Morphological changes and clinical impact of unstable plaques within untreated segments of acute myocardial infarction patients during a 3-year follow-up: an analysis from the HORIZONS-AMI trial.

OBJECTIVES: Plaque ruptures and attenuated plaques are considered to be unstable and have been identified in both culprit and nonculprit lesions of patients with ST-segment elevation myocardial infarction (STEMI). However, there are limited data available on the natural evolution of these plaques and their long-term clinical outcome. We investigated the natural evolution and long-term impact of plaque ruptures and attenuated plaques in untreated segments of infarct-related arteries in patients with STEMI. METHODS: In the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial, 389 patients with 429 lesions underwent intravascular ultrasound (IVUS) at baseline. Follow-up IVUS at 13 months was conducted in 245 patients. Three-year follow-up data were available for all patients. RESULTS: Segments not treated between baseline and follow-up were compared. Baseline IVUS identified 29 plaque ruptures in 27 patients (7%). Of 11 plaque ruptures with follow-up IVUS, four healed and seven persisted. Conversely, through follow-up IVUS, nine new plaque ruptures in nine patients (4%) were identified. Attenuated plaques were identified in 31 of 38 plaque ruptures (81.5%), of which 24 were in the same circumferential segment as the ruptured cavity and seven were within 5 mm proximal or distal to the plaque rupture. Morphologic changes during follow-up, including new plaque ruptures and changes in the attenuated plaque frequency and distribution, were not accompanied by either serious lumen compromise or clinical events. CONCLUSION: Serial IVUS analysis demonstrated that the morphology of unstable plaques within untreated segments in STEMI patients treated with optimal systemic therapies markedly changed during the 13-month follow-up period, without lumen compromise or clinical events at the 3-year follow-up.

Reducing contrast-induced acute kidney injury using a regional multicenter quality improvement intervention.

BACKGROUND: Contrast-induced acute kidney injury (CI-AKI) is associated with increased morbidity and mortality after percutaneous coronary interventions and is a patient safety objective of the National Quality Forum. However, no formal quality improvement program to prevent CI-AKI has been conducted. Therefore, we sought to determine whether a 6-year regional multicenter quality improvement intervention could reduce CI-AKI after percutaneous coronary interventions. METHODS AND RESULTS: We conducted a prospective multicenter quality improvement study to prevent CI-AKI (serum creatinine increase ≥0.3 mg/dL within 48 hours or ≥50% during hospitalization) among 21 067 nonemergent patients undergoing percutaneous coronary interventions at 10 hospitals between 2007 and 2012. Six intervention hospitals participated in the quality improvement intervention. Two hospitals with significantly lower baseline rates of CI-AKI, which served as benchmark sites and were used to develop the intervention, and 2 hospitals not receiving the intervention were used as controls. Using time series analysis and multilevel poisson regression clustering to the hospital level, we calculated adjusted risk ratios for CI-AKI comparing the intervention period to baseline. Adjusted rates of CI-AKI were significantly reduced in hospitals receiving the intervention by 21% (risk ratio, 0.79; 95% confidence interval: 0.67-0.93; P=0.005) for all patients and by 28% in patients with baseline estimated glomerular filtration rate <60 mL/min per 1.73 m(2) (risk ratio, 0.72; 95% confidence interval: 0.56-0.91; P=0.007). Benchmark hospitals had no significant changes in CI-AKI. Key qualitative system factors associated with improvement included multidisciplinary teams, limiting contrast volume, standardized fluid orders, intravenous fluid bolus, and patient education about oral hydration. CONCLUSIONS: Simple cost-effective quality improvement interventions can prevent ≤1 in 5 CI-AKI events in patients with undergoing nonemergent percutaneous coronary interventions.

Frequency, mechanisms, and implications of late peri-stent contrast staining: analysis (from the HORIZONS-AMI Trial).

