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Biomedical subjects

C Macaya

Publications and source records attributed to C Macaya.

At least 55 records · Page 3Linked to original sources
PubMed1999

Initial results and long-term clinical and angiographic implications of coronary stenting in elderly patients.

Results of 378 consecutive elderly patients (> or = 65 years) undergoing coronary stenting were compared with those of 601 younger patients. Although the restenosis rate was similar in the 2 groups, age > or = 65 years was an independent predictor of in-hospital mortality (relative risk 5.4, 95% confidence interval 1.2 to 20.1) and follow-up mortality (relative risk 2.8, 95% confidence interval 1.3 to 6.1).

Aged↗
PubMed1999

Long-term outcome and determinants of event-free survival in patients treated with balloon angioplasty for in-stent restenosis.

Long-term prognosis and predictors of event-free survival were studied in 56 consecutive patients with in-stent restenosis successfully treated with balloon angioplasty. Most patients sustained prolonged clinical benefit, but during follow-up, those with diabetes or with a short time interval (<4 months) from stenting to repeat angioplasty experienced adverse cardiac events more often.

Angioplasty, Balloon, Coronary↗
PubMed1999

Long-term clinical and echocardiographic follow-up after percutaneous mitral valvuloplasty with the Inoue balloon.

BACKGROUND: The objective of this study was to assess the long-term clinical outcome and valvular changes (area and regurgitation) after percutaneous mitral valvuloplasty (PMV). METHODS AND RESULTS: After PMV, 561 patients were followed up for 39 (+/-23) months and clinical/echocardiographic data obtained yearly. Kaplan-Meier and Cox regression analyses were performed to estimate event-free survival, its predictors, and the relative risks of several patient subgroups. There were several nonexclusive events: 19 (3.3%) cardiac deaths, 55 (9.8%) mitral replacements, 6 (1%) repeated PMVs, 56 (10%) cases of restenosis, and 108 (19%) cases of clinical impairment. Survival free of major events (cardiac death, mitral surgery, repeat PMV, or functional impairment) was 69% at 7 years, ranging from 88% to 40% in different subgroups of patients. Wilkins score was the best preprocedural predictor of mitral opening, but the procedural result (mitral area and regurgitation) was the only independent predictor of major event-free survival. Mitral area loss, though mild [0.13 (+/-0.21)cm2], increased with time and was >/=0.3 cm2 in 12%, 22%, and 27% of patients at 3, 5, and 7 years, respectively. Regurgitation did not progress in 81% of patients, and when it occurred it was usually by 1 grade. CONCLUSIONS: Seven years after PMV, more than two thirds of patients were in good clinical condition and free of any major event. The procedural result was the main determinant of long-term outcome, although a high score had also negative implications. Mitral area decreased progressively over time, whereas regurgitation did not tend to progress.

Aged↗
PubMed1999

Value of intravascular ultrasound in the assessment of coronary pseudostenosis during coronary interventions.

Coronary pseudostenosis (PS) are increasingly visualized during coronary interventions. In many patients PS are readily recognized by a characteristic angiographic pattern, but in other cases the diagnosis remains difficult. The value of intravascular ultrasound (IVUS) in the study of PS remains unknown. In this study, IVUS was used to assess the morphologic appearance of the vessel wall in 10 consecutive patients showing images of PS during coronary interventions. Mean age of the group was 60+/-12 years and two patients were female. IVUS was performed with a motorized pullback system to assess lumen, plaque, and total vessel cross-sectional areas. Measurements were performed both at the site of PS and at the distal reference segment. PS were always located on angled coronary segments. In one patient no lumen narrowing was detected with IVUS at the site of PS. In the remaining nine patients, however, a very localized elliptic-shaped lumen narrowing was demonstrated. As compared with the distal reference segment, coronary lumen (6.3+/-2.2 vs. 12.7+/-4.8 mm2, P < 0.001) and total vessel area (11.9+/-3.3 vs. 16.1+/-6.1 mm2, P < 0.05) were smaller at the site of PS. Severe lumen asymmetry was also documented at this site. In addition, a characteristic image of a flattened, three-layered wall, overlying a hypoechogenic space, was visualized in five patients. This unique pattern was considered the correlate of a partial coronary intussusception. PS induced some resistance to the advancement of catheters in two patients and temporary flow impairment in two additional patients. However, in every case, the image of PS disappeared once the guidewire was removed. Thus, at sites with PS, IVUS allows ruling out severe atherosclerosis and coronary dissections. In addition, IVUS also provides important diagnostic clues, including the image of intussusception, for making the correct diagnosis of this benign entity.

