Transmyocardial laser revascularisation in patients with refractory angina: a randomised controlled trial

Schofield, P. M.; Sharples, Linda D.; Caine, N; Burns, Sharon M; Tait, Sue; Wistow, Trevor; Buxton, Martin; Wallwork, J.

doi:10.1016/s0140-6736(98)11478-2

Cited by 335 publications

(181 citation statements)

References 18 publications

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“…Although the size of this initial cohort did not permit the changes observed in exercise testing to reach statistical significance, the increase in treadmill time after VEGF2 GTx (91.8 seconds) far exceeded that observed for control subjects (3.9 seconds) and was similar to or in excess of what has been previously described for patients receiving laser myocardial revascularization or continued medical therapy in 5 contemporary controlled studies. [21][22][23][24][25] The possibility that improvement in symptomatic status documented in the current and previous trials of myocardial VEGF2 GTx constitutes evidence of bioactivity is further supported by objective evidence in these trials of enhanced myocardial perfusion. In patients undergoing intraoperative, direct myocardial injection of VEGF naked DNA, for example, stress SPECT Tc 99m sestamibi myocardial imaging disclosed that mean perfusion-defect scores for both stress and rest images were significantly decreased (ie, improved) at day 60.…”

Section: Discussionmentioning

confidence: 75%

Phase 1/2 Placebo-Controlled, Double-Blind, Dose-Escalating Trial of Myocardial Vascular Endothelial Growth Factor 2 Gene Transfer by Catheter Delivery in Patients With Chronic Myocardial Ischemia

et al. 2002

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Background — This phase 1/2 study investigated the safety of percutaneous catheter-based gene transfer of naked plasmid DNA encoding for vascular endothelial growth factor 2 (phVEGF2) to left ventricular (LV) myocardium in a prospective, randomized, double-blind, placebo-controlled, dose-escalating study of inoperable patients with class III or IV angina. Methods and Results — A steerable deflectable 8F catheter with a 27-gauge needle at its distal tip was advanced percutaneously to the endocardial surface of the LV in 19 patients (age, 61±2 years) with chronic myocardial ischemia who were not candidates for conventional revascularization. Patients were randomized in a double-blind fashion to receive 6 injections (total volume, 6.0 mL) of placebo or phVEGF2 in doses of 200 μg (n=9), 800 μg (n=9), or 2000 μg (n=1) guided by LV electromechanical (NOGA) mapping with a gene-to-placebo ratio of 2:1. A total of 114 LV injections were delivered and caused no hemodynamic alterations, sustained ventricular arrhythmias, ECG evidence of infarction, or ventricular perforation. End-point analysis at 12 weeks disclosed a statistically significant improvement in Canadian Cardiovascular Society (CCS) angina class in phVEGF2-treated versus placebo-treated patients (−1.3 versus −0.1, P =0.04). Remaining efficacy end points—including change in exercise duration (91.8 versus 3.9 seconds), functional improvement by ≥2 CCS classes (9 of 12 versus 1 of 6), and Seattle Angina Questionnaire data—all showed strong trends favoring efficacy of phVEGF2 versus placebo treatment. Conclusions — This phase 1/2, double-blind, randomized trial provides preliminary data that support safety of phVEGF2 catheter-mediated myocardial gene transfer. The statistically significant reduction in anginal class and strong positive trends for remaining end points suggest that a larger phase 2/3 trial is warranted.

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Section: Discussionmentioning

confidence: 75%

Phase 1/2 Placebo-Controlled, Double-Blind, Dose-Escalating Trial of Myocardial Vascular Endothelial Growth Factor 2 Gene Transfer by Catheter Delivery in Patients With Chronic Myocardial Ischemia

et al. 2002

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“…Although the results of these studies appear promising, there is still a paucity of data on the intermediateand long-term benefit of these devices. [42][43][44][45][46][47][48] The goal in both approaches is to create a series of transmural endomyocardial channels to improve myocardial revascularization. Percutaneous TMR technology has not been approved by the Food and Drug Administration and should therefore be considered an experimental therapy.…”

