First experience with hybrid percutaneous transmyocardial laser revascularization and angioplasty in patients with lesions at high risk for restenosis: Results of a phase 1 feasibility study

Background Prior studies have suggested that percutaneous transmyocardial l aser 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 ad junctive 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 some myocardial territory as PCI is able to ameliorate symptomatic recurrence from restenosis. Results After successful and uncomplicated PCI in 26 patients with class II I-IV angina and lesion(s) at high risk For restenosis, PTMR was performed i n the same myocardial territories subtended by the treated vessel(s). Major periprocedural adverse events (death, Q-wave myocardial infarction, and by pass surgery) occurred in 3 (11.5%) patients, as the result of subacute ves sel closure in 2 patients, and tamponade in the third. Cumulative 6-month m ortality rate was 19.2%, including 2 late deaths between 3 and 4 months aft er discharge (1 death caused by late stent closure and I 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 addit ional 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 ris k for restenosis, recently created PTMR channels are not protective against severe ischemia caused by acute vessel closure and that late symptomatic r estenosis after PCI may still frequently occur despite PTMR in the some reg ion.