Aged↗
PubMed1999

Long-term angiographic results of stenting in chronic total occlusions: influence of stent design and vessel size.

BACKGROUND: Although coronary stenting has decreased the high restenosis rate associated with percutaneous transluminal coronary angioplasty of chronic total occlusions (CTOs), the results are still less satisfactory than those found in nonoccluded lesions, at least as reported with the Palmaz-Schatz stent. The present work compares the restenosis rate of other stent designs with that of the Palmaz-Schatz stent. METHODS: We studied the long-term angiographic outcome of 120 CTOs successfully recanalized with balloon-expandable stents and without concomitant debulking techniques. Angiographic follow-up and full quantitative coronary angiography analysis was prospectively performed in all patients. Three different stent designs were compared: Palmaz-Schatz (n = 47), coil (n = 24), and multicellular (n = 49). Particular attention was paid to their performance in vessels of 3 mm or less and greater than 3 mm in diameter. Restenosis was defined as a 50% or greater diameter stenosis at follow-up. RESULTS: Multicellular stents were implanted more frequently in the left anterior descending artery and in patients with multivessel disease. No other significant differences in clinical or angiographic baseline characteristics, including vessel size, were noted between groups. At follow-up, multicellular stents presented a lower restenosis rate (22% vs 36% and 58% in the Palmaz-Schatz and coil stent groups, respectively; P =.01 ) and larger minimal luminal diameters (1.92 +/- 0.85 mm vs 1.73 +/- 0.98 and 1.38 +/- 0.83 mm in the Palmaz-Schatz and coil stent groups, respectively; P = 0.0). The superiority of the multicellular stent design resulted from a lower restenosis rate in vessels of 3.0 mm or less in diameter (20% vs 47% and 79% in the Palmaz-Schatz and coil stent groups, respectively; P =.006). CONCLUSIONS: These results suggest that the restenosis rate after stent recanalization of CTOs is influenced by both stent design and vessel size and may indicate a superiority of multicellular over Palmaz-Schatz and coil stent designs for this purpose.

Coronary Angiography↗
PubMed1999

Laser angioplasty of restenosed coronary stents: results of a multicenter surveillance trial. The Laser Angioplasty of Restenosed Stents (LARS) Investigators.

OBJECTIVES: This study evaluated safety and efficacy of excimer laser angioplasty for treatment of restenosed or occluded coronary stents. BACKGROUND: Balloon angioplasty of in-stent restenosis is limited by a high recurrence rate. Debulking by laser angioplasty is a novel concept to treat in-stent restenosis. METHODS: A total of 440 patients with restenoses or occlusions in 527 stents were enrolled for treatment with concentric or eccentric laser catheters and adjunctive balloon angioplasty. RESULTS: Laser angioplasty success (< or =50% diameter stenosis after laser treatment or successful passage with a 2.0-mm or 1.7-mm eccentric laser catheter) was achieved in 92% of patients. Adjunctive balloon angioplasty was performed in 99%. Procedural success (laser angioplasty success followed by < or =30% stenosis with or without balloon angioplasty) was 91%. There was neither a significant difference in success with respect to lesion length, nor were there differences between small and large vessels or native vessels and vein grafts. Success was higher and residual stenosis lower using large or eccentric catheters. Serious adverse events included death (1.6%, not directly laser catheter related), Q-wave myocardial infarction (0.5%), non-Q-wave infarction (2.7%), cardiac tamponade (0.5%) and stent damage (0.5%). Perforations after laser treatment occurred in 0.9% of patients and after balloon angioplasty in 0.2%. Dissections were visible in 4.8% of patients after laser treatment and in 9.3% after balloon angioplasty. Reinterventions during hospitalization were necessary in 0.9% of patients; bypass surgery was performed in 0.2%. CONCLUSIONS: Excimer laser angioplasty with adjunctive balloon angioplasty is a safe and efficient technology to treat in-stent restenoses. These data justify a randomized comparison with balloon angioplasty.

