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G W Stone

Publications and source records attributed to G W Stone.

At least 19 recordsLinked to original sources
PubMed2001

Cost-effectiveness of coronary stenting in acute myocardial infarction: results from the stent primary angioplasty in myocardial infarction (stent-PAMI) trial.

BACKGROUND: Although several randomized trials have demonstrated that coronary stenting improves angiographic and clinical outcomes for patients with acute myocardial infarction (AMI), the cost-effectiveness of this practice is unknown. The objective of the present study was to evaluate the long-term costs and cost-effectiveness (C/E) of coronary stenting compared with primary balloon angioplasty as treatment for AMI. Methods and Results- Between December 1996 and November 1997, 900 patients with AMI were randomized to undergo balloon angioplasty (PTCA, n=448) or coronary stenting (n=452). Detailed resource utilization and cost data were collected for each patient's initial hospitalization and for 1 year after randomization. Compared with conventional PTCA, stenting increased procedural costs by approximately $2000 per patient ($6538+/-1778 versus $4561+/-1598, P<0.001). During the 1-year follow-up period, stenting was associated with significant reductions in the need for repeat revascularization and rehospitalization. Although follow-up costs were significantly lower with stenting ($3613+/-7743 versus $4592+/-8198, P=0.03), overall 1-year costs remained approximately $1000/patient higher with stenting than with PTCA ($20 571+/-10 693 versus 19 595+/-10 990, P=0.02). The C/E ratio for stenting compared with PTCA was $10 550 per repeat revascularization avoided. In analyses that incorporated recent changes in stent technology and pricing, the 1-year cost differential fell to <$350/patient, and the C/E ratio improved to $3753 per repeat revascularization avoided. The cost-utility ratio for primary stenting was <$50 000 per quality-adjusted life year gained only if stenting did not increase 1-year mortality by >0.2% compared with PTCA. CONCLUSIONS: As performed in Stent-PAMI, primary stenting for AMI increased 1-year medical care costs compared with primary PTCA. The overall cost-effectiveness of primary stenting depends on the societal value attributed to avoidance of symptomatic restenosis, as well as on the relative mortality rates of primary PTCA and stenting.

Aged↗
PubMed2001

Importance of time to reperfusion on outcomes with primary coronary angioplasty for acute myocardial infarction (results from the Stent Primary Angioplasty in Myocardial Infarction Trial).

The mortality benefit of thrombolytic therapy for acute myocardial infarction (AMI) is strongly dependent on time to treatment. Recent observations suggest that time to treatment may be less important with primary percutaneous transluminal coronary angioplasty (PTCA). Patients with AMI of <12 hours duration, without cardiogenic shock, who were treated with primary PTCA from the Stent PAMI Trial (n = 1,232) were evaluated to assess the effect of time to reperfusion on outcomes. Thrombolysis In Myocardial Infarction grade 3 flow was achieved in a high proportion of patients regardless of time to treatment. Improvement in ejection fraction from baseline to 6 months was substantial with reperfusion at <2 hours but was modest and relatively independent of time to reperfusion after 2 hours (<2 hours, 12.3% vs > or =2 hours, 4.2%, p = 0.004). There were no differences in 1- or 6-month mortality by time to reperfusion (6-month mortality: <2 hours [5.5%], 2 to <4 hours [4.6%], 4 to <6 hours [4.5%], >6 hours [4.2%], p = 0.97). There were also no differences in other clinical outcomes by time to reperfusion, except that reinfarction and infarct artery reocclusion at 6 months were more frequent with later reperfusion. The lack of correlation between time to treatment and mortality in patients without cardiogenic shock suggests that the survival benefit of primary PTCA may be related principally to factors other than myocardial salvage. These data may also have implications regarding the triage of patients with AMI for primary PTCA.

Aged↗
PubMed2001

Quality of life after balloon angioplasty or stenting for acute myocardial infarction. One-year results from the Stent-PAMI trial.

