Gary Walford

Drug-Eluting Stents vs. Coronary-Artery Bypass Grafting in Multivessel Coronary Disease

BACKGROUND Numerous studies have compared the outcomes of two competing interventions for multivessel coronary artery disease: coronary-artery bypass grafting (CABG) and coronary stenting. However, little information has become available since the introduction of drug-eluting stents. METHODS We identified patients with multivessel disease who received drug-eluting stents or underwent CABG in New York State between October 1, 2003, and December 31, 2004, and we compared adverse outcomes (death, death or myocardial infarction, or repeat revascularization) through December 31, 2005, after adjustment for differences in baseline risk factors among the patients. RESULTS In comparison with treatment with a drug-eluting stent, CABG was associated with lower 18-month rates of death and of death or myocardial infarction both for patients with three-vessel disease and for patients with two-vessel disease. Among patients with three-vessel disease who underwent CABG, as compared with those who received a stent, the adjusted hazard ratio for death was 0.80 (95% confidence interval [CI], 0.65 to 0.97) and the adjusted survival rate was 94.0% versus 92.7% (P=0.03); the adjusted hazard ratio for death or myocardial infarction was 0.75 (95% CI, 0.63 to 0.89) and the adjusted rate of survival free from myocardial infarction was 92.1% versus 89.7% (P<0.001). Among patients with two-vessel disease who underwent CABG, as compared with those who received a stent, the adjusted hazard ratio for death was 0.71 (95% CI, 0.57 to 0.89) and the adjusted survival rate was 96.0% versus 94.6% (P=0.003); the adjusted hazard ratio for death or myocardial infarction was 0.71 (95% CI, 0.59 to 0.87) and the adjusted rate of survival free from myocardial infarction was 94.5% versus 92.5% (P<0.001). Patients undergoing CABG also had lower rates of repeat revascularization. CONCLUSIONS For patients with multivessel disease, CABG continues to be associated with lower mortality rates than does treatment with drug-eluting stents and is also associated with lower rates of death or myocardial infarction and repeat revascularization.

A Randomized Trial of Intravenous Tissue Plasminogen Activator for Acute Myocardial Infarction with Subsequent Randomization to Elective Coronary Angioplasty

Patients presenting within four hours of the onset of acute myocardial infarction were randomly assigned to receive 80 to 100 mg of recombinant human-tissue plasminogen activator (t-PA) intravenously over a period of three hours (n = 72) or placebo (n = 66). Administration of the study drug was followed by coronary arteriography, and candidates for percutaneous transluminal coronary angioplasty were randomly assigned either to undergo angioplasty on the third hospital day (n = 42) or not to undergo angioplasty during the 10-day study period (n = 43). The patency rates of the infarct-related arteries were 66 percent in the t-PA group and 24 percent in the placebo group. No fatal or intracerebral hemorrhages occurred, and episodes of bleeding requiring transfusion were observed in 7.6 percent of the placebo group and 9.8 percent of the t-PA group. As compared with the use of placebo, administration of t-PA was associated with a higher mean (+/- SEM) ejection fraction on the 10th hospital day (53.2 +/- 2.0 vs. 46.4 +/- 2.0 percent, P less than 0.02), an improved ejection fraction during the study period (+3.6 +/- 1.3 vs. -4.7 +/- 1.3 percentage points, P less than 0.0001), and a reduction in the prevalence of congestive heart failure from 33 to 14 percent (P less than 0.01). Angioplasty improved the response of the ejection fraction to exercise (+8.1 +/- 1.4 vs. +1.2 +/- 2.2 percentage points, P less than 0.02) and reduced the incidence of postinfarction angina from 19 to 5 percent (P less than 0.05), but did not influence the ejection fraction at rest. These data support an approach to the treatment of acute myocardial infarction that includes early intravenous administration of t-PA and deferred cardiac catheterization and coronary angioplasty.