Adult↗
PubMed1999

Does focal destruction of the thoracic aorta wall by Staphylococcus aureus lead to the development of infected aneurysms? An experimental study.

OBJECTIVE: The infrequency of infected aneurysms suggests that either infection of segments of the aortic wall is uncommon, or that infections do not always lead top infected aneurysm formation. The purpose of the study was to determine whether focal Staphylococcus aureus infection of aortic wall segments leads consistently to the development of infected aneurysms and to evaluate the segments in which infection did not lead to the infected aneurysm formation. METHODS: Twenty pigs were inoculated with 0.1 ml of a Staphylococcus aureus inoculum in three segments of the thoracic aorta wall (study group). In another 10 pigs, 0.1 ml of saline solution was injected in three segments of the thoracic aorta wall (control group). STUDY GROUP: histological abnormalities and bacterial culture of the inoculation sites were evaluated at 10 days (n = 5 pigs), 30 days (n = 5 pigs), and 90 days (n = 10 pigs). CONTROL GROUP: histological abnormalities were evaluated at 10 days (n = 5 pigs) and 90 days (n = 5 pigs). RESULTS STUDY GROUP: infected aneurysms developed in only two animals killed at 30 days. At 90 days, destruction of the elastic tissue, scar tissue and neointima formation were found in all the aortic segments studied. CONTROL GROUP: no significant changes were found in any of the segments evaluated. CONCLUSION: In our experimental model, acute local infection by S. aureus caused the development of infected aortic aneurysm in only 10% of the animals. In the remaining 90%, healing of the site of infection followed resolution of the infection.

Aneurysm, Infected↗
PubMed1999

A randomized placebo-controlled trial of fluvastatin for prevention of restenosis after successful coronary balloon angioplasty; final results of the fluvastatin angiographic restenosis (FLARE) trial.

BACKGROUND: The 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors competitively inhibit biosynthesis of mevalonate, a precursor of non-sterol compounds involved in cell proliferation. Experimental evidence suggests that fluvastatin may, independent of any lipid lowering action, exert a greater direct inhibitory effect on proliferating vascular myocytes than other statins. The FLARE (Fluvastatin Angioplasty Restenosis) Trial was conceived to evaluate the ability of fluvastatin 40 mg twice daily to reduce restenosis after successful coronary balloon angioplasty (PTCA). METHODS: Patients were randomized to either placebo or fluvastatin 40 mg twice daily beginning 2-4 weeks prior to planned PTCA and continuing after a successful PTCA (without the use of a stent), to follow-up angiography at 26+/-2 weeks. Clinical follow-up was completed at 40 weeks. The primary end-point was angiographic restenosis, measured by quantitative coronary angiography at a core laboratory, as the loss in minimal luminal diameter during follow-up. Clinical end-points were death, myocardial infarction, coronary artery bypass graft surgery or re-intervention, up to 40 weeks after PTCA. RESULTS: Of 1054 patients randomized, 526 were allocated to fluvastatin and 528 to placebo. Among these, 409 in the fluvastatin group and 427 in the placebo group were included in the intention-to-treat analysis, having undergone a successful PTCA after a minimum of 2 weeks of pre-treatment. At the time of PTCA, fluvastatin had reduced LDL cholesterol by 37% and this was maintained at 33% at 26 weeks. There was no difference in the primary end-point between the treatment groups (fluvastatin 0.23+/-0.49 mm vs placebo 0.23+/-0.52 mm, P=0.95) or in the angiographic restenosis rate (fluvastatin 28%, placebo 31%, chi-square P=0.42), or in the incidence of the composite clinical end-point at 40 weeks (22.4% vs 23.3%; logrank P=0.74). However, a significantly lower incidence of total death and myocardial infarction was observed in six patients (1.4%) in the fluvastatin group and 17 (4.0%) in the placebo group (log rank P=0.025). CONCLUSION: Treatment with fluvastatin 80 mg daily did not affect the process of restenosis and is therefore not indicated for this purpose. However, the observed reduction in mortality and myocardial infarction 40 weeks after PTCA in the fluvastatin treated group has not been previously reported with statin therapy. Accordingly, a priori investigation of this finding is indicated and a new clinical trial with this intention is already underway.