OBJECTIVES: The goal of this study was to compare the impact of primary stenting or percutaneous transluminal coronary angioplasty (PTCA) on health-related quality of life (HRQOL) in patients undergoing direct angioplasty for acute myocardial infarction (AMI). BACKGROUND: Previous studies have demonstrated that coronary stenting reduces clinical and angiographic restenosis compared with PTCA. However, the impact of stenting on HRQOL from the patient's perspective remains unknown. METHODS: We administered the Seattle Angina Questionnaire and the Medical Outcomes Study Short-form Survey at 1, 6 and 12 months after initial treatment to all North American patients in the Stent-Primary Angioplasty for Myocardial Infarction trial (Stent-PAMI) (n = 509)-a randomized trial comparing primary stenting to conventional PTCA for patients with AMI. RESULTS: At one month, most HRQOL measures were similar for the two groups, but stent patients reported less bodily pain than PTCA patients (p = 0.03). At six-month follow-up, stenting resulted in significant improvements in several dimensions of HRQOL including reduced anginal frequency and bodily pain as well as improved disease perception (all p < or = 0.03) and a trend towards better anginal stability (p = 0.056). By 12-month follow-up, however, none of these differences remained statistically significant. These differences in HRQOL were largely explained by the greater need for ischemia-driven target-vessel repeat revascularization procedures in PTCA patients during the first six months (16.0% vs. 6.2%, p < 0.001). CONCLUSIONS: In patients undergoing revascularization for AMI, initial stent placement is associated with improvements in several dimensions of health status during the first six months of follow-up. In the absence of differences in mortality, these findings add to the overall argument in favor of initial stenting in patients treated with mechanical reperfusion for myocardial infarction.

Angioplasty, Balloon, Coronary↗
PubMed2001

The current practice of intra-aortic balloon counterpulsation: results from the Benchmark Registry.

OBJECTIVES: This study presents clinical data from the first large registry of aortic counterpulsation, a computerized database that incorporates prospectively gathered data on indications for intra-aortic balloon counterpulsation (IABP) use, patient demographics, concomitant medication and in-hospital outcomes and complications. BACKGROUND: The intra-aortic balloon pump (IABP) is widely used to provide circulatory support for patients experiencing hemodynamic instability due to myocardial infarction, cardiogenic shock, or in very high risk patients undergoing angioplasty or coronary artery bypass grafting. METHODS: Between June 1996 and August 2000, 203 hospitals worldwide (90% U.S., 10% non-U.S.) collected 16,909 patient case records (68.8% men, 31.2% women; mean age 65.9 +/- 11.7 years). RESULTS: The most frequent indications for use of IABP were as follows: to provide hemodynamic support during or after cardiac catheterization (20.6%), cardiogenic shock (18.8%), weaning from cardiopulmonary bypass (16.1%), preoperative use in high risk patients (13.0%) and refractory unstable angina (12.3%). Major IABP complications (major limb ischemia, severe bleeding, balloon leak, death directly due to IABP insertion or failure) occurred in 2.6% of cases; in-hospital mortality was 21.2% (11.6% with the balloon in place). Female gender, high age and peripheral vascular disease were independent predictors of a serious complication. CONCLUSIONS: This registry provides a useful tool for monitoring the evolving practice of IABP. In the modern-day practice of IABP, complication rates are generally low, although in-hospital mortality remains high. There is an increased risk of major complications in women, older patients and patients with peripheral vascular disease.

Age Factors↗
PubMed2001

Normal flow (TIMI-3) before mechanical reperfusion therapy is an independent determinant of survival in acute myocardial infarction: analysis from the primary angioplasty in myocardial infarction trials.

