include procedural variables. The predicted relative risk of TVR for DES vs. BMS varies widely based on patients' clinical characteristics. These models may be useful in engaging patients in stent selection prior to PCI.

One-Year Outcomes from the TAXUS Express Stent Versus Cypher Stent

We compared 1-year outcomes in patients treated with paclitaxel-eluting stents (PESs) or sirolimus-eluting stents (SESs) in "real-world" clinical practice. Clinical outcomes were evaluated in 1,558 consecutive, unselected, retrospectively collected patients treated with drug-eluting stents (DESs; PES = 816, SES = 742) at 19 United States centers. The primary end point was 1-year target vessel revascularization (TVR). The study included a prespecified diabetic cohort (PES = 289, SES = 247), for which efficacy comparisons between DESs were analyzed according to vessel diameter and presence of chronic kidney disease. Baseline demographic, angiographic, and procedural characteristics were similar between patients treated with PESs and those treated with SESs. At 1 year, there were no overall statistical differences in death, myocardial infarction, TVR, or stent thrombosis. In the diabetic cohort, however, the cumulative incidence of TVR was significantly lower for patients treated with PESs (3%) compared with SESs (9%, p <0.01), which persisted after adjustment for baseline differences (hazard ratio 0.29, 95% confidence interval 0.12 to 0.67). This decrease in TVR with PES was similar in insulin- and noninsulin-requiring diabetic patients. In multivariate analysis, independent predictors of TVR included diabetes, bifurcation stenting, and overlapping stents; in the diabetic cohort, treatment with SESs was also a multivariate predictor of TVR. In conclusion, in this observational, retrospective analysis of DES-treated patients, PESs and SESs demonstrated similar overall safety and efficacy, but PESs were associated with a significant decrease in 1-year TVR rates in diabetic patients.

Revascularization (surgical or percutaneous) in patients with chronic total occlusions confers a significant survival advantage when compared to medical therapy

The aim of our study was to examine the trends in procedural success, in-hospital, and long-term outcomes after percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) over the last 25 years from a single PCI registry and to examine the impact of drug-eluting stents.The percutaneous treatment of CTO remains a major challenge. Past studies have used variable definitions of CTO, and there are limited data available from contemporary practice.We evaluated the outcomes of 1,262 patients from the Mayo Clinic registry who required PCI for a CTO. The patients were divided into 4 groups according to the time of their intervention: group 1 (percutaneous transluminal coronary angioplasty era), group 2 (early stent era), group 3 (bare-metal stent era), and group 4 (drug-eluting stent era).Procedural success rates were 51%, 72%, 73%, and 70% (p < 0.001), respectively, in the 4 groups. In-hospital mortality (2%, 1%, 0.4%, and 0%, p = 0.009), emergency coronary artery bypass grafting (15%, 3%, 2%, and 0.7%, p < 0.001), and rates of major adverse cardiac events (8%, 5%, 3%, and 4%, p = 0.052) decreased over time. During follow-up, the combined end point of death, myocardial infarction, or target lesion revascularization, was significantly lower in the 2 most recent cohorts compared with those patients treated before (p = 0.001 for trend). Technical failure to treat the CTO was not an independent predictor of long-term mortality (hazard ratio 1.16 [95% confidence interval 0.90 to 1.5], p = 0.25).Procedural success rates for CTO have not improved over time in the stent era, highlighting the need to develop new techniques and devices. Compared with the prestent era, in-hospital major adverse cardiac events and 1-year target vessel revascularization rates have declined by approximately 50%.