Section: A Spinal Cord Stimulationmentioning

confidence: 99%

“…43,44, 47 Despite the apparent benefit in decreasing anginal symptoms, no definite benefit has been demonstrated in terms of increasing myocardial perfusion. 43,46,47 There are currently no published studies to document the long-term efficacy of surgical TMR. Nonetheless, this technique appears to provide symptomatic relief for end-stage chronic angina in the short term.…”

Section: A Spinal Cord Stimulationmentioning

confidence: 99%

ACC/AHA 2002 Guideline Update for the Management of Patients With Chronic Stable Angina—Summary Article

Abrams¹,

Chatterjee²,

Daley³

et al. 2003

Circulation

609

271

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“…[2][3][4][5][6][7] Although the mechanism for their putative benefit is controversial, these surgical and percutaneous laser procedures are widely believed to create clinical benefit through angiogenesis at the treatment sites. 8 A more direct approach for angiogenesis has relied on the delivery of genes encoded for angiogenic and vasculogenic growth factors into ischemic myocardium.…”

Section: Discussionmentioning

confidence: 99%

Percutaneous In Situ Coronary Venous Arterialization

et al. 2001

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Abstract-Diffuse coronary artery disease is frequently untreatable by coronary artery bypass or angioplasty. Many such "no-option" patients have been subjects for trials of angiogenesis using growth factor manipulation or laser injury. We think these novel revascularization strategies are limited by insufficient inflow to putative areas of new microvasculature and thus seek a more mechanical solution. We report the use of a catheter-based system for arterializing the adjacent anterior cardiac vein in a patient with chronic total occlusion of the left anterior descending coronary artery. A composite catheter system (phased-array ultrasound imaging system mounted on a catheter with extendable nitinol needle) was used to deliver an exchange-length intracoronary guidewire from the proximal left anterior descending coronary artery into the parallel anterior interventricular vein. Using standard angioplasty techniques, a fistula was then constructed from the proximal artery to the coronary vein using a self-expanding connector. The proximal vein was blocked with a novel self-expanding "blocker," thus precluding "steal" through the coronary sinus and forcing retroperfusion of the anterior wall. The procedure was completed without complication, and a follow-up angiogram at 3 months confirmed continued patency of the arteriovenous connection. This patient, who had severe angina before the procedure, has been asymptomatic for 12 months. Percutaneous in situ venous arterialization may be an effective therapy for diffuse, "untreatable" coronary disease by supplying a robust inflow of arterialized blood via retroperfusion to severely ischemic myocardium. W ith the combination of coronary artery bypass surgery and percutaneous coronary interventions, many patients with symptomatic coronary insufficiency can be effectively revascularized. Each year in the United States alone, nearly 1 million individuals undergo a percutaneous catheterbased intervention, with intracoronary stents used in most. An additional half million Americans have their coronary disease treated by aortocoronary surgical bypass.Despite the successful and widespread application of these revascularization procedures, a large number of patients are not good candidates for either angioplasty or surgery. These "no-option" patients frequently have diffuse coronary disease without a discrete target for angioplasty, stenting, or surgical bypass. It has been estimated that Ͼ100 000 patients each year may fall beneath the no-option rubric. 1 Many of these patients have recently been investigational subjects in trials focused on angiogenesis by vascular growth factor infusions or laser injury.We suspect that gene therapy and laser revascularization strategies may have a fundamental flaw: the creation of new blood vessels in ischemic myocardial tissue requires significant arterial inflow, which is not obviously enhanced by these techniques. Therefore, we sought a novel percutaneous revascularization approach with the potential to provide robust arterial inflow to a sev...

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Transmyocardial laser revascularisation in patients with refractory angina: a randomised controlled trial

Cited by 335 publications

References 18 publications

Phase 1/2 Placebo-Controlled, Double-Blind, Dose-Escalating Trial of Myocardial Vascular Endothelial Growth Factor 2 Gene Transfer by Catheter Delivery in Patients With Chronic Myocardial Ischemia

Phase 1/2 Placebo-Controlled, Double-Blind, Dose-Escalating Trial of Myocardial Vascular Endothelial Growth Factor 2 Gene Transfer by Catheter Delivery in Patients With Chronic Myocardial Ischemia

ACC/AHA 2002 Guideline Update for the Management of Patients With Chronic Stable Angina—Summary Article

Percutaneous In Situ Coronary Venous Arterialization

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