BACKGROUND: Whereas survival after lytic therapy for myocardial infarction is strongly dependent on early administration, it is unknown whether the otherwise excellent outcomes in patients undergoing primary PTCA for acute myocardial infarction, in whom TIMI-3 flow rates of >90% may be achieved, can be further improved by early reperfusion. METHODS AND RESULTS: Among 2507 patients enrolled in 4 PAMI trials undergoing primary PTCA, spontaneous reperfusion (TIMI-3 flow) was present in 16% at initial angiography. Compared with patients without TIMI-3 flow, those with TIMI-3 flow before PTCA had greater left ventricular ejection fraction (57+/-10% versus 53+/-11%, P=0.003) and were less likely to present in heart failure (7.0% versus 11.6%, P=0.009). Patients with initial TIMI-3 flow had significantly lower in-hospital rates of mortality, new-onset heart failure, and hypotension and had a shorter hospital stay. Cumulative 6-month mortality was 0.5% in patients with initial TIMI-3 flow, 2.8% with TIMI-2 flow, and 4.4% with initial TIMI-0/1 flow (P=0.009). By multivariate analysis, TIMI-3 flow before PTCA was an independent determinant of survival (odds ratio 2.1, P=0.04), even when corrected for by postprocedural TIMI-3 flow. CONCLUSIONS: Patients undergoing primary PTCA in whom TIMI-3 flow is present before angioplasty present with greater clinical and angiographic evidence of myocardial salvage, are less likely to develop complications related to left ventricular failure, and have improved early and late survival. These data warrant prospective randomized trials of pharmacological strategies to promote early reperfusion before definitive mechanical intervention in acute myocardial infarction.

Aged↗
PubMed2001

Differential impact on survival of electrocardiographic Q-wave versus enzymatic myocardial infarction after percutaneous intervention: a device-specific analysis of 7147 patients.

BACKGROUND: The relative prognostic importance of ECG myocardial infarction (MI) after intervention compared with varying degrees of enzymatic elevation has not been characterized, and the device-specific implications of periprocedural MI are also unknown. METHODS AND RESULTS: Serial creatine phosphokinase (CPK)-MB levels were determined after elective percutaneous intervention of 12 098 lesions in 7147 consecutive patients at a tertiary referral center. Procedural, in-hospital, and follow-up data were collected by independent research nurses, and clinical and ECG events were adjudicated by a separate committee. Stents were implanted in 50.6% of lesions, atheroablation was performed in 54.8%, and PTCA alone was performed in 9.8%. The peak periprocedural CPK-MB level was >3x the upper limit of normal (ULN) in 17.9% of patients, and Q-wave MI developed in 0.6%. By multivariate analysis, the periprocedural development of new Q waves was the most powerful independent determinant of death (2-year mortality rate, 38.3%; hazard ratio, 9.9; P<0.0001). Non-Q-wave MI with CPK-MB >8x ULN was also a strong predictor of death (2-year mortality rate, 16.3%; hazard ratio, 2.2; P<0.0001); survival was unaffected by lesser degrees of CPK-MB elevation. Though CPK-MB elevation was more common after atheroablation and stenting than PTCA, the rates of Q-wave MI and survival were device-independent. CONCLUSIONS: Myonecrosis after percutaneous intervention is common in a high-risk referral population dominated by atheroablation and stent use. Large periprocedural infarctions (signified by new Q waves and CPK-MB >8xULN) are powerful determinants of death, whereas lesser degrees of CPK-MB release and specific device use do not adversely affect survival.

Aged↗
PubMed2001

Comparison of two platelet glycoprotein IIb/IIIa inhibitors, tirofiban and abciximab, for the prevention of ischemic events with percutaneous coronary revascularization.

BACKGROUND: In the setting of percutaneous coronary revascularization, agents in the class known as platelet glycoprotein IIb/IIIa inhibitors have significantly reduced the incidence of death or nonfatal myocardial infarction at 30 days. We assessed whether there are differences in safety or efficacy between two such inhibitors, tirofiban and abciximab. METHODS: Using a double-blind, double-dummy design at 149 hospitals in 18 countries, we randomly assigned patients to receive either tirofiban or abciximab before undergoing percutaneous coronary revascularization with the intent to perform stenting. The primary end point was a composite of death, nonfatal myocardial infarction, or urgent target-vessel revascularization at 30 days. The trial was designed and statistically powered to demonstrate the noninferiority of tirofiban as compared with abciximab. RESULTS: The primary end point occurred more frequently among the 2398 patients in the tirofiban group than among the 2411 patients in the abciximab group (7.6 percent vs. 6.0 percent; hazard ratio, 1.26; one-sided 95 percent confidence interval of 1.51, demonstrating lack of equivalence, and two-sided 95 percent confidence interval of 1.01 to 1.57, demonstrating the superiority of abciximab over tirofiban; P=0.038). The magnitude and the direction of the effect were similar for each component of the composite end point (hazard ratio for death, 1.21; hazard ratio for myocardial infarction, 1.27; and hazard ratio for urgent target-vessel revascularization, 1.26), and the difference in the incidence of myocardial infarction between the tirofiban group and the abciximab group was significant (6.9 percent and 5.4 percent, respectively; P=0.04). The relative benefit of abciximab was consistent regardless of age, sex, the presence or absence of diabetes, or the presence or absence of pretreatment with clopidogrel. There were no significant differences in the rates of major bleeding complications or transfusions, but tirofiban was associated with a lower rate of minor bleeding episodes and thrombocytopenia. CONCLUSIONS: Although the trial was intended to assess the noninferiority of tirofiban as compared with abciximab, the findings demonstrated that tirofiban offered less protection from major ischemic events than did abciximab.