Impact of Completeness of Percutaneous Coronary Intervention Revascularization on Long-Term Outcomes in the Stent Era

Background— The importance of completeness of revascularization by percutaneous coronary intervention in patients with multivessel disease is unclear in that there is little information on the impact of incomplete revascularization outside of randomized trials. The objective of this study is to compare long-term mortality and subsequent revascularization for percutaneous coronary intervention patients receiving stents who were completely revascularized (CR) with those who were incompletely revascularized (IR). Methods and Results— Patients from New York States Percutaneous Coronary Interventions Reporting System were subdivided into patients who were CR and IR. Then subsets of IR patients were contrasted with CR patients. Differences in long-term survival and subsequent revascularization for CR and IR patients were compared after adjustment for differences in preprocedural risk. A total of 68.9% of all stent patients with multivessel disease who were studied were IR, and 30.1% of all patients had total occlusions and/or ≥2 IR vessels. At baseline, the following patients were at higher risk: those who were older and those with more comorbid conditions, worse ejection fraction, and more renal disease and stroke. After adjustment for these baseline differences, IR patients were significantly more likely to die at any time (adjusted hazard ratio=1.15; 95% confidence interval, 1.01 to 1.30) than CR patients. IR patients with total occlusions and a total of ≥2 IR vessels were at the highest risk compared with CR patients (hazard ratio=1.36; 95% confidence interval, 1.12 to 1.66). Conclusions— IR with stenting is associated with an adverse impact on long-term mortality, and consideration should be given to either achieving CR, opting for surgery, or monitoring percutaneous coronary intervention patients with IR more closely after discharge.

Culprit Vessel Percutaneous Coronary Intervention Versus Multivessel and Staged Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction Patients With Multivessel Disease

OBJECTIVES The purpose of this study was to examine the differences in in-hospital and longer-term mortality for ST-segment elevation myocardial infarction (STEMI) patients with multivessel disease as a function of whether they underwent single-vessel (culprit vessel) percutaneous coronary interventions (PCIs) or multivessel PCI. BACKGROUND The optimal treatment of patients with STEMI and multivessel disease is of continuing interest in the era of drug-eluting stents. METHODS STEMI patients with multivessel disease undergoing PCIs in New York between January 1, 2003, and June 30, 2006, were subdivided into those who underwent culprit vessel PCI and those who underwent multivessel PCI during the index procedure, during the index admission, or staged within 60 days of the index admission. Patients were propensity-matched and mortality rates were calculated at 12, 24, and 42 months. RESULTS A total of 3,521 patients (87.5%) underwent culprit vessel PCI during the index procedure. A total of 259 of them underwent staged PCI during the index admission and 538 patients underwent staged PCI within 60 days of the index procedure. For patients without hemodynamic compromise, culprit vessel PCI during the index procedure was associated with lower in-hospital mortality than multivessel PCI during the index procedure (0.9% vs. 2.4%, p = 0.04). Patients undergoing staged multivessel PCI within 60 days after the index procedure had a significantly lower 12-month mortality rate than patients undergoing culprit vessel PCI only (1.3% vs. 3.3%, p = 0.04). CONCLUSIONS Our findings support the American College of Cardiology/American Heart Association (ACC/AHA) recommendation that culprit vessel PCI be used for STEMI patients with multivessel disease at the time of the index PCI when patients are not hemodynamically compromised. However, staged PCI within 60 days after the index procedure, including during the index admission, is associated with risk-adjusted mortality rates that are comparable with the rate for culprit vessel PCI alone.

Volume-outcome relationships for percutaneous coronary interventions in the stent era.

Background—Most studies that are the basis of recommended volume thresholds for percutaneous coronary interventions (PCIs) predate the routine use of stent placement. Methods and Results—Data from New York’s Percutaneous Coronary Interventions Reporting System in 1998 to 2000 (n=107 713) were used to examine the impact of annual hospital volume and annual operator volume on in-hospital mortality, same-day coronary artery bypass graft (CABG) surgery, and same- stay CABG surgery after adjustment for differences in patients’ severity of illness. For a hospital-volume threshold of 400, the odds ratios for low-volume hospitals versus high-volume hospitals were 1.98 (95% CI, 1.17, 3.35) for in-hospital mortality, 2.07 (95% CI, 1.36, 3.15) for same-day CABG surgery, and 1.51 (95% CI, 1.03, 2.21) for same-stay CABG surgery. For an operator-volume threshold of 75, the odds ratios for low-volume versus high-volume operators were 1.65 (95% CI, 1.05, 2.60) for same-day CABG surgery and 1.55 (95% CI, 1.10, 2.18) for same-stay CABG surgery. Operator volume was not significantly associated with mortality. Also, for hospital volumes below 400 and operator volumes below 75, the respective odds of mortality, same-day CABG surgery, and same-stay CABG surgery were 5.92, 4.02, and 3.92 times the odds for hospital volumes of 400 or higher and operator volumes of 75 or higher. Conclusions—Higher-volume operators and hospitals continue to experience lower risk-adjusted PCI outcome rates.