Angioplasty, Balloon, Coronary↗
PubMed1999

Double stenting as a treatment for stent collapse in the left main coronary artery.

We report on a case of double stent implantation in the left main coronary artery due to collapse of the first implanted stent. The case illustrates a complication of stenting presumably dictated by the specific characteristics of left main disease, and the feasibility and good long-term results of double stenting in this situation.

Aged↗
PubMed1998

Randomized evaluation of anticoagulation versus antiplatelet therapy after coronary stent implantation in high-risk patients: the multicenter aspirin and ticlopidine trial after intracoronary stenting (MATTIS).

BACKGROUND: Although the association of ticlopidine and aspirin has been shown to be superior to anti-vitamin K agents and aspirin after coronary stent implantation in low-risk patients, the latter combination has remained an unproven reference regimen for high-risk patients until recently. METHODS AND RESULTS: We randomized 350 high-risk patients within 6 hours after stent implantation to receive during 30 days either aspirin 250 mg and ticlopidine 500 mg/d (A+T group) or aspirin 250 mg/d and oral anticoagulation (A+OAC group) targeted at an international normalized ratio of 2.5 to 3. The primary composite end point was defined as the occurrence of cardiovascular death, myocardial infarction, or repeated revascularization at 30 days. Patients were eligible if (1) the stent(s) were implanted to treat abrupt closure after PTCA; (2) the angiographic result after implantation was suboptimal; (3) a long segment was stented (>45 mm and/or >/=3 stents); or (4) the largest balloon inflated in the stent had a nominal diameter of </=2.5 mm. The primary cardiac end point was reached for 10 patients (5.6%) in the A+T group and 19 (11%) in the A+OAC group (relative risk [RR], 1. 9; 95% CI, 0.9 to 4.1; P=0.07). Major vascular and bleeding complications were less frequent in the A+T group (3 patients, 1.7%) than in the A+OAC group (12 patients, 6.9%) (RR, 4.1; 95% CI, 1.2 to 14.3; P=0.02). CONCLUSIONS: High-risk patients should be treated with A+T rather than A+OAC after coronary stenting because the bleeding and vascular complications are significantly reduced and there is a marked trend suggesting a decrease in cardiac events.

Adult↗
PubMed1998

Randomised comparison of implantation of heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II)

BACKGROUND: The multicentre, randomised Benestent-II study investigated a strategy of implantation of a heparin-coated Palmar-Schatz stent plus antiplatelet drugs compared with the use of balloon angioplasty in selected patients with stable or stabilised unstable angina, with one or more de-novo lesions, less than 18 mm long, in vessels of diameter 3 mm or more. METHODS: 827 patients were randomly assigned stent implantation (414 patients) or standard balloon angioplasty (413 patients). The primary clinical endpoint was event-free survival at 6 months, including death, myocardial infarction, and the need for revascularisation. The secondary endpoints were the restenosis rate at 6 months and the cost-effectiveness at 12 months. There was also one-to-one subrandomisation to either clinical and angiographic follow-up or clinical follow-up alone. Analyses were by intention to treat. FINDINGS: Four patients (one stent group, three angioplasty group) were excluded from analysis since no lesion was found. At 6 months, a primary clinical endpoint had occurred in 53 (12.8%) of 413 patients in the stent group and 79 (19.3%) of 410 in the angioplasty group (p=0.013). This significant difference in clinical outcome was maintained at 12 months. In the subgroup assigned angiographic follow-up, the mean minimum lumen diameter was greater in the stent group than in the balloon-angioplasty group, (1.89 [SD 0.65] vs 1.66 [0.57] mm, p=0.0002), which corresponds to restenosis rates (diameter stenosis > or =50%) of 16% and 31% (p=0.0008). In the group assigned clinical follow-up alone, event-free survival rate at 12 months was higher in the stent group than the balloon-angioplasty group (0.89 vs 0.79, p=0.004) at a cost of an additional 2085 Dutch guilders (US$1020) per patient. INTERPRETATION: Over 12-month follow-up, a strategy of elective stenting with heparin-coated stents is more effective but also more costly than balloon angioplasty.