Impact of Stent Deployment Procedural Factors on Long-Term Effectiveness and Safety of Sirolimus-Eluting Stents (Final Results of the Multicenter Prospective STLLR Trial)

Drug-eluting stent failures were associated with various clinical factors. However, the clinical impact of stent deployment technique was unknown. This study was designed to evaluate the frequency and impact of suboptimal percutaneous coronary intervention on long-term outcomes of 1,557 patients treated with sirolimus-eluting stents (SESs) in 41 US hospitals. All steps of the interventional procedure were scrutinized by an independent core laboratory to determine the occurrence of geographic miss (GM). GM included longitudinal (LGM; injured or diseased segment not covered by SES) or axial GM (balloon-artery size ratio <0.9 or >1.3) mismatches. Patients with and without GM were stratified (GM vs no-GM group). Patients, investigators, and the independent clinical event adjudication committee were blind to study group assignments. The primary end point was 1-year target-vessel revascularization (TVR) rate. Incidences and predictors of GM and safety outcomes were secondary end points. GM occurred in 943 patients (66.5%): 47.6% had LGM, 35.2% had axial GM, and 16.5% had both. One-year TVR rates were 5.1% in the GM group versus 2.5% in the no-GM group (p=0.025). TVR was 6.1% in the LGM versus 2.6% in the no-LGM subgroups (p=0.001). The association of GM with 1-year TVR was independent of clinical or anatomic factors (hazard ratio 2.0, 95% confidence interval 1.0 to 4.02, p=0.05). There was a 3-fold increase in myocardial infarction rates associated with GM (2.4% vs 0.8%; p=0.04). In conclusion, GM occurred frequently during SES implantation and was associated with increased risk of TVR and myocardial infarction at 1 year. These results emphasized the need for improvement in contemporary percutaneous coronary intervention practices and technologies.

Trends in Outcomes After Percutaneous Coronary Intervention for Chronic Total Occlusions: A 25-Year Experience From the Mayo Clinic

The aim of our study was to examine the trends in procedural success, in-hospital, and long-term outcomes after percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) over the last 25 years from a single PCI registry and to examine the impact of drug-eluting stents. The percutaneous treatment of CTO remains a major challenge. Past studies have used variable definitions of CTO, and there are limited data available from contemporary practice. We evaluated the outcomes of 1,262 patients from the Mayo Clinic registry who required PCI for a CTO. The patients were divided into 4 groups according to the time of their intervention: group 1 (percutaneous transluminal coronary angioplasty era), group 2 (early stent era), group 3 (bare-metal stent era), and group 4 (drug-eluting stent era). Procedural success rates were 51%, 72%, 73%, and 70% (p < 0.001), respectively, in the 4 groups. In-hospital mortality (2%, 1%, 0.4%, and 0%, p = 0.009), emergency coronary artery bypass grafting (15%, 3%, 2%, and 0.7%, p < 0.001), and rates of major adverse cardiac events (8%, 5%, 3%, and 4%, p = 0.052) decreased over time. During follow-up, the combined end point of death, myocardial infarction, or target lesion revascularization, was significantly lower in the 2 most recent cohorts compared with those patients treated before (p = 0.001 for trend). Technical failure to treat the CTO was not an independent predictor of long-term mortality (hazard ratio 1.16 [95% confidence interval 0.90 to 1.5], p = 0.25). Procedural success rates for CTO have not improved over time in the stent era, highlighting the need to develop new techniques and devices. Compared with the prestent era, in-hospital major adverse cardiac events and 1-year target vessel revascularization rates have declined by approximately 50%.

“Full metal jacket” (stented length ≥64 mm) using drug-eluting stents for de novo coronary artery lesions

Stented segment length was a predictive factor for restenosis in the bare metal stent era. The objective of the study was to evaluate the medium-term clinical outcome and the potential for adverse effects when very long segments (ie, > or =64 mm of stented length) are treated by drug-eluting stent (DES) implantation, an approach colloquially referred to as a "full metal jacket." Since April 2002, we have used DES as the default stent for all percutaneous coronary interventions. From our prospective institutional database we identified 122 consecutive patients, with de novo coronary lesions, in whom a coronary artery was treated with at least 64 mm of overlapping DES: 81 patients were treated with sirolimus-eluting stents and 41 with paclitaxel-eluting stents. The mean number of stents per lesion was 3.3 +/- 1.1, and the median stented length was 79 mm (range 64-168 mm). Periprocedural Q-wave myocardial infarction (MI) occurred in 2 patients (1.6%) and subacute stent thrombosis in 1 patient (0.8%). During 1-year follow-up, 5 patients (4.1%), including 3 patients treated for acute MI with cardiogenic shock, died and 10 patients (8.2%) had nonfatal MI (creatine kinase-MB >3 times). The 1-year target vessel revascularization rate was 7.5% and the overall incidence of major adverse cardiac events was 18%. Outcomes in sirolimus-eluting stents and paclitaxel-eluting stents groups did not differ statistically. The use of DES for the treatment of diffuse lesions was associated with a low rate of repeat revascularization, irrespective of stent type. No safety concerns were raised at medium-term follow-up.

