Coronary intravascular lithotripsy for severe coronary artery calcification: The Disrupt CAD I-IV trials.

Coronary artery calcification (CAC) severity is associated with increased vessel inflammation, atherosclerosis, stent failure, and risk of percutaneous coronary intervention-related complications. Current modalities for CAC modification include atherectomy techniques (rotational, orbital, and laser) and balloon modification (cutting and scoring). However, these methods are limited by their risk of slow flow/no reflow, coronary dissection, perforation, and myocardial infarction. Intravascular lithotripsy (IVL) emits high-energy sonic waves that induce calcium fractures within a target lesion to improve vessel compliance for stent placement. Low rates of major cardiac adverse events (MACE) and high rates of procedural and angiographic success were observed with IVL in the Disrupt CAD I-IV trials. Optical coherence tomography sub-studies identified calcium fracture as the likely etiology of improved vessel compliance and increased luminal diameter post-IVL. Rates of MACE, procedural, and angiographic success were consistent across the Disrupt CAD trials, suggesting IVL is less operator-dependent compared to other calcium-modifying techniques. Coronary IVL offers interventional cardiologists a safe and effective method of severe CAC modification, while providing reproducible outcomes.

Causes of death in patients undergoing percutaneous coronary intervention with drug-eluting stents in a real-world setting.

BACKGROUND: Reports of stent thrombosis and death in patients who have received drug-eluting stents (DES) have provoked debate regarding their long-term safety. We investigated the specific causes of death in patients receiving DES at an academic tertiary-care center. METHODS: A retrospective analysis of 1,023 consecutive patients who underwent percutaneous coronary intervention (PCI) with DES from 2003 to 2006 at UCLA Medical Center was performed. Dates and cause of death were obtained by reviewing the patient's medical record, contacting the patient's doctor, or accessing the Social Security Death Index and obtaining copies of death certificates at the Los Angeles County Registrar-Recorder/County Clerk office. If the cause of death could not be determined, it was reported "unknown." RESULTS: At a mean follow up of 2.9 +/- 1.3 years, 96 patients who underwent PCI with DES died during the analysis (9.4% mortality). The mean duration between index PCI and death was 331 +/- 324 days. The cause of death was unknown in 9 patients, thus the analysis was based upon 87 patients. There were similar number of cardiac (n = 44) and non-cardiac deaths (n = 43). The risk of PCI-related death was 1.3% (13/1023), which included 11 patients (1.1%) who died from stent thrombosis. Fourteen patients (1.4%) who presented with myocardial infarction (MI) and underwent PCI died, and 14 patients (1.4%) died from heart failure. Non-cardiac deaths included cancer, infection, respiratory failure and a cerebrovascular event. Age, chronic renal insufficiency, presentation with MI, chronic obstructive pulmonary disease, history of cerebrovascular event, orthotopic heart transplantation and left ventricular ejection fraction were significantly associated with increased mortality. CONCLUSIONS: Cardiac and non-cardiac causes of death contributed similarly to mortality in patients who underwent PCI with DES at a large tertiary care center that manages high-risk patients. Overall PCI-related death and stent thrombosis causing death were low. The majority of deaths occurred in patients after hospital discharge. The majority of patients who died in the hospital presented with acute MI and were in critical condition on presentation.

Preprocedural white blood cell count as a predictor of death and major adverse cardiac events in patients undergoing percutaneous coronary intervention with drug-eluting stents.

BACKGROUND: Patients with elevated white blood cell (WBC) counts who undergo percutaneous coronary intervention (PCI) are at increased risk for short- and long-term mortality as well as major adverse cardiac events (MACE). We assessed the relationship between elevated WBC counts and clinical events in patients who underwent PCI with drug-eluting stents (DES). METHODS: Our retrospective study includes 878 consecutive patients who underwent both elective and emergent PCI with DES at the UCLA Medical Center. The cohort was divided into tertiles based upon the presenting WBC count: 2.8-6.3 x 109 cells/L (tertile 1 [T1]), 6.4-8.7 x 109 cells/L (tertile 2 [T2]), > or = 8.8 x 109 cells/L (tertile 3 [T3]). RESULTS: Survival at 1 year was significantly different between all three tertiles, and was poorest in patients with WBC counts in T3 (93.9%-T1, 98.4%-T2, 87.3%-T3; p < 0.0001), while T2 had the highest survival rate at 1 year. Age, chronic renal insufficiency, chronic obstructive pulmonary disease, low WBC count in T1, elevated WBC count in T3 and presentation with myocardial infarction were identified as multivariable predictors for survival at 1 year. CONCLUSION: Both elevated and low WBC counts are associated with increased mortality and MACE at 1 year following PCI with DES. WBC count is an independent predictor of survival in patients who undergo PCI with DES implantation.

Impact of diabetes and acute coronary syndrome on survival in patients treated with drug-eluting stents.

BACKGROUND: Diabetics who undergo percutaneous coronary intervention (PCI) are at increased risk for death, myocardial infarction, repeat revascularization, and stent thrombosis. METHODS: Our retrospective study includes 887 consecutive patients who underwent PCI with drug-eluting stents (DES) at UCLA Medical Center. The cohort was divided into four groups: group 1, no diabetes and no acute coronary syndrome (ACS); group 2, no diabetes and ACS; group 3, diabetes and no ACS; group 4, diabetes and ACS. RESULTS: Survival at 1 year was the lowest in diabetics who presented with ACS (90% in diabetics with ACS, 95% in diabetics without ACS, 95% in non-diabetics with ACS, and 96% in the non-diabetics without ACS, P = 0.03). At 1 year, age, diabetes, chronic renal insufficiency, ejection fraction, and myocardial infarction were identified as independent predictors for mortality. CONCLUSION: In the DES era, diabetics who undergo PCI for ACS continue to have an excess risk of death and major adverse cardiac events at 1 year.