Abciximab↗
PubMed2001

Creatine kinase-MB fraction elevation after percutaneous coronary intervention in patients with chronic renal failure.

We evaluated the short- and long-term clinical outcomes of 326 consecutive patients with chronic renal failure, not on dialysis, who had creatine kinase (CK)-myocardial band (MB) fraction elevation after successful percutaneous coronary intervention in a native coronary artery. Based on peak CK-MB levels measured after intervention, patients were divided into 3 groups: no elevation (group 1, n = 184), 1 to 3 x upper normal levels (group 2, n = 72), and >3 x upper normal levels (group 3, n = 70). Baseline clinical and angiographic characteristics were similar among the 3 groups. Angiographic success was similar among the 3 groups, although there was a significantly higher use of intra-aortic balloon pump in patients who had postprocedural CK-MB >3 x normal values and a higher rate of in-hospital complications, i.e., repeat catheterization, repeat target lesion intervention, pulmonary edema, renal function deterioration, emergency dialysis, and major bleeding complications. At 1-year follow-up, mortality rates were significantly higher in these patients (35.4% vs 22.0% for patients with CK-MB 1 to 3 x normal values and 16.7% for patients without CK-MB elevation, p = 0.007). Multivariate analysis showed that CK-MB >3 x normal (odds ratio 3.04; 95% confidence interval 1.41 to 6.57, p = 0.005) and intra-aortic balloon pump (odds ratio 1.49; confidence interval 1.15 to 1.93, p = 0.002) were independent predictors of late mortality. Therefore, patients with chronic renal failure who had CK-MB elevation >3 x the upper normal limit after a successful percutaneous coronary intervention had a higher incidence of in-hospital complications and a significantly higher mortality rate at 1-year follow-up than patients without CK-MB elevation or with <3 x normal CK-MB elevation.

Aged↗
PubMed2001

Long-term mortality benefit with abciximab in patients undergoing percutaneous coronary intervention.

OBJECTIVES: The goal of this study was to test: 1) if platelet glycoprotein IIb/IIIa (GP IIb/IIIa) blockade with abciximab bolus plus 12-h infusion reduces mortality after percutaneous coronary intervention (PCI); 2) if prevention of early myocardial infarction (MI) after PCI is a mechanism for reducing mortality; and 3) for risk factors for mortality after PCI. BACKGROUND: Studies of PCI suggest that MI after intervention is predictive of mortality. Abciximab, a platelet GP IIb/IIIa receptor inhibitor, has consistently reduced the incidence of MI among PCI patients in several trials. The presumed mechanism is prevention of platelet thrombus associated with vessel wall injury and downstream embolization into the microcirculation. METHODS: In eight trials, 5,154 patients were randomized to a regimen comprising conventional therapy plus a bolus of abciximab within 1 h before PCI followed by a 12-h infusion; 4,136 controls were randomized to conventional therapy alone. Patient follow-up from six months to three years was available. Survival differences are examined using proportional hazards regression and survival curves. RESULTS: A hazard ratio of 0.71 (95% confidence interval 0.57 to 0.89; p = 0.003) suggests a mortality benefit with abciximab. The absolute reduction in mortality was estimated to be 0.5% through 30 days, 0.7% through six months, 0.9% through one year and 1.8% through three years. Early MI explained 18% of the observed mortality benefit at one year. Multivariate regression suggests that patients with advanced cardiovascular disease may derive the greatest mortality benefit from abciximab. CONCLUSIONS: The evidence from 9,290 randomized PCI patients shows a mortality benefit provided by abciximab bolus plus 12-h infusion.