Previous studies have suggested that angiographically detected persistent contrast staining (PSS) at follow-up may predict subsequent very late stent thrombosis. The Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial was a dual-arm, factorial, randomized trial in patients with ST-segment elevation myocardial infarctions. All follow-up angiograms (1,330 lesions in 1,115 patients, median time 13.3 months) without major cardiovascular events before follow-up angiography were analyzed at a core laboratory blinded to clinical events for the presence of PSS (defined as contrast staining outside the stent contour extending to ≥20% of the stent diameter). Corresponding follow-up intravascular ultrasound (IVUS) data (275 lesions in 248 patients) were also evaluated to assess the mechanisms of PSS. PSS was present in 23 patients (2.1%) at follow-up and was not more common with paclitaxel-eluting than with bare-metal stents. All 6 PSS patients with follow-up IVUS had stent malapposition (vs 41.2% malapposition in the follow-up IVUS cohort). Comparing poststent and follow-up IVUS, 2 patients had late acquired and 4 had persistent malapposition; all 6 showed positive vessel remodeling from baseline to follow-up (mean vessel area 22.0 ± 8.0 to 32.4 ± 11.7 mm(2), p = 0.07). During 3-year follow-up, stent thrombosis developed in no patient with PSS compared with 8 PSS-negative patients (0% vs 0.8%, p = 0.68). The rates of revascularization and major adverse cardiovascular events were also not increased in PSS patients. In conclusion, in the large-scale HORIZONS-AMI trial, PSS at angiographic follow-up was infrequent and was associated with late stent malapposition and positive remodeling but was independent of stent type. Identification of PSS was not associated with subsequent stent thrombosis.

Adverse event rates following primary PCI for STEMI at US and non-US hospitals: three-year analysis from the HORIZONS-AMI trial.

AIMS: To examine outcomes in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) at US sites versus sites outside the US (OUS). METHODS AND RESULTS: In the HORIZONS-AMI trial 3,602 STEMI patients in 11 countries were randomised to primary PCI with bivalirudin versus heparin + glycoprotein IIb/IIIa inhibitors. US patients (n=814) had more diabetes, prior infarction, prior bypass surgery, and renal insufficiency. OUS patients (n=2,788) had longer door-to-balloon times, more radial access, fewer bypass surgeries, and were discharged more often on beta-blockers and statins. At three years US patients had higher mortality (9.7% vs. 6.0%, p=0.0003), reinfarction (10.2% vs. 6.4%, p=0.001), major adverse cardiac events (MACE; 28.2% vs. 20.1%, p<0.0001), major bleeding (16.9% vs. 6.4%, p<0.0001) and net adverse clinical events (NACE; 36.6% vs. 23.8%, p<0.0001), which persisted after adjusting for baseline risk. CONCLUSIONS: In the HORIZONS-AMI trial, STEMI patients undergoing primary PCI at US versus OUS sites had higher rates of adverse events, which persisted after adjusting for baseline risk. The reasons for these differences are not clear but may be due to unmeasured confounders, different thresholds for event reporting, or valid differences in systems of care and treatments.

Usefulness of minimum stent cross sectional area as a predictor of angiographic restenosis after primary percutaneous coronary intervention in acute myocardial infarction (from the HORIZONS-AMI Trial IVUS substudy).