Clinical presentation of patients with in-stent restenosis in the drug-eluting stent era.

BACKGROUND: Drug-eluting stents (DES) represent a significant improvement in the treatment of coronary artery disease as they decrease restenosis rates by approximately 50% compared with bare-metal stents. In-stent restenosis (ISR) is perceived to be a benign phenomenon because it is a gradual process and may lead to angina pectoris. With bare-metal stents, ISR has been associated with myocardial infarction in approximately 10% to 15% of cases. Comparable data with DES are lacking. METHODS: From April 2003 to December 2005, 42 out of 889 patients (4.7%) with DES ISR were identified at our institution. We excluded 3 orthotopic heart transplant patients who had ISR. Therefore, the final analysis included 39 patients. RESULTS: The mean age was 66 +/- 10 years, 77% were male, and 33% were diabetic. A mean of 1.8 +/- 0.9 stents were implanted with a total stent length of 39 +/- 24 mm. The mean time from percutaneous coronary intervention to detection of ISR was 396 +/- 290 days. At a mean from follow up of 35 +/- 10 months, 8% were asymptomatic, 77% presented with angina pectoris, 5% with unstable angina, and 10% with non-ST-segment elevation myocardial infarction. CONCLUSIONS: In the DES era, although most patients with ISR have stable symptoms, myocardial infarction occurred in 10%, suggesting that ISR is not a benign clinical entity. DES with improved designs or drug elution systems that further decrease the incidence of ISR are needed.

Outcomes of nonagenarians who undergo percutaneous coronary intervention with drug-eluting stents.

BACKGROUND: Age is an important predictor of mortality after percutaneous coronary intervention (PCI). The safety and efficacy of PCI with drug-eluting stents (DES) in nonagenarians have not been extensively studied. METHODS: A retrospective analysis of 889 consecutive patients identified 28 (3.1%) nonagenarians who underwent PCI with DES from May 2003 to December 2005 at our institution. RESULTS: The mean age was 92 +/- 2 years, 39% were male, and 4% were diabetic. Sirolimus-eluting stents were used in 79%. A mean of 1.5 +/- 0.9 stents/patient were implanted with a total stent length of 31 +/- 20 mm. Twenty-nine percent presented with unstable angina and 39% with myocardial infarction. The angiographic success rate obtained was 100%. The 30-day mortality rate was 21%. The 6 patients who died within 30 days included 3 patients who had cardiogenic shock and one patient with critical aortic stenosis who died due to complications during percutaneous aortic valvuloplasty. The cumulative survival rate for all nonagenarians at 1 year and 3 years was (68 +/- 9)% and (61 +/- 9)%. When the four patients who were in extremis on presentation were excluded, there were no in-hospital deaths, the 30-day mortality was 8%, and the 1 year and 3 year survival rate was (79 +/- 8)% and (71 +/- 9)% for the nonagenarians. No patient had definite stent thrombosis. CONCLUSIONS: The majority of the nonagenarians who underwent PCI with DES presented with acute coronary syndrome. Percutaneous coronary intervention with DES was safe in nonagenarians as there were no in-hospital deaths and acceptable 3-year survival rates when patients who were in extremis on presentation were excluded. The high-risk profile of these patients and the expected attrition of nonagenarians may contribute to their mortality rates.

Stent fracture associated with drug-eluting stents: clinical characteristics and implications.

OBJECTIVE: To evaluate the clinical characteristics and implications of stent fracture in drug-eluting stents. BACKGROUND: Approximately 2.5 million drug-eluting stents are implanted every year worldwide. In 10 randomized controlled trials involving 2,602 patients, no incidence of stent fracture was recognized or reported. METHODS: From April 2003 to December 2005, 2,728 patients underwent drug-eluting stenting. The angiograms of all 530 patients who underwent repeat angiography were analyzed to identify the presence of stent fracture. We then documented the incidence of adverse events associated with drug-eluting stent fracture and systematically analyzed the clinical, procedural, and structural factors, which might predispose to stent fracture. RESULTS: Stent fracture was identified in 10 patients. None of these fractures were detectable at the time of stent placement. The median time interval from stent implantation to detection of fracture at repeat angiography was 226 days (range, 7-620 days). Adverse clinical outcomes associated with stent fracture occurred in 7 patients (6 patients had binary restenosis and 1 patient had stent thrombosis), all necessitating repeat intervention. Analysis of potential predisposing clinical, procedural, and structural factors revealed that 4 patients had excessive tortuosity in the proximal segment, and overlapping stents were used in 5 cases. All fractures occurred in sirolimus-eluting stents. CONCLUSIONS: Stent fracture may represent a new potential mechanism of restenosis and stent thrombosis in drug-eluting stents. Predisposing clinical and procedural factors may be vessel tortuosity and use of overlapping stents. The most important predisposing factor, however, may be stent structure, since all fractures occurred in sirolimus-eluting stents.