Abciximab↗
PubMed2001

Influence of gender on early and one-year clinical outcomes after saphenous vein graft stenting.

Compared with men, women may have a worse prognosis after native coronary revascularization. However, the influence of gender on clinical outcomes after saphenous vein graft (SVG) stenting is unknown. The purpose of this study was to compare early and 1-year clinical outcomes between men and women after stent implantation in SVG. A total of 1,199 consecutive patients with 1,858 SVG lesions were studied. Procedural success, in-hospital events, and late clinical outcomes were compared between men (n = 951) and women (n = 248). Overall procedural success was similar between men and women (97% vs 96%, p = NS). However, in-hospital (3.2% vs 1.6%, p = 0.07) and 30-day cumulative (4.4% vs 1.9%, p = 0.02) mortality rates were higher in women than in men. In addition, women had a higher incidence of vascular complications (12% vs 7.3%, p = 0.006) and postprocedural acute renal failure (8.1% vs 4%, p = 0.02). At 1-year follow-up, mortality was 13% in women and 11% in men (p = NS) and target lesion revascularization was 18% versus 23%, respectively (p = NS). By multivariate regression analysis, independent correlates of in-hospital mortality were female gender (odds ratio [OR] 3.6, confidence interval [CI] 1.0 to 12.5, p = 0.05) and left ventricular ejection fraction (OR 0.9, CI 0.9 to 1.0, p = 0.01). Female gender was found to predict 30-day mortality (OR 2.5, CI 1.1 to 5.5, p = 0.02). The sole predictor of 1-year mortality was diabetes mellitus (OR 1.6, CI 1.1 to 2.3, p = 0.01). This study shows that women compared with men treated with stent implantation in SVG lesions have (1) a trend toward higher in-hospital mortality, (2) higher risk of 30-day mortality, (3) increased incidence of vascular complications and postprocedure acute renal failure, and (4) similar 1-year clinical outcome.

Aged↗
PubMed2001

Combination therapy with aspirin plus clopidogrel versus aspirin plus ticlopidine for prevention of subacute thrombosis after successful native coronary stenting.

We compared the combination of aspirin plus clopidrogrel (A+C) with aspirin and ticlopidine (A+T) for prevention of subacute stent thrombosis in 827 patients. At 30-day follow-up, there were trends toward increased subacute thrombosis with A+C compared with A+T (1.3% vs 0.2%, p = 0.10). These results suggest that A+C may have marginally higher subacute stent thrombosis than A+T.

Aged↗
PubMed2001

Are we making progress with percutaneous saphenous vein graft treatment? A comparison of 1990 to 1994 and 1995 to 1998 results.

OBJECTIVES: We sought to determine whether strategies to reduce procedural distal embolization and late repeat revascularization have resulted in more favorable outcomes after saphenous vein graft (SVG) angioplasty. BACKGROUND: Angioplasty of SVG lesions has been associated with frequent procedural and late cardiac events. Therefore, evolving strategies have been attempted to improve outcomes after SVG angioplasty. METHODS: We compared our earlier experience (1990 to 1994) of 1,055 patients with 1,412 SVG lesions with a recent group (1995 to 1998) of 964 patients with 1,315 lesions. RESULTS: Baseline characteristics were similar between the groups. However, there were significantly more unfavorable lesion characteristics (older, longer and significantly more degenerated SVGs) in the recent series. Between the two periods, there was decreased use ofatheroablative devices, whereas stent use increased. The procedural success rates (96.6% vs. 96.1%) were similar. However, one-year outcome (event-free survival) was significantly improved in the more recent experience (70.7% vs. 59.1%, p < 0.0001), especially late mortality (6.1% vs. 11.3%, p < 0.0001). Multivariate analysis showed stent use to be the only protective variable for both periods. CONCLUSIONS: This study shows that despite higher risk lesions, strategies to reduce distal embolization have maintained high procedural success. Late cardiac events, including mortality, have also been substantially reduced.