Adult↗
PubMed1998

Advantage of stents in the most proximal left anterior descending coronary artery.

OBJECTIVES: Balloon angioplasty of the proximal left anterior descending artery is associated with a high rate of restenosis. We hypothesized that the significant reduction in restenosis rates demonstrated by stent implantation in the coronary arteries in general would be especially prominent in the most proximal left anterior descending coronary artery. METHODS: We reviewed 65 consecutive patients in whom stents were placed in the most proximal left anterior descending artery between March 1990 and July 1995 and compared them with 56 consecutive patients with angioplasty. Minimum luminal diameter was measured angiographically before, after, and 6 months after the intervention. We compared the change in minimum luminal diameter and restenosis rate between the patients with stents and the patients with angioplasty to clarify the response of this important artery to these different procedures. RESULTS: There was 6-month angiographic follow-up of the treated lesion in 99% of the patients. The postprocedure minimum luminal diameter, acute gain, and minimum luminal diameter at follow-up were greater in arteries treated with stents than in those treated with balloons. Of importance, late loss was not significantly different between the two groups after treatment at this site. Thus the restenosis rate after angioplasty was 52% compared with 20% after stent implantation (p < 0.001). CONCLUSIONS: Stent implantation in the most proximal left anterior descending artery is associated with an even greater reduction in restenosis rate than implantations elsewhere in the coronary arteries. This enhanced reduction in restenosis appears to be due to an unusually large amount of late loss after angioplasty at this site.

Angioplasty, Balloon↗
PubMed1998

Risk factors of stroke after percutaneous transluminal coronary angioplasty.

Objective: to determine possible risk factors of a stroke after percutaneous transluminal coronary angioplasty (PTCA). Design: this is a retrospective evaluation of a consecutive group of 4088 patients undergoing PTCA between 1988 and 1995. We have studied the incidence, clinical characteristics, risk factors, and outcome. Results: seven patients, six males and one female (0.17%) developed a stroke after this procedure. In comparison with the control group, the stroke group did not differ regarding age or gender. The existence of a stroke (six located in the brain, and one in the spinal cord), represented 1.24% of all complications (P < 0.001), and 5% of all deaths (P < 0.01) of PTCA. Three patients developed TIA, two patients developed hemorrhagic strokes (in which they received previous thrombolytic therapy), and the other two patients suffered from an ischemic stroke. The statistically significant risk factors of a stroke after PTCA included: intracoronary thrombolytic therapy (P < 0.01), hypercholesterolemia (P < 0.001) and a prior PTCA (P < 0.05). Conclusions: although these procedural complications are infrequent, they are usually serious and important risk factors which could be identified prior to the procedure. These risk factors would allow identification of patients who are prone to a stroke after PTCA. Intracranial hemorrhage occurred only after thrombolytic therapy, and the factors related to hemorrhagic strokes were probably different from those predisposed to ischemic strokes and TIA. Copyright 1998 Lippincott Williams & Wilkins

Journal Article↗
PubMed1998

Clinical and Angiographic Results with the Multi-Link Stent Implanted under Intravascular Ultrasound Guidance (West-2 Study).

In view of the side effects of ticlopidine, stenting with the sole use of aspirin as post-stent treatment, has been attempted under the guidance of intravascular imaging to guarantee the optimization of the deployment. It was also hypothesized that optimal stenting under IVUS guidance would subsequently reduce the restenosis rate. With these aims the WEST-2 trial using the ACS MULTI-LINK stent was designed. This stent is composed of multiple corrugated rings connected to multiple links Ñ a design that combines radial strength, flexibility and conformability. In WEST-2, between February 1996 and August 1996, 18 centers enrolled 165 patients with stable or stabilized unstable angina and a single de novo lesion in vessel sizes ³ 2.75 mm. Optimal stenting was assessed using predefined QCA (DS% post-stent ³ 15% and stent/artery ratio ³ 1) and IVUS criteria. Patients fulfilling all criteria were treated with aspirin alone. MACE (death, MI, target lesion revascularization) as well as the restenosis rate were assessed at 6 months. In view of the results it may be concluded that the use of aspirin alone as post-stent treatment is safe when preset IVUS criteria are achieved. The target lesion revascularization rate, the restenosis percentage and the incidence of MACE encountered in this registry are among the lowest observed so far.