Impact of obesity on revascularization and restenosis rates after bare-metal and drug-eluting stent implantation (from the TAXUS-IV trial)

The effect of obesity on repeat coronary revascularization and restenosis in patients who undergo stent implantation has not been reported. We therefore examined the database from the multicenter randomized TAXUS-IV trial to determine the effect of body mass index (BMI) on outcomes after bare-metal and drug-eluting stent implantation. In TAXUS-IV, patients were randomized to receive a slow-release, polymer-based, paclitaxel-eluting stent or a bare-metal stent. Outcomes were stratified by baseline BMI. Of the 1,307 randomized patients who had documented BMI, 233 (17.8%) had normal weight (BMI <25 kg/m2), 531 (40.6%) were overweight (BMI < or =25 to 30 kg/m2), and 543 (41.5%) were obese (BMI > or =30 kg/m2). Patients who had been assigned to receive bare-metal stents and were overweight and obese compared with those who had normal weight had higher rates of 9-month binary restenosis (29.2% and 30.5% vs 9.3%, respectively; p = 0.01) and 1-year major adverse cardiac events (20.8% and 23.2% vs 11.1%, respectively; p = 0.02), whereas rates of these events did not differ significantly among those who received a paclitaxel-eluting stent (7.6% and 9.3% vs 4.9%, respectively for binary restenosis; p = 0.65; 11.3% and 10.4% vs 10.1%, respectively; p = 0.82 for major adverse cardiac events). By multivariate analysis, BMI > or =30.0 kg/m2 independently predicted binary restenosis (hazard ratio 4.26, p = 0.005), 1-year target vessel revascularization (hazard ratio 1.95, p = 0.04), and major adverse cardiac events (hazard ratio 1.95, p = 0.004) in patients who received bare-metal stents but not paclitaxel-eluting stents. In conclusion, obesity is an important risk factor for clinical and angiographic restenosis and for composite major adverse cardiac events in patients who receive bare-metal stents. Paclitaxel-eluting stents attenuate the increased risk associated with obesity, such that the intermediate-term prognosis after percutaneous coronary intervention is independent of weight.

Feasibility, safety, cost-effectiveness and 1 year follow-up of coronary stenting without predilation: a matched comparison with the standard approach

Background: We evaluated the feasibility, safety, procedural cost-effectiveness, radiation dose and time and 1-year target vessel revascularization rate of direct unprotected mounted stenting without previous balloon dilatation (DS) in native coronary artery lesions. Methods: DS was attempted in 119 patients; 39 had a recent myocardial infarction, 62 had unstable angina, and 18 had stable angina. The clinical follow-up was obtained at 14±5 months (range 6 to 24 months). These results were compared with those for a consecutive group of 160 patients matched for type and length of lesions and who had a stent only if the post-balloon residual stenosis was >30%. Results: The feasibility of DS was 112/119 (94%). The number of inflations, the length of the stent/length of the lesion ratio, the time and the dose of radiation were dramatically lower in the DS group ( P<0.001). DS conferred a slight reduction in procedure-related cost [$820±157 for DS vs. 894±427 for standard dilatation (SD) per patient]. The 1-year target vessel revascularization rate was similar in both groups [nine (8%) for DS vs. 17 (11%) patients for SD, ns]. Conclusions: DS is feasible and safe in selected coronary lesions. This method provides a low rate of repeat revascularization and reduces the time and the dose of radiation compared with the standard approach.