Aged↗
PubMed2001

Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices.

OBJECTIVES: We evaluated the vascular complications after hemostasis with arteriotomy closure devices (ACD) versus manual compression after percutaneous coronary interventions (PCI). BACKGROUND: Previous clinical studies have indicated that ACD can be used for achievement of hemostasis and early ambulation after PCI. This study investigated the safety of ACD in achieving hemostasis after PCI compared with manual compression in a large cohort of consecutive patients. METHODS: A total of 5,093 patients were followed after PCI was performed with the transfemoral approach. Univariate and multivariate analysis were used to identify the predictors of vascular complications with ACD (n = 516) or with manual compression (n = 5,892) as a hemostasis option after sheath removal. RESULTS: The use of ACD was associated with a more frequent occurrence of hematoma compared with manual compression (9.3 vs. 5.1%, p < 0.001). There was also a higher rate of significant hematocrit drop (>15%) with ACD versus manual compression (5.2% vs. 2.5%, p < 0.001). Similar rates of pseudoaneurysm and arteriovenous fistulae were noted with either hemostasis technique. Vascular surgical repair at the access site was required more often with ACD versus manual compression (2.5 vs. 1.5%, p = 0.03). CONCLUSIONS: In this early experience with ACD after PCI, their use was associated with higher vascular complication rates than hemostasis with manual compression.

Aged↗
PubMed2001

Interventional procedures in acute myocardial infarction.

BACKGROUND: Acute myocardial infarction (MI) remains a leading cause of death in the United States. There is evidence that primary (direct) percutaneous intervention (PCI) may improve survival and reduce morbidity in patients with acute MI. METHODS: We present a concise, comprehensive, evidence-based literature review of modern techniques of primary PCI in patients with acute MI. A comparison to thrombolytic therapy, especially in selected patient subgroups is made. Rescue angioplasty is also addressed. Adjunctive pharmacology, economic implications, and feasibility of implementation are discussed. A brief discussion of experimental therapies is included. RESULTS: Primary PCI is an acceptable alternative to thrombolytic therapy in patients with acute MI and may result in superior outcomes in select patient populations, especially the elderly, patients with prior coronary artery bypass surgery, those with congestive heart failure, and those in cardiogenic shock. CONCLUSIONS: Clinical trials support the use of primary PCI as first-line therapy for acute myocardial infarction. Patients in whom thrombolytic therapy is contraindicated or known to have reduced efficacy are also excellent candidates for this therapy. Ongoing advancements in equipment and adjunctive therapies continue to enhance delivery of this treatment as well as improve patient outcome.

Aged↗
PubMed2001

Treatment of focal in-stent restenosis with balloon angioplasty alone versus stenting: Short- and long-term results.

BACKGROUND: Although both percutaneous transluminal coronary angioplasty (PTCA) and additional stenting can be used for the treatment for focal in-stent restenosis (ISR), no large-scale comparative data on the clinical outcomes after these interventional procedures have been reported. METHODS: In the current study we compared the in-hospital and long-term clinical results of PTCA alone (n = 266 patients, n = 364 lesions) versus stenting (n = 135 patients, n = 161 lesions) for the treatment of focal ISR, defined as a lesion length less than or equal to 10 mm. RESULTS: There were significantly more diabetic patients in the PTCA group than in the stent group (36% vs 26%, P =.04), but other baseline characteristics were similar. Lesion length and preprocedure minimal lumen diameter (MLD) were also similar in the two groups, but the stent group had a larger reference vessel diameter (3.40 +/- 0.73 mm vs 2.99 +/- 0.68 mm, P <.001). Stenting achieved a larger postprocedure MLD than PTCA did (2.95 +/- 0.95 mm vs 2.23 +/- 0.60 mm, P <.001) and a smaller residual diameter stenosis (11% +/- 15% vs 23% +/- 16%, P =.04). Angiographic success was achieved in all cases. The rate of death/Q-wave infarction of urgent revascularization was higher with PTCA than with stent (5.6% vs 0.7%, P =.02). Postprocedure creatine kinase myocardial band enzyme elevation >5 times normal was more frequent with stent (18.5% vs 9.7%, P =.05). At 1 year the two interventional strategies had similar cumulative mortality (4.6% PTCA vs 5.1% stent, P not significant) and target lesion revascularization rate (24.6% PTCA vs 26.5% stent, P not significant). By multivariate analysis, the sole predictor of target lesion revascularization was diabetes (odds ratio 2.4, 95% confidence intervals 1.2-4.7, P =.01). CONCLUSION: Repeat stenting for the treatment of focal ISR had a higher postprocedure creatine kinase myocardial band elevation rate and similar long-term clinical results compared with PTCA alone.