Journal Article↗
PubMed1997

Contemporary percutaneous treatment of unprotected left main coronary stenoses: initial results from a multicenter registry analysis 1994-1996.

BACKGROUND: Coronary artery bypass surgery (CABG) has been considered the therapy of choice for patients with unprotected left main (ULMT) coronary stenoses. Selected single-center reports suggest that the results of percutaneous intervention may now approach those of CABG. METHODS AND RESULTS: To assess the results of percutaneous ULMT treatment from a wide variety of experienced interventional centers, we requested data on consecutive patients treated after January 1, 1994, from 25 centers. One hundred seven patients were identified who were treated either electively (n=91) or for acute myocardial infarction (n=16). Of patients treated electively, 25% were considered inoperable, and 27% were considered high risk for bypass surgery. Primary treatment included stents (50%), directional atherectomy (24%), and balloon angioplasty (20%). Follow-up was 98.8% complete at 15+/-8 months. Results varied considerably, depending on presentation and treatment. For patients with acute myocardial infarction, technical success was achieved in 75%, and survival to hospital discharge was 31%. For elective patients, technical success was achieved in 98.9%, and in-hospital survival was strongly correlated with left ventricular ejection fraction (P=.003). Longer-term event (death, infarction, or bypass surgery) -free survival was correlated with ejection fraction (P<.001) and was inversely related to presentation with progressive or rest angina (P<.001). Surgical candidates with ejection fractions > or = 40% had an in-hospital survival of 98% and a 9-month event-free survival of 86+/-5%, whereas patients with ejection fractions < 40% had 67% and 22+/-12% in-hospital and 9-month event-free survivals, respectively. Nine hospital survivors (10.6%) experienced cardiac death within 6 months of hospital discharge. CONCLUSIONS: While results for selected patients appear promising, until early post-hospital discharge cardiac death can be better understood and minimized, percutaneous revascularization of ULMT stenosis should not be considered an alternative to bypass surgery for most patients. When percutaneous revascularization of ULMT is required, directional atherectomy and stenting appear to be the preferred techniques, and follow-up angiography 6 to 8 weeks after treatment is probably advisable.

Aged↗
PubMed1997

Effect of nadroparin, a low-molecular-weight heparin, on clinical and angiographic restenosis after coronary balloon angioplasty: the FACT study. Fraxiparine Angioplastie Coronaire Transluminale.

BACKGROUND: Experimental studies suggest that the antiproliferative effect of heparin after arterial injury is maximized by pretreatment. No previous studies of restenosis have used a pretreatment strategy. We designed this study to determine whether treatment with nadroparin, a low-molecular-weight heparin, started 3 days before the procedure and continued for 3 months, affected angiographic restenosis or clinical outcome after coronary angioplasty. METHODS AND RESULTS: In a prospective multicenter, double-blind, randomized trial, elective coronary angioplasty was performed on 354 patients who were treated with daily subcutaneous nadroparin (0.6 mL of 10,250 anti-Xa IU/mL) or placebo injections started 3 days before angioplasty and continued for 3 months. Angiography was performed just before and immediately after angioplasty and at follow-up. The primary study end point was angiographic restenosis, assessed by quantitative coronary angiography 3 months after balloon angioplasty. Clinical follow-up was continued up to 6 months. Clinical and procedural variables and the occurrence of periprocedural complications did not differ between groups. At angiographic follow-up, the mean minimal lumen diameter and the mean residual stenosis in the nadroparin group (1.37+/-0.66 mm, 51.9+/-21.0%) did not differ from the corresponding values in the control group (1.48+/-0.59 mm, 48.8+/-18.9%). Combined major cardiac-related clinical events (death, myocardial infarction, target lesion revascularization) did not differ between groups (30.3% versus 29.6%). CONCLUSIONS: Pretreatment with the low-molecular-weight heparin nadroparin continued for 3 months after balloon angioplasty had no beneficial effect on angiographic restenosis or on adverse clinical outcomes.

Adolescent↗