HORIZONS-AMI was a prospective dual-arm randomized trial of different antithrombotic regimens and stent types in patients with ST-segment elevation myocardial infarction. A formal intravascular ultrasound (IVUS) substudy enrolled 464 patients with baseline and 13-month follow-up at 36 centers. Of them, 318 patients with 355 lesions were evaluated for this study. Angiographic restenosis occurred in 45 of 355 lesions (12.7%). Bare-metal stent use (45.5% vs 21.2%, p <0.001) and diabetes mellitus (29.5% vs 10.9%, p <0.001) were more prevalent in patients with versus without restenosis. Postprocedure IVUS minimum lumen area (5.6 mm(2), 5.0 to 6.1, vs 6.7 mm(2), 6.5 to 6.9, p <0.001), minimum stent area (5.7 mm(2), 5.1 to 6.3, vs 6.9 mm(2), 6.6 to 7.1, p <0.001), and reference average lumen area (7.7 mm(2), 6.8 to 8.6, vs 9.7 mm(2), 9.3 to 10.1, p <0.001) were smaller in restenotic versus nonrestenotic lesions. By multivariable analysis, minimum stent area was an independent predictor of angiographic restenosis (odds ratio 0.75, 95% confidence interval 0.61 to 0.93, p = 0.009) in addition to diabetes, bare-metal stent use, and longer stent length. Attenuated plaque behind the stent struts had a trend to predict less binary restenosis (p = 0.07). In conclusion, a smaller IVUS minimum stent area was an independent predictor of angiographic restenosis after primary percutaneous intervention in patients with ST-segment elevation myocardial infarction, similar to patients with stable coronary artery disease.

How do centres begin the process to prevent contrast-induced acute kidney injury: a report from a new regional collaborative.

OBJECTIVES: This study evaluates the variation in practice patterns associated with contrast-induced acute kidney injury (CI-AKI) and identifies clinical practices that have been associated with a reduction in CI-AKI. Background CI-AKI is recognised as a complication of invasive cardiovascular procedures and is associated with cardiovascular events, prolonged hospitalisation, end-stage renal disease, and all-cause mortality. Reducing the risk of CI-AKI is a patient safety objective set by the National Quality Forum. METHODS: This study prospectively collected quantitative and qualitative data from 10 centres, which participate in the Northern New England Cardiovascular Disease Study Group PCI Registry. Quantitative data were collected from the PCI Registry. Qualitative data were obtained through clinical team meetings to map care processes related to CI-AKI and focus groups to understand attitudes towards CI-AKI prophylaxis. Fixed and random effects modelling were conducted to test the differences across centres. RESULTS: Significant variation in rates of CI-AKI were found across 10 medical centres. Both fixed effects and mixed effects logistic regression demonstrated significant variability across centres, even after adjustment for baseline covariates (p<0.001 for both modelling approaches). Patterns were found in reported processes and clinical leadership that were attributable to centres with lower rates of CI-AKI. These included reducing nil by mouth (NPO) time to 4 h prior to case, and standardising volume administration protocols in combination with administering three to four high doses of N-acetylcysteine (1200 mg) for each patient. CONCLUSIONS: These data suggest that clinical leadership and institution-focused efforts to standardise preventive practices can help reduce the incidence of CI-AKI.

Intravascular ultrasound findings of early stent thrombosis after primary percutaneous intervention in acute myocardial infarction: a Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) substudy.

BACKGROUND: Small stent area and residual inflow/outflow disease have been reported as the strongest intravascular ultrasound (IVUS) predictors of early stent thrombosis (ST) in patients with stable angina. IVUS predictors of early ST in patients with acute myocardial infarction have not been studied. METHODS AND RESULTS: In the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) study, a formal substudy included poststent and 13-month follow-up IVUS at 36 centers. Twelve patients with baseline IVUS who had definite/probable early ST ≤30 days after enrollment were compared with 389 patients without early ST. Significant residual stenosis was a lumen area <4.0 mm(2) with ≥70% plaque burden ≤10 mm from each stent edge. Significant edge dissection was more than medial dissection with lumen area <4 mm(2) or dissection angle ≥60°. Randomization to bivalirudin (P=0.29) or paclitaxel-eluting stent (P=0.74) was not related to early ST. Minimum lumen area was smaller in patients with versus without early ST (4.4 mm(2) [3.6, 6.9] versus 6.7 mm(2) [5.3, 8.0], respectively, P=0.014). Minimum lumen area <5 mm(2), significant residual stenosis, significant stent edge dissection, and significant tissue (plaque/thrombus) protrusion (more than the median that narrowed the lumen to <4 mm(2)) were more prevalent in patients with early ST, but significant acute malapposition (more than the median) was not. Overall, 100% of patients with early ST had at least 1 of these significant features: minimum lumen area <5 mm(2), edge dissection, residual stenosis, or tissue protrusion versus 23% in patients without early ST (P<0.01). CONCLUSIONS: Smaller final lumen area and inflow/outflow disease (residual stenosis or dissection) but not acute malapposition were related to early ST after acute myocardial infarction intervention. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00433966.