Aged↗
PubMed2001

First experience with hybrid percutaneous transmyocardial laser revascularization and angioplasty in patients with lesions at high risk for restenosis: Results of a phase I feasibility study.

BACKGROUND: Prior studies have suggested that percutaneous transmyocardial laser revascularization (PTMR) may be effective as a sole treatment modality in reducing angina in patients with severe coronary artery disease and no revascularization alternatives. The safety and efficacy of the hybrid or adjunctive use of PTMR during the same procedure as percutaneous intervention (PCI) has not previously been reported. METHODS: A US phase I feasibility study was therefore performed to determine whether PTMR performed in the same myocardial territory as PCI is able to ameliorate symptomatic recurrence from restenosis. RESULTS: After successful and uncomplicated PCI in 26 patients with class III-IV angina and lesion(s) at high risk for restenosis, PTMR was performed in the same myocardial territories subtended by the treated vessel(s). Major periprocedural adverse events (death, Q-wave myocardial infarction, and bypass surgery) occurred in 3 (11.5%) patients, as the result of subacute vessel closure in 2 patients, and tamponade in the third. Cumulative 6-month mortality rate was 19.2%, including 2 late deaths between 3 and 4 months after discharge (1 death caused by late stent closure and 1 unexplained death during sleep.) Late repeat revascularization for restenosis in the PCI plus PTMR treated target vessel was required in 19.2% of patients, and an additional 11.5% of patients had class III-IV angina at 6-month follow-up. CONCLUSIONS: These data demonstrate that in a patient population at high risk for restenosis, recently created PTMR channels are not protective against severe ischemia caused by acute vessel closure and that late symptomatic restenosis after PCI may still frequently occur despite PTMR in the same region.

Angina Pectoris↗
PubMed2001

One-year follow-up after primary coronary intervention for acute myocardial infarction in diabetic patients. A substudy of the STENT PAMI trial.

OBJECTIVE: This analysis was undertaken to determine the composite incidence of cumulative adverse events (death, reinfarction, disabling stroke, and target vessel revascularization) at the end of the first year after acute myocardial infarction, in diabetic patients who underwent coronary stenting or primary coronary balloon angioplasty. METHODS: From the STENT PAMI trial, we analyzed the 6-month angiographic and 1-year clinical outcomes of 135 diabetic (112, noninsulin dependent) patients who underwent the randomization process of the trial and compared them with 758 nondiabetic patients. RESULTS: Coronary stenting did not significantly reduce the primary composite clinical end point when compared with PTCA (20 vs. 30%, p=0.2). A significant benefit from stenting was observed in patients with noninsulin dependent diabetes, with a trend toward a lesser need for new revascularization procedures (10 vs. 21%, p<.001), with a significant reduction in the primary composite clinical end point at 1 year (12 vs. 28%, p=. 04). At 6 months, the restenosis rate were significantly reduced only in nondiabetic patients (18 vs. 33%, p<. 001). Diabetic patients had the same restenosis rate (38%) either with stenting or balloon PTCA. CONCLUSIONS: Coronary Stenting in diabetics noninsulin dependent offered a significant reduction in the composite incidence of major clinical adverse events compared with balloon PTCA.

Angioplasty, Balloon, Coronary↗