Incomplete Revascularization in the Era of Drug-Eluting Stents: Impact on Adverse Outcomes

OBJECTIVES We sought to compare outcomes for percutaneous coronary intervention patients undergoing complete revascularization (CR) and incomplete revascularization (IR) in the drug-eluting stent era. BACKGROUND There have been relatively few studies that have examined the impact of IR in patients undergoing coronary stenting, particularly in the era of drug-eluting stents. METHODS New York States Percutaneous Coronary Intervention Reporting System was used to identify 11,294 stent patients with multivessel disease undergoing either IR or CR in 39 hospitals between October 1, 2003, and December 31, 2004. These patients were followed through December 31, 2005, and IR patients were subdivided based on the number of IR vessels and presence of a chronic total occlusion. Risk-adjusted mortality and mortality/myocardial infarction (MI) for CR and IR patients were compared at 18 months. RESULTS Incomplete revascularization was performed in a total of 7,795 patients (69.0%). Incomplete revascularization was associated with higher 18-month mortality (adjusted hazard ratio [HR]: 1.23, 95% confidence interval [CI]: 1.04 to 1.45) and higher 18-month MI/mortality (adjusted HR: 1.27, 95% CI: 1.09 to 1.47). The risk-adjusted survival rates for CR and IR were 94.9% and 93.8% (p = 0.01). The risk-adjusted survival/freedom from MI rates were 93.3% and 91.7% (p = 0.002). Patients with 2 diseased vessels unattempted with a total occlusion were at highest risk (adjusted survival HR: 1.44, 95% CI: 1.14 to 1.82, risk-adjusted survival 94.9% vs. 92.9%, p = 0.002; and adjusted survival/freedom from MI: 1.50, 95% CI: 1.21 to 1.86, rates 93.3% vs. 90.3%, p < 0.001). CONCLUSIONS Patients undergoing coronary stenting who receive IR experience more adverse outcomes even in the era of drug-eluting stents. This has implications for choice of procedure and post-procedural monitoring.

Adherence of Catheterization Laboratory Cardiologists to American College of Cardiology/American Heart Association Guidelines for Percutaneous Coronary Interventions and Coronary Artery Bypass Graft Surgery What Happens in Actual Practice?

Background— The American College of Cardiology and the American Heart Association have issued guidelines for the use of coronary artery bypass graft surgery (CABG) and percutaneous coronary interventions (PCI) for many years, but little is known about the impact of these evidence-based guidelines on referral decisions. Methods and Results— A cardiac catheterization laboratory database used by 19 hospitals in New York State was used to identify treatment (CABG surgery, PCI, medical treatment, or nothing) recommended by the catheterization laboratory cardiologist for patients undergoing catheterization with asymptomatic/mild angina, stable angina, and unstable angina/non–ST-elevation myocardial infarction between January 1, 2005, and August 31, 2007. The recommended treatment was compared with indications for these patients based on American College of Cardiology/American Heart Association guidelines. Of the 16 142 patients undergoing catheterization who were found to have coronary artery disease, the catheterization laboratory cardiologist was the final source of recommendation for 10 333 patients (64%). Of these 10 333 patients, 13% had indications for CABG surgery, 59% for PCI, and 17% for both CABG surgery and PCI. Of the patients who had indications for CABG surgery, 53% were recommended for CABG and 34% for PCI. Of the patients with indications for PCI, 94% were recommended for PCI. For the patients who had indications for both CABG surgery and PCI, 93% were recommended for PCI and 5% for CABG surgery. Catheterization laboratory cardiologists in hospitals with PCI capability were more likely to recommend patients for PCI than hospitals in which only catheterization was performed. Conclusions— Patients with coronary artery disease receive more recommendations for PCI and fewer recommendations for CABG surgery than indicated in the American College of Cardiology/American Heart Association guidelines.