The relationship between attenuated plaque identified by intravascular ultrasound and no-reflow after stenting in acute myocardial infarction: the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial.

OBJECTIVES: The aim of this study was to understand the impact of attenuated plaque on distal embolization during stent implantation in patients with acute myocardial infarction (AMI). BACKGROUND: Attenuated plaques identified by grayscale intravascular ultrasound (IVUS) might predict transient deterioration in coronary flow and/or no-reflow during percutaneous coronary intervention (PCI). METHODS: We analyzed clinical, angiographic, and IVUS data from 364 patients (n = 364 infarct-related arteries) enrolled in the randomized HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial. No-reflow was final Thrombolysis In Myocardial Infarction (TIMI) flow grade ≤2 in the absence of mechanical obstruction. Attenuated plaque was hypoechoic or mixed atheroma with ultrasound attenuation without calcification. A mean attenuation score was created by measuring the angle of attenuation each 1 mm, scoring the angle as 1 to 4 (corresponding to <90°, 90° to 180°, 180° to 270°, or 270° to 360°, respectively), summing the scores, and normalizing for analysis length. RESULTS: Overall, 284 (78.0%) patients had attenuated plaques; no-reflow occurred in 37 (10.2%). Patients with no-reflow had a higher mean attenuation score (median [interquartile range] 2.2 [0.0 to 2.8] vs. 1.3 [0.7 to 1.8], p < 0.001), lower baseline left ventricular ejection fraction (52.8% [43.2% to 61.5%] vs. 61.4% [52.2% to 68.1%], p = 0.002), and more baseline angiographic thrombus (89.2% vs. 74.1%, p = 0.043) with no differences in post-PCI stent expansion versus patients without no-reflow. Multivariate analysis indicated that mean attenuation score was the strongest predictor of no-reflow. The mean attenuation score that best predicted no-reflow was ≥2 points (90° to 180°, sensitivity of 81.5%, and specificity of 80.5%). CONCLUSIONS: Attenuated plaque was present in three-quarters of patients with AMI. The amount of attenuated plaque strongly correlated with no-reflow; the larger the attenuated plaque, the greater the likelihood of no-reflow. (Dual Arm Factorial Randomized Trial in Patients w/ST Segment Elevation AMI to Compare the Results of Using Anticoagulation With Either Unfractionated Heparin + Routine GP IIb/IIIa Inhibition or Bivalirudin + Bail-out GP IIb/IIIa Inhibition; and Primary Angioplasty with stent implantation with Either a Slow Rate-release Paclitaxel-eluting Stent [TAXUS™] or Uncoated Bare Metal Stent [EXPRESS2™]; NCT00433966).

A prospective evaluation of the safety and efficacy of TAXUS Element paclitaxel-eluting coronary stent implantation for the treatment of de novo coronary artery lesions in small vessels: the PERSEUS Small Vessel trial.

