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.