Short- and long-term mortality for patients undergoing primary angioplasty for acute myocardial infarction

OBJECTIVES The goal of this study was to learn more about the risk factors and short- and long-term outcomes for primary angioplasty. BACKGROUND Primary angioplasty (direct angioplasty without antecedent thrombolytic therapy) has been an effective alternative to thrombolytic therapy for patients with acute myocardial infarction (AMI). However, most reported studies have been compromised by small sample sizes and short observation times. METHODS New Yorks coronary angioplasty registry was used to identify New York patients undergoing angioplasty within 6 h of AMI between January 1, 1993 and December 31, 1996. Statistical models were used to identify significant risk factors for in-patient and long-term survival and to estimate long-term survival for all patients as well as various subsets of patients undergoing primary angioplasty. RESULTS The in-hospital mortality rate for all primary angioplasty patients was 5.81%. When patients in preprocedural shock (who had a mortality rate of 45%) were excluded, the in-hospital mortality rate dropped to 2.60%. Mortality rates for all primary angioplasty patients at one year, two years and three years were 9.3%, 11.3% and 12.6%, respectively. Patients treated with stent placement did not have significantly lower risk-adjusted in-patient or two-year mortality rates. CONCLUSIONS Primary angioplasty is a highly effective option for AMI.

Appropriateness of Coronary Revascularization for Patients Without Acute Coronary Syndromes

OBJECTIVES The purpose of this study was to determine appropriateness of percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery performed in New York for patients without acute coronary syndrome (ACS) or previous CABG surgery. BACKGROUND The American College of Cardiology Foundation (ACCF) and 6 other societies recently published joint appropriateness criteria for coronary revascularization. METHODS Data from patients who underwent CABG surgery and PCI without acute coronary syndrome or previous CABG surgery in New York in 2009 and 2010 were used to assess appropriateness and to examine the variation across hospitals in inappropriateness ratings. RESULTS Of the 8,168 patients undergoing CABG surgery in New York without ACS/prior CABG who could be rated, 90.0% were appropriate for revascularization, 1.1% were inappropriate, and 8.6% were uncertain. Of the 33,970 PCI patients eligible for rating, 28% lacked sufficient information to be rated. Of the patients who could be rated, 36.1% were appropriate, 14.3% were inappropriate, and 49.6% were uncertain. A total of 91% of the patients undergoing PCI who were classified as inappropriate had 1- or 2-vessel disease without proximal left anterior descending artery disease and had no or minimal anti-ischemic medical therapy. CONCLUSIONS For patients without ACS/prior CABG, only 1% of patients undergoing CABG surgery who could be rated were found to be inappropriate for the procedure according to the ACCF appropriateness criteria, but 14% of the PCI patients who could be rated were found to be inappropriate, and 28% lacked enough noninvasive test information to be rated.

A Comparison of Short- and Long-Term Outcomes for Balloon Angioplasty and Coronary Stent Placement

OBJECTIVES We sought to compare patient outcomes for coronary stent placement and balloon angioplasty. BACKGROUND Since 1994, the number of patients treated only with balloon angioplasty has decreased nationally, whereas the use of coronary stents as an alternative has grown tremendously. The objectives of this study were to compare short- and long-term survival and subsequent revascularization rates for patients undergoing single-vessel balloon angioplasty and coronary stent placement. METHODS New Yorks Coronary Angioplasty Registry was used to identify New York patients undergoing either balloon angioplasty or stent placement between July 1, 1994, and December 31, 1996. Statistical models were used to compare risk-adjusted short- and long-term survival and subsequent coronary artery bypass graft surgery (CABG) and percutaneous coronary interventions (PCIs). RESULTS No significant differences were found in adjusted in-patient mortality, but patients who had balloon angioplasty were, on average, 1.36 times more likely to have died at any time during the two-year period after the index procedure (p = 0.003). The adjusted in-patient CABG rate was significantly higher for balloon angioplasty (2.72% vs. 1.66%, p<0.0001), and the adjusted two-year CABG rate was also significantly higher for balloon angioplasty (10.81% vs. 7.25%, p<0.001). The adjusted two-year rate for subsequent PCIs was also significantly higher for balloon angioplasty (19.6% vs. 14.3%, p<0.0001). Although measures were taken to eliminate or minimize the effect of selection bias, it should be noted that patients with stents were healthier at hospital admission than patients who had balloon angioplasty. CONCLUSIONS Stent placement is associated with significantly lower risk-adjusted long-term mortality, CABG and subsequent PCI rates, as compared with balloon angioplasty.