AIMS: Small reference vessel diameter predicts adverse outcomes following coronary stenting. TAXUS Express and TAXUS Liberté paclitaxel-eluting stents (PES) reduce restenosis compared to bare metal stents (BMS) in small diameter vessels. TAXUS Element is a novel thin-strut, platinum chromium stent designed to enhance visibility, conformability, and drug delivery in small diameter vessels. METHODS AND RESULTS: The PERSEUS Small Vessel (SV) prospective, single-arm, superiority trial evaluates the TAXUS Element PES in 224 subjects with target lesion length≤20 mm and vessel diameter≥2.25 to <2.75 mm, compared to 125 lesion-matched historical Express BMS control subjects from the TAXUS V trial. The primary endpoint was nine-month in-stent late loss. The secondary endpoint was 12-month target lesion failure (TLF) compared to a pre-specified performance goal (PG). Outcomes were analysed with and without propensity-score adjustment. TAXUS Element was superior to the Express BMS for late loss (0.38±0.51 versus 0.80±0.53 mm respectively; P<0.001), and TLF (7.3%) was significantly less than the 19.5% PG (P<0.001). No differences in mortality, myocardial infarction, or stent thrombosis were observed through 12 months. Results were similar after adjustment. CONCLUSIONS: PERSEUS SV supports the efficacy and safety of the platinum chromium, thin-strut TAXUS Element stent in small coronary vessels.

Extended Outcomes of Complex Coronary Disease in the Drug Eluting Stent Era.

BACKGROUND: Several randomized trials comparing bare-metal stents to Drug-Eluting Stents (DES) have demonstrated a significant reduction in Target Vessel Revascularization (TVR) and Target Lesion Revascularization (TLR) exists with the use of drug-eluting stents, without compromising survival. These conclusions are based on restricted inclusion criteria for patients and lesion. It is unknown if these results can be generalized to an unselected patient population and more complex disease. The objective of this study was to determine to what extent the availability of DES has impacted survival, TVR, and TLR in a large regional experience without the restriction of on-label indications. METHODS: Patients registered with the Northern New England Cardiovascular Disease Study Group's PCI registry with single vessel coronary disease undergoing a first PCI were sorted according to the Bare-Metal stent (BMS) era (2001 - 2002) or the Drug-Eluting stent (DES) era (2004 - 2005) based on the time period their first PCI took place. Totally, 6,093 BMS and 5,651 DES patients were identified. Outcomes of survival, TLR and TVR were measured after one year. RESULTS: After 1 year, survival was comparable, TLR was reduced by 4.9% (absolute) and TVR was reduced by 5.4% (absolute) in the DES era compared to the BMS era. The TLR/TVR differences remained significant after propensity matching in the DES era vs BMS era (Mortality: HR 1.00, 95% CI: 0.83 - 1.28; TLR: HR 0.40, 95% CI 0.32 - 0.46; TVR: HR 0.44, 95% CI 0.38 - 0.51). CONCLUSIONS: In large regional experience with a consecutive series of patients representing the contemporary practice of PCI, including both on and off label use, the frequent use of DES reduces the risk of TVR and TLR without compromising survival.

Same admission cardiac catheterization and cardiac surgery: is there an increased incidence of acute kidney injury?

BACKGROUND: Acute kidney injury (AKI) is predictive of increased long-term mortality after cardiac surgery. Patients often undergo surgery after cardiac catheterization during the same admission for reasons of instability and threatening anatomy as well as nonurgent reasons such as patient convenience. We hypothesized that patients undergoing cardiac catheterization and cardiac surgery during the same admission are more likely to develop AKI after cardiac surgery than patients for whom surgery is performed on a later admission. METHODS: We prospectively enrolled 668 nonemergent adult cardiac surgical cases. Patients having heart catheterization were divided into two groups: cardiac catheterization followed by cardiac surgery during the same hospital admission (same admission) or catheterization followed by surgery during a later admission (later admission). The AKI was defined by an increase in serum creatinine from baseline by 50% or greater or 0.3 (mg/dL) or greater. Univariable and multivariable logistic regression and propensity-matched analyses were conducted. RESULTS: The incidence of AKI was significantly higher in the patients who had same admission cardiac catheterization and surgery (50.2%) compared with patients who had surgery on a later admission (33.7%, p = 0.009). The adjusted odds ratio for surgery on a later admission was 1.54 (95% confidence interval: 1.11 to 2.13) suggesting a 54% increased risk of AKI. Propensity-matched results were similar with 1.58 (95% confidence interval: 1.13 to 2.22). CONCLUSIONS: When cardiac catheterization and cardiac surgery occur during the same hospitalization, there is an increased risk for postoperative AKI. After cardiac catheterization, discharge and readmission for nonurgent surgery should be considered as such an approach might reduce the risk of AKI.

Incidence, mechanisms, predictors, and clinical impact of acute and late stent malapposition after primary intervention in patients with acute myocardial infarction: an intravascular ultrasound substudy of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial.

BACKGROUND: The incidence and mechanisms of acute and late stent malapposition after primary stent implantation in ST-segment elevation myocardial infarction remain unclear. METHODS AND RESULTS: The Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial was a dual-arm, factorial, randomized trial comparing paclitaxel-eluting stents (PES) and otherwise equivalent bare metal stents (BMS) in ST-segment elevation myocardial infarction patients. The intravascular ultrasound substudy enrolled 241 patients with 263 native coronary lesions (201 PES, 62 BMS) with baseline and 13-month follow-up imaging. Postintervention acute stent malapposition (ASM) occurred in 34.3% PES- and 40.3% BMS-treated lesions. Of these, 39.1% PES- and 40.0% BMS-treated lesions resolved at follow-up, especially within the stent body (66.7%); complete resolution was accompanied by a reduction in external elastic membrane area. An ASM area >1.2 mm(2) best separated persistent from resolved ASM. At follow-up, a higher frequency of late stent malapposition was detected in PES-treated lesions (46.8%) mainly because of more late acquired stent malapposition (30.8%) compared with BMS-treated lesions. Late acquired stent malapposition area correlated to the decrease of peri-stent plaque in the subset of lesions without positive remodeling and only to change in external elastic membrane in the group with positive remodeling. Independent predictors of late acquired stent malapposition were plaque/thrombus protrusion (odds ratio, 5.60; 95% confidence interval [CI], 2.32 to 13.54) and PES use (odds ratio, 6.32; 95% CI, 2.15 to 18.62). CONCLUSIONS: The incidence of ASM was similar in PES- and BMS-treated lesions, but late acquired stent malapposition was more common in PES-treated lesions. The reason for resolved ASM was negative remodeling, with larger ASM areas separating persistent from resolved ASM. Late acquired stent malapposition was due mainly to positive remodeling and plaque/thrombus resolution. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00433966.

Intravascular ultrasound findings of stent fractures in patients with Sirolimus- and Paclitaxel-eluting stents.

We compared intravascular ultrasound (IVUS) findings of fractures of sirolimus-eluting stents (SESs) versus paclitaxel-eluting stents (PESs). IVUS findings in 6 PES fractures (all in the right coronary artery) in 6 patients from a clinical trial cohort were compared to 14 SES fractures (8 in the right coronary artery, 2 in the left anterior descending coronary artery, and 4 in the left circumflex coronary artery) in 13 patients from our institutional cohort. Comparing PES fractures to SES fractures, IVUS analysis showed (1) similar frequency of complete stent fracture (1 of 6, 17%, vs 3 of 14, 21%, p >0.99), (2) similar frequency of fracture adjacent to calcified plaque or stent metal overlap (5 of 6, 86%, vs 14 of 14, 100%, p = 0.99), (3) more frequent complete malalignment of proximal and distal fragments in PES strut fractures compared to SES fractures (5 of 6, 83%, vs 1 of 14, 7%, p = 0.002), (4) similar stent lengths (45.2 mm, 23.8 to 50.7, vs 39.3 mm, 22.6 to 73.4, p >0.99), (5) similar fracture lengths (0.5 mm, 0.4 to 0.7, vs 0.7 mm, 0.6 to 1.0, p = 0.14), and (6) larger reference external elastic membrane area (15.0 mm(2), 13.5 to 18.0, vs 10.4 mm(2), 6.8 to 13.6, p = 0.01). In conclusion, malalignment of proximal and distal stent fragments more often occurred in PES fractures compared to SES fractures; otherwise the IVUS features of PES and SES fractures were similar.

Serial intravascular ultrasound analysis of the impact of myocardial bridge on neointimal proliferation after coronary stenting in patients with acute myocardial infarction.

BACKGROUND: Mechanisms underlying the association between myocardial bridge (MB)-stenting and in-stent restenosis (ISR) are still unclear. OBJECTIVE: To assess the impact of MB on ISR using intravascular ultrasound (IVUS). METHODS: In the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, 100 left anterior descending artery (LAD) culprit lesions (79 treated with paclitaxel-eluting stents [PES] and 21 treated with bare metal stents) were imaged with serial IVUS immediately postprocedure and at 13 months. RESULTS: At baseline the LAD stent extended into the MB segment beyond the culprit lesion in seven patients (MB-stent group). In the remaining 93 patients the LAD stent was implanted only in the culprit lesion without extending into the MB segment (non-MB-stent group). In PES-treated lesions intimal hyperplasia (IH) was greater in MB-stent group than in non-MB-stent group (1.0 [0.9, 1.3] mm(2) vs. 0.4 [0.2, 0.7] mm(2), P = 0.007). When comparing the MB-stent segment with the non-MB-stent segment in the MB-stent group treated with PES, a significant reduction in lumen area was observed in only the MB-stent segment, owing to an augmented IH within the MB-stent segment (1.56 [1.40, 1.91] mm(2) vs. 0.77 [0.55, 1.23] mm(2) for non-MB-stent segment, P = 0.08), not significant stent recoil (Deltastent area). At follow-up, the minimum lumen area was smaller in the MB-stent group than in the non-MB-stent group (2.9 [2.5, 4.2] mm(2) vs. 5.2 [4.1, 6.7] mm(2), P = 0.02). CONCLUSIONS: Increased incidence of ISR associated with MB-stenting may be attributable to enhanced IH, specific to stented MB segment, not to chronic stent recoil.

Diabetic and nondiabetic patients with left main and/or 3-vessel coronary artery disease: comparison of outcomes with cardiac surgery and paclitaxel-eluting stents.

OBJECTIVES: This study was designed to compare contemporary surgical revascularization (coronary artery bypass graft surgery [CABG]) versus TAXUS Express (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stents (PES) in diabetic and nondiabetic patients with left main and/or 3-vessel disease. BACKGROUND: Although the prevalence of diabetes mellitus is increasing, the optimal coronary revascularization strategy in diabetic patients with complex multivessel disease remains controversial. METHODS: The SYNTAX (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery) study randomly assigned 1,800 patients (452 with medically treated diabetes) to receive PES or CABG. RESULTS: The overall 1-year major adverse cardiac and cerebrovascular event rate was higher among diabetic patients treated with PES compared with CABG, but the revascularization method did not impact the death/stroke/myocardial infarction rate for nondiabetic patients (6.8% CABG vs. 6.8% PES, p = 0.97) or for diabetic patients (10.3% CABG vs. 10.1% PES, p = 0.96). The presence of diabetes was associated with significantly increased mortality after either revascularization treatment. The incidence of stroke was higher among nondiabetic patients after CABG (2.2% vs. PES 0.5%, p = 0.006). Compared with CABG, mortality was higher after PES use for diabetic patients with highly complex lesions (4.1% vs. 13.5%, p = 0.04). Revascularization with PES resulted in higher repeat revascularization for nondiabetic patients (5.7% vs. 11.1%, p < 0.001) and diabetic patients (6.4% vs. 20.3%, p < 0.001). CONCLUSIONS: Subgroup analyses suggest that the 1-year major adverse cardiac and cerebrovascular event rate is higher among diabetic patients with left main and/or 3-vessel disease treated with PES compared with CABG, driven by an increase in repeat revascularization. However, the composite safety end point (death/stroke/myocardial infarction) is comparable between the 2 treatment options for diabetic and nondiabetic patients. Although further study is needed, these exploratory results may extend the evidence for PES use in selected patients with less complex left main and/or 3-vessel lesions. (SYNergy Between PCI With TAXus and Cardiac Surgery [SYNTAX]; NCT00114972).

Volumetric intravascular ultrasound analysis of Paclitaxel-eluting and bare metal stents in acute myocardial infarction: the harmonizing outcomes with revascularization and stents in acute myocardial infarction intravascular ultrasound substudy.

BACKGROUND: Vascular responses to drug-eluting stents in ST-segment elevation myocardial infarction are unknown. In the prospective, multicenter Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, patients with ST-segment elevation myocardial infarction within 12 hours of symptom onset were randomized 3:1 to TAXUS EXPRESS paclitaxel-eluting stents (PES) or EXPRESS bare metal stents (BMS). METHODS AND RESULTS: A formal intravascular ultrasound substudy enrolled 464 patients with baseline and 13-month follow-up imaging at 36 centers. Overall, 446 lesions in 402 patients were suitable for standard qualitative and quantitative analyses, which were performed at an independent blinded core laboratory. The primary prespecified end point was the in-stent percent net volume obstruction at follow-up. Median stent length measured 23.4 mm (first and third quartiles, 18.5 and 31.9 mm). PES compared with BMS significantly reduced 13-month percent net volume obstruction (6.5% [first and third quartiles, 2.2% and 10.8%] versus 15.6% [first and third quartiles, 7.2% and 28.8%]; P<0.0001). PES compared with BMS also resulted in more late-acquired stent malapposition (29.6% versus 7.9%; P=0.0005) resulting from positive vessel remodeling. Plaque and/or thrombus protrusion through stent struts was initially present in 70.4% of PES and 64.8% of BMS; all resolved during follow-up. New aneurysm formation, stent fracture, and subclinical thrombus were uncommon, although seen only in PES. CONCLUSIONS: PES compared with BMS significantly reduce neointimal hyperplasia in patients with ST-segment elevation myocardial infarction but also result in a high frequency of late-acquired stent malapposition as a result of positive vessel remodeling. Ongoing long-term follow-up is required to establish the clinical significance of these findings. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00433966.

Comparing long-term survival of patients with multivessel coronary disease after CABG or PCI: analysis of BARI-like patients in northern New England.

BACKGROUND: Randomized trials comparing coronary artery bypass graft surgery (CABG) with percutaneous coronary interventions (PCIs) for patients with multivessel coronary disease (MVD) report similar long-term survival for CABG and PCI. These studies used a highly selected population of patients and providers, and their results may not be generalizable to actual care. Our goal in this study was to compare long-term survival of MVD patients treated with CABG vs PCI in contemporary practice. METHODS AND RESULTS: From our northern New England registries of consecutive coronary revascularizations, we identified 10,198 CABG and 4,295 PCI patients with MVD who may have been eligible for either procedure between 1994 and 2001. Vital status was obtained by linkage to the National Death Index. Proportional-hazards regression was used to calculate hazard ratios (HRs) for survival in CABG vs PCI patients after adjustment for comorbidities and disease characteristics. CABG patients were older; had more comorbidities, more 3-vessel disease, and lower ejection fractions; and were more completely revascularized. Adjusted long-term survival for patients with 3-vessel disease was better after CABG than PCI (HR, 0.60; P<0.01) but not for patients with 2-vessel disease (HR, 0.98; P=0.77). The survival advantage of CABG for 3-vessel disease patients was present in all patient populations, including women, diabetics, and the elderly and in the era of high stent utilization. CONCLUSIONS: In contemporary practice, survival for patients with 3-vessel coronary disease is better after CABG than PCI, an observation that patients and physicians should carefully consider when deciding on a